【作者】 徐亚丽；

【导师】 刘福友；

【作者基本信息】 成都中医药大学 ， 中西医结合临床， 2009， 硕士

【摘要】 目的通过本次临床研究,对神安交泰颗粒治疗失眠症苯二氮(?)类药物(benzodiazepines drugs, BZD)戒断综合征的临床有效性与安全性做出评价。方法本研究采用随机、双盲、安慰剂对照、多中心临床试验的方法,由三个医院完成。样本量为120例,采用区组随机方法,两组病例分配比例为1：1。试验组口服神安交泰颗粒,每次1袋,每日3次。对照组口服安慰剂颗粒,每次1袋,每日3次。疗程2周,随防两周。两组患者在用药前、用药第5±2天、第10±2天、第15±2天及停用试验药后14±2天各观察一次BZD的用量,修订匹兹堡睡眠质量指数(Pittsburgh sleep quality index, PSQI)量表,Zung焦虑自评量表(Self—rating Anxiety Scale, SAS),中医心肾不交证候积分表,同时观察不良反应。结果1.疗效性评价此次试验共入选120例受试者,全分析数据集(full analysis set, FAS)120例,符合方案数据集(per-protocol set, PPS) 117例。试验组60人,治疗后35人(58.33%)成功停用BZD,17人(28.33%)重新服用BZD；8人(13.33%)未停用BZD；与对照组(38.33%,30.0%,31.67%)比较,停药率有统计学差异(P<0.05)。试验组修订PSQI临床控制40.68%,总有效率81.36%；与对照组比较(22.41%,60.34%)均有统计学差异(P<0.05),试验组优于对照组。两组修订PSQI评分治疗前后组内比较,均有统计学差异(P<0.05),治疗后指数均低于治疗前。试验组SAS临床控制50.85%,总有效率88.14%；与对照组比较(24.14%,67.24%)均有统计学差异(P<0.05),试验组优于对照组；两组SAS标准分治疗前后组内比较,均有统计学差异(P<0.05),治疗后指数均低于治疗前。试验组中医心肾不交证候临床控制42.37%,总有效率89.83%；与对照组比较(20.69%,48.28%)均有统计学差异(P<0.05),试验组优于对照组。两组中医心肾不交证候积分治疗前后组内比较均有统计学差异(P<0.05),治疗后分值低于治疗前。2.安全性评价此次临床试验期间两组临床观察未见不良事件,未发生与试验药物相关的不良作用。结论神安交泰颗粒治疗失眠症BZD戒断综合征安全有效,能够改善失眠症BZD戒断综合征患者的睡眠情况,减轻戒断症状,从而帮助失眠症BZD依赖患者停用BZD。试验期间未见与药物相关的不良反应发生,提示该药有较好的安全性。更多还原

【Abstract】 Objective:To judge and reveal the clinical efficiency and safety of the treatment by Shen-An-Jiao-Tai grains on insomnia with benzodiazepines drugs withdrawal syndrome, through the study and research on this clinical trial.Methods:Adopted randomization, double blinding, placebo controlled trial, multicenter clinical trial methods, in this trial select 120 suitable cases that were parted two groups at random, the ratio of treat group to control group was 1:1. The treat group was given the Shen-An-Jiao-Tai grains (1bag, tid), the control group was given the placebo grains (1bag, tid). The period of treatment lasted for two weeks, and follow two weeks. Before the medication, medication 5±2day、10±2day、15±2day and withdrawal 14±2day, every patient of the two groups would get evaluated according to measurement of the BZD sume information, the revised Pittsburgh sleep quality index (PSQI), Zung self-rating anxiety scale(SAS) and the disharmony of heart and kidney symptom scale; the adverse effect would also be observed and recorded.Results:Curative effect evaluation:After the trial there were 120 cases in full analysis set (FAS),117 cases in per-protocol set (PPS). Curative effect valued by the PPS. After treatment, in the treat group, the rate of drug withdrawal was 58.33%; in the control group, the rate of drug withdrawal was 28.33%. There were difference between two groups.In the treat group, the total rate of the revised PSQI efficiency came to 81.36%,compared with the control group (60.34%), there were difference revised PSQI between two groups (P<0.05). It showed that the treat group had better effect than the control group. In two groups, the revised PSQI were difference between before and after the treatment (P<0.05).In the treat group, the total rate of the SAS efficiency came to 88.14%,compared with the control group (67.24%), there were difference SAS between two groups (P<0.05),the treat group had better effect than the control group. In two groups, the SAS standard scores were difference between before and after the treatment (P<0.05), score after the therapy was lower than that before.In the treat group, the total rate of disharmony of heart and kidney efficiency was 89.93%, which was compared with the control group (48.28%), and showed statistics difference (P<0.05), the treat group had better effect than the control group. In two groups, the disharmony of heart and kidney symptom scores were difference between before and after the treatment (P<0.05), score after the therapy was lower than that before.Safety analysis:There were no untoward reactions in both treat group and control group in the clinical trial.Conclusions:The treatment on insomnia and benzodiazepines drugs withdrawal syndrome by Shen-An-Jiao-Tai grains can have good effect on insomnia with BZD withdrawal syndrome. It can improve the sleep quality, reduce the the impact of withdrawal syndrome, as well as reduce the impact of TCM symptome. It also helps patients get rid of dependence on BZD. Safety examination finds no abnormality. During the testing period, no harmful reaction appears which point out that this medicine is relatively safe.更多还原