Gluud Lise L, Klingenberg Sarah, Nikolova Dimitrinka, Gluud Christian
Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen, Denmark.
Am J Gastroenterol. 2007 Dec;102(12):2842-8; quiz 2841, 2849. doi: 10.1111/j.1572-0241.2007.01564.x.
To compare banding ligation versus beta-blockers as primary prophylaxis in patients with esophageal varices and no previous bleeding.
Randomized trials were identified through electronic databases, reference lists in relevant articles, and correspondence with experts. Three authors extracted data. Random effects meta-analysis and metaregression were performed. The reported allocation sequence generation and concealment were extracted as measures of bias control.
The initial searches identified 1,174 references. Sixteen trials were included. In 15 trials, patients had high-risk varices. Three trials reported adequate bias control. All trials reported mortality for banding ligation (116/573 patients) and beta-blockers (115/594 patients). Mortality in the two treatment groups was not significantly different in the trials with adequate bias control (relative risk 1.22, 95% CI 0.84-1.78) or unclear bias control (RR 1.02, 95% CI 0.75-1.39). Trials with adequate bias control found no significant difference in bleeding rates (RR 0.86, 95% CI 0.55-1.35). Trials with unclear bias control found that banding ligation significantly reduced bleeding (RR 0.56, 95% CI 0.41-0.77). Both treatments were associated with adverse events. In metaregression analyses, the estimated effect of ligation was significantly more positive if trials were published as abstracts. Likewise, the shorter the follow-up, the more positive the estimated effect of ligation.
Banding ligation and beta-blockers may be used as primary prophylaxis in high-risk esophageal varices. The estimated effect of banding ligation in some trials may be biased and was associated with the duration of follow-up. Further high-quality trials are still needed.
比较套扎术与β受体阻滞剂作为食管静脉曲张且既往无出血患者的一级预防措施。
通过电子数据库、相关文章的参考文献列表以及与专家通信来识别随机试验。三位作者提取数据。进行随机效应荟萃分析和元回归分析。提取报告的分配序列产生和隐藏情况作为偏倚控制的指标。
初步检索识别出1174篇参考文献。纳入16项试验。15项试验中的患者有高危静脉曲张。3项试验报告了充分的偏倚控制。所有试验均报告了套扎术（573例患者中的116例）和β受体阻滞剂（594例患者中的115例）的死亡率。在偏倚控制充分的试验（相对危险度1.22，95%可信区间0.84 - 1.78）或偏倚控制不明确的试验（RR 1.02，95%可信区间0.75 - 1.39）中，两个治疗组的死亡率无显著差异。偏倚控制充分的试验发现出血率无显著差异（RR 0.86，95%可信区间0.55 - 1.35）。偏倚控制不明确的试验发现套扎术显著降低了出血率（RR 0.56，95%可信区间0.41 - 0.77）。两种治疗均与不良事件相关。在元回归分析中，如果试验以摘要形式发表，套扎术的估计效果显著更积极。同样，随访时间越短，套扎术的估计效果越积极。
套扎术和β受体阻滞剂可作为高危食管静脉曲张的一级预防措施。一些试验中套扎术的估计效果可能存在偏倚，且与随访时间有关。仍需要进一步的高质量试验。
