参附脱毒胶囊治疗阿片类急性戒断综合征的系统评价  

Shenfutuodu Capsule for Acute Opioid Withdrawal Syndrome:A Systematic Review

作　　者：李博[1] 李峰[1] 吴泰相[2] 

机构地区：[1]北京中医药大学基础医学院中医诊断系,北京100029 [2]四川大学华西医院循证医学与临床流行病学中心,成都610041

出　　处：《中国循证医学杂志》2005年第9期684-691,共8页Chinese Journal of Evidence-based Medicine

基　　金：高等学校优秀青年教师教学科研奖励计划资助~~

摘　　要：目的评价中药参附脱毒胶囊(Shenfutuodu capsule)治疗阿片类物质依赖急性戒断综合征的疗效和安全性.方法计算机检索MEDLINE(1966～2005 年),EMBASE(1974～2005 年),Cochrane图书馆光盘2005年第1期,中国生物医学文献光盘数据库(CBMdisc),中文生物医学期刊数据库(CMCC), VIP中文科技期刊数据库(Web版),中国期刊网全文数据库(Web版),万方数据库,中国医学学术会议论文数据库(CMAC)和日本<医学中央雑誌>,并辅以手工检索.对纳入研究的质量进行评价,用RevMan 4.2软件进行Meta 分析.结果共收集到有关参附脱毒胶囊的文献12 篇,其中符合纳入标准的仅3篇,共293例.3个研究均比较了参附脱毒胶囊和可乐定治疗期间的戒断症状评分,第5天时两组差异有统计学意义[WMD -3.14, 95%CI (-6.28,-0.01)];第0～4天及第6～10天时两组差异无统计学意义,其WMD(95%CI)分别为58.45 (53.88,63.02), -1.15 (-5.69,3.40), -0.42 (-4.55,3.70), -0.77 (-4.37,2.84), -1.54 (-4.78,1.69), -1.76 (-4.25,0.74), -1.74 (-3.89,0.41), -1.24 (-3.28,0.80), -0.52 (-1.96,0.92), -0.27 (-1.64,1.11).参附脱毒胶囊组与可乐定组第3天疗效差异无统计学意义,OR(95%CI)值为1.52 (0.79, 2.95). 治疗后各组HAMA量表评分差异无统计学意义,其第0天、第5天和第10天的HAMA量表评分的WMD(95%CI)分别为-0.55 (-3.74,2.64), 0.34 (-2.02,2.70), 0.63 (-0.21,1.47).两组头晕发生率差异有统计学意义,其RR (95%CI)为0.73 (0.62,0.87).但两组口干、思睡和视物模糊的发生率差异无统计学差异,RR(95%CI)分别为1.11 (0.95,1.29), 0.99 (0.82,1.21)和0.92 (0.70,1.19).第2天时两组不良反应评分差异有统计学意义[WMD -1.26, 95%CI (-2.40, -0.12)].第1天、第3～10天两组不良反应评分差异无统计学意义,其WMD(95%CI)分别为-0.55 (-1.48,0.38), -0.63 (-1.67,0.42), -0.84 (-1.77,0.09), -0.29 (-1.09,0.51), 0.15 (-0.52,0.81), 0.22 (-0.22,0.67), 0.09 (-0.25, 0.44), 0.03 (-0.21,0.27), -0.03 (-0.33,0.26).结论根据现有证据,参附�Objective To assess the effectiveness and safety of Shenfutuodu capsule in the treatment of opioid withdrawal syndrome. Methods We searched The Cochrane Library （ Issue 1 , 2005 ） , MEDLINE （1966 -2005） , EMBASE （1974-2005） , and some Chinese databases for additional articles （ CBMdisc, CMCC, VIP, CNKI ） （1980-2005 ）. The quality of included randomized controlled trials was evaluated and meta-analysis was performed.Results Our initial search identified just three studies involving 293 patients met the inclusion criteria and were of higher quality. There was a statistical difference between Shenfutuodu capsule and clonidine groups on the fifth day in withdrawl symptom score with weight mean difference （WMD） -3.14 and 95% confidence interval （CI） -6.28 to -0.01. And no statistical difference was detected between the two groups in withdrawal symptom score on the 0^th-4^th day and the 6^th-10^th daywith WMD 58.45（95% CI 53.88 to 63.02）, -1. 15 （95% CI -5.69 to 3.40） , -0.42（95% CI -4.55 to 3.70）, -0.77（95%CI -4.37 to 2. 84）, -1.54（95%CI -4.78 to 1.69）, -1.76（95%CI -4.25 to0.74） , -1.74（95%CI -3.89 to0.41）, -1.24（95%CI -3.28 to0.80）, -0.52（95%CI -1.96 to0.92 ） and -0.27（95% CI -1.64 to 1.11 ） respectively. There was no statistical difference on effectiveness between the two groups on the third day with WMD 1.52, （95% CI 0.79 to 2.95）. There was no statistical difference between the two groups in HAMA score on the first , fifth and tenth day with WMD -0.55（95% CI -3.74 to 2.64） , 0.34 （95% CI -2.02 to 2.70） , 0. 63 （95% CI -0.21 to 1.47 ） respectively. There was a statistical difference between the two groups in dizziness rate with RR 0.73 （95% CI 0.62 to 0.87 ） . No statistical difference was detected between the two groups in dry mouth with RR 1.11（ 95% CI 0.95 to 1.29） , somnolence with RR 0.99（ 95% CI 0.82 to 1.21） , and blurred vision with RR 0.92（ 95% CI 0.70 to 1.19）. Statistical difference was detected between

关 键 词：参附脱毒胶囊/康复新/康复欣胶囊 阿片类急性戒断综合征 系统评价 

分 类 号：R749.6[医药卫生—神经病学与精神病学]