Man Yicong, Na Junfu, Wang Hongxu, Lan Fang, Yu Liying
Department of Orthopedics and Traumatology, Lishui Hospital of Traditional Chinese Medicine, Lishui, Zhejiang, China.
Department of Orthopedics and Traumatology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning, China.
Front Pharmacol. 2025 Jul 14;16:1592184. doi: 10.3389/fphar.2025.1592184. eCollection 2025.
To evaluate the efficacy and safety of Jintiange in osteoporosis treatment via systematic review and meta-analysis, thereby presenting more supporting evidence.
Up to 27 October 2024, PubMed, Web of Science, Cochrane Library, Embase, China National Knowledge Infrastructure (CNKI), and Wanfang were searched for studies on the use of Jintiange/artificial tiger bone powder in osteoporosis treatment. Studies were selected based on predefined eligibility criteria. Outcome measures encompassed bone mineral density (BMD), pain scores, adverse event (AE), fracture incidence, serum calcium, and phosphorus concentrations, as well as bone resorption and formation markers.
This study included 18 studies involving 21 trials on 2,580 patients (1,303 in the Jintiange group and 1,277 in the control group). A pooled analysis demonstrated that, in comparison to the control group, the Jintenge group achieved significantly greater improvements in BMD at various anatomical sites, including the lumbar spine (SMD = 0.52), femoral neck (SMD = 0.31), greater trochanter (SMD = 0.59), and Ward's triangle (SMD = 0.94). In addition, the Jintenge group exhibited a greater reduction in Visual Analogue Scale (VAS) scores (SMD = -0.87). No significant differences were observed between the two groups in terms of AEs or incidence of fractures. The level of bone Gla protein (BGP) was significantly higher in the Jintenge group compared with the control group (SMD = 1.28), whereas there were insignificant intergroup differences in serum calcium and phosphorus concentrations or changes in the type I collagen carboxy-terminal peptide (CTX). Sensitivity analysis revealed inconsistent results of Procollagen type I N-terminal propeptide (PINP) and bone alkaline phosphatase (BALP).
Jintiange possibly improves BMD and alleviates pain in osteoporosis patients, with a favorable safety profile. Prolonged treatment duration (exceeding 6 months) yields greater therapeutic benefit than shorter courses, and the combination of Jintiange with standard therapies demonstrates superior efficacy relative to Jintiange alone. However, in consideration of the limitations of the present study, further high-quality investigations are necessitated to strengthen the evidence base and to elucidate the long-term efficacy, safety, and impact of this agent on fracture incidence.
https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42025630527.
通过系统评价和荟萃分析评估金天格治疗骨质疏松症的疗效和安全性，从而提供更多支持性证据。
截至2024年10月27日，检索PubMed、Web of Science、Cochrane图书馆、Embase、中国知网（CNKI）和万方数据库，查找关于使用金天格/人工虎骨粉治疗骨质疏松症的研究。根据预先设定的纳入标准选择研究。结局指标包括骨密度（BMD）、疼痛评分、不良事件（AE）、骨折发生率、血清钙和磷浓度，以及骨吸收和形成标志物。
本研究纳入18项研究，涉及21项试验，共2580例患者（金天格组1303例，对照组1277例）。汇总分析表明，与对照组相比，金天格组在多个解剖部位的骨密度均有显著改善，包括腰椎（标准化均数差[SMD]=0.52）、股骨颈（SMD=0.31）、大转子（SMD=0.59）和Ward三角区（SMD=0.94）。此外，金天格组的视觉模拟评分（VAS）降低幅度更大（SMD=-0.87）。两组在不良事件或骨折发生率方面未观察到显著差异。金天格组的骨钙素（BGP）水平显著高于对照组（SMD=1.28），而血清钙和磷浓度或Ⅰ型胶原羧基末端肽（CTX）变化的组间差异不显著。敏感性分析显示，Ⅰ型前胶原氨基端前肽（PINP）和骨碱性磷酸酶（BALP）的结果不一致。
金天格可能改善骨质疏松症患者的骨密度并减轻疼痛，安全性良好。延长治疗时间（超过6个月）比短疗程治疗更具疗效，且金天格与标准疗法联合使用比单独使用金天格疗效更佳。然而，鉴于本研究的局限性，需要进一步开展高质量研究以加强证据基础，并阐明该药物的长期疗效、安全性及其对骨折发生率的影响。
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