The First Affiliated Hospital of Soochow University, Jiangsu, China.
Pain Physician. 2013 Sep-Oct;16(5):447-53.
Osteoporotic vertebral compression fractures (VCFs) commonly occur in aged people. Balloon kyphoplasty (KP) has been proven to be efficacious for pain relief and reduction of vertebral height for patients with osteoporotic VCFs. However, very little is known about the comparison of clinical and radiographic outcomes between unilateral and bilateral balloon KP in treating this kind of patients.
To compare the safety and long-term radiographic and clinical outcomes of unilateral or bilateral balloon KP to treat patients with osteoporotic VCFs.
A systemic review and meta-analysis of all randomized controlled trials (RCTs) comparing the analgesic efficacy, radiographic outcomes, and complications between unilateral and bilateral balloon KP in patients with osteoporotic VCFs.
The MEDLINE, EMBASE, Pubmed, CINAHL databases, Bandolier, and the Cochrane Controlled Trials Register were systematically searched for evidence from their inception to July 2012 by 2 of the authors (J.L. and L.Z.).
Relevant reports were reviewed by 2 assessors independently and the reference lists of retrieved papers were scrutinized to identify further studies for inclusion, using guidelines set by PRISMA statement criteria.
Three RCTs were enrolled in this study. The VAS scores showed no statistical difference between the groups before surgery and either at short-term or long-term follow-up. There was no statistical significance in polymethylmethacrylate (PMMA) leakage between the groups. Analysis of 2 studies showed statistical significance in surgery time (WMD -23.77 [-27.83, -19.71]; P < 0.00001) and PMMA (WMD -1.65 [-2.28, -1.02]; P < 0.00001) consumption between the groups.
There were few data sources from which to extract abstracted data or published studies. There were only 3 RCTs that met criteria enrollment in this meta-analysis. The quality of these trials was quite low (Jadad score: 1-2). Variable reporting of end points and inconsistent definitions meant that we were not able to include every study for each outcome. There was also clinical heterogeneity among the studies.
The efficacy of both unilateral and bilateral balloon KP to provide rapid, significant, and sustained pain relief for patients with osteoporotic VCFs is validated. Unilateral balloon KP is a reasonable treatment for patients with osteoporotic VCFs considering that it could achieve equivalent pain relief with less surgery time and PMMA consumption compared to bilateral balloon KP. There was no evidence to prove that unilateral balloon KP results in higher incidence of PMMA leakage than bilateral balloon KP. Although unilateral balloon KP was less efficacious in the reduction of fractured vertebral body, it is still unclear if the clinical results of balloon KP were positively correlated with the restoration of vertebral height and amount.
骨质疏松性椎体压缩性骨折（VCF）常见于老年人。球囊扩张椎体后凸成形术（KP）已被证明对缓解疼痛和恢复椎体高度有效治疗骨质疏松性 VCF 患者。然而，关于单侧和双侧球囊 KP 在治疗此类患者的临床和影像学结果比较，知之甚少。
比较单侧和双侧球囊 KP 治疗骨质疏松性 VCF 患者的安全性和长期影像学及临床结果。
对所有比较单侧和双侧球囊 KP 在骨质疏松性 VCF 患者中止痛效果、影像学结果和并发症的随机对照试验（RCT）进行系统评价和荟萃分析。
作者（J.L.和 L.Z.）通过 MEDLINE、EMBASE、Pubmed、CINAHL 数据库、Bandolier 和 Cochrane 对照试验登记处，从成立之初到 2012 年 7 月系统地搜索证据。
两名评估员独立审查相关报告，并仔细审查检索文献的参考文献，以根据 PRISMA 声明标准确定其他纳入研究。
本研究纳入了 3 项 RCT。两组患者术前、短期和长期随访的 VAS 评分均无统计学差异。两组之间聚甲基丙烯酸甲酯（PMMA）渗漏无统计学意义。对 2 项研究的分析显示，手术时间有统计学意义（WMD -23.77 [-27.83，-19.71]；P < 0.00001）和 PMMA（WMD -1.65 [-2.28，-1.02]；P < 0.00001）消耗有统计学意义。
从提取摘要数据或已发表研究的数据源很少。这项荟萃分析只符合标准纳入了 3 项 RCT。这些试验的质量相当低（Jadad 评分：1-2）。终点报告的变量和不一致的定义意味着我们无法为每个结果纳入每一项研究。研究之间也存在临床异质性。
单侧和双侧球囊 KP 均可迅速、显著、持续缓解骨质疏松性 VCF 患者的疼痛，这已得到验证。单侧球囊 KP 是骨质疏松性 VCF 患者的一种合理治疗方法，因为与双侧球囊 KP 相比，它可以在手术时间和 PMMA 消耗更少的情况下达到等效的止痛效果。没有证据表明单侧球囊 KP 会导致 PMMA 渗漏的发生率高于双侧球囊 KP。尽管单侧球囊 KP 在减少骨折椎体方面的效果较差，但仍不清楚球囊 KP 的临床结果是否与椎体高度和数量的恢复呈正相关。
