半夏厚朴汤加味对海洛因依赖脱毒后稽延性戒断症状和1年复吸率的影响(英文)

Effect of modified banxia houpu decoction on protracted abstinence syndrome and 1-year relapse rate after heroin-dependence detoxification

背景:半夏厚朴汤是汉代张仲景治疗情志病名方之一,一直沿用至今用以治疗抑郁症、焦虑症、神经官能症等疾病。目的:观察半夏厚朴汤加味对海洛因依赖脱毒后稽延性戒断症状和1年复吸率的影响,并与服用红糖水模拟制剂作用结果进行比较。设计:随机区组设计,安慰剂随机对照观察。单位:湖北民族学院医学院和恩施自治州公安局戒毒所。对象:选择2000-08/2002-09在湖北恩施自治州公安局强制戒毒所接受强制戒毒的海洛因依赖者187例,男101例,女86例,年龄18～44岁。均对实验目的知情同意。采用随机区组双盲法将纳入对象分为3组:对照组(n=58),服用中药60d组(n=62)和服用中药72d组(n=67)。方法:①戒毒期间3组均给予盐酸洛啡西定片(由中美合资湖南正太药业有限公司生产,批号:990619,10mg/片)脱毒治疗12d后分别隔离给药,即服用半夏厚朴汤加味60d组不间断服半夏厚朴汤加味煎剂(主要成分:制半夏15g,姜厚朴30g,茯苓20g,紫苏10g,生姜20g,刺五加20g,陈皮6g,大腹皮20g,藿香10g,均购自湖北省药材公司),1剂分2d6次服用,共60d。对照组服30%红糖水模拟制剂共60d(方法同中药煎剂),服用半夏厚朴汤加味72d组从用盐酸洛啡西定开始脱毒时即服用等量的半夏厚朴汤加味煎剂共72d(为比较本药方早期和晚期给药疗效,本组在盐酸洛啡西定脱毒期间12d内即开始给药,脱毒后继续服用60d)。即3组均在从盐酸洛啡西定脱毒治疗开始至停用所有药物共72d。患者服药采用单盲法。②采用海洛因稽延性戒断症状评定量表(量表内容:失眠状况,疼痛症状群,卡他症状,精神情绪,性功能情况,分别按轻、中、重评1,2,3分。)评估各组稽延性戒断症状轻重。③1年后尿检复查,尿检毒品代谢产物阳性者均视为复吸。④计量和计数资料差异性比较分别用t检验和χ2检验。主要观察指标:①各组药物干预后稽延性戒断症状评分结果比较。②各组1年复吸率比较。结果:海洛因依赖者187例均进入结果分析。①服用半夏厚朴汤加味60d组和服用半夏厚朴汤72d组的各稽延性戒断症状评分明显低于对照组(P<0.01)。服用半夏厚朴汤加味72d组的疼痛症状和卡他症状评分与服用半夏厚朴汤加味60d组相当(P>0.05),而失眠症状、精神情绪症状和性功能情况评分却明显低于服用半夏厚朴汤加味60d组(P<0.01)。②服用半夏厚朴汤加味72d组1年复吸率明显低于对照组和服用半夏厚朴汤加味60d组[73%(49/67),95%(55/58),82%(51/62),P<0.05],而服用半夏厚朴汤加味60d组1年复吸率与对照组相当(P>0.05)。结论:半夏厚朴汤加味可改善海洛因依赖脱毒后的稽延性戒断症状。早期运用半夏厚朴汤加味缓解稽延性戒断症状比后期运用疗效更加明显,有降低复吸率作用。

BACKGROUND： Modified banxia houpu decoction （MBHD） is one of the famous methods and has been used by Zhang Zhong-jin to treat emotional diseases in Han dynasty, and it has been used till now. It can be used to treat depression, anxiety, phychoneurosis and so on. OBJECTIVE： To observe the therapeutic effect of MBHD on treating beroin abusers with protracted abstinence syndrome and compare the effect with brown sugar water. DESIGN： Randomized grouping and placebo randomized controlled study. SETTING： School of Medicine, Hubei Institute for Nationalities and the Abstinence Institute of Public Security Bureau of Enshi Autonomous Prepecture. PARTICIPANTS： Totally 187 cases were the abusers of heroin who had been forced to abstinence in the Abstinence Institute of Public Security Bureau of Enshi Autonomous Prepecture from August 2000 to September 2002. There were 101 males and 86 females aged 18-44 years. All patients were known the fact and were randomly divided into control group （n=58）, 60-day MBHD group （n=62） and 72-MBHD group （n=67） according to double-blind method. METHODS： ① During the abstinence, three groups were treated by lofexidine hydreehloride （LFX） which was produced by the Limited Company of Zhengtai Pharmaceuticals Enterprise of Hunan Province （lot number： 990619, 10 mg/pitl） for 12 days, then they were treated separated. Give medicine to 60-MBHD group continuously for 60 days （MBHD： Pinellia Temate 15 g, Magnolia Bark 30 g, Poria Cocos 20 g, Perilla 10 g, Ginger 20 g, Radix Acanthopanacis Senticosi 20 g, Pericarpium Citri Reticulate 6 g, Pericarpium Arecae 20 g, Herba Agastachis 10 g. Traditional Chinese medicines were all bought from HuBei Medicine Company; three times a day, one portion for two days）, gave the control group red sugar water imitate medicine for 60 days （the method was the same as above）, 72-MBHD group were given the same quantity of MBHD as 60-MBHD group when LFX began to detoxificate, the whole time was 72 days （The time before LFX treat 12 days and after 60 days）. It took 72 days for the three groups to be treated by LFX according to single-blind method. ② Heroin protracted abstinence syndrome scale： insomnia, pain syndromes, catarrh syndromes, mental conditions and sexual function. They were scored respectively to 1, 2, 3 according to mild, moderate and severe. ③ One year tater collected the urina sanguinis （three times a week continuously） regarded the positive as re-abusers. ④ Measurement and enumeration data were compared with t test and X^2 test respectively. MAIN OUTCOME MEASURES： ① Scores of protracted abstinence syndrome; ② Comparisons of drug re-abusing rate within one year. RESULTS： Totally 187 heroin-dependence patients entered the final analysis.① Scores of protracted abstinence syndrome were lower in 60- day MBHD group and 72-day MBHD group than those in control group （P 〈 0.01）. Scores of pain and catarrh symptoms in 72-day MBHD groupwere similar to those in 60-day MBHD group （P 〉 0.05）, but scores of insomnia, mental conditions and sexual function were lower than those in 60-day MBHD group （P 〈 0.01）. ② Drug re-abusing rate within one year was lower in 72-day MBHD group than that in control group and 60-day MBHD group [73% （49/67）, 95% （55/58）, 82% （51/62）,P 〈 0.05], but rate in 60-day MBHD group was similar to that in control group （P 〉 0.05）. CONCLUSION： MBHD can improve the protracted abstinence symptoms of heroin abusers after detoxificatien. In spite of the complexity of various factors, to effectively control the early stage abstinence symptoms and median stage protracted abstinence symptoms is one of the effective measures to prevent drug re-abusing.