仙灵骨葆胶囊上市后用药安全性系统评价

报告7篇，共分析167项研究。7 496例患者使用仙灵骨葆胶囊，累计发生不良反应共377例，严重不良反应4例，其中包含1例死亡病例，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。该研究分析发现仙灵骨葆胶囊总体安全性可接受，虽系统分析了关于该药安全性病例报告的直接证据，但缺少针对该药上市后安全性的机制研究或前瞻性长期的临床观察性研究，因此关于其安全性研究还需进一步深入；同时仙灵骨葆胶囊在适应症方面，临床中存在超说明书使用范围，因此需要相关部门尽快制定用药规范，给临床用药提供更好的指导。

[关键词]仙灵骨葆胶囊； 不良反应； 系统评价； 安全性

Systematic review on safety of Xianling Gubao capsule

ZHANG Yili， LIAO Xing， LIU Fumei， WANG Guiqian， XIE Yanming*

（Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， Beijing 100700， China）

[Abstract]To 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 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 included 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 cases of adverse reactions （ADR） 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 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 was beyond the manual， in urgent needs of the relevant departments to formulate norms and provide better guidance for clinical medication

[Key words]Xianling Gubao capsule； evidencebased medicine； systematic review； safety

推荐访问:胶囊 用药 安全性 评价 上市