枳术宽中胶囊治疗功能性消化不良及抑郁症状疗效及安全性多中心、开放、随机对照研究

目的:观察枳术宽中胶囊治疗功能性消化不良餐后不适综合征患者消化不良症状和抑郁症状的疗效和安全性。方法:观察北京5家医院202例功能性消化不良餐后不适综合征患者,将其随机分为治疗组(97例),给予枳术宽中胶囊3粒Tidpo;对照组(105例),给予多潘立酮10mgTidpo。分别观察2周、4周疗程后消化不良症状和抑郁症状积分变化,同时观察记录不良事件。结果:治疗组经治疗后消化不良症状积分及抑郁积分明显下降,较治疗前差异具统计学意义。抑郁症状积分明显优于对照组。治疗4周后,治疗抑郁的有效率高于对照组,差异具统计学意义(P<0.05)。结论:枳术宽中胶囊治疗功能性消化不良餐后不适综合征有效、安全,并能改善功能性消化不良患者抑郁症状。

Efficacy and Safety of Zhizhu Kuanzhong Capsule in the Treatment of Functional Dyspepsia and Depression Symptoms in a Multi-centre Open Randomized Controlled Trial

Objective： To investigate the clinical efficacy and safety of Zhizhu Kuanzhong capsule in the treatment of dyspepsia symptoms and depression symptoms in postprandial distress syndrome （PDS） of functional dyspepsia （FD）. Methods：A total of 202 patients with PDS were divided into two groups randomly. The treatment group（ n = 97）received Zhizhu Kuanzhong capsule 1.29g tid po, the control group （n = 105）received Domperidone 10mg tid po. After 2 weeks and 4 weeks, the changes of dyspepsia symptoms score and depression symptoms score were recorded. Results：After treatment, the indigestion and depression symptom score points in treatment group decreased significantly, and had statistically significant differences compared with before treatment. Depressive symptom score was significantly better than that of the control group. 4 weeks after treatment, the effective rate for depression in treatment group was higher than that of control group, and the difference was statistically significant （ P 〈 0. 05 ）. Conclusion： Zhizhu Kuanzhong capsule is Safe and effective for dyspepsia symptoms and depression symptoms in postprandial distress syndrome （PDS）of functional dyspepsia.