济泰片治疗轻度海洛因依赖者稽延性戒断症状的随机双盲对照研究

目的探讨济泰片治疗轻度海洛因依赖者稽延性戒断症状的有效性和安全性,为降低轻度海洛因依赖者的复吸率提供参考。方法在河南省新乡市第一强制隔离戒毒所选取符合《精神障碍诊断与统计手册(第4版)》(DSM-IV)诊断标准的轻度海洛因依赖者81例,采用随机数字表法分为济泰片组(n=40)和对照组(n=41)。济泰片组接受济泰片治疗,对照组给予济泰模拟片,两组均治疗24周。采用海洛因依赖稽延性戒断症状评定量表(RSPWSHA)评定疗效,采用汉密尔顿焦虑量表(HAMA)、汉密尔顿抑郁量表17项版(HAMD-17)及海洛因渴求问卷(HCQ)评定焦虑、抑郁症状和心理渴求程度,治疗期间监测药物不良反应、生命体征和实验室检查指标评估安全性。结果济泰片组和对照组RSPWSHA、HAMA、HAMD-17及HCQ总评分随治疗时间延长而降低(P0.05),RSPWSHA总评分减分率随治疗时间延长而增加(P0.05)。治疗8周后两组HCQ评分和治疗24周后两组HAMD-17总评分比较差异有统计学意义(P0.05),其他各治疗时点两组各量表评分比较差异均无统计学意义(P均0.05)。结论济泰片治疗轻度海洛因依赖者稽延性戒断症状可能疗效不明确。

Randomized doubled blind controlled study of Jitai tabelets treating protracted syndrome mild heroin addicts

Objective To investigate the efficacy and safety of Jitai tabelets in the treatment of protracted withdrawal symptoms and to provide references for reducing relapse rate in mild heroin addicts. Methods From July 2011 to February 2012, a total of 81 mild heroin addicts who met the criteria of Diagnostic and Statistical Manual of Mental Disorders, fourth edition ( DSM - IV) were selected from the first compulsory and isolation drug rehabilitation center in Xinxiang, He''nan. The random number table methodwas used to divide the patients into the Jitai tabelets group ( n = 40) and the control group ( n = 41 ) . Both two groups received medicine for 24 weeks. Rating Scale for Protracted Withdrawal Symptoms of Heroin Addicts ( RSPWSHA) was used to measure the efficacy. Hamilton Anxiety Scale ( HAMA) , Hamilton Depression Scale - 17 item ( HAMD - 17 ) and Heroin Craving Questionnaire( HCQ) were used to assess anxiety, depression symptoms and heroin craving symptoms. During the treatment, adverse drug reactions,vital signs and laboratory examination indexes were monitored to evaluate the safety. Results In the two groups, the total scores of RSPWSHA, HAMA, HAMD - 17 and HCQ decreased with the time of treatment ( P < 0. 05 ) , and the reduction rate of RSPWSHA score increased along with treatment ( P < 0. 05 ) . The HCQ score of the two groups after 8 weeks of treatment and the HAMD - 17score of the two groups after 24 weeks of treatment were significantly different from before the treatment ( P < 0. 05 ) . There was no significant difference in scale scores between the two groups at other treatment time points ( P > 0. 05) . Conclusion Jitai tabelets may not be effective in the treatment of protracted withdrawal symptoms for mild heroin addicts.