疏肝消痞安神方联合常规西药治疗肝郁脾虚型功能性消化不良伴焦虑的临床效果

Clinical effect of Shugan Xiaopi Anshen decoction combined with conventional western medicine for functional dyspepsia of liver stagnation and spleen deficiency complicated with anxiety

目的 观察疏肝消痞安神方联合常规西药治疗肝郁脾虚型功能性消化不良(FD)伴焦虑的临床效果。方法 选取2022年6—11月安徽中医药大学附属六安市中医院接受治疗的肝郁脾虚型FD伴焦虑患者60例,按照随机数字表法分为对照组和观察组,每组30例。对照组患者采用常规西药治疗,观察组患者在对照组基础上采用疏肝消痞安神方治疗,2组患者均持续治疗4周。比较2组临床疗效,治疗前及治疗4周后中医证候积分、汉密尔顿焦虑量表(HAMA)评分、尼平消化不良生活质量指数(NDLQI)评分,不良反应及随访3个月疾病复发率。结果 观察组总有效率为93.33%,显著高于对照组的73.33%(χ^(2)=4.320,P=0.038)。治疗4周后,2组各中医证候积分、HAMA评分低于治疗前,NDLQI评分高于治疗前,且观察组降低/升高幅度大于对照组(P<0.05或P<0.01)。观察组不良反应总发生率为6.67%,与对照组的10.00%比较,差异无统计学意义(P=1.000)。观察组随访3个月疾病复发率为14.29%,低于对照组的45.45%(χ^(2)=5.937,P=0.015)。结论 疏肝消痞安神方联合常规西药治疗能提高肝郁脾虚型FD伴焦虑患者的临床疗效,能更有效地缓解患者临床症状,改善焦虑情绪,降低疾病复发率,提高生活质量,且安全性较高。

Objective To observe the clinical efficacy of Shugan Xiaopi Anshen decoction combined with conventional western medicine for FD of liver stagnation and spleen deficiency complicated with anxiety.Methods Sixty patients with FD with liver stagnation and spleen deficiency complicated with anxiety were selected from June to November 2022 in Lu′an Hospital of Traditional Chinese Medicine Affiliated to Anhui University of Chinese Medicine,and they were divided into the control group and the observation group by random number table method,with 30 cases in each group.The control group was treated with conventional western medicine,and the observation group was treated with Shugan Xiaopi Anshen decoction orally based on the control group,and both groups were treated continuously for 4 weeks.Clinical efficacy,TCM syndrome score,HAMA score,NDLQI score before and after 4 weeks of treatment,incidence of adverse reactions during treatment and disease recurrence rate followed-up for 3 months were compared between the two groups.Results The total effective rate of patients in the observation group was 93.33%,it was significantly higher than 73.33%of the control group(χ2=4.320,P=0.038).Compared with pre-treatment,the TCM symptom score and HAMA score after 4 weeks of treatment of the two groups were significantly lower,and NDLQI score was significantly higher,and the decrease/increase in the observation group were significantly greater than those in the control group after 4 weeks of treatment(P<0.05 or P<0.01).There was no significant difference in the incidence of adverse reactions between the observation group(6.67%)and the control group(10.00%)(P=1.000).Followed-up for 3 months,the disease recurrence rate in the observation group(14.29%)was significantly lower than control group(45.45%)(χ2=5.937,P=0.015).Conclusion Shugan Xiaopi Anshen decoction combined with conventional western medicine can improve the clinical efficacy of patients with FD of liver stagnation and spleen deficiency complicated with anxiety,and it can alleviate patients′clinical symptoms,improve anxiety state,reduce disease recurrence rate,improve quality of life,and with higher safety.