中西医治疗直肠癌术后排便功能障碍的结局指标比较研究  

A Comparative Study of Outcomes Used in Trials for postoperative bowel dysfunction in rectal cancer Treated by Western Medicine and Traditional Chinese Medicine

作　　者：陆美吉 张蕊[2,3,4] 李芮 彭蓉晏 杨宇飞 LU Meji;ZHANG Rui;LI Rui;PENG Rongyan;YANG Yufei(Xiyuan Clinical School,Graduate School of Beijing University of Traditional Chinese Medicine,Beijing 100029,China;Xiyuan Hospital of China Academy of Chinese Medicine Sciences,Beijing 100091,China;Hebei Yiling Medical Research Institute,Shijiazhuang 050035,China;Sleep Medicine Department,Air Force Medical Center,Beijing 100142,China)

机构地区：[1]北京中医药大学研究生院(西苑临床学院),北京100029 [2]中国中医科学院西苑医院,北京100091 [3]河北以岭医药集团,石家庄050035 [4]空军特色医学中心睡眠医学科,北京100142

出　　处：《世界科学技术-中医药现代化》2024年第10期2739-2747,共9页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：中国中医科学院科技创新工程(C12021A03003):多学科肿瘤康复模式改善直肠癌根治术后排便功能障碍的随机对照研究及应用推广,负责人:杨宇飞;中国中医科学院西苑医院提升高水平临床研究和成果转化能力试点建设项目课题(XYZX0201-19):基于健脾补肾解毒法在结直肠癌全程诊疗路径及优势环节的循证临床研究,负责人:杨宇飞。

摘　　要：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RCT121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。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.

关 键 词：直肠癌 排便功能障碍 低位前切除综合征 LARS 临床评价指标 结局指标 

分 类 号：R574.63[医药卫生—消化系统]