生长抑素与生长激素联合应用治疗重症急性胰腺炎多中心对照临床初步研究

Preliminary assessmet on combination therapy of somatostatin with growth hormone for severe acute pancreatitis:a prospective,controlled,multicenter study

目的 评价生长抑素 (SS)和生长激素 (GH)联合应用对重症急性胰腺炎 (SAP)的治疗效果 ,并试图揭示两者联合应用的作用机制。方法 采用前瞻性、对照、开放、多中心临床研究 ,将确诊为SAP的患者分为SS治疗组和SS联合GH治疗组 ,共有 5 9例患者完成此方案规定内容 ,其中SS治疗组31例 ,SS联合GH治疗组 2 8例。急性胰腺炎 (AP)的诊断依据临床症状、体征、血淀粉酶及影像学 (B超或CT)检查。AP严重度评估分别依据Ranson标准、APACHEⅡ评分或BalthazarCT积分。结果 两组患者入院时年龄、性别、病因构成及SAP严重度评分诸方面差异均无显著性。与单用SS治疗组相比 ,SS联合GH治疗组患者的血清白蛋白于入院 2周后显著升高 ;血浆内毒素水平自入院后第 3天开始显著降低 ,肿瘤坏死因子 (TNF) α、白细胞介素 (IL) 1β水平明显降低 ;血清胰岛素样生长因子 (IGF 1)和胰岛素样生长因子结合蛋白 (IGFBP 3)水平于入院后第 10天显著升高 ;APACHEⅡ评分及Binder合并症积分明显改善 ;并发症和平均住院时间明显缩短 ,死亡率降低 (0比 16 % )。但血清淀粉酶和乳酸脱氢酶 (LDH)活性于治疗后无明显变化。住院费用两组差异无显著性。结论 SS和GH联合应用可显著改善SAP患者的预后 ,缩短住院时间 ,其可能的作用机制是通过促进IGF

Objective To assess the therapeutic efficacy of somatostatin (SS) combined with growth hormone (GH) in patients with severe acute pancreatitis (SAP) and to elucidate its possible mechanisms. Methods In this prospective,open-label and controlled clinical trial,59 consecutive patients with diagnosis of SAP were enrolled. Thirty one patients were allocated in SS group and 28 patients in SS combined with GH group. The diagnostic criteria of acute pancreatitis (AP) was made upon clinical manifestations,physical signs,elevated serum amylase activity and positive image findings including transcutaneous ultrasonography and contrast computerized tomography. The severity of AP was also ascertained based on Ranson's criteria,APACHE Ⅱor Balthazar CT scoring. Results There were no statistical differences between two groups in age,gender,etiology and severity of SAP. Compared with SS group,patients in SS combined with GH group had a significant increasing of serum albumin level on day 14;a marked decreasing of plasma endotoxin level on day 3,7,10,14;a notable decreasing of serum TNF-α,IL-1β levels on day 3;a significant up-regulation in serum level of insulin-like growth factor-1 and insulin-like growth factor binding protein-3 on day 10,14 and 21 and a obviously improvement in APACHEⅡand Binder's scoring and a extremely reduction in complication,hospitalization days and mortality. There was no statistical difference in the cost between two groups. However,serum amylase and lactate dehydrogenase activity kept in same level between two groups. Conclusions The present study indicates that such combination therapy can improve the prognosis of SAP. The possible mechanisms may involve in the attenuation of bacteria translocation and systemic endotoxin level,inhibition of the production and release of TNF-α,IL-1β and improvement of systemic host defenses as well as intestinal mucosa barrier. As a result,the high stress response in SAP was mitigated and the complication of multiple organ failure was prevented.