健胃消食口服液治疗244例小儿厌食(脾胃气虚证)多中心随机对照临床研究

Multicenter randomized controlled trial of Jianwei Xiaoshi Oral Liquid in treating 244 children of infantile anorexia(qi deficiency of spleen and stomach syndrome)

目的:观察健胃消食口服液治疗小儿厌食(脾胃气虚证)的临床疗效。方法:将244例小儿厌食(脾胃气虚证)患儿按照多中心中央随机平行对照的原则分为治疗组(166例)和对照组(78例),治疗组给予健胃消食口服液治疗,对照组给予胃蛋白酶口服液治疗,疗程均为2周,比较两组患儿治疗前后主症(饮食、神气、形体),次症(面色、唇色、甲色、腹部症状、呕吐、大便、小便、舌象、脉象)的症状积分,并判定临床疗效。结果:用药后1、2周,治疗组有效率(55.15%、91.52%)均显著高于对照组(25.64%、73.08%)(P<0.01)。两组治疗后,主症(饮食、神气)积分较前显著降低,且两组间差异有统计学意义(P<0.05);次症(面色、腹部症状、呕吐、大便、小便、舌象)积分较治疗前显著降低(P<0.05),面色、唇色、甲色、小便、舌象积分治疗组较对照组显著降低(P<0.05)。治疗组唇色、甲色积分治疗前后比较,差异有统计学意义(P<0.05)。结论:治疗组、对照组治疗小儿厌食(脾胃气虚证)均有效,治疗组总体效果优于对照组。

Objective:To observe therapeutic effect of Jianwei Xiaoshi Oral Liquid in treating children with infantile anorexia(qi deficiency of spleen and stomach syndrome).Methods:A total of 244 cases of children with infantile anorexia(qi deficiency of spleen and stomach syndrome)were divided into treatment group(165 cases)and control group(78 cases)according to multicenter central random parallel control design.They were given Jianwei Xiaoshi Oral Liquid and Pepsin Oral Liquid,respectively for 2 weeks.Comparing scores of main symptoms(including food,spirit,body),secondary symptoms(including color of face,lips,and nails,abdominal symptom,vomiting,stool,urine,color of tongue and pulse)and scores of total syndromes of children in two groups before and after treatment,the clinical curative effect was evaluated.Results:After treatment,the one,two weeks’curative rate in the treatment group were 55.15%,91.52%,while the control group were 25.64%,73.08%.The difference between the two groups was statistically significant(P<0.01).Scores of most of main and secondary symptoms were remarkably decreased than that before treatment(P<0.05).After treatment,scores of main symptoms(food and spirit)were increased obviously compared with the control group(P<0.05),scores of the secondary symptoms(including color of face,abdominal symptom,vomiting,shit,urine color of tongue)which were increased well in each group,were statistically significant between before and after treatment(P<0.05).Scores of the secondary symptoms(including color of face,lips,and nail,urine,color of tongue)were increased a lot between two groups(P<0.05).Scores of the secondary symptoms(including color of lips and nail)were changed well in the treatment group between before and after treatment(P<0.05).Conclusion:The results shows that both the treatment group and the control group are effective in the treatment of infantile anorexia(qi deficiency of spleen and stomach syndrome),and the overall effect of the treatment group is better than the control group.