两种电针戒毒仪对治疗急性脱毒期戒断症状的临床比较

目的:以韩氏戒毒仪为参照,验证JY-I型低频戒毒仪(简称:低频戒毒仪)治疗阿片类成瘾戒断综合征的有效性和安全性。方法:筛查合格的受试者以1∶1的比例按入组顺序随机分配到低频戒毒仪或韩氏戒毒仪组,进行10 d的治疗,并分别在基线、治疗d1、2、3、4、5、7、d11进行疗效评价和戒断症状评分,并以治疗d4作为有效评价时间。结果:d4,在符合方案(PP)人群中,低频戒毒仪组和韩氏戒毒仪组治疗总有效率分别为33.34%和25.00%,两组比较差异无显著性(P=0.2898)。在不同时间点戒断症状的评分中,低频戒毒仪组d2、d5、d7治疗前评分较基线有明显下降,与韩氏戒毒仪组相比在PP人群中差异有显著性(P=0.0193、0.0138、0.0140)。两者不良反应发生率组间统计差异无显著性。结论:低频戒毒仪和韩氏戒毒仪一样,都能够明显控制阿片类成瘾者急性脱毒期戒断症状,并具有良好的治疗效果和安全性能。

CLINICAL COMPARISON OF TWO KINDS OF ELECTRO-ACUPUNCTURE DETOXIFICATION INSTRUMENTS FOR TREATMENT OF ACUTE OPIATE WITHDRAWAL SYNDROME

Objective:To verify the efficacy of JY-I-type low-frequency detoxification instrument(JY-I)for treating acute opiate withdrawal syndrome by using HAN's detoxification instrument(HDI) as a reference.Methods:Qualified subjects were randomly assigned to JY-I group and HDI group according to the ratio of 1∶1 and were treated for 10 days.The efficacy and withdrawal symptom scores were evaluated at baseline and on day 1,2,3,4,5,7,11,and the efficacy on day 4 was set as evaluation criteria.Results:On day 4,for the per-protocol(PP) population,whole effective rates of JY-I group and HDI group were 33.44% and 25.00%,respectively,and there were no differences between the two groups(P=0.2898).In the reduction of scores of withdrawal symptoms at various time points,JY-I group showed a significant decline on day 2,5 and 7 before the treatment with statistical difference comparing to HDI group in PP population(P=0.0193,0.0138,0.0140).No serious adverse drug reactions were observed in the clinical trial.Conclusion:The JY-I can significantly and safely control acute withdrawal symptoms of opiate addicts as HDI.