罗通定联合曲唑酮治疗稽延性戒断症状的临床研究

Clinical research of rotundine combined with trazodone in treatment of protracted withdrawal symptoms

目的评价罗通定联合曲唑酮治疗阿片类物质依赖者稽延性戒断症状的临床疗效及安全性。方法将120例海洛因依赖者随机分成2组,试验组62例,对照组58例。2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,试验组给予罗通定联合曲唑酮治疗,对照组单纯给予曲唑酮治疗,2组疗程均为8周。治疗前与治疗2,4,6,8周后用稽延性戒断症状量表(PWSS),汉密尔顿焦虑量表(HAMA)进行评分分析,用不良反应症状量表(TESS)评价安全性。结果控制了吸食时间和剂量这2个变量以后,组效应和治疗时间效应:PWSS(F=792.23,P<0.01;F=716.76,P<0.01)、HAMA(F=125.47,P<0.01;F=1873.08,P<0.01),分析显示组别和治疗时间差异有统计学意义;同时组别和治疗时间之间有明显的交互效应,PWSS(F=61.43,P<0.01)、HAMA(F=12.96,P<0.01)。治疗8周后,试验组有效率为78%,对照组有效率为47%,2组比较差异有统计学意义(P<0.05)。结论罗通定联合曲唑酮是一种疗效高,安全,耐受性好,无潜在药物成瘾性的治疗稽延性戒断症状的治疗方案。

Objective To investigate the efficacy and safety of rotundine combined with trazotone in opioid dependent patients with protracted with-drawal symptoms.Methods After detoxification with Yang ’s 1＋1 therapy, 120 subjects with heroin dependence were randomly divided into the treat-ment group （n=62） and the control group （n=58）.The treatment group was given rotundine combined with trazotone , while the controls were given trazotone only , when the detection of morphine in urine was negative.The patients were rated with protracted withdrawal symptoms scale （ PWSS） and Hamilton anxiety scale （HAMA） before treatment and the 2,4,6,8 week af-ter treatment , and the safety was evaluated with treatment emergernt symp-tom scale （ TESS）.Results After the feeding time and dose of heroin were controlled , significant drug effect and treatment time effect were observed in PWSS（F =792.23,P ＆lt;0.01, F =716.76,P ＆lt;0.01） and HAMA （F =125.47,P＆lt;0.01,F=1873.08,P＆lt;0.01）,respectively.Significant interac-tion effects between treatment group and treatment time were also found in PWSS（F=61.43,P＆lt;0.01） and HAMA（F=12.96,P＆lt;0.01）.The effec-tive rate was 78%in the treatment group and 47%in the control group （ P＆lt;0.05 ） after 8 weeks treatment.Conclusion Rotundine combined with trazotone may significantly reduce the protracted withdrawal symptoms.The treatment is safe , well tolerated , and has low risk of abuse.