宝儿康散剂量加倍治疗小儿慢性迁延性腹泻病脾虚湿困证评价其有效性和安全性的随机双盲、阳性药和原剂量平行对照、多中心临床试验

Efficacy and safety of double dose Baoerkang powder in children with chronic persistent diarrhea disease of damp retention due to spleen deficiency: A block randomized, double-blind, positive-controlled, parallel to the original dose, multi-center clinical trials

关键词:  宝儿康散  止泻灵颗粒  随机对照试验  小儿迁延性和慢性腹泻病

Key words:  Baoerkang powder  Zhixieling granule  RCT  children with chronic persistent diarrhea disease

摘要:

[目的] 评价不同剂量宝儿康散对于小儿慢性迁延性腹泻病脾虚湿困证的腹泻症状治疗作用，以及缩短病程和改善中医证候作用，同时观察临床应用的安全性。[方法] 采用随机、双盲双模拟、阳性药平行对照、多中心临床试验的方法。15家中心共入选受试者168例，按照1：1：1的比例随机分配到加倍剂量组、原剂量组和对照组（止泻灵颗粒）。疗程为5 d。评价腹泻症状疗效、止泻时间、中医证候疗效、单项症状疗效，并观察其安全性。[结果] 腹泻症状疗效的总有效率，加倍剂量组为89.29%、原剂量组为69.09%、对照组为65.45%，3组间比较差异有统计学意义，加倍剂量组优于原剂量组和对照组。中位止泻时间，加倍剂量组为4 d、原剂量组为5 d、对照组超过5 d，3组间比较差异有统计学意义，加倍剂量组短于原剂量组和对照组。中医证候疗效的总有效率，加倍剂量组为94.64%、原剂量组为89.09%、对照组为81.82%，3组间比较差异有统计学意义，加倍剂量组优于对照组。单项症状中，在大便稀溏、便次增多方面，加倍剂量组优于对照组。试验过程中，仅原剂量组发生不良事件1例，发生率1.79%，经研究者判断，与试验用药无关。[结论] 宝儿康散剂量加倍治疗小儿慢性迁延性腹泻病脾虚湿困证，具有改善腹泻症状、缩短腹泻病程和改善中医证候作用，疗效优于止泻灵颗粒以及原剂量宝儿康散，且安全性良好。

Abstract:

[Objective] To evaluatethetherapeutic effect of Baoerkang powder of different doses on chronic persistent diarrhea disease with syndrome of dampness stagnancy due to spleen deficiency in children, as well as shortening the course and improvement of traditional Chinese medicine syndrome, while observing the safety of clinical applications.[Methods] A randomized, double-blind, double-dummy, parallel, active-controlled and multi-center clinical research method was adopted. The 168 patients of 15 centers were enrolled and randomly separated into double dose group, original dose group and control group(Zhixieling granules) in the rate of 1:1:1. Treatment course lasted for 5 days. Diarrhea efficacy, traditional Chinese medicine syndrome efficacy,antidiarrheal time, single symptom efficacy were observed. And the security was evaluated.[Results] The total effective rate of diarrhea was 89.29% in the double dose group,69.09% in the original dose group and 65.45% in the control group. There was statistical difference amongthe three groups. The double dose group was superior to the original dose group and the control group. the median antidiarrheal time were 4 days, 5 days and 5 days in double dose group, low dose group and control group,respectively. Double dose group recover faster, and there is significant difference between them. The total effective rate of traditional Chinese medicine syndrome efficacy was 94.64% in the double dose group,89.09% in the original dose group and 81.82% in the control group. There was statistical difference among the three groups. The double dose group was superior to the control group,and the same for single symptoms,such as thin sloppy stool and increased stool frequency. During the study,there were 1 case (1.79%) adverse event in the original dose group. The researchers determined that it had nothing to do with the experimental medication.[Conclusion] Baoerkang powder in double dose that has the effect of improving the symptoms of diarrhea, shortening the course and improving traditional Chinese medicine syndrome was superior to the control dose group(Zhixieling granules)and the original group(the dosage of instructions)on treating chronic persistent diarrhea disease with syndrome of dampness stagnancy due to spleen deficiency in children, and has good safety.