加味参附汤治疗68例海洛因瘾的临床疗效观察

A Clinical Study of Modified Shen Fu Decoction on 68 Cases of Heroin Addicts

目的 :评价加味参附汤 (MSFD)对海洛因依赖的脱毒效应、不良反应及安全度。方法 :采用开放式随机分组对照试验 ,按照 1 0日疗程给药方案量化评定了 6 8例海洛因成瘾者的每日戒断症状分值、Hamilton焦虑量表分值、不良反应分值等 ,并将其作用与洛非西丁 (Lof)进行了比较。结果 :治疗第 1～ 3天MSFD组自发戒断症状评分分别为 77 6 8± 1 5 0 6、6 3 73± 1 2 36、49 5 5± 9 0 4,分别低于Lof组的 84 1 6± 8 33,70 98± 1 0 0 5 ,5 4 0 2± 8 74(P <0 .0 5 ) ;两组对Hamilton焦虑量表分值的影响无统计学差异 (P >0 .0 5 ) ;MSFD组出现了口干、视物模糊等不良反应 ,出现率及程度低于Lof组 ;MSFD对血压、心率无明显影响。结论 :MSFD在阿片类成瘾戒断急性期的疗效优于Lof,且不良反应轻微。

Objective: To observe the efficacy, adverse reaction and safety of Modified Shen Fu Decoction (MSFD). Method: A random controlled, compared and open clinical trial was adopted. 68 cases with heroin addicts were treated with MSFD according a 10 days course of treatment, and the effects of MSFD were compared with those of Lofexidine (Lof). Result: In the first 3 days after treatment, the score of abstinent syndrome in MSFD group was 77.68±15.06, 63.73±12.36, 49.55±9.04, was respectively lower than the score in Lof group: 84.16±8.33, 70.98±10.05, 54.02±8.74(P<0.05). No significant difference of the Hamilton scores between the two groups was observed (P>0.05). In MSFD group some slight adverse reactions such as dry mouth, blurred vision were observed, but MSFD had no affect on the blood press and the heart rats. Conclusion: MSFD is more effective than Lof in controlling acute opiate withdrawal syndrome, and it is safety and the adverse reactions are slight.