疏肝健脾养心方治疗肝郁脾虚证功能性消化不良伴焦虑抑郁状态的临床研究

Clinical Study on the Treatment of Functional Dyspepsia with Anxiety and Depression of Liver Depression and Spleen Deficiency Syndrome with Shugan Jianpi Yangxin Decoction

目的探讨疏肝健脾养心方对肝郁脾虚型功能性消化不良(fuctionaldyspepsia,FD)患者临床疗效及安全性评价。方法采用随机数字表将108例肝郁脾虚型FD患者随机分为3组,试验组、对照组与基础组各36例,分别予疏肝健脾养心方+多潘立酮、疏肝健脾方+多潘立酮、中药模拟剂+多潘立酮治疗,疗程为12周;最终完成病例99例,其中试验组34例,对照组33例,基础组共32例。采用治疗前后中医证候、SF-36生活量表、汉密尔顿焦虑量表(HAMA)、汉密尔顿抑郁量表(HAMD)、用药安全性情况对功能性消化不良(FD)伴焦虑抑郁状态患者进行观察。结果(1)试验组可显著改善肝郁脾虚型FD伴焦虑抑郁状态患者的相关中医证候,在改善食后腹胀、食少纳差、情志抑郁或烦躁易怒、倦怠乏力方面,其疗效优于对照组及基础组;(2)试验组可改善患者的生活质量,在社会功能(SF)、情感职能(RE)、心理健康(MH)方面,其疗效优于对照组及基础组;(3)试验组可显著改善患者的焦虑抑郁状态,其疗效优于对照组及基础组;(4)疏肝健脾养心方临床使用安全,未发现毒副作用。结论疏肝健脾养心方疗效显著,安全性好,值得推广。

Objective To explore the clinical efficacy and safety evaluation of Shugan Jianpi Yangxin decoction for functional dyspepsia(FD)patients with liver depression and spleen deficiency.Methods 108 FD patients with liver depression and spleen deficiency were divided into three groups by random number table.36 cases in the experimental group,36 cases in the control group and 36 cases in the basic group were treated with Shugan Jianpi Yangxin decoction+domperidone,Shugan Jianpi decoction domperidone,traditional Chinese medicine simulator+Domperidone for 12 weeks,and finally 99 cases were included,including 34 cases in the experimental group,33 cases in the control group and 32 cases in the basic group.The symptoms of traditional Chinese medicine,SF-36 life scale,Hamilton Anxiety Scale(HAMA),Hamilton Depression Scale(HAMD)and medication safety were observed before and after treatment in patients with functional dyspepsia(FD)accompanied by anxiety and depression.Results The experimental group can significantly improve the symptoms of FD patients with anxiety and depression of liver depression and spleen deficiency type.It is better than the control group and the basic group in improving postprandial abdominal distention,poor appetite,depression or irritability,fatigue.In terms of SF,RE and MH,the curative effect is better than that of the control group and the basic group;And the experimental group can significantly improve the anxiety and depression state of patients,its curative effect is better than that of the control group and the basic group;in terms of safety,the experimental group is safe in clinical usage,and no toxic reaction is found.Conclusion Shugan Jianpi Yangxin decoction is effective,safe and worth popularizing.