Patil Basavaraj, Meena Laxmi Narayan, Sharma Dinesh Chandra, Agarwal Garima, Dadhich Yogendra, Gupta Gaurav
Department of General Surgery, SMS Medical College, Jaipur, Rajasthan, India, 302004.
Int J Surg. 2022 May;101:106621. doi: 10.1016/j.ijsu.2022.106621. Epub 2022 Apr 27.
Acute pancreatitis is inflammation of pancreatic parenchyma which is an emergency condition. It is classified as mild, moderately severe, and severe categories. In severe acute pancreatitis, mortality is up to 10%-30%. Pancreatic abscess increases the mortality to 40%, and infected pancreatitis carries 100% mortality without surgical drainage. Anti-coagulant, anti-inflammatory and anti-protease activities of low-molecular-weight heparin are involved in preventing pancreatic necrosis and curbing the adverse outcomes of acute pancreatitis.
To determine the effect of low-molecular-weight heparin on the outcome of moderately severe and severe acute pancreatitis.
Hospital based, single centre, randomized, single blind, phase 3 control trial. First 140 patients with moderately severe and severe acute pancreatitis admitted in hospital in the given period who met the inclusion and exclusion criteria were taken. 70 patients were placed in the control and the trial group each by simple randomization (closed envelope method). The control group received conventional treatment for pancreatitis & the trial group received 1mg/kg body weight Enoxaperin, subcutaneously, 12 hourly for seven days along with the conventional treatment. Progression of disease in Computed Tomography Severity Index and incidence of pancreatic necrosis were the main outcomes studied at the end of 7 days of treatment.
1386 acute abdomen cases were screened, of which 269 were diagnosed with acute pancreatitis. 147 patients with acute pancreatitis met the selection criteria and 7 were dropouts. Recruitment started on April 9, 2021 and closed on December 5, 2021. Computed Tomography Severity Index progressed in 22(31.40%) patients in control group and 6(8.6%) patients in the trial group and 18(25.71%) in the control group and 4(5.71%) in the trial group showed the presence of necrosis. The differences are significant (P value is 0.001 in each). No adverse events were seen.
Use of low-molecular-weight heparin in early stage of moderately severe and severe acute pancreatitis significantly reduces the chance of disease progression and pancreatic necrosis.
急性胰腺炎是胰腺实质的炎症，属于急症。它分为轻度、中度重症和重症三类。在重症急性胰腺炎中，死亡率高达10%-30%。胰腺脓肿会使死亡率升至40%，而感染性胰腺炎若不进行手术引流，死亡率为100%。低分子量肝素的抗凝、抗炎和抗蛋白酶活性参与预防胰腺坏死并抑制急性胰腺炎的不良后果。
确定低分子量肝素对中度重症和重症急性胰腺炎预后的影响。
基于医院的单中心随机单盲3期对照试验。选取在给定时期内入院的首批140例符合纳入和排除标准的中度重症和重症急性胰腺炎患者。通过简单随机化（封闭信封法）将70例患者分别置于对照组和试验组。对照组接受胰腺炎的常规治疗，试验组在接受常规治疗的同时，每12小时皮下注射1mg/kg体重的依诺肝素，共7天。治疗7天后，主要研究的结果是计算机断层扫描严重指数的疾病进展情况和胰腺坏死的发生率。
筛查了1386例急腹症病例，其中269例被诊断为急性胰腺炎。147例急性胰腺炎患者符合入选标准，7例退出研究。招募工作于2021年4月9日开始，2021年12月5日结束。对照组中有22例（31.40%）患者的计算机断层扫描严重指数有所进展，试验组中有6例（8.6%）；对照组中有18例（25.71%）出现坏死，试验组中有4例（5.71%）。差异具有显著性（每项P值均为0.001）。未观察到不良事件。
在中度重症和重症急性胰腺炎的早期使用低分子量肝素可显著降低疾病进展和胰腺坏死的几率。
