章轶立+廖星+刘福梅+王桂倩+谢雁鸣

[摘要]系統评价仙灵骨葆胶囊上市后用药安全性，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研究质量的评价，提取资料并进行分析。该研究最终纳入156篇文献，随机对照试验117篇，半随机对照试验11篇，非随机对照试验10篇，病例系列 11 篇，个案报告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 nonrandomized 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； safetyendprint

仙灵骨葆胶囊是在苗族民间验方的基础上，采用现代科研手段研制成的新型民族药。本方由著名骨伤科专家时光达教授对苗族验方进行收集、整理和筛选，最终将淫羊藿、续断、补骨脂、地黄、丹参、知母等9味中药配伍而成，主要用于治疗骨质疏松、骨折、骨关节炎、骨无菌性坏死等[1]。目前，由贵州同济堂制药有限公司独家生产（国药准字Z20025337）[2]，并作为防治骨质疏松症的首选药物入选《国家基本药物目录》[3]。……