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唑来膦酸联合 PVP/PKP 治疗骨质疏松性椎体压缩骨折的临床疗效及安全性:一项随机对照试验的系统评价和荟萃分析。

Clinical Efficacy and Safety of Zoledronic Acid Combined with PVP/PKP in the Treatment of Osteoporotic Vertebral Compression Fracture: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

机构信息

Beijing University of Chinese Medicine, Beijing 100029, China.

Department of Orthopaedics, China-Japan Friendship Hospital, Beijing 100029, China.

出版信息

Biomed Res Int. 2021 Apr 8;2021:6650358. doi: 10.1155/2021/6650358. eCollection 2021.

Abstract

OBJECTIVE

We conducted this meta-analysis to provide better evidence of the efficacy and safety of zoledronic acid (ZA) combined with percutaneous vertebroplasty/kyphoplasty (PVP/PKP) on osteoporotic vertebral compression fracture (OVCF) and proposed a protocol for its application in clinical practice.

METHODS

All randomized controlled trials (RCTs) of ZA combined with PVP or PKP compared to individual PVP/PKP for the management of patients with OVCFs were included in this study. Electronic database searches were conducted from database inception to November 2020, including the Cochrane Library, PubMed, Web of Science, and Embase. The pooled data were analyzed using RevMan 5.3 software.

RESULTS

Seven RCTs with 929 subjects were finally included. All included studies reported visual analog scores (VAS), and no statistically significant differences were identified at follow-ups of 3 d and 1 w ( > 0.05). In contrast, significant differences were observed at the 1 mo, 3 mo, 6 mo, and 12 mo follow-ups ( < 0.05). Two trials reported the Cobb angle and vertebral body height (VBH), including 182 subjects without significant differences at the 12 mo follow-up ( > 0.05). In addition, significant differences in the bone mineral density (BMD), -isomerized C-terminal telopeptide of type I collagen (-CTX), N-terminal propeptide of type I collagen (PINP), and N-terminal molecular fragment (N-MID) levels were observed between the two groups ( < 0.05). All trials reported side effects. Significant differences in recurrent fractures, fever, flu-like symptoms, and arthralgia or myalgia were identified ( < 0.05); however, no significant difference in postoperative leakage was detected ( > 0.05).

CONCLUSION

Compared to PVP/PKP alone, an additional ZA injection had advantages of long-term analgesic effects with improved bone metabolism indexes. Moreover, combination therapy significantly prevented complications and drug reactions were well tolerated. Overall, this systematic review revealed that ZA combined with PVP/PKP was an effective, safe, and comprehensive therapy for patients with OVCFs.

摘要

目的

本研究旨在提供更好的证据,证明唑来膦酸(ZA)联合经皮椎体成形术/后凸成形术(PVP/PKP)治疗骨质疏松性椎体压缩性骨折(OVCF)的疗效和安全性,并提出其在临床实践中的应用方案。

方法

纳入所有比较 ZA 联合 PVP 或 PKP 与单独 PVP/PKP 治疗 OVCF 患者的随机对照试验(RCT)。从数据库建立到 2020 年 11 月进行电子数据库检索,包括 Cochrane 图书馆、PubMed、Web of Science 和 Embase。使用 RevMan 5.3 软件对汇总数据进行分析。

结果

最终纳入 7 项 RCT,共 929 例患者。所有纳入的研究均报告了视觉模拟评分(VAS),在 3d 和 1w 随访时无统计学差异(>0.05)。然而,在 1mo、3mo、6mo 和 12mo 随访时观察到显著差异(<0.05)。两项试验报告了 Cobb 角和椎体高度(VBH),182 例患者在 12mo 随访时无统计学差异(>0.05)。此外,两组间骨密度(BMD)、I 型胶原 C 端肽(CTX)、I 型前胶原氨基端肽(PINP)和 N 端分子片段(N-MID)水平差异有统计学意义(<0.05)。所有试验均报告了不良反应。在复发性骨折、发热、流感样症状、关节痛或肌痛方面,两组间差异有统计学意义(<0.05);然而,在术后渗漏方面,两组间无统计学差异(>0.05)。

结论

与单独 PVP/PKP 相比,额外注射 ZA 具有长期镇痛效果,改善骨代谢指标的优势。此外,联合治疗显著预防了并发症,且药物反应可耐受。总体而言,本系统评价显示,ZA 联合 PVP/PKP 是治疗 OVCF 的有效、安全、全面的治疗方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da4e/8049795/6df234054f07/BMRI2021-6650358.001.jpg

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