健脾疏肝法治疗功能性消化不良脾虚气滞证:基于患者评价的随机、对照试验

Efficacy of the Method for Smoothing the Liver and Strengthening the Spleen on Functional Dyspepsia of Spleen-deficiency and Qi-stagnation Syndrome: A Randomized Controlled Patient-reported Trial

目的:评价健脾疏肝法治疗功能性消化不良脾虚气滞证的疗效和安全性,并采用了基于患者的结局评价从患者的角度考察其最关心的问题的变化情况。方法:采用多中心、随机、双盲、安慰剂对照的方法将来自5个分中心的160例脾虚气滞证功能性消化不良患者按2∶1的比例分为试验组和对照组,分别给予具有健脾疏肝作用的中药健脾理气方以及安慰剂治疗。中药及安慰剂均为配方颗粒,由70℃温水冲服,分早晚2次服用,每次150 m L。2组治疗疗程均为4周,治疗结束后4周进行随访。主要评价指标为基于患者评价的消化道症状积分,包括消化道总体症状积分和单项症状积分,分别在第0,1,2,3,4和8周观察记录。次要评价治疗为钡条胃排空试验,在第0和4周完成。结果:与安慰剂比较,治疗4周后及随访试验组患者消化道总体症状积分和单项症状积分改善优于对照组(P<0.01或P<0.05)钡条胃排空试验中药组对胃肠动力改善亦优于对照组(P<0.05)。临床试验期间未出现与药物相关的不良事件。结论:中药健脾疏肝法可改善功能性消化不良脾虚气滞证患者的临床症状,且安全性良好。

Objective：To assess the efficacy and safety of the method for soothing the liver and strengthening the spleen in patients with FD of spleen-deficiency and qi-stagnation syndrome .The major concerns of patients were investigated by patient-reported out-come.Methods： A randomized, double-blind, placebo-controlled trial was performed with patients from five centers .Patients with FD of spleen-deficiency and qi-stagnation syndrome （n=160） were randomly assigned to groups given CHM spleen-strengthe-ning and liver-qi regulating decoction or placebo in a 2∶1 ratio.Herbal medicine or placebo granules were dissolved in 300 ml of boiled water cooled to 70 ℃.Patients in both groups were administered 150 ml twice daily.The trial included a 4-week treatment period and a 4-week follow-up period.The primary outcomes were dyspepsia symptom scores , measured by the total dyspepsia symptom scale and the single dyspepsia symptom scale at weeks 0, 1, 2, 3, 4 and 8.The secondary outcome was the change of radiopaque barium markers emptied from the stomach between week 0 and week 4 of treatment .Results：Compared with patients in the placebo group , patients in the CHM group showed significant improvement according to the scores of total dyspepsia symp -toms and single dyspepsia symptoms obtained from patients （ P〈0.01 or P〈0.05 ） .They also showed an improvement in the number of radiopaque barium markers emptied from the stomach （ P〈0.05 ） .During the clinical trial , there is no adverse event related to the herbal medicine .Conclusion：The method for soothing the liver and strengthening the spleen appears to offer symp-tomatic improvement in patients with FD of spleen-deficiency and qi-stagnation syndrome and is safe .