骨康胶囊治疗骨质疏松症临床应用专家共识

Expert Consensus on Clinical Application of Gukang Capsule(骨康胶囊) in Treatment of Osteoporosis

骨康胶囊用于骨质疏松症之肝肾阴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骨康胶囊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。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,主要考虑证据质量、疗效、安全性、经济性、患者可接受性及其他等6个方面的因素。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。共识对骨康胶囊用于骨质疏松症之肝肾阴虚证的疗效、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,在全国范围内进行征求意见和同行评议,可为临床的合理用药提供参考。

Gukang Capsule(骨康胶囊)has good clinical efficacy and safety when used in osteoporosis(liver and kidney Yin deficiency syndrome).Based on questionnaire investigation of doctors and a systematic review of research literature on Gukang Capsule,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 Gukang Capsule in clinical practice was developed by 30 multidisciplinary experts from the nationwide,aimed at guiding and standardizing the rational use of Gukang Capsule.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 was no sufficient evidence,a"consensus opinion"was formed,using majority counting rule.The expert consensus focused on the indication,usage and dosageand safety of Gukang Capsule.Through experts’meetings and correspondence,a nationwide consultation and peer review was conducted to provide guidance and reference for the rational use of Gukang Capsule.