目的 比较分析中西医结合治疗直肠癌术后排便功能障碍的结局指标，划分指标域。方法 检索8大中英文数据库和两个临床注册中心，提取数据并进行描述性分析。结果 共获得西医RCT 121项、中西医结合RCT 25项、中医RCT 8项，得到93种结局指标，划分为5个核心域和13个结局域。西医RCT结局指标常使用低位前切除综合征评分量表(Low anterior resection syndrome score，LARS)、肛管直肠压力、生活质量核心评价量表QLQ-30(Quality of life questionnaire-core 30，QLQ-30)。中医RCT结局指标常使用中医临床疗效判定标准、中医症候评价、LARS评分。中西医结合RCT结局指标常使用徐忠法五项十分制量表、LRAS评分、肛管直肠压力。结论 目前中西医治疗直肠癌术后排便功能障碍的RCT存在总体质量较低、依从性与经济学指标使用较少、缺乏中医特色等问题。基于上述问题，本研究提出未来构建具有中医药特色的直肠癌根治术后排便功能障碍核心指标集。
A Comparative Study of Outcomes Used in Trials for postoperative bowel dysfunction in rectal cancer Treated by Western Medicine and Traditional Chinese Medicine
Objective The purpose of this study is to compare and analyze the outcome indicators for the combined Chinese and Western medicine treatment of postoperative bowel dysfunction in rectal cancer,divide the indicator domains.Methods Eight major Chinese and English databases and two clinical registration centers were searched for RCTs.The outcome indicators reported were extracted and analyzed.Results A total of 121 Western medicine RCTs,25 Chinese and Western medicine combined RCTs,and 8 Chinese medicine RCTs were obtained,93 outcome indicators were obtained and divided into five core domains and 13 outcome domains.Western medicine RCTs outcome indicators are often used in the Low Anterior Resection Syndrome Score(LRASS),anal rectal pressure,and the Quality of Life Questionnaire-Core 30(QLQ-30).Chinese medicine RCTs outcome indicators are often used in the Chinese clinical efficacy judgment standard,Chinese symptom evaluation,and the LARSS.Chinese and Western medicine combined RCTs outcome indicatorsare are often used in the Xu Zhongfa Five-Point Scale,LARSS,and anal rectal pressure.Conclusion The RCTs on Chinese and Western medicine treatment of postoperative bowel dysfunction in rectal cancer currently have issues such as overall low quality,less use of compliance and economic indicators,and lack of traditional Chinese medicine characteristics.Based on these problems,this study proposes to construct the core index set of defecation dysfunction after rectal cancer with TCM characteristics.
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