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目的评价重组人血管内皮抑制素注射液(恩度)联合GP方案(吉西他滨+顺铂)化疗治疗中晚期非小细胞肺癌(NSCLC)的临床疗效及临床应用的安全性。方法48例符合入组条件的中晚期NSCLC患者随机分为两组,试验组22例,采用吉西他滨(GEM)1 000 mg/m2d1,8,顺铂(DDP)75 mg/m2分3 d给药,并于第1～14天每次给予恩度15 mg/d,21 d为1个周期。对照组26例,单用化疗,方案同治疗组,每3 w重复,至少2个周期评价疗效。结果两组可评价疗效42例,48例均可评价安全性。试验组和对照组的客观有效率分别为47.4%和30.4%(P>0.05),疾病控制率分别为89.5%和82.6%(P>0.05);试验组和对照组中位肿瘤进展时间(time to progression,TTP)分别为7和4.5个月(P<0.05);在血液学及非血液学毒性主要有中性粒细胞减少、血小板减少、恶心、呕吐、乏力、心律失常、过敏,两组不良反应发生率和治疗后生活质量差异不显著(P>0.05)。结论恩度与GP方案联合治疗晚期NSCLC与单用化疗相比,近期疗效略有提高,中位TTP显著延长;恩度不增加化疗的不良反应,具有较好的安全性。
Objective To evaluate the clinical efficacy and clinical safety of recombinant human endostatin injection (Endo) combined with GP (gemcitabine + cisplatin) chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC). Methods 48 patients with advanced NSCLC who met the enrollment criteria were randomly divided into two groups. Twenty-two patients in the experimental group were treated with gemcitabine (GEM) 1 000 mg/m 2d 1, 8 and cisplatin (DDP) 75 mg/m 2 for 3 days. , And on the 1st to the 14th day each time of Endo 15 mg/d, 21d is 1 cycle. In the control group, 26 patients were treated with chemotherapy alone, the treatment group was treated with the treatment group and repeated every 3 weeks. Efficacy was evaluated with at least 2 cycles. The results of the two groups can evaluate the efficacy of 42 cases, 48 cases can evaluate the safety. The objective effective rates of the test group and control group were 47.4% and 30.4% (P>0.05), the disease control rate was 89.5% and 82.6%, respectively (P>0.05); the median tumor progression time in the test group and control group (time To progression (TTP) were 7 and 4.5 months, respectively (P < 0.05); in hematological and non-hematologic toxicity, there were mainly neutropenia, thrombocytopenia, nausea, vomiting, fatigue, arrhythmias, and allergies. There was no significant difference in the incidence of adverse reactions and quality of life after treatment (P>0.05). Conclusion Endotherapy combined with GP regimen in the treatment of advanced NSCLC has slightly improved short-term efficacy compared with chemotherapy alone. The median TTP is significantly prolonged; Endo does not increase the adverse reactions of chemotherapy, and has good safety.