目的 觀察艾迪注射液聯(lián)合GP化療方案治療表皮生長(zhǎng)因子酪氨酸激酶抑制劑(EGFR-TKI)治療失敗后的晚期非小細(xì)胞肺癌(NSCLC)的臨床療效。方法 選取2011年12月—2013年12月襄陽(yáng)市中心醫(yī)院接受EGFR-TKI治療后出現(xiàn)獲得性耐藥的62例晚期NSCLC患者, 分為對(duì)照組和治療組, 每組各31例。對(duì)照組給予GP方案常規(guī)化療:注射用鹽酸吉西他濱1 000 mg/m², 1次/d, 持續(xù)靜脈滴注3 h, 第1、8天給藥;順鉑注射液75 mg/m², 1次/d, 靜脈滴注, 第1天給藥。21天為1個(gè)周期, 連續(xù)觀察2個(gè)周期。治療組在對(duì)照組的基礎(chǔ)上靜脈滴注艾迪注射液, 50 mL溶于5%葡萄糖溶液500 mL靜滴, 1次/d, 2周為1個(gè)療程, 連續(xù)使用3個(gè)療程。評(píng)價(jià)兩組患者的近期療效指標(biāo)客觀有效率(ORR)、疾病控制率(DCR)以及遠(yuǎn)期療效指標(biāo)無(wú)進(jìn)展生存期(PFS)、總生存期(OS)。患者的生活質(zhì)量(KPS)以Karnofsky評(píng)分進(jìn)行評(píng)定。對(duì)毒副反應(yīng)進(jìn)行評(píng)價(jià)。結(jié)果 62例患者均可評(píng)價(jià)療效, 其中治療組ORR 61.29%, DCR 83.87%, 對(duì)照組ORR 35.48%, DCR 70.97%, 治療組的ORR、DCR均明顯高于對(duì)照組, 兩組比較差異具有統(tǒng)計(jì)學(xué)意義(P<0.05、0.01)。治療組中位PFS為6.3(1.2~20.6)個(gè)月, 對(duì)照組中位PFS為3.4(0.7~10.3)個(gè)月, 兩組比較差異具有統(tǒng)計(jì)學(xué)意義(P<0.05)。治療組死亡患者的中位OS為15.1(1.4~28.2), 對(duì)照組死亡患者的中位OS為8.9(1.0~17.2)個(gè)月, 兩組患者中位OS差異無(wú)統(tǒng)計(jì)學(xué)意義。治療后, 治療組患者的KPS評(píng)分顯著高于對(duì)照組, 兩組比較差異具有統(tǒng)計(jì)學(xué)意義(P<0.01)。治療組不良反應(yīng)發(fā)生率為32.3%, 對(duì)照組不良反應(yīng)發(fā)生率為37.8%, 兩組不良反應(yīng)發(fā)生率比較無(wú)顯著性差異。治療組胃腸道反應(yīng)發(fā)生率為38.7%(12/31), 對(duì)照組胃腸道反應(yīng)發(fā)生率為51.6%(16/31), 與對(duì)照組比較顯著減少(P<0.01)。結(jié)論 艾迪注射液聯(lián)合GP化療方案治療EGFR-TKI獲得性耐藥的晚期NSCLC的療效較好, 能延緩疾病進(jìn)展, 延長(zhǎng)生存期, 提高生存質(zhì)量, 且減輕化療帶來(lái)的胃腸道反應(yīng), 值得臨床進(jìn)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.