中国临床药理学杂志
中國臨床藥理學雜誌
중국림상약이학잡지
THE CHINESE JOURNAL OF CLINICAL PHARMACOLOGY
2015年
12期
1197-1201
,共5页
骨质疏松症%双膦酸盐%网状荟萃分析%骨折%胃肠道不良反应
骨質疏鬆癥%雙膦痠鹽%網狀薈萃分析%骨摺%胃腸道不良反應
골질소송증%쌍련산염%망상회췌분석%골절%위장도불량반응
osteoporosis%bisphosphonate%network Meta-analysis%fracture%gastrointestinal adverse event
目的:比较双膦酸盐类抗骨质疏松药物的相对疗效与安全性。方法检索PubMed及Cochrane Database of Systematic Review,收集有关双膦酸盐有效性及安全性的Meta分析及网络Meta分析,并手工检索获得双膦酸盐之间直接比较的随机对照研究,对双膦酸盐直接比较及间接比较证据进行描述性分析。结果共纳入Meta分析17篇,包括双膦酸盐之间直接比较的Meta分析1篇,不同双膦酸盐与安慰剂对比的Meta分析10篇,双膦酸盐间相对作用比较的网络Meta分析6篇。手工检索获得双膦酸盐之间直接比较的随机对照研究8篇,直接比较结果显示,双膦酸盐间在骨折预防及安全性上差异无统计学意义( P>0.05)。间接比较结果显示,在预防腰椎、髋部、腕部、非腰椎(非髋部)骨折发生方面,分别为唑来膦酸、阿仑膦酸钠或唑来膦酸、阿仑膦酸钠、利塞膦酸钠疗效最佳。最常见导致胃肠道不良事件、恶心、因不良事件导致停药的药物,分别为唑来膦酸、唑来膦酸、依替膦酸二钠。结论双膦酸盐用于抗骨质疏松治疗是有效、安全的。在多种双磷酸盐中,唑来膦酸预防多种骨折疗效最佳,但其胃肠道不良事件也相对较多。目前双膦酸盐预防骨折直接比较及间接比较的证据质量较低,还需要设计良好的临床研究支持上述结论。
目的:比較雙膦痠鹽類抗骨質疏鬆藥物的相對療效與安全性。方法檢索PubMed及Cochrane Database of Systematic Review,收集有關雙膦痠鹽有效性及安全性的Meta分析及網絡Meta分析,併手工檢索穫得雙膦痠鹽之間直接比較的隨機對照研究,對雙膦痠鹽直接比較及間接比較證據進行描述性分析。結果共納入Meta分析17篇,包括雙膦痠鹽之間直接比較的Meta分析1篇,不同雙膦痠鹽與安慰劑對比的Meta分析10篇,雙膦痠鹽間相對作用比較的網絡Meta分析6篇。手工檢索穫得雙膦痠鹽之間直接比較的隨機對照研究8篇,直接比較結果顯示,雙膦痠鹽間在骨摺預防及安全性上差異無統計學意義( P>0.05)。間接比較結果顯示,在預防腰椎、髖部、腕部、非腰椎(非髖部)骨摺髮生方麵,分彆為唑來膦痠、阿崙膦痠鈉或唑來膦痠、阿崙膦痠鈉、利塞膦痠鈉療效最佳。最常見導緻胃腸道不良事件、噁心、因不良事件導緻停藥的藥物,分彆為唑來膦痠、唑來膦痠、依替膦痠二鈉。結論雙膦痠鹽用于抗骨質疏鬆治療是有效、安全的。在多種雙燐痠鹽中,唑來膦痠預防多種骨摺療效最佳,但其胃腸道不良事件也相對較多。目前雙膦痠鹽預防骨摺直接比較及間接比較的證據質量較低,還需要設計良好的臨床研究支持上述結論。
목적:비교쌍련산염류항골질소송약물적상대료효여안전성。방법검색PubMed급Cochrane Database of Systematic Review,수집유관쌍련산염유효성급안전성적Meta분석급망락Meta분석,병수공검색획득쌍련산염지간직접비교적수궤대조연구,대쌍련산염직접비교급간접비교증거진행묘술성분석。결과공납입Meta분석17편,포괄쌍련산염지간직접비교적Meta분석1편,불동쌍련산염여안위제대비적Meta분석10편,쌍련산염간상대작용비교적망락Meta분석6편。수공검색획득쌍련산염지간직접비교적수궤대조연구8편,직접비교결과현시,쌍련산염간재골절예방급안전성상차이무통계학의의( P>0.05)。간접비교결과현시,재예방요추、관부、완부、비요추(비관부)골절발생방면,분별위서래련산、아륜련산납혹서래련산、아륜련산납、리새련산납료효최가。최상견도치위장도불량사건、악심、인불량사건도치정약적약물,분별위서래련산、서래련산、의체련산이납。결론쌍련산염용우항골질소송치료시유효、안전적。재다충쌍린산염중,서래련산예방다충골절료효최가,단기위장도불량사건야상대교다。목전쌍련산염예방골절직접비교급간접비교적증거질량교저,환수요설계량호적림상연구지지상술결론。
Objective To evaluate the comparative effectiveness and safety of bisphosphonates.Methods PubMed and Cochrane Database of Systematic Review were electronically searched for Meta -analysis and network Meta-analysis about the effectiveness and safety of bisphospho-nates.The randomized controlled trials ( RCTs ) comparing different bi-sphosphonates were manually searched.We then complete the descriptive analysis about the direct and indirect comparison between bisphospho-nates.Results Seventeen Meta-analyses were included, including 1 Meta-analysis comparing different bisphosphonates, 10 Meta-analyses comparing bisphosphonates and placebo, and 6 network Meta-analyses. The results of direct comparison showed that there was no significant difference between different bisphosphonates in effectiveness and safety. The results of indirect comparison showed that zoledronic acid, alendr-onate or zoledronic acid, alendronate, risedronate ranked first in preven-ting vertebral fracture, hip fracture, wrist, non -hip -non -vertebral fracture among different bisphosphonates, respectively.Zoledronic acid, zoledronic acid, etidronate ranked highest in causing any gastrointestinal adverse events, nausea, and discontinuation due to adverse drug reactions among different bisphosphonates, respective-ly.Conclusion Bisphosphonates are effective and safe medications for treating osteoporosis.Although zoledronic acid ranked highest in preventing fracture, it was also more likely to cause gastrointestinal adverse events.However, the quality of a body of evidence comparing different bisphosphonates is low.More well -designed clinical studies are needed to support above conclusion.