生长抑素及其类似物联合质子泵抑制剂应用于急性非静脉曲张性上消化道出血的循证分析

目的 系统评价生长抑素及其类似物联合质子泵抑制剂（proton pump inhibitor,PPI）治疗急性非静脉曲张性上消化道出血（acute non-variceal upper gastrointestinal bleeding,ANVUGIB）的有效性和安全性,并分析其用药经济性。方法 采用循证医学方法搜集生长抑素及其类似物联合PPI治疗ANVUGIB的RCT、队列研究进行meta分析,得到相应的有效性及安全性分析结果,并进行成本-效果分析。结果 最终纳入6个RCT均未接受内镜治疗,共610例受试者。Meta分析结果显示,生长抑素及其类似物联合高、中、低剂量PPI治疗在以下方面均优于单用高、中、低剂量PPI治疗,差异有统计学意义,总有效率OR=3.34,95%CI（2.03,5.47）,P<0.000 01]、止血时间MD=-9.04,95%CI（-11.69,-6.38）,P<0.000 01]、输血量MD=-1.10,95%CI（-1.46,-0.74）,P<0.000 01];在不良反应发生率方面,2组差异无统计学意义OR=0.49,95%CI（0.11,2.12）,P=0.34]。ANVUGIB患者予生长抑素联合高、中、低剂量奥美拉唑与单用高、中、低剂量奥美拉唑进行成本-效果分析,增量成本效果比分别为172.28,217.26,330.37,敏感性分析后显示结果稳定。而接受内镜治疗后应用生长抑素及其类似物联合PPI治疗仅1个队列研究,研究结果显示内镜治疗成功后联合治疗并不优于PPI单药治疗。结论 现有证据表明,生长抑素及其类似物联合PPI治疗未经内镜治疗的ANVUGIB患者为较有效的方案,两者安全性相当、耐受性较好,从药品直接成本考虑,高剂量PPI组联合治疗较中、低剂量PPI组联合治疗更具有成本效果性。而对于经内镜下止血治疗的患者两者疗效相当,可考虑单用PPI。

Evidence-based Analysis of Somatostatin and Its Analogues Combined with Proton Pump Inhibitor for Acute Non-variceal Upper Gastrointestinal Bleeding

OBJECTIVE To systematically review the effectiveness and safety of somatostatin and its analogues combined with proton pump inhibitor(PPI) for acute non-variceal upper gastrointestinal bleeding(ANVUGIB), and evaluate the cost-effectiveness of the two groups. METHODS Evidence-based medicine method was used to collect random clinical controlled trials(RCTs) and cohort studies for the treatment of ANVUGIB with somatostatin and its analogues combined with PPI. Meta analysis was performed to obtain analysis results of effectiveness and safety, and cost-effectiveness analysis was performed. RESULTS A total of six RCTs involving 610 patients were included. The results of meta-analysis showed that the treatment of somatostatin and its analogues combined with high, medium and low doses of PPI was superior to PPI treatment in the following aspects, the difference was statistically significant:total effective rateOR=3.34, 95%CI(2.03, 5.47), P<0.000 01], hemostasis timeMD=-9.04, 95%CI(-11.69, -6.38), P<0.000 01], blood transfusionMD=-1.10, 95%CI(-1.46, -0.74), P<0.000 01]. While there was no significant difference in the incidence of adverse events between two groupsOR=0.49, 95%CI(0.11, 2.12), P=0.34]. And the cost-effectiveness analysis of somatostatin combined with high, medium and low doses of omeprazole to high, medium and low doses of omeprazole in patients with ANVUGIB were performed respectively. The incremental cost-effectiveness ratio were 172.28, 217.26, 330.37, respectively. Sensitivity analysis showed that the results were stable. The use of somatostatin and its analogues in combination with PPI after endoscopic hemostasis was only a cohort study. The results showed that the combination therapy after endoscopic hemostasis was not superior to PPI monotherapy. CONCLUSION Current evidence indicates that, somatostatin and its analogues combined with PPI is more effective scheme without endoscopic therapy. Both treatments are safe and well tolerated. Considering the direct cost of drugs, the high-dose PPI combined therapy is more cost-effectiveness than the medium-dose and the low-dose PPI combined therapy. And PPI can be considered for patients undergoing endoscopic hemostasis because both are effective.