甘氨双唑钠对晚期非小细胞肺癌化疗的增敏作用

Sensitization-enhancing Efficacy of Glycididazole Natrium in Patients with Advanced Non-small Cell Lung Cancer

目的观察甘氨双唑钠(CMNa)对晚期非小细胞肺癌(NSCLC)化疗增敏作用及其安全性。方法经病理或细胞学证实的晚期NSCLC患者56例,随机分为化疗增敏组(TP方案+CMNa组)25例和单独化疗组(TP方案组)31例进行比较。结果总有效率增敏组为40.0%,化疗组为35.5%,前者略高于后者,但差异无统计学意义(P>0.05);平均生存期增敏组和化疗组分别为19.4月和19.5月,1、2年生存率增敏组分别为70.8%、40.1%,化疗组分别为69.4%、32.7%,两组间差异无统计学意义(P>0.05)。主要毒副反应是血液学毒性,恶心呕吐、肌肉酸痛,周围神经毒性,肾功能损害等,但两组间差异无统计学意义(P>0.05)。结论CMNa对晚期非小细胞肺癌的化疗增敏作用,在近期疗效及1、2年生存率上较单纯化疗略有提高,但均无统计学差异,不良反应无明显增加。扩大样本量及增加化疗周期能否取得较好的近、远期疗效,尚有待于进一步临床研究。

Objective To explore whether the administration of Glycididazole natrium （CMNa） in advanced nonsmall cell lung cancer （NSCLC） patients can enhance the chemo-sensitivity and to evaluate its safety. Methods Patients with NSCLC confirmed by pathologic and/or cellular evidences were randomly divided into to chemo-sensitivity enhancing （CSE） group （25 patients, TP treating and CMNa） or control group （31 patients, TP treating alone）. The chemo-therapy efficacy and side-effects were recorded and analyzed. Results Compared with the control group, the patients in the CSE group seems had a higher total effective rate with no significant difference （40.0% in CSE group, 35.5% in control group, P〉0.05）. The mean survival time, 1 year and 2 years survival rate of the CSE and control group was 19. 4 months, 19. 5 months, and 70. 8%, 40.1%, and 69. 4%, 32. 7% respectively. The main side-effects were hematologic toxicity, nausea and vomiting, muscular soreness, peripheral neurotoxicity and renal dysfunction There was no significant difference existing between groups. Conclusion Administration of CMNa may enhance the chemo-sensitivity of NSCLC without obvious side effects. However, large scale clinical trial is required for the further confirmation of short and long term efficacy