乌司他丁治疗老年急性重症胰腺炎的临床研究

Clinical trial of ulinastatin in the treatment of elderly patients with acute severe pancreatitis

目的观察乌司他丁对老年急性重症胰腺炎患者血清D-乳酸、肿瘤坏死因子-α(TNF-α)及白细胞介素-6(IL-6)水平的影响。方法将120例老年急性重症胰腺炎患者随机分为试验组和对照组,每组60例。对照组给予注射用生长抑素,首次剂量250μg,然后以250μg·h^(-1)维持,奥美拉唑40 mg+0.9%NaCl注射液100 mL,静脉滴注,每日2次。试验组在对照组的基础上给予乌司他丁1.0×10~5U+5%葡萄糖注射液250 mL,静脉滴注,每日2次。2组患者均持续治疗1周。观察患者治疗前后血清D-乳酸、TNF-α、IL-6、淀粉酶及脂肪酶水平和症状缓解时间、临床疗效及安全性。结果治疗后,对照组有效率为75.00%(45例/60例),试验组为93.34%(56例/60例),差异有统计学意义(P<0.05)。治疗后,对照组和试验组血清D-乳酸分别为(8.16±0.93),(6.24±0.77)μg·L^(-1),TNF-α分别为(261.13±32.34),(216.32±25.54)pg·mL^(-1),C-反应蛋白(CRP)分别为(36.84±5.18),(19.66±2.78)mg·L^(-1),IL-6分别为(74.82±10.21),(52.51±7.12)pg·mL^(-1),差异均有统计学意义(均P<0.05)。治疗后,对照组和试验组血淀粉酶分别为(264.41±31.12),(134.64±18.81)U·L^(-1),尿淀粉酶分别为(1864.42±233.43),(1019.53±135.42)U·L^(-1),脂肪酶分别为(73.23±10.11),(34.43±4.65)U·L^(-1),差异均有统计学意义(均P<0.05)。对照组和试验组腹痛缓解时间分别为(4.63±0.63),(3.18±0.44)d,腹胀缓解时间分别为(5.71±0.76),(4.28±0.61)d,首次排便时间分别为(32.64±4.27),(17.82±2.43)d,肠鸣音恢复时间分别为(29.56±4.06),(14.39±2.02)d,差异均有统计学意义(均P<0.05)。对照组发生的药物不良反应有恶心、皮疹,药物不良反应发生率为13.33%(8例/60例);试验组发生的药物不良反应有恶心、皮疹和注射部位疼痛,药物不良反应发生率为8.33%(5例/60例),差异无统计学意义(P>0.05)。结论乌司他丁对老年急性重症胰腺炎有较好的临床疗效,保护肠道黏膜屏障功能,促进胃肠功能恢复,且明显降低血清D-乳酸、TNF-α及IL-6水平,具有较高的安全性。

Objective To evaluate the clinical effect of ulinastatin on serum D-lactic acid（ D-LA）,tumor necrosis factor-α（ TNF-α）and interleukin-6（ IL-6） levels in elderly patients with acute severe pancreatitis. Methods A total of 120 cases of elderly patients with acute severe pancreatitis were randomly divided into treatment group and control group, 60 cases in each group. Control group was given somatostatin injection,the first dose of 250 μg,and then maintained with250 μg·h^-1,omeprazole sodium chloride injection 40 mg ＋ 0. 9% NaCl100 mL,intravenously guttae,twice a day. The treatment group was given ulinastatin 1. 0 × 10~5 U ＋ 5% glucose injection 250 mL,intravenous drip on the basis of control group,twice a day. All patients were treated for 1 week. The D-LA,TNF-α,IL-6,amylase and lipase concentration,time of symptom remission,clinical efficacy and safety were compared in two groups. Results After treatment,the effective rates in control and treatment groups were75. 00%（ 45 cases/60 cases） and 93. 34%（ 56 cases/60 cases,P〈0. 05）. After treatment,the D-LA levels were（ 8. 16 ± 0. 93）,（ 6. 24 ± 0. 77） μg · L^-1 in control group and treatment group. The TNF-α levels were（ 261. 13 ± 32. 34）,（ 216. 32 ± 25. 54） pg · mL^-1. The C-reactive protein（ CRP） were（ 36. 84 ± 5. 18）,（ 19. 66 ± 2. 78） mg·L^-1. The IL-6 were（ 74. 82 ± 10. 21）,（ 52. 51 ± 7. 12） pg·mL^-1,with significant difference（ P〈0. 05）. After treatment,the serum amylase in control group and treatment group were（ 264. 41 ± 31. 12）,（ 134. 64 ± 18. 81） U·L^-1. The urine amylase were（ 1864. 42 ± 233. 43）,（ 1019. 53 ± 135. 42） U·L^-1. The lipase were（ 73. 23 ± 10. 11）,（ 34. 43 ± 4. 65） U · L^-1. The differences in two groups were statistically significant（ P〈0. 05）. The relief time of abdominal pain in control group and treatment group were（ 4. 63 ± 0. 63）,（ 3. 18 ± 0. 44） d. The relief time of abdominal distension were（ 5. 71 ± 0. 76）,（ 4. 28 ± 0. 61） d. The first defecation time were（ 32. 64 ± 4. 27）,（ 17. 82 ± 2. 43） d. The recovery time of bowel sound were（ 29. 56 ± 4. 06）,（ 14. 39 ± 2. 02） d. The differences of those items between the two groups were all statistically significant（ P〈0. 05）.The adverse drug reactions in control group were nausea,rash,and the incidence was 13. 33%（ 8 cases/60 cases）.The adverse drug reactions in treatment group were nausea,rash pain,injection site pain,and the incidence was8. 33%（ 5 cases/60 cases）. There was no significant difference in adverse drug reactions between the two groups（ P〉0. 05）. Conclusion Ulinastatin has a prominent therapeutic effect on elderly patients with acute severe pancreatitis. It can protect the intestinal mucosal barrier function,promote the recovery of gastrointestinal function,and significantly reduce the serum D-LA,TNF-α and IL-6 level,with high safety.