柴胡加龙骨牡蛎汤联合耳穴压豆治疗肝郁化火型失眠的随机平行对照研究

Randomized Parallel Control Study of Chaihu Plus Longgu Muli Decoction Combined with Auricular Acupoint Pressing on Insomnia Caused by Liver Depression Transforming into Fire

目的:观察柴胡加龙骨牡蛎汤联合耳穴压豆治疗肝郁化火型失眠的疗效。方法:选取符合纳入标准的80例肝郁化火型失眠患者依据随机数字表随机分为观察组和对照组,每组各40例。观察组给予柴胡加龙骨牡蛎汤口服联合耳穴压豆法进行治疗,对照组口服右佐匹克隆进行治疗,治疗周期均为4周。比较治疗前后匹兹堡睡眠质量指数量表(PSQI)、汉密尔顿焦虑量表(HAMA)、汉密尔顿抑郁量表(HAMD)和中医证候自评量表评分的变化情况。观察两组不良反应情况及治愈患者停止治疗4周后睡眠障碍的复发情况。结果:观察组总有效率90%(36/40),对照组总有效率70%(28/40),两组比较有统计学意义(P<0.05)。治疗前,两组患者PSQI、HAMA、HAMD、中医证候自评量表评分比较,没有统计学意义(P>0.05);治疗后,两组患者PSQI、HAMA、HAMD、中医证候自评量表评分均降低(P<0.05),且观察组均低于对照组(P<0.05)。观察组不良反应发生率2.5%(1/40),对照组不良反应发生率22.5%(9/40),两组比较有统计学意义(P<0.05)。观察组治愈患者停止治疗4周后复发睡眠障碍率22.22%(4/18),对照组治愈患者停止治疗4周后复发睡眠障碍率70%(7/10),两组比较有统计学意义(P<0.05)。结论:柴胡加龙骨牡蛎汤联合耳穴压豆治疗肝郁化火型失眠疗效显著,能显著改善患者的临床症状,且不良反应发生率和复发率低。

Objective:To observe the curative effect of Chaihu plus Longgu Muli Decoction combined with auricular acupoint pressing in treatment of insomnia caused by Liver depression transforming into fire.Methods:80 insomnia patients who were diagnosed as Liver depression transforming into fire were randomly divided into the observation group and the control group,with 40 cases in each group.The observation group was treated with Chaihu plus Longgu Muli Decoction combined with auricular acupoint pressing,whereas the control group was treated with Dexzopiclone.Both groups were treated for 4 weeks.The scores of Pittsburgh Sleep Quality Index Scale(PSQI),Hamilton Anxiety Scale(HAMA),Hamilton Depression Scale(HAMD)and Chinese Medicine Syndrome Self-rating Scale were compared between before and after the treatment in the two groups.The occurrence of adverse reactions and the relapse of insomnia after 4 weeks of treatment were observed in the two groups.Results:The total effective rate was 90%(36/40)in the observation group,which was significantly higher than 70%(28/40)in the control group(P<0.05).There were no statistical differences in the scores of PSQI,HAMA,HAMD and TCM syndrome before the treatment(P>0.05);which were decreased after the treatment in the two groups(P<0.05),and the decreases in the observation group were more significant than those in the control group(P<0.05).The rate of adverse reactions was 2.5%(1/40)in the observation group,which was lower than 22.5%(9/40)in the control group(P<0.05).The relapse rate of insomnia after four weeks of treatment was 22.22%(4/18)in the observation group,which was lower than 70%(7/10)in the control group(P<0.05).Conclusion:Chaihu plus Longgu Muli Decoction combined with auricular acupoint pressing is effective in treating insomnia caused by Liver depression transforming into fire.The therapy can significantly improve clinical symptoms,reduce the rate of adverse reactions and the rate of relapse.