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Antifibrinolytic amino acids for upper gastrointestinal bleeding in people with acute or chronic liver disease
Marti-Carvajal AJ, Sola I
Cochrane Database of Systematic Reviews.. 2015;((6)):CD006007
Abstract
BACKGROUND Upper gastrointestinal bleeding is one of the most frequent causes of morbidity and mortality in the course of liver cirrhosis. People with liver disease frequently have haemostatic abnormalities such as hyperfibrinolysis. Therefore, antifibrinolytic amino acids have been proposed to be used as supplementary interventions alongside any of the primary treatments for upper gastrointestinal bleeding in people with liver diseases. This is an update of this Cochrane review. OBJECTIVES To assess the beneficial and harmful effects of antifibrinolytic amino acids for upper gastrointestinal bleeding in people with acute or chronic liver disease. SEARCH METHODS We searched The Cochrane Hepato-Biliary Controlled Trials Register (February 2015), Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2 of 12, 2015), MEDLINE (Ovid SP) (1946 to February 2015), EMBASE (Ovid SP) (1974 to February 2015), Science Citation Index EXPANDED (1900 to February 2015), LILACS (1982 to February 2015), World Health Organization Clinical Trials Search Portal (accessed 26 February 2015), and the metaRegister of Controlled Trials (accessed 26 February 2015). We scrutinised the reference lists of the retrieved publications. SELECTION CRITERIA Randomised clinical trials irrespective of blinding, language, or publication status for assessment of benefits and harms. Observational studies for assessment of harms. DATA COLLECTION AND ANALYSIS We planned to summarise data from randomised clinical trials using standard Cochrane methodologies and assessed according to the GRADE approach. MAIN RESULTS We found no randomised clinical trials assessing antifibrinolytic amino acids for treating upper gastrointestinal bleeding in people with acute or chronic liver disease. We did not identify quasi-randomised, historically controlled, or observational studies in which we could assess harms. AUTHORS' CONCLUSIONS This updated Cochrane review identified no randomised clinical trials assessing the benefits and harms of antifibrinolytic amino acids for upper gastrointestinal bleeding in people with acute or chronic liver disease. The benefits and harms of antifibrinolytic amino acids need to be tested in randomised clinical trials. Unless randomised clinical trials are conducted to assess the trade-off between benefits and harms, we cannot recommend or refute antifibrinolytic amino acids for upper gastrointestinal bleeding in people with acute or chronic liver diseases.
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2.
Antifibrinolytic amino acids for upper gastrointestinal bleeding in patients with acute or chronic liver disease
Marti-Carvajal AJ, Sola I, Marti-Carvajal PI
Cochrane Database of Systematic Reviews. 2012;9:CD006007.
Abstract
BACKGROUND Upper gastrointestinal bleeding is one of the most frequent causes of morbidity and mortality in the course of liver cirrhosis. Patients with liver disease frequently have haemostatic abnormalities like hyperfibrinolysis. Therefore, antifibrinolytic amino acids have been proposed to be used as supplementary interventions alongside any of the primary treatments for upper gastrointestinal bleeding in patients with liver diseases. OBJECTIVES To assess the beneficial and harmful effects of antifibrinolytic amino acids for upper gastrointestinal bleeding in patients with acute or chronic liver disease. SEARCH METHODS We searched the Cochrane Hepato-Biliary Group Controlled Trials Register (11 June 2012), Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (2012, Issue 5 of 12), MEDLINE (Ovid SP) (1946 to June 2012), EMBASE (Ovid SP) (1974 to June 2012), Science Citation Index EXPANDED (1900 to June 2012), LILACS (1982 to June 2012), Clinical Trials Search Portal of the WHO (accessed June 18, 2012), and the Metaregister of Controlled Trials (accessed June 18, 2012). We scrutinised the reference lists of the retrieved publications. SELECTION CRITERIA Randomised clinical trials irrespective of blinding, language, or publication status for assessment of benefits and harms. Observational studies for assessment of harms. DATA COLLECTION AND ANALYSIS Data from randomised clinical trials were to be summarised by standard Cochrane Collaboration methodologies. MAIN RESULTS We could not find any randomised clinical trials assessing antifibrinolytic amino acids for treating upper gastrointestinal bleeding in patients with acute or chronic liver disease. We could not identify quasi-randomised, historically controlled, or observational studies in which we could assess harms. AUTHORS' CONCLUSIONS No randomised clinical trials assessing the benefits and harms of antifibrinolytic amino acids for upper gastrointestinal bleeding in patients with acute or chronic liver disease were identified. The benefits and harms of antifibrinolytic amino acids need to be tested in randomised clinical trials. Unless randomised clinical trials are conducted to assess the trade off between benefits and harms, we cannot recommend nor refute antifibrinolytic amino acids for upper gastrointestinal bleeding in patients with acute or chronic liver diseases.
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3.
Platelet activation and the protective effect of aprotinin in hepatolithiasis patients
Feng WM, Bao Y, Fei MY, Chen QQ, Yang Q, Dai C
Hepatobiliary & Pancreatic Diseases International. 2003;2((4):):602-4.
Abstract
OBJECTIVE To explore platelet activation and the protective effect of aprotinin in patients with hepatolithiasis. METHODS The count of platelets and levels of CD62P and CD63 were measured by flow cytometry in 38 patients with hepatolithiasis. Several measurements were carried out after treatment with aprotinin. RESULTS The levels of CD62P, CD63 in patients with hepatolithiasis were higher than those in patients with cholecystolithiasis (P<0. 05), but the count of platelets was lower (P<0. 05). After operation, the levels of CD62P, CD63 were significantly increased in patients with hepatolithiasis, but the count of platelets was lower (P<0. 05). Postoperative levels of CD62P, CD63 were significantly lower in patients treated with aprotinin than in normal controls (P<0. 05); but there was no significant change in the count of platelets in the two groups. CONCLUSION Platelet activation occurs in patients with hepatolithiasis, and may be inhibited by aprotinin.
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4.
Peritoneal lavage with aprotinin in patients with severe acute pancreatitis. Effects on plasma and peritoneal levels of trypsin and leukocyte proteases and their major inhibitors
Berling R, Borgstrom A, Ohlsson K
International Journal of Pancreatology. 1998;24((1):):9-17.
Abstract
CONCLUSION Although high-dose aprotinin given intraperitoneally to patients with severe acute pancreatitis seems to inhibit activated trypsin in the peritoneal cavity, the treatment has little effect on the balance between proteases and antiproteases. Plasma levels of leukocyte proteases were high in all the patients, indicating leukocyte activation to be an important feature of the pathophysiology of severe acute pancreatitis. A surprise finding was that the patients had higher peritoneal levels of pancreatic secretory trypsin inhibitor (PSTI) after the lavage procedure. BACKGROUND Although most studies have shown protease inhibitor therapy to have little or no effect on acute pancreatitis, in an earlier study we found that very high doses of the protease inhibitor aprotinin given intraperitoneally to patients with severe acute pancreatitis seemed to reduce the need of surgical treatment for pancreatic necrosis. In the present study we have further analyzed plasma and peritoneal samples from the same patients to ascertain whether the aprotinin treatment affects the balance between proteases and endogenous antiproteases. METHODS In a prospective double-blind randomized multicenter trial, 48 patients with severe acute pancreatitis were treated with intraperitoneal lavage. One group (aprotinin group, n = 22) was also treated with high doses (20 million KIU given over 30 h) of aprotinin intraperitoneally. The remaining 26 patients made up the control group. The protease-antiprotease balance was studied by measuring immunoreactive anionic trypsin (irAT), cationic trypsin (irCT), complexes between cationic trypsin and alpha 1-protease inhibitor (irCT-alpha 1 PI), leukocyte elastase and neutrophil proteinase 4 (NP4), as well as the endogenous protease inhibitors, pancreatic secretory trypsin inhibitor (PSTI), alpha 2-macroglobulin (alpha 2M), alpha 1-protease inhibitor (alpha 1 PI), antichymotrypsin (ACHY), and secretory leukocyte protease inhibitor (SLPI). Intraperitoneal levels were studied before and after the lavage procedure, and plasma levels were followed for 21 d. RESULTS The control group had lower plasma levels of SLPI and analysis of peritoneal fluid showed the reduction of irCT-alpha 1 PI to be more pronounced in the aprotinin group. None of the other variables measured differed significantly between the two groups. All patients had very high levels of leukocyte elastase and NP4 both in peritoneal exudate and in plasma. Peritoneal levels of PSTI were higher after the lavage procedure in contrast to the other measured variables that all showed lower peritoneal levels after the lavage.
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5.
Gabexate mesilate vs aprotinin in human acute pancreatitis (GA.ME.P.A.). A prospective, randomized, double-blind multicenter study
Pederzoli P, Cavallini G, Falconi M, Bassi C
International Journal of Pancreatology. 1993;14((2):):117-24.
Abstract
The authors report the results of a randomized, double-blind multicenter clinical trial on the use of gabexate mesilate vs aprotinin in the therapy of acute pancreatitis. The size of the study sample and the end points chosen for evaluation of the early systemic complications of the pancreatitis--carefully selected targets for reliable assessment of the efficacy of any protease inhibitor--lead to the conclusion that gabexate mesilate is more efficacious than aprotinin in reducing the early complications of necrotizing acute pancreatitis, if administered within 72 h of onset of symptoms. Its good tolerability means that it can be used safely even at the dose of 3 g/24 h.
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6.
The effect of peritoneal lavage and aprotinin in the treatment of severe acute pancreatitis
Balldin G, Borgstrom A, Genell S, Ohlsson K
Research in Experimental Medicine. 1983;183((3):):203-13.
Abstract
Fifty-five patients with severe acute pancreatitis were treated with peritoneal lavage at the Dept. of Surgery at Malmo General Hospital. In a randomized study 26 of the 55 patients received in addition 500,000 KIU aprotinin in the lavage fluid every 2 h. There were no significant differences between the aprotinin- and non-aprotinin-treated groups as to mortality and clinical results. The initial concentration of alpha 1-antitrypsin in plasma was mainly within normal range with increasing values during the treatment. No differences were seen between the two groups. The initial mean level of alpha 2-macroglobulin in plasma was slightly decreased, but 17 patients showed values below normal range. The alpha 2-macroglobulin level during the lavage showed a similar course in the two groups. alpha 1-Antitrypsin and alpha 2-macroglobulin in the lavage fluids showed signs of complexation but in plasma these inhibitors did not show any signs of complexation. On admission to the hospital the mean levels of C3 and kininogen in the plasma were slightly below normal. During the lavage treatment no differences were seen between the two groups. Degradation products of C3 and kininogen were seen in both serum and peritoneal fluids. The electrophoretic patterns of C3 and kininogen normalized in serum as well as in lavage fluids during the lavage treatment without any significant differences in the two groups. High levels of immunoreactive trypsin, pancreatic elastase, PSTI, and leukocyte elastase in serum were seen equally in both groups of patients.
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7.
Morbidity of acute pancreatitis: the effect of aprotinin and glucagon
Anonymous
Gut. 1980;21((4):):334-9.
Abstract
In a double-blind, randomised trial, neither aprotinin nor glucagon given in relatively high doses for five days influenced the rate of recovery or incidence of complications in 257 patients with acute pancreatitis.
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8.
Controlled therapeutic trial of aprotinin and glucagon in acute pancreatitis (author's transl) . French
Gauthier A, Gillet M, Di Costanzo J, Camelot G, Maurin P, Sarles H
Gastroenterologie Clinique et Biologique. 1978;2((10):):777-84.
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9.
A single-centre double-blind trial of Trasylol therapy in primary acute pancreatitis
Imrie CW, Benjamin IS, Ferguson JC, McKay AJ, Mackenzie I, O'Neill J, Blumgart LH
British Journal of Surgery. 1978;65((5):):337-41.
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10.
Death from acute pancreatitis. M.R.C. multicentre trial of glucagon and aprotinin
Anonymous
Lancet. 1977;2((8039):):632-5.
Abstract
The influence of glucagon and aprotinin ('Trasylol') on the death-rate of acute pancreatitis has been studied in a randomised double-blind multicentre trial. The death-rate in 257 patients was 11%. In the doses used neither drug was found to diminish the risk of death.