独一味胶囊疗效和安全性的循证评价  

Efficacy and Safety of Lamiophlomis Rotata(Benth)Kudo:A Systematic Review of Randomized Controlled Trials

作　　者：王凌[1] 徐琳[1] 李雨璘[1] 艾昌林[1] 李静[1] 

机构地区：[1]四川大学华西医院循证医学与临床流行病学教研室,成都610041

出　　处：《中国循证医学杂志》2008年第12期1060-1078,共19页Chinese Journal of Evidence-based Medicine

摘　　要：目的系统评价藏药独一味胶囊止血、镇痛和抗炎的疗效与安全性。方法计算机检索CBM光盘版(1978～2008.6)、CNKI(1980～2008.6)、MEDLINE(1966～2008.6)以及CochraneCentralRegisterofControlledTrial(Cochrane图书馆2008年第2期)数据库发表的独一味胶囊文献,结合厂家提供的独一味胶囊临床研究,筛选合格随机对照试验(RCT)。根据Cochrane评价员手册5.0评估纳入研究偏倚风险,采用RevMan5.0软件进行统计分析。结果共纳入70个RCT,其中止血20篇,止血及镇痛10篇,镇痛29篇,抗炎11篇。纳入研究存在发生偏倚的高度风险,Meta分析结果显示:①止血:纳入30个RCT,独一味胶囊止血总有效率优于有效药物[OR=3.86,95%CI(2.56,5.82)]和空白对照[OR=14.85,95%CI(7.16,30.80)],对出血量的影响优于有效药物和空白对照,对出血时间的影响优于空白对照,但与有效药物比较差异无统计学意义。②镇痛:纳入37个RCT,独一味胶囊镇痛总显效率优于有效药物[OR=3.01,95%CI(2.23,4.06)]、空白对照[OR=6.06,95%CI(3.14,11.70)]和安慰剂[OR=2.91,95%CI(1.48,5.73)]。与空白对照比较可以降低疼痛患者的疼痛积分[MD=?–?0.84,95%CI(–?0.97,–?0.72)]。③抗炎:独一味胶囊抗炎总有效率优于有效药物[OR=3.36,95%CI(1.90,5.96)],单个RCT显示独一味胶囊降低关节肿胀度优于有效药物,但关节肿胀数两组比较差异无统计学意义。④安全性:共有12个研究报告了轻微不良反应,如轻微恶心、轻度腹泻、胃部不适,未见严重不良反应事件。结论现有研究显示独一味胶囊治疗不同原因引起的出血、疼痛和炎症有一定疗效,且安全性好。但纳入研究间存在异质性和发生偏倚的高度风险,影响结果的真实性和可靠性,故应谨慎看待结果。仍需高质量、多中心的随机对照研究为独一味胶囊疗效提供更真实、可靠的证据。Objective To assess the efficacy and safety of Lamiophlomis rotata （Benth） Kudo in treating bleeding, pain, and inflammation of different causes. Methods Based on the principles and methods of Cochrane systematic reviews, we searched CBM （from establishment to June 2008）, CNKI （1980 to June 2008）, MEDLINE （1966 to June 2008）, and Cochrane Central Register of Controlled Trials （The Cochrane Library, issue 2, 2008 ） to identify randomized controlled trials （RCTs） of Lamiophlomis rotata （Benth） Kudo. We assessed the risk of bias of the included RCTs according to the Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1. The Cochrane Collaboration＇s software RevMan 5.0 was used for meta-analysis. Results We included 70 RCTs, of which there were 20 RCTs on bleeding, 10 RCTs on both bleeding and pain, 29 RCTs on pain, and 11 RCTs on inflammation. Most of the included studies were of low quality with a high risk of bias. ① Bleeding： We included 30 RCTs on bleeding. Meta-analysis showed that Lamiophlomis rotata （Benth） Kudo had a higher total effective rate of hemostasis compared with other hemostatics （OR 3.86, 95%CI 2.56 to 5.82） or the blank control group （OR 14.85, 95%CI 7.16 to 30.80）. Patients in the Lamiophlomis rotata （Benth） Kudo group had less blood loss compared with other hemostatics or the blank control group and were associated with shorter duration of bleeding compared with the blank control group, but no statistical difference was noted when compared with other hemostatics. ② Pain： We included 37 RCTs on pain. Meta-analysis showed that Lamiophlomis rotata （Benth） Kudo had a higher total effective rate of analgesia compared with other paregorics （OR 3.01, 95%CI 2.23 to 4.06）, the blank control group （OR 6.06, 95%CI 3.14 to 11.70）, or placebo （OR 2.91, 95%CI 1.48 to 5.73）. Patients in the Lamiophlomis rotata （Benth） Kudo group had lower pain score compared with the blank control group （MD -0.84, 95%CI -0.97 to -0.7

关 键 词：独一味胶囊 系统评价 META分析 

分 类 号：R29[医药卫生—民族医学]