Zhang Bin, Liang Long, Chen Wenbo, Liang Changhong, Zhang Shuixing
Department of Radiology, Guangdong Academy of Medical Sciences/Guangdong General Hospital, Guangzhou, Guangdong Province, China; Graduate College, Southern Medical University, Guangzhou, China.
Department of Radiology, Guangdong Academy of Medical Sciences/Guangdong General Hospital, Guangzhou, Guangdong Province, China.
PLoS One. 2015 Jun 15;10(6):e0129720. doi: 10.1371/journal.pone.0129720. eCollection 2015.
Nephrogenic systemic fibrosis (NSF) is a rare but serious disorder disease affecting patients with advanced renal disease. Although multiple studies have indicated an association between gadolinium-based contrast agents (GBCAs) and NSF, some studies published after 2007 found no association. We therefore performed a meta-analysis to evaluate the association and analyze related (co)factors.
Studies for analysis were identified by searching PubMed, Embase, and the Cochrane Central Register of Controlled Trials through December 2014. Pooled odds ratios (OR) with 95% confidence intervals (CI) were calculated using the fixed-effects model. Statistical heterogeneity was assessed by Q statistics and the I2 test. Publication bias was evaluated using Begg's test, Egger's test, funnel plot, and classic fail-safe N. Study quality was assessed using the Newcastle-Ottawa Scale. We also conducted sensitivity analyses, subgroup analyses and a cumulative meta-analysis. All statistical analyses were performed using Comprehensive Meta-Analysis 2.0.
A total of 14 studies (6,398 patients) met the inclusion criteria, but 3 were excluded since they reported no NSF events. Meta-analysis of controlled trials indicated a significant association between GBCAs and NSF development (OR = 16.504; 95% CI: 7.455-36.533; P < 0.001) and between gadodiamide and NSF (OR = 20.037; 95% CI: 3.725-107.784; P < 0.001). No statistical heterogeneity was observed across studies (P = 0.819, I2 = 0%; P = 0.874, I2 = 0%, respectively). Cumulative analysis demonstrated that the pooled ORs for association between GBCAs and NSF decreased post-2007 compared to pre-2007 (OR = 26.708; 95% CI: 10.273-69.436; P<0.001).
Although this updated meta-analysis found a significant association between GBCAs and the incidence of NSF in patients with advanced renal disease, the association decreased after 2007. More studies, especially randomized controlled trials, are warranted to examine the potential association between GBCAs other than gadodiamide and NSF.
肾源性系统性纤维化（NSF）是一种罕见但严重的疾病，影响晚期肾病患者。尽管多项研究表明钆基造影剂（GBCAs）与NSF之间存在关联，但2007年后发表的一些研究未发现这种关联。因此，我们进行了一项荟萃分析，以评估这种关联并分析相关（协）因素。
通过检索截至2014年12月的PubMed、Embase和Cochrane对照试验中央注册库来确定用于分析的研究。使用固定效应模型计算合并比值比（OR）及其95%置信区间（CI）。通过Q统计量和I²检验评估统计异质性。使用Begg检验、Egger检验、漏斗图和经典的失效安全数N评估发表偏倚。使用纽卡斯尔-渥太华量表评估研究质量。我们还进行了敏感性分析、亚组分析和累积荟萃分析。所有统计分析均使用Comprehensive Meta-Analysis 2.0进行。
共有14项研究（6398例患者）符合纳入标准，但3项研究因未报告NSF事件而被排除。对照试验的荟萃分析表明，GBCAs与NSF发生之间存在显著关联（OR = 16.504；95%CI：7.455 - 36.533；P < 0.001），钆双胺与NSF之间也存在显著关联（OR = 20.037；95%CI：3.725 - 107.784；P < 0.001）。各研究之间未观察到统计学异质性（分别为P = 0.819，I² = 0%；P = 0.874，I² = 0%）。累积分析表明，与2007年前相比，2007年后GBCAs与NSF之间关联的合并OR值有所下降（OR = 26.708；95%CI：10.273 - 69.436；P < 0.001）。
尽管这项更新的荟萃分析发现GBCAs与晚期肾病患者的NSF发病率之间存在显著关联，但这种关联在2007年后有所下降。需要更多研究，尤其是随机对照试验，来研究除钆双胺之外的其他GBCAs与NSF之间的潜在关联。
