中药药理学家李连达逝世:曾撰文质疑天士力复方丹参滴丸

2018-10-21 包雨朦 澎湃新闻

10月19日,中国中医科学院官方微信号发布讣告称,我国著名中药药理学家、中国工程院院士、中国中医科学院首席研究员李连达同志因病医治无效,于2018年10月18日11时55分在北京逝世,享年84岁。李连达1934年7月24日出生于辽宁省沈阳市。1956年毕业于北京医学院医疗系,后到中国中医科学院西苑医院工作。1956-1974年在西苑医院从事中医儿科临床工作,1974年开始从事中药药理学研究工作。先

10月19日,中国中医科学院官方微信号发布讣告称,我国著名中药药理学家、中国工程院院士、中国中医科学院首席研究员李连达同志因病医治无效,于2018年10月18日11时55分在北京逝世,享年84岁。

李连达1934年7月24日出生于辽宁省沈阳市。1956年毕业于北京医学院医疗系,后到中国中医科学院西苑医院工作。1956-1974年在西苑医院从事中医儿科临床工作,1974年开始从事中药药理学研究工作。先后担任西苑医院基础医学研究室主任、中国中医科学院首席研究员、中国中医科学院医学实验中心主任、博士生导师、博士后指导老师、著名中医药学专家、第六批全国老中医药专家学术经验继承工作指导老师、国家药典委员会委员。

中国中医科学院官方微信发布的信息称,李连达是我国中药药理学专业最具影响力的专家之一,在该领域做出了重要贡献,对中药药理学研究影响深远。他建立我国中药药效学评价标准及技术规范,在国内首先建立了一些新的研究方法,并在全国推广应用。阐明“血瘀证”的科学内涵及“活血化瘀”治疗的基本规律与作用机理,该项研究获得国家科技进步一等奖。首创中药与自体骨髓干细胞经心导管输入冠状动脉移植于心脏治疗冠心病的新方法。

李连达在世时,曾多次质疑上市公司天士力(600535.SH)旗下的明星中成药产品复方丹参滴丸在申请美国上市的过程中存在隐瞒和欺骗公众的行为。

不过,作为中药赴美注册的先行者,复方丹参滴丸在国内在国内被作为“中药国际化的标杆”,在国内也连续13年问鼎中成药单品年销量冠军。

2009年2月5日,李连达第一次对天士力复方丹参滴丸的安全性提出了批评意见。他在采访中对媒体表示,自己在研究中发现复方丹参滴丸存在严重不良反应,且不良反应发生率高达3.1%,且天士力未作长期毒性试验等。

此言一出在资本市场上引发剧烈震动,天士力在当日被迫进行紧急停牌,并发布“关于李连达不实言论的严正声明”,否认复方丹参滴丸存在质量问题。

随后国家食药监部门介入,并召开发布会进行了回应,表示该药品毒性实验一直在做,任何药品都会有不良反应,只是反应的程度不同,复方丹参滴丸未收到严重药品不良反应报告。

在此后的多年内,李连达与天士力复方丹参滴丸的论战一直在持续。最近一次引发关注是在去年9月4日至9月15日,李连达在博客上连载三篇文章炮轰复方丹参滴丸在美国三期临床惨遭失败,其原因在于药品安全性有效性不符合注册要求,药品本身疗效不佳。

2017年9月19日,天士力集团在报刊上刊登了整版说明,称复方丹参滴丸三期临床研究顺利,李连达院士发表上述文章是出于个人恩怨。

李连达与天士力关于复方丹参滴丸的争论至今没有结论。不过,复方丹参滴丸目前还未在美国完成注册,仍处于国际多中心临床试验阶段。

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    2019-06-18 saikp
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    2019-04-29 zhangph
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