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Data mining and network analysis of Xiyanping injection in the treatment of viral intestinal infection based on the real world JI Hong, WANG Zhifei, XIE Yanming, LI Lixun, WEI Ruili, WANG Qi 2022, 19(2): 117-120.  DOI: 10.19803/j.1672-8629.2022.02.01 Abstract ( 306 )   PDF (1243KB) ( 181 )   Objective To analyze the way in which Xiyanping injection is used in the treatment of viral intestinal infections so as to guide clinical rational medication. Methods Based on the hospital information management system (HIS) database constructed by the Institute of Clinical Basic Medicine of Chinese Academy of Traditional Chinese Medicine, the clinical data on 1 814 patients with intestinal infections treated with Xiyanping injection in 29 hospitals between December 1, 2006 and June 30, 2016 was analyzed; and the patterns of combined medications were studied. The data was processed with the Tabu search algorithm. Results The most frequently used western medicine was oral rehydration salt, compound vitamin, cimetidine and antibiotics. The most frequently used traditional Chinese medicine was antipyretic, astringent and antipyretic antidote. Conclusion In the treatment of viral intestinal infections, Xiyanping injection is often combined with vitamins, oral rehydration salt or with antipyretic antidotes and astringents to combat viruses, cure diarrhea, adjust the gastrointestinal environment and provide symptomatic treatment. References | Related Articles | Metrics

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The real world Ciwujia injection for the treatment of emotional disorders analyzed based on data mining algorithm ZHANG Jiajia, ZHI Yingjie, XIE Yanming, SUN Linxi, ZHUANG Junni, ZHUANG Yan 2022, 19(2): 121-125.  DOI: 10.19803/j.1672-8629.2022.02.02 Abstract ( 170 )   PDF (2171KB) ( 112 )   Objective To study the information about medications with Ciwujia injection in the treatment of emotional disorders based on the real-world data and summarize clinical medication schemes of Ciwujia injection. Methods A total of 1 093 patients who had been treated with Ciwujia injection between January 8, 2004 and August 22, 2014 were selected from the hospital information system of 16 big hospitals in China, and the information on their drug combinations was analyzed by using the tabu search (TS) algorithm. The clinical combination regimens of Ciwujia injection for patients with emotional disorders were screened out through drug analysis in the subnetwork. Results For patients with anxiety and depression accompanied by sleep disorders, Ciwujia injection + Bailemian capsules + halupentixil/paroxetine could be considered. The combination of Ciwujia injection + Wenxin granules + flupentixol could be chosen for patients with cardiac neurosis. Conclusion The combined application of Chinese and western medicines can help to improve efficacy and reduce side effects. On this basis, prospective clinical efficacy and safety evaluation can be conducted for a sub-network module. References | Related Articles | Metrics

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Therapeutic effects of Lianhua Qingwen capsules(granules) against pulmonary infections based on data mining in the real world ZHANG Lidan, XIE Yanming, SUN Menghua 2022, 19(2): 126-129.  DOI: 10.19803/j.1672-8629.2022.02.03 Abstract ( 257 )   PDF (1357KB) ( 166 )   Objective To find out whether there is any difference in the evaluation of treatment of Lianhua Qingwen capsules(granules) used in patients with pulmonary infections. Methods The data on diagnosis and treatment of patients with pulmonary infections was retrieved from the hospital information system (HIS) of 18 large hospitals in China. A non-randomized control matching design was used to study the therapeutic effect among 2 790 aged- and gender-matched lung infection patients treated with or without Lianhua Qingwen capsules(granules) between September 15, 2004 and December 15, 2015. A propensity score was used to balance confounding factors and to compare the outcomes of regrouped patients. Results After controlling for confounding factors, there was statistically significant difference in Evaluation of treatment between the combined use of Lianhua Qingwen capsules(granules) and the non-combined use. Conclusion Based on the real-world electronic medical data and research methods currently available, it is believed that the use of Lianhua Qingwen capsules(granules) in the treatment of pulmonary infections has a good therapeutic effect. However, the results of this research need to be confirmed by prospective studies. References | Related Articles | Metrics

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Data mining of clinical characteristics and combined medications of 4 832 patients with heart failure treated with Shengmai injection SUN Chunquan, XIE Yanming, HOU Hengyue 2022, 19(2): 130-133.  DOI: 10.19803/j.1672-8629.2022.02.04 Abstract ( 142 )   PDF (1276KB) ( 122 )   Objective To make an in-depth study on the clinical characteristics of Shengmai Injection (SMI) in the treatment of heart failure and the patterns of combined medications based on the real world data from the hospital information system (HIS). Methods R software was used to analyze the data on 4 832 patients with heart failure in HIS databases from January 1, 2002 to December 31, 2016. Results There were 2 273 male patients and 2 499 female ones, but the data on gender was missing for 60 patients. The age of the patients averaged (72.57±13.45) years old and the length of hospital stay averaged (22.18±19.28) days. The main route of administration of SMI was intravenous drip (3 915 cases, accounting for 81.02%). The average single dose was (57.16±20.16) mL, and the average course of treatment was (4.76±6.16) days. The most commonly-used drug combinations included spironolactone+furosemide, and acetylsalicylic acid+spironolactone+furosemide. Conclusion This real world study of combined medications for heart failure has shed light on the basic clinical characteristics of patients with heart failure in the real world and the medication characteristics of SMI and provided reference for clinicians. References | Related Articles | Metrics

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Complex network analysis of combined medication with Xiyanping injection in treating patients with myocardial damage and myocarditis ZNANG Lei, WANG Zhifei, XIE Yanming, LI Lixun, LIU Zhishuai 2022, 19(2): 134-136.  DOI: 10.19803/j.1672-8629.2022.02.05 Abstract ( 162 )   PDF (1390KB) ( 93 )   Objective To explore optimized combined medications with Xiyanping injection in the treatment of myocardial damage and myocarditis. Methods Between December 1, 2006 and June 30, 2016, the clinical data on 19 729 patients with myocardial damage and myocarditis treated with Xiyanping injection and combined medications was retrieved from the integrated data warehouse of large hospital information system (HIS) established by the Institute of Clinical Basic Medicine, Chinese Academy of Chinese Medical Sciences. Complex network analysis was performed using the tabu search algorithm. Results Among the included patients with myocardial damage and myocarditis, 84.77% were under 3 years old. As for drug combinations, the most frequently used ones in clinical practice were heat-clearing prescriptions, phlegm-resolving and cough-relieving and asthma-relieving prescriptions, heat-clearing and detoxicating prescriptions, and blood-activating and stasis-resolving ones, with the main effects attributed to “clearing” and “activating” properties. Heat-clearing prescriptions were used most frequently in combined medications with of Xiyanping injection, and there was a close structural relationship between the heat-clearing prescriptions and other Chinese medicines in network analysis. Conclusion It is recommended that the main therapeutic principle be “clearing heat and detoxification, cooling blood and activating blood, as well as nourishing Yin and consolidating Yang”. The flexible compatibility of Chinese medicines with the effects of clearing heat and detoxification, cooling blood and activating blood can be used to improve the health of patients and their life quality after recovery. References | Related Articles | Metrics

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Development of the first national reference substance of ritonavir as a candidate drug against COVID-19 XIONG Jing, LIU Yi, LIU Zhaoxia, LI Jie, ZHANG Caiyu, WU Xiangxiang, HE Lan 2022, 19(2): 137-141.  DOI: 10.19803/j.1672-8629.2022.02.06 Abstract ( 167 )   PDF (1366KB) ( 102 )   Objective To establish the first national reference standard for determination of the content of ritonavir. Methods The structure of ritonavir was identified by means of IR, MS, 1H-NMR and 13C-NMR. HPLC purity was calculated via peak area normalization, principal component self-comparison, external standard methods and response factors. The homogeneity, stability and other physicochemical properties were investigated using various analytical methods. The content was determined using the mass balance method and verified by the NMR quantitative method and differential scanning calorimeter. Results The structure of the first national reference substance of ritonavir was confirmed and its content was determined to be 99.8%. Conclusion The development of the first national reference substance of ritonavir can meet the production needs of raw materials, preparations and compound preparations of ritonavir. References | Related Articles | Metrics

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Mechanism of nephrotoxicity of 5-hydroxymethylfurfural based on mass spectrometry imaging JIANG Haiyan, GAO Shanshan, LI Jie, LIU Zhigang, HAO Ruirui, PANG Fei, HU Yuchi, HE Jiuming, JIN Hongtao 2022, 19(2): 142-147.  DOI: 10.19803/j.1672-8629.2022.02.07 Abstract ( 120 )   PDF (3177KB) ( 83 )   Objective To explore the spatial and temporal metabolic profiles of kidney after 5-hydroxymethylfurfural (5-HMF) administration and elucidate possible mechanisms of the nephrotoxicity from the omics level. Methods ICR mice were divided into control group and administration group, which were intravenously injected with saline and 5-HMF (300 mg·kg-1), respectively. Kidney tissues were collected at 1, 4 and 24 hours time points, and then the frozen renal tissue sections were scanned and visualized by air flow-assisted desorption electrospray ionization mass spectrometry imaging (AFADESI-MSI). Microregional metabolic information was extracted, and then the differential metabolites at each time point were screened out for identification and pathway enrichment analysis. Results The main difference metabolites between the administration group and the control group were phenylalanine, adenosine, adenine, hypoxanthine, guanosine monophosphate, FA-22∶6 and others. The important metabolic pathways are purine metabolism, alanine aspartate and glutamate metabolism, arginine biosynthesis, TCA cycle and pyrimidine metabolism. Meanwhile, long chain fatty acids and phospholipids were up-regulated, suggesting that the toxicity mechanism of 5-HMF may also be related to the disruption of fatty acid oxidation and lipid metabolism. By comparing the different metabolites at each time point, hypoxanthine, FA-22∶ 6 and LPG-22∶ 6 could be used as potential toxicity prediction biomarkers, and the best detection time was 4 h after administration. Conclusion This method can realize the spatiotemporal analysis of kidney metabolism caused by 5-HMF, reveal the possible nephrotoxicity mechanism of 5-HMF, and demonstrate the advantages of mass spectrometry imaging technology in drug toxicology studies. References | Related Articles | Metrics

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Antibacterial effect of dandelion aqueous extract on enterobacteriaceae in vitro WANG Xiaoning, ZHANG Weihua, ZHANG Xiangyang, DOU Jianwei, WANG Cui 2022, 19(2): 148-153.  DOI: 10.19803/j.1672-8629.2022.02.08 Abstract ( 104 )   PDF (3060KB) ( 87 )   Objective To study the antibacterial effect of dandelion aqueous extract on Enterobacteriaceae in vitro. Methods The minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) of dandelion aqueous extract against Enterobacteriaceae were determined using the minimum double dilution method. The MALDI-TOF mass spectrometer was used to detect the effect of dandelion aqueous extract on the types and contents of Enterobacteriaceae bacteria protein. Results The MIC and MBC of dandelion for Escherichia coli were 0.125 g·mL-1 and 0.5 g·mL-1 respectively, 0.125 g·mL-1 and 0.5 g·mL-1 for Enterobacter kobei, 0.06 g·mL-1 and 0.25 g·mL-1 for Enterobacter cloacae, 0.06 g·mL-1 and 0.5 g·mL-1 for Citrobacter freundii, and 0.125 g·mL-1 and 0.5 g·mL-1 for Salmonella typhi. Dandelion could inhibit the types and contents of proteins of five strains of bacteria. Conclusion The aqueous extract of dandelion has different degrees of inhibition on the growth and protein synthesis of Enterobacteriaceae. References | Related Articles | Metrics

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Determination of Sodium Valproate Concentration in Human Serum by LC-MS/MS LIU Hong, DENG Yan, XU Yongshou, WANG Sen, WANG Tingting, LI Lian, ZHAO Xinqian, WU Hui, HE Xingyou, HE Mei, YE Linhu 2022, 19(2): 154-157.  DOI: 10.19803/j.1672-8629.2022.02.09 Abstract ( 206 )   PDF (1664KB) ( 96 )   Objective To establish and validate an LC-MS/MS method for the determination of sodium valproate in human serum, and apply this method to clinical therapeutic drug monitoring (TDM). Methods Cyclohexane carboxylic acid was used as the internal standard (IS). After protein precipitation with acetonitrile, the determination was performed on a triple quadrupole mass spectrometer that used the ESI technique and operated in the multiple reaction monitoring and negative ion mode. The analyte and IS were separated on a Thermo Hypersil BDS C18 column (10×4.6 mm) with a mobile phase composed of 0.1% formic acid-methanol (15∶85) at a flow rate of 0.4 mL·min-1. The column temperature was set at 30℃. Results The linear range of sodium valproate was 5~120 μg·mL-1. The limit of quantification was 5 μg·mL-1. The RSD of accuracy and precision (within-run and between-runs) was less than 15%. The recoveries were within ±15% of the labeled values. The variation coefficient of the internal normalized matrix factor of the serum matrix was less than 15%. The samples were found to be stable when stored at 2~8℃ and -40℃. Approximately 40% of the patients in this study whose serum concentration of sodium valproate were out of the therapeutic ranges. Conclusion The established method has a high specificity and sensitivity, and the accuracy and precision meet the acceptance criteria of bioanalytical methods. The stability and dilution are acceptable. Thus this method could be used for clinical TDM and pharmacokinetic research for determination of VPA in human serum. References | Related Articles | Metrics

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Network pharmacology of protection against angina pectoris by Ginkgo Biloba ZHANG Qiang, DU Pengcheng, MAN Chunrui, SUN Qian 2022, 19(2): 158-163.  DOI: 10.19803/j.1672-8629.2022.02.10 Abstract ( 144 )   PDF (3724KB) ( 123 )   Objective To explore the biological mechanism by which Ginkgo Biloba protects against angina pectoris（AP）using network pharmacology. Methods The chemical active ingredients of Ginkgo Biloba leaves were screened from the Traditional Chinese Medicine System Pharmacology Analysis Platform (TCMSP) and the targets were collected. Such databases as TTD, TTTD, Drugbank, OMIM and GeneCards were searched for AP-related targets. A component-target-disease network was constructed with Cytoscape software. The protein-protein interaction (PPI) network was analyzed using STRING database. GO enrichment analysis and KEGG signal pathway analysis were performed on related targets. Results After selection, 30 active components of Ginkgo Biloba leaves and 111 potential target genes for AP were obtained. The active ingredients, such as quercetin, kaanide and ferulic acid, mainly acted on PIK3CG, MAPK14, NOS3, Akt1 and other key targets. Through fluid shear stress, PI3K-Akt, MAPK, calcium signaling pathway and other signaling pathways, these active ingredients protected against angina pectoris by means of anti-inflammation, anti-oxidation, anti-apoptosis, and regulation of ion channels. Conclusion The potential mechanism of Ginkgo Biloba for AP has been explored based on the multi-component, multi-target, and multi-pathway characteristics of traditional Chinese medicine, which can facilitate subsequent research and clinical application of Ginkgo Biloba in the treatment of AP and extended indications. References | Related Articles | Metrics

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Efficacy and safety of sintilimab in patients with advanced colorectal cancer CAI Jiangxia, CHEN Siying, DONG Kai, QIN Jianpin, ZHANG Yue, QI Ruifeng, YE Yinmei 2022, 19(2): 164-168.  DOI: 10.19803/j.1672-8629.2022.02.11 Abstract ( 1255 )   PDF (1378KB) ( 134 )   Objective To study the efficacy and adverse reaction of sintilimab combined with chemotherapy in patients with advanced colorectal cancer. Methods 82 patients with advanced colorectal cancer who had failed first-line chemotherapy with oxaliplatin in Bayinguoleng Mongolian Autonomous Prefecture Hospital between January 1, 2018 and July 31, 2020 were randomly divided into group A and group B. Patients in group A underwent second-line chemotherapy involving irinotecan and capecitabine (referred to as XELIRI regimen), while those in group B were given sintilimab combined with XELIRI chemotherapy. The short-term efficacy, long-term efficacy and adverse reactions were compared between the two groups. Results As of February 28, 2021, the clinical efficacy among the 82 patients with advanced colorectal cancer could be evaluated. The Objective response rate (ORR) was 20.00% in group A and 21.42% in group B. The disease control rate (DCR) was 65.00% in group A and 71.43% in group B. There was no significant difference in ORR or DCR between the two groups (P>0.05). The median PFS of group B was superior to that of group A, with statistically significant significance (P<0.05). As for adverse reactions, there was no significant difference between the two groups in blood toxicity, gastrointestinal tract reactions (nausea/vomiting), diarrhea or elevation of transaminase (P > 0.05). However, the incidence of such adverse reactions (mainly mild reactions of grade I to II) as rash, hypothyroidism and proteinuria was higher in group B than in group A, which were considered to be related to sintilimab. One patient developed grade III rash reaction, but the rash was completely relieved one month after withdrawal and after one week of symptomatic treatment. Overall adverse reactions were tolerable in both groups. Conclusions intilimab combined with second-line XELIRI chemotherapy is of potential benefit for patients with advanced colorectal cancer, with generally tolerable adverse reactions and controllable safety. References | Related Articles | Metrics

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Common questions about statistics in communication between drug sponsors and regulators in China LI Xinxu, TANG Zhimin, ZHOU Jun, TAN Mingmin, LU Mingliang, WANG Jingzhao, WANG Jun 2022, 19(2): 169-175.  DOI: 10.19803/j.1672-8629.2022.02.12 Abstract ( 243 )   PDF (1372KB) ( 314 )   Objective To encourage drug sponsors to optimize communication applications and to improve the efficiency of communication with the Center for Drug Evaluation (CDE) of National Medical Products Administration in China by summarizing the common questions about statistics encountered in communication between drug developers and technical reviewers, analyzing the flaws, and giving proposals for improvement. Methods The communication applications submitted by drug sponsors and handled by the author in the communication subsystem of the CDE drug technical review system between 2018 and 2020 were collected. Statistics-related questions were extracted from applications and categorized and then the commonly-asked questions were selected from categories. Finally, the inadequacies of these common questions were analyzed and regulatory considerations for improvement were elaborated. Results More than 400 communication applications were collected. The common questions related to statistics involved sample size estimations and margins of hypothesis tests, multiplicities, adaptive designs, interim analyses, bridging studies in clinical trials, and Chinese subgroup evaluations of global multi-regional clinical trials. The analysis results showed that there were such inadequacies as insufficient supporting information and misplaced or implicit questions. Accordingly, corresponding regulatory considerations were recommended. Conclusion Good communication requires the joint efforts of both sides. It is hoped that drug sponsors will optimize communication applications, ensure the sufficiency of supporting information and ask explicit questions so as to improve the efficiency of communication. References | Related Articles | Metrics

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Problems with and suggestions about expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs in China LIU Min, PEI Xiaojing, WANG Haixue 2022, 19(2): 176-179.  DOI: 10.19803/j.1672-8629.2022.02.13 Abstract ( 966 )   PDF (1261KB) ( 1046 )   Objective To improve the quality of expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs. Methods This article was based on the questions of safety reports received by regulators over the past two years combined with the current requirements and developments of expedited reporting at home and, screened several common problems. Results Some common problems about expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs in China were analyzed and suggestions were offered. Conclusion Personnel engaged in expedited reporting during clinical trials of drugs should have accurate understanding of the requirements of guidelines and regulations related to pharmacovigilance at home and abroad so as to better protect the safety of subjects. References | Related Articles | Metrics

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The Mechanism of monitoring of adverse drug reaction cluster signals and disposal at the provincial level LU Changfei, CUI Xiaokang, LIU Wenwen, ZHANG Huaqi, GAO Wenzheng, WU Shifu 2022, 19(2): 180-184.  DOI: 10.19803/j.1672-8629.2022.02.14 Abstract ( 626 )   PDF (1355KB) ( 627 )   Objective To explore the working mechanism of monitoring of adverse drug reaction cluster signals and disposal at the provincial level. Methods Based on ways of monitoring in Shandong Province, the patterns and characteristics of adverse drug reaction cluster signals were summarized, specific requirements were clarified and advice on improving the monitoring of ADR cluster signals was given. Results and Conclusion The monitoring and disposal of adverse drug reaction cluster signals requires that the main responsibilities of drug marketing authorization holders are fulfilled, risk control be given the top priority, multi-sided collaboration and closed-loop disposal be ensured. References | Related Articles | Metrics

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Pesudoallergic reactions during post-marketing non-clinical safety reevaluation of traditional Chinese medicine injections YI Yan, TIAN Jingzhuo, LI Chunying, ZHAO Yong, LIANG Aihua 2022, 19(2): 185-188.  DOI: 10.19803/j.1672-8629.2022.02.15 Abstract ( 151 )   PDF (1184KB) ( 147 )   Objective To advise on post-marketing non-clinical safety evaluation of traditional Chinese medicine injection TCMI. Methods The importance of post marketing non clinical safety reevaluation of TCMI was highlighted while the main problems and causes were discussed. Based on the related research by the author's team and focusing on pesudoallergic reactions which were the main ADR of TCMI, this paper elaborated on ways to establish a post-marketing non-clinical safety re-evaluation technical system of TCMI in terms of detection, risk control and prevention of pseudoallergic reactions. Results and Conclusion It is of special importance to identify the major problems with each type of TCMI, analyze the all the factors related to these problems, systematically design the post-marketing safety research scheme, and innovate the ideas and methodology of research. References | Related Articles | Metrics

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Evaluation and significance of benefit-risk analysis of benzbromarone-induced liver injury WANG Yi, REN Jingtian 2022, 19(2): 189-192.  DOI: 10.19803/j.1672-8629.2022.02.16 Abstract ( 196 )   PDF (1263KB) ( 147 )   Objective To analyze the benefit-risk of DILI caused by benzbromarone and to provide reference for its safe use. Methods The adverse reactions to benzbromarone recorded in the National ADR Database from building to June 30, 2020 and the UMC database from building to August 9, 2020 and related literature were collected and analyzed. Results A total of 874 reports of DILI were retrieved from spontaneous reports of adverse reactions to benzbromarone received from the real world in both domestic and international adverse reaction monitoring databases. Patients were mostly males aged 18 to 64. Adverse reactions were mostly described as abnormal liver function and elevated aminotransferase. The outcome of domestic patients was good. Conclusion There is the risk of DILI from benzbromarone. Strengthening intervention and monitoring of liver function can effectively help prevent serious DILI. References | Related Articles | Metrics

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Effects of voriconazole on immunosuppressive concentrations and clinical outcomes in transplant patients CAO Xin, CUI Xiangli 2022, 19(2): 193-195.  DOI: 10.19803/j.1672-8629.2022.02.17 Abstract ( 107 )   PDF (1176KB) ( 76 )   Objective To review the concentrations of immunosuppressants when used with voriconazole and the adverse clinical outcomes caused by voriconazole in order to provide references for safe and rational clinical use of this drug. Methods Domestic and foreign literature about the effect of voriconazole on immunosuppressants as well as the combined dosage recommended in guidelines in different countries were reviewed. Results The effect of voriconazole on immunosuppressants varied widely from individual to individual. The dosage of voriconazole recommended in different instructions and guidelines was not applicable to each patient. Conclusion The combination of voriconazole and immunosuppressants requires individualized administration according to the blood concentration and genetic polymorphisms of enzymes in liver drugs References | Related Articles | Metrics

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Analysis and treatment of drug- induced anaphylactic shock in a third-class hospital from 2009 to 2019 TENG Wei, PANG Xiaoyun 2022, 19(2): 196-199.  DOI: 10.19803/j.1672-8629.2022.02.18 Abstract ( 160 )   PDF (1343KB) ( 173 )   Objective To standardize the prevention and treatment of drug-related anaphylactic shock, so as to ensure the safety and effectiveness of clinical medication. Methods The drug-related anaphylactic shock reports reported by Renji Hospital, Shanghai Jiaotong University School of Medicine through the National Adverse Drug Reaction Monitoring System from January 1, 2009 to December 31, 2019 were collected. The general information, sensitizing drugs, treatment drugs and prognosis of the patients were retrospectively analyzed. Results A total of 62 reports of drug-related anaphylactic shock were included. The sexes of the patients were 56 males and 6 females. The ratio of males to females was 9.33∶1. The ages were mainly distributed over 60 years old (61.29%). The average time of anaphylactic shock was (9.90±11.44) min, and it mainly occurred in the initial stage of medication <10 min (74.2%). In terms of drug treatment, 36 cases (58.06%) were treated with epinephrine, and most (27 cases, 75%) were administered by intravenous bolus injection, followed by intramuscular injection (3 cases, accounting for 8.35%) . In the reports of 27 cases of intravenous bolus injection and 3 cases of intramuscular injection, the single dose was too large. Outcome: cured or improved accounted for 98.38%. Conclusion Anaphylactic shock usually occurs quickly and severely. While paying attention to the prevention of adverse reactions, it is necessary to pay attention to the correct rescue of anaphylactic shock and regulate the use of epinephrine in time to ensure the safety of patients. References | Related Articles | Metrics

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115 cases of drug-related adverse reactions in the liver LYU Juan, GUO Weiyan, WANG Yuanji, LI Yamei, WANG Yingli, DUAN Shiwan 2022, 19(2): 200-204.  DOI: 10.19803/j.1672-8629.2022.02.19 Abstract ( 297 )   PDF (1416KB) ( 287 )   Objective To investigate the incidence and clinical characteristics of drug-induced liver injury and provide reference for medication. Methods The medical records of drug induced liver injury collected from the hospital information management system between January 1, 2016 and December 31, 2019 were retrospectively analyzed. The basic information, biochemical indexes, clinical classification, grades of injuries, drugs involved, onset time, outcomes and therapeutic drugs were recorded. Results Fifty males and sixty-five females with a mean age of (57.98±16.64) years were enrolled in this study. Drug induced liver injury mostly occurred within 3 months of medication (n=74, 62.71%). The top three drugs were cardiovascular agents (n=38, 32.20%), traditional Chinese medicine (n=32, 27.12%) and endocrine drugs (n=13, 11.02%). Conclusion This study has found that females are more vulnerable to liver injury, and that cardiovascular drugs are most likely to lead to liver injury. Medical institutions should strengthen medical staff's training, advance their understanding of drug induced liver injury, and ensure active prevention, early identification and quick treatment for patients. References | Related Articles | Metrics

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Detection and evaluation of adverse event signals of ribavirin, lopinavir / ritonavir and chloroquine phosphate based on FAERS database ZHOU Ruiou, JI Huanhuan, GONG Li, ZHANG Ni, SONG Lin 2022, 19(2): 205-209.  DOI: 10.19803/j.1672-8629.2022.02.20 Abstract ( 256 )   PDF (1329KB) ( 187 )   Objective To mine and evaluate the safety signals of ribavirin, lopinavir/ ritonavir, chloroquine phosphate and to provide reference for clinical rational drug use. Methods The reporting odd ratio (ROR) data mining algorithm was used to investigate ADE risk signals from FAERS submitted to the FDA between January 1, 2004 and December 31, 2019. The top 30 reporting ADE and designated medical event (DME) signals were the focus of analysis. Results The top 30 ADEs of the three target drugs were similar. What was more significant was the signals from the hematological toxicity of ribavirin, the hepatotoxicity, cardiac toxicity and immune reconstitution inflammatory syndrome of lopinavir / ritonavir and from the cardiotoxicity and ocular toxicity of chloroquine phosphate. The common DME signals of the three drugs were involved in liver failure, hemolysis, hemolytic anemia, bone marrow failure and Steven-Johnson syndrome. Conclusion The detection of ADE signals based on the real-world spontaneous reporting database can contribute to safety evaluation of ribavirin, lopinavir/ritonavir, chloroquine phosphate while reducing the risk of clinical medication. References | Related Articles | Metrics

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Literature analysis of 191 cases of anaphylactic shock induced by lidocaine ZHU Zhixiang, YANG Jun, DAI Yuanyuan 2022, 19(2): 210-212.  DOI: 10.19803/j.1672-8629.2022.02.21 Abstract ( 207 )   PDF (1313KB) ( 128 )   Objective To study the characteristics and regularity of anaphylactic shock induced by lidocaine and provide reference for clinical application. Methods Three cases of anaphylactic shock developed after administration of lidocaine between October 1, 2016 and December 31, 2019 in the National Cancer Center were analyzed. Literature related to anaphylactic shock that was published as of December 2019 was retrieved from such databases as Pubmed, CNKI and Wanfang. Results A total of 191 cases were collected. The median age was 35 years old and the ratio of males to females was 1：1.15. Among these cases, 57 (29.8%) had a history of allergy, 155 (81.2%) developed anaphylactic shock within 10 minutes of lidocaine use, 164 (85.9%) recovered and 27 cases (14.1%) died. The mortality rate, which varied according to the onset time of shock, was statistically different not only between the group with an onset time ≤5 min and the group with an onset time of 5 min<t≤10 min, but also between the group under topical anesthesia and the group with local infiltration. Conclusion The occurrence and fatality of anaphylactic shock induced by lidocaine may be related to the allergy history of local anesthetics, dosage and ways of anesthesia. Clinicians should inquire about the allergy history in detail, choose proper dosage and speed of administration and monitor patients in the whole course of lidocaine use. References | Related Articles | Metrics

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One case of serious liver injury induced by Xiaojin tablets YANG Xiaolu, CAO Shan, XIONG Bo, QIN Zhen, XIA Yun, QU Hong 2022, 19(2): 213-216.  DOI: 10.19803/j.1672-8629.2022.02.22 Abstract ( 215 )   PDF (1164KB) ( 270 )   Objective To explore the correlations between serious liver function injury and Xiaojin tablets. Methods The adverse reactions of one case of serious liver injury caused by Xiaojin tablets were analyzed to study the correlation with Xiaojin tablets. The mechanism by which the medicinal ingredients and preparations caused adverse reactions was investigated by searching literature. Results According to the RUCAM table specified in the Guidelines for Clinical Diagnosis and Treatment of Herb-induced Liver Injury, this patient was diagnosed with chronic drug-induced liver cell injury. The RUCAM score was 8 (most likely), and the severity level was 3. The side effects of Xiaojin tablets might have been related to the toxic components. Conclusion The serious liver injury caused by Xiaojin tablets is related to the patient's autoimmunity, drug composition and quality standard. References | Related Articles | Metrics

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One case of erythema multiforme drug eruption induced by acetylcysteine capsule combined with fudosteine tablets WANG Xin, ZHANG Jie, ZHANG Ming, ZHANG Nan, AI Chao 2022, 19(2): 217-218.  DOI: 10.19803/j.1672-8629.2022.02.23 Abstract ( 302 )   PDF (1171KB) ( 248 )   Objective To explore the possible mechanism by which acetylcysteine capsules combined with fordostetin tablets cause erythema multiforme drug eruption. Methods One case of erythema multiforme drug eruption caused by oral acetylcysteine capsules combined with fordosteine tablets in February 2020 and rdlared Literature were analyzed. Results Three days after taking acetylcysteine capsules and fudosteine tablets, the patient had blisters on feet, followed by skin rupture and epidermal peeling. The same symptoms were then observed in hands, which was believed to be erythema multiform drug eruption caused by drugs. After the discontinuation of acetylcysteine capsules and fudosteine tablets, the patient's skin symptoms gradually improved. Conclusion The combined application of acetylcysteine capsules and fudosteine tablets may cause erythema multiform drug eruption, so clinicians should be alert to related adverse drug reactions. References | Related Articles | Metrics

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Toxic epidermal necrolysis caused by multi-drug combinations: a case report LIU Xuejiao, YUE Huijie, WU Yanzi, HUANG Xiaohui 2022, 19(2): 219-220.  DOI: 10.19803/j.1672-8629.2022.02.24 Abstract ( 141 )   PDF (1129KB) ( 137 )   Objective To investigate the etiology of toxic epidermal necrolysis. Methods The process of diagnosis and treatment of one case of toxic epidermal necrolysis was reviewed. The causes of serious drug adverse reactions were analyzed based on drug screening, pathogen detection and genetic detection. Results The drugs that might have caused toxic epidermal necrolysis included cefoperazone sulbactam sodium, loperamide and pantoprazole. The Narranjo score failed to distinguish suspicious drugs. The ALDEN score judged the three drugs as“probable”, “possible” and “possible”. Genetic test showed that the patient did not have any mutation of human leukocyte antigen alleles. The etiology of the patient's blood detected the fine ring virus type 16, type 27 and human herpes virus type 5, which might have increased the susceptibility to the disease. Conclusion The toxic epidermal necrolysis of this patient might have been caused by cefoperazone sulbactam sodium along with viral infection and low immunity. References | Related Articles | Metrics

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One case of long-term blurred vision induced by atropine combined with penehyclidine hydrochloride injection HU Zhihong, ZHAO Yunhua 2022, 19(2): 221-223.  DOI: 10.19803/j.1672-8629.2022.02.25 Abstract ( 137 )   PDF (1163KB) ( 103 )   Objective To investigate the mechanism of blurred vision induced by atropine combined with penehyclidine hydrochloride. Methods The process of diagnosing and treating a patient with blurred vision caused by atropine and penehyclidine hydrochloride during general anesthesia was analyzed while the mechanism by which long-term blurred vision was caused by atropine combined with penehyclidine hydrochloride was investigated based on literature analysis. Results The patient had blurred vision postoperatively, but no obvious abnormality was found after eye examination, so no special treatment was given. The patient recovered spontaneously after 2 weeks. Conclusion The long-term blurred vision caused by atropine combined with penehyclidine hydrochloride is related to the fact that both of them are anticholine drugs. To prevent adverse reactions, drugs of the same type should not be used in combination. When the combination is absolutely necessary, it is critical to prevent the synergy of two drugs and reduce the dosage. References | Related Articles | Metrics

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One case of acute hepatic and renal failure induced by flurbiprofen axetil injection YUAN Xiaolong, TAO Donghong, WAN Qihua 2022, 19(2): 224-227.  DOI: 10.19803/j.1672-8629.2022.02.26 Abstract ( 228 )   PDF (1172KB) ( 135 )   Objective To provide evidence for clinical use of flurbiprofen axetil injection and to prevent liver and kidney damage. Methods A retrospective view of the process of diagnosis and treatment of one patient was analyzed, who was cured with flurbiprofen axetil injection after unicompartmental knee arthroplasty and then appeared acute hepatic and renal failure. The relevance evaluation of severe adverse reaction was carried according to the ADR criteria established by National ADR Monitoring Center. Results The liver and kidney functions of the patient were restored to normal after the patient was stopped the flurbiprofen axetil injection and treated with blood purification combined with hemoperfusion and some liver protection and anti-infection medicines. Conclusion This case reminds us that in the clinical application of flurbiprofen axetil injection, in addition to paying attention to adverse reactions such as gastrointestinal tract and skin allergies, we also need to pay close attention to changes in liver and kidney function. At the same time, be vigilant for the symptoms and signs that predict liver and kidney toxicity, so as to ensure that clinical medications are effective and safe. References | Related Articles | Metrics

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Research progress in human serum albumin injections LU Song, YANG Ping, YANG Li, DONG Xianzhe, ZHANG Lan 2022, 19(2): 228-232.  DOI: 10.19803/j.1672-8629.2022.02.27 Abstract ( 725 )   PDF (1260KB) ( 316 )   Human serum albumin (HSA) injections based on the “Guidelines for Comprehensive Evaluation of Chinese Drugs”were evaluated. The guidelines for diagnosis and treatment, pharmacopoeias, drug inserts, literature and official data related to HSA injections were consulted, while the safety, efficacy, compliance, cost, and clinical value of HSA were assessed. HSA injections are widely used in clinical practice and are quite safe, but they are too expensive and have not yet entered the national medical insurance catalogue. HSA injections have been recommended by guidelines in many countries for the treatment of such diseases as liver cirrhosis and hypovolemic shock, but there are still cases of inappropriate medication. References | Related Articles | Metrics