香砂六君子颗粒治疗功能性消化不良脾虚证的随机、双盲、对照研究

Randomized,double-blinded and controlled trial of Xiangsha Liujunzi Granule in the treatment of functional dyspepsia with spleen deficiency syndrome

目的:研究香砂六君子颗粒治疗功能性消化不良(FD)脾虚证的有效性与安全性。方法:将2018年10月-2020年1月中国中医科学院西苑医院收治的60例FD脾虚证患者随机分为试验组与对照组,每组30例,试验组予香砂六君子颗粒治疗,对照组予安慰剂治疗,疗程4周。观察2组临床总体印象量表应答率、中医证候积分、生活质量评分、安全性指标。结果:治疗后,与对照组比较,试验组临床总体印象量表应答率升高,但差异无统计学意义(P>0.05);中医证候总积分明显下降(P<0.05),胃脘痞满、胃脘痛、四肢乏力单项症状消失率明显升高(P<0.01,P<0.05);SF-36量表评分中的总体健康、躯体疼痛、生命活力、情感职能、精神健康评分明显升高(P<0.05)。试验期间未出现明显不良反应。结论:香砂六君子颗粒治疗FD脾虚证具有一定的疗效,且安全性好。

Objective: To study the efficacy and safety of Xiangsha Liujunzi Granule in the treatment of functional dyspepsia(FD) with spleen deficiency syndrome. Methods: Sixty patients with FD spleen deficiency syndrome admitted from October 2018 to January 2020 were randomly divided into the treatment and control groups, with 30 patients in each group. The treatment group was treated with Xiangsha Liujunzi Granule, and the control group was treated with placebo. The treatment course was 4 weeks. The response rate of clinical global impression scale, TCM syndrome score, life quality score and safety index were observed in the two groups. Results: After treatment, the response rate of clinical impression scale in the treatment group was higher than that in the control group, however, there was no significant difference between the two groups(P>0.05);The total score of TCM syndromes was significantly lower than that in the control group(P<0.05);The disappearance rate of epigastric fullness, epigastric pain and limb weakness was significantly increased(P<0.01, P<0.05);Overall health, physical pain, life vitality, emotional function, mental health scores of SF-36 scale were significantly increased(P<0.05). No significant adverse reactions were reported in the two groups. Conclusion: Xiangsha Liujunzi Granule has a certain curative effect and safety in the treatment of FD with spleen deficiency syndrome.