复方斑蝥胶囊联合化学治疗对转移性结直肠癌的疗效观察

目的 观察复方斑蝥胶囊联合奥沙利铂(L-OHP)、5-氟尿嘧啶/亚叶酸钙(5-FU/CF)组成的FOLFOX4方案治疗转移性结直肠癌的临床疗效及不良反应.方法 收集2006年4月至2008年10月收治的无手术指征的转移性结直肠癌患者107例,随机分为复方斑蝥胶囊联合FOLFOX4方案组(联合治疗组)54例和FOLFOX4方案组53例.联合治疗组给予L-OHP 85mg/m2,第1天静脉滴注2 h,同时或之后予CF 200 mg/m2,静脉滴注2 h,续5-FU 400 mg/m2静脉推注,600 mg/m2持续静脉滴注22 h,次目重复,CF与5-FU每2周重复一次,同时予以复方斑蝥胶囊口服750 mg,每天2次.FOLFOX4方案组患者单纯接受FOLFOX4方案化学治疗.结果 联合治疗组和FOLFOX4方案组有效率分别为44.4%和37.7%,两组间差异无统计学意义(P=0.481).联合治疗组的中位无进展时间(TTP)为11.6个月,FOLFOX4方案组为7.9个月,两组间差异有统计学意义(P=0.020).生活质量评价,联合治疗组的改善率为57.4%,FOLFOX4方案组为32.1%,两组间差异有统计学意义(P=0.008).两组不良反应主要表现为消化道反应、神经系统毒性、脱发和骨髓抑制.联合治疗组Ⅲ/Ⅳ度粒细胞减少发生率为37.0%,FOLFOX4方案组为58.5%,两组间差异有统计学意义(P=0.043).结论 复方斑蝥胶囊联合FOLFOX4方案一线治疗转移性结直肠癌能协同增效,能提高患者TTP及改善患者生活质量,降低粒细胞减少发生.

The efficacy of Fufangbanmao capsules combined with chemotherapy in the treatment of patients with metastatic colorectal cancer

Objective To investigate the efficacy and side effects of Fufangbanmao capsules combined with FOLFOX-4 (Oxaliplatin + 5-fluorouracil /Calcium folinate) regimen in the treatment of metastatic colorectal cancer (MCC). Methods A total of 107 patients with previously untreated MCC, who were admitted to the hospital between April 2006 and October 2008, were randomly divided into combination group (n = 54) and chemotherapy group (n = 53). In combination group, patients received Fufangbanmao capsules (750 mg twice daily) and FOLFOX4 regimen (oxaliplatin 85 mg/m2 day 1, infusion of CF 200 mg/m2 for 2 hours followed by bolus 5-FU 400 mg/m2 and a 22-hour infusion of 5-FU 600 mg/m2 ). Whereas the patients in chemotherapy group were treated with FOLFOX4 regimen. Results The effective rate was 44. 4% in combination group and 37. 7% in chemotherapy group with no significant difference (P = 0. 481). The median time to progression (TTP) was 11. 6 and 7. 9 months in combination group and chemotherapy group, respectively, with significant difference (P=0. 020). The difference was found in improvement of quality of life (QOL) between combination group and chemotherapy group (57. 4% vs 32. 1 % , P=0. 008). The side effects in two groups included gastrointestinal toxicities, neuropathy, alopecia and bone marrow suppression. However, Ⅲ/Ⅳ neutropenia was significantly less in combination group(37. 0%) when compared with chemotherapy group (58. 5%, P = 0. 043). Conclusions In first-line treatment of MCC, Fufangbanmao capsules combined with FOLFOX4 regimen showed synergic and enhanced effect for improving TTP and QOL, and also reduced the incidence of neutropenia.