骨折是骨伤科常见疾病之一。结骨七里片(胶囊)是临床常用治疗骨折的中成药,已列入国家医疗保险制度所覆盖药品目录的A类药品。然而,尚未达成共识或指南,以详细的基于证据的方法指导临床医生,这严重限制了这种药物的临床价值。根据证据为关键的指导原则,共识作为补充,和经验作为参考,严格按照中成药临床应用专家共识中规定的步骤达成共识。在文献综述和问卷调查的基础上,共识是及时总结接骨七里片(胶囊)治疗骨折的现有临床证据,并结合了一些临床专家的治疗经验。准备过程历时一年多,共识(GS/CACM293-2021)于2021年9月由中国中药协会正式发布,来自27个中西医组织和研究机构的多学科专家参与。本文详细介绍了共识的背景和目标,并描述了提案的主要过程,起草,专家共识,和咨询。特别是,就适应症的关键问题形成了5项共识建议和12项共识建议,治疗时机,剂量,持续时间,接骨七里片(胶囊)治疗骨折的临床应用及安全性,指导和规范临床医师合理用药,提高药品的准确性和安全性。
Fracture is one of the common diseases in the department of orthopaedics and traumatology. Jiegu Qili Tablets(Capsules) are a Chinese patent medicine commonly used to treat fractures in clinical practice, which has been included in the Class A drugs of the catalog of medicines covered by the National Medical Insurance System. However, no
consensus or
guideline has yet been developed to guide clinicians based on an evidence-based approach in detail, which has severely limited the clinical value of this drug. According to the guiding principle of evidence as the key, consensus as the supplement, and experience as the reference, a consensus was developed in strict accordance with the steps stipulated in the expert
consensus on clinical applications of proprietary Chinese medicines. Based on literature review and questionnaire survey, the consensus was a timely summary of the existing clinical evidence on the treatment of fractures with Jiegu Qili Tablets(Capsules), and incorporated the treatment experience of a number of clinical experts. The preparation process took more than a year and the consensus(GS/CACM 293-2021) was officially released by the China Association of Chinese Medicine in September 2021, with the participation of multidisciplinary experts from 27 organizations of Chinese and Western medicine and research institutions. This article introduces the background and objectives of the consensus in detail, and describes the main process of proposal, drafting, expert
consensus, and consultation. In particular, 5
consensus recommendations and 12
consensus suggestions are formed with regard to the key issues of indications, treatment timing, dose, duration, and safety in the clinical application of Jiegu Qili Tablets(Capsules) for the treatment of fractures, which guide and standardize the rational use by clinicians and improve the accuracy and safety of drugs.