Objective To evaluate the efficacy and safety of Huanglian Wendan Decoction(黄连温胆汤,HLWDD)alone or combined with western medicine in treating insomnia caused by phlegm-heat internal disturbance in recent 10 years.M...Objective To evaluate the efficacy and safety of Huanglian Wendan Decoction(黄连温胆汤,HLWDD)alone or combined with western medicine in treating insomnia caused by phlegm-heat internal disturbance in recent 10 years.Methods The randomized controlled trials of HLWDD alone or combined with western medicine in treating insomnia caused by phlegm-heat internal disturbance from January 1,2012 to April 1,2022 were searched in China National Knowledge Infrastructure(CNKI),China Science and Technology Journal Database(VIP),Wanfang Database,China BioMedical Literature Database(CBM),PubMed,Web of Science,Embase,and Cochrane Library databases.After being screening,the included literature was analyzed to evaluate the effective rate,Pittsburgh Sleep Quality Index(PSQI)score,traditional Chinese medicine(TCM)syndrome score,and adverse reactions of HLWDD on insomnia caused by phlegm-heat internal disturbance.The subgroup analyzed the effect of HLWDD after different treatment courses,and compared the therapeutic effects of HLWDD alone and HLWDD combined with western medicine.Results Twenty-seven randomized controlled trials were finally included,with a total of 2395 patients.The results of the meta-analysis showed that the curative effect of HLWDD alone or combined with the western medicine group was better than that of the western medicine group[RR=1.14,95%CI(1.06,1.22),P=0.000].The PSQI score[SMD=-0.31,95%CI(-0.42,-0.20),P=0.000],TCM syndrome score[SMD=-0.40,95%CI(-0.67,-0.12),P=0.005],and adverse reaction rate[RR=0.21,95%CI(0.15,0.29),P=0.000]of HLWDD alone or combined with western medicine group were significantly reduced compared with the western medicine group.The subgroup’s analysis showed that the curative effect of HLWDD alone or combined with western medicine group of 4 weeks treatment course was better than that of the western medicine group[RR=1.14,95%CI(1.03,1.26),P<0.05].The TCM syndrome score of HLWDD alone or combined with the western medicine group of 4 weeks treatment course decreased more obviously than that of the western medicine group[SMD=-0.60,95%CI(-0.96,-0.25),P<0.05].There were no significant differences between HLWDD alone or combined with western medicine group and western medicine group with different treatment courses based on PSQI score and adverse reaction rate.Based on the effective rate,the comparison between the HLWDD alone group and the western medicine group[RR=1.09,95%CI(1.00,-1.20)P<0.05],and between the HLWDD combined with western medicine group and the western medicine group[RR=1.15,95%CI(1.03,1.29),P<0.05]was the same.PSQI score[SMD=-0.44,95%CI(-0.59,-0.30),P<0.05]and TCM syndrome score[SMD=-1.10,95%CI(-1.59,-0.61),P<0.05]of HLWDD combined with western medicine group were significantly lower than those of the western medicine group.There were no significant differences of adverse reaction rate between HLWDD alone group[RR=0.08,95%CI(0.04,0.17),P<0.05]and HLWDD combined with western medicine group[RR=0.36,95%CI(0.24,0.53),P<0.05].Conclusion HLWDD alone or combined with western medicine is an effective treatment for insomnia caused by phlegm-heat internal disturbance,which has a high effective rate,significantly reduced PSQI score and TCM syndrome score,and favorable safety.The best course of treatment is 4 weeks.展开更多
【目的】探讨定颤解郁方(由经方天麻钩藤饮合柴胡龙骨牡蛎汤化裁而来)对帕金森抑郁(depression in Parkinson’s disease,DPD)患者的临床疗效和安全性。【方法】将80例DPD肝郁风动扰神证患者随机分为单纯西药治疗组(简称西药组)和定颤...【目的】探讨定颤解郁方(由经方天麻钩藤饮合柴胡龙骨牡蛎汤化裁而来)对帕金森抑郁(depression in Parkinson’s disease,DPD)患者的临床疗效和安全性。【方法】将80例DPD肝郁风动扰神证患者随机分为单纯西药治疗组(简称西药组)和定颤解郁方联合西药治疗组(简称联合组),每组各40例。西药组给予美多芭联合盐酸普拉克索片的西医常规治疗,联合组在西药组的基础上联合定颤解郁方治疗,连续服用14 d为1个疗程,共治疗6个疗程(共12周)。观察2组患者治疗前后主要结局指标24项汉密尔顿抑郁量表(HAMD-24)评分以及次要结局指标世界运动障碍学会新版帕金森病综合评价量表(MDSUPDRS)、帕金森病睡眠障碍量表(PDSS)和汉密尔顿焦虑量表(HAMA)评分的变化情况,并评价2组患者的临床疗效(根据HAMD-24评分的改善情况判定)和安全性。【结果】(1)疗效方面,治疗12周后,联合组的总有效率为70.0%(28/40),西药组为27.5%(11/40),组间比较,联合组的疗效明显优于西药组(P<0.01)。(2)HAMD-24、HAMA、PDSS评分方面,治疗后,2组患者的HAMD-24、HAMA、PDSS评分均较治疗前明显下降(P<0.05),且联合组的下降幅度均明显优于西药组(P<0.05)。(3)MDS-UPDRS评分方面,治疗后,2组患者MDS-UPDRS的日常生活非运动症状评分及联合组的日常生活运动症状评分均较治疗前明显下降(P<0.05),而2组患者的运动检查和运动并发症评分及西药组的日常生活运动症状评分均较治疗前无明显下降(P>0.05);组间比较,联合组对日常生活非运动症状评分的下降幅度明显优于对照组(P<0.05)。(4)不良事件发生率方面,治疗过程中,2组患者的所有不良事件都是轻微的,其中联合组的不良事件发生率为12.5%(5/40),西药组为10.0%(4/40),组间比较,差异无统计学意义(P>0.05)。【结论】在西医常规治疗基础上联合定颤解郁方治疗DPD肝郁风动扰神证患者临床疗效确切,可有效改善患者的生活质量和其他非运动症状,且具有较高的安全性。定颤解郁方有望推荐为治疗DPD的有价值的替代治疗选择。展开更多
基金Basic Research Fund Project of the Central Public Welfare Research Institute of China Academy of Chinese Medical Sciences(Zz13-zd-09).
文摘Objective To evaluate the efficacy and safety of Huanglian Wendan Decoction(黄连温胆汤,HLWDD)alone or combined with western medicine in treating insomnia caused by phlegm-heat internal disturbance in recent 10 years.Methods The randomized controlled trials of HLWDD alone or combined with western medicine in treating insomnia caused by phlegm-heat internal disturbance from January 1,2012 to April 1,2022 were searched in China National Knowledge Infrastructure(CNKI),China Science and Technology Journal Database(VIP),Wanfang Database,China BioMedical Literature Database(CBM),PubMed,Web of Science,Embase,and Cochrane Library databases.After being screening,the included literature was analyzed to evaluate the effective rate,Pittsburgh Sleep Quality Index(PSQI)score,traditional Chinese medicine(TCM)syndrome score,and adverse reactions of HLWDD on insomnia caused by phlegm-heat internal disturbance.The subgroup analyzed the effect of HLWDD after different treatment courses,and compared the therapeutic effects of HLWDD alone and HLWDD combined with western medicine.Results Twenty-seven randomized controlled trials were finally included,with a total of 2395 patients.The results of the meta-analysis showed that the curative effect of HLWDD alone or combined with the western medicine group was better than that of the western medicine group[RR=1.14,95%CI(1.06,1.22),P=0.000].The PSQI score[SMD=-0.31,95%CI(-0.42,-0.20),P=0.000],TCM syndrome score[SMD=-0.40,95%CI(-0.67,-0.12),P=0.005],and adverse reaction rate[RR=0.21,95%CI(0.15,0.29),P=0.000]of HLWDD alone or combined with western medicine group were significantly reduced compared with the western medicine group.The subgroup’s analysis showed that the curative effect of HLWDD alone or combined with western medicine group of 4 weeks treatment course was better than that of the western medicine group[RR=1.14,95%CI(1.03,1.26),P<0.05].The TCM syndrome score of HLWDD alone or combined with the western medicine group of 4 weeks treatment course decreased more obviously than that of the western medicine group[SMD=-0.60,95%CI(-0.96,-0.25),P<0.05].There were no significant differences between HLWDD alone or combined with western medicine group and western medicine group with different treatment courses based on PSQI score and adverse reaction rate.Based on the effective rate,the comparison between the HLWDD alone group and the western medicine group[RR=1.09,95%CI(1.00,-1.20)P<0.05],and between the HLWDD combined with western medicine group and the western medicine group[RR=1.15,95%CI(1.03,1.29),P<0.05]was the same.PSQI score[SMD=-0.44,95%CI(-0.59,-0.30),P<0.05]and TCM syndrome score[SMD=-1.10,95%CI(-1.59,-0.61),P<0.05]of HLWDD combined with western medicine group were significantly lower than those of the western medicine group.There were no significant differences of adverse reaction rate between HLWDD alone group[RR=0.08,95%CI(0.04,0.17),P<0.05]and HLWDD combined with western medicine group[RR=0.36,95%CI(0.24,0.53),P<0.05].Conclusion HLWDD alone or combined with western medicine is an effective treatment for insomnia caused by phlegm-heat internal disturbance,which has a high effective rate,significantly reduced PSQI score and TCM syndrome score,and favorable safety.The best course of treatment is 4 weeks.
文摘【目的】探讨定颤解郁方(由经方天麻钩藤饮合柴胡龙骨牡蛎汤化裁而来)对帕金森抑郁(depression in Parkinson’s disease,DPD)患者的临床疗效和安全性。【方法】将80例DPD肝郁风动扰神证患者随机分为单纯西药治疗组(简称西药组)和定颤解郁方联合西药治疗组(简称联合组),每组各40例。西药组给予美多芭联合盐酸普拉克索片的西医常规治疗,联合组在西药组的基础上联合定颤解郁方治疗,连续服用14 d为1个疗程,共治疗6个疗程(共12周)。观察2组患者治疗前后主要结局指标24项汉密尔顿抑郁量表(HAMD-24)评分以及次要结局指标世界运动障碍学会新版帕金森病综合评价量表(MDSUPDRS)、帕金森病睡眠障碍量表(PDSS)和汉密尔顿焦虑量表(HAMA)评分的变化情况,并评价2组患者的临床疗效(根据HAMD-24评分的改善情况判定)和安全性。【结果】(1)疗效方面,治疗12周后,联合组的总有效率为70.0%(28/40),西药组为27.5%(11/40),组间比较,联合组的疗效明显优于西药组(P<0.01)。(2)HAMD-24、HAMA、PDSS评分方面,治疗后,2组患者的HAMD-24、HAMA、PDSS评分均较治疗前明显下降(P<0.05),且联合组的下降幅度均明显优于西药组(P<0.05)。(3)MDS-UPDRS评分方面,治疗后,2组患者MDS-UPDRS的日常生活非运动症状评分及联合组的日常生活运动症状评分均较治疗前明显下降(P<0.05),而2组患者的运动检查和运动并发症评分及西药组的日常生活运动症状评分均较治疗前无明显下降(P>0.05);组间比较,联合组对日常生活非运动症状评分的下降幅度明显优于对照组(P<0.05)。(4)不良事件发生率方面,治疗过程中,2组患者的所有不良事件都是轻微的,其中联合组的不良事件发生率为12.5%(5/40),西药组为10.0%(4/40),组间比较,差异无统计学意义(P>0.05)。【结论】在西医常规治疗基础上联合定颤解郁方治疗DPD肝郁风动扰神证患者临床疗效确切,可有效改善患者的生活质量和其他非运动症状,且具有较高的安全性。定颤解郁方有望推荐为治疗DPD的有价值的替代治疗选择。
