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目的评估曲唑酮联合纳曲酮治疗海洛因依赖者防复吸的临床疗效及安全性。方法将160例海洛因依赖者随机分成两组,试验组和对照组各80例。两组患者均先经过东莨菪碱复合麻醉(杨氏1+1)脱毒治疗,待尿吗啡检测转阴性后,研究组给予曲唑酮(100~200 mg·d-1,bid)联合纳曲酮(50 mg·d-1,qd)治疗,对照组单纯给予纳曲酮治疗,住院治疗2周后维持治疗12个月。采用心理渴求量表(PCS)、稽延性戒断症状量表(PWSS)和纳曲酮维持率在出院时与维持治疗1、3、6、9、12个月后进行评分分析,用副反应症状量表(TESS)评价安全性。结果共135例完成全部研究,对照组67例,研究组68例。与出院时相比,两组治疗1、3、6、9、12个月的PCS得分及PWSS得分均下降(P<0.01)。治疗1、3、6个月时研究组的PCS和PWSS均低于对照组(P<0.05),9、12个月时两组组间无显著差异(P>0.05);研究组的纳曲酮维持率高于对照组,有非常显著差异(P<0.01)。两组不良反应轻微,研究组的TESS总分小于对照组(P<0.05或P<0.01);6个月后两组比较无显著差异(P>0.05)。结论曲唑酮能明显提高纳曲酮维持治疗的依从性。曲唑酮联合纳曲酮是一种安全、有效的预防海洛因依赖者复吸的治疗方案。
Objective To evaluate the clinical efficacy and safety of trazodone combined with naltrexone in the treatment of heroin addicts. Methods 160 cases of heroin addicts were randomly divided into two groups, the experimental group and the control group of 80 cases. Patients in both groups were treated with scopolamine anesthesia (Yang’s 1 + 1) for detoxification. After the urine morphine was tested negative, the study group was given trazodone (100-200 mg · d-1, bid) combined with naltrexone (50 mg · d-1, qd). The control group was treated with naltrexone alone. After 2 weeks of hospitalization, the patients were treated for 12 months. The scores of PCS, PWSS and naltrexone maintenance were measured at 1,3,6,9 and 12 months after discharge, Symptom Inventory (TESS) to evaluate safety. Results A total of 135 patients completed all studies, 67 in the control group and 68 in the study group. Compared with the time of discharge, the scores of PCS and PWSS decreased at 1, 3, 6, 9 and 12 months in both groups (P <0.01). The PCS and PWSS in the study group were lower than those in the control group at 1, 3, and 6 months after treatment (P <0.05). There was no significant difference between the two groups at 9 and 12 months (P> 0.05) Ketone maintenance rate higher than the control group, there is a very significant difference (P <0.01). Adverse reactions were mild in both groups, and the TESS score of the study group was smaller than that of the control group (P <0.05 or P <0.01). There was no significant difference between the two groups after 6 months (P> 0.05). Conclusion Trazodone can significantly improve the compliance of naltrexone maintenance therapy. Trazodone in combination with naltrexone is a safe and effective regimen for the prevention of relapse in heroin addicts.