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Incidence of Severe Cases of COVID-19 Treated with Favipiravir TIAN Di, GE Ziruo, QIAN Fang, ZHANG Tingyu, SONG Meihua, HAN Bing, WANG Aibin, MA Ruize, CHEN Zhihai, XU Yanli 2021, 18(10): 901-904.  DOI: 10.19803/j.1672-8629.2021.10.01 Abstract ( 222 )   PDF (1135KB) ( 133 )   Objective To analyze the efficacy of favipiravir in the treatment of COVID-19 via a matched cohort study. Methods According to age, gender, blood routine results, C-reactive protein and SAA levels at admission, propensity scores were calculated and matched at the ratio of 1∶1 (treatment group vs control group). The treatment group was given oral FPV (day 1: twice, a single dose of 1600 mg, day 2: twice, a single dose of 1 600 mg, and days 2~5: twice a day, a single dose of 600 mg). The control group received routine treatment. There were 147 patients in either group. The duration of hospital stay, rate of virus clearance and chest CT were compared between the two groups. Results The median time of hospital stay was 29 (24,39) days in the treatment group and 32 (22,44) days in the control group, so there was no significant difference between the two groups (P=0.575). The median time taken by viral clearance was 25 (18,33) days in the treatment group and 25 (13,40) days in the control group, so there was no significant difference between the two groups (P=0.982). In the treatment group, 9 patients became severe or critically severe, compared with 32 in the control group. The incidence of severe cases in the treatment group was significantly lower than in the control group (P=0.000). For severe patients, the mean time of hospital stay and viral shedding in the treatment group was shorter than in the control group, but there was no significant difference between the two groups (P=0.116, 0.133). The remission time of CT in the treatment group was (9.38±4.94) days and (13.44±4.67) days in the control group, which were significantly shorter than in the control group (P=0.033). Conclusion In this study, treatment of COVID-19 with FPV can reduce the incidence of critically ill cases, and FPV can contribute to the remission of CT in severe or critically ill patients. References | Related Articles | Metrics

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Efficacy of Human COVID-19 Immunoglobulin (pH4) for Intravenous Injection against COVID-19 SONG Meihua, ZHANG Tingyu, GE Ziruo, XU Yanli, CHEN Zhihai, QIAN Fang 2021, 18(10): 905-909.  DOI: 10.19803/j.1672-8629.2021.10.02 Abstract ( 319 )   PDF (1261KB) ( 103 )   Objective To investigate the safety and efficacy of human COVID-19 immunoglobulin (pH4) (hCoVIgG pH4) for intravenous injection in the treatment of common COVID-19 by obtaining the study cohort using the propensity score matching method. Methods A retrospective study was conducted of 525 patients with COVID-19 who were hospitalized in Beijing Ditan Hospital between January 2020 and January 2021. These patients were divided into two groups: the treatment group (n=10) and control group (n=515). The propensity scores of the two groups were matched according to age, gender, clinical classification, complications and the level of C-reactive protein at admission. After matching, the demographic characteristics, clinical manifestations, laboratory examination results and other indexes were compared between the two groups, while the nucleic acid negative conversion time, imaging inflammatory absorption time and clinical improvement time of the two groups were analyzed. At the same time, artificial intelligence was used to assist pulmonary CT in analyzing pulmonary inflammation. Results Nine cases were obtained from the treatment group and from the control group respectively after matching. Compared with the control group, the nucleic acid negative conversion time and imaging inflammatory absorption time in the treatment group were significantly shortened. C-reactive protein decreased significantly (P<0.05). Conclusion hCoVIgG can help the body to clear the virus and promote the absorption of pulmonary inflammation. References | Related Articles | Metrics

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Glucocorticoid Therapy for Early Intervention in Quick Progression of Hospitalized Patients with COVID-19 LI Xingang, GUAN Chunshuang, LU Xingmeng, MU Xuechun, WANG Aibin, ZHANG Tingyu, GE Ziruo, XU Yanli, CHEN Zhihai, SONG Rui 2021, 18(10): 910-914.  DOI: 10.19803/j.1672-8629.2021.10.03 Abstract ( 115 )   PDF (1575KB) ( 101 )   Objective To explore the clinical application of sequential therapy with dexamethasone 10mg/5mg in the treatment of COVID-19. Methods Cases of COVID-19 who were hospitalized in Beijing Ditan Hospital between January 20, 2020 and March 20, 2021 were retrospectively investigated. By propensity score matching, 32 patients in the glucocorticoid-treated group and another 32 patients in the control group were selected. Results Compared with the control group, the duration of oxygen inhalation, time taken by chest improvement shown by CT, clinical complete remission and the proportion of patients treated in ICUs in the glucocorticoid group were significantly shortened or reduced. On the fourth, seventh and fourteenth day of the course, levels of C-reactive protein and NE/LY recovered quickly（P<0.01）. AI-assisted CT showed that there was significant difference in the volume of inflammation lesions of the total lung and average density of lesions of the total lung between the two groups on the fourth day of the course（P<0.05）. There was significant difference in the percentage of volumes of inflammation lesions of the total lung on the fourth and seventh day of the course（P<0.05）. There was no statistically significant difference in the time taken by clearance of SARS-CoV-2 RNA and lengths of hospital stay between the two groups（P>0.05）. Conclusion Dexamethasone 10mg/5mg sequential therapy may be an effective treatment for progression of hospitalized patients with COVID-19, and can be tried in the process of diagnosis and treatment. References | Related Articles | Metrics

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Adjunctive Role and Prospects of Zinc Supplementation for Treatment of COVID-19 TIAN Di, MU Xuechun, CHEN Zhihai 2021, 18(10): 915-919.  DOI: 10.19803/j.1672-8629.2021.10.04 Abstract ( 167 )   PDF (1114KB) ( 64 )   Objective To explore the adjunctive role and prospects of zinc supplementation in the treatment of COVID-19. Methods Current research on the role of zinc in antiviral immunity and the potential role of zinc in combating COVID-19 was reviewed, and findings of the ongoing clinical trials related to COVID-19 were summarized. Results Zinc supplementation could improve immunity and alleviate infection and inflammation. Zinc could inhibit the replication process of a variety of viral RNA, so it had some antiviral effect. Zinc status was a key factor that affected the immune response to COVID-19. Conclusion It is recommended that zinc supplementation be used as an adjunctive treatment for COVID-19. References | Related Articles | Metrics

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Research Progress in the Treatment of COVID-19 with Mesenchymal Stem Cells SONG Meihua, GE Ziruo, CHEN Zhihai, XU Yanli 2021, 18(10): 920-923.  DOI: 10.19803/j.1672-8629.2021.10.05 Abstract ( 86 )   PDF (1021KB) ( 56 )   COVID-19 caused by SARS-CoV-2 is characterized by respiratory tract infections that range from mild upper respiratory tract infection to severe pneumonia, acute respiratory distress syndrome and even death. Antiviral drugs with specific therapeutic effect against COVID-19 are currently lacking, and there is an urgent need for clinical treatment of infected individuals (especially severe and critical patients). In recent years, mesenchymal stem cells (MSC) have attracted much attention in clinical trials because of their immunomodulatory and regeneration characteristics. This article reviews the immunomodulatory effect of MSC on COVID-19 and the current clinical trials so as to contribute to research on MSC. References | Related Articles | Metrics

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Acute Toxicity of Huoxin Pills in Mice MO Zunhui, CHEN Meixian, WANG Pengcheng, WANG Lingli, LIAO Yiqiu, LI Zehua 2021, 18(10): 924-929.  DOI: 10.19803/j.1672-8629.2021.10.06 Abstract ( 84 )   PDF (1913KB) ( 56 )   Objective To investigate the acute toxicity of Huoxin pills in mice. Methods The maximum tolerance dose (MTD) test was chosen due to the unmeasurable LD50. Eighty SPF-grade KM mice (half male and half female) were randomly divided into the blank control group and treatment group, and a single intragastric administration was given within 24 hours. The treatment group was given 3.5 g/kg Huoxin pill liquid, while the control group was given the same volume of normal saline. After administration, the mice were observed for 14 consecutive days. The body weight, food intake and water consumption of mice were recorded before administration and 1, 3, 5, 8, and 14 days after administration. Ten males and females were chosen from each group at 1 d and 14 d after administration, and blood was drawn after removal of the eyeballs. The blood routine analysis was conducted and blood biochemical indicators were detected. The changes of dissected organs were observed, and the heart, liver, spleen, lung, and kidney were also dissected for histopathological examination. Results Within 3 hours of administration the mice showed symptoms of poisoning, including ataxia, malaise, prone convulsions and accelerated breathing. The second day, mice in the treated group returned to normal. The food intake of male mice in the treatment group was significantly lower than that in the control group at the first day after administration (P<0.05), but there was no significant change in the food intake of either group 3 days after administration. Compared with the control group, no significant change in body weight, water consumption, organ indexes, blood routine analysis, or blood biochemical indexes was observed in the treatment group (P>0.05). Histopathology showed inflammatory cell infiltration in the heart epicardium, inflammatory cell infiltration in the central vein of livers, and slight vacuolation of hepatocytes in the treatment group. Conclusion The maximum tolerance dose of mice is orally 3.5 g/kg, which is 1 750 times the daily dosage of a 60 kg adult, suggesting that Huoxin pills are orally safe. References | Related Articles | Metrics

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The Mechanism of Bazhen Decoction in Treating Immune Thrombocytopenia Based on Network Pharmacology HUANG Wei, LUO Yaqin, WANG Xiao 2021, 18(10): 930-935.  DOI: 10.19803/j.1672-8629.2021.10.07 Abstract ( 135 )   PDF (2580KB) ( 79 )   Objective To explore the mechanism by which Bazhen Decoction combats immune thrombocytopenia (ITP) using network pharmacology. Methods The main active ingredients of Bazhen Decoction were screened using the pharmacological database and analysis platform (TCMSP) of the Chinese Medicine System. Drugbank database was searched for target prediction. Cytoscape 3.7.1 software was used to build a chemical composition-target network. Online Mendelian Inheritance In Man (OMIM), human gene database (Gene Cards), and Drugbank were searched for the related target genes of ITP.The target of active ingredients of the drug was mapped to the ITP target to obtain the intersection target, which was the predicted target for ITP of Bazhen Decoration. The STRING database was used to construct an online intersection target protein interaction network (PPI) to screen out key target genes. Gene ontology (GO) analysis and enrichment analysis based on the Kyoto Encyclopedia of Genes and Genomes (KEGG) were used to analyze intersection targets using DAVID 6.8 and online tools. Results A total of 160 chemical components, 247 potential targets, 304 ITP-related targets, and 20 common targets were found in Bazhen Decoration. Quercetin, kaempferol, and 7-Methoxy-2-methyl isoflavone regulated most of the targets associated with ITP. GO biological function analysis showed that this decoration was involved in such biological processes as protein phosphorylation, apoptosis, signal transduction, and proliferation. The enrichment results of KEGG pathway showed that the potential pathways through which Bazhen Decoration could treat ITP included PI3K-Akt signaling pathway, Ras signaling pathway, insulin signaling pathway, FoxO signaling pathway, MAPK signaling pathway, Rap1 signaling pathway, and T cell receptor signaling pathway. Conclusion Bazhen Decoction can combat ITP through the complex mechanism of multiple components, multiple targets and multiple pathways. The core targets are RAF1, PIK3CG, IKBKB, MAPK10, EGFR, GSK3B, and MAPK14. The regulatory mechanism mainly involves immune regulation, signal transduction and proteoglycan regulation in related signaling pathways. References | Related Articles | Metrics

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Influencing Factors of Suspected Allergic Reactions Caused by Yinzhihuang Granules in the Real World QIN Xueying, SUN Linxi, XIE Yanming, LYU Jian, ZHANG Cheng, XIE Yuting, GUO Peng 2021, 18(10): 936-939.  DOI: 10.19803/j.1672-8629.2021.10.08 Abstract ( 126 )   PDF (1162KB) ( 80 )   Objective To explore the influencing factors of suspected allergic reactions caused by Yinzhihuang granules in the real world. Methods This study collected information form 4 966 patients who had used Yinzhihuang granules in the hospital information systems of 21 tertiary hospitals across the country from March 2008 to March 2011. Prescription sequence analysis and nested case-control study were performed, prescription sequence analysis and nested case-control study were performed to select the allergic group and the control group (non-allergic patients) to find out about the potential relationship between the medication allergy to Yinzhihuang granules and forty-three influencing factors including the combination of diseases, combined medication, age, sex, length of hospital stay, course of treatment and dosage using the conditional Logistic regression analysis model. Results Single factor Logistic regression showed that three factors, including ascites, viral hepatitis B and the active stage of post-hepatitis cirrhosis, were statistically significant (P<0.05). After the univariate analysis results were incorporated into the multivariate Logistic regression model, no statistical significance was observed for the above three factors (P>0.05). Conclusion Based on the current sample size, no statistically significant factors related to allergic reactions caused by Yinzhihuang granules have been screened out. Real risk factors remain to be discovered and confirmed by pharmacological and clinical studies. References | Related Articles | Metrics

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Discussion on the Monitoring and Analysis of Cluster Adverse Drug Events by Drug Marketing Authorization Holders YANG Le, TIAN Chunhua, XIA Dongsheng, DON Duo, FAN Rong, ZHANG Meiling 2021, 18(10): 940-943.  DOI: 10.19803/j.1672-8629.2021.10.09 Abstract ( 676 )   PDF (1134KB) ( 742 )   Objective To provide reference for drug marketing authorization holders (MAH) to monitor and analyze cluster adverse drug events (referred to as "cluster events"). Methods The main characteristics and causes of cluster risks/events were analyzed, introduces Monitoring methods of cluster risks, setting rules for early warning signals, key points of on-site investigation, cluster risks/event analysis were introduced. Results and Conclusion MAH can identify and judge cluster risk signals in the adverse drug reaction(ADR) database by establishing monitoring methods, to confirm and control potential drug quality risks or use risks in advance, and maximize the protection of public medication safety. References | Related Articles | Metrics

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Post-marketing Monitoring and Evaluation System in Japan MENG Kangkang, SUN Nan, DONG Duo 2021, 18(10): 944-948.  DOI: 10.19803/j.1672-8629.2021.10.10 Abstract ( 303 )   PDF (1135KB) ( 387 )   Objective To provide references for the establishment and improvement of post-marketing evaluation systems in China. Methods By referring to Japanese laws and regulations, the important elements of the post-listing monitoring system in Japan were studied. Results Under the guidance of Good Vigilance Practice (GVP) and Good Post-marketing Study Practice (GPSP), Japan has not only completed the reevaluation of old drugs, but also exercised rigorous control over the marketing of new drugs through reexamination. Through the post-marketing survey and risk management plan (RMP), the management of the whole life cycle of drugs has been improved. Compared with the Japanese drug post-marketing monitoring and evaluation system, the coordination before and after marketing in China is not effective enough, the legal framework of post-marketing evaluation is imperfect, and the drug monitoring model needs to be innovated. Conclusion It is recommended that technical support institutions of drug evaluation before and after marketing in China be improved through functional adjustment, legislation be updated, post-marketing evaluation systems of drugs be established, and drug evaluation methods be innovated. References | Related Articles | Metrics

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Drug Risk Communication between Drug Regulatory Agencies and the Public WEI Fuqian, ZHANG Wei, YANG Yue 2021, 18(10): 949-952.  DOI: 10.19803/j.1672-8629.2021.10.11 Abstract ( 248 )   PDF (1193KB) ( 350 )   Objective To summarize the practices of the FDA in public drug risk communication, and provide reference for the improvement of drug risk communication in China. Methods Chinese and foreign literature was reviewed in order to summarize the influencing factors of public perceptions of drug risks based on the risk perception theory. The practices regarding drug risk communication adopted by the FDA and its counterpart in China were analyzed in terms of ways of communication, time of communication, contents of communication and channels of communication. Results There are some problems with drug risk communication in China, such as limited public participation, a lack of workable guidelines for risk communication, communication channels that fail to distinguish targeted audiences, and improper contents of communication. Conclusion It is suggested that China's regulatory authorities should learn from internationally accepted practices and formulate strategic plans or guidelines for risk communication, and optimize risk communication between drug regulatory agencies and the public by advancing public understanding of drug safety, promoting public participation, improving communication contents and diversifying communication channels. References | Related Articles | Metrics

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Risks of Gastrodin Injection LIU Cuili, ZHU Lan, WANG Tao, WU Chen 2021, 18(10): 953-955.  DOI: 10.19803/j.1672-8629.2021.10.12 Abstract ( 159 )   PDF (1211KB) ( 92 )   Objective To analyze the risk of the mouse nerve growth factor for injection 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 (ADR) database between January 1, 2004 and October 31, 2019, domestic and foreign literature published from the inception of the library to February 29, 2020, and risk management measures taken in China were analyzed. Results and Conclusion It was found that this product should be used at the dosage stipulated in the specifications, clinicians should be alert to such adverse reactions as severe allergies, and that indications of special populations should be monitored. Drug manufacturers should assume more responsibility for adverse drug reaction monitoring and evaluation, improve the information collection channels of ADR, upgrade the analysis and evaluation of adverse drug reactions, update the information on safety in drug labels, and take the initiative to carry out post-market safety studies when necessary. References | Related Articles | Metrics

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Influencing Factors of Suspected Allergic Reactions Caused by Ciwujia Injection Based on Prescription Sequence Analysis and Nested Case-control Design ZHANG Baiyu, XIE Yanming, LIU Huan, SUN Linxi, ZHUANG Yunni 2021, 18(10): 956-959.  DOI: 10.19803/j.1672-8629.2021.10.13 Abstract ( 124 )   PDF (1096KB) ( 54 )   Objective To explore the influencing factors of suspected allergic reactions caused by Ciwujia injection in the real world and to guide safe clinical medication. Methods Retrospective analysis was conducted of the data on inpatients who had used Ciwujia injection in the hospital information system (HIS) of 24 large tertiary hospitals in China between 2006 and 2014. Patients who discontinued Ciwujia injection within 24 hours of the first use and switched to loratadine, desloratadine, promethazine and dexamethasone within 24 hours of the first use were regarded as suspected cases of allergic reactions. A total of 93 cases were collected. Logistic regression analysis was used to explore the correlation between the information about comorbidities, combinations of drugs, single doses and the incidence of suspected allergic reactions. Results Data analysis found that the use of vitamin C or glycerin combined with Ciwujia injection could increase the chance of suspected allergic reactions. The combination of Ciwujia injection with isosorbide mononitrate, Huayu Tongmai traditional Chinese medicine preparation, nifedipine and its analogues, insulin for injection and its analogues, metoprolol, acetylsalicylic acid preparation and furosemide had no significant effect on the occurrence of suspected allergic reactions caused by Ciwujia injection. Comorbidities and single doses were not risk factors for suspected allergic reactions. Conclusion Ciwujia injection should not be combined with vitamin C or glycerin clinically to minimize the risk of suspected allergic reactions. References | Related Articles | Metrics

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Rationality and Safety of New Monoclonal Antibody Antitumor Drugs Used Clinically in a Tertiary Tumor Hospital WU Hong, LI Xin, HAN Feng 2021, 18(10): 960-964.  DOI: 10.19803/j.1672-8629.2021.10.14 Abstract ( 143 )   PDF (1253KB) ( 153 )   Objective To investigate the clinical applications of new monoclonal antibody antitumor drugs in a hospital and analyze the rationality and safety of related medications in order to provide data for regulation and safe use of novel anticancer drugs. Methods A total of 480 medical records of inpatients who had used novel monoclonal antibody antitumor drugs from January 1, 2019 to December 31, 2020 were randomly chosen from a hospital and the rationality and safety of clinical applications were retrospectively analyzed. Results Among the 480 medical records, there were 125 cases of improper use of medicines, accounting for 26% of the total and involving off-label drug use(27.2%), wrong usage and dosage(41.6%), improper pretreatment drug use(20.0%), and imperfect solvent selection and dosage of solvents (11.2%).There were 362 cases of adverse drug reactions (ADR) found in these medical records. The top three organ-system ADRs were skin mucosal injury (20.8%), infusion related reactions (19.7%) and digestive system injury (14.7%). Conclusion The clinical use of new monoclonal antibody antitumor drugs is imperfect in this hospital. The hospital should regulate and rationally use new antitumor drugs according to the latest clinical guidelines, be alert to their adverse reactions, and ensure the safety and effectiveness of drug use. References | Related Articles | Metrics

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Comparative Analysis of Adverse Drug Reactions of Evolocumab and Alirocumab Based on OpenFDA LI Jiangfan, HU Ye, PANG Hongxian, ZHAO Dan, LI Xinru, WANG Xuhong 2021, 18(10): 965-968.  DOI: 10.19803/j.1672-8629.2021.10.15 Abstract ( 1439 )   PDF (1215KB) ( 179 )   Objective To search the database of the US Food and Drug Administration public data open project (OpenFDA) for adverse drug reactions (ADR) of PCSK9 inhibitors evolocumab and alirocumab, and to compare and analyze the related ADR so as to provide reference for clinical rational use. Methods Using the API module in the interactive chart section of the ADR endpoint in OpenFDA database, the data on ADR reports of evolocumab and alirocumab harvested between January 1, 2004 and January 18, 2021 was retrieved. Results The number of ADR reports of evolocumab and alirocumab was 71 676 and 8 006, respectively. ADR reports of evolocumab mostly came from doctors, consumers and non-health professionals, compared with consumers, non-health professionals and other health professionals for alirocumab. Most of the ADR occurred in the United States. Female patients outnumbered male ones. Adults and the elderly made up the majority of the patients. The main indications for the drug were cardiovascular diseases. The dominating ADR related to elouzumab was pain at the injection site, and myalgia for alirocumab. The outcomes of most of these patients were unknown. Conclusion In the process of using evolocumab and alirocumab clinically, clinicians should be alert to the related ADR so as to promote the rational use of drugs. References | Related Articles | Metrics

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Efficacy and Safety of Batroxobin in the Treatment of Sudden Hearing Loss: a Meta-analysis GONG Li, SU Shuping, TIAN Xiaojiang, TANG Xuewen, JI Huanhuan, MENG Long, JIA Yuntao 2021, 18(10): 969-974.  DOI: 10.19803/j.1672-8629.2021.10.16 Abstract ( 96 )   PDF (1317KB) ( 60 )   Objective To systematically review the efficacy and safety of batroxobin in the treatment of sudden hearing loss in order to provide evidence-based data for clinical medication. Methods Such databases as Pubmed, Embase, Cochrane Library, ClinicalTrials.gov, CNKI, Wanfang data, and Weipu were searched for randomized controlled trials of sudden hearing loss, and related literature was searched for manually. The data was screened and retrieved according to the inclusion and exclusion criteria. The quality of the enrolled literature was assessed by the quality assessment standard from Cochrane Handbook 5.0, with the cure rate, effective rate and incidence of adverse reactions as evaluation indexes. Software of RevMan 5.0 was used for the meta-analysis and subgroup analysis. Results A total of 25 randomized controlled trials were enrolled, involving 2 458 patients. Meta-analysis results suggested that the therapeutic effect in the batroxobin group was better than in the control with statistically significant difference. Only 4 randomized controlled trials reported adverse reactions that manifested themselves as a decrease of fibrinogen, dizziness, nausea, purpura, and a mild increase of transaminase. Conclusion Meta-analysis results show that batroxobin can be used alone or in combination with other drugs for the treatment of sudden hearing loss. But whether it can be used as a first-line drug needs to be confirmed by more rigorous and scientific clinical trials. References | Related Articles | Metrics

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Influencing Factors of Off-label Use of Drugs among Pediatric Outpatients at a Tertiary Hospital SONG Shizu, WANG Wanjing 2021, 18(10): 975-977.  DOI: 10.19803/j.1672-8629.2021.10.17 Abstract ( 119 )   PDF (1246KB) ( 118 )   Objective To retrospectively investigate the off-label use of drugs in a pediatric outpatient clinic of a hospital within three months, to study results and influencing factors, and to promote the safe use of drugs in pediatric outpatient clinics. Methods A total of 19 686 pediatric prescriptions were chosen from the outpatient prescriptions of the hospital between October 1, 2018 and December 31, 2018 using the simple random sampling method. According to related criteria, the off-label use of drugs was calculated and analyzed. Results A total of 5 445 prescriptions involving off-label use of drugs were found. The incidence of off-label use of drugs was 27.7%. The off-label use of drugs largely involved overdosing (41.9%), overage patients (30.2%) and medication at too short intervals (20.1%). Drugs for the respiratory system (54.0%) and anti-infectives (25.6%) were used in most of the cases of off-label use of drugs. The age group with the highest proportion of off-label use of drugs was pre-school children (35.7%), followed by infants (28.2%) and school-age children (18.9%). Conclusion The incidence of off-label use of drugs in this pediatric outpatient clinic is high. It is necessary to formulate relevant measures to minimize off-label use of drugs and ensure patients' safety. References | Related Articles | Metrics

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Information Labeling in Instructions of Anti-tumor Drugs for Intravenous Infusion in a Hospital ZHAO Shuang, GU Rui, SONG Yanqing, WANG Xiangfeng, MIAO Qiuli 2021, 18(10): 978-980.  DOI: 10.19803/j.1672-8629.2021.10.18 Abstract ( 83 )   PDF (1139KB) ( 71 )   Objective To investigate the problems with information labeling in instructions of antineoplastic drugs for intravenous infusion in order to provide reference for the rational use of antineoplastic drugs. Methods The instructions of anti-tumor drugs for intravenous infusion were collected from a hospital, the completeness of information in the instructions was statistically analyzed, and problems with the instructions of anti-tumor drugs for intravenous infusion were investigated. Results Among the ninety-one instructions of antineoplastic drugs for intravenous infusion, there were eight (7.41%) that involved pre-treatment. There were five instructions (5.49%) involving infusion instruments, two (2.20%) involving flushing tubes, eight involving (8.79%) infusion stability, fifteen (16.48%) involving the need for monitoring during infusion and thirteen involving (14.29%) rescue measures. Conclusion The information labeled in the 91 instructions of anti-tumor drugs for intravenous infusion is seriously inadequate. Therefore, it is necessary to revise the instructions, and standardize information labeling in drug instructions. References | Related Articles | Metrics

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Safety Information in Oral Chinese Patent Medicine Instructions for Big Brand Traditional Chinese Medicine ZHOU Sha, YANG Hongjun, JING Zhiwei, LI Geng 2021, 18(10): 981-985.  DOI: 10.19803/j.1672-8629.2021.10.19 Abstract ( 172 )   PDF (1206KB) ( 196 )   Objective To summarize and analyze the integrity, standardization and rigor of the safety information of oral Chinese patent medicines that are listed among the top 100 in the scientific and technological competitiveness of major varieties of big brand traditional Chinese medicine, and to provide reference for the clinical safe use and development and application of oral Chinese patent medicines. Methods 95 copies of the current drug instructions of oral Chinese patent medicines that are listed among the top 100 in the scientific and technological competitiveness of major varieties of big brand traditional Chinese medicine were collected, then the security information, including ingredients, adverse reactions, contraindications, cautions, medication tips for special populations, drug interactions, clinical trials and pharmacological toxicology reports, warnings were statistically analyzed, then the security information, including ingredients, adverse reactions, contraindications, cautions, medication tips for special populations, drug interactions, clinical trials and pharmacological toxicology reports, warnings were statistically analyzed. Results There exit some medicine instructions lack of warnings for toxic and powerful drugs and the eighteen incompatible medicaments &the nineteen medicaments of mutual restraint drugs. Adverse reactions, cautions, and contraindications were not clear. Invalid information exists in cautions, drug interactions, and warnings. Conclusion The safety information of oral Chinese patent medicine specifications should be standardized, so as to provide basis for rational drug use by doctors and patients. References | Related Articles | Metrics

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Raise of Serum Concentration of Quetiapine Induced by Sodium Valproate Sustained Release Tablets and Literature Analysis ZHUANG Hongyan, LIU Jie, DU Haixia, BAO Shuang, ZHAO Yan, HE Yue, GUO Wei 2021, 18(10): 986-988.  DOI: 10.19803/j.1672-8629.2021.10.20 Abstract ( 212 )   PDF (841KB) ( 86 )   Objective To report a severe increase in quintiapine serum concentration caused by taking emotional stabilizer sodium valproate sustained release tablets at the same time. Methods This paper analyzed one case of quintiapine concentration increase caused by sodium valproate sustained release tablets in our hospital, suggestions were put forward on rational use of drugs in clinic. Results and Conclusion The pharmaceutical care of patients taking quintiapine and sodium valproate sustained release tablets in combination should be strengthened. The effect and adverse reactions should be closely observed in clinical practice, and the blood concentration of both drugs should be monitored regularly to protect the drug safety of patients. References | Related Articles | Metrics

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One Case of Acute Liver Failure in Children with Kawasaki Disease Induced by High-dose Aspirin YU Mingli, LUO Ji, CHEN Yonggang, CHEN Jie, PENG Jiangli 2021, 18(10): 989-991.  DOI: 10.19803/j.1672-8629.2021.10.21 Abstract ( 170 )   PDF (1009KB) ( 120 )   Objective To improve the safety of clinical use of high-dose aspirin. Methods One case of severe liver failure in a child with Kawasaki disease after using high-dose aspirin was reported and analyzed in combination with domestic and foreign literature. Results The patient was likely to suffer from aspirin-induced liver injury, which is rare in clinical practice and mainly related to the dosage. Conclusion When children with Kawasaki disease need to use large doses of aspirin, the liver function and related digestive system reactions should be closely monitored. Blood concentration monitoring of aspirin should be popularized to prevent such adverse drug reactions such as severe liver injury. References | Related Articles | Metrics

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One Case of Severe Liver Dysfunction Induced by Latamoxef Sodium for Injection LI Xiaoli, LU Lu, XING Xiaoxuan, DONG Yuexin, CHU Yanqi 2021, 18(10): 992-994.  DOI: 10.19803/j.1672-8629.2021.10.22 Abstract ( 275 )   PDF (871KB) ( 124 )   Objective To analyze one case of severe adverse reactions—liver damage caused by latamoxef sodium for injection in order to provide reference for rational use of latamoxef sodium. Methods A clinical pharmacist participated in the treatment of one patient with cholecystitis. The pharmacist screened the drugs used by this patient before and after hospitalization to find the cause of liver damage. The drugs that might have caused liver injury were evaluated by the relevance evaluation standard for adverse drug reactions (ADR). Finally, it was determined that the drug that caused abnormal liver function was latamoxef sodium for injection. According to the clinical symptoms and laboratory examination indexes of the patient, glutathione was added as a symptomatic therapy to protect the liver. Latamoxef sodium was replaced by efoperazone/sulbactam sodium as an anti-infection therapy, followed by efficacy evaluation of drugs and liver function index detection. Results Clinicians adopted the advice of the clinical pharmacist. The abnormal liver function and infection of the patient were gradually improved. Conclusion Clinicians ought to be alert to the changes of liver function when using latamoxef sodium for injection and do a better job of tracking and medication monitoring in order to ensure the safe use of drugs for patients. References | Related Articles | Metrics

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Research Progress in Characterization Methods of Pharmaceutical Cocrystals XIONG Jing, DAI Xialin, HE Lan, WU Xiangxiang 2021, 18(10): 995-999.  DOI: 10.19803/j.1672-8629.2021.10.23 Abstract ( 177 )   PDF (1041KB) ( 111 )   Pharmaceutical cocrystals are a new solid form which can improve many physical and chemical properties of active pharmaceutical ingredients. As a potential new drug development technology, pharmaceutical cocrystals have many advantages over single component and compound drugs. In recent years, some pharmaceutical cocrystals have been approved for marketing, so a challenge to regulatory departments of drugs in China is to establish effective quality control methods for pharmaceutical cocrystals. Through the review of characterization methods of pharmaceutical cocrystals, we can find out more about the analytical techniques that can effectively identify pharmaceutical cocrystals so as to provide reference for the establishment of quality standards for pharmaceutical cocrystals. References | Related Articles | Metrics