通脉养心丸治疗冠心病心绞痛(气阴两虚证)临床应用专家共识

Expert Consensus on Clinical Application of TongmaiYangxin Pill(通脉养心丸)in Treatment of Angina Pectoris(Qi-Yin Deficiency Syndrome)

通脉养心丸用于冠心病心绞痛之气阴两虚证具有良好的临床疗效及安全性。在临床医生问卷调查和通脉养心丸研究文献系统回顾的基础上,采用国际临床医学专家共识研制方法,基于现有最佳证据,充分结合专家经验,遵循"循证为举,共识为主,经验为鉴"的原则,国内30余位中、西医临床与方法学等多学科专家共同研制该共识,旨在进一步提高临床医生对该药的认识,更好地指导其临床合理用药。该共识采用国际公认的证据分级推荐标准:GRADE系统。专家共识意见的形成采用名义组法,主要考虑6个方面的因素:证据质量、疗效、安全性、经济性、患者可接受性及其他。如果证据充分则形成"推荐意见",采用GRADE网格计票规则;如果证据不充分,则形成"共识建议",采用多数计票规则。该共识对通脉养心丸用于治疗冠心病心绞痛(气阴两虚证)的疗效、用法用量、疗程进行了推荐或建议,并完善了安全性信息,最后通过专家会议以及函审的方式,在全国范围内进行了征求意见和同行评议,可为临床的合理用药提供参考。

Tongmai Yangxin Pill(通脉养心丸) has good clinical efficacy and safety when used in angina pectoris(Qi-Yin deficiency syndrome).Based on questionnaire investigation of doctors and a systematic review of research literature on TongmaiYangxin Pill, using international clinical practice guidelines’ developing methods, with the best available evidence and fully combining experts’ experience, and following the principle of "evidence-based, consensus-based and experience-based",the expert consensus statement on TongmaiYangxin Pill in clinical practice was developed by more than 30 multidisciplinary experts from the nationwide, aimed at guiding and standardizing the rational use of TongmaiYangxin Pill. The expert consensus adopts internationally recognized recommendation criteria for classification of evidence: GRADE. The formation of expert consensus adopted the nominal group technique. Six main considerations were quality of evidence, curative effect, safety, economical efficiency, patient acceptability and other factors. If there was sufficient evidence, a "recommendation"was formed, using GRADE grid voting rule. If there wasno sufficient evidence, a "consensus opinion"was formed, using majority counting rule. The expert consensus focused on the indication, usage and dosage, and safety of Tongmai Yangxin Pill. Through experts’ meetings and correspondence, a nationwide consultation and peer review was conductedto provide guidance and reference for the rational use of Tongmaiangxin Pill.