小儿急性非细菌感染性腹泻病126例随机对照临床研究

Clinical randomized controlled study of 126 cases of acute non-bacterial infectious diarrhea in children

目的对中医治疗小儿泄泻进行随机对照临床研究,以客观规范地评价运脾化湿法治疗小儿急性非细菌感染性腹泻病的临床疗效。方法采用前瞻性、多中心的随机对照临床研究方法,将126例急性非细菌性腹泻病患儿分为试验1组、试验2组、对照组,分配比例为1∶1∶1,分别采用中药汤剂、中药汤剂+推拿、蒙脱石散(思密达)进行治疗,观察临床症状改善情况及治疗效果。结果 (1)试验1组、试验2组、对照组的显效率分别为51.16%、65.71%、34.15%,组间比较差异有统计学意义(P<0.05);(2)试验1组、试验2组、对照组治疗2d成形便分别为11例、7例、1例,组间差异均有统计学意义(P<0.05);(3)试验1组、试验2组、对照组的止泻时间分别为(4.30±2.39)d、(4.31±2.79)d、(5.49±2.69)d,差异无统计学意义(P>0.05)。结论中药及中药+推拿治疗小儿泄泻在显效率及改善患儿大便性状方面优于思密达。

Objective A randomized controlled clinical study of Chinese medicine in infantile diarrhea treatment was conducted to evaluate objectively and in a standard way the effect of main therapeutic method of Activating Spleen and Dissipating Dampness on infantile acute nonbacterial infectious diarrhea.Methods The clinical study was designed as a prospective,multi-center,randomized,control trial.Totally 126 infants with acute nonbacterial diarrhea were allocated into test group A,test group B and the control group in proportion of 1∶1∶1 with central randomization system.The treatment of Chinese herb,Chinese herb combined with massage and Montmorillonite powder was applied to the three groups respectively.Results Significant effect rate in test group A,test group B and the control group was 51.16%,65.17%,34.15%,respectively,and there was a significant difference（P0.05）in the three groups.（2）On the second day of treatment,there was a significant difference on changing characters of stool in the three groups（P0.05）.（3）The antidiarrheal time of test group A,test group B and the control group was（4.30±2.39）days,（4.31±2.79）days,（5.49±2.69）days,which showed no significant difference by statistical analysis（P0.05）.Conclusions Chinese medicine group and Chinese herb combined with massage are superior to Montmorillonite powder on changing characters of stool.