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15 July 2020, Volume 17 Issue 7 Previous Issue    Next Issue

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Pharmacologic Mechanism and Safety Risk Analysis of Hydroxychloroquine WANG Tao, LIU Jicai, PANG Yu 2020, 17(7): 385-388.  DOI: 10.19803/j.1672-8629.2020.07.01 Abstract ( 836 )   PDF (882KB) ( 879 )   Objective To analyze the safety risk of hydroxychloroquine so as to provide reference for clinical rational use of this drug. Methods The individual adverse drug reaction cases reported by WHO Vigilyze, China adverse drug reaction database, domestic literature and risk management plans of foreign regulatory agencies were analyzed. Results As of April 26, 2020, a total of 28 031 cases of hydroxychloroquine-caused ADRs were reported in the WHO Vigilyze database, 13 498 of which (48.2%) were serious ones. Clinical manifestations included skin rashes, nausea, allergic reactions, pain, joint swelling, fatigue and diarrhea. Between January 2004 and December 2019, 2 506 cases of ADRs associated with hydroxychloroquine sulfate tablets were reported to China adverse drug reaction database, 285 of which (11.4%) were serious, mainly related to skin and appendages disorders, gastrointestinal disorders, neurological disorders, vision disorders, and general disorders. The adverse reactions were mainly manifested as rashes, itching, dizziness, headache, nausea, abnormal vision, diarrhea and vomiting. Conclusion Attention should be paid to the possible adverse reactions caused by hydroxychloroquine in clinical use, such as cutaneous damage, gastrointestinal disorders, neurological disorders, visual damage and cardiovascular diseases. We should reinforce the safety monitoring of hydroxychloroquine, with special attention to such adverse reactions as cardiac toxicity, in order to promote the rational application of this medicine. References | Related Articles | Metrics

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Improving Pharmacovigilance System in China amid the COVID-19 Epidemic LIU Pengcheng, CHEN Jinmin, YAO Wenbing 2020, 17(7): 389-392.  DOI: 10.19803/j.1672-8629.2020.07.02 Abstract ( 908 )   PDF (1096KB) ( 420 )   Objective To propose ways to improve China's pharmacovigilance system amid the COVID-19 epidemic. Methods Such methods as literature research were employed to study the applicability of the current pharmacovigilance system in China to the outbreak of COVID-19. Results During the COVID-19 pandemic, the current pharmacovigilance system could be weak in terms of ADR reporting, evaluation, communication and feedbacks. Conclusion The National Medical Products Administration (NMPA) needs to cooperate with the National Health Commission (NHC) to set up a collaborative working group on drug safety. An automated and intelligent data transmission channel should be established between the National Center for ADR Monitoring and medical institutions. A special reporting and feedback channel during the outbreak should be added to meet the needs of rapid collection of all suspected adverse drug reactions. Experts from research institutions should be invited to speed up the analysis and evaluation of adverse drug reactions. Also, risk communication methods and contents should be tailored for medical institutions and public media based on different goals. References | Related Articles | Metrics

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Meta Analysis of Efficacy and Safety of Ribavirin in the Treatment of COVID-19 ZHANG Jin, LIU Ziyun, ZHANG Jun, YANG Jianjun, ZHANG Xiaoyu, JIANG Fengli, WU Yiping, YANG Beibei, LI Xinghuan, CHEN Yuyan, LIU Dong, REN Wei 2020, 17(7): 393-398.  DOI: 10.19803/j.1672-8629.2020.07.03 Abstract ( 617 )   PDF (1473KB) ( 267 )   Objective To evaluate the efficacy and safety of ribavirin for COVID-19 by systematically reviewing previous clinical studies of coronavirus pneumonia. Methods Such databases as Pubmed, EMbase, Cochrane Library, Google Scholar, CNKI, Wanfang Data, VIP and CBM were searched. The date of the latest search was April 29, 2020. Clinical studies on ribavirin used in the severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) were included. The literature was screened according to the inclusion and exclusion criteria and the methodological quality of the included studies was assessed by two reviewers independently. Meta-analysis was performed using Review Manager 5.3 software. Results In total, 7 studies were included, resulting in a sample size of 870 cases. The overall pooled data demonstrated that the difference in mortality rates between the ribavirin group and control group was not statistically significant in the treatment of SARS and MERS[OR=1.10,95％CI（0.79,1.55）,P=0.57]. In the subgroup analysis, the mortality rate was not significantly different between the ribavirin group and control group in the treatment of SARS and MERS whether ribavirin was combined with interferon or not. Conclusion Ribavirin does not make much difference to mortality in the treatment of SARS and MERS, but it can increase drug safety risks. Thus, the applicability of ribavirin in the treatment of COVID-19 remains to be investigated References | Related Articles | Metrics

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A Case of Adverse Drug Reactions of Lopinavir and Ritonavir Tablets and Literature Analysis AN Wei, TIAN Ying, CHEN Min, YANG Ping, ZHANG Mingwei 2020, 17(7): 399-402.  DOI: 10.19803/j.1672-8629.2020.07.04 Abstract ( 433 )   PDF (733KB) ( 157 )   Objective To analyze the adverse reactions of lopinavir and ritonavir tablets in a COVID-19 patient in order to provide reference for clinical medication. Methods The clinical data of a patient with newly diagnosed COVID -19 in the Third People's Hospital of Hubei province was collected, including medical history, results of physical examination, diagnosis and treatment plans, outcomes of laboratory and imaging examination. The relationships between nausea, vomiting, diarrhea, epistaxis and medication were determined. Results Based on the analysis of the patient's medication and treatment of adverse reactions, and according to the national Provisions for Adverse Drug Reaction Reporting and Monitoring, the correlations of lopinavir and ritonavir with nausea, vomiting, diarrhea and epistaxis were evaluated. It was found that the above symptoms were probably caused by the antiviral drug lopinavir and ritonavir. Conclusion Lopinavir and ritonavir is recommended for the antiviral treatment of COVID -19, but it is worth noting that it is associated with such adverse reactions as nausea, vomiting, diarrhea and interactions with other drugs. References | Related Articles | Metrics

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Effect of Aristolochic Acid I on Liver Metabolic Enzymes of Mice JI Hainan, LI Haishan, SONG Naining, LI Bin, SUI Feng, LI Yingfei, GUO Jiabin, JIA Qiang, LI Hua, GAO Yue, SHEN Guolin 2020, 17(7): 403-407.  DOI: 10.19803/j.1672-8629.2020.07.05 Abstract ( 282 )   PDF (1150KB) ( 124 )   Objective To determine the effect of aristolochic acid I (AAI) on the liver metabolic enzymes of mice and the associated mechanism using metabolic kinetics and related techniques. Methods Male 6-week-old C57BL/6 mice were assigned to four treatment groups and one control group. Established doses of AAI (0.2, 2, 10, and 20 mg/kg) were administered intragastrically 5 days per week for 4 weeks. The effects of AAI on liver metabolic enzymes were determined using metabolic kinetics and molecular biology techniques. Results AAI induced enzyme activities and mRNA expressions of liver cyp1a2 and cyp3a11, and increased the content of indoxylsulfuric acid by inducing sulfotransferase (SULT1B1). However, renal toxicity induced by AAI was the main cause of the accumulation of indoxylsulfuric acid in the plasma, liver, and kidney, which in turn aggravated the renal toxicity caused by AAI. Conclusion AAI has multiple effects on liver metabolic enzymes in mice. References | Related Articles | Metrics

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Self-reporting of Adverse Drug Reactions by Inpatients Based on Internet plus Big Data Technology XING Weiqing, WU Jianru, MAO Qiurong, CHENG Bin 2020, 17(7): 408-411.  DOI: 10.19803/j.1672-8629.2020.07.06 Abstract ( 487 )   PDF (1018KB) ( 424 )   Objective To explore means for patients' self-reporting of adverse drug reactions so as to provide reference for a spontaneous reporting model. Methods Based on analysis of the status quo,patients' means of self-reporting were designed and used in related medical institutions. Results In the process of adopting these means on a trial basis in medical institutions,169 people scanned the applet. Excluding the repeated ADR reports , 25 copies of report forms were collected.A total of 10 effective reports which had not been spotted by the health care providers were collected. Conclusion Due to the limited scope and duration of the pilot project, the number of reports collected this way was limited.The results can be further studied so as to provide reference for the promotion of spontaneous reporting. References | Related Articles | Metrics

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Application of QCC in Improving Monitoring of ADR Reports in a Hospital YANG Juanyan, YANG Fangrong, YANG Shuang, DAI Jiansong, YANG Ling, BAO Gang 2020, 17(7): 412-417.  DOI: 10.19803/j.1672-8629.2020.07.07 Abstract ( 444 )   PDF (1933KB) ( 314 )   Objective To enhance the monitoring and management of adverse drug reaction (ADR)reports so as to improve the quality of ADR surveillance and management and promote the safe and rational use of drugs. Methods The data on ADR reports was statistically analyzed and designed by the Department of Pharmacy as a table to find, using QCC management tools, the causes of problems with ADR surveillance and management before the QCC was employed. Measures for improvement were drafted and the effect was confirmed. Results After the adoption of the QCC, the level of ADR monitoring and management was greatly improved. The incidence of unrecorded causes of disease, delayed reports and improper writing of reports was decreased significantly, with an improvement rate of 68.1%. The target achievement rates were 123.1%, 112.5% and 116.7%, respectively. The levels of communication and coordination and work efficiency were obviously improved, and the QCC technique was improved significantly. Conclusion The QCC activities carried out in our hospital have helped to standardize the monitoring and management of ADR reports while improving the patients' awareness of safe and rational drug use. References | Related Articles | Metrics

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325 Cases of Adverse Drug Reactions Induced by Drospirenone and Ethinylestradiol Tablets (II) ZHOU Boya, YUAN Sisi, LIN Jingyu, ZHOU Yingqun, FENG Xin 2020, 17(7): 418-424.  DOI: 10.19803/j.1672-8629.2020.07.08 Abstract ( 396 )   PDF (1119KB) ( 392 )   Objective To analyze the data on adverse drug reactions caused by of drospirenone and ethinylestradiol tablets (II) in order to contribute to clinical rational application of this drug and to make recommendations for clinical application. Methods Case reports on adverse reactions associated with drospirenone and ethinylestradiol tablets (II) in Beijing between 2015 and 2018 were analyzed retrospectively. Results The adverse reactions caused by drospironone and ethinylestradiol tablets (II) were mainly manifested as reproductive system diseases, gastrointestinal diseases and nervous system diseases. Conclusion The adverse reactions induced by drospirenone and ethinylestradiol tablets are generally tolerable. Although low-dose drospironone and ethinylestradiol tablets cause fewer adverse reactions, the risk of venous thromboembolism remains. It is recommended that the risk of medication be assessed before use, a long-term, systematic follow-up be maintained with the patients, and high-quality reporting of adverse reactions be encouraged. In order to reduce the risk of drug use and promote the long-term rational use of drospirenone and ethinylestradiol (II), evidence should be updated and new adverse reactions should be added to the drug instructions. References | Related Articles | Metrics

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1270 Cases of Adverse Drug Reactions Induced by Acanthopanax Injection WEN Xiaoling, ZHANG Yan, LAN Shan 2020, 17(7): 425-430.  DOI: 10.19803/j.1672-8629.2020.07.09 Abstract ( 440 )   PDF (1196KB) ( 330 )   Objective To analyze the safety of acanthopanax injection used in Sichuan Province, and explore the patterns and characteristics of adverse reactions induced by acanthopanax injection in order to provide technical support for safe and rational use of drugs in clinic. Methods A total of 1 270 cases of adverse reactions induced by acanthopanax injection collected between January 1, 2014 and August 31, 2019 were retrospectively studied and statistically analyzed. Results According to the information on monitoring, the ADRs of acanthopanax injection mostly occurred in middle-aged and elderly patients over 45 years old, and most of the ADRs occurred in the first 30 minutes after medication, involving a wide range of organs and systems. The main ADRs were skin and accessory lesions, systemic damage, respiratory damage, cardiovascular damage, gastrointestinal damage, nervous system damage, vascular damage and coagulopathy, damage to the injection site, immune dysfunction and infection . Prompt interventions in ADRs could help alleviate or cure the symptoms. Conclusion Attention should be paid to safe and rational use of acanthopanax injection. Clinical nursing and monitoring of adverse drug reactions have to be enhanced to prevent over-indications and over-dosage medication. References | Related Articles | Metrics

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Analysis of 70 Cases of Children with Drug-induced Liver Injury LI Jing, HE Limei, ZHANG Haixia, YANG Zhi, PENG Cuiying 2020, 17(7): 431-436.  DOI: 10.19803/j.1672-8629.2020.07.10 Abstract ( 570 )   PDF (1047KB) ( 295 )   Objective To study the clinical features, causal drugs and treatment of drug-induced liver injury(DILI) in children in order to contribute to rational drug application. Methods The clinical data on 70 children with DILI treated in Hunan Children's Hospital between January 2015 and May 2019 was analyzed. Results The ratio of males to females among these 70 cases was 2.04:1. Most of the children were aged 1 month to 1 year. Forty percent of the patients exhibited few apparent symptoms, except a few of them who exhibited fever, fatigue and poor appetite without specificity. Diagnosis suggested that most of these patients suffered from hepatocellular liver injury (28.57%), cholestasis liver injury (28.57%) or mixed liver injury (18.57%). Among these cases, 21 (24.29%) were induced by antipyretic analgesics, 13 (24.29%) by antimicrobials and 12 (17.14%) by antiviral drugs. Bifendate, glutathione and diisopropylamine dichloroacetate were commonly used drugs for DILI patients. Sixty-six of these cases (94.29%) were treated with two or more types of drugs. Moreover, improper drug use was observed, such as wrong usage and dosage of biphenyl diester, wrong solvents of glycyrrhizin and polyene phosphatidylcholine injection, and inappropriate concentrations of potassium and magnesium aspartate. Conclusion Overdose of antipyretic and analgesic drugs, antibacterial drugs and antiviral drugs in patients can result in significant hepatotoxicity. Clinicians should carefully select drugs and treat DILI children with drugs according to the instructions. References | Related Articles | Metrics

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Infusion Requirements on Labels of 39 Chinese Traditional Medicine Injections WENG Lihong, GAO Huan, HU Xue, ZHANG Wenrui 2020, 17(7): 437-440.  DOI: 10.19803/j.1672-8629.2020.07.11 Abstract ( 391 )   PDF (1048KB) ( 273 )   Objective To investigate the instructions on infusion on some labels of Traditional Chinese Medicine (TCM) injections in order to provide reference for clinical treatment and standardized management. Methods The instructions of some TCM injections were collected, and the requirements specified in the instructions were analyzed, involving the administration route, preparation methods, solvents, concentration, storage conditions, and infusion speed before the integrity of and problems with the labels were examined. Results All the thirty-nine instructions of TCM injections had the routes of administration specified. Twenty-seven of them (87.10%) were marked with preparation methods, twenty-four (77.42%) concentrations of preparation solutions, ten (32.26%) storage conditions, twenty-four (61.54%) the infusion speed, eighteen (48.65%) flushing tubes, and two (5.13%) with material requirements of infusion sets. Conclusion Among these TCM injection instructions, requirements are not quite specific as to the storage of solvents, flushing of tubes and the materials of infusion sets. It is suggested that manufacturers supplement the details in the instructions to provide reference for clinical treatment and standardized management. References | Related Articles | Metrics

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Analysis of One Case of purpura fulminans Induced by Gefitinib Tablets FAN Pengli, LU Lele, WANG Yimeng, LIU Yinping 2020, 17(7): 441-443.  DOI: 10.19803/j.1672-8629.2020.07.12 Abstract ( 524 )   PDF (726KB) ( 321 )   Objective To explore the treatment of purpura fulminans induced by gefitinib tablets, so as to provide reference for clinical rational use of drugs. Methods The mechanism and countermeasures of purpura fulminans induced by gefitinib tablets were studied by literature retrieval and analyzing the treatment process of a patient. Results 5 days after taking gefitinib tablets, the patient was diagnosed with purpura fulminans. The drug was stopped immediately so that the symptoms on the patient’s skin were relieved gradually via treatment with vitamin C, calcium gluconate, methylprednisolone sodium succinate and other supportive treatment. Conclusion Gefitinib-induced purpura fulminans should be stopped immediately, and the EGFR-TKI should be given again after the adverse reactions have improved. References | Related Articles | Metrics

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Research Progress of Weight Gain Induced by Antidepressants ZHENG Xue, SI Jigang 2020, 17(7): 444-447.  DOI: 10.19803/j.1672-8629.2020.07.13 Abstract ( 448 )   PDF (717KB) ( 441 )   Objective Antidepressants, especially new antidepressants, are widely used, and the weight gain caused by them has been taken seriously into account. Methods Search the articles about weight gain caused by antidepressants published at home and abroad, and summarize the manifestations and reason of weight gain caused by antidepressants, and compare the effects of different drugs on weight, and look for prevention and treatment measures. Results Alot of antidepressants can lead to weight gain, especially in the second and third year. The most important reason is the increase of intake after blocking H1 receptor and 5-HT2C receptor. Mirtazapine has been supposed to causes the most weight gain, then SSRI and so on. Bupropion, wotexitin, verazolone and minopram did not gain weight. During the course of antidepressant treatment, weight gain can be solved by changing life style and replacement of drugs. Conclusion Doctors should pay attention to the possible weight gain when using antidepressants。It is improment to choose drugs reasonably,to inform and remind patients appropriately, to intervene in time after weight gain. References | Related Articles | Metrics