小儿七星茶口服液与保和口服液对照治疗小儿积滞乳食内积证的临床研究  

Clinical Research of Xiao'er Qixingcha Oral Liquid Treating Pediatric Stagnation Food Accumulation Syndrome Controlled with Baohe Oral Liquid

作　　者：张淳[1] 胡思源[2] 成金乐 张会红 李新民[2] 冯自威 张广舫[6] 王明月[7] 

机构地区：[1]天津中医药大学,2011级硕士研究生天津300193 [2]天津中医药大学第一附属医院儿科,天津300193 [3]中智药业集团有限公司,广东中山528437 [4]北京远博康惠医药科技开发公司,北京100039 [5]漯河市中医院儿科,河南漯河462000 [6]廊坊市中医医院儿科,河北廊坊065000 [7]山东中医药大学第二附属医院儿科,山东济南250001

出　　处：《辽宁中医杂志》2014年第12期2621-2624,共4页Liaoning Journal of Traditional Chinese Medicine

基　　金：国家科技重大专项十二五"重大新药创制"课题(2011ZX09302-006-03);2012年度中山市科技计划项目(2013A275)

摘　　要：目的:评价小儿七星茶口服液治疗小儿积滞乳食内积证(消化功能紊乱症)的有效性与安全性。方法:采用分层区组随机、双盲、阳性药平行对照、多中心、双侧差异性检验临床研究方法。结果:小儿七星茶口服液治疗小儿积滞乳食内积证(消化功能紊乱症),对主症不思饮食、大便不畅、夜寐不安的总有效率,优效性检验结果,试验药物组不劣于阳性药对照组,对中医证候的总有效率,试验药物组为96.23%,阳性药对照组为88.68%,差异有显著统计学意义,试验药物组优于阳性药对照组;两组在脘腹胀痛、舌质舌苔改善方面治疗前后有显著统计学意义,试验药物组优于阳性药对照组。试验中,试验药物组出现不良事件3例,阳性药对照组出现不良事件4例,不良事件/反应发生率比较,差异无统计学意义。结论:小儿七星茶口服液对小儿积滞乳食内积证(消化功能紊乱症)治疗效果优于对照药保和口服液,且临床应用较为安全。Objective ：To evaluate the efficacy and safety of Xiao＇er Qixingcha oral liquid treating pediatric stagnation food accumulation syndrome（ digestive function disorder）. Methods：The stratified blocked randomization, double blind, positive parallel control, multi-center, bilateral difference test clinical research methods were used. Results：Xiao＇er Qixingcha oral liquid treating pediatric stagnation food accumulation syndrome （ digestive function disorder） had effective rates of main symptom and the trial group was not inferior to the control group. The total effective rate of TCM syndrome in the trial group was 96.23% and that of the control group was 88.68%. There was significant difference. The trial group was better than the control group. The two groups in terms of abdominal distension and tongue coating had significant statistical significance before and after the treatment and the trail group was better than the control group. In trials ,the trial group appearred adverse events （3 cases） and control group had 4 cases of adverse events. The incidence of adverse events/reaction in two groups had no statistically significant difference. Conclusion： The therapeutic efficacy of Xiao＇er Qixingcha oral liquid treating pediatric stagnation food accumulation syndrome（ digestive function disorder） is better and the clinical application of safer.

关 键 词：小儿七星茶口服液 小儿积滞 乳食内积 中药疗法 临床试验 

分 类 号：R725.7[医药卫生—儿科]