摘要
系统评价心元胶囊临床用药时不良反应/事件发生情况。计算机检索Medline,EMbase,the Web of Science,Clinical Trials,the Cochrane Library,CNKI,VIP,Wan Fang Data和CBM。根据纳排标准筛选文献、提取资料。由于各研究之间异质性较大,该研究只作描述性分析。按照研究类型、疾病诊断、不良反应/事件发生情况分别描述。所有纳入研究均按目前国际上公认的报告质量评价标准或方法学质量评价工具进行评估。最终纳入42个研究,其中2 439人服用心元胶囊,1 242人未服用。所有纳入研究中未见严重不良反应发生,1例不良事件为死亡。在单独或联合服用心元胶囊的病人中,发生各种不良反应16例,其中心元胶囊联合其他药发生各种不良反应7例,心元胶囊单独用药发生各种不良反应9例。最多报告的不良反应来自消化系统,主要表现口干、恶心、呕吐、上腹不适、胀痛等。消化系统不良反应10例,泌尿系统3例,皮肤、呼吸、循环各发生1例。心元胶囊临床用药总体安全,关于心元胶囊用药安全性的研究虽有报道,但均散在各种临床研究之中,今后仍需加强该药安全性的研究,如开展专门针对该药安全性的机制研究或临床观察性研究,以便将来更好地指导临床用药。
To systematically review the adverse drug reactions/adverse events（ ADRs/AEs） of Xinyuan capsules in clinical application. A systematic literature search was performed in the databases of the Cochrane Library,Medline,EMBASE,the Web of Science,Clinical trials,CNKI,VIP,Wan Fang Data and CBM. The literature was screened and data was extracted according to the inclusion and exclusion criteria. Because of the substantial heterogeneity among different studies,we assessed them only with descriptive analysis by study type,disease diagnosis,and ADRs / AEs conditions. All included studies were assessed by using the internationally recognized report quality evaluation standard or methodological quality assessment tools. A total of 42 studies involving 3 671 patients were included finally. Two thouand four hundred and thirty-mine patients of them took Xinyuan capsules,and 1 242 patients did not take Xinyuan capsules. No serious ADRs occurred in all patients. One patient died as AE during the research. Sixteen patients of the 2 439 patients taking Xinyuan capsules（ alone or in combination） had ADRs,including 7 patients with polytherapy of Xinyuan capsules and 9 patients with monotherapy. The most common ADRs were in gastrointestinal tract,mainly including thirst,nausea,vomiting and abdominal pain,etc. The ADRs included 10 gastrointestinal tract ADRs,3 renal ADRs and 1 ADR respective in skin system,respiratory system and cardiovascular system. Xinyuan capsules was generally safe in clinical application. The reports on the study of Xinyuan capsules were dispersed in various clinical studies,the study on drug safety still should be strengthened in the future. Further mechanism studies or clinical observation studies of the drug safety shall be conducted to better guide clinical application in the future.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2016年第9期1744-1753,共10页
China Journal of Chinese Materia Medica
基金
国家"重大新药创制"科技重大专项(2015ZX09501004-001-002)
中央级公益性科研院所基本业务费项目(Z0406
PY1303)
中国中医科学院客座研究员联合创新研究项目(ZZ070817)
关键词
心元胶囊
不良反应
系统综述
安全性
Xinyuan capsules
adverse drug reaction（ADR）
systemic review
safety
