目的 观察艾迪注射液联合GP化疗方案治疗表皮生长因子酪氨酸激酶抑制剂(EGFR-TKI)治疗失败后的晚期非小细胞肺癌(NSCLC)的临床疗效。方法 选取2011年12月—2013年12月襄阳市中心医院接受EGFR-TKI治疗后出现获得性耐药的62例晚期NSCLC患者, 分为对照组和治疗组, 每组各31例。对照组给予GP方案常规化疗:注射用盐酸吉西他滨1 000 mg/m², 1次/d, 持续静脉滴注3 h, 第1、8天给药;顺铂注射液75 mg/m², 1次/d, 静脉滴注, 第1天给药。21天为1个周期, 连续观察2个周期。治疗组在对照组的基础上静脉滴注艾迪注射液, 50 mL溶于5%葡萄糖溶液500 mL静滴, 1次/d, 2周为1个疗程, 连续使用3个疗程。评价两组患者的近期疗效指标客观有效率(ORR)、疾病控制率(DCR)以及远期疗效指标无进展生存期(PFS)、总生存期(OS)。患者的生活质量(KPS)以Karnofsky评分进行评定。对毒副反应进行评价。结果 62例患者均可评价疗效, 其中治疗组ORR 61.29%, DCR 83.87%, 对照组ORR 35.48%, DCR 70.97%, 治疗组的ORR、DCR均明显高于对照组, 两组比较差异具有统计学意义(P<0.05、0.01)。治疗组中位PFS为6.3(1.2~20.6)个月, 对照组中位PFS为3.4(0.7~10.3)个月, 两组比较差异具有统计学意义(P<0.05)。治疗组死亡患者的中位OS为15.1(1.4~28.2), 对照组死亡患者的中位OS为8.9(1.0~17.2)个月, 两组患者中位OS差异无统计学意义。治疗后, 治疗组患者的KPS评分显著高于对照组, 两组比较差异具有统计学意义(P<0.01)。治疗组不良反应发生率为32.3%, 对照组不良反应发生率为37.8%, 两组不良反应发生率比较无显著性差异。治疗组胃肠道反应发生率为38.7%(12/31), 对照组胃肠道反应发生率为51.6%(16/31), 与对照组比较显著减少(P<0.01)。结论 艾迪注射液联合GP化疗方案治疗EGFR-TKI获得性耐药的晚期NSCLC的疗效较好, 能延缓疾病进展, 延长生存期, 提高生存质量, 且减轻化疗带来的胃肠道反应, 值得临床进一步研究。

Objective To observe clinical efficacy of Aidi Injection combined with GP chemotherapy in advanced non-small cell lung cancer (NSCLC) with acquired resistance to Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI). Methods Patients (62 cases) with advanced NSCLC after failure of EGFR-TKI from Xiangyang Central Hospital from December 2011 to December 2013 were randomly divided into the control and treatment groups, and each group had 31 cases. The control group was treated with GP conventional chemotherapy. The patients were iv administered with Gemcitabine Hydrochloride for injection 1 000 mg/m², once daily, continuous intravenous dripping for 3 h in the first day. And also iv administered with Oxaliplatin for injection 75 mg/m², once daily, intravenous dripping in the first day. One course of treatment was 21 d, and the patients were treated for three courses. The patients in treatment group were iv administered with Aidi Injection 50 mL added into 500 mL 5% glucose injection on the basis of control group, twice daily. One course of treatment was 2 weeks, and the patients were treated for three courses. Recent clinical efficacy index including objective response rate (ORR) and disease control rate (DCR), and long-term clinical efficacy index including progression free survival (PFS) and overall survival (OS) in two groups were evaluated. At the same time, quality of life (KPS, characterized as Karnofsky score) and adverse reaction were compared between two groups. Results All 62 patients had been evaluated. ORR and DCR in treatment group were 61.29% and 83.87%, and those of control group were 35.48% and 70.97%, respectively, and there were differences between two groups (P < 0.05, 0.01). The median PFS of the treatment group and control group were 6.3 (1.2 — 20.6) months and 3.4 (0.7 — 10.3) months, respectively, with the significant difference between two groups (P < 0.05). The median OS of the treatment group and control group were 15.1 (1.4 — 28.2) months and 8.9 (1.0 — 17.2) months respectively, and the difference was no statistically significant in the same group. Karnofsky score of the treatment group was higher than that of control group, and there were differences between two groups (P < 0.01). Adverse reaction rates in the treatment and control groups were 32.3% and 37.8%, respectively, but there was no difference between two groups. Incidence of gastrointestinal reaction in the treatment and control groups were 38.7% (12/31) and 51.6% (16/31), respectively, with significant differences between two groups (P < 0.01). Conclusion Aidi Injection combined with GP chemotherapy is effective in patients with advanced NSCLC after acquired EGFR-TKI resistance, which can slow disease progression, prolong survival, improve the quality of life, and reduce the gastrointestinal reaction from chemotherapy, so it is worthy of further clinical research and promotion.