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Real-world analysis of combined administration of elemene emulsion injection in patients with liver cancer SU Xinxin, ZHAO Xiaoxiao, XIE Yanming 2022, 19(9): 929-934.  DOI: 10.19803/j.1672-8629.2022.09.01 Abstract ( 157 )   PDF (2497KB) ( 129 )   Objective To analyze the way in which elemene emulsion injection is used in combination with other drugs among liver cancer patients in the real world. Methods Based on the hospital information system (HIS) database of 21 hospitals in China, 441 patients with liver cancer who used elemene emulsion injection were described and analyzed. By using the Apriori algorithm to establish a model and clementine12.0 to carry out association analysis, the characteristics of liver cancer populations and combined use with elemene emulsion injection were analyzed. Results 760 cases of malignant tumors of the liver were diagnosed based on Western medicine, accounting for 22.66% of the total. No cases were diagnosed via TCM. 102 patients (23.13%) were diagnosed at the Tumor Diagnosis and Treatment Center. More female patients with liver cancer were treated with elemene emulsion injection than female ones. There were 206 patients (46.71%) aged 46 to 65, with an average of 58.39 years. The median length of hospital stay was 24 days and the percentage of patients who had been hospitalized for 28 days was the highest (40.36%). 104 patients were critically ill, 100 of whom (22.68% of the total) were critically ill for one day or longer. 269 patients were seriously ill for a median 11 days. The administration route was mostly intravenous drip. The number of patients whose single dose was 200 mg or above was 390 (99.49%). Drugs that were often used in combination with elemene emulsion injection were vitamin, dexamethasone, glutathione, Kangai injection and amino acid as well as blood substitutes and infusions, antitumor drugs, immune stimulants, antibacterial drugs and mineral supplement. The results of elemene emulsion injection combinations were consistent with the results of analysis of drug properties based on complex network analysis. The major reason elemene emulsion injection was used in combination with other drugs was to help combat tumors and balance the basic needs of the body. Conclusion Based on the analysis of properties of elemene emulsion injection and of liver cancer patients,via the complex network, it has been found that elemene emulsion injection is generally used in combination with vitamins, dexamethasone, glutathione, Kangai injection and amino acids. This study is expected to provide evidence for clinical drug use and in-depth analysis. References | Related Articles | Metrics

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Clinical applications of Ciwujia injection in elderly patients in the real world HUANG Yanli, XIE Yanming, WANG Lianxin, SUN Linxi, LIU Huan, ZHUANG Yunni 2022, 19(9): 935-939.  DOI: 10.19803/j.1672-8629.2022.09.02 Abstract ( 171 )   PDF (1738KB) ( 101 )   Objective To analyze the clinical applications of Ciwujia injection in elderly patients based on the real-world electronic medical database, and to provide reference for rational clinical medication. Methods In this study, association rules in data mining methods were used to conduct a retrospective analysis of electronic medical data collected by the information system of 24 big hospitals in China from January 1, 2004 to December 31, 2019. The basic information, diagnosis and usage of Chinese and western medicine related to inpatients aged 65 and older who had used Ciwujia injection were recorded. The Apriori algorithm was used to analyze how drugs were used in combination. Results A total of 6 561 elderly patients who had used Ciwujia injection were collected, most of whom were between 65 and 75 years old. There were fewer male patients than female ones. According to Western medicine, most of the patients were diagnosed with hypertension, cerebral infarction and coronary heart disease. Ciwujia injection was commonly used in combination with acetyl salicylic acid, isosorbide mononitrate and nifedipine. Drugs that were usually used in combination with Ciwujia injection were intended to protect blood vessels and the heart and block calcium channels. Conclusion The way Ciwujia injection is used among elder patients in the real world conforms to clinical diagnosis and drug instructions. The retrospective study shows Ciwujia injection is effective for elderly patients. Clinicians are advised to be cautious with TCM diagnosis and evidence-based medicine and prescribe Ciwujia injection in strict accordance with the guidelines and instructions. References | Related Articles | Metrics

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Clinical applications of elemene emulsion injection in the treatment of lung cancer in the real world based on association rules ZHAO Xiaoxiao, XIE Yanming, WANG Lianxin 2022, 19(9): 940-946.  DOI: 10.19803/j.1672-8629.2022.09.03 Abstract ( 89 )   PDF (2599KB) ( 76 )   Objective To explore the ways in which elemene emulsion injection is used in the treatment of lung cancer in the real world and to provide reference for standardized use of elemene emulsion injection among lung cancer patients. Methods In this study, the electronic cases of 21 hospitals collected between January 1, 2003 and July 31, 2019 were retrieved from the multi-dimensional data warehouse of electronic cases established by the Institute of Traditional Chinese Medicine, Chinese Academy of Chinese Medical Sciences. Lung cancer patients who had used this injection were screened from the database. Basic information about these patients, the usage of elemene emulsion injection and concomitant medications were analyzed, and the number of patients with suspected adverse reactions (including patients with suspected liver and kidney function damage and suspected allergic reactions) was calculated. In addition, the discharge records of patients who were regarded as “cured” and “improved”, were retrieved and the complex network of drugs was analyzed using the Louvain clustering method to identify the core drugs. Results A total of 1 856 patients with lung cancer who had received elemene emulsion injection were collected, including 1 149 (61.91%) males and 686 (36.96%) females. There were 851 patients aged 46 to 65, accounting for 45.85% of the total. The routes of administration were basically consistent with the instructions, but there were sub-standard prescriptions. There were 12 cases of suspected liver function damage, 8 cases of suspected renal function damage, and 10 cases of suspected allergic reactions. Elemene emulsion injection was often used in combination with such Western medicines as heparin, lidocaine, potassium chloride, vitamins, dexamethasone and thymosin and with other traditional Chinese medicine preparations. The results were further verified by association rule analysis. Conclusion The combined medications with elemene emulsion injection in the treatment of lung cancer are intended to combat tumors and bacteria, regulate immunity, provide nutritional support and improve lung function. Most of the clinical applications comply with the instructions, but there are some cases of off-label use. More studies are needed on the correlations between adverse drug reactions and the use of this injection. References | Related Articles | Metrics

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Clinical characteristics and combined medications of elemene emulsion injection in the treatment of brain tumors TAN Chang, ZHAO Xiaoxiao, ZHI Yingjie, WANG Lianxin, XIE Yanming 2022, 19(9): 947-953.  DOI: 10.19803/j.1672-8629.2022.09.04 Abstract ( 76 )   PDF (1979KB) ( 75 )   Objective To investigate the clinical characteristics and combined drug use of elemene emulsion injection in the treatment of brain tumors so as to help ensure the safety and efficacy of related medications. Methods The clinical information about 502 patients with brain tumors treated with elemene emulsion injection was collected from the database of the hospital information system (HIS) of twenty-one hospitals between January 1, 2003 and July 31, 2019. Statistical methods were used to analyze the basic information on these patients, such as gender, age, admissions, condition, length of hospital stay, diagnosis by TCM and western medicine, and combined medications. The complex network of combined medications was analyzed using the Louvain clustering method to explore how elemene emulsion injection was used in combination with other traditional Chinese medicines or Western medicines among brain tumor patients who had been cured or improved. Results The average age of these patients was 50.4, and there were almost as many male patients as female ones. Most of the hospitalizations were related to radiotherapy centers. Elemene emulsion injection was often used together with mannitol, heparins, dexamethasone, thymosin, potassium chloride, vitamins, compound matrine injection, lidocaine and glycerol. Conclusion There are some regularities in the way elemene emulsion injection is used in combination with other drugs. This drug is effective for brain tumors and is unlikely to increase the chance of adverse reactions. References | Related Articles | Metrics

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Differences of chemical compounds between Glycyrrhiza uralensis Fisch. and Glycyrrhiza glabra L. by UHPLC-Q-TOF-MS/MS CHEN Jia, NIE Lixing, HU Xiaoru, LIU Wei, WEI Feng, MA Shuangcheng 2022, 19(9): 954-958.  DOI: 10.19803/j.1672-8629.2022.09.05 Abstract ( 80 )   PDF (1753KB) ( 70 )   Objective To identify the differential chemical compounds of Glycyrrhiza uralensis Fisch. and Glycyrrhiza glabra L., so as to provide reference for quality evaluation of licorice. Methods Ultra performance liquid chromatography-quadrupole time-of-flight mass spectrometry (UHPLC-Q-TOF-MS/MS) technology was used to detect the composition of Glycyrrhiza uralensis Fisch. and Glycyrrhiza glabra L.. Using data analysis software, principal component analysis (PCA) and orthogonal partial least squares analysis (OPLS-DA) were conducted to analyze the collected data in order to reveal the difference in compounds between Glycyrrhiza uralensis Fisch. and Glycyrrhiza glabra L.. Ultra performance liquid chromatography triple quadrupole mass spectrometry (UHPLC-TQ-MS/MS) was conducted to further verify the accuracy of detection of the differential compounds. Results Eleven compounds such as glabridin, neoliquiritin and glabrol were identified as the differential chemical components of Glycyrrhiza uralensis Fisch. and Glycyrrhiza glabra L.. Conclusion There are obvious differences in some chemical compounds between Glycyrrhiza uralensis Fisch. and Glycyrrhiza glabra L., which can be used for reference in the formulation of quality standards for licorice. References | Related Articles | Metrics

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Determination of inositol in oral solution B12 lysine inositol by HPLC-CAD QIAN Zhongyi, GE Weiwei, QIU Yajing, XU Mingzhe 2022, 19(9): 959-961.  DOI: 10.19803/j.1672-8629.2022.09.06 Abstract ( 71 )   PDF (1785KB) ( 65 )   Objective To establish an HPLC-CAD method for the determination of inositol in oral solution B12. Methods The Agilent Zorbax NH2 (4.6 mm×250 mm, 5 μm) column was used. The mobile phase consisted of acetonitrile-0.5% ethanol solution (90:10), and the flow rate was 1.0 mL·min-1. The charged aerosol detector (CAD） was used at an atomization temperature of 55℃, a power rate of 2.0, a sampling frequency of 5 Hz with a filtration constant of 10 s. Results Baseline separation was achieved between inositol, sucrose and other peaks. When the concentrations of inositol ranged from 0.090 8 to 1.815 mL·min-1, the linear equation was Y=331.85X -28.812, the detection limit was 3 μg·mL-1, with a quantitative limit of 13 μg·mL-1. The recoveries of 80%, 100% and 120% inositol reference substances were 99.4%, 101.2% and 101.6%, respectively. Conclusion This method is highly specific, sensitive and user-friendly, which can be used for the determination of inositol content in oral solution B12. References | Related Articles | Metrics

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Interventional effect and safety of modified Shaoganfuzi decoction with different doses in CIA rats LI Yuan, BAI Zhiyi, WANG Haiyu, QIAN Tangliang, WANG Ruoyi, KANG Tianlun, DU Mengmeng, BAI Xuejiao, LIU Xiaoping, HOU Xiujuan 2022, 19(9): 962-966.  DOI: 10.19803/j.1672-8629.2022.09.07 Abstract ( 67 )   PDF (2377KB) ( 67 )   Objective To investigate the effects of different doses of modified Shaoganfuzi Decoction on inflammatory cytokines and safety indexes in rats with collagen-induced arthritis, and to study its efficacy and safety. Methods Thirty-six Wistar rats were randomly divided into 6 groups according to their body weight: normal group, CIA model group, control group, and traditional Chinese medicine group with low, medium and high dose groups, with 6 rats in each group. The normal group was fed routinely, after the CIA cold syndrome model was replicated in the other groups, the model group was gavaged with normal saline, the control group was gavaged with Tripterygium wilfordii polyglycosides (6.25 mg·kg-1), and the traditional Chinese medicine group was given low, medium and high doses of modified Shaoganfuzi decoction. (0.625 g·mL-1, 1.25 g·mL-1, 2.5 g·mL-1) were intragastrically administered and intervened for 4 weeks. The joint inflammation index score, the pathological changes of the ankle joint synovium and the peripheral blood inflammatory cytokine IL-6 were measured in each group. levels, and cardiac (troponin), liver (CK18, HMGB1, GLDH), kidney (NGAL, cystatin C) early warning and routine safety indicators. Results After 4 weeks of intervention, the AI scores of the middle and high dose groups of modifined Shaoganfuzi Decoction were significantly lower than those of the CIA model group (P<0.05). Stenosis, synovial cell hyperplasia, lymphocyte infiltration and articular surface damage were alleviated; serum IL-6 levels in the middle and high doses of modifined Shaoganfuzi decoction groups were lower than those in the CIA model group (P<0.05); peripheral blood biochemical changes of rats in each group There was no significant difference in the indexes and the levels of CK18, HMGB1 and cystatin C between the groups; the levels of GLDH in the control group and the low, middle and high doses of traditional Chinese medicine groups were lower than those in the normal group (P<0.05); the levels of NGAL in the control group were higher than those in the normal group (P<0.05); the levels of troponin in the control group and low-dose group were lower than those in the normal group (P<0.05). Conclusion Modified Shaoganfuzi Decoction has no toxic effects on the heart, liver and kidney, and can reduce joint swelling and IL-6 level, which provides the basis for subsequent research and clinical application. References | Related Articles | Metrics

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Potential mechanism of Ginkgo biloba in the treatment of Alzheimer's disease based on network pharmacology LI Yuanyuan, LIU Shengwei, REN Zhongyang, DING Ling, LIU Jie, LIAO Yuan 2022, 19(9): 967-972.  DOI: 10.19803/j.1672-8629.2022.09.08 Abstract ( 103 )   PDF (2828KB) ( 109 )   Objective To explore the potential mechanism of Ginkgo biloba against Alzheimer’s disease (AD) using the network pharmacology method. Methods Via the Traditional Chinese Medicine System Pharmacology Database and Analysis Platform (TCMSP), highly active chemical components of Ginkgo biloba were screened to predict potential targets. GeneCards, OMIM, CTD, TTD and Drugbank databases were searched for AD-related targets. Based on the Uniprot database, the potential targets of the active ingredients were converted while AD-related targets were crossed to obtain the AD-related targets of Ginkgo biloba. The STRING11.0 database was used to construct the target protein interaction network diagram. The key genes were screened, and the “Clue GO” plug-in in the software Cytoscape 3.8.2 was used for GO function enrichment analysis and KEGG signal pathway analysis of AD-related targets. Results A total of 32 effective chemical constituents of Ginkgo biloba leaves, 144 effective constituent targets, 470 AD-related targets, and 51 potential targets of Ginkgo biloba against AD were detected. Such active ingredients as β-sitosterol, stigmasterol and dibutyl phthalate mainly acted on such key targets as ALB, PTGS2, ESR1and BCL-2 by exerting anti-inflammatory, anti-oxidation and anti-apoptosis effects or by activating blood through the GABA synaptic signaling pathway, calcium signaling pathway or PI3K-Akt signaling pathway. Conclusion Based on the multi-component, multi-target and multi-pathway properties of traditional Chinese medicine, the potential mechanism of Ginkgo biloba against Alzheimer’s disease has been explored, which is expected to facilitate research on clinical application of Ginkgo biloba in the treatment of Alzheimer’s disease. References | Related Articles | Metrics

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Study on genotoxicity of Yanhuning for injection CUI Miao, WANG Tao, SONG Yanping, YANG Yanping, ZHOU Xin 2022, 19(9): 973-976.  DOI: 10.19803/j.1672-8629.2022.09.09 Abstract ( 112 )   PDF (1693KB) ( 91 )   Objective To evaluate the genotoxicity of Yanhuning for injection and to provide data for clinical safety medication. Methods Genotoxicity of Yanhuning for injection was studied using standard combination [bacterial reverse mutation test (Ames), In vitro chromosomal aberration test, mouse bone marrow erythrocyte micronucleus test]. In Ames test, there were five dose groups respectively as follows: 50, 158, 500, 1 581 5 000 μg per dish. In vitro chromosome aberration test, there were three dose groups respectively as follows: 0.125, 0.250,0.5 mg·mL-1; In mouse bone marrow erythrocyte micronucleus test, there were three dose groups respectively as follows: 100, 200, and 400 mg·kg-1, for 2 days, once per day. Results In Ames test, both under metabolic and non-metabolic activation conditions, Yanhuning for injection had no significant increase in the number of colonies of histidine auxotrophic Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 strains. In vitro CHL cell chromosome aberration test, both under metabolic and non-metabolic activation conditions, Yanhuning for injection had no significantly increase in the number of chromosomal aberrations. In mouse bone marrow erythrocyte micronucleus test, Yanhuning for injection had no significantly increase in the number of micronucleus in bone marrow erythrocyte. Conclusion No significant genetic toxicity was observed for Yanhuning for injection. References | Related Articles | Metrics

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Effects of pyrazinamide on lipid peroxidation in L02 cells LIU Mengxing, LIU Yuan, YANG Min, LUO Ji, YU Mingli, WANG Junlong, CHEN Jie 2022, 19(9): 977-981.  DOI: 10.19803/j.1672-8629.2022.09.10 Abstract ( 56 )   PDF (1708KB) ( 61 )   Objective To study the lipid peroxidation of human normal hepatocyte L02 induced by pyrazinamide (PZA) and to explore the related mechanism of liver injury. Methods L02 cells were treated with different concentrations of PZA solution and N-acetyl-L-cysteine (NAC). The effects of PZA and NAC on L02 cells were detected by MTT, while the level of reactive oxygen species (ROS), the content of malondialdehyde (MDA) and the activity of superoxide dismutase (SOD) in L02 cells were detected. Results MTT results showed that the 50% inhibitory concentration (IC50) of L02 cells treated with PZA for 24, 48 and 72 h was 1 753.36, 1 344.32 and 1 367.80 µg·mL-1, respectively, and the inhibition rate was concentration- dependent, but the inhibition rate of 3 125 µg·mL-1 PZA was time-dependent. Compared with the control group, the intracellular ROS content of the 125, 625 µg·mL-1 PZA group was significantly higher than that of the control group. The intracellular MDA content increased significantly in 625 and 3 125 µg·mL-1 PZA groups, but the intracellular SOD activity decreased significantly in 125,3 125 µg· µg·mL-1 PZA groups. Compared with PZA alone, the ROS content decreased in 10 mmol·L-1 NAC+125 and 625 µg· µg·mL-1 PZA groups, MDA content decreased significantly in 10 mmol·L-1 NAC+625 and 3 125 µg·mL-1 PZA groups, and SOD activity increased in 10 mmol·L-1 NAC+625 and 3 125 µg·mL-1 PZA groups. Conclusion PZA can reduce the ability of the antioxidant system of L02 cells, induce lipid peroxidation in L02 cells, lead to apoptosis of L02 cells and damage hepatocytes. The combined use of NAC can reduce the severity of liver injury to some extent. References | Related Articles | Metrics

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Determination of 5 saponins in Xuesaitong injection by quantitative analysis of multi-components by single marker WANG Bing, LI Dongmei, WANG Changshun, FENG Yanan, LIU Yongli 2022, 19(9): 982-986.  DOI: 10.19803/j.1672-8629.2022.09.11 Abstract ( 70 )   PDF (1934KB) ( 54 )   Objective To establish a method for simultaneous assay of 5 kinds of saponins in Xuesaitong injection by quantitative analysis of multi-components by single marker (QAMS),and to investigate the factors influencing the correction factors. Methods Ultra high performance liquid chromatography（UPLC）was used,the determination was performed on Waters HSS T3 (2.1 mm×100 mm, 1.7 µm) column with mobile phase consisted of acetonitrile and water gradient elution. The detection wavelength was set at 203nm. Ginsenoside Rg1 was used as control to establish the relative correction factors（RCF）with panax notoginseng R1, ginsenoside Re, Rb1 and Rd. The contents of notoginseng saponin R1, ginsenoside Re, Rb1 and Rd were calculated by using the correction factor, and the contents of these four components were determined by external standard method. The difference between them was compared to verify the accuracy and scientificity of the method. Results There was no obvious difference between the content value calculated by correction factor and the measured value by external standard method. Conclusion It is feasible and accurate to control the quality of Xuesaitong injection with one test and multiple evaluation. References | Related Articles | Metrics

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Descriptions of pharmacovigilance in materia medica works of Sui, Tang and the Five Dynasties JIANG Hao, ZHANG Bing, ZHANG Xiaomeng, LIN Zhijian, LYU Jintao, ZHANG Dan 2022, 19(9): 987-993.  DOI: 10.19803/j.1672-8629.2022.09.12 Abstract ( 150 )   PDF (2028KB) ( 126 )   Objective To summarize ideas about pharmacovigilance documented in representative materia medica works of the Sui, Tang and the Five Dynasties based on ancient beliefs about pharmacovigilance—identification of toxicity, use of toxicity, protection against toxicity and detoxification in order to ensure the transmission of notions of pharmacovigilance related to traditional Chinese medicine. Methods Taking Newly Revised Materia Medica,Materia Medica Supplements,Dietetic Material Medica,Medicinal Properties,Rihuazi Materia Medica and Extrinsic Materia Medica as representative works of materia medica published during the Sui, Tang and the Five Dynasties, descriptions about pharmacovigilance in these books were retrieved for statistical analysis. Results The included masterpieces had a wealth of ideas about and countermeasures against pharmacovigilance, which contributed greatly to the refinement of toxicity classification, establishment and development of systems for food and drug contraindications, identification of sources of medicines, expansion of compatibility contraindications, contraindications among special populations, and detoxification via processing. Conclusion Sui, Tang and the Five Dynasties were important ages when perceptions of pharmacovigilance related to traditional Chinese medicine were fast accumulated. The pharmacovigilance-related theories formulated in this period were comparatively systematic, especially in terms of identification and prevention of toxicity. There were some innovative ideas about the use of toxicity, but the knowledge of detoxification was far from adequate. References | Related Articles | Metrics

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Thoughts on design and quality management of active safety surveillance research of traditional Chinese medicine injections initiated by Marketing Authorization Holder ZHONG Lumiao, DU Juan, DENG Hua, WANG Yafeng, QIU Ping, ZENG Linggui 2022, 19(9): 994-998.  DOI: 10.19803/j.1672-8629.2022.09.13 Abstract ( 187 )   PDF (1641KB) ( 208 )   Objective To provide ideas for MAH to carry out the research design and quality management of active safety monitoring of traditional Chinese medicine injections. Methods It analyzed the characteristics and causes of adverse reactions of traditional Chinese medicine injections, drawing lessons from the current status of active safety surveillance in literature research and the experiences of Spontaneous monitoring, and it put forward suggestions on the research design and quality management of active safety surveillance in MAH. Results The design elements of active safety surveillance included comprehensively investigating policy and product related information, determining the factors related to the target population, collecting comprehensive usage information, setting evaluation indicators to achieve the objectives of active monitoring research, designing standardized and completed data collection tables, and selecting scientific and appropriate data management and analysis methods. The quality management of active surveillance research included establishing a research team with clear rights and responsibilities, setting a standard operating process and strengthening personnel training, selecting an appropriate data management system, and making full use of centralized monitoring technology. Conclusion Active safety surveillance is one of the effective ways to find safety risk signal of traditional Chinese medicine injections, and it also can provide evidence for risk signal review and validation. References | Related Articles | Metrics

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Risks posed by misoprostol tablets used in obstetrics and gynecology LIU Cuili, WU Chen, WANG Tao 2022, 19(9): 999-1001.  DOI: 10.19803/j.1672-8629.2022.09.14 Abstract ( 149 )   PDF (1467KB) ( 166 )   Objective To analyze the risk to safety posed by misoprostol tablets used in obstetrics and gynecology in China in order to provide reference for clinical rational drug use. Methods The individual cases of adverse drug reactions reported in China adverse drug reaction database between January 1, 2015 and October 31, 2019 were analyzed, domestic and foreign literature published from the inception of the database to December 31, 2021 was retrieved, and precautions taken in China were outlined. Results and Conclusion The adverse reactions of misoprostol tablets are generally mild, and most of them do not require special treatment. But more serious adverse reactions are worthy of attention. Medical institutions should use misoprostol tablets strictly in accordance with the instructions and be alert to the serious adverse reactions. Drug manufacturers should make more effort to monitor and evaluate adverse drug reactions of their products, improve the safety information in drug instructions and take the initiative to carry out post-marketing safety studies when necessary. References | Related Articles | Metrics

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Systematic evaluation and Meta-analysis of Danhuang Quyu capsules in the treatment of chronic pelvic inflammatory disease ZHAO Xiaoxiao, LIU Fumei, XI Junyu, SHI Buwen, XIE Yanming, WANG Lianxin 2022, 19(9): 1002-1008.  DOI: 10.19803/j.1672-8629.2022.09.15 Abstract ( 70 )   PDF (2314KB) ( 83 )   Objective To evaluate the efficacy and safety of Danhuang Quyu capsules in the treatment of chronic pelvic inflammatory disease. Methods Eight electronic databases (the Cochrane Library, PubMed, EMBASE, Web of Science, China Biomedical Database Web, China National Knowledge Infrastructure Databases, Chinese Scientific Journal Database, and Wanfang database) were searched for related articles published from inception to August 16, 2021 to retrieve RCTs related to Danhuang Quyu capsules in the treatment of chronic pelvic inflammatory disease. The improved Jadad score was used to assess the quality of literature. The criteria established by Cochrane Handbook 5.3 and RevMan 5.4 software were used for meta-analysis. Results 10 RCTs were included, with a total sample size of 1 411 cases (813 in the experimental group and 598 in the control group). Measures of intervention described in the literature were Danhuang Quyu capsules + conventional antibiotic treatment vs conventional antibiotic treatment, Danhuang Quyu capsules vs proprietary Chinese medicine treatment, and Danhuang Quyu capsules combined with proprietary Chinese medicine treatment vs proprietary Chinese medicine treatment. Meta-analysis showed that the therapeutic effect of Danhuang Quyu capsules was significantly better than in the control group as was evidenced by the disappearance rate of symptoms and signs (RR=1.40, 95%CI [1.13, 1.75], P=0.003), that of pelvic mass (RR=1.55, 95%CI [1.19, 2.03], P=0.001), pelvic mass size (MD=-1.03, 95%CI[-1.29, -0.77], P < 0.000 01) and that of lower abdominal tenderness (RR=1.56, 95%CI[1.18, 2.07], P=0.002) . However, there was no statistically significant difference between Danhuang Quyu capsules combined with conventional antibiotic treatment and treatment with antibiotics alone in the effect of reducing the recurrence rate within one month (RR=1.26, 95%CI [0.95, 1.65],P=0.10). There was no significant difference in the incidence of adverse reactions between the experimental group and the control group. Conclusion Danhuang Quyu capsules alone or combined with the control group are much more effective in mitigating chronic pelvic inflammation than in the control group. Due to the limited amount of the literature, the results of the above research need to be verified by high-quality RCT studies. References | Related Articles | Metrics

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Safety and efficacy of participation of pharmacists in warfarin anticoagulation therapy：a Meta-analysis WEN Dusu, SUN Jianjun, WANG Yi 2022, 19(9): 1009-1014.  DOI: 10.19803/j.1672-8629.2022.09.16 Abstract ( 105 )   PDF (1715KB) ( 113 )   Objective To assess the impact of the pharmacist-managed anticoagulant therapy on clinical outcomes compared with other models. Methods PubMed, Embase and Cochrane Library were searched for related literature published from inception to April 13, 2020. The pharmacist-led anticoagulation model was compared and contrasted with doctor- or nurse-led anticoagulation models. Endpoint events included the percentage of time within the target therapeutic range (TTR), bleeding events, and thrombotic events. Results A total of 23 studies involving 10 772 patients were included. The pharmacist-managed anticoagulation model could significantly reduce total bleeding and the incidence of minor bleeding and thrombosis compared with other models. According to sub-set analysis by types of intervention, the pharmacist-led group could reduce total bleeding and the incidence of minor bleeding and thrombosis more significantly than the physician-led group. Conclusion The pharmacist-managed anticoagulation model is safer and more effective than other anticoagulation models. References | Related Articles | Metrics

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Effects of pioglitazone on plasma adiponectin in patients with type 2 diabetes mellitus: a Meta-analysis MU Sicong, WANG Zhuo, LU Junyang, JI Liwei, LIU Xin 2022, 19(9): 1015-1018.  DOI: 10.19803/j.1672-8629.2022.09.17 Abstract ( 91 )   PDF (1611KB) ( 73 )   Objective To investigate the impact of pioglitazone on plasma adiponectin levels in patients with type 2 diabetes mellitus through meta-analysis. Methods Wanfang, CNKI, PubMed, the Cochrane Library and Embase were systematically searched for randomized controlled trials of pioglitazone in treatment of type 2 diabetes modulating adiponectin from the establishment to April 30, 2021. Literature selection and data extraction were conducted according to the PRISMA criteria. Quality assessment was conducted according to the Cochrane criteria. Data analysis was done with Revman 5.3 and Stata 14.0 software. Results Ten randomized controlled clinical trials were included. The analysis results demonstrated that pioglitazone treatment significantly increased plasma adiponectin levels by 8.65 μg·mL-1 (95% CI, 7.18~10.12 μg·mL-1) compared with placebo. Pioglitazone treatment showed a stronger effect on increasing adiponectin concentrations by 4.92 μg·mL-1 (95% CI, 3.27~6.58 μg·mL-1 ) compared with other oral antidiabetic agents. Conclusion Pioglitazone could increase plasma adiponectin concentrations in patients with type 2 diabetes mellitus compared to placebo or other oral antidiabetic agents. References | Related Articles | Metrics

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Influencing factors of severe anaphylactic reactions of Yanhuning injections in children ZHANG Jingyu, ZHANG Yuanyuan, WANG Jing, MA Bo, LI Wenjuan 2022, 19(9): 1019-1022.  DOI: 10.19803/j.1672-8629.2022.09.18 Abstract ( 139 )   PDF (1575KB) ( 140 )   Objective To investigate the influencing factors of severe anaphylactic reactions (SAR) of Yanhuning injections in children, and to provide reference for clinical rational drug use. Methods A retrospective study was performed. The medical records of 7 320 children who had received Yanhuning injections in two hospitals from October 1, 2017 to October 31, 2020 were collected. SAR patients and non-SAR patients were selected by the diagnostic criteria of SAR. The SAR patients were included into the SAR group (n=57). Propensity score matching was used to match the control group from non-SAR patients at a ratio of 1:4 (n=228). The general data, primary diseases, drug combinations, and usage of Yanhuning injections were compared between the two groups. Univariate analysis and multivariate logistic analysis were used to analyze the factors that affected SARs of Yanhuning injections. Results The incidence of SAR in children who had used Yanhuning injections in our hospital was 0.78% (57/7 320). Univariate analysis showed that there was statistically significant difference between the two groups in the incidence of renal insufficiency, number of combined drugs, rate of overdose, infusion concentrations and ways of pretreatment. More logistic regression analysis showed that a creatinine clearance rate less than 30 mL/min(OR= 2.336, 95% CI: 1.227 to 4.362, P=0.009), more than 3 types of combined drugs (OR= 2.147, 95% CI: 1.189 to 3.878, P= 0.015), and overdose (OR= 3.708, 95%CI: 1.942 to 7.014, P= 0.000) were independent risk factors for SARs induced by Yanhuning injections in children, while pretreatment (OR= 0.473, 95% CI: 0.248 to 0.887, P= 0.043) was a protective factor. Conclusion Renal dysfunction, overdose of drugs, and drug combinations can increase the risk of SAR in children using Yanhuning injections, while tube flushing before and after infusion can reduce the incidence of SAR. References | Related Articles | Metrics

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Analgesia-related risks after thoracoscopic surgery in elderly patients CHU Yanqi, JIANG Yongxian, SHEN Jianghua, XING Xiaoxuan, ZHANG Qingxia, YAN Suying 2022, 19(9): 1023-1026.  DOI: 10.19803/j.1672-8629.2022.09.19 Abstract ( 80 )   PDF (2069KB) ( 65 )   Objective To investigate the management and usage of analgesic pumps after thoracoscopic surgery in the elderly in order to identify the risks and provide reference for postoperative analgesia and interventions by clinical pharmacists. Methods The usage of analgesic pumps after thoracoscopic (partial) lobectomy among elderly patients treated in our hospital between January 1, and October 31, 2020 was retrospectively analyzed. The basic information about these patients, analgesic scores, analgesic methods in different steps of postoperative analgesia, usage of analgesic drugs and adverse reactions were recorded before fishbone diagrams were used to analyze the causes of risks and propose precautions. Results A total of 114 cases were included, whose age averaged (67.64±5.83) years. The types of non-steroidal drugs used in all cases were(2.12±0.64). Cases of combined use of two NSAIDs or more accounted for 85.09% of the total. The average length of parecoxib use was(5.46±2.76) days. There were also cases of overdose of parecoxib and flurbiprofen. During postoperative analgesia, 36 patients (31.58%) developed nausea and vomiting, 5 patients (4.39%) dizziness and 2 (1.75%) pruritus, all of which were mitigated after symptomatic treatment. Brainstorming and fishbone diagram analysis showed that the risks were probably due to the lack of standard handover processes, a multidisciplinary pain management team, intelligent reminders of doctors’ orders and pre-review, and re-organization of analgesic drugs. Conclusion This type of patient needs to stay in different rooms after surgery. During postoperative analgesia, there is a lack of communication between all these links, leading to the high rate of repeated use of non-steroidal drugs and overdose. Hospitals should improve the communication between all the related links and establish a multidisciplinary pain management team and an information-based risk warning system, while clinical pharmacists can innovate the organization of analgesic drugs. References | Related Articles | Metrics

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Effects of sodium valproate on children with epilepsy and determinants of blood concentrations XUN Xiaoqing, PENG Lingling 2022, 19(9): 1027-1029.  DOI: 10.19803/j.1672-8629.2022.09.20 Abstract ( 85 )   PDF (1680KB) ( 88 )   Objective To explore the effect of blood concentration monitoring on children with epilepsy treated with sodium valproate (VPA) and to provide reference for medications. Methods The clinical data on 258 patients with epilepsy treated between Jan 1, 2018 and Dec 12, 2019 was collected and analyzed retrospectively. Blood drug concentrations of VPA, drug efficacy and adverse reactions were recorded. Mutiple regression analysis was used to analyze the influence of various factors on blood drug concentrations. Results Plasma drug concentrations ranged from 50 to 100 μg·mL-1 in 159 cases (61.63%), were below 50 μg·mL-1 in 90 cases (34.88%), and above 100 μg·mL-1 in 9 cases (3.45%). The effective rate was the highest in the > 100 μg·mL-1 group, and the difference was statistically significant compared with the <50 μg·mL-1 group (P=0.025). The incidence of adverse reactions was the highest in the >100 μg·mL-1 group (69.39%), and the difference was statistically significant compared with other groups (P<0.05). Multiple linear regression analysis found that age, dosage forms, doses, and albumin could make statistically significant differences to plasma concentrations of VPA (P<0.05). Conclusion There are considerable individual differences in blood concentrations of VPA, and there are many influencing factors. Monitoring blood concentrations is of great significance for improving clinical efficacy and reducing adverse reactions. References | Related Articles | Metrics

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Logistic regression analysis of influencing factors of adverse drug reaction of glimepiride and their effect on treatment of T2DM YANG Liu, SHI Fenghua, MA Lijuian 2022, 19(9): 1030-1034.  DOI: 10.19803/j.1672-8629.2022.09.21 Abstract ( 92 )   PDF (1645KB) ( 84 )   Objective To analyze the influencing factors of adverse drug reaction (ADR) of glimepiride and their effect on the efficacy of treatment of type 2 diabetes mellitus (T2DM). Methods From June 1, 2018 to June 30, 2020, 123 patients with T2DM admitted to our hospital were prospectively selected and treated with glimepiride. The incidence of ADR was recorded, and these patients were divided into the ADR group and non-ADR group according to the presence or absence of ADR. The baseline data, blood glucose levels [fasting blood glucose (FBG), 2 h postprandial blood glucose (2hBG), hemoglobin A1c (HbA1c)], pancreatic β cell function [homeostasis model assessment of insulin resistance (HOMA-IR), homeostasis model assessment for β-cell function (HOMA-β)] and blood lipids [triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C)] were compared between the two groups. Factors affecting the ADR of glimepiride were analyzed, and the efficacy of treatment was compared between the two groups. Results After the 123 patients with T2DM were treated with glimepiride, ADR occurred in 29 of them (23.58%). Age over 70, alcohol consumption, off-label medications, single doses of 2~4 mg, lack of compliance, and long medication were independent risk factors for ADR of glimepiride (P<0.05). The total effective rate of the ADR group was 72.41% (21/29), which was lower than 92.55% (87/94) in the non-ADR group (P<0.05). Conclusion The risk of ADR associated with glimepiride is high among those who are over 70 years old, drink alcohol, take large single doses, and take this drug for a long time. Such measures such as improving compliance and strengthening the supervision of indications can help reduce the ADR of glimepiride. References | Related Articles | Metrics

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Applicability of PDCA cycle in standardization of outpatient prescriptions LIU Bin, SHAO Meiling, CAI Yiran, MA Fengyi, LAN Hong 2022, 19(9): 1035-1039.  DOI: 10.19803/j.1672-8629.2022.09.22 Abstract ( 92 )   PDF (1890KB) ( 88 )   Objective To explore the applicability of the PDCA cycle in standardizing outpatient prescriptions in our hospital so as to reduce medication errors and drug costs. Methods A total of 2 000 outpatient prescriptions were selected using the random number table method between November 1, 2019 and June 30, 2020 (before intervention). The rate of qualification of outpatient prescriptions and the distribution and proportion of substandard ones were calculated. Based on the results of analysis, the PDCA cycle was adopted for intervention. 1 000 problematic outpatient prescriptions were statistically analyzed between July 1, 2020 and October 31, 2020 (after intervention). Results From November 1, 2019 to June 30, 2020, the rate of qualification of prescriptions averaged 88.8%, which failed to meet the national requirement (over 95%). After the intervention by the PDCA cycle, the rate of qualification of prescriptions not only rose to 95.70% between July 1, 2020 and October 31, 2020, which met the national requirement, but maintained a trend of month-on-month increase, from the lowest (86.27%) before intervention to the highest (96.38%) after the intervention. The achievement rate of tangible goals was 111.29%, and the progress rate was 7.77%. Conclusion The PDCA cycle has a significant effect on the quality of outpatient prescriptions by increasing the rate of qualification, improving the quality of hospital pharmacy services, and ensuring the safety of patients. References | Related Articles | Metrics

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Analysis and prevention of medication errors related to stored pharmaceuticals in National Monitoring Network for Clinical Safety Medication ZHANG Qingxia, JIANG Yongxian, LI Gen, YAN Suying, WANG Yuqin 2022, 19(9): 1040-1044.  DOI: 10.19803/j.1672-8629.2022.09.23 Abstract ( 286 )   PDF (1883KB) ( 209 )   Objective To analyze the current drug storage safety and identify the risks in the storage process of drugs so as to provide data for targeted precautions. Methods Reports about drug storage-related medication error (ME) were collected from the National Monitoring Network for Clinical Safety Medication between September 22, 2012 and September 30, 2020. The types of drugs involved, severity of errors, types of errors, where errors were made, the personnel who made these errors, and causes of errors were retrospectively analyzed statistically. Results The National Monitoring Network for Clinical Safety Medication received 67 storage-related ME reports from 33 hospitals in 15 provinces and cities across the country. The top three provinces and cities in terms of the number of reported cases were Beijing (24 cases, 35.82%), Anhui (17 cases, 25.37%) and Xinjiang (5 cases, 7.46%), involving 15 types of drugs. The top three types of drugs were hormones and endocrine-regulating drugs (17 cases, 25.37%), drugs for hematopoiesis (12 cases, 11.94%) and drugs for digestive diseases (7 cases,10.45%,). As for types of errors, there were 37 cases of temperature-related storage errors (55.22%), 19 cases (28.36%) of light-related errors, 6 cases (8.96%) of errors resulting from storage too close to children, and 3 cases (4.48%) of errors arising from too long storage after preparation, and 2 cases of humidity-related errors (2.99%). When it came to severity of errors, errors of class B were dominating (43 cases, 64.18%), followed by those of class C (9 cases, 13.43%), class D (6 cases, 8.96%), and class E (5 cases, 7.46%) and class F (4 cases, 5.97%). These errors involved 16 pharmacists (23.88%), 24 nurses (35.86%), 21 patients and family members (31.34%), 4 doctors (5.97 %) and equipment (2 cases, 2.99%). The most common causes of errors were lack of knowledge, insufficient training and personal negligence. Conclusion MEs relating to drug storage are not uncommon and have a wide range of causes. Related departments of hospitals should pay more attention to drug storage in the whole process of drug circulation so as to ensure the safety and effectiveness of clinical medications. References | Related Articles | Metrics