摘要
目的综合评价玄七健骨片治疗膝骨关节炎筋脉瘀滞证的临床价值,明确玄七健骨片的临床优势及特点。方法本研究采用定性与定量结合法,基于建库至2024年9月的循证医学证据、问卷调查结果、官方网站数据信息、药物经济学评价等,应用多准则决策分析模型,对玄七健骨片治疗膝骨关节炎筋脉瘀滞证的临床价值进行多维度综合评价。结果综合药品临床研究、自发呈报系统等结果显示,玄七健骨片安全性证据充分,已知风险较小,风险较可控,安全性较好;与安慰剂比较,玄七健骨片有显著优势,可提高中医证候疗效和中医证候积分、改善疼痛(疼痛积分、疼痛程度、疼痛缓解率、疼痛消失时间)、改善疾病相关症状(如夜间疼痛、晨僵疼痛、行走疼痛、站立坐起、最大行走距离、日常活动、下蹲活动、路上行走、浮髌试验等)、降低西安大略和麦克马斯特大学骨关节炎指数(总分、疼痛积分、僵硬积分、日常活动积分),有效性证据质量高,临床意义较大,有效性较好;经济性研究显示,与具有治疗膝骨关节炎循证医学证据的盘龙七片比较,玄七健骨片更具有成本-效果优势,证据报告比较充分、结果明确;玄七健骨片为经验方,临床应用时间20余年,用于治疗膝骨关节炎筋脉瘀滞证,创新性好;医护给药与患者用药便捷,易于掌握,药品信息规范、完整,适宜性较好;本品限定日费用占城镇/农村居民可支配收入比例较低,可负担性较好,销售范围广,产能高,药材资源可持续,可获得性较好,可及性较好;玄七健骨片为经验方和证候药,中医药特色较突出。结论玄七健骨片治疗膝骨关节炎筋脉瘀滞证的临床价值较好,建议进一步发表玄七健骨片治疗膝骨关节炎的高质量循证证据。
Objective To comprehensively evaluate the clinical value of Xuanqi Jiangu Tablets in the treatment of knee osteoarthritis with tendon and vessel stasis syndrome,and to clarify its clinical advantages and characteristics.Methods This study utilizes a combination of qualitative and quantitative methods.Drawing on evidence from evidence-based medicine,survey findings,official website information,and pharmacoeconomic assessments spanning from the inception of the database to September 2024,the study employs a multi-criteria decision analysis model to conduct a com prehensive,multi-dimensional evaluation of the clinical value of Xuanqi Jiangu Tablets in treating knee os teoarthritis with tendon and ves sel stasis syndrome.Results The comprehensive results from clinical drug studies and spontaneous reporting systems indicate that Xuanqi Jiangu Tablets possess sufficient evidence of safety,with known risks being relatively minor and manageable,resulting in an overall favorable safety profile.Compared to placebo,Xuanqi Jiangu Tablets have significant advantages,improving the efficacy of TCM syndromes and TCM syndrome scores,alleviating pain(pain score,pain intensity,pain relief rate,time of pain disappearance),improving disease-related symptoms(such as night pain,morning stiffness pain,walking pain,standing up and sitting down,maximum walking distance,daily activities,squatting activities,walking on the road,patellar float test,etc.),and reducing Western Ontario and McMaster Universities osteoarthritis index(total score,pain score,stiffness score,daily activity score).The evidence of effectiveness is of high quality,with important clinical significance and good effectiveness.Economic studies show that compared to Panlongqi Tablets with evidence-based medical evidence for the treatment of knee osteoarthritis,Xuanqi Jiangu Tablets have a cost-effectiveness advantage,with comprehensive evidence reports and clear results.Xuanqi Jiangu Tablets are an empirical formula with over 20 years of clinical application for the treatment of knee osteoarthritis with tendon and vessel stasis syndrome,demonstrating good innovation.The medication is convenient for both healthcare providers and patients,easy to master,with standardized and complete drug information,indicating good suitability.The daily cost of the product accounts for a low proportion of urban/rural residents’disposable income,indicating good affordability,with a wide sales range,high production capacity,sustainable medicinal resources,good availability,and good accessibility.Xuanqi Jiangu Tablets are empirical medications tailored to specific syndromes,embodying the prominent characteristics of traditional Chinese medicine.Conclusion Xuanqi Jiangu Tablets have good clinical value in the treatment of knee osteoarthritis with tendon and vessel stasis syndrome.It is suggest that high-quality evidence-based research should be carried out on the treatment of knee osteoarthritis with Xuanqi Jiangu Tablets.
作者
崔晓丽
苏鑫鑫
黎元元
孙莉
谢雁鸣
CUI Xiaoli;SU Xinxin;LI Yuanyuan;SUN Li;XIE Yanming(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Department of Geriatrics,Jilin Academy of Chinese Medicine Sci ences,Jilin,Changchun 130022,China)
出处
《中国医药科学》
2025年第15期96-100,共5页
China Medicine And Pharmacy
基金
谢雁鸣全国名老中医药专家传承工作室建设项目(国中医药人教函〔2022〕75号)。
关键词
玄七健骨片
膝骨关节炎
临床综合评价
多准则决策分析
Xuanqi Jiangu Tablets
Knee osteoarthritis
Comprehensive clinical evaluation
Multi-criteria decision analysis
