消痞丸方治疗餐后不适综合征的中医证候疗效评估

The efficacy of Xiao Pi Wan on the traditional Chinese medicine syndrome of functional dyspepsia postprandial discomfort syndrome

[目的]观察消痞丸方治疗餐后不适综合征(PDS)的中医证候疗效。[方法]开展随机、双盲双模拟、安慰剂对照研究。将66例PDS患者随机分至治疗组(消痞丸)和对照组(安慰剂),患者在入组研究前至少接受过2种药物(抑酸剂、促动力剂或抗Hp治疗)治疗无效;患者入组后分别接受消痞丸方颗粒和消痞丸方模拟颗粒治疗,每次1包,2次/d,治疗4周。采用脾胃病状量表(胃系症状)计算患者的中医证候积分,进行疗效评估。[结果]治疗4周后,治疗组早饱(30.4%、4.5%,P=0.047)和厌油腻(40.0%、0,P=0.024)症状消失的患者比例显著高于对照组;治疗组和安慰剂组分别有3/30(10%)和0/30例患者获得临床痊愈(定义为治疗改善率≥90%),但与安慰剂组比较,差异无统计学意义(P=0.237)。治疗组和安慰剂组的显效率(治疗改善率≥70%)分别为6/30(20%)和2/30(6.7%),组间比较差异无统计学意义(P=0.254);治疗组和对照组有效率(治疗改善率≥30%)分别为15/30(50%)和15/30(50%),组间比较差异无统计学意义(P=1.000)。[结论]消痞丸方可有效改善PDS的早饱和厌油腻症状。

[Objective]To evaluate the clinical effect of Xiao Pi Wan on treating Functional Dyspepsia Postprandial Discomfort Syndrome(PDS),measured by Traditional Chinese Medicine Syndrome.[Methods]Sixty-six patients with PDS,who have received two or all of the following agents and failed to the treatment,proton pump inhibitors,motility modifying agents,and helicobacter pylori(Hp)eradication,were included in this randomized,double-blind,and placebo control trial.Patients received Xiao Pi Wan(1package,bid)or placebo(1package,bid)for 4weeks.Spleen and Stomach Symptom Rating Scale(for stomach)was used to access the efficacy.[Results]Sixty patients completed the trial.The proportion of patients without early satiety(30.4%vs.4.5%,P=0.047),and fat aversion(40.0%vs.0,P=0.024)were significantly higher in the Xiao Pi Wan group than that in the placebo group.Three patients(10%)in the Xiao Pi Wan group and 0/30patients from the placebo group achieved clinical recovery(defined as≥90%improve-ment,P=0.237),6/30patients(20%)in the Xiao Pi Wan group and 2/30patients(6.7%)from the placebo group achieved marked clinical improvement(defined as≥70%improvement,P=0.254),15/30patients(50%)in the Xiao Pi Wan group and 15/30patients(50%)from the placebo group achieved clinical improvement(defined as≥30%improvement,P=1.000).[Conclusion]Xiao Pi Wan can effectively alleviate early satiety and fat aversion,which are two main symptoms of PDS.