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Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding
Kanno T, Yuan Y, Tse F, Howden CW, Moayyedi P, Leontiadis GI
The Cochrane database of systematic reviews. 2022;1:Cd005415
Abstract
BACKGROUND Upper gastrointestinal (GI) bleeding is a common reason for emergency hospital admission. Proton pump inhibitors (PPIs) reduce gastric acid production and are used to manage upper GI bleeding. However, there is conflicting evidence regarding the clinical efficacy of proton pump inhibitors initiated before endoscopy in people with upper gastrointestinal bleeding. OBJECTIVES To assess the effects of PPI treatment initiated prior to endoscopy in people with acute upper GI bleeding. SEARCH METHODS We searched the CENTRAL, MEDLINE, Embase and CINAHL databases and major conference proceedings to October 2008, for the previous versions of this review, and in April 2018, October 2019, and 3 June 2021 for this update. We also contacted experts in the field and searched trial registries and references of trials for any additional trials. SELECTION CRITERIA We selected randomised controlled trials (RCTs) that compared treatment with a PPI (oral or intravenous) versus control treatment with either placebo, histamine-2 receptor antagonist (H(2)RA) or no treatment, prior to endoscopy in hospitalised people with uninvestigated upper GI bleeding. DATA COLLECTION AND ANALYSIS At least two review authors independently assessed study eligibility, extracted study data and assessed risk of bias. Outcomes assessed at 30 days were: mortality (our primary outcome), rebleeding, surgery, high-risk stigmata of recent haemorrhage (active bleeding, non-bleeding visible vessel or adherent clot) at index endoscopy, endoscopic haemostatic treatment at index endoscopy, time to discharge, blood transfusion requirements and adverse effects. We used standard methodological procedures expected by Cochrane. MAIN RESULTS We included six RCTs comprising 2223 participants. No new studies have been published after the literature search performed in 2008 for the previous version of this review. Of the included studies, we considered one to be at low risk of bias, two to be at unclear risk of bias, and three at high risk of bias. Our meta-analyses suggest that pre-endoscopic PPI use may not reduce mortality (OR 1.14, 95% CI 0.76 to 1.70; 5 studies; low-certainty evidence), and may reduce rebleeding (OR 0.81, 95% CI 0.62 to 1.06; 5 studies; low-certainty evidence). In addition, pre-endoscopic PPI use may not reduce the need for surgery (OR 0.91, 95% CI 0.65 to 1.26; 6 studies; low-certainty evidence), and may not reduce the proportion of participants with high-risk stigmata of recent haemorrhage at index endoscopy (OR 0.80, 95% CI 0.52 to 1.21; 4 studies; low-certainty evidence). Pre-endoscopic PPI use likely reduces the need for endoscopic haemostatic treatment at index endoscopy (OR 0.68, 95% CI 0.50 to 0.93; 3 studies; moderate-certainty evidence). There were insufficient data to determine the effect of pre-endoscopic PPI use on blood transfusions (2 studies; meta-analysis not possible; very low-certainty evidence) and time to discharge (1 study; very low-certainty evidence). There was no substantial heterogeneity amongst trials in any analysis. AUTHORS' CONCLUSIONS There is moderate-certainty evidence that PPI treatment initiated before endoscopy for upper GI bleeding likely reduces the requirement for endoscopic haemostatic treatment at index endoscopy. However, there is insufficient evidence to conclude whether pre-endoscopic PPI treatment increases, reduces or has no effect on other clinical outcomes, including mortality, rebleeding and need for surgery. Further well-designed RCTs that conform to current standards for endoscopic haemostatic treatment and appropriate co-interventions, and that ensure high-dose PPIs are only given to people who received endoscopic haemostatic treatment, regardless of initial randomisation, are warranted. However, as it may be unrealistic to achieve the optimal information size, pragmatic multicentre trials may provide valuable evidence on this topic.
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Clinical characteristics and treatment of terlipressin-induced ischemic skin necrosis: A synthesis of 35 literature reported cases
Zhou Y, Zeng J, Song L, Wang C
Journal of clinical pharmacy and therapeutics. 2022
Abstract
WHAT IS KNOWN AND OBJECTIVE The clinical features of terlipressin-induced ischemic skin necrosis are unknown. The purpose of this study is to explore the clinical features of terlipressin-induced skin necrosis. METHODS We searched Chinese and English databases to collect case reports of terlipressin-induced skin necrosis for retrospective analysis. RESULTS AND DISCUSSION A total of 42 patients (31 males and 11 females) from 35 studies were included, with a median age of 54 years (range 0.17-84). The onset of skin ischemia ranged from a few hours to 21 days. The most common clinical manifestations were bulla (15 cases, 35.7%), cyanosis (12 cases, 28.6%), necrosis (11 cases, 26.2%), and purpura (10 cases, 23.8%). The following were often affected: the legs (26 cases), 61.9%), abdomen (13, 31.0%), scrotum (10 cases, 23.8%), feet (10 cases, 23.8%), upper extremities (8 cases, 19.0%), and hands (7 cases, 16.7%). Skin biopsy showed fibrin thrombus (7 cases, 38.9%), nonspecific inflammation (6 cases, 33.3%), and necrosis (10 cases, 55.6%). After discontinuation of terlipressin, skin symptoms improved in most patients. WHAT IS NEW AND CONCLUSION Ischemic skin necrosis is a rare and serious adverse effect of terlipressin. Patients receiving terlipressin therapy should be monitored closely for terlipressin-related ischemic complications. Terlipressin should be discontinued immediately if ischemic complications occur.
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Vonoprazan vs proton pump inhibitors in treating post-endoscopic submucosal dissection ulcers and preventing bleeding: A meta-analysis of randomized controlled trials and observational studies
Martin BS, Zhou Y, Meng CX, Takagi T, Tian YS
Medicine. 2020;99(9):e19357
Abstract
BACKGROUND Vonoprazan is a potassium-competitive acid blocker (P-CAB) that is frequently used in Japan for Helicobacter pylori (H. pylori) eradication, treatment of gastroesophageal reflux disease, and treatment of post endoscopic submucosal dissection (ESD) complications. We sought to determine if vonoprazan was superior to proton pump inhibitors (PPIs) for treating ESD-induced ulcers (as assessed by ulcer healing and shrinkage ratios) and preventing delayed bleeding over various treatment durations (2, 4, and 8 weeks). METHODS We collected randomized controlled trials (RCTs) and observational studies that discussed the effectiveness of vonoprazan and PPIs on ESD-induced ulcers and bleeding from PubMed, Cochrane Library, ClinicalTrials.gov, and Google Scholar. Studies were selected according to pre-established eligibility criteria and data were extracted separately by 2 researchers with double-check. We used the Cochrane risk of bias tool to assess RCTs and the Newcastle-Ottawa Quality Assessment Scale to assess observational studies. Meta-analyses, based on the random-effects model, were conducted to compare differences in ulcer shrinkage ratios (%) and odds ratios (ORs) for ulcer healing and delayed bleeding. Publication bias was evaluated using funnel plots and Egger regression test. Heterogeneity was assessed using I statistics. A sensitivity analysis was conducted to check the robustness of results. The evidential quality of the findings was assessed using the GRADE profiler. RESULTS Thirteen studies were included in this meta-analysis. The OR effect sizes of vonoprazan relative to PPIs for ulcer healing were 1.33 (P = .13) with a 95% CI (0.33-3.21) at 4 weeks and 1.48 (P = .09) with a 95% CI (0.81-5.20) at 8 weeks. The overall effect size for the shrinkage ratio was 12.24% (P = .16) with a 95% CI (-4.96-29.44) at 2 weeks. The effect size of its subgroup of H. pylori-positive patients was 19.51% (P < .001) with a 95% CI (11.91-27.12). The overall OR for the occurrence of delayed bleeding was 0.66 (P = .26) with a 95% CI (0.32-1.35). After excluding combination drug studies, the overall ORs between vonoprazan and PPIs on ulcer healing and delayed bleeding were 1.44 and 0.76, respectively. CONCLUSION During the first 2 weeks of treatment, vonoprazan was more effective than PPIs for treating H. pylori-positive patients with ESD-induced gastric ulcers.
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Histamine2-Receptor Antagonists, Proton Pump Inhibitors, or Potassium-Competitive Acid Blockers Preventing Delayed Bleeding After Endoscopic Submucosal Dissection: A Meta-Analysis
Jiang X, Li J, Xie J, Liang Z, Wan N, Jiang J, Zhang T, Wu Y
Frontiers in pharmacology. 2019;10:1055
Abstract
Background: Endoscopic submucosal dissection (ESD) was commonly used for en bloc resection in gastric cancer and adenoma with the risk of delayed bleeding after ESD. We conducted a direct and indirect comparison meta-analysis to evaluate the best choice in preventing post-ESD bleeding among proton pump inhibitors (PPIs), histamine2-receptor antagonists (H2RAs), and the most widely used potassium-competitive acid blocker, vonoprazan. Methods: The Pubmed, Cochrane Library, and Embase were searched for randomized trials. We pooled odds ratios (OR) for preventing post-ESD bleeding using meta-analysis. Results: Sixteen randomized trials met the inclusion criteria including 2,062 patients. Direct comparisons showed slightly significant efficacy in PPIs rather than H2RAs in preventing post-ESD bleeding [OR: 1.83; 95% confidence interval (CI): 1.10 to 3.05] and vonoprazan was better than PPIs (OR: 0.46; 95% CI: 0.25 to 0.86). The adjusted indirect comparison indicated vonoprazan was superior to H2RAs (OR: 0.30, 95% CI: 0.12 to 0.74). In subgroup analysis, PPIs had similar efficacy as H2RAs in 4 weeks, while PPIs were better than H2RAs in 8 weeks' treatment (OR: 1.91; 95% CI: 1.08 to 3.40). The superiority of vonoprazan than PPIs was more significant in combination therapy (OR: 0.18; 95% CI: 0.04 to 0.69). There was a significant difference in vonoprazan for 8 weeks of medication (OR: 0.44; 95% CI: 0.21 to 0.92). Conclusions: The effects of vonoprazan is better than PPIs than H2RAs in preventing bleeding after ESD. When vonoprazan combined with mucosal protective antiulcer drug in treatment or used in 8 weeks of medication, the efficacy may be even better.
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High-dose vs. low-dose proton pump inhibitors post-endoscopic hemostasis in patients with bleeding peptic ulcer. A meta-analysis and meta-regression analysis
Sgourakis G, Chatzidakis G, Poulou A, Malliou P, Argyropoulos T, Ravanis G, Vagia A, Kpogho I, Briki, Tsuruhara H, et al
The Turkish Journal of Gastroenterology : the Official Journal of Turkish Society of Gastroenterology. 2018;29((1)):22-31.
Abstract
BACKGROUND/AIMS: Present meta-analysis aims to evaluate studies of low- versus high-dose proton pump Inhibitors (PPI) post-endoscopic hemostasis, including the newly published randomized controlled trials (RCTs) and to conclude whether low-dose PPI can generate the comparable results as high-dose PPI. MATERIALS AND METHODS To identify suitable trials, the electronic databases PubMed, Medline, Cochrane Library, and the Embase were used. All RCTs concerning low- versus high-dose PPI administration post-endoscopic hemostasis published until December 2016 were identified. Primary outcomes were rebleeding rates, need for surgical intervention, and mortality. RESULTS Studies included a total of 1.651 participants. There were significantly less cases of rebleeding in the low-dose PPI treatment arm (p=0.003). All but one study provided data concerning need for Surgical Intervention and Mortality. The respective effect sizes were [odds ratio (OR), 95% confidence intervals (CI): 1.35, 0.72-2.53] and [OR, 95% CI: 1.20, 0.70-2.05]. Both treatment arms were comparable considering the aforementioned outcomes (p=0.35 and p=0.51, respectively). Meta-regression analysis likewise unveiled comparable outcomes between studies using pantoprazole versus lansoprazole concerning all three outcomes [rebleeding (p=0.944), surgical intervention (p=0.884), and mortality (p=0.961)]. CONCLUSION A low-dose PPI treatment is equally effective as a high-dose PPI treatment following endoscopic arresting of bleeding. However, we anticipate the completion of more high-quality RCTs that will embrace distinct ethnicities, standardized endoscopic diagnosis and management, double-blind strategies, and appraisal of results working specific standards over clear-cut follow-up periods.
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Effects of preoperative proton pump inhibitor administration on bleeding after gastric endoscopic submucosal dissection: A systematic review and meta-analysis
Nishizawa, T., Suzuki, H., Akimoto, T., Maehata, T., Morizane, T., Kanai, T., Yahagi, N.
United European Gastroenterology Journal. 2016;4(1):5-10
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Abstract
BACKGROUND AND AIM The efficacy of using proton pump inhibitors (PPIs) prior to gastric endoscopic submucosal dissection (ESD) to reduce gastric bleeding remains controversial. This study aimed to systematically review the literature to evaluate the efficacy of preoperative PPI use to reduce post-ESD bleeding. METHODS PubMed, the Cochrane library, and the Igaku-Chuo-Zasshi database were searched to identify randomized trials eligible for inclusion in the systematic review. Data from four studies (406 patients) were combined to calculate a pooled risk difference (RD) for developing post-ESD bleeding. RESULTS Compared with patients who received no premedication, the pooled RD for post-ESD bleeding in patients who received preoperavive PPI was -0.027 (95% confidence interval: -0.070-0.017, p = 0.228), without significant heterogeneity. Preoperavive PPI use significantly increased gastric pH (weighted mean difference: 1.289, 95% CI: 0.227-2.352, p = 0.0174). CONCLUSIONS This systematic review and meta-analysis showed that premedication with PPI had no advantage for the prevention of post-ESD bleeding, despite increasing gastric pH.