Khuroo M S, Khuroo N S, Farahat K L C, Khuroo Y S, Sofi A A, Dahab S T
Department of Medicine, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.
Aliment Pharmacol Ther. 2005 Feb 15;21(4):347-61. doi: 10.1111/j.1365-2036.2005.02346.x.
The treatment effects of primary prophylactic endoscopic variceal ligation are unclear.
To compare the treatment effects of endoscopic variceal ligation and beta-blockers for primary prophylaxis of oesophageal variceal bleeding. In addition, a subgroup analysis was done with the purpose to delineate differences in the effects of intervention that were biologically based.
We performed a literature search for randomized controlled trials, which compared the treatment effects of endoscopic variceal ligation with beta-blockers for primary prophylaxis of oesophageal variceal bleeding. Of the 955 articles screened, eight randomized-controlled trials including 596 subjects (285 with endoscopic variceal ligation and 311 with beta-blockers) were analysed. Outcomes measures evaluated were first gastrointestinal bleed, first variceal bleed, all-cause deaths, bleed-related deaths and severe adverse events. The measure of association employed was relative risk; with heterogeneity and sensitivity analyses.
Variceal obliteration was obtained in 261 (91.6%) patients and target beta-blockers therapy was achieved in 294 (94.5%) patients (P = 0.19). Endoscopic variceal ligation compared with beta-blockers significantly reduced rates of first gastrointestinal bleed by 31% (RR, 0.69; 95% CI: 0.49-0.96; P = 0.03; NNTB = 15) and first variceal bleed by 43% (RR, 0.57; 95% CI: 0.38-0.85; P = 0.0067; NNTB = 11). All-cause deaths and bleed-related deaths were unaffected (RR, 1.03; 95% CI: 0.79-1.36; P = 0.81 and RR, 0.84; 95% CI: 0.44-1.61; P = 0.60 respectively). Severe adverse events were significantly less in endoscopic variceal ligation compared with beta-blockers (RR, 0.34; 95% CI: 0.17-0.69; P = 0.0024; NNTB = 28). Sensitivity analysis of five trials published in peer review journals and four trials with high quality showed results similar to those seen in the primary analysis of all the eight trials, confirming stability of conclusions. Following variceal obliteration with endoscopic variceal ligation, oesophageal varices recurred in 83 (29.1%) patients. Seven (28.1%) patients bled with one fatal outcome. In subgroup analyses, endoscopic variceal ligation had significant advantage compared wtih beta-blockers in trials including < or =30% patients with alcoholic cirrhosis, >30% patients with Child Class C cirrhosis and >50% patients with large varices.
In patients with cirrhosis with moderate to large varices and who have not bled, endoscopic varices ligation compared with beta-blockers significantly reduced bleeding episodes and severe adverse events, but had no effect on mortality.
内镜下静脉曲张套扎术进行一级预防的治疗效果尚不清楚。
比较内镜下静脉曲张套扎术与β受体阻滞剂对食管静脉曲张出血一级预防的治疗效果。此外,进行亚组分析以明确基于生物学的干预效果差异。
我们检索了随机对照试验的文献,比较内镜下静脉曲张套扎术与β受体阻滞剂对食管静脉曲张出血一级预防的治疗效果。在筛选的955篇文章中,分析了8项随机对照试验,包括596名受试者(285例行内镜下静脉曲张套扎术,311例使用β受体阻滞剂)。评估的结局指标为首次胃肠道出血、首次静脉曲张出血、全因死亡、出血相关死亡和严重不良事件。采用的关联度量为相对风险;并进行了异质性和敏感性分析。
261例(91.6%)患者实现了静脉曲张闭塞,294例(94.5%)患者达到了目标β受体阻滞剂治疗(P = 0.19)。与β受体阻滞剂相比,内镜下静脉曲张套扎术显著降低了首次胃肠道出血率31%(RR,0.69;95%CI:0.49 - 0.96;P = 0.03;需治疗人数为15)和首次静脉曲张出血率43%(RR,0.57;95%CI:0.38 - 0.85;P = 0.0067;需治疗人数为11)。全因死亡和出血相关死亡未受影响(RR分别为1.03;95%CI:0.79 - 1.36;P = 0.81和RR,0.84;95%CI:0.44 - 1.61;P = 0.60)。与β受体阻滞剂相比,内镜下静脉曲张套扎术的严重不良事件显著更少(RR,0.34;95%CI:0.17 - 0.69;P = 0.0024;需治疗人数为28)。对同行评审期刊发表的5项试验和4项高质量试验进行的敏感性分析显示,结果与所有8项试验的初步分析结果相似,证实了结论的稳定性。在内镜下静脉曲张套扎术使静脉曲张闭塞后,83例(占29.1%)患者食管静脉曲张复发。7例(占28.1%)患者出血,1例死亡。在亚组分析中,在内镜下静脉曲张套扎术在包括≤30%酒精性肝硬化患者、>30%Child C级肝硬化患者和>50%大静脉曲张患者的试验中,与β受体阻滞剂相比具有显著优势)。
在患有中度至大静脉曲张且未出血的肝硬化患者中,与β受体阻滞剂相比,内镜下静脉曲张套扎术显著减少了出血发作和严重不良事件,但对死亡率无影响。