Bassi C, Falconi M, Lombardi D, Briani G, Vesentini S, Camboni M G, Pederzoli P
Clinical Chirurgica, Policlinico Borgo Roma, Verona, Italia.
Digestion. 1994;55 Suppl 1:41-7. doi: 10.1159/000201188.
An Italian prospective multicentre study evaluated the efficacy of octreotide, a synthetic somatostatin analogue, in preventing the complications of elective pancreatic surgery. 303 patients with tumours of the pancreas or the ampullary region, in whom ultrasonography and computed tomography scan had shown a resectable lesion, or with chronic pancreatitis, were randomized in a double-blind fashion to treatment with octreotide 100 micrograms t.i.d. s.c. starting at least 1 h before surgery and continued till the 7th postsurgical day, or with matching placebo. Unresectable lesions were found at laparatomy in 31 patients (15% of those with tumours). In 14 others, procedures not anticipated in the study protocol had to be performed, and in 6 additional cases there were other protocol violations so that these 20 patients were excluded from the study analysis. Considering the 252 evaluable patients, the complication rate was significantly higher in the 130 placebo-treated patients than in the 122 who received octreotide (29.2 vs. 15.6%; p = 0.01). We therefore suggest that octreotide may substantially reduce the risk of complications after elective pancreatic surgery.
一项意大利前瞻性多中心研究评估了合成生长抑素类似物奥曲肽在预防择期胰腺手术并发症方面的疗效。303例胰腺或壶腹周围区域肿瘤患者，经超声和计算机断层扫描显示为可切除病变，或患有慢性胰腺炎，被双盲随机分为两组，一组从手术前至少1小时开始皮下注射奥曲肽100微克，每日3次，持续至术后第7天；另一组注射匹配的安慰剂。31例患者（占肿瘤患者的15%）在剖腹手术中发现病变不可切除。另有14例患者必须进行研究方案未预期的手术，还有6例存在其他违反方案的情况，因此这20例患者被排除在研究分析之外。在252例可评估患者中，130例接受安慰剂治疗患者的并发症发生率显著高于122例接受奥曲肽治疗的患者（29.2%对15.6%；p = 0.01）。因此，我们认为奥曲肽可能会大幅降低择期胰腺手术后的并发症风险。
