今日药学

2018, v.28(02) 134-139

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双膦酸盐治疗原发性骨质疏松致严重不良反应系统评价再评价
The Safety of Bisphosphonates for Primary Osteoporosis: An Overview of Systematic Reviews

张建萍;卢丽清;陈永昌;邓伟民;李健;
ZHANG Jianping;LU Liqing;CHEN Yongchang;DENG Weimin;Li Jian;College of Pharmacy,Jinan University;General Hospital of Guangzhou Military Command of PLA;

摘要(Abstract):

目的对双膦酸盐(Bisphosphonate,BPs)治疗原发性骨质疏松致严重不良反应进行系统评价再评价。方法计算机检索Cochrane Library、Pub Med、Web of science、中国知网(CNKI)、维普数据库(VIP)、中国生物医学文献数据库(CBM)及万方数据库,并进行手工检索,收集BPs治疗原发性骨质疏松的安全性系统评价/Meta分析,提取心血管不良反应、致癌性、下颌骨坏死和非典型性骨折等主要结局指标。采用AMSTAR工具评价纳入系统评价的方法学质量,采用Revman5.3软件对心血管不良反应进行Meta分析。结果共纳入有关BPs安全性的系统评价19篇,AMSTAR评分均为中高等质量。心血管不良反应Meta分析结果显示,使用BPs后房颤和严重房颤发生率明显高于其他抗骨质疏松药及安慰剂(P<0.05)。对其他不良反应进行描述性分析结果显示,使用BPs会增加非典型性骨折和下颌骨坏死发生率,延长骨折愈合时间。结论 BPs治疗骨质疏松引起的严重不良反应主要为房颤和严重房颤,长期使用者应注意非典型性骨折及下颌骨坏死等罕见且严重不良反应。
OBJECTIVE To systematically assess serious adverse drug reaction(ADR) of bisphosphonates(BPs) in the treatment of primary osteoporosis. METHODS Cochrane Library,Pub Med,Web of science,CNKI,VIP,CBM and Wanfang Database were electronically searched for meta-analysis and systematic reviews about the safety of bisphosphonates. Primary outcomes were extracted: cardiovascular adverse reactions,carcinogenicity,atypical fracture,osteonecrosis of jaw and fracture union time. References of some primary studies were hand-searched. Methodological qualities of the included systematic reviews were assessed by the AMSTAR tool. Meta analysis was conducted for cardiovascular adverse reactions using Revman5.3 software. RESULTS A total of 19 systematic reviews were included for this overview. All included systematic reviews were of moderate or high quality. Meta analysis showed that BPs treatment for primary osteoporosis significantly increased risk of atrial fibrillation and serious atrial fibrillation( P < 0. 05). Descriptive analysis showed that BPs treatment also increased risk of atypical fracture and osteonecrosis of jaw,increased fracture union time compared with placebo or other anti-osteoporosis drug. CONCLUSION The serious ADR of BPs are atrial fibrillation and serious atrial fibrillation. Long-term user should pay attention to risk of atypical fracture and osteonecrosis of jaw.

关键词(KeyWords): 原发性骨质疏松;双膦酸盐;安全性;Meta分析;系统评价再评价
primary osteoporosis;bisphosphonates;safety;Meta-analysis;overviews of systematic review

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作者(Author): 张建萍;卢丽清;陈永昌;邓伟民;李健;
ZHANG Jianping;LU Liqing;CHEN Yongchang;DENG Weimin;Li Jian;College of Pharmacy,Jinan University;General Hospital of Guangzhou Military Command of PLA;

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