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30026例参芪扶正注射液真实世界联合用药注册登记研究
引用本文:王连心,谢雁鸣,艾青华,冯倩.30026例参芪扶正注射液真实世界联合用药注册登记研究[J].中国中药杂志,2016,41(24):4500-4509.
作者姓名:王连心  谢雁鸣  艾青华  冯倩
作者单位:中国中医科学院 中医临床基础医学研究所, 北京 100700,中国中医科学院 中医临床基础医学研究所, 北京 100700,中国中医科学院 中医临床基础医学研究所, 北京 100700,中国人民大学, 北京 100872
基金项目:国家自然科学基金面上项目(81473798);国家“重大新药创制”科技重大专项(2015ZX09501004-001-002);北京市中医药科技专项(JJ2014-53);中国中医科学院第九批自主选题项目(Z0417)
摘    要:该文采取前瞻性、多中心、大样本、注册登记式研究方法,进行参芪扶正注射液上市后临床应用真实世界联合用药特征分析,了解真实世界联合用药情况。注册登记使用参芪扶正注射液患者共30 026例,合并用药化学药(57 436例次,占82.76%)多于中成药(11 962例次,占17.24%),以抗酸药物及抗溃疡病药物、营养剂、免疫增强剂等居多,根据关联规则,2种合并用药与抑制胃酸分泌和抗肿瘤密切相关;3种合并用药与抑制胃酸分泌、止吐和抗肿瘤密切相关;4种合并用药与抑制胃酸分泌、止吐、抗肿瘤、免疫增强密切相关,与说明书适应症相符,为精准治疗提供线索,也为临床合理用药奠定基础。

关 键 词:参芪扶正注射液  注册登记  联合用药  关联规则  真实世界
收稿时间:2016/8/15 0:00:00

Registration of 30 026 cases of Shenqi Fuzheng injection combined with other drugs in real world
WANG Lian-xin,XIE Yan-ming,AI Qing-hua and FENG Qian.Registration of 30 026 cases of Shenqi Fuzheng injection combined with other drugs in real world[J].China Journal of Chinese Materia Medica,2016,41(24):4500-4509.
Authors:WANG Lian-xin  XIE Yan-ming  AI Qing-hua and FENG Qian
Affiliation:Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China,Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China,Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China and Renmin University of China, Beijing 100872, China
Abstract:Prospective, multi-center, large-sample and registered design was used to analyze the drug combination features of Shenqi Fuzheng injection in the real world clinical application, and comprehend the drug combination in the real world. A total of 30 026 patients with the use of Shenqi Fuzheng injection were registered, where the chemical drugs were used for 57 436 times (accounting for 82.76%), and the Chinese patent medicines were used for 11 962 times (accounting for 17.24%), mainly including anti-acid drugs and anti-ulcer drugs, nutritional agent, immune enhancement agent, etc. According to the association rules, drug combinations of 2 drugs were closely related to inhibiting gastric acid secretion and anti-tumor; drug combinations of 3 drugs were closely related to inhibiting gastric acid secretion, antiemetic and anti tumor; drug combinations of 4 drugs were closely related to inhibiting gastric acid secretion, antiemetic, anti-tumor, and immune enhancement. The above results were consistent with the Instruction, providing clues for accurate treatment, and laying the foundation for clinical rational drug use.
Keywords:Shenqi Fuzheng injection  registration  drug complication  association rules  real world
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