背景:本研究旨在系统评价金天格胶囊(JTG胶囊)辅助经皮椎体强化术(PVA)治疗骨质疏松性椎体压缩骨折(OVCF)的临床疗效和不良反应。
方法:对包括PubMed在内的多个数据库进行了全面搜索,科克伦图书馆,EMBASE,WebofScience数据库,中国生物医学数据库,中国贵宾网,中国国家知识基础设施,万方,和VIP中文期刊数据库,直到2022年6月1日。还在相关期刊中进行了手动搜索。确定并选择纳入研究JTG胶囊辅助PVA治疗OVCF疗效的随机对照试验。使用Cochrane风险偏倚评估工具和Jadad量表评估纳入研究的质量。采用StataMP18软件进行Meta分析。
结果:共检索到138篇文献,经过筛查,最终纳入了12个RCTS,涉及1099名患者。总的来说,纳入文献质量较低,所有纳入的文献均为随机对照实验,其中9个按随机数字表分组,3没有指定随机分配计划。试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=.868,I2=0%)。视觉模拟评分的异质性,Oswestry残疾指数,腰椎骨密度(BMD),股骨颈的骨密度和含γ-羧基谷氨酸的蛋白质高。高度异质性的原因是患者的年龄,随访时间和样本量小。视觉模拟评分存在出版偏见,Oswestry残疾指数得分,和腰椎骨密度,我们认为出版偏倚可能与作者选择性地报告阳性结果和出版商选择性地发表阳性结果有关。
结论:JTG胶囊在减轻PVP术后OVCF患者的疼痛方面表现出了有希望的结果。此外,具有增强术后腰背部功能的作用。此外,JTG胶囊与术后椎骨BMD和血清含骨γ-羧基谷氨酸蛋白水平的改善有关。这些发现表明,JTG胶囊可能作为治疗PVA后骨质疏松症的可行辅助治疗选择。
BACKGROUND: 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).
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.