中成药促进骨质疏松性骨折术后康复的临床应用现状
Clinical Status of Applicaiton of Chinese Patent Medicine in Promoting the Rehabilitation of Osteoporotic Fractures
投稿时间:2025-08-25  修订日期:2026-03-18
DOI:
中文关键词:  骨质疏松性骨折  术后康复  仙灵骨葆胶囊  金天格胶囊
英文关键词:Osteoporotic Fracture  Postoperative Rehabilitation  XianLingGuBao Capsule  JinTianGe Capsule
基金项目:中华中医药学会2024年度中成药治疗骨质疏松症临床研究专项(GA_CACM_2024001)浙江省中医药科技计划(2025ZR130)浙江省“尖兵领雁+X”科技计划项目(2026C02A1083)
作者单位邮编
唐彬彬 浙江中医药大学附属第二医院 310005
李威 浙江中医药大学第二临床医学院 
叶佰盛 浙江中医药大学第二临床医学院 
袁一峰 浙江中医药大学附属第二医院 
刘康 浙江中医药大学附属第二医院 
史晓林* 浙江中医药大学附属第二医院 310005
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中文摘要:
      目的:对多种中成药促进骨质疏松性骨折术后康复的临床报道进行系统性回顾及分析,评估应用现状。方法:按照2023年《骨质疏松性骨折中医诊疗指南》推荐的6种中成药在中国知网、万方数据库和Pubmed数据库中进行检索。纳入临床前瞻性和回顾性对照研究。设定检索时间2019年1月1日-2024年12月31日。对纳入文献进行证据级别与辨证论治评分。结果:纳入64项临床研究进行系统性分析。其中报道接骨七厘片5篇(7.8),骨疏康胶囊4篇(6.3),全杜仲胶囊3篇(4.7),强骨胶囊2篇(3.1),仙灵骨葆胶囊34篇(53.1),金天格胶囊16篇(25.0)。药物运用在椎体骨折术后50篇(78.1),桡骨远端骨折术后3篇(4.7),股骨骨折术后11篇(17.2)。文献提示总体质量较高,Ib级别占82.8%(53/64),均为随机对照研究。根据中医辨证理论,合理使用中成药的文献仅有11篇(17.2), 53篇(82.8)文献未记录任何病例临床症候,使用中成药无确切依据。所有文献均记录了疗效指标,31篇(48.4)文献记录了影像学指标,5篇(7.8)文献记录了中医症候指标。结论:不同中成药具有改善骨折术后疼痛,促进功能恢复,提高骨密度,调节骨代谢的作用。当前报道缺乏中医辨证论治内容,中成药使用依据不明。呼吁加强临床证治协同,提高药物疗效。
英文摘要:
      Objective: To systematically review and analyze the reports on various Chinese patent medicines promoting the postoperative rehabilitation of osteoporotic fractures (OPF) and evaluate the application status. Methods: A search was conducted in the CNKI, Wanfang Data, and PubMed databases for the six Chinese patent medicines recommended in the "2023 Guidelines for the Diagnosis and Treatment of OPF in Traditional Chinese Medicine (TCM)". Clinical prospective and retrospective controlled studies were included. The search period was set from January 1, 2019, to December 31, 2024. The included literature was scored for evidence level and syndrome differentiation and treatment. Results: A total of 64 clinical studies were included for systematic analysis. Among them, JieGuQiLi Tablets were reported in 5 articles (7.8), GuShuKang Capsules in 4 articles (6.3), QuanDuZhong Capsules in 3 articles (4.7), QiangGuCapsules in 2 articles (3.1), XianLingGuBao Capsules in 34 articles (53.1), and JinTianGe Capsules in 16 articles (25.0). The drugs were used in 50 articles (78.1) for vertebral fractures, 3 articles (4.7) for distal radial fractures, and 11 articles (17.2) for femoral fractures. The literature indicated that the overall quality was relatively high, with 82.8% (53/64) being Ib level, all of which were randomized controlled studies. According to the theory of syndrome differentiation and treatment in traditional Chinese medicine, only 11 articles (17.2) used Chinese patent medicines reasonably, while 53 articles (82.8) did not record any clinical symptoms of the cases, and the use of Chinese patent medicines had no clear basis. All articles recorded therapeutic effect indicators, 31 articles (48.4) recorded imaging indicators, and 5 articles (7.8) recorded traditional Chinese medicine syndrome indicators. Conclusion: Different Chinese patent medicines have the effects of alleviating postoperative pain, promoting functional recovery, increasing bone density, and regulating bone metabolism. The current reports lack content on syndrome differentiation and treatment in TCM, and the evidence for using Chinese patent medicines is unclear. Strengthening the synergy between clinical diagnosis and treatment and improving drug efficacy is necessary.
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