术前腹腔注射沙培林治疗进展期胃癌的临床观察

Effect of preoperative intraperitoneal injection of Sapylin in advanced gastric cancer

背景与目的:沙培林是一种生物反应调节剂。作为癌症晚期综合治疗的方法之一,其临床疗效已得到肯定。本研究主要评价术前腹腔注射沙培林治疗进展期胃癌的临床疗效。方法:将79例临床评估可行胃癌根治术的患者用随机数字表法随机分为研究组(沙培林+丝裂霉素C治疗组40例)和对照组(丝裂霉素C治疗组39例)。研究组术前48h向患者腹腔内注入沙培林5KE(1KE相当于0.1mg的干链球菌+2700u的青霉素),手术关腹前腹腔内注入4mg丝裂霉素C;对照组于手术关腹前腹腔内注入4mg丝裂霉素C。结果:两组患者均无手术死亡,均未发生十二指肠残端瘘。研究组中发生吻合口瘘和切口裂开的各1例,对照组仅1例发生切口裂开。两组手术并发症的发生率差异无统计学意义(P>0.05)。研究组患者术后3年生存率为76.5%,对照组为49.4%,两组之间的差异有统计学意义(P<0.05)。结论:术前48h腹腔注射沙培林能显著提高胃癌根治术患者术后的3年生存率,且不增加手术并发症的发生率,具有一定的临床应用价值。

Background and Objective：Sapylin is one of the biological response modifiers. It has been used in the comprehensive treatment for advanced cancer,and its clinical efficacy has been proved. This study was to evaluate the effect of preoperative intraperitoneal injection of Sapylin in treatment of advanced gastric cancer. Methods：Seventy-nine patients eligible for radical gastrectomy were randomly divided into the treatment group （Sapylin＋ mitomycin C,40 patients） and the control group （mitomycin C alone,39 patients）. In the treatment group,5 KE Sapylin was injected intraperitoneally 48 h before operation and 4 mg of mitomycin C was injected into peritoneal cavity before the closure of the peritoneum. In the control group,only 4 mg mitomycin C was injected into peritoneal cavity before the closure of the peritonium. Results：There was no operative mortality or duodenal stump leakage in the two groups. Postoperative complications were anastomotic leakage （2.5%,1/40） and incision rupture （2.5%,1/40） in the treatment group,and incision rupture （2.6%,1/39） in the control group,with no significant difference between the two groups （ P〉0.05）. The 3-year survival rate was significantly higher in the treatment group than in the control group （76.5% vs. 49.4%,P〈0.05）. Conclusions：Preoperative intraperitoneal injection of Sapylin can raise the 3-year survival rate after radical gastrectomy,without increasing the incidence rate of operative complications. Preoperative intraperitoneal injection of Sapylin is therefore a valuable therapy for advanced gastric cancer in clinic.