注射用丹参多酚酸盐的临床应用综合评价

韩晟, 赵熙子, 史录文, 林丽开, 李大魁, 陈凯先, 宣利江, 马传江, 马海英, 方唯一, 王丽霞, 文爱东, 付秀娟, 左燕, 刘小玲, 刘向红, 刘国强, 朱珠, 陈万生, 陈维红, 吴方建, 吴玉波, 吴晖, 张伟, 张毕奎, 林慧, 周国华, 欧阳荣, 胡元会, 姜明燕, 赵春景, 贾乐川, 晋月萍, 唐洪梅, 曹俊岭, 梁春, 商洪才, 董占军, 董吁钢, 翟所迪

中国药学杂志 ›› 2021, Vol. 56 ›› Issue (6) : 507-514.

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中国药学杂志
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中国药学杂志 ›› 2021, Vol. 56 ›› Issue (6) : 507-514. DOI: 10.11669/cpj.2021.06.013
论著

注射用丹参多酚酸盐的临床应用综合评价

  • 韩晟1, 赵熙子1, 史录文1*, 林丽开2, 李大魁3, 陈凯先4, 宣利江4, 马传江5, 马海英6, 方唯一7, 王丽霞8, 文爱东9, 付秀娟10, 左燕11, 刘小玲12, 刘向红13, 刘国强14, 朱珠3, 陈万生15, 陈维红16, 吴方建17, 吴玉波18, 吴晖19, 张伟20, 张毕奎21, 林慧22, 周国华23, 欧阳荣24, 胡元会8, 姜明燕25, 赵春景26, 贾乐川27, 晋月萍28, 唐洪梅29, 曹俊岭30, 梁春15, 商洪才31, 董占军32, 董吁钢33, 翟所迪34
作者信息 +

Clinical Application Evaluation of Salvia Miltiorrhiza Depside Salts for Injection

  • HAN Sheng1, ZHAO Xi-zi1, SHI Lu-wen1*, LIN Li-kai2, LI Da-kui3, CHEN Kai-xian4, XUAN Li-jiang4, MA Chuan-jiang5, MA Hai-ying6, FANG Wei-yi7, WANG Li-xia8, WEN Ai-dong9, FU Xiu-juan10, ZUO Yan11, LIU Xiao-ling12, LIU Xiang-hong13, LIU Guo-qiang14, ZHU Zhu3, CHEN Wan-sheng15, CHEN Wei-hong16, WU Fang-jian17, WU Yu-bo18, WU Hui19, ZHANG Wei20, ZHANG Bi-kui21, LIN Hui22, ZHOU Guo-hua23, OUYANG Rong24, HU Yuan-hui8, JIANG Ming-yan25, ZHAO Chun-jing26, JIA Le-chuan27, JIN Yue-ping28, TANG Hong-mei29, CAO Jun-ling30, LIANG Chun15, SHANG Hong-cai31, DONG Zhan-jun32, DONG Yu-gang33, ZHAI Suo-di34
Author information +
文章历史 +

摘要

目的 以注射用丹参多酚酸盐为例,探索中药注射剂临床应用的综合评价方法,为今后相关工作的开展和完善提供参考。方法 通过文献检索和获取相关文献资料,从有效性、安全性、经济性、顺应性和标签信息等方面对注射用丹参多酚酸盐进行系统综合评价。结果 除说明书适应证外,丹参多酚酸盐在心血管疾病、脑血管疾病等多种超说明书适应证中都存在具有一定质量的临床研究证据;在安全性、经济性方面的文献证据较为丰富。结论 注射用丹参多酚酸盐在有效性、安全性及经济性等方面的临床研究证据较多,且具有一定的体系。但作为一个临床应用大品种,该药依然需要在一些方面做出更多的研究努力。

Abstract

OBJECTIVE To take Salvia Miltiorrhiza depside salts for injection as an example, to explore the comprehensive clinical application evaluation method of traditional Chinese medicine injection, and to provide reference for the development and improvement of related work in the future. METHODS Through literature search and obtaining relevant literature information, systematically evaluate Salvia Miltiorrhiza depside salts for injection from the aspects of effectiveness, safety, pharmacoeconomics,compliance and label information. RESULTS In addition to the indications in the instructions, Danshen polyphenolate has considerable amount of high-quality clinical research evidence in cardiovascular disease, cerebrovascular disease and other over-indication indications.The literature evidence is also abundant in terms of safety and pharmacoeconomics. CONCLUSION The Salvia Miltiorrhiza depside salts for injection has plentiful and systematic clinical research evidence in terms of effectiveness, safety and pharmacoeconomics.However, as a large variety drug of clinical applications, itstill needs to make more research efforts in some aspects.

关键词

丹参酚酸B镁 / 药品综合评价 / 中药注射剂 / 有效性 / 安全性

Key words

magnesium lithospermate B / comprehensive drug evaluation / traditional Chinese medicine injection / effectiveness / safety

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韩晟, 赵熙子, 史录文, 林丽开, 李大魁, 陈凯先, 宣利江, 马传江, 马海英, 方唯一, 王丽霞, 文爱东, 付秀娟, 左燕, 刘小玲, 刘向红, 刘国强, 朱珠, 陈万生, 陈维红, 吴方建, 吴玉波, 吴晖, 张伟, 张毕奎, 林慧, 周国华, 欧阳荣, 胡元会, 姜明燕, 赵春景, 贾乐川, 晋月萍, 唐洪梅, 曹俊岭, 梁春, 商洪才, 董占军, 董吁钢, 翟所迪. 注射用丹参多酚酸盐的临床应用综合评价[J]. 中国药学杂志, 2021, 56(6): 507-514 https://doi.org/10.11669/cpj.2021.06.013
HAN Sheng, ZHAO Xi-zi, SHI Lu-wen, LIN Li-kai, LI Da-kui, CHEN Kai-xian, XUAN Li-jiang, MA Chuan-jiang, MA Hai-ying, FANG Wei-yi, WANG Li-xia, WEN Ai-dong, FU Xiu-juan, ZUO Yan, LIU Xiao-ling, LIU Xiang-hong, LIU Guo-qiang, ZHU Zhu, CHEN Wan-sheng, CHEN Wei-hong, WU Fang-jian, WU Yu-bo, WU Hui, ZHANG Wei, ZHANG Bi-kui, LIN Hui, ZHOU Guo-hua, OUYANG Rong, HU Yuan-hui, JIANG Ming-yan, ZHAO Chun-jing, JIA Le-chuan, JIN Yue-ping, TANG Hong-mei, CAO Jun-ling, LIANG Chun, SHANG Hong-cai, DONG Zhan-jun, DONG Yu-gang, ZHAI Suo-di. Clinical Application Evaluation of Salvia Miltiorrhiza Depside Salts for Injection[J]. Chinese Pharmaceutical Journal, 2021, 56(6): 507-514 https://doi.org/10.11669/cpj.2021.06.013
中图分类号： R969.3   

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