清风合剂联合美沙酮脱毒疗法治疗海洛因依赖脱毒期的临床研究

A Clinical Study on Qingfeng Mixture Combined with Methadone Therapy for Detoxifying Period of Heroin Dependence

目的:评价非阿片类复方中药制剂清风合剂联合美沙酮梯度递减疗法治疗海洛因依赖脱毒期的临床疗效。方法:按照《抗阿片症状药物临床实验指导原则》,采用多中心随机对照临床研究。临床观察指标为《戒断症状评分量表》、 《Hamilton焦虑评定量表》。将150例患者分为2组,2组均用美沙酮替代递减法治疗7天后,治疗组100例使用清风合剂治疗7天;对照组50例使用丁丙诺啡治疗7天。观察治疗期间及停药后1天的戒断症状、焦虑症状,记录不良反应并进行评定和比较。 结果:治疗组第12～14天及停药后1天戒断症状明显减少,与对照组比较,差异有非常显著性意义(P<0.01)。 停药后对照组戒断症状评分值反跳性增加;2组焦虑症状评分第10天及停药后1天与治疗前比较,差异均有非常显著性意义(P<0.01),但治疗组较对照组明显降低。结论:清风合剂联合美沙酮替代递减疗法治疗海洛因依赖患者能够更好地治疗脱毒期的戒断症状,安全可靠,无严重不良反应。

Objective: To evaluate the clinical effect of decremental therapy with Qingfeng mixture (QM) (an opium-free herbal compound) combined with methadone (MD) for detoxifying period of heroin dependence (DPHD). Methods: According to the Clinical Guideline for Anti - Opiumism Drugs, a multicenter randomized controlled trial was carried out. Abstinence symptom scoring scale and Hamilton Anxiety Scale were used for clinical observation. 150 cases were allocated to 2 goups. After MD substitution decremental therapy was given for 7 days, group A (100 cases) was treated by QM 7 days, group B (50 cases) by buprenorphine (BP) for 7 days as control. The abstinence symptoms and anxiety symptoms and adverse effects were compared during treatment and one day after treatment. Results: In the 12th and 14th day of treatment and 1 day after treatment, the abstinence symptoms were markedly decreased in group A ( P <0. 01 as compared with group B), and its scoring rebounded significantly in group B after treatment. In the 10 th day after treatment and 1 day after treatment, the axiety symptom score decreased significantly in both groups, but more marked in group A. Conclusion: Substitution decremental QM and MD therapy is effective for abstinence symptoms of DPHD. It is reliable and safe and free of severe adverse effect.