金橘开胃颗粒剂治疗小儿厌食脾失健运证临床研究

Clinical Study on Jinjukaiwei Granules in Treating Anorexia Spleen Fails to Transport and Transform Syndrome in Children

目的:验证金橘开胃颗粒剂治疗小儿厌食脾失健运证的有效性与安全性。方法:采用随机分组、平行对照的方法进行临床对照研究。结果:试验组的愈显率为76.86%,明显高于对照组(P<0.001)。试验组食欲不振、食量减少、异常舌脉的消失率,以及治疗前后证候积分总值差值,均明显高或大于对照组(P<0.01～0.001)。治疗后,两组周围血HB含量和RBC数均较治疗前明显升高(P<0.001～0.05),且试验组HB的治疗前后差值明显大于对照组(P<0.05);两组患儿尿D-木糖排泄率均值与治疗前比较均有明显提高(P<0.001和P<0.05)。安全性指标观测未发现除轻度腹泻外的其他毒副反应。结论:金橘开胃颗粒剂对小儿脾失健运型厌食症具有较好的治疗作用,且临床应用比较安全。

Objective: To verify the effectiveness and reliability of Jinjukaiwei Granules in treating anorexia spleen fails to transport and transform syndrome in children. Method: 243 patients were randomly divided into two groups. Compared by parallel control. Results: The effective rate was 76.86% in the treated group, which was higher significantly than that in the control group (P<0.01). Both the disappearance rates of some symptoms including anorexia, poor appetite, abnormal tongue, pulse and the difference of total score between pre-treatment and post-treatment in the treated group were significantly higher than those in the control group (P<0.01～0.001). The content of HB and the RBC count were remarkably improved after treatment in both groups (P<0.001～0.05). The difference of HB between pre-treatment and post-treatment in the treated group was significantly higher than that in the control group (P<0.05); the excretory rates of D-xylose in urine were both significantly improved in two groups (P<0.001, P<0.05, respectively). The observation about reliability markers indicated: there was no other toxic and side effects except mild diarrhea. Conclusion: Jinjukaiwei Granules possesses better effects in treating anorexia spleen fails to transport and transform syndrome in children, during the reliability observation, which indicated the better clinical reliability.