Objective  To summarize and sort out the clinical research literature on the treatment of osteoporosis with Chinese patent medicines by using the evidence mapping, and to obtain the evidence distribution of related studies.

Methods  Relevant literature on the treatment of osteoporosis with Chinese patent medicines published from January 1, 2012 to July 1, 2024 in CNKI, VIP, WanFang Data, and CBM, PubMed, Web of Science Core Collection, and the Cochrane Library was retrieved. Evidence mapping was used to describe the characteristics of evidence distribution.

Results  A total of 378 articles were included, including 355 clinical studies and 23  systematic reviews/Meta-analysis, and 46 kinds of Chinese patent medicines were included. The results showed that Xianling Bone Preserver Capsules were the most frequently used in clinical studies; the research type was mainly randomized controlled trials, with sample sizes ranging from 80 to 110 cases; the research subjects were mainly patients with primary osteoporosis and renal yin deficiency osteoporosis; the intervention measures in the experimental group were mainly Chinese patent medicines or Chinese patent medicines combined with Western medicines, and the duration of treatment mostly ranged from 3 to 12 months; and the outcome indicators were mainly bone mineral density, clinical effective rate, and bone formation markers. Systematic reviews or Meta-analysis showed evidence of potential validity or effectiveness, but the AMSTAR quality scores were low.

Conclusion  The treatment of osteoporosis with Chinese patent medicines has its unique advantages, but lacks high-quality clinical research evidence. In the future, multi-center, large-sample, double-blind randomized controlled trials should be conducted to acquire high-quality research evidence.

1.陈天鑫, 张智龙, 朱瑜琪, 等. 恶性肿瘤与骨密度因果关系的双向两样本孟德尔随机化研究[J]. 现代预防医学, 2023, 50(18): 3276-3280, 3287. [Chen TX, Zhang ZL, Zhu YQ, et al. The causal relationship between cancer and bone mineral density: a bidirectional two-sample Mendelian randomization analysis[J]. Modern Preventive Medicine, 2023, 50(18): 3276-3280, 3287.] DOI: 10.20043/j.cnki.MPM.202305001.

2.朱洁云, 高敏, 宋秋韵, 等. 中国老年人骨质疏松症患病率的Meta分析[J]. 中国全科医学, 2022, 25(3): 346-353. [Zhu JY, Gao M, Song QY, et al. Prevalence of osteoporosis in Chinese elderly people: a Meta-analysis[J]. Chinese General Practice, 2022, 25(3): 346-353.] DOI: 10.12114/j.issn.1007-9572. 2021.02.083.

3.陈天鑫, 张智龙, 张帅, 等. 免疫细胞与代谢性骨病的因果关系: 国际数据库欧洲群体的孟德尔随机化分析[J]. 中国组织工程研究, 2025, 29(29): 6326-6332. [Chen TX, Zhang ZL, Zhang S, et al. Causal relationship between immune cells and bone metabolic diseases: a Mendelian randomization analysis of European populations in international databases[J]. Chinese Journal of Tissue Engineering Research, 2025, 29(29): 6326-6332.] DOI: 10.12307/2025.760.

4.陈天鑫, 张智龙, 杨胜平, 等. 中医药调控破骨细胞分化的知识图谱分析[J]. 数理医药学杂志, 2025, 38(6): 430-439. [Chen TX, Zhang ZL, Yang SP, et al. Knowledge map analysis of osteoclast differentiation regulated by traditional Chinese medicine[J]. Journal of Mathematical Medicine, 2025, 38(6): 430-439.] DOI: 10.12173/j.issn.1004-4337.202501081.

5.吴佳俊, 张曾, 刘丞豪. 口服中成药治疗2型糖尿病性骨质疏松临床疗效的网状Meta分析[J]. 现代医学, 2024, 52(8): 1187-1197. [Wu JJ, Zhang Z, Liu CH, et al. Network Meta-analysis of the clinical efficacy of oral Chinese patent medicine in the treatment of type 2 diabetic osteoporosis[J]. Modern Medical Journal, 2024, 52(8): 1187-1197.] DOI: 10.3969/j.issn.1671- 7562.2024.08.005.

6.李双蕾, 倪青, 舒晓春. 糖尿病合并骨质疏松症病证结合诊疗指南[J]. 世界中医药, 2023, 18(17): 2413-2422. [Li SL, Ni Q, Shu XC, et al. Guideline for the integration of disease and syndrome differentiation in the diagnosis and treatment of diabetes mellitus with osteoporosis[J]. World Chinese Medicine, 2023, 18(17): 2413-2422.] DOI: 10.3969/j.issn.1673-7202.2023.17.002.

7.中国医师协会骨科医师分会骨质疏松学组,中华医学会骨科学分会青年骨质疏松学组,中华预防医学会健康传播分会, 等. 中国人群骨质疏松症风险管理公众指南（2024） [J]. 中华骨质疏松和骨矿盐疾病杂志, 2024, 17(6): 533-548. [Osteoporosis Group, Branch of Orthopedic Surgeons, Association of Chinese Medical Doctors; Youth Osteoporosis Group, Orthopedic Branch of Chinese Medical Association; Health Communication Branch, Society of Chinese Preventive Medicine, et al. Public guidelines for osteoporosis risk management in the Chinese population (2024)[J]. Chinese Journal of Osteoporosis and Bone Mineral Research, 2024, 17(6): 533-548.] DOI: 10.3760/j.cn115530-20240630-00275.

8.Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials[J]. BMJ, 2019, 366: l4898. DOI: 10.1136/bmj.l4898.

9.Rotta I, Diniz JA, Fernandez-Llimos F. Assessing methodological quality of systematic reviews with meta-analysis about clinical pharmacy services: a sensitivity analysis of AMSTAR-2[J]. Res Social Adm Pharm, 2025, 21(2): 110-115. DOI: 10.1016/j.sapharm.2024.11.002.

10.熊俊, 陈日新. 系统评价/Meta分析方法学质量的评价工具AMSTAR[J]. 中国循证医学杂志, 2011, 11(9): 1084-1089. [Xiong J, Chen RX. An introduction to a measurement tool to assess the methodological quality of systematic reviews/ Meta-analysis: AMSTAR[J]. Chinese Journal of Evidence-Based Medicine, 2011, 11(9): 1084-1089.] DOI: 10.3969/j.issn.1672- 2531.2011.09.017.

11.陈勍, 刘钟, 陈文亮, 等. 股骨近端防旋髓内钉固定联合口服仙灵骨葆胶囊治疗肾阳虚型骨质疏松性股骨转子间骨折[J]. 中医正骨, 2017, 29(7): 69-70, 73. [Chen Q, Liu Z, Chen WL, et al. Proximal femur anti-rotation intramedullary nail fixation combined with oral Xianling Bone Bo capsule in the treatment of osteoporotic intertrochanteric femur fracture of kidney-yang deficiency type[J]. The Journal of Traditional Chinese Orthopedics and Traumatology, 2017, 29(7): 69-70, 73.] DOI: CNKI:SUN:ZYZG.0.2017-07-018.

12.王晓军. 骨愈灵胶囊治疗骨质疏松性桡骨远端骨折效果分析[J]. 航空航天医学杂志, 2012, 23(10): 1229-1230. [Wang XJ. Analysis of the effect of bone healing capsule in the treatment of osteoporotic distal radius fracture[J]. Journal of Aerospace Medicine, 2012, 23(10): 1229-1230.] DOI: 10.3969/j.issn.2095-1434.2012.10.050.

13.张馨予, 杨珂璐, 刘小南, 等. 胃食管反流病的全病程管理策略: 一项基于临床实践指南的证据图研究[J]. 中华胃肠外科杂志, 2023, 26(4): 389-395. [Zhang XY, Yang KL, Liu XN, et al. Whole-course management strategies for gastroesophageal reflux disease: an evidence mapping study based on clinical practice guidelines[J]. Chinese Journal of Gastrointestinal Surgery, 2023, 26(4): 389-395.] DOI: 10.3760/cma.j.cn441530-20230219-00043.

14.李猛, 胡晓艺, 罗臻, 等. 针灸治疗荨麻疹临床研究的证据图分析[J/OL]. 中国针灸. (2025-03-19). [Li M, Hu XY, Luo Z, et al. Evidence mapping analysis of clinical studies of acupuncture for urticaria[J/OL]. Chinese Acupuncture & Moxibustion. (2025-03-19)] DOI: 10.13703/j.0255-2930.20240906-0002.

15.吴广, 铁梦意, 杨俊红, 等. 近10年中医药治疗癫痫的临床研究证据图[J]. 中国中医急症, 2024, 33(12): 2082-2087, 2092. [Wu G, Tie MY, Yang JH, et al. Evidence mapping of clinical research on traditional Chinese medicine treatment for epilepsy in recent ten years[J]. Journal of Emergency in Traditional Chinese Medicine, 2024, 33(12): 2082-2087, 2092.] DOI: 10.3969/j.issn.1004-745X.2024.12.003.

16.钱芳, 匡清清. 传承精华下中成药现代剂型发展现状与综合评价的建议[J]. 中医药管理杂志, 2024, 32(7): 69-72. [Qian F, Kuang QQ. Current status and comprehensive evaluation of the development of modern dosage forms of proprietary Chinese medicines under the essence of inheritance proposal[J]. Journal of Traditional Chinese Medicine Management, 2024, 32(7): 69-72.] DOI: 10.16690/j.cnki.1007-9203.2024.07.089.

17.吴琨, 周惠琼, 王国春. 补肾壮骨中成药对绝经后骨质疏松症治疗机理初探[J]. 中国骨质疏松杂志, 2013, 19(5): 482-487. [Wu K, Zhou HQ, Wang GC. The mechanism of Chinese patent drugs of Tonifying the kidney and strengthening the bone in the treatment of postmenopausal osteoporosis[J]. Chinese Journal of Osteoporosis, 2013, 19(5): 482-487.] DOI: 10.3969/j.issn.1006-7108.2013.05.014.

18.钱凤英. 基于《中国药典》分析基层医院中成药重复用药现状与管理建议[J]. 中医药管理杂志, 2024, 32(16): 239-241. [Qian FY. Analyzing the current situation of duplicate use of proprietary Chinese medicines in primary hospitals based on the Chinese Pharmacopoeia and management suggestions[J]. Journal of Traditional Chinese Medicine Management, 2024, 32(16): 239-241.] DOI: 10.16690/j.cnki.1007-9203.2024.16.087.

19.谭小艳, 李新华, 陈光华, 等. 六味地黄丸联合唑来膦酸治疗绝经后骨质疏松症患者的临床疗效[J]. 中国药物经济学, 2024, 19(10): 47-51. [Tan XY, Li XH, Chen GH, et al. Clinical effect of Liuwei Dihuang pill combined with zoledronic acid on patients with postmenopausal osteoporosis[J]. China Journal of Pharmaceutical Economics, 2024, 19(10): 47-51.] DOI: 10.12010/j.issn.1673-5846.2024.10.007.

20.王玉超, 徐琬梨, 陈云刚, 等. 青娥丸治疗绝经后骨质疏松机制研究进展[J]. 辽宁中医药大学学报, 2025, 27(10): 118-123. [Wang YC, Xu WL, Chen YG, et al. Progress on the mechanism of Qing'e Pills in the treatment of postmenopausal osteoporosis[J]. Journal of Liaoning University of Traditional Chinese Medicine, 2025, 27(10): 118-123.] DOI: 10.13194/j.issn.1673-842X.2025.10.021.

21.周甜甜, 左佳鑫, 王宏, 等. 中医药随机对照试验对照组患者入组困难的解决思路[J]. 中国中药杂志, 2025, 50(7): 1980-1986. [Zhou TT, Zuo JX, Wang H, et al. Strategies for overcoming enrollment challenges of patients in control group in randomized controlled trials of traditional Chinese medicine[J]. China Journal of Chinese Materia Medica, 2025, 50(7): 1980-1986.] DOI: 10.19540/j.cnki.cjcmm.20250108.501.

22.张颖, 王俊慧, 胡烨胤, 等. 中医药临床研究中预试验样本量的确定[J]. 中医杂志, 2021, 62(4): 307-311. [Zhang Y, Wang JH, Hu YY, et al. Determining sample size of pilot trials in traditional Chinese medicine[J]. Journal of Traditional Chinese Medicine, 2021, 62(4): 307-311.] DOI: 10.13288/j.11-2166/r.2021.04.008.

23.严正, 马佳, 崔胤哲, 等. 口服中成药治疗2型糖尿病性骨质疏松症的网状Meta分析[J]. 天津中医药, 2024, 41(3): 332-343. [Yan Z, Ma J, Cui YZ, et al. Network Meta-analysis of oral Chinese patent medicine in the treatment of type 2 diabetic osteoporosis[J]. Tianjin Journal of Traditional Chinese Medicine, 2024, 41(3): 332-343.] DOI: 10.11656/j.issn.1672-1519. 2024.03.12.

24.谷敬欣, 赵振军, 左惠芬, 等. 雷公藤多苷片联合甲氨蝶呤对类风湿关节炎合并骨质疏松患者血清骨代谢标志物水平及炎症因子的影响[J]. 现代中西医结合杂志, 2020, 29(22): 2424-2428. [Gu JX, Zhao ZJ, Zuo HF, et al. Effects of tripterygium glycoside tablets combined with methotrexate on levels of serum bone metabolism markers and inflammatory factors in patients with rheumatoid arthritis and osteoporosis[J]. Modern Journal of Integrated Traditional Chinese and Western Medicine, 2020, 29(22): 2424-2428.] DOI: 10.3969/j.issn.1008-8849. 2020.22.007.

25.郑丽, 宋江曼, 郭丹, 等. 中成药临床实践指南和专家共识中安全性推荐意见的现况分析[J]. 药物不良反应杂志, 2024, 26(11): 652-657. [Zheng L, Song JM, Guo D, et al. Analysis of safety recommendations in clinical practice guidelines and expert consensuses for Chinese patent medicine[J]. Adverse Drug Reactions Journal, 2024, 26(11): 652-657.] DOI: 10.3760/cma.j.cn114015-20240505-00299.

26.赖福崇. 仙灵骨葆、金天格对Ⅰ型骨质疏松症治疗的初步经济学分析[D]. 昆明: 云南中医药大学, 2020. [Lai FC. Clinical study of Xianlinggubao and Jintiange capsules in treating type I osteoporosischinese abstract[D]. Kunming: Yunnan University of Chinese Medicine, 2020.] DOI: 10.27460/d.cnki.gyzyc.2020.000079.

27.孙浩鹏, 吴炯林, 丁悦. 骨转换生化标志物在骨质疏松症早期筛查中的应用进展[J]. 中华骨质疏松和骨矿盐疾病杂志, 2024, 17(5): 481-490. [Sun HP, Wu JL, Ding Y. Progress in the application of bone turnover markers in early screening of osteoporosis[J]. Chinese Journal of Osteoporosis and Bone Mineral Research, 2024, 17(5): 481-490.] DOI: 10.3969/j.issn.1674- 2591.2024.05.009.

28.严靖, 覃湫珺, 李芬, 等. 骨质疏松症特异性生命质量量表的系统综述[J]. 中国组织工程研究, 2025, 29(35): 7649-7655. [Yan J, Qin QJ, Li F, et al. A systematic review of osteoporosis-specific quality-of-life scales[J]. Chinese Journal of Tissue Engineering Research, 2025, 29(35): 7649-7655.] DOI: 10.12307/2025.975.

29.张英英, 申晨, 张颖, 等. 以“总有效率”作为中医药疗效评价指标存在的误区[J]. 中国药物评价, 2020, 37(5): 337-340. [Zhang YY, Shen C, Zhang Y, et al. Misunderstandings in using "total effective rate" as an index for evaluating the therapeutic effect of traditional Chinese medicine[J]. Chinese Journal of Drug Evaluation, 2020, 37(5): 337-340.] DOI: 10.3969/j.issn.2095-3593.2020.05.005.

30.沈智, 曾景奇, 李益亮, 等. 强骨胶囊联合维D2磷葡钙片治疗老年性骨质疏松症50例总结[J]. 湖南中医杂志, 2018, 34(10): 7-9. [Shen Z, Zeng JQ, Li YL, et al. Clinical effect of Qianggu capsules combined with vitamin D2, calcium hydrophosphate, and calcium gluconate tablets in treatment of senile osteoporosis: an analysis of 50 cases[J]. Hunan Journal of Traditional Chinese Medicine, 2018, 34(10): 7-9.] DOI: 10.16808/j.cnki.issn1003-7705.2018.10.003.

31.《中成药治疗优势病种临床应用指南》标准化项目组. 中成药治疗骨质疏松症临床应用指南（2021年）[J]. 中国中西医结合杂志, 2022, 42(4): 393-404. [Standardization Project of Clinical Application Guidelines for Chinese Patent Drugs in the Treatment of Advantageous Diseases. Clinical application guidelines for Chinese patent drugs in the treatment of osteoporosis (2021) [J]. Chinese Journal of Integrated Traditional and Western Medicine, 2022, 42(4): 393-404.] DOI: 10.7661/j.cjim.20220204.063.