培美曲塞联合吉西他滨与吉西他滨单药治疗胰腺癌患者的临床对照研究

Controlled clinical study on effect of Pemetrexed combined with Gemcitabine contrasted with Gemcitabine in pancreatic adenocarcinoma

目的对比观察培美曲塞联合吉西他滨化疗与吉西他滨单药治疗胰腺癌的临床疗效,进一步优化胰腺癌化疗方案。方法将72例非手术治疗的胰腺癌患者随机分为两组:联合化疗组35例,静脉滴注培美曲塞600 mg/m2与吉西他滨1 000mg/m2联合化疗。单药治疗组37例,吉西他滨单药600 mg/m2化疗,疗程均为4个周期(每个周期间隔21 d)。26周进行近期疗效及安全性分析,随访2年观察患者生存期。结果 (1)疾病控制率(DCR):联合治疗组为62.86%,单药治疗组为51.35%,两组比较差异无统计学意义(χ2=0.97,P=0.32);但早期患者联合治疗组DCR(85.71%)优于单药治疗组(56.52%),两组比较差异有统计学意义(χ2=4.49,P=0.034);(2)生存时间:联合治疗组中位生存时间为8.9个月,单药治疗组为8.1个月,两组比较无统计学差异。(3)不良反应:联合治疗组粒细胞、血小板减少和肝功能异常的发生率(60.2%、53.9%、54.2%)均高于单药组(32.1%、24.3%、27.0%),差异有统计学意义(P<0.05)。结论培美曲塞与吉西他滨联合化疗可以提高早期胰腺癌患者的疗效,同时也相应地增加对骨髓造血功能的抑制和肝损伤的风险。

Objective To observe the different effects of Pemetrexed combined with Gemcitabine vs Gemcitabine alone in treatment of pancreatic adenocarcinoma, and to optimize the chemotherapy further. Methods The pancreatic cancer patients(72 cases) with non-surgical treatment were divided into two groups. The 35 patients in combined group were administered with Pemetrexed 600 mg/m2 combined with Gemcitabine 1 000 mg/m2, and the 37 patients in monotherapy group accepted Gemcitabine single for 4 cycles(Q21days). The shot-term efficacy and safety were observed and analysed at 26 weeks. The survival time of patients was followed up for 2 years. Results(1) The disease control rate(DCR) of two groups had no significant difference(χ2 = 0.97, P = 0.32), and that of combined group was 62.86%, monotherapy group was 51.35%. But the DCR of combined group was higher than that of the other group in the early stage patients(85.71% vs 56.52%), with significant difference(χ2 = 4.49, P = 0.034).(2) The medium survival time was 8.9 months in combined group and 8.1 months in monotherapy group. There was no difference between two groups.(3) The incidence rate of neutrophilic granulocytopenia, thrombocytopenia, and liver function damage in combined group(60.2%, 53.9%, and 54.2%) were higher than those in the other group(32.1%, 24.3%, and 27.0%). There was significant difference between two groups, but the incidence rate of the whole body and the digestive tract symptoms in two groups had no difference. Conclusion Pemetrexed combined with Gemcitabine chemotherapy could improve the curative effect of early pancreatic carcinoma vs Gemcitabine singe chemotherapy, however, increased the inhibition of bone marrow hematopoietic function and live function damage meanwhile.