| Background:Acute pancreatitis is a disease with high mortality worldwide, especially in patients with severe acute pancreatitis the mortality of which is up to 36%-50%. A variety of complications would occur in the course of acute pancreatitis, among which intra-abdominal hypertension or abdominal compartment syndrome is a special type with poor prognosis and high fatality rate. Nowadays it is generally believed that intra-abdominal hypertension is a prelude of abdominal compartment syndrome, the progressing speed from IAH to ACS varied in different patients with SAP. The phase of IAH could be considered as a window period or turning point to progress to the phase of ACS and is also an important timing for consevative treatment.The paralytic ileus caused by the exudation of pancreatic juice is an important reason for intra-abdominal hypertension in the progession of acute pancreatitis. Therefor, it would obviously relieve the symptoms, reduce the incidence of complications and lower the mortality in patients with acute pancreatitis once we focus on the therapy for the IAH caused by exudation of pancreatic juice. Neostigmine is a kind of anticholinesterase drugs, it can inhibit the hydrolysis of acetylcholine, enhance effects of cholinergic, increase the activity of excitatory parasympathetic by competition with acetylcholine in combining with cholinesterase in cholinergic loci. This will make the body manifest a muscarinic effects and then restore the patient's intestinal peristalsis. Excitement of gastrointestinal M receptor can enhance intestinal peristalsis, which can promote anal aerofluxus and defecation.As a result, neostigmine may play a role in decresing intra-abdominal hypertension and improving the paralysis ileus. At present there is no prospective clinical controlled study on the effect of neostigmine for AP combined with intra-abdominal hypertension in China. So our study is innovative and practical.Objective:1. Investigate the clinical value of neostigmine on improving the paralytic ileus and reducing intra-abdominal hypertension caused by acute pancreatitis.2. Identify the therapy value of neostigmine on reducing the incidence of organ failure and improving prognosis in patients with acute pancreatitis.Methods:This randomized controlled trial was conducted from August, 01, 2015 to February, 29, 2016 in the Department of Gastroenterology, the First Affiliated Hospital of Nanchang University. The study protocol was registered as NCT02543658 at the U.S. National Institutes of Health and was approved by the medical ethics committee. Written, informed consents were obtained from all the patients or from their responsible relatives before enrollment. 483 patients were diagnosed with AP according to the revision of the Atlanta classification in the period, fulfilling any two of these features by(1) the onset of acute abdominal pain,(2) elevated serum levels of amylase and/or lipase of at least 3-folds higher than the upper limit of the reference range or(3) ultrasonographic or computed tomographic(CT) evidence of AP, with mild AP(MAP) 229 cases, moderate to severe AP(MSAP) 187 cases and SAP 67 cases. IAH is defined by a sustained or repeated pathological elevation in IAP ? 12 mmHg. 33 cases fulfilled the diagnosis criteria of AP complicated with IAH and were assigned to receive either conventional therapy plus neostigmine(group A) or conventional therapy(group B) according to a computer generated random number table using a simple block randomization procedure.Results:In this randomized controlled trial, 33 patients with AP complicated with IAH were randomly assigned to receive either conventional therapy or conventional therapy + neostigmine, All patients, beginning as soon as possible after diagnosis. 33 cases of patients were recruited, including 24 males(72.7%)and 9 females(27.3%), including 25 patients with severe acute pancreatitis(75.7%), 8 with moderately severe acute pancreatitis(24.3%), no people with moderately acute pancreatitis. At different time points measured was statistically significant between patients in the amount of feces(F=19.410, P=0.000). The experimental group and control group in the amount of feces all showed a trend of gradual rising, the experimental group was higher than the control group(F=8.509, P=0.007). The amount of feces in the experimental group was higher than that of the control group in first, second and third days after treatment(P<0.05), the rest of the time points in the experimental group and control group had no significant difference(P>0.05). There is interaction in the amount of feces between the experimental group and the control group(F=3.756, P=0.006). At different time points measured was statistically significant between patients with intra-abdominal pressure(F=35.820, P=0.000). The experimental group and control group in intra-abdominal pressure all showed a trend of gradual decline, no statistically difference was found between the experimental group and control group(F=2.566, P=0.119). intra-abdominal pressure of the experimental group of the third day lower than that of the control group(P=0.036), but there were no statistically significant differences between the experimental group and the control group at other time points(P>0.05). There is no interaction in intra-abdominal pressure between the experimental group and the control group(F=1.250, P=0.282). To compare the intra-abdominal pressure decreased percentage after 24 h, 48 h, 72 h and the compliance rate within 72 hours(below 12mmHg), found that the 24 h decline rate of experimental group is higher than control group, the difference has statistical significance(F=5.270, P=0.029), the rest of the time no statistical difference(P>0.05). 15 patients reached the intra-abdominal pressure level II in two groups, including 7 cases in the experimental group, 8 cases in the control group. After treatment, patients in the experimental group at 24 h, 48 h, 72 h intra-abdominal pressure decreased percentage, the compliance rate within 72 hours and the time of down to grade I(< 15 mmHg) were better than the control group, the difference has statistical significance(P<0.05). The number of patients recovery from intra-abdominal hypertension in experimental group significantly increased compared with the control group in the fifth day, the difference has statistical significance(P=0.038), the rest of the time has no statistical significance(P>0.05). the duration time of organ failure between two groups has no statistically significant difference(P=0.465). The difference has no statistical significance in ICU stay, hospitalization time and the duration time of organ failure between the experimental group and the control group(P > 0.05).Conclusions:Neostigmine can obviously improve the paralytic ileus caused by acute pancreatitis;Neostigmine can reduce intra-abdominal pressure in patients with acute pancreatitis the level of intra-abdominal pressure of which is over grade-II;No adverse events were found in neosigmine-treated experimental group;Neostigmine has no obvious effect on reducing the duration time of organ failure, ICU stay, hospitalization stay and improving prognosis. |
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