小儿积滞中药临床试验设计与评价技术指南

目的 以“肠-关节”轴为切入点,探讨金藤清痹颗粒抗类风湿关节炎的作用机制。方法 按体质量将大鼠随机分为6组,即对照组、模型组、双氯芬酸钠组以及金藤清痹颗粒高、中、低剂量组,每组6只。采用胶原诱导法进行造模,设计金藤清痹颗粒高、中、低剂量组给药剂量分别为6.30、3.15、1.58 g/kg;双氯芬酸钠组给药剂量为3 mg/kg;对照组和模型组ig等量生理盐水,给药4周。苏木精-伊红染色法（HE）观察大鼠踝关节部位病理变化,酶联免疫吸附测定法（ELISA）检测大鼠血清相关炎症指标,16S rDNA分析盲肠内容物中肠道菌群变化。结果 与模型组比较,金藤清痹颗粒可明显降低胶原诱导型关节炎模型大鼠关节肿胀度,减少踝关节炎性细胞浸润,同时可显著降低胶原诱导型关节炎大鼠血清肿瘤坏死因子-α（TNF-α）、白细胞介素（IL）-1β、C反应蛋白（CRP）水平（P＜0.05、0.01）;16S rDNA结果显示,金藤清痹颗粒6.30 g/kg可增加Cyanobacteria、软壁菌门、疣微菌门、梭杆菌门、毛螺菌科NK4A136群和Ruminiclostridium 5等菌群的相对丰度,以及降低变形菌门、乳杆菌属和瘤胃球菌属1等菌群的相对丰度。结论 金藤清痹颗粒可能通过调控“肠-关节”轴发挥抗类风湿关节炎的作用。

Guideline on design and evaluation of clinical trials for Chinese medicine in common pediatric diseases: Food accumulation and stagnation in children

Guideline on Design and Evaluation of Clinical Trials for Chinese Medicine in Common Pediatric Diseases: Food Accumulation and Stagnation in children is one of the standardization projects of the China Association of Traditional Chinese Medicine Guideline on Design and Evaluation of Clinical Trials for Chinese Medicine in Common Pediatric Diseases. The purpose is to discuss the clinical positioning, experimental design and implementation of the characteristics of diseases, children and traditional Chinese medicine under the mode of combining disease and syndrome with clinical value, so as to provide suggestions and methods for the design and evaluation of clinical trial of food accumulation and stagnation in children with traditional Chinese medicine. In the process of developing, working group on the guidelines, drafter group and a finalizer group were established, and the methods of literature research and consensus meeting were adopted to form the final draft of the guidelines. The main contents of this guideline include clinical positioning, overall design of the trial, diagnostic and syndrome differentiation criteria, selection and withdrawal of subjects, administration scheme, effectiveness evaluation, safety observation, trial process, quality control of the trial. The formulation of this guideline provides references for the sponsor or contract research organizations and researchers to design clinical trials and post-marketing evaluation on the treatment of food accumulation and stagnation in children with traditional Chinese medicine.