【摘要】 目的分析脾胃宁口服液治疗小儿厌食症脾虚食积证的临床有效性及安全性。方法根据脾胃宁口服液Ⅲ期临床试验方案在5个试验中心选取480例厌食症脾虚食积证患儿,按照3∶1的比例,试验组纳入360例,对照组纳入120例。将实际纳入的464例厌食症患儿按照分层分段随机方法分为试验组348例,其中脱落22例,剔除3例,对照组116例,其中脱落7例,剔除0例。两组分别给予脾胃宁口服液(试验组)及化积口服液(对照组)口服2周,采用意向性分析集(ITT)和符合方案集(PP)分别对疾病疗效、中医证候积分及安全性进行分析。结果 ITT集试验组的愈显率为51.7%,对照组的愈显率为43.1%,PP集试验组的愈显率为55.1%,对照组的愈显率为45.9%,从ITT集及PP集分析显示,愈显率试验组均好于对照组,但差异无统计学意义(P值> 0.05);治疗2周后主症食量,次症面色、舌质舌苔的积分试验组优于对照组(P <0.05);在本次临床试验研究全过程中,安全性级别评价只有1例评为2级,其他安全性级别均为1级,无严重不良事件发生。结论脾胃宁口服液治疗小儿厌食症脾虚食积证是有效的、安全的。更多还原

【Abstract】 Objective To analyze the clinical efficacy and safety of piweining oral liquid in the treatment of children anorexia. Methods According to the Phase Ⅲ clinical trial program of Piweining Oral Liquid, 480 children with anorexia and spleen deficiency and food stagnation were selected from 5 test centers. According to a ratio of 3∶1, 360 cases were included in the experimental group and 120 cases in the control group. The actually included 464 children with anorexia were randomly divided into the experimental group 348 cases according to the stratified segmentation method, of which 22 cases were dropped out, 3 cases were eliminated, and the control group 116 cases, of which 7 cases were dropped out and 0 cases were eliminated. The two groups were given Piweining Oral Liquid(test group) and Huaji Oral Liquid(control group) orally for 2 weeks. Intentional analysis set(ITT) and compliance protocol set(PP) were used to treat the disease efficacy, TCM syndrome scores, and Security analysis. Results The cure rate of the ITT set test group was 51.7%, the cure rate of the control group was 43.1%, the cure rate of the PP set test group was 55.1%, and the cure rate of the control group was 45.9%,from the ITT set and the PP set The analysis showed that the recovery rate of the test group was better than the control group,but the difference was not statistically significant; after 2 weeks of treatment, the scores of the main symptoms of food intake, secondary symptoms, and tongue texture were better than those of the control group(P < 0.05); During the process, only one case of safety evaluation was rated as level 2, and the other safety levels were all level 1, and no serious adverse events occurred. Conclusion Piweining oral liquid is effective and safe in treating children anorexia.更多还原