参香健脾理气颗粒治疗脾虚气滞证功能性消化不良随机双盲对照研究

A randomized double-blind controlled study:Shenxiang Jianpi Liqi Granule in the treatment of functional dyspepsia with Spleen Deficiency and Qi Stagnation Syndrome

目的:观察参香健脾理气颗粒治疗脾虚气滞证功能性消化不良的临床疗效。方法:将120例脾虚气滞证功能性消化不良患者随机分成试验组(60例)、对照组(60例),分别采用参香健脾理气颗粒和参香健脾理气颗粒模拟剂治疗,疗程4周,治疗后1个月随访,对中医证候积分、中医总体疗效评价、西医单项症状进行综合评价。结果:试验组中医证候积分的改善在治疗2周、4周后及治疗后1个月随访时均明显优于对照组,差异有统计学意义(P<0.01)。治疗4周后中医总体疗效评价:试验组总有效率为93.3%,明显优于对照组的68.3%,差异有统计学意义(P<0.01);西医单项症状评价:试验组的餐后饱胀不适、早饱感的症状积分改善明显优于对照组,差异有统计学意义(P<0.01);试验组上腹痛的症状积分改善与对照组比较差异无统计学意义(P>0.05),治疗后1个月随访,试验组上腹痛症状积分改善优于对照组,差异有统计学意义(P<0.01);上腹烧灼感症状积分的改善,在治疗2周、4周后及治疗后1个月随访,两组比较差异无统计学意义(P>0.05)。结论:参香健脾理气颗粒治疗脾虚气滞证功能性消化不良,中医总体有效率达93.3%,且能明显改善中医证候积分、餐后饱胀不适、早饱感等西医单项症状。

Objective To observe the clinical efficacy of Shenxiang Jianpi Liqi Granule in the treatment of functional dyspepsia with Spleen Deficiency and Qi Stagnation Syndrome.Methods One hundred and twenty cases of functional dyspepsia with Spleen Deficiency and Qi Stagnation Syndrome were randomly divided into experimental group(60 cases)and control group(60 cases).They were treated with Shenxiang Jianpi Liqi Granule and Shenxiang Jianpi Liqi Granule simulant respectively.The course of treatment was four weeks.One month after treatment,they were followed up to evaluate the Traditional Chinese Medicine(TCM)syndrome score,the overall efficacy of TCM and the single symptom of Western medicine.Results the improvement of TCM syndrome score in the experimental group was significantly better than that in the control group after two weeks,four weeks and 1 month of treatment(P<0.01).After four weeks of treatment,the total effective rate in the experimental group was 93.3%,which was significantly better than 68.3%in the control group(P<0.01).Western medicine single symptom evaluation:the improvement of symptom score in the experimental group was significantly better than that in the control group(P<0.01)There was no significant difference in the symptom score of upper abdominal pain between the two groups(P>0.05).After one month of follow-up,the symptom score of upper abdominal pain in the experimental group was better than that in the control group(P<0.01),and the symptom score of upper abdominal burning sensation was improved.There was no significant difference between the two groups after two weeks,four weeks and one month of follow-up(P>0.05).Conclusion Shenxiang Jianpi Liqi Granule has an overall effective rate of 93.3%in the treatment of functional dyspepsia with Spleen Deficiency and Qi Stagnation Syndrome,and can significantly improve TCM syndrome,postprandial satiety discomfort,early satiety and other single symptoms of Western medicine.