摘要
[目的]评价胃病3号复方治疗功能性消化不良(FD)脾胃湿热证的疗效和安全性。[方法]采用多中心、随机、双盲、安慰剂对照的方法将104例脾胃湿热证FD患者分为试验组和对照组,分别用胃病3号复方以及安慰剂治疗。2组治疗疗程均为4周,治疗结束后第1个月随访。分别在治疗前,治疗4周结束,治疗结束后第1个月,记录患者的总体症状积分、中医证候积分等情况。[结果]①中医证候总体疗效评价:试验组总有效率为92.9%,对照组82.4%,疗效优于对照组(P<0.05)。②总体症状疗效评价(医生版):试验组总有效率为77.1%,对照组55.9%,疗效明显优于对照组(P<0.01)。③总体症状疗效评价(患者版):试验组总有效率为78.6%,对照组55.9%,疗效明显优于对照组(P<0.01)。④安全性评价:治疗及随访过程中2组均未出现不良反应,安全性良好。[结论]与安慰剂比较,胃病3号复方治疗FD脾胃湿热证具有良好的临床疗效和安全性。
[Objective]To evaluate the clinical therapeutic effects and safety of No.3 compound on functional dyspepsia（FD）with syndrome of dampness-heat of spleen and stomach. [Methods]One hundred and four patients were randomly divided into two groups for a double-blind control study.The treatment group received No.3 compound and the control group received placebo.The course was 4 weeks and the follow-up was 1 month.The scores of TCM syndromes,digestive symptoms were recorded before the treatment,the 4th week during the treatment,and the 1st month of follow-up. [Results]The difference of the effective rate between the treatment group and the control group had statistical significance（92.9% vs 82.4%,P0.05）.The effective rate of the treatment group and the control group collected from doctors was 77.1% and 55.9% respectively,and the difference between which was statistically significant（P0.01）.The effective rate of the two groups collected from patients was 78.6% and 55.9% respectively,the difference between which had statistical significance（P0.01）.No adverse effects were found during the treatment and follow-up in two groups. [Conclusion]No.3 compound was effective and safe in the treatment of FD with syndrome of dampness-heat of spleen and stomach.
出处
《中国中西医结合消化杂志》
CAS
2011年第5期284-289,共6页
Chinese Journal of Integrated Traditional and Western Medicine on Digestion
基金
"十一五"国家科技支撑计划课题资助项目(2007BAI20B092)
关键词
消化不良
功能性
胃病3号复方
脾胃湿热证
functional dyspepsia
No.3 compound
syndrome of dampness-heat of spleen and stomach
