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[目的]观察舒肝解郁胶囊治疗伴轻中度抑郁症状的功能性消化不良(functional dyspepsia,FD)患者的临床疗效及不良反应。[方法]将245例伴轻中度抑郁症的FD患者随机分为观察组与对照组,采用随机双盲对照研究,2组均服用多潘立酮片、雷贝拉唑片,观察组135例加服舒肝解郁胶囊,对照组110例加服用安慰剂,疗程均为4周。比较2组治疗前后临床疗效、胃肠道症状评定量表(gastrointestinal symptom rating scale,GSRS)积分、医院焦虑抑郁量表(hospital anxiety depression scale,HADS)抑郁症状评分及不良反应。[结果]治疗4周后,观察组显效24例(17.8%),有效81例(60.0%),无效30例(22.2%),总有效率为77.8%;对照组显效4例(3.6%),有效35例(31.8%),无效71例(64.5%),总有效率为35.5%;观察组总有效率显著高于对照组(P<0.05)。观察组GSRS积分及HADS抑郁症状评分均显著低于对照组(P<0.05)。[结论]舒肝解郁胶囊联合质子泵抑制剂及促胃动力药治疗伴轻中度抑郁症状的FD疗效显著,安全可靠。
[Objective] To observe the clinical efficacy and side effects of Shugan Jieyu capsule in functional dyspepsia (FD) patients with mild to moderate depressive symptoms. [Methods] A total of 245 FD patients with mild-to-moderate depression were randomly divided into observation group and control group. Randomized double-blind controlled study was conducted in both groups. Domperidone tablets, rabeprazole tablets and 135 cases of observation group were added Shugan Jieyu capsule, control group, 110 cases plus placebo, treatment for 4 weeks. The clinical curative effect, the score of gastrointestinal symptom rating scale (GSRS), the depressive symptom scores of hospital anxiety depression scale (HADS) and adverse reactions were compared between the two groups before and after treatment. [Results] After 4 weeks of treatment, the observation group was significantly improved in 24 cases (17.8%), effective 81 cases (60.0%), ineffective in 30 cases (22.2%), the total effective rate was 77.8% , Effective in 35 cases (31.8%), ineffective in 71 cases (64.5%), the total effective rate was 35.5%. The total effective rate in the observation group was significantly higher than that in the control group (P <0.05). The scores of GSRS and HADS depressive symptoms in the observation group were significantly lower than those in the control group (P <0.05). [Conclusion] Shuganjieyu capsules combined with proton pump inhibitors and gastric motility agents in treatment of FD with mild to moderate depressive symptoms are effective and safe.