仙灵骨葆胶囊联合氨基葡萄糖治疗膝骨关节炎有效性和安全性的Meta分析  

Efficacy and Safety of Xianling Gubao Capsule Combined with Glucosamine in the Treatment of Knee Osteoarthritis:A Meta-analysis

作　　者：郑子恢[1] 张田 李琼[1] 李文英[1] 袁华[1] 张白鸽 马琳[1] 金鹏飞[1] ZHENG Zihui;ZHANG Tian;LI Qiong;LI Wenying;YUAN Hua;ZHANG Baige;MA Lin;JIN Pengfei(Dept.of Pharmacy,Beijing Hospital/National Center of Gerontology/Institute of Geriatric Medicine,Chinese Academy of Medical Sciences/Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application(Beijing Hospital),Beijing 100730,China)

机构地区：[1]北京医院药学部/国家老年医学中心/中国医学科学院老年医学研究院/北京市药物临床风险与个体化应用评价重点实验室(北京医院),北京100730

出　　处：《中国药房》2021年第7期870-875,共6页China Pharmacy

基　　金：国家自然科学基金资助项目(No.81303216);北京市自然科学基金资助项目(No.7113164)。

摘　　要：目的:系统评价仙灵骨葆胶囊联合氨基葡萄糖治疗膝骨关节炎(KOA)的有效性和安全性,为临床KOA的治疗提供循证参考。方法:计算机检索Cochrane图书馆、PubMed、Embase、中国知网、万方数据库、中国生物医学文献数据库和维普网,检索时限为各数据库建库起至2020年11月。收集在氨基葡萄糖(对照组)的基础上联用仙灵骨葆胶囊(试验组)治疗KOA的随机对照试验(RCT),对符合纳入标准的临床研究进行资料提取后,采用Cochrane 5.1.0系统评价员手册评价质量,并采用Rev Man 5.4软件进行Meta分析。结果:共纳入11项RCT,包括970例患者。Meta分析结果显示,试验组患者治愈率[OR=2.41,95%CI(1.48,3.93),P<0.001]、显效率[OR=1.95,95%CI(1.49,2.56),P<0.001]、总有效率[OR=4.00,95%CI(2.57,6.24),P<0.001]、疼痛视觉模拟(VAS)评分[MD=-2.34,95%CI(-2.51,-2.17),P<0.001]、膝关节功能评分[MD=31.32,95%CI(27.89,34.75),P<0.001]、日本骨科协会(JOA)腰痛评分[MD=12.22,95%CI(9.68,14.76),P<0.001]和疼痛缓解时间[MD=-1.55,95%CI(-1.84,-1.25),P<0.001]方面均显著优于对照组,不良反应发生率显著低于对照组[OR=0.04,95%CI(0.02,0.12),P<0.001]。结论:仙灵骨葆胶囊联合氨基葡萄糖治疗KOA在治愈率、显效率、总有效率、VAS评分、膝关节功能评分、JOA腰痛评分和疼痛缓解时间方面明显优于单独使用氨基葡萄糖,并可明显降低不良反应发生率。OBJECTIVE:To systematically evaluate the efficacy and safety of Xianling gubao capsule combined with glucosamine in the treatment of knee osteoarthritis(KOA),and to provide evidence-based reference for clinical treatment of KOA.METHODS:Retrieved from Cochrane library,PubMed,Embase,CNKI,Wanfang database,CBM and VIP during the inception to Nov.2020,randomized controlled trials(RCTs)about glucosamine(control group)combined with Xianling gubao capsule(trial group)in the treatment of KOA were collected.After data extraction,Cochrane 5.1.0 system evaluator manual was used to evaluate the quality of the included clinical studies met inclusion criteria,and Rev Man 5.4 software was used for Meta-analysis.RESULTS:A total of 11 RCTs with 970 patients were included in this study.Results of Meta-analysis showed that cure rate[OR=2.41,95%CI(1.48,3.93),P<0.001],marked effective rate[OR=1.95,95%CI(1.49,2.56),P<0.001],total effective rate[OR=4.00,95%CI(2.57,6.24),P<0.001],visual analogue scale(VAS)score[MD=-2.34,95%CI(-2.51,-2.17),P<0.001],knee function score[MD=31.32,95%CI(27.89,34.75),P<0.001],Japanese Orthopaedic Association(JOA)low back pain score[MD=12.22,95%CI(9.68,14.76),P<0.001]and pain relief time[MD=-1.55,95%CI(-1.84,-1.25),P<0.001]of trial group were all significantly better than those of control group.The incidence of ADR in trial group was significantly lower than control group[OR=0.04,95%CI(0.02,0.12),P<0.001].CONCLUSIONS:Xianing gubao capsule combined with glucosamine in the treatment of KOA is significantly better in cure rate,marked effective rate,total effective rate,VAS,score,knee function score,JOA low back pain score and pain relief time,and could significantly reduce the incidence of ADR.

关 键 词：仙灵骨葆胶囊 氨基葡萄糖 膝骨关节炎 有效性 安全性 META分析 

分 类 号：R684.3[医药卫生—骨科学]