Oral or intravenous proton pump inhibitor in patients with peptic ulcer bleeding after successful endoscopic epinephrine injection

AIMS

We aimed to assess the clinical effectiveness of oral vs. intravenous (i.v.) regular-dose proton pump inhibitor (PPI) after endoscopic injection of epinephrine in patients with peptic ulcer bleeding.

METHODS

Peptic ulcer patients with active bleeding, nonbleeding visible vessels, or adherent clots were enrolled after successful endoscopic haemostasis achieved by epinephrine injection. They were randomized to receive either oral rabeprazole (RAB group, 20 mg twice daily for 3 days) or i.v. omeprazole (OME group, 40 mg i.v. infusion every 12 h for 3 days). Subsequently, the enrolled patients receive oral PPI for 2 months (rabeprazole 20 mg or esomeprazole 40 mg once daily). The primary end-point was recurrent bleeding up to 14 days. The hospital stay, blood transfusion, surgery and mortality within 14 days were compared as well.

RESULTS

A total of 156 patients were enrolled, with 78 patients randomly allocated in each group. The two groups were well matched for factors affecting the clinical outcomes. Primary end-points (recurrent bleeding up to 14 days) were reached in 12 patients (15.4%) in the OME group and 13 patients (16.7%) in the RAB group [95% confidence interval (CI) of difference −12.82, 10.22]. All the rebleeding events occurred within 3 days of enrolment. The two groups were not different in hospital stay, volume of blood transfusion, surgery or mortality rate (1.3% of the OME group and 2.6% of the RAB group died, 95% CI of difference −5.6, 3.0).

CONCLUSIONS

Oral rabeprazole and i.v. regular-dose omeprazole are equally effective in preventing rebleeding in patients with high-risk bleeding peptic ulcers after successful endoscopic injection with epinephrine.     

内镜下注射去氨加压素与肾上腺素治疗老年急性消化性溃疡出血的效果比较

目的 比较内镜下注射去氨加压素与肾上腺素治疗老年急性消化性溃疡出血的临床疗效。方法 选取2014年10月—2018年11月杨凌示范区医院收治的老年急性消化性溃疡出血患者70例作为研究对象。采用随机数字表法将患者分为对照组和观察组,每组各35例。对照组内镜下注入0.1%盐酸肾上腺素注射液,0.5~1 mL/次,总量控制在2.0~6.0 mL。观察组注入醋酸去氨加压素注射液,0.3 μg/kg。观察两组患者的临床疗效、止血情况、诺丁汉健康调查问卷（NHP）和不良反应发生情况。结果 两组治疗总有效率比较差异无统计学意义。治疗后,观察组止血时间、即时止血率、再出血率、输血量和转外科手术率改善程度均优于对照组,但相比差异无统计学意义。治疗后,观察组患者精力、情感、睡眠、社会生活和躯体活动评分均显著低于对照组（P<0.05）,疼痛评分比较无显著差异。治疗期间,观察组心血管不良反应发生率显著低于对照组（P<0.05）。结论 内镜下注射去氨加压素治疗老年急性消化性溃疡出血效果与注射肾上腺素相当,但内镜下注射去氨加压素的心血管不良发应发生率低,患者生活质量高,尤其是对于合并心血管疾病的老年患者,值得进一步临床推广应用。     

High-dose intravenous proton pump inhibition following endoscopic therapy in the acute management of patients with bleeding peptic ulcers in the USA and Canada: a cost-effectiveness analysis

BACKGROUND: The efficacy of high-dose intravenous proton pump inhibition has recently been shown, yet its cost-effectiveness remains poorly studied. AIM: To assess the cost-effectiveness of this approach separately for American and Canadian health care settings. METHODS: A validated decision model included patients with bleeding ulcers after successful endoscopic haemostasis. Probabilities were determined from the literature, and charges and lengths of stay from national databases. A third-party payer perspective was adopted over a 30-day time horizon. RESULTS: Re-bleeding rates were 5.9% for patients who received high-dose intravenous proton pump inhibition and 22.9% for those who did not. Hospitalization costs for patients with and without re-bleeding were 11,802 US dollars and 7993 US dollars, and 5220 Canadian dollars and 2696 Canadian dollars, respectively. High-dose intravenous proton pump inhibition was more effective and less costly than the alternative of not administering it. The cost-effectiveness ratios for high-dose and no high-dose intravenous proton pump inhibition were 9112 US dollars and 11,819 US dollars (3293 dollars and 4284 dollars for the Canadian case), respectively. Sensitivity and threshold analyses showed that the results were robust across a wide range of clinically relevant assumptions. CONCLUSION: In the USA and Canada, administering high-dose intravenous proton pump inhibition for 3 days is both more effective and less costly than not doing so for patients with bleeding ulcers after successful endoscopic haemostasis.     

胃镜下注射去甲肾上腺素联合奥美拉唑治疗消化性溃疡出血的疗效观察

目的探讨胃镜下注射去甲肾上腺素联合奥美拉唑治疗消化性溃疡出血的疗效及安全性。方法将82例消化性溃疡出血患者随机分为观察组和对照组,每组各4l例。观察组采用胃镜下注射去甲肾上腺素联合奥美拉唑治疗,对照组采用奥美拉唑联合立止血治疗。结果观察组总有效率明显高于对照组,两组比较差异有统计学意义（P〈0．05）;两组患者24h、48h及72h空腹胃液pH值逐渐升高,与治疗前相比有统计学意义（P〈0．05）,且观察组升高幅度明显优于对照组（P〈0．05）;观察组患者止血时间、输液时间、住院时间均明显低于对照组（P〈0．05）,输血量及住院费用较对照组明显减少（P〈0．05）,再出血发生率明显低于对照组（P〈0．05）。两组均未见明显不良反应。结论胃镜下注射去甲肾上腺素联合奥美拉唑治疗消化性溃疡出血疗效确切,安全可靠,值得临床推广应用。     

Meta-analysis: predictors of rebleeding after endoscopic treatment for bleeding peptic ulcer

Aliment Pharmacol Ther 2011; 34: 888–900

Summary

Background Determining the risk of rebleeding after endoscopic therapy for peptic ulcer bleeding (PUB) may be useful for establishing additional haemostatic measures in very high‐risk patients. Aim To identify predictors of rebleeding after endoscopic therapy. Methods Bibliographic database searches were performed to identify studies assessing rebleeding after endoscopic therapy for PUB. All searches and data abstraction were performed in duplicate. A parameter was considered to be an independent predictor of rebleeding when it was detected as prognostic by multivariate analyses in ≥2 studies. Pooled odds ratios (pOR) were calculated for prognostic variables. Results Fourteen studies met the prespecified inclusion criteria. Pre‐endoscopic predictors of rebleeding were: (i) Haemodynamic instability: significant in 9 of 13 studies evaluating the variable (pOR: 3.30, 95% CI: 2.57–4.24); (ii) Haemoglobin value: significant in 2 of 10 (pOR: 1.73, 95% CI: 1.14–2.62) and (iii) Transfusion: significant in two of six (pOR not calculable). Endoscopic predictors of rebleeding were: (i) Active bleeding: significant in 6 of 12 studies (pOR: 1.70, 95% CI: 1.31–2.22); (ii) Large ulcer size: significant in 8 of 12 studies (pOR: 2.81, 95% CI: 1.98–4.00); (iii) Posterior duodenal ulcer location: significant in four of eight studies (pOR: 3.83, 95% CI: 1.38–10.66) and (iv) High lesser gastric curvature ulcer location: significant in three of eight studies (pOR: 2.86; 95% CI: 1.69–4.86). Conclusions Major predictors for rebleeding in patients receiving endoscopic therapy are haemodynamic instability, active bleeding at endoscopy, large ulcer size, ulcer location, haemoglobin value and the need for transfusion. These risk factors may be useful for guiding clinical management in patients with PUB.     

消化性溃疡合并出血急诊胃镜下注射治疗的临床效果分析

目的探讨经胃镜下行肾上腺素联合乙氧硬化醇注射治疗消化性溃疡合并出血患者的临床治疗效果。方法选取于2011年1月至2012年12月因黑便及呕血前来本院就诊的120例患者为研究对象,随机将患者分为观察组及对照组,每组各60例。观察组患者采用胃镜下1/100000肾上腺素联合1%乙氧硬化醇进行注射治疗,对照组患者经胃镜下行凝血酶喷洒治疗,对比分析两组患者的临床治疗效果。结果观察组患者在临床总有效率为95%,对照组患者临床总有效率为76.67%,两组显效率差异有统计学意义（P〈0.05）;观察组患者再出血发生率、手术率、输血量、平均住院时间均优于对照组患者,差异具有统计学意义（P〈0.05）。结论经急诊胃镜行肾上腺素联合乙氧化醇进行治疗溃疡性出血具有操作简单、安全有效的特点,值得在基层医院中应用推广。     

The cost-effectiveness of high-dose oral proton pump inhibition after endoscopy in the acute treatment of peptic ulcer bleeding

BACKGROUND: Recent data suggest a role for high-dose oral proton pump inhibition in ulcer bleeding. AIM: To compare the cost-effectiveness of oral high-dose proton pump inhibition to both high-dose intravenous proton pump inhibition and placebo administration. METHODS: The model adopted a 30-day time horizon, and focused on patients with ulcer haemorrhage initially treated endoscopically for high-risk stigmata. Re-bleeding rates were set a priori based on non-head-to-head data from the literature, and charges and lengths of stay from a national American database. Sensitivity analyses were carried across a broad range of clinically relevant assumptions. RESULTS: Re-bleeding rates for patients receiving intravenous, oral, or placebo therapies were 5.9%, 11.8%, and 27%, respectively. The mean lengths of stay and costs for admitted patients with and without re-bleeding were 4.7 and 3 days; $11,802, and $7993, respectively. High-dose intravenous proton pump inhibition was more effective and less costly (dominant) than high-dose oral proton pump inhibition with incremental savings of $136.40 per patient treated. The oral high-dose strategy in turn dominated placebo administration. Results remained robust according to one- and two-way sensitivity analyses. CONCLUSION: In patients undergoing endoscopic haemostasis, subsequent high-dose intravenous proton pump inhibition is more cost-effective than high-dose oral proton pump inhibition, which in turn dominates placebo. The results from this exploratory-type cost analysis require confirmation by head-to-head prospective trials performed in Western populations.     

Impact of intravenous omeprazole on Helicobacter pylori eradication by triple therapy in patients with peptic ulcer bleeding

AIM: To test the impact of intravenous omeprazole on Helicobacter pylori eradication for bleeding peptic ulcers. METHODS: A total of 175 H. pylori-infected patients with bleeding peptic ulcers were randomized into either an omeprazole group or a ranitidine group, receiving intravenous omeprazole or ranitidine for 3 days after endoscopy. Afterwards, 1-week triple therapy was used to eradicate H. pylori for both groups. Six weeks later, either a 13C-urea breath test or follow-up endoscopy was performed to assess the success of H. pylori eradication. RESULTS: The rebleeding rate was lower in the omeprazole group vs. the ranitidine group (6% vs. 17%, P < 0.05). The H. pylori eradication rate was higher in the omeprazole group (intention-to-treat analysis: 83% vs. 66%, P < 0.05; per protocol analysis: 93% vs. 80%, P < 0.05). For patients with duodenal ulcers, the per protocol H. pylori eradication rate of the omeprazole group was higher than that of the ranitidine group (93% vs. 73%, P < 0.05). CONCLUSIONS: Intravenous omeprazole can decrease the risk of rebleeding of peptic ulcers. For duodenal ulcers, in particular, intravenous omeprazole may even improve the H. pylori eradication rate of the subsequent triple therapy.     

Therapeutic and cost effectiveness of proton pump inhibitor regimens for idiopathic or drug-induced peptic ulcer complication

Peptic ulcer (PU) disease has a high rate of occurrence and recurrence in Korean and the selection of drug for treatment is diverse. In this study, the therapeutical effectiveness of regimens including proton pump inhibitors (PPI) was compared with the single PPI therapy. The clinical data were collected from 1,658 patients having idiopathic or drug-induced PU complication from a Medical Center in Daegu, Korea, and analyzed retrospectively based on the results of endoscopic examination, the drug history and the therapeutic cost depending on drugs used. The comparison of complete healing rate and recurrence rate showed no significant differences between the single PPI groups and the combination group with antacids, prokinetic agent or mucosa protectants. However, the combination therapy of PPI with mucosa protectants gave a slightly better therapeutic outcome than single PPI treatment in gastric ulcer patients. Comparatively, the combination of PPI with antacids significantly reduced the therapeutic effectiveness in duodenal ulcer patients. The analysis of cost-based therapeutic effectiveness reveals that any economic benefits in PU treatment were not gained by the combination of other class of ulcer drugs. Even though the rapidity of healing rate was not considered, it can be concluded that the PPI combination therapy might be not desirable in PU treatment. Particularly triplet or quartet combination therapy in PPI regimen was absolutely economically ineffective therapy in spite of the increase of medication costs.     

Factors associated with non-response in proton pump inhibitor users: a study of lansoprazole therapy

Background: Proton pump inhibitors (PPI) demonstrate high healing rates of 8598% in clinical trials. Due to the limited knowledge regarding response and nonresponse to lansoprazole in daily practice and for the reason that resistance to PPIs is scarce, we investigated factors possibly associated with nonresponse. Methods: Data were used from a prospective, open label, observational followup study in which 10,008 lansoprazole users were followed over time. The study was designed according to the SAMM guidelines. A matched nested casecontrol design was used to compare nonresponding (cases) and responding (controls) lansoprazole users. Nonresponse was defined as worsening or nonimprovement of symptoms at the first evaluation after at least 8 weeks of use, response as disappearance or improvement of symptoms within 8 weeks of use. Controls were matched for the evaluating physician.Results: A total of 186 nonresponders and 372 responders to PPI treatment were identified as cases and controls. Age of over 60 years, heavy smoking and previous use of PPIs were significantly more common in nonresponding patients compared with responding patients. There were no differences found between the reported diagnosis regarding response. Conclusion: In daily clinical practice, previous use of PPIs, heavy smoking and an age > 60 years were significantly associated with nonresponse to treatment with lansoprazole. Previous use of PPIs in nonresponding patients might suggest resistance to PPIs. The knowledge that nonresponse drives nonresponse may encourage physicians to follow PPI users with previous PPI use more closely.     

胃镜下注射治疗消化性溃疡并急性上消化道出血的疗效分析

目的 探讨胃镜下注射治疗消化性溃疡并急性上消化道出血的疗效.方法 收集我院2013年4月至2015年4月入院的100例消化性溃疡并急性上消化道出血患者随机分为两组.对照组患者给予胃镜下病灶处药物喷洒治疗,实验组患者给予胃镜下病灶处药物注射治疗.比较两组患者治疗前后血红蛋白含量、总体治疗效果评价、相关临床指标与不良反应.结果 实验组患者治疗后Hb水平(108.56±19.77) g/L显著高于对照组(96.17±15.89) g/L,差异有统计学意义(P＜0.01).实验组患者治疗总有效率(96％)明显高于对照组(84％),差异有统计学意义(P＜0.05).实验组患者止血时间(4.58±1.22)d、住院时间(8.76±3.25)d与大便频繁发生率0％、血压紊乱发生率0％显著低于对照组(8.46±3.09)d、(13.34±5.11)d、22％、12％,差异有统计学意义(P＜0.05).结论 胃镜下注射治疗消化性溃疡并急性上消化道出血的疗效显著,具有借鉴性.     

Pre-endoscopic proton pump inhibitor therapy reduces recurrent adverse gastrointestinal outcomes in patients with acute non-variceal upper gastrointestinal bleeding

BACKGROUND: Proton pump inhibitors (PPIs) following endoscopic haemostasis reduce rebleeding rates in patients with high-risk acute non-variceal upper gastrointestinal bleeding. Many advocate the use of PPIs prior to endoscopy, although its incremental benefit is unproven. AIM: To determine if providing PPIs before endoscopy reduces adverse gastrointestinal outcomes in acute non-variceal upper gastrointestinal bleeding patients. METHODS: We performed a retrospective review to identify patients presenting to two tertiary care centres with acute non-variceal upper gastrointestinal bleeding between 1999 and 2004. Subjects receiving PPI therapy before endoscopy were compared with those not receiving pre-endoscopic PPI therapy. The primary outcome measure was the development of any adverse bleeding outcome (rebleeding, surgery for control of bleeding, in-hospital mortality, readmission within 30 days for acute non-variceal upper gastrointestinal bleeding). RESULTS: 385 patients were included in our study [132 (12 intravenous/120 po) pre-endoscopic PPI vs. 253 no pre-endoscopic PPI]. Patients receiving pre-endoscopic PPI therapy were significantly less likely to develop adverse outcomes compared with those not given pre-endoscopic PPIs (25% vs. 13%, P = 0.005). Rebleeding, upper gastrointestinal surgery, mortality and length of hospital stay were also significantly lower in patients receiving pre-endoscopic PPI. CONCLUSIONS: The use of PPIs before endoscopy significantly reduces the risk of developing adverse gastrointestinal outcomes in patients with acute non-variceal upper gastrointestinal bleeding. Future studies are required to better characterize this relationship.     

某院急诊注射用质子泵抑制剂的临床应用分析

目的：对某院急诊注射用质子泵抑制剂（PPIs）的使用情况进行分析,为临床合理用药提供参考。方法：采用回顾性调查研究的方法,检索某院HIS,获取2015年7月份使用过注射用PPIs的急诊患者处方,依据SAHP（美国医院药师协会）指南及药品说明书对其临床应用进行合理性分析。结果：在1 754份处方中,统计结果显示某院急诊使用PPIs注射剂的临床诊断不符合使用指征占比24.7%,用法用量不合理的处方占比7.5%,联合用药不合理占比为1.7%,老年患者使用潘妥洛克日剂量超40 mg一项为5.4%,具有统计学意义,其合理性有待进一步讨论研究。结论：某院急诊科使用注射用质子泵抑制剂存在不合理现象。为减轻患者经济负担及降低用药风险,临床医生应规范诊疗行为,做到诊断与用药相适应,杜绝无正当理由超适应证用药;可通过处方点评或信息系统引导用药等干预措施来改善目前的用药现状。     

反流性食管炎质子泵抑制剂治疗失败 51例分析

目的探讨反流性食管炎病人质子泵抑制剂治疗后失败的危险因素。方法回顾性分析重庆市大足区人民医院 2018年 4月至 2020年 4月 205例接受质子泵抑制剂治疗反流性食管炎病人临床资料,并依据治疗结果分为治疗成功组(胃镜检查食管黏膜完全愈合, 154例)、治疗失败组(胃镜检查食管黏膜愈合不完全或复发, 51例)。所有病人入院后给予奥美拉唑(质子泵抑制剂)或奥美拉唑联合莫沙必利(胃动力)治疗。统计并对比两组性别、年龄、民族、体质量指数( BMI)、是否吸烟、是否饮酒、家族史、是否焦虑、是否抑郁、治疗时间、是否幽门螺旋杆菌( Hp)感染、用药方式、疾病严重程度差异。再将两组有差异的信息纳入多因素 logistic回归分析模型,行量化赋值,以治疗结果为因变量(Y,失败 =1,成功 =0),明确反流性食管炎病人经质子泵抑制剂治疗后失败的危险因素。结果两组性别、年龄、民族、家族史、治疗时间、 Hp感染对比差异无统计学意义( P>     

Cost-effectiveness in Canada of intravenous proton pump inhibitors for all patients presenting with acute upper gastrointestinal bleeding

BACKGROUND: The administration of proton pump inhibitors intravenously after endoscopic treatment of peptic ulcers significantly reduces the recurrence of bleeding. AIM: To evaluate the incremental cost-effectiveness in Canada of intravenous proton pump inhibitor before endoscopic therapy to patients presenting with acute upper gastrointestinal bleeding, compared with endoscopic treatment alone. METHODS: From a third-party payer perspective, we modelled the costs and effectiveness over 60 days of the two approaches using decision analysis. The probabilities of various outcomes, such as re-bleeding and the need for surgery, were taken from the published literature. We included the costs of intravenous proton pump inhibitor, therapeutic endoscopy, surgical procedures and hospitalizations, all expressed in 2001 Canadian dollars. RESULTS: In a hypothetical cohort of 1000 patients, the intravenous proton pump inhibitor approach resulted in mean savings of 20,700 Canadian dollars with 37 re-bleeding episodes averted. The investigation of uncertainty resulted in a likelihood of intravenous proton pump inhibitor being cost-effective of at least 0.73. CONCLUSION: It is common in Canada to administer intravenous proton pump inhibitors to patients with upper gastrointestinal bleeding even before endoscopic confirmation of bleeding peptic ulcers. Our results suggest that this approach has a high likelihood of being cost-effective.     

胃镜下注射去甲肾上腺素联合常规三联疗法治疗消化性溃疡并消化道出血疗效观察

目的观察胃镜下注射去甲肾上腺素联合奥美拉唑、克拉霉素及甲硝唑等三联疗法治疗消化性溃疡并消化道出血的临床疗效及安全性。方法在知情同意情况下,84例消化性溃疡并消化道出血患者按数字表法随机分为观察组和对照组各42例,对照组予奥美拉唑、克拉霉素及甲硝唑等三联疗法,配合常规止血药物治疗;观察组在对照组的基础上在胃镜下于胃黏膜出血点处注射去甲。肾上腺素治疗,观察两组治疗总有效率及不良反应发生情况。结果观察组显效36例、有效5例、无效1例、总有效率97．6％,对照组分别为21例、16例、5例、88．1％,两组总有效率差异有统计学意义（X^2=5．137,P〈0．05）,两组均未发生严重不良反应。结论胃镜下注射去甲。肾上腺素联合常规三联疗法治疗消化性溃疡并消化道出血疗效显著,不良反应。