A群链球菌制剂联合化疗用于结肠癌根治术后的前瞻性随机对照研究

A prospective randomized controlled trial of Sapylin combined with chemotherapy for advanced colon cancer following radical operation

目的 研究A群链球菌制剂联合化疗对结肠癌根治术后局部复发、肝转移及生存率的影响.方法 将2004年1月至2005年12月间行根治手术的132例Ⅱ期和Ⅲ期结肠癌患者,根据计算机产生的随机数字表将患者随机分成试验组60例（A群链球菌制剂联合腹腔灌注及全身静脉化疗）和对照组72例（单纯化疗,给药方式和化疗方案同试验组）,比较两组患者的毒性反应、腹腔局部复发、肝转移率及生存率.结果 两组患者化疗期间不良反应的差异无统计学意义（P〉0.05）.试验组患者术后3年内有9例（15.0%）发生肝转移,11例（18.3%）出现局部复发,均低于对照组（30.6%和34.7%）,差异具有统计学意义（均P〈0.05）.两组术后3年生存率分别为73.3%和54.2%,差异有统计学意义（P〈0.05）.结论 A群链球菌制剂联合腹腔灌注及全身静脉化疗可降低结肠癌根治术后局部复发和肝转移发生率,并提高术后生存率.

Objective To evaluate the effect of Sapylin combined with intrapefitoneal and systemic chemotherapy for advanced colon cancer following radical operation on local recurrence,hepatic metastasis,and overall survival rate. Methods From Jan.2004 to Dec.2005,132 patients with stage Ⅱ or Ⅲ colon carcinoma after radical operation were randomly divided into two groups：Sapylin combined with chemotherapy（Sapylin）group and the control group.Toxic reaction,local recurrence,hepatic metastasis,and overall survival rate between two groups were compared. Results Both groups successfully completed the trial.There was no significant difference in toxic reaction between two groups.the recurrence and hepatic metastasis rate in Sapylin group were lower than those in the control group （9/60,15.0% vs.22/72,30.6%;11/60,18.3% vs.22/72,34.7%,respectively）,which were statistically significant（P〈0.05 respectively）.The 3-year survival rate in Sapylin group was higher than that in control group （73.3%vs.54.2%）,which was statistically significant （P〈0.05）. Conclusion Sapylin combined with intraperitoneal and systemic chemotherapy can effectively decrease local recurrence and hepmic metastasis,and improve the survival in patients with advanced colon cancer following radical operation.