沙利度胺联合CHOP方案治疗侵袭性非霍奇金淋巴瘤临床对照研究

Clinical study of comparison of thalidomide combined with CHOP regimen on treatment of invasive NHL

目的观察沙利度胺在侵袭性非霍奇金淋巴瘤（NHL）中的治疗作用及不良反应。方法52例侵袭性恶性淋巴瘤患者，随机分为两组，每组26例。CHOP组：环磷酰胺600mg／m2静脉注射第1天；表柔比星50mg／m2，静脉注射第1天；长春新碱1．4mg／m2，静脉注射第1天，泼尼松50mg／m2，口服，第1天至第7天。沙利度胺组：化疗方案同CHOP组，加用沙利度胺，200mg第1天至第14天，口服，第2个疗程剂量增加为400mg，第1天至第14天。结果CHOP组CR7例（26．9％），PR12例（46．2％），CR＋PR19例，总有效率为73．1％；沙利度胺组CR9例（34．6％），PR14例（53．8％），CR＋PR23例，总有效率为88．4％；两组比较差异无统计学意义（P=0．25）。沙利度胺组1年生存率（OS）92．6％，2年OS为83．5％，CHOP组分别为90．8％、68．8％，两组1年OS差异无统计学意义，2年OS差异有统计学意义（P〈0．05）。沙利度胺组外周神经毒性、便秘、疲乏等不良反应发生率高于CHOP组，两组比较差异有统计学意义（P〈0．05）。结论沙利度胺联合CHOP方案治疗侵袭性NHL，不良反应可以耐受，且在缓解率及生存期方面均优于单纯化疗组。

Objective To determine the curative effect and adverse effect of thalidomide regimen in treatment of invasive non-Hodgkin lymphoma （NHL）. Methods Fifty-two patients with invasive NHL were divided into two groups randomly, with twenty-six patients in each group. In CHOP regimen （cyclophosphamide 600 mg/m2 iv dl, epirubicin 50 mg/m2 iv dl, vincristine 1.4 mg/m2 iv dl, prednisone 50 mg/m2 dl-d7） were given. In thalidomide regimen, the same shema with the CHOP regimen exception thalidomide, thalidomide 200 mg/m2 po d1-d14 in the first course, 400 mg/m2 po dl-d14 in the second time of therapy were given. Results The response rate （RR） of CHOP regimen and thalidomide regimen were 73.1% and 88.4 %, respectively. There was no significant difference （P 〉0.05）. the OS rate in the first year and the second year of CHOP regimen and thalidomide regimen were 90.8 % and 68.8 %, 92.6 % and 83.5 %, respectively, There was no significant difference in the first year of OS （P 〉0.05）. There was significant difference in the second year of OS （P 〈0.05）. The major side effect of the Two groups had significant difference （P 〈0.05）. Conclusion Thalidomide combined with CHOP regimen on treatment of invasive NHL showed better efficacy than CHOP regimen on invasive NHL. The toxic reactions are tolerable.