Pub Date : 2020-03-28DOI: 10.3760/CMA.J.CN114015-20200214-00113
Li Chen, Hailong Li, Xun Liu, Chen Chen, Qiusha Yi, Chuan Zhang, Dan Liu, Haibo Song, Lingli Zhang
Objective To explore the clinical safety of lopinavir/ritonavir (LPV/r) by mining the risk signals of adverse events (AEs) related to LPV/r for the safe application of the drug in the treatment of novel coronavirus pneumonia (COVID-19). Methods The risk signals related to LPV/r in AE reports of US FDA Adverse Event Reporting System (FAERS) from the first quarter of 2010 to the third quarter of 2019 were mined by reporting odds ratio (ROR). An AE with reports more than 3 and 95% confidence interval (CI) lower limit of ROR greater than 1 was defined as a positive signal. AEs were counted and classified using the preferred system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities (MedDRA). The PTs of top 50 adverse event reports and signal strength were selected and analyzed. Results From the first quarter of 2010 to the third quarter of 2019, a total of 13 335 AE reports with LPV/r as the primary suspicious drug were reported in the FAERS database. Four hundred and fifty-five AE risk signals with reports more than 3 and the 95%CI lower limit of ROR greater than 1 were detected, involving 7 718 AE reports. The top 2 system organs involved in AE reports were "injury, poisoning and procedural complications" [13.6% (1 051/7 718)] and "pregnancy, puerperium and perinatal conditions" [11.7% (899/7 718)]. However, 998 (95.0%) of 1051 AE reports involved in "injury, poisoning and procedural complications" were related to drug exposure during pregnancy. The system organ with the highest signals was "congenital, familial and genetic disorders" [16.3% (74/455)]. In addition, 144 AEs caused by drug interactions were detected, which ranked the 7th in the AE reports. Conclusions The risk signals of fetal, neonatal and infant abnormalities related to LPV/r during pregnancy were detected, suggesting that attention should be paid to the risk of using LPV/r in pregnant women and infants. The interaction between LPV/r and other drugs was also worthy of attention. Key words: Lopinavir; Ritonavir; Coronavirus; Coronavirus infections; Adverse drug reaction reporting systems; United States Food and Drug Administration; Signal processing, computer-assisted
{"title":"Study on the risk signal mining related to lopinavir/ritonavir based on the US FDA Adverse Event Reporting System","authors":"Li Chen, Hailong Li, Xun Liu, Chen Chen, Qiusha Yi, Chuan Zhang, Dan Liu, Haibo Song, Lingli Zhang","doi":"10.3760/CMA.J.CN114015-20200214-00113","DOIUrl":"https://doi.org/10.3760/CMA.J.CN114015-20200214-00113","url":null,"abstract":"Objective \u0000To explore the clinical safety of lopinavir/ritonavir (LPV/r) by mining the risk signals of adverse events (AEs) related to LPV/r for the safe application of the drug in the treatment of novel coronavirus pneumonia (COVID-19). \u0000 \u0000 \u0000Methods \u0000The risk signals related to LPV/r in AE reports of US FDA Adverse Event Reporting System (FAERS) from the first quarter of 2010 to the third quarter of 2019 were mined by reporting odds ratio (ROR). An AE with reports more than 3 and 95% confidence interval (CI) lower limit of ROR greater than 1 was defined as a positive signal. AEs were counted and classified using the preferred system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities (MedDRA). The PTs of top 50 adverse event reports and signal strength were selected and analyzed. \u0000 \u0000 \u0000Results \u0000From the first quarter of 2010 to the third quarter of 2019, a total of 13 335 AE reports with LPV/r as the primary suspicious drug were reported in the FAERS database. Four hundred and fifty-five AE risk signals with reports more than 3 and the 95%CI lower limit of ROR greater than 1 were detected, involving 7 718 AE reports. The top 2 system organs involved in AE reports were \"injury, poisoning and procedural complications\" [13.6% (1 051/7 718)] and \"pregnancy, puerperium and perinatal conditions\" [11.7% (899/7 718)]. However, 998 (95.0%) of 1051 AE reports involved in \"injury, poisoning and procedural complications\" were related to drug exposure during pregnancy. The system organ with the highest signals was \"congenital, familial and genetic disorders\" [16.3% (74/455)]. In addition, 144 AEs caused by drug interactions were detected, which ranked the 7th in the AE reports. \u0000 \u0000 \u0000Conclusions \u0000The risk signals of fetal, neonatal and infant abnormalities related to LPV/r during pregnancy were detected, suggesting that attention should be paid to the risk of using LPV/r in pregnant women and infants. The interaction between LPV/r and other drugs was also worthy of attention. \u0000 \u0000 \u0000Key words: \u0000Lopinavir; Ritonavir; Coronavirus; Coronavirus infections; Adverse drug reaction reporting systems; United States Food and Drug Administration; Signal processing, computer-assisted","PeriodicalId":7863,"journal":{"name":"药物不良反应杂志","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90624849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Opinions on safety of chloroquine phosphate dosing regimen for novel coronavirus pneumonia","authors":"Xiaohan Xu, N. He, Ning Shen, Jie Xu, S. Zhai","doi":"10.3760/CMA.J.CN114015-20200310-00179","DOIUrl":"https://doi.org/10.3760/CMA.J.CN114015-20200310-00179","url":null,"abstract":"国家卫生健康委员会和国家中医药管理局2020年2月18日发布的《新型冠状病毒肺炎诊疗方案（试行第六版）》将磷酸氯喹作为抗病毒试用药物之一，其后又于同月26日发布了《关于调整试用磷酸氯喹治疗新冠肺炎用法用量的通知》，2020年3月3日发布的《新型冠状病毒肺炎诊疗方案（试行第七版）》对磷酸氯喹给药方案进行了修订。磷酸氯喹半衰期长、全身分布广泛，易在体内蓄积，且不良反应与剂量相关。本文结合磷酸氯喹的药代动力学特点对给药方案进行了安全性分析，供临床医师和药师在诊治新型冠状病毒肺炎患者时参考，以降低发生不良反应的风险。","PeriodicalId":7863,"journal":{"name":"药物不良反应杂志","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77914675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Rational use and pharmaceutical care of traditional Chinese medicine injections in the treatment of novel coronavirus pneumonia","authors":"Jia Li, Juan Xu, Liang Yang, Fang Liu, Chun-miao Xue","doi":"10.3760/CMA.J.CN114015-20200224-00162","DOIUrl":"https://doi.org/10.3760/CMA.J.CN114015-20200224-00162","url":null,"abstract":"我国《新型冠状病毒肺炎诊疗方案（试行第六版）》推荐了8个品种的中药注射剂，包括喜炎平注射液、血必净注射液、热毒宁注射液、痰热清注射液、醒脑静注射液、参附注射液、生脉注射液和参麦注射液。8个中药注射剂主要适用于重型和危重型患者，其中喜炎平注射液适用于疫毒闭肺证患者，血必净注射液适用于瘀毒互结证和内闭外脱证患者，热毒宁注射液适用于疫毒闭肺证患者，痰热清注射液适用于痰热阻肺证患者，醒脑静注射液适用于热入营血，内陷心包证患者，参附注射液适用于内闭外脱证和阳气暴脱之厥脱证患者，生脉注射液适用于气阴两虚证和内闭外脱证患者，参麦注射液适用于气阴两虚证患者。中药注射剂最常见的不良反应为过敏反应，严重者可发生过敏性休克，应注意监测。","PeriodicalId":7863,"journal":{"name":"药物不良反应杂志","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75984118","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-02-28DOI: 10.3760/CMA.J.ISSN.1008-5734.2020.02.007
Hao-dong Cai
Three antiviral drugs, including interferon α (aerosol inhalation), lopinavir/ritonavir (oral medication), and ribavirin (intravenous infusion), are recommended by Diagnosis and Treatment of Novel Coronavirus Pneumonia (revised version, the 5th ed), which was issued by the National Health Commission of People′s Republic of China and National Administration of traditional Chinese Medicine. In addition, clinical trials on a new antiviral drug ---remdesivir which is not yet on the market has also been launched in China. Medication safety related data on treatment for infections of severe acute respiratory syndrome coronavirus, middle respiratory syndrome coronavirus, human immunodeficiency virus, lopinavir/ritonavir, and ribavirin, safety data of remdesivir in animal experiment, phase I clinical trials and clinical trials of treating Ebola virus infection, and preliminary reports of treatment in novel coronavirus pneumonia were briefly reviewed, aiming to provide evidence for clinical safety medication. Key words: Coronavirus infections; SARS virus; Middle East respiratory syndrome coronavirus; Antiviral agents
{"title":"Safety application of novel coronavirus pneumonia antiviral drugs","authors":"Hao-dong Cai","doi":"10.3760/CMA.J.ISSN.1008-5734.2020.02.007","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1008-5734.2020.02.007","url":null,"abstract":"Three antiviral drugs, including interferon α (aerosol inhalation), lopinavir/ritonavir (oral medication), and ribavirin (intravenous infusion), are recommended by Diagnosis and Treatment of Novel Coronavirus Pneumonia (revised version, the 5th ed), which was issued by the National Health Commission of People′s Republic of China and National Administration of traditional Chinese Medicine. In addition, clinical trials on a new antiviral drug ---remdesivir which is not yet on the market has also been launched in China. Medication safety related data on treatment for infections of severe acute respiratory syndrome coronavirus, middle respiratory syndrome coronavirus, human immunodeficiency virus, lopinavir/ritonavir, and ribavirin, safety data of remdesivir in animal experiment, phase I clinical trials and clinical trials of treating Ebola virus infection, and preliminary reports of treatment in novel coronavirus pneumonia were briefly reviewed, aiming to provide evidence for clinical safety medication. \u0000 \u0000 \u0000Key words: \u0000Coronavirus infections; SARS virus; Middle East respiratory syndrome coronavirus; Antiviral agents","PeriodicalId":7863,"journal":{"name":"药物不良反应杂志","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77685003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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