Department of Orthopedics, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.
Department of Orthopedics, Honghui-Hospital, Xi'an Jiaotong University, Xi'an, China.
Medicine (Baltimore). 2024 May 31;103(22):e38192. doi: 10.1097/MD.0000000000038192.
This study aims to systematically evaluate the clinical efficacy and adverse reactions associated with Jintiange capsule (JTG capsule)-assisted percutaneous vertebral augmentation (PVA) in the treatment of osteoporotic vertebral compression fracture (OVCF).
A comprehensive search was conducted across multiple databases including PubMed, Cochrane Library, EMBASE, Web of Science Database, China Biomedical Database, China VIP Network, China National Knowledge Infrastructure, Wanfang, and VIP Chinese Journal databases until June 1, 2022. Manual searches were also performed in relevant journals. Randomized controlled trials investigating the efficacy of JTG capsule-assisted PVA in the treatment of OVCF were identified and selected for inclusion. The quality of the included studies was assessed using the Cochrane risk bias assessment tool and Jadad scale. Meta-analysis was conducted using Stata MP18 software.
A total of 138 literatures were retrieved, and 12 RCTS were finally included after screening, involving 1099 patients. Overall, the quality of the included literature was low, and all the included literatures were randomized controlled experiments, among which 9 were grouped by random number table, and 3 did not specify the random assignment plan. The total effective rate of the experimental group was higher than that of the control group (relative ratio: 1.19, 95% confidence interval: 1.11, 1.26, P = .868, I2 = 0%). The heterogeneity of visual analog score, Oswestry disability index, bone mineral density (BMD) of lumbar vertebrae, BMD of femoral neck and bone-γ-carboxyglutamic acid-containing protein was high. The reasons for the high heterogeneity were the age of patients, the follow-up time and the small sample size. There is publication bias in visual analog score, Oswestry disability index scores, and lumbar spine bone mineral density, and we believe that publication bias may be related to selective reporting of positive results by the authors and selective publication of positive results by the publishers.
JTG capsule has demonstrated promising outcomes in alleviating the pain experienced by OVCF patients following PVP. Additionally, it has shown efficacy in enhancing postoperative lumbar and back function. Furthermore, JTG capsule has been associated with improvements in postoperative vertebral BMD and serum bone-γ-carboxyglutamic acid-containing protein levels. These findings suggest that JTG capsule could potentially serve as a viable adjunctive treatment option for managing osteoporosis following PVA.
本研究旨在系统评估金天格胶囊（JTG 胶囊）辅助经皮椎体强化术（PVA）治疗骨质疏松性椎体压缩性骨折（OVCF）的临床疗效和不良反应。
通过对 PubMed、Cochrane 图书馆、EMBASE、Web of Science 数据库、中国生物医学文献数据库、中国维普网、中国知网、万方和 VIP 中文期刊数据库进行全面检索，检索时间截至 2022 年 6 月 1 日，并在相关期刊中进行手工检索。纳入 JTG 胶囊辅助 PVA 治疗 OVCF 的疗效研究的随机对照试验。使用 Cochrane 风险偏倚评估工具和 Jadad 量表评估纳入研究的质量。使用 Stata MP18 软件进行荟萃分析。
共检索到 138 篇文献，经过筛选后最终纳入 12 项 RCT，共纳入 1099 例患者。总体而言，纳入文献质量较低，均为随机对照试验，其中 9 项为随机数字表分组，3 项未说明随机分配方案。实验组总有效率高于对照组（相对比：1.19，95%置信区间：1.11，1.26，P=0.868，I2=0%）。视觉模拟评分、Oswestry 功能障碍指数、腰椎骨密度、股骨颈骨密度和骨γ-羧基谷氨酸蛋白的异质性较高。异质性高的原因是患者年龄、随访时间和样本量小。视觉模拟评分、Oswestry 功能障碍指数评分和腰椎骨密度存在发表偏倚，我们认为发表偏倚可能与作者对阳性结果的选择性报告以及出版商对阳性结果的选择性发表有关。
金天格胶囊在缓解 PVP 后 OVCF 患者疼痛方面表现出良好的效果，同时在改善术后腰椎和腰背功能方面也具有一定的疗效。此外，金天格胶囊还能提高术后椎体骨密度和血清骨γ-羧基谷氨酸蛋白水平。这些发现表明，金天格胶囊可能成为 PVA 治疗骨质疏松症的一种可行的辅助治疗方法。
