摘要
目的：评价厚朴排气合剂治疗有腹部胀满症状的功能性消化不良（FD）患者的有效性和安全性。方法于2014年7月至2015年6月，在9个中心共纳入162例有腹部胀满症状、符合罗马Ⅲ餐后不适综合征（PDS）诊断标准的 FD 患者。随机分为试验组和对照组，每组81例，试验组和对照组分别餐前口服厚朴排气合剂和安慰剂，均25 mL／次，均2次／d，疗程均为2周。比较两组治疗前后的主要症状改善率、临床总有效率和中医药疗效。统计学方法采用卡方检验、Fisher 确切概率法、Wilcoxon 秩和检验等。结果按照符合方案集（PP）分析，试验组患者治疗后的总有效率为69.4%（50／72），对照组为59.2%（42／71），两组差异无统计学意义（χ2＝1.650，P ＝0.199），两组 PDS 主要症状（餐后饱胀不适、早饱感）的改善率比较差异无统计学意义[（56.3±27.9）%比（54.4±32.1）%，t ＝0.606，P ＝0.727]。基线消化不良总分＊14分的患者，试验组的早饱感症状中位评分值下降至0分，低于对照组的1分，差异有统计学意义（Z ＝-2.370，P ＝0.018）。试验组中医主要症状的总有效率为80.8%（59／73），对照组为72.0%（54／75），差异无统计学意义（χ2＝0.676，P ＝0.411）。结论厚朴排气合剂对于有腹部胀满症状的 FD 有一定疗效，可用于以腹胀为主的 FD 治疗。
Objective To evaluate the efficacy and safety of Houpu Paiqi mixture in treatment of functional dyspepsia （FD）with abdominal distension symptom.Methods From July 2014 to June 2015 , in nine centers,a total of 162 FD patients with abdominal distension symptom and met Rome Ⅲpostprandial distress syndrome （PDS）diagnostic criteria were enrolled.All patients were randomly divided into trial group and control group,81 patients in either group.The patients of trial group and control group took Houpu Paiqi mixture or placebo,respectively,25 mL per time,twice daily,and both the courses of treatment were two weeks.Before and after the treatment,the improvement of main symptoms,total clinical efficacy rate and efficacy of traditional medicine between two groups were compared.Chi square test,Fisher exact probability method and Wilcoxon test were performed for statistical analysis.Results According to the results of per-protocol （PP）analysis,the total efficacy rate of trial group and control group was 69.4% （50/72）and 59.2% （42/71）,respectively,and there was no statistically significant difference in total efficacy rate between the two groups （χ2 =1 .650,P =0.199 ）. And there was no statistically significant difference in the improvement of PDS main symptoms（postprandial fullnessand early satiety）between the two groups （56.3% ±27.9% vs 54.4% ±32.1%,t =0.606,P =0.727 ）.For those with baseline symptom score over 14,median early satiety score of trial group after the treatment was 0,which was lower than that of control group,and the difference was statistically significant （Z =-2.370,P =0.018）.The total efficacy rate of traditional medicine of trial group was 80.8% （59/73 ）and that of control group was 72.0% （54/75 ）,and the difference was not statistically significant （χ2 = 0.676,P =0.411 ）.Conclusion Houpu Paiqi mixture has certain efficacy in FD with abdominal distension,and could be used for the treatment of PDS-predominant FD.
出处
《中华消化杂志》
CAS
CSCD
北大核心
2016年第6期412-417,共6页
Chinese Journal of Digestion
