Efficacy and Safety of IV albumin for non-spontaneous bacterial peritonitis infection among patients with cirrhosis: A systematic review and meta-analysis
Dig Liver Dis. 2020
Efficacy and Safety of intravenous albumin for non-spontaneous bacterial peritonitis infection among patients with cirrhosis: A systematic review and meta-analysis of randomized controlled trials INTRODUCTION Bacterial infection is a common cause of acute-on-chronic liver failure (ACLF) and death among cirrhosis. The benefit of intravenous (IV) albumin among cirrhosis with non-SBP infection remains unclear as individual studies are underpowered to detect the survival benefit of IV albumin. AIM: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of intravenous albumin for non-SBP infection among cirrhosis patients. METHODS We performed a systematic search of electronic databases (Pubmed, MEDLINE and Clinicalkey) up to 1(st) December 2019. Studies evaluating IV albumin for non-SBP infection were selected. Using random effect model, the pooled odds ratio (OR), 95% confidence interval (95%CI) and heterogeneity were assessed. RESULTS A total of 3 RCTs (406 subjects) fulfilling the inclusion criteria among 218 citations were identified. There was no significant heterogeneity across included studies. In this meta-analysis, we found that the pooled risk of renal impairment (RI) (OR=0.58, 95%CI: 0.28-1.23, I(2)=0%), mortality at 30 days (OR=1.61, 95%CI: 0.87-3.00, I(2)=0%) as well as mortality at 90 days (OR=1.30, 95%CI: 0.81-2.07, I(2)=0%) were similar between albumin and control group. Pooled event of pulmonary edema occurred more commonly in albumin group (OR 5.17, 95%CI 1.62-16.47, I(2)=0%). More subjects achieved resolution of ACLF in IV albumin group as compared to control group (OR=0.11, 95%CI: 0.02-0.69, p=0.02). CONCLUSION Albumin did not reduce the risk of RI and mortality, yet increases the risk of pulmonary edema. Albumin may promote recovery of ACLF, however, more data is required to validate this benefit.
Strategies to Optimize Anti-tumor Necrosis Factor Therapy for Perianal Fistulizing Crohn's Disease: A Systematic Review
Digestive diseases and sciences. 2019
Tumor necrosis factor (TNF) antagonists are considered the cornerstone therapy for fistulizing perianal Crohn's disease (PCD), yet a substantial proportion of patients fail to achieve healing. Therefore, we reviewed the evidence for strategies to enhance the efficacy of TNF antagonists for PCD. A systematic search of electronic databases through July 2018 was performed to identify studies that assessed the effectiveness of TNF antagonists combined with another medical or surgical intervention for PCD; or assessed the association between anti-TNF serum concentrations and fistula healing. Twelve studies compared anti-TNF therapy alone versus a combined approach: four with surgery, three with antibiotics, and five with immunomodulators. Only two studies, both with antibiotics, were rated high quality. The addition of antibiotics to anti-TNF therapy resulted in significantly higher rates of fistula response and healing in one study, and a trend toward reduction in fistula drainage in the other. Three of four studies found higher rates of fistula healing when surgery was combined with TNF antagonists. In contrast, one of five studies found a trend toward higher rates of fistula healing in patients treated concomitantly with immunomodulators. Five observational studies assessed the association between anti-TNF concentration and fistula healing. Higher infliximab serum concentrations were consistently associated with fistula healing. In conclusion, few high-quality studies assessing strategies to optimize anti-TNF therapy for PCD exist. Although antibiotics, possibly surgery, and higher serum infliximab concentrations appear to improve fistula healing, future prospective studies are needed to determine the optimal treatment strategy.
Four-factor prothrombin complex concentrate reduces time to procedure in vitamin K antagonist-treated patients experiencing gastrointestinal bleeding: a post hoc analysis of two randomized controlled trials
Emergency Medicine International. 2017;2017:8024356.
INTRODUCTION To investigate the impact of a 4-factor prothrombin complex concentrate (4F-PCC [Beriplex(R)/Kcentra(R)]) versus plasma on "time to procedure" in patients with acute/severe gastrointestinal bleeding requiring rapid vitamin K antagonist (VKA) reversal prior to invasive procedure. METHODS A post hoc analysis of two phase III trials of 4F-PCC versus plasma in patients with acute/severe gastrointestinal bleeding. The treatment arms were compared for study treatment volume, infusion times, and time from start of study treatment to procedure. RESULTS Analysis included 42 patients (plasma, n = 20; 4F-PCC, n = 22). Median (interquartile range) infusion time was significantly shorter for the 4F-PCC group than for the plasma group (16 [13, 26] min versus 210 [149, 393] min; P < 0.0001). Median infusion volumes were significantly smaller (103 [80, 130] mL versus 870 [748, 1001] mL; P < 0.0001) and median time from study treatment initiation to first procedure was significantly shorter in the 4F-PCC group than in the plasma group (17.5 [12.8, 22.8] versus 23.9 [18.5, 62.0] h; P = 0.037). CONCLUSIONS In this analysis of patients with acute/severe gastrointestinal bleeding requiring urgent VKA reversal prior to an invasive procedure, 4F-PCC (compared with plasma) was associated with smaller infusion volumes, shorter infusion times, and reduced time to procedure.
A double-blind, placebo-controlled trial of oral human immunoglobulin for gastrointestinal dysfunction in children with autistic disorder
Journal of Autism and Developmental Disorders. 2009;39((5):):796-805.
Controversy exists regarding the extent and possible causal relationship between gastrointestinal symptoms and autism. A randomized, double-blind, placebo-controlled, parallel groups, dose-ranging study of oral, human immunoglobulin (IGOH 140, 420, or 840 mg/day) was utilized with 125 children (ages 2-17 years) with autism and persistent GI symptoms. Endpoint analysis revealed no significant differences across treatment groups on a modified global improvement scale (validated in irritable bowel syndrome studies), number of daily bowel movements, days of constipation, or severity of problem behaviors. IGOH was well-tolerated; there were no serious adverse events. This study demonstrates the importance of conducting rigorous trials in children with autism and casts doubt on one GI mechanism presumed to exert etiological and/or symptomatic effects in this population.
Lack of clinical efficacy of additional factor XIII treatment in patients with steroid refractory colitis. The Factor XIII Study Group
Zeitschrift fur Gastroenterologie. 1999;37((10):):999-1004.
Patients with active ulcerative colitis have decreased levels of factor XIII (FXIII) activity, which is important for woundhealing. Recent uncontrolled studies claimed a beneficial effect of Factor XIII on clinical symptoms of ulcerative colitis, in particular intestinal bleeding. The objective of this trial was to evaluate the benefits of additional FXIII treatment in steroid-refractory patients with ulcerative colitis in a prospective, double blind, placebo-controlled study. A total of 28 patients were enrolled between October 1994 and January 1997. Primary objective of this study was the time until cessation of visible intestinal bleeding with 14 days after the start of treatment. Patients were treated for ten days either by i.v. application of FXIII concentrate or by placebo. The analysis of the primary efficacy criterion, cessation of intestinal bleeding, by a planned interim analysis showed no significant differences between the treatment groups (p = 0.8). This resulted in the termination of the study. The same applied to the CAI score. No patient in both treatment groups reached remission according to the colo-/-sigmoidoscopy score. Due to the high number of patients (16 of 28) who had to be excluded from the per-protocol analysis (e.g. changes to the concomitant medication) only the intention-to-treat population was analyzed. Overall the study showed no beneficial effect of additional FXIII treatment on active steroid-refractory ulcerative colitis. These results do not confirm previous open label studies which had reported a significant improvement of clinical symptoms.
Evaluation of using fibrin tissue adhesive (Beriplast) and preparations of thrombin and adrenalin in injection hemostasis methods for gastric and duodenal ulcer hemorrhage. Randomized, prospective clinical trial Polish
Wiadomosci Lekarskie. 1997;50((Suppl 1, Pt 2):):383-7.
A prospective randomized trial involving 30 patients was performed to assess whether second-look endoscopy could improve the efficacy of injection therapy for bleeding peptic ulcers. The inclusion criteria were the presence of active arterial bleeding or a non-bleeding visible vessel at emergency endoscopy. All the patients received emergency injection of thrombin with adrenaline solution and were subsequently randomized (15 patients in each group). All the patients receive a second elective endoscopy within the first 24 hours with repeated injection of thrombin-adrenaline solution (Group I) or fibrin sealant-Beriplast-(Group II). A tendency towards better results was noted in the Group II. Recurrent bleeding was observed in 6.6% versus 26.6% patients in Group I. The need for emergency surgery occurred in (6.6% in Group I versus 0 in Group II) and length of hospital stay was (13.2 in Group I versus 7.4 in Group II [p < 0.05]). No mortality was observed in both of the groups. In conclusion, our data suggest the possibility of a small benefit with second-look endoscopy with repeated injection of fibrin sealant.
Injection of fibrin tissue adhesive versus laser photocoagulation in the treatment of high-risk bleeding peptic ulcers: a controlled randomized study
Gastrointestinal Endoscopy. 1997;46((2):):198-9.
Randomized trial of fibrin tissue glue for low output enterocutaneous fistula
British Journal of Surgery. 1996;83((1):):112.
Endoscopic hemostasis in bleeding gastroduodenal ulcer--a contribution to the cost aspect . German
Zentralblatt f³r Chirurgie. 1996;121((10):):847-50.
Endoscopic injections of fibrin glue for the treatment of gastroduodenal ulcer hemorrhage have been increasingly used instead of sclerosing agents since 1987. Sclerosants have the drawback that they themselves have tissue-destroying or rather ulcerogenic effects. A difficult form of administration and a relatively high price are set against the good biological properties of the fibrin glue. In a randomized study comparing fibrin glue with polidocanol there was a statistically significant lower rebleeding rate in the fibrin group. The data of this study were analysed with regard to economic aspects. They showed an improved cost-benefit and cost-effectiveness ratio of the fibrin glue compared with polidocanol.
Oral immunoglobulins for treatment of acute rotaviral gastroenteritis
OBJECTIVE Preliminary evidence has been reported on the antirotavirus effect of human serum immunoglobulin administered orally. The aim was to see whether such treatment might be effective in rotavirus acute gastroenteritis. METHODS A prospective, double-blind, placebo-controlled study was performed. Ninety-eight children admitted with acute gastroenteritis were enrolled and randomly assigned to groups A (treated) and B (control). Children in group A received a single oral dose of 300 mg/kg body weight of human serum immunoglobulin. Parameters of efficacy were clinical condition, frequency and consistency of stools, duration of diarrhea, duration of viral excretion, and length of hospital stay. Antirotaviral activity was determined in the immunoglobulin preparation by a specific neutralization assay. RESULTS Seventy-one of the 98 children enrolled had rotaviral gastroenteritis; 36 belonged to group A. Children who received immunoglobulin had significantly faster clinical improvement of clinical condition and stool pattern than control children. Mean total duration of rotaviral diarrhea was 76 hours in group A and 131 in group B (P < .01). Viral excretion lasted 114 and 180 hours, respectively (P < .01). Hospital stay was significantly reduced in children in group A. Neutralizing antibodies against rotavirus were detected in the immunoglobulin preparation. CONCLUSION Oral administration of immunoglobulin is associated with a faster recovery from acute gastroenteritis and should be given to children hospitalized with this illness.