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目的:在Ⅱ、Ⅲ期临床试验的基础上,对小儿脾胃乐颗粒治疗小儿厌食脾失健运证的有效性做进一步评价并进行安全性观察。方法:采用安慰剂对照设计、分层区组随机、随机双盲试验、多中心临床研究、优效性检验的方法,入选144例患者,试验组72例,剔除2例,脱落7例,对照组72例,剔除5例,脱落3例。结果:小儿脾胃乐治疗小儿厌食脾失健运证食欲不振疗效的总有效率为92.86%,对照组为56.72%,两组比较,差异有统计学意义(P<0.05)。两组食量减少疗效的总有效率,试验组为90.00%,对照组为67.16%,两组比较,差异有统计学意义(P<0.05)。优效性检验结果显示,试验组疗效优于对照组。结论:小儿脾胃乐颗粒治疗小儿厌食脾失健运证有效并且安全。
Objective: On the basis of clinical trials of stage Ⅱ and stage Ⅲ, the effectiveness of spleen and stomach in children treated with anorexia spleen deficiency syndrome was evaluated and safety observed. METHODS: A total of 144 patients were enrolled in the placebo-controlled design, stratified randomized, double-blinded trial, multicenter clinical study, and superiority-effectiveness test. The study group consisted of 72 patients, 2 patients were excluded, and 7 patients were absent. Group of 72 cases, excluding 5 cases, 3 cases off. Results: The total effective rate of pediatric spleen and stomach music in treating children with anorexia and spleen loss syndrome was 92.86% and 56.72% respectively in the control group. There was significant difference between the two groups (P <0.05). The total effective rate of two groups to reduce the curative effect was 90.00% in the test group and 67.16% in the control group. There was significant difference between the two groups (P <0.05). Superiority test results show that the experimental group than the control group. Conclusion: Pediatric Spleen and stomach particles treatment of children with anorexia spleen lose card is effective and safe.