肠吉泰治疗腹泻型肠易激综合征的随机双盲安慰剂平行对照试验

A randomized,double-blinded and placebo-controlled trial of "Chang Ji Tai Granule" in treating diarrhea-predominant diarrhea

目的观察中药验方肠吉泰治疗腹泻型肠易激综合征(肝郁脾虚型)的疗效和安全性。方法采用随机双盲、安慰剂平行对照的方法,将60例符合纳入标准的腹泻型肠易激综合征患者,以1:1比例按随机数字进入试验组或对照组(各30例),对受试者、干预措施实施者及结果测量者实施盲法;试验组予肠吉泰颗粒剂,对照组予安慰剂,两组临床试验疗程均为28天;实施干预措施前、干预结束后对受试者采用症状尺度量表(IBS-BSS)、大便性状量表(IBS-DSQ)观察临床症状变化及生活质量改善情况,疗程结束后评价临床疗效。结果试验组和对照组主要症状有效率符合方案集(PP)分别为83.33%、62.10%,全分析集(FAS)分别为83.33%、60.00%(P<0.05);试验组和对照组的次要症状有效率符合方案集(PP)分别为86.67%、58.62%,全分析集(FAS)分别为86.67%、56.67%。组间主要症状和次要症状有效率比较,各分析集差异均有统计学意义(P<0.05)。试验组治疗前后主要症状总积分及各单项症状积分差异均有统计学意义(P<0.05);对照组除腹胀症状外,主要症状总积分及其他各单项积分差异有统计学意义(P<0.05);组间治疗后比较,主要症状总积分及各单项积分差异均有统计学意义(P<0.05)。两组治疗前后自身比较,排便次数和10天内大便急迫天数积分差异有统计学意义(P<0.05);组间治疗后比较,10天内大便急迫天数积分差异有统计学意义(P<0.05)。两组治疗过程中均未发生不良事件。结论中药验方肠吉泰治疗腹泻型肠易激综合征(肝郁脾虚型)安全有效。

Objective To observe the clinical efficacy and safety of ＂Chang Ji Tai Granule＂（CJTG） in the treatment of diarrhea-predominant IBS（IBS-D） of liver depression and spleen deficiency.Methods According to a randomized,double-blinded and placebo-controlled trial,60 IBS-D cases were randomized into CJTG group（n=30） and placebo group（n=30）.Bowel symptom scale（BSS） and defecation status questionnaire（DSQ） were completed at baseline and after treatment to assess CJTG efficacy.Laboratory tests were taken before and after treatment to assess CJTG safety.Results The total effective rates of CJTG and the placebo groups were 83.33% and 62.00% respectively（FAS,P0.05）,while 83.33% and 62.00%（PP,P0.05）.Compared with the patients in the placebo group,the patients in CJTG group had significant improvement in stool form,urgency and defecation frequency;the effective rates of CJTG and the placebo groups were 86.67% and 56.67%（FAS,P0.05）,while 86.67% and 58.62%（PP,P0.05）.There were no any adverse events in either the CJTG group or the placebo group.Conclusion CJTG is safe and effective in treating IBS-D of liver depression and spleen deficiency.