济泰片治疗轻度海洛因依赖急性戒断综合征随机双盲对照研究

目的：研究济泰片与济泰片联合丁丙诺啡治疗轻度海洛因依赖者急性戒断综合征的有效性及安全性。方 法：共150例轻度海洛因依赖者随机分为济泰组(50例)、济泰片联合丁丙诺啡组(50例)和对照组(50例)，临床实验期 间为10 d，采用阿片戒断量表评估海洛因戒断症状严重程度；汉密尔顿焦虑量表评估基线、第5天、第10天服药前及 服药后1或2 h焦虑症状；戒断症状总分及每天减分率评估济泰片及济泰片联合丁丙诺菲疗效；治疗基线及治疗结束时 药物不良反应、生命体征(血压、心率、呼吸)、实验室检查(血尿常规、肝肾功能)及心电图评估治疗药物安全性。结 果：共142例轻度海洛因依赖者完成实验，包括济泰片组48例、济泰片联合丁丙诺菲组48例、对照组46例；三组基线 戒断症状平均分数分别为43.520±19.786, 42.640±17.648和 47.100±24.450，组间比较差异无统计学意义(均P>0.05)。在10 d药物治疗期间，急性戒断症状减分率逐日增加，从基线到戒断第10天急性戒断症状及焦虑症状评分逐渐下降，但是 三组之间两两比较差异仍无统计学意义(均P>0.05)。济泰片对血压、呼吸、心率及肝肾功能等均无影响。结论：济泰 片及济泰片联合丁丙诺啡治疗轻度海洛因依赖者急性戒断症状缺乏有效性。

A randomized,double-blind,controlled study: Ji-Tai tablet for the treatment of acute withdrawl syndrome of mild heroin dependence

Objective: To investigate the efficacy and safety of Ji-Tai tablet and Ji-Tai tablet combined with buprenorphine in the treatment of patients with acute withdrawal syndrome of mild heroin dependence. Methods: A total of 150 patients with mild heroin dependence were recruited, and were randomly assigned to a Ji-Tai tablet group (n=50), a Ji-Tai tablet combined with buprenorphine group (n=50) and a control group (n=50) during a 10-day clinical trial. Opiate withdrawal scale (OWS) was used to measure the severity of withdrawal symptoms. Anxiety symptoms assessments were made at 0 day (baseline), the day 5 (middle), and the day 10 (end) by the Hamilton anxiety scale (HAMA). Symptoms were assessed before and 1 h or 2 h after medication each day. The total withdrawal symptoms scores and the daily reduction rate were used to measure the effect of Ji-Tai tablet vs Ji- Tai tablet plus buprenorphine. Safety evaluation was carried out by the following measures: baseline of treatment, drug side effects after the treatment, vital signs (blood pressure, heart rate, and respiration rate), laboratory examination (routine blood and urine tests and the liver and kidney function tests), and electrocardiograms. Results: A total of 142 mild heroin dependence patients performed the experiments (including 48 in the Ji-Tai tablet group, 48 in the Ji-Tai tablet with buprenorphine group and 46 in the control group). The scores of baseline withdrawal symptoms were 43.520±19.786, 42.640±17.648 and 47.100±24.450, respectively, with no significant differences among the 3 groups (all P>0.05 ). During the 10-day treatment, the reduction rate of acute withdrawal symptoms scores increased daily, the acute withdrawal syndrome scores and the anxiety symptoms scores declined from day 0 to day 10, there was also no significant difference among the 3 groups (all P>0.05). Ji-Tai tablet did not affect vital signs such as blood pressure, heart rate, and respiration rate. Conclusion: Ji-Tai tablet or Ji-Tai tablet combined with buprenorphine had no effect on acute withdrawal symptoms of mild heroin dependence.