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1、仙灵骨葆胶囊上市后用药安全性系统评价 平安性，计算机检索Medline，EMbase，the Web of Science，Clinical Trials gov，the Cochrane Library，CNKI，VIP，WanFang Data，CBM。按纳入、排出标准筛选文献，依据国际公认的质量评价标准进行各类探讨质量的评价，提取资料并进行分析。该探讨最终纳入156篇文献，随机比照试验117篇，半随机比照试验11篇，非随机比照试验10篇，病例系列 11 篇，个案报告7篇，共分析167项探讨。7 496例患者运用仙灵骨葆胶囊，累计发生不良反应共377例，严峻不良反应4例，其中包含1例死亡病
2、例，1例脑血管意外，1例皮肤过敏反应和1例胃肠道不适；轻度ADR中最常见为胃肠损害。该探讨分析发觉仙灵骨葆胶囊总体平安性可接受，虽系统分析了关于该药平安性病例报告的干脆证据，但缺少针对该药上市后平安性的机制探讨或前瞻性长期的临床视察性探讨，因此关于其平安性探讨还需进一步深化；同时仙灵骨葆胶囊在适应症方面，临床中存在超说明书运用范围，因此须要相关部门尽快制定用药规范，给临床用药供应更好的指导。 关键词仙灵骨葆胶囊； 不良反应； 系统评价； 平安性 Systematic review on safety of Xianling Gubao capsule ZHANG Yili， LIAO Xing
3、， LIU Fumei， WANG Guiqian， XIE Yanming* AbstractTo systemically evaluate the safety of Xianling Gubao capsule after launching Computer retrieval of Medline， EMbase， the Web of Science， Clinical Trials gov， the Cochrane Library， CNKI， VIP， WanFang Data and CBM was conducted to collect information on
4、all the research types of Xianling Gubao capsule The literature was screened according to inclusion and exclusion criteria， and the quality of the studies was assessed according to the internationally accepted quality evaluation standards for data extraction and analysis A total of 156 papers were i
5、ncluded in this study， including 117 randomized control trials， 11 quasirandomized control trials， 10 noandomized control trials， 11 case report series， and 7 individual case reports； a total of 167 studies were analyzed Xianling Gubao capsules were used in 7 496 patients， with an accumulative 377 c
6、ases of adverse reactions and 4 cases of severe adverse reactions， including 1 death， 1 cerebrovascular accident， 1 case of skin allergy reaction， and 1 case of gastrointestinal discomfort； gastrointestinal system damage was most common in mild ADRs In this study， we found that the overall safety of
7、 Xianling Gubao capsule was acceptable， but it lacked the mechanism study on the safety of the drug after marketing or the prospective longterm clinical observation study， so the further studies on the safety of drug use should be conducted Meanwhile， the application scope of Xianling Gubao capsules
8、 was beyond the manual， in urgent needs of the relevant departments to formulate norms and provide better guidance for clinical medication Key wordsXianling Gubao capsule； evidencebased medicine； systematic review； safety 第3页 共3页第 3 页 共 3 页第 3 页 共 3 页第 3 页 共 3 页第 3 页 共 3 页第 3 页 共 3 页第 3 页 共 3 页第 3 页 共 3 页第 3 页 共 3 页第 3 页 共 3 页第 3 页 共 3 页