Surendar, K (2020) A Clinical study of the Efficacy of Ulinastatin in Treatment of Acute Pancreatitis. Masters thesis, Madras Medical College, Chennai.
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Abstract
BACKGROUND: Acute pancreatitis is spectrum of disease where there is an acute inflammatory disease of the pancreas, with involvement of other regional tissues or remote organ systems. Acute pancreatitis is a frequent inpatient diagnosis that gastroenterologists, and surgeons confront. The most common causes include gallstones and heavy alcohol intake. Its management is typically : intravenous fluids, analgesia, and nil per oral with maximum intensive care supporting vital organs in case of multi organ failure, termed as standard management . Acute pancreatitis can be mild , moderately severe or severe depending on local complications and persistent organ failure. Here we utilises the drug Ulinastatin, a trypsinogen inhibitor in moderately severe and severe pancreatitis to reduce the morbidity and mortality of the disease in a tertiary care centre. OBJECTIVES: To compare the efficacy of ulinastatin in addition to standard treatment versus only standard treatment in subjects with moderately severe or severe acute pancreatitis. MATERIALS AND METHODS: Study Centre: Institute of General Surgery, Madras Medical College and Rajiv Gandhi Government General Hospital, Chennai. Duration of Study: January 2018 to June 2019. Study Design: Randomized control study (Prospective). Sample Size: 40 { n = Z2 1-α/2 P(1-P) /e2 P=3% e= 5% Z=1.96}. Inclusion Criteria: Subjects may be included in the study if they meet all of the following criteria: 1. Males and females, aged 18 years to 75 years, inclusive 2. Any 2 of the following 3 must be present: a. Upper abdominal pain characteristic of acute pancreatitis (acute onset of persistent, severe, epigastric pain often radiating to the back). b. Serum amylase and/or lipase ≥3 times the upper limit of normal. c. Characteristic findings of acute pancreatitis on contrast-enhanced CT or MRI or ultrasonography. 3. Diagnosis of moderately severe or severe acute pancreatitis, based on the Revised Atlanta classification (2012) for acute pancreatitis. Exclusion criteria: Subjects will be excluded from the study if any of the following exclusion criteria: 1. Mild pancreatitis (absence of organ failure, local or systemic complications). 2. History of or radiological evidence of chronic pancreatitis (pancreatic atrophy or calcification, ductal irregularity or dilatation). 3. Post-ERCP(endoscopicretrograde cholangiopancreatography) pancreatitis. 4. Significant co-morbidities at screening, as judged by the Principal Investigator. 5. Anticipated need for intervention, surgical or endoscopic within 7 days of screening, 6. Moribund state in which death is perceived to be imminent (within 48 hours), 7. Known hypersensitivity, 8. Pregnant or nursing (lactating) women. DISCUSSION: This is a prospective randomised control study, which included 40 patients of moderately severe and severe acute pancreatitis.It is divided into Group A and B. In group A who recieved ulinastatin along with standard treatment, 9 patients had new onset organ failure when compared to group B who recieved only standard treatment where 16 patients had new onset organ failure. In Group A, 3 patients required mechanical ventilation, 1 patient needed dialysis, 2 patients needed inotropes and 7 patients developed local complications. In Group B, 5 patients required mechanical ventilation, 3 patient needed dialysis, 4 patients needed inotropes and 14 patients developed local complications. In Group A, length of ICU stay is 3 days and length of hospital stay is 10 days, whereas in Group B, length of ICU stay is 7 days and length of hospital stay is 18 days. In Group A, 2 patients died in first week after the onset of acute pancreatitis, whereas in Group B 4 patients died in first week after the onset of acute pancreatitis. CONCLUSION: Ulinastatin has reduced the morbidity rate by 28 % and the mortality rate by 10% in moderately severe and severe acute pancreatitis. Hence it is proven to be effective in the treatment of moderately severe and severe acute pancreatitis.
| Item Type: | Thesis (Masters) |
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| Additional Information: | 221711020 |
| Uncontrolled Keywords: | Efficacy, Ulinastatin, Treatment, Acute Pancreatitis, Clinical study. |
| Subjects: | MEDICAL > General Surgery |
| Depositing User: | Subramani R |
| Date Deposited: | 09 Feb 2021 00:55 |
| Last Modified: | 09 Feb 2021 00:55 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/13937 |
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