福康片治疗阿片类戒断症状的疗效及安全性评价

目的系统评价中药福康片(Fukangpian)治疗阿片类戒断症状的疗效和安全性.方法计算机检索Medline(1966～2004年)、EMBase(1974～2004年)、Cochrane Library 2004年的Cochrane ControlledTrials Register、Current Controlled Trials和The National Research Register数据库.同时检索中国生物医学文献数据库、中文科技期刊全文数据库、中文学术期刊全文数据库和中国生物医学期刊文献数据库(1980～2004年),并辅以手工检索.对纳入研究的质量进行评价,用RevMan 4.2.7软件进行Meta分析.结果共收集到有关福康片的文献31篇,其中符合纳入标准的仅2篇,403例.2个研究比较了福康片组、可乐定组治疗期间的戒断症状总分,随着治疗的进展,总分逐渐下降,前3天下降最为明显,福康片组较可乐定组下降更为明显,其差异有统计学意义,第1、2、3、4天的95%CI分别为(3.48,13.14)、(4.79,15.10)、(3.01,10.59)和(5.47,12.52);治疗前各组HAMA量表评分较高,治疗后各组HAMA量表评分快速下降.22个研究比较了福康片组、安慰剂组治疗期间的戒断症状总分,随着治疗的进展,总分逐渐下降,前3天下降最为明显,福康片组较安慰剂组下降更为明显,其差异有统计学意义,第4天下降无统计学意义.第1、2、3天的95%CI分别为(5.50,29.30)、(17.70,40.33)、(12.49,35.91),第4天WMD 4.10,95%CI(-8.36.16.56);结论根据现有证据,福康片是一种有效的戒毒药物,但尚需更多高质量研究以增加证据的强度.

Systematic Review of Effectiveness and Safety of Fukangpian in the Treatment of Opiate Withdrawal Symptoms

Objective To assess the effectiveness and safety of fukangpian in the treatment of opiate withdrawl symptoms. Methods We performed an electronic search for Cochrane Library (2004 version of Cochrane Controlled Trials Register), Medline (19662004), EMbase (19742004), and handsearched some Chinese journals for additional articles (such as CBM disc, VIP, CNKI, CMCC) (19802004). The quality of included randomized controlled trials was evaluated and meta-analysis was performed. Results We collected 31 studies about fukangpian, of which two studies involving 403 patients met the inclusion criteria. These two studies were of poor quality. Cmpared with clonidine, fukangpian showed a greater decrease than Clonidine group in the withdrawal symptom score for day 1 to day 4 (WMD of 9 points at day 4, 95%CI 5.47 to 12.52). Cmpared with placebo, the two studies for change in the withdrawal symptom score, fukangpian showed a greater decrease at day 1 to 3, but not at day 4 (WMD of 4.10 points at day 4, 95%CI -8.36 to 16.56; 1 study). Conclusions Based on the current evidence fukangpian is an effective and safe drug for abstinence of drug addiction. More high quality randomized controlled trials are required to promote the strength of evidence.