上市后循证医学研究提高了基本药物临床价值

2019-10-15 小M MedSci原创

国家基本药物制度是药品供应保障体系的基础,是医疗卫生领域基本公共服务的重要内容。新一轮医改以来,国家基本药物制度的建立和实施,对健全药品供应保障体系、保障群众基本用药、减轻患者用药负担发挥了重要作用。2018年12月,25个“4+7”带量采购中选品种公布,按照此前国家医保局部署,到今年年3月底,“4+7”带量采购已经全面执行。


国家基本药物制度是药品供应保障体系的基础,是医疗卫生领域基本公共服务的重要内容。新一轮医改以来,国家基本药物制度的建立和实施,对健全药品供应保障体系、保障群众基本用药、减轻患者用药负担发挥了重要作用。2018年12月,25个“4+7”带量采购中选品种公布,按照此前国家医保局部署,到今年年3月底,“4+7”带量采购已经全面执行。

国家医保目录所纳入的都是拥有诊疗规范、临床诊疗指南和专家共识依据,疗效确切、价格合理、临床应用价值高的药物。根据规定,甲类品种药物是100%报销的;乙类品种药物则由各地区根据承受能力,设定一定的个人自付比例,再按基本医疗保险的规定给付。这意味着这些专利中药在造福患者的同时,将会有着更广阔的市场前景。

药品临床综合评价是基于多种学科、从多种角度出发的多维度评价方式,其评价方式是定量(药物技术评估)和定性(药物政策评价)方式的综合,融合了循证医学、流行病学、临床医学、临床药学、循证药学、药物经济学、卫生技术评估等知识体系。

上市后循证医学研究成为国内外医学界认可的疗效证据


通心络胶囊等系列专利中药是中医络病理论创新催生的成果。中医络病理论是吴以岭院士从1979年即开始系统性研究的重大学术创新成果,通过40年的砥砺研究,终于将“络病”这一在中华民族医学史上绵延了近三千年的散落记载,整理、归纳、提炼成为络脉清晰、内容丰富、具有指导现代重大、难治性疾病治疗价值的系统理论,使中医络病理论在中医学术界中的地位达到了全新的高度。

循证医学研究是国际公认的评价药物疗效与安全性的科学方法,其主要特点是采用大范围、多样本、双盲实验来检验药物疗效,最大程度地保证了药物疗效的客观性,得出真正医生认可、患者信赖的用药依据。



通心络明显降低心脑血管风险

凭借卓越的临床疗效,通络创新中药连续斩获了4项国家科技进步二等奖,1项国家技术发明二等奖和多项省部级奖项,使得通络创新中药在我国医药界形成了特有的品牌。

迄今为止,通心络胶囊等通络中药已经接受10余次循证医学的考验,取得了一系列可靠的循证证据。2009年,以中国医学科学院阜外医院为组长单位,全国9家医院参加的“通心络胶囊防治急性心梗介入治疗后心肌无复流循证医学临床试验”结果显示,通心络胶囊对于急性心梗介入治疗后心肌无复流具有显著防治作用,从而为解决介入术后无再流这一困扰心血管领域的世界性难题提供了循证医学证据。

2019年3月,由张运院士领衔的“应用通心络干预颈动脉斑块的随机、双盲、安慰剂对照、多中心临床研究”在国际权威科技期刊《自然》子刊《科学报告》上发表。该研究在18个省内筛选出的1212例颈动脉粥样硬化斑块患者作为研究对象,发现通心络胶囊能减小颈动脉内中膜厚度、斑块面积和血管重构指数。接受通心络治疗的患者主要心血管事件显著减少,特别是减少不稳定心绞痛的发生率。

这意味着通心络胶囊不仅能稳定斑块,抑制斑块形成,而且能逆转斑块对血管带来的不良影响,减少心绞痛、心梗、脑梗塞等主要心血管事件的发生。《美国生理学杂志》评论通心络研究“为未来可能发展成冠心病事件的高危患者点燃了希望之灯!”



参松养心解决心律失常药物治疗难题

循证研究证实了参松养心胶囊“整合调节、快慢兼治”的治疗优势。2008年参松养心胶囊同时完成四项循证医学研究,证实参松养心胶囊能有效治疗室性早搏及阵发性房颤,有效提高缓慢性心律失常患者平均心率。

此后,围绕参松养心胶囊又相继完成了针对心衰伴室性早搏、窦性心动过缓伴室性早搏的循证医学研究,有力地证明了参松养心胶囊治疗心衰伴早搏效果显著,填补了窦缓伴室早的药物治疗空白。



芪苈强心有效改善慢性心衰患者生活质量

芪苈强心胶囊疗效也得到了循证证据支撑。2013年,由南京医科大学第一附属医院及中国医学科学院阜外医院为组长单位,联合国内23家综合三甲医院进行的芪苈强心胶囊治疗慢性心衰临床循证研究圆满结束。

研究结果表明:芪苈强心胶囊对心衰关键指标NT-proBNP具有强大作用,能够有效改善心衰患者的心脏功能,显著提高左心室射血分数,缓解心慌气短、不能平卧、尿少浮肿、乏力等症状,改善慢性心衰患者的生活质量。

研究论文在线发表于《美国心脏病学会杂志》(JACC,影响因子19.896),杂志编辑部发表评论称:“中医药让衰竭的心脏更加强劲,该研究开启了心衰治疗协同作用的希望之门。”



今年3月月国家医疗保障局发布 《2019 年国家医保药品目录调整工作方案》,其中明确指出:“对同类药品按照药物经济学原则进行比较,优先选择有充分证据证明其临床必需、安全有效、价格合理的品种”。科学论证在医保中显得非常重要,尤其在安全,有效,经济,适用这四个方面。

在医保准入过程中,无论是专家还是医保基金管理方,均会从以下角度评估药品的医保价值。此次以岭药业进入新版医保目录的7个专利中药品种中,通心络胶囊、参松养心胶囊、芪苈强心胶囊均被新版国家基本药物目录纳入。这些中药专利大品种进入指南、共识、教材、国家医保目录及基药目录,医生、消费者对这些产品的使用更有信心。

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    2019-10-23 Dr Z

    学习了

    0

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    2019-10-17 xjy04
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