藿香正气滴丸治疗功能性消化不良痰湿中阻证疗效与安全性的临床研究

Clinical study on curative effect and safety of Huoxiang Zhengqi dropping pills in treating functional dyspepsia of stagnation of phlegm-damp in middle Jao

关键词:  功能性消化不良  藿香正气滴丸  痰湿中阻型  胃排空  疗效

Key words:  functional dyspepsia  Huoxiang Zhengqi dropping pill  phlegm-damp stagnation  gastric emptying  therapeutic effect

摘要:

[目的] 探讨藿香正气滴丸治疗功能性消化不良(痰湿中阻证)临床疗效及调节胃排空作用.[方法] 功能性消化不良餐后不适综合征(FD)痰湿中阻证共229例,按分层区组随机、平行对照、双盲双模拟、多中心临床研究的方法,以1:1比例分为试验组和对照组,可供疗效分析的有218例,治疗组109例采用口服藿香正气滴丸及舒丽启能模拟剂;对照组109例采用舒丽启能片剂口服及藿香正气滴丸模拟剂,疗程为4周.疗后观察两组的临床疗效.用药前日行胃排空检查并对其中74例胃排空障碍的病例于第28日行胃排空复查.[结果] 1)证候疗效的总有效率两组相当, 2周访视点,治疗组为78.90%、对照组为72.48%.4周访视点,治疗组为93.58%、对照组为93.58%.2周、4周访视点证候积分和情况比较,组间差异均无统计学意义;组内提示4周疗效优于2周疗效.2)两组均能改善功能性消化不良的临床症状,单项证候的整体疗效分析显示腹胀、口淡不渴等证候改善程度治疗组优于对照组.3)两组治疗后胃排空均有改善,组间比较差异无统计学意义.[结论] 藿香正气滴丸能改善痰湿中阻型功能性消化不良患者的临床症状,部分单项症状疗效优于舒丽启能.藿香正气滴丸、舒丽启能均能有效改善胃排空减缓的状态,提示藿香正气滴丸有调节胃肠运动的作用.

Abstract:

[Objective] To explore the clinical effect of Huoxiang Zhengqi dropping pills in treating functional dyspepsia(FD) syndrome(syndrome with stagnation of phlegm-damp in middle Jiao)and to detect its role in adjusting the gastric emptying. [Methods] Total 229 patients with FD were enrolled in a multi-center, randomized, double-blinded, double-simulation and parallel-controlled trial. The course of treatment was 4 weeks. Total 218 cases were finally analyzed. Among them 109 subjects in the trial group were administrated with Huoxiang Zhengqi dropping pills and cerekinon simulation agents. The 109 subjects in the control group were administrated with cerekinon and Huoxiang Zhengqi dropping pills's simulation agent. Gastric emptying was checked in the all cases on the day before the start of the trial and rechecked in 74 cases with disorder of gastric empty at the 28th day of the trial. [Results] 1)The relief of symptoms of total efficiency was 78.90% in the trial group and 72.48% in the control respectively 2 weeks after treatment, while 93.58% and 93.58% 4 weeks after treatment. There was no significant difference between the trial group and control group at the same time point but significant difference between the two groups at different time point. 2)The relief of FD symptoms was observed among both groups. The relief of single syndrome,such as taste poor without thirsty,abdominal distension was observed more in the trial group than control group. 3)The function of gastric empty was improved in two groups after treatment with Huoxiang Zhengqi dropping pills and cerekinon. [Conclusion] Huoxiang Zhengqi dropping pills can relive symptoms of FD patients(with phlegm-damp stagnation). The improvement of a part of single therapeutic parameter was better than that of cerekinon. The effective improvement of delayed gastric empty was observed in both of groups,suggesting that Huoxiang Zhengqi dropping pills may play a role of adjusting gastrointestinal motility.