基于“寒热虚实”辨证治疗功能性消化不良:患者评价结局的随机对照试验

Efficacy of syndrome differentiation based on 'han,re,xu,shi' on functional dyspepsia:A randomized controlled patient-reported trial

目的:从患者的角度,评价中药基于"寒热虚实"辨证治疗功能性消化不良的疗效和安全性。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527例功能性消化不良患者,基于"寒热虚实"辨证分为脾胃虚弱(寒)、脾虚气滞、脾胃湿热、寒热错杂4个证型,分别随机给予中药1、2、3、4号配方或安慰剂治疗。中药及安慰剂均为配方颗粒,分早晚2次服用,每次150m L。两组治疗疗程均为4周,治疗结束后4周进行随访。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、4、8周观察记录。结果:4种证型患者接受治疗4周后及随访时,试验组消化道总体症状积分和单项症状积分改善均优于对照组(P<0.01,P<0.05)。临床试验期间未出现与药物相关的不良反应。结论:中药基于"寒热虚实"辨证治疗功能性消化不良,可改善患者的临床症状,效果明显优于安慰剂,且安全性良好。

Objective：In this trial,it aimed to assess the efficacy and safety of syndrome differentiation based on＇han,re,xu,shi＇ in patients with FD.The major concerns of patients were investigated by patient-reported outcome.Methods：A randomized,double-blind,placebo-controlled trial was performed with patients from five centers.Patients with FD（527 cases）were divided into 4 groups（deficiency of spleen and stomach,spleen deficiency and liver-qi blocking,spleen and stomach damp-heat,cold-heat jumble）.Patients in both groups were administered herbal or placebo granules dissolved in 150 mL water 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 0,4 and 8.Results：Compared with patients in the placebo group,patients in the CHM group showed significant improvements according to the scores of total dyspepsia symptoms and single dyspepsia symptoms obtained from patients（P〈0.01,P〈0.05）.During the clinical trial,there is no adverse event related to the herb.Conclusion：The method of syndrome differentiation based on＇han,re,xu,shi＇appears to offer symptomatic improvement in patients with FD and is safe.