福康片治疗阿片类戒断症状的疗效及安全性评价  

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

作　　者：王雪[1] 李素霞[1] 祝三平 李进[1] 况伟宏[1] 吴泰相[3] 

机构地区：[1]四川大学华西医院精神科,成都610041 [2]成都云克药业有限公司 [3]四川大学华西医院临床流行病学教研室中国循证医学中心

出　　处：《中国循证医学杂志》2004年第8期545-549,共5页Chinese Journal of Evidence-based Medicine

摘　　要：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(196 6～ 2 0 0 4年 )、EMBase(1974～ 2 0 0 4年 )、CochraneLibrary 2 0 0 4年的CochraneControlledTrialsRegister、CurrentControlledTrials和TheNationalResearchRegister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 (1980～2 0 0 4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 ,4 0 3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 4 8,13 14 )、(4 79,15 10 )、(3 0 1,10 5 9)和 (5 4 7,12 5 2 ) ;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。 2 2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.

关 键 词：福康片 阿片类戒断症状 系统评价 

分 类 号：R749.6[医药卫生—神经病学与精神病学]