调和营卫法戒断治疗营卫不和型镇静催眠药依赖性失眠的临床疗效

Clinical Efficacy of Withdrawal Therapy Based on Regulating Nutritive Qi and Defensive Qi in Treating Sedative-Hypnotic Dependent Insomnia of Disharmony Between Nutritive Qi and Defensive Qi Type

【目的】观察调和营卫法戒断治疗营卫不和型镇静催眠药依赖性失眠的临床疗效。【方法】将90例营卫不和型镇静催眠药依赖性失眠患者随机分为治疗组和对照组,每组各45例。对照组给予艾司唑仑口服,以每周减25%药量的递减治疗;治疗组在对照组的基础上给予基于调和营卫法拟定的中药煎剂调和营卫助眠方治疗,疗程为4周。观察2组患者治疗前后匹兹堡睡眠质量指数(PSQI)评分、中医证候总积分以及药物戒断综合征量表评分的变化情况,并评价2组患者的睡眠效率值(IUSEV)改善疗效和安全性。【结果】(1)脱落情况:治疗组脱落2例,纳入统计43例;对照组脱落3例,纳入统计42例。(2)IUSEV改善疗效:治疗4周后,治疗组的总有效率为88.37%(38/43),对照组为61.90%(26/42);组间比较(非参数秩和检验),治疗组的IUSEV改善疗效明显优于对照组(P<0.05)。(3)PSQI评分情况:治疗后,2组患者的睡眠质量、入睡时间、睡眠时间、睡眠效率、睡眠障碍和日间功能障碍等各项评分及总积分均较治疗前降低(P<0.05);组间比较,除睡眠障碍及日间功能障碍外,治疗组对PSQI的其余各项评分及总积分的降低作用均明显优于对照组(P<0.05)。(4)中医证候评分情况:治疗后,2组患者的中医证候总积分均较治疗前明显降低(P<0.05),且治疗组对中医证候总积分的降低作用明显优于对照组(P<0.05)。(5)药物戒断综合征量表评分情况:治疗后,2组患者的药物戒断综合征量表总积分均较治疗前明显降低(P<0.05),且治疗组对药物戒断综合征量表总积分的降低作用明显优于对照组(P<0.05)。(6)安全性评价:治疗过程中,2组患者均无明显不良反应发生,患者的血、尿、大便常规及肝肾功能、心电图等安全性指标均无异常变化。【结论】调和营卫法戒断治疗营卫不和型镇静催眠药依赖性失眠患者临床疗效显著,能有效改善患者的睡眠质量,降低患者的戒断综合征发生率,且具有较高的安全性。

Objective To observe the clinical efficacy of withdrawal therapy based on regulating nutritive qi and defensive qi(shortened to Tiaohe Yingwei method)in treating sedative-hypnotic dependent insomnia of disharmony between nutritive qi and defensive qi type.Methods Ninety patients with sedative-hypnotic dependent insomnia of disharmony between nutritive qi and defensive qi type were randomly divided into the treatment group and the control group,with 45 patients in each group.The control group was given oral use of Estazolam by 25%of weekly dose-reduction,while the treatment group was treated with Chinese medicinal decoction of Tiaohe Yingwei Zhumian Prescription based on Tiaohe Yingwei method together with Estazolam.The treatment course for the two groups lasted for 4 weeks.The changes of Pittsburgh Sleep Quality Index(PSQI)scores,total TCM syndrome scores,and Drug-withdrawal Syndrome Scale(DWSS)scores in the two groups were observed before and after treatment.After treatment,the efficacy for improving sleep efficiency value(IUSEV)and clinical safety in the two groups were evaluated.Results(1)During the trial,2 cases fell off in the treatment group,and 43 cases included in the statistics;3 cases fell off in the control group,and 42 cases included in the statistics.(2)After 4 weeks of treatment,the total effective rate for improving IUSEV of the treatment group was 88.37%(38/43),and that of the control group was 61.90%(26/42).The intergroup comparison by non-parametric rank-sum test showed that the efficacy for improving IUSEV in the treatment group was significantly superior to that in the control group(P<0.05).(3)After treatment,obvious reduction was shown in the overall PSQI scores and the scores of the items of sleep quality,time for falling asleep,sleep time,sleep efficiency,sleep disorder and daytime dysfunction in the two groups when compared with those before treatment(P<0.05).The intergroup comparison showed that except for the items of sleep disorder and daytime dysfunction,the treatment group had stronger effect on decreasing the scores of the remaining items and the overall PSQI scores than the control group(P<0.05).(4)After treatment,the total scores of TCM syndromes of both groups were significantly decreased compared with those before treatment(P<0.05),and the decrease of the total scores of TCM syndrome in the treatment group was significantly superior to that in the control group(P<0.05).(5)After treatment,the total DWSS scores of the two groups were significantly decreased compared with those before treatment(P<0.05),and the effect on lowering the scores in the treatment group was significantly superior to that in the control group(P<0.05).(6)During the course of treatment,no significant adverse reactions occurred in the two groups,or no abnormal changes were found in the safety indexes such as routine test of blood,urine and stool,liver and kidney function,and electrocardiogram of the patients.Conclusion Withdrawal therapy based on Tiaohe Yingwei method exerts certain effect for the treatment of sedative-hypnotic dependent insomnia of disharmony between nutritive qi and defensive qi type.The therapy is effective on improving the quality of sleep and reducing the incidence of drug-withdrawal syndrome,and has a high safety.