The role of refined nursing combined with targeted nursing in patients with digestive tract hemorrhages complicated by liver cirrhosis
American journal of translational research. 2021;13(5):5336-5342
OBJECTIVE To explore the effect of refined nursing combined with targeted nursing on patients with gastrointestinal bleeding complicated by liver cirrhosis. METHODS 128 patients with gastrointestinal bleeding and liver cirrhosis admitted to our hospital from April 2018 to April 2019 were recruited as the study cohort and were randomly divided into a control group and an experimental group with 64 patients in each group. The patients in the control group underwent conventional nursing, and the experimental group underwent refined nursing combined with targeted nursing. The two groups' clinical efficacy, complication rates, psychological states, prognoses, quality of life, and nursing satisfaction were statistically analyzed. RESULTS The clinical curative effect, prognosis complication rate, psychological state scores, quality of life scores, and nursing satisfaction in the experimental group were significantly better than they were in the control group (P<0.05). CONCLUSION Refined nursing combined with targeted nursing has a more significant clinical effect than the conventional nursing mode due to its strengths in improving patients' prognoses, psychological states, and quality of life, and reducing the incidence of complications, improving the patients' nursing satisfaction, and establishing good doctor-patient relationships.
Tranexamic acid for acute gastrointestinal bleeding (the HALT-IT trial): statistical analysis plan for an international, randomised, double-blind, placebo-controlled trial
BACKGROUND Acute gastrointestinal (GI) bleeding is an important cause of mortality worldwide. Bleeding can occur from the upper or lower GI tract, with upper GI bleeding accounting for most cases. The main causes include peptic ulcer/erosive mucosal disease, oesophageal varices and malignancy. The case fatality rate is around 10% for upper GI bleeding and 3% for lower GI bleeding. Rebleeding affects 5-40% of patients and is associated with a four-fold increased risk of death. Tranexamic acid (TXA) decreases bleeding and the need for blood transfusion in surgery and reduces death due to bleeding in patients with trauma and postpartum haemorrhage. It reduces bleeding by inhibiting the breakdown of fibrin clots by plasmin. Due to the methodological weaknesses and small size of the existing trials, the effectiveness and safety of TXA in GI bleeding is uncertain. The Haemorrhage ALleviation with Tranexamic acid - Intestinal system (HALT-IT) trial aims to provide reliable evidence about the effects of TXA in acute upper and lower GI bleeding. METHODS The HALT-IT trial is an international, randomised, double-blind, placebo-controlled trial of tranexamic acid in 12,000 adults (increased from 8000) with acute upper or lower GI bleeding. Eligible patients are randomly allocated to receive TXA (1-g loading dose followed by 3-g maintenance dose over 24 h) or matching placebo. The main analysis will compare those randomised to TXA with those randomised to placebo on an intention-to-treat basis, presenting the results as effect estimates (relative risks) and confidence intervals. The primary outcome is death due to bleeding within 5 days of randomisation and secondary outcomes are: rebleeding; all-cause and cause-specific mortality; thromboembolic events; complications; endoscopic, radiological and surgical interventions; blood transfusion requirements; disability (defined by a measure of patient's self-care capacity); and number of days spent in intensive care or high-dependency units. Subgroup analyses for the primary outcome will consider time to treatment, location of bleeding, cause of bleed and clinical Rockall score. DISCUSSION We present the statistical analysis of the HALT-IT trial. This plan was published before the treatment allocation was unblinded. TRIAL REGISTRATION Current Controlled Trials, ID: ISRCTN11225767. Registered on 3 July 2012; Clinicaltrials.gov, ID: NCT01658124. Registered on 26 July 2012.
Effects of Burdock tea on recurrence of colonic diverticulitis and diverticular bleeding: An open-labelled randomized clinical trial
Scientific reports. 2019;9(1):6793
Colonic diverticular bleeding (CDB) and acute colonic diverticulitis (ACD) show high recurrence rates. The establishment of optimal strategies that prevent the recurrence of CDB and ACD is a major concern among gastroenterologists. This study aimed to assess the efficacy of burdock tea for preventing CDB and ACD recurrences. Newly diagnosed patients with CDB (n = 91) or ACD (n = 70) were randomly assigned into two groups. The experimental group received 1.5 g of burdock tea three times a day, whereas the control group did not receive any treatment. The median (interquartile range) of observation for recurrence of CDB or ACD was 22.0 (14.1) months and 30.3 (18.6), respectively. The burdock tea treatment showed significant preventive effects on recurrence of ACD. A lower ACD recurrence rate (5/47 [10.6%] vs. 14/44 [31.8%]) and longer recurrence-free duration was observed in the burdock tea group (59.3 months [95% CI: 54.0-64.7] vs. 45.1 months [95% CI: 37.1-53.0] by the Kaplan-Meier analysis; p = 0.012 by log rank test) than in the control group, although there was no significant preventive effects on the CDB recurrence. This randomized clinical trial demonstrated that daily intake of burdock tea could be an effective strategy for prevention of ACD recurrence, but not for CDB recurrence.
Randomised clinical trial: intravenous vs oral iron for the treatment of anaemia after acute gastrointestinal bleeding
Alimentary pharmacology & therapeutics. 2019
BACKGROUND Acute gastrointestinal bleeding is prevalent condition and iron deficiency anaemia is a common comorbidity, yet anaemia treatment guidelines for affected patients are lacking. AIM: To compare efficacy and safety of intravenous ferric carboxymaltose (FCM) and oral ferrous sulphate (FeSulf) in patients with anaemia secondary to non-variceal gastrointestinal bleeding METHODS A prospective 42-day study randomised 61 patients with haemoglobin <10 g/dL upon discharge (Day 0) to receive FCM (n = 29; Day 0: 1000 mg, Day 7: 500 or 1000 mg; per label) or FeSulf (n = 32; 325 mg/12 hours for 6 weeks). Outcome measures were assessed on Days 0 (baseline), 7, 21 and 42. The primary outcome was complete response (haemoglobin ≥12 g/dL [women], ≥13 g/dL [men]) after 6 weeks. RESULTS A higher proportion of complete response was observed in the FCM vs the FeSulf group at Days 21 (85.7% vs 45.2%; P = 0.001) and 42 (100% vs 61.3%; P < 0.001). Additionally, the percentage of patients with partial response (haemoglobin increment ≥2 g/dL from baseline) was significantly higher in the FCM vs the FeSulf group (Day 21:100% vs 67.7%; P = 0.001, Day 42:100% vs 74.2%; P = 0.003). At Day 42, normalisation of transferrin saturation to 25% or greater was observed in 76.9% of FCM vs 24.1% of FeSulf-treated patients (P < 0.001). No patient in the FCM group reported any adverse event vs 10 patients in the FeSulf group. CONCLUSION FCM provided greater and faster Hb increase and iron repletion, and was better tolerated than FeSulf in patients with iron deficiency anaemia secondary to non-variceal acute gastrointestinal bleeding.
Comparison of Oral versus Intravenous Proton Pump Inhibitors in Preventing Re-bleeding from Peptic Ulcer after Successful Endoscopic Therapy
Middle East journal of digestive diseases. 2018;10(4):236-241
BACKGROUND Proton pump inhibitors (PPIs) are now widely prescribed for the management of patients with acute upper gastrointestinal bleeding; although its optimal dose and route of administration has remained a controversial issue. The aim of this study was to assess the clinical effectiveness of high dose oral versus intravenous (IV) PPI after successful endoscopic therapy in patients with bleeding peptic ulcer disease. METHODS 178 patients with active upper gastrointestinal bleeding due to a peptic ulcer with stigmata of high risk for re-bleeding entered the study. After successful endoscopic hemostasis, they were randomized to receive either high dose oral pantoprazole (80 mg stat and 80 mg twice daily for 3 days) or high dose intravenous pantoprazole (80 mg IV infusion within 30 minutes and 8 mg per hour for 3 days). After the 3rd day, the patients in both groups received oral pantoprazole 40 mg twice daily for one month. The end points were comparing the rate of re-bleeding or mortality, and the need for blood transfusion or surgery during the first month between the two groups. RESULTS There were not significant statistical differences between the two groups in the volume of blood transfusion, mean duration of hospital stay, need to surgery, or mortality rates. However, the rates of re-bleeding were 2.3% (2:88) in the IV group and 3.3% (3:90) in the oral group (p = 0.6). CONCLUSION According to our findings, it seems that high dose oral PPI can be a good alternative to high dose IV PPI in patients with bleeding peptic ulcer who are at high risk of re-bleeding. Due to the lower cost and the availability of oral PPIs, their use can be economically much more affordable.
Comparison of the efficacy of intravenous tranexamic acid with and without topical administration versus placebo in urgent endoscopy rate for acute gastrointestinal bleeding: A double-blind randomized controlled trial
United European Gastroenterology Journal. 2018;6((1)):46-54.
Background: Tranexamic acid (TXA), a synthetic antifibrinolytic drug, is effective as a treatment for serious hemorrhage, including bleeding arising from major trauma and post-operative interventions. Significant acute gastrointestinal bleeding may have a poor outcome despite routine medical and endoscopic treatments. The aim of this study was to assess whether early intravenous and/or intravenous plus topical administration of TXA reduces the need for urgent endoscopy for acute gastrointestinal bleeding. Method: This double-blind randomized clinical trial included 410 patients with proven acute gastrointestinal bleeding. All patients received conventional therapy. The subjects were randomized to three groups: (A) 138 patients received intravenous TXA (1 g q6h); (B) 133 patients received topical TXA (1 g single dose by nasogastric tube) plus systemic TXA; and (C) 139 patients received a placebo (sodium chloride 0.9%) for 24 hours. Subgroup statistical analyses were conducted for urgent endoscopy, mortality, re-bleeding, blood transfusion, endoscopic and/or surgical intervention rates, and health status. Results: The time to endoscopy was significantly shorter in group C (15.58 +/- 7.994, p < 0.001). A need for urgent endoscopy was seen in 14.49%, 10.52%, and 30.21% of patients in groups A, B, and C, respectively (p < 0.001). No significant statistical differences were seen between treatment groups regarding mortality, re-bleeding, blood transfusion, and endoscopic and/or surgical intervention rates. No thromboembolic event was documented during the 1-week follow up. Conclusions: Our results showed that the antifibrinolytic properties of TXA can aid in changing an urgent endoscopy to an elective procedure, with better outcomes for both physicians and patients.
Efficacy and safety of pasireotide-LAR for the treatment of refractory bleeding due to gastrointestinal angiodysplasias: results of the ANGIOPAS multicenter phase II noncomparative prospective double-blinded randomized study
Therapeutic Advances in Gastroenterology. 2018;11
Background: Gastrointestinal angiodysplasias (GIADs) could be responsible for recurrent bleeding and severe anemia. Somatostatin analogs could reduce transfusion requirements in these patients but no randomized controlled study is available. The main objective of the ANGIOPAS phase II double-blinded randomized, noncomparative study was to assess the effectiveness of pasireotide-LAR in reducing transfusion requirements in patients with refractory GIADs bleeding. Methods: A total of 22 patients with transfusion requirements 6 units of packed red blood cells (pRBCs) during the 6 months prior to inclusion were randomized to receive pasireotide-LAR 60 mg (n = 10) or placebo (n = 12) every 28 days for 6 months. Patients were then followed for an additional 6 months after stopping treatment. Results: The pasireotide-LAR and placebo groups were equivalent for age, sex, comorbidities and transfusion requirement during the reference period (median 13 and 9.5 pRBCs). A 50 and 83% success rate (success defined as a decrease of at least 30% of transfused pRBCs) was observed in the pasireotide-LAR arm in the Intent to Treat (ITT) and per protocol (PP) analysis respectively. The need for transfusion during the intervention period was 3 pRBC units in the pasireotide-LAR group (range 0-26) and 11.5 pRBC units in the placebo group (range 0-23). Overall, three cases with glycemic control impairment were observed in the pasireotide-LAR group including one de novo diabetes. Conclusion: This double-blinded noncomparative randomized phase II study suggests, for the first time, the effectiveness of pasireotide-LAR 60 mg every 28 days to decrease the transfusion requirement in patients with recurrent bleeding due to GIADs.
Improved Hemoglobin Response with Ferric Carboxymaltose in Patients with Gastrointestinal-Related Iron-Deficiency Anemia Versus Oral Iron
Digestive Diseases and Sciences. 2018;63((11):):3009-3019.
AIMS: To compare the efficacy and safety of intravenous (IV) ferric carboxymaltose (FCM) versus oral iron and other IV iron therapies in patients with iron-deficiency anemia (IDA) resulting from gastrointestinal (GI) disorders. METHODS A pooled analysis of four prospective, randomized, active-controlled trials in patients with IDA was performed. Efficacy measures included change from baseline in hemoglobin (Hb), ferritin, and transferrin saturation (TSAT) and correlations of baseline Hb, ferritin, and TSAT to change in Hb. The incidence and type of adverse events were evaluated. RESULTS A total of 191 patients were evaluated. The mean change in Hb from baseline to the maximum value was 0.8 g/dL with oral iron (P = 0.001 vs. FCM), 2.2 g/dL with FCM, 2.0 g/dL with any IV iron (P = 0.391 vs. FCM), and 1.9 g/dL with iron sucrose (P = 0.329 vs. FCM). Patients treated with FCM and iron sucrose had larger increases in Hb. This effect may have been attributed to a lower baseline Hb level. Drug-related adverse events occurred in 11.9, 12, 26.2, and 25% and serious adverse events (SAEs) occurred in 6.9, 4, 9.8, and 12.5% of patients in the FCM, oral iron, other IV iron therapies, and iron sucrose groups, respectively. No SAEs were considered treatment related in the FCM group, compared with two treatment-related SAEs in two patients (6.3%) in the iron sucrose group. CONCLUSIONS FCM is an effective therapy in patients with IDA who have GI disorders and has a safety profile comparable to that of other IV iron agents.
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.
Evaluation of argon plasma coagulation in healing of a solitary rectal ulcer in comparison with conventional therapy: a randomised controlled trial
Przeglad Gastroenterologiczny. 2017;12((2)):128-134.
INTRODUCTION Argon plasma coagulation (APC) has been reported to be effective in the treatment of solitary rectal ulcer syndrome (SRUS). However, it has not appeared to be effective in healing ulcers. AIM: This study aimed at assessing the effectiveness of APC in controlling rectal ulcer-induced bleeding, and at examining the ultimate effect of this approach in healing these lesions. MATERIAL AND METHODS This randomised, controlled trial was conducted on 99 patients with SRUS. Patients were randomly enrolled into two groups of APC therapy (intervention) and conventional therapy (control). The control group (n = 58) received a high-fibre diet, laxatives, behaviour therapy, and sucralfate enemas, and the intervention group (n = 41) were treated with APC plus conventional therapy; in fact they received directed and focused argon gas in addition to a high-fibre diet and laxatives. RESULTS Responses to treatment in the control group and in the APC-receiving group were 29.3% and 75.6%, respectively. The continuation of ulcer healing after 3 months in the control group was 10.3%, and it was 70.7% in the APC-treated group. There was a significant statistical difference between the two groups (p < 0.004), i.e. bleeding was controlled more frequently in the group receiving APC plus conventional therapies than in the group receiving only the conventional therapies. However, the results showed no statistically significant difference between the two groups in terms of pain relief (p < 0.36). CONCLUSIONS Argon plasma coagulation not only controlled bleeding in patients with SRUS, but also, in comparison with the conventional methods of treating SRUS, led to healing and continuation of healing of rectal ulcers.