重组人血管内皮抑制素联合化疗治疗晚期非小细胞肺癌的临床观察

Clinical Observation of Recombinant Human Endostatin Combined with Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer

目的：观察重组人血管内皮抑制素联合吉西他滨和奈达铂序贯给药治疗晚期非小细胞肺癌（NSCLC）的疗效和安全性。方法：将48例NSCLC患者随机分为观察组与对照组。观察组采用序贯给药方案：重组人血管内皮抑制素7.5 mg/m2（d1-d14）＋吉西他滨1 000 mg/m2（d4、d11）＋奈达铂80 mg/m2（d4）。对照组单用化疗方案：吉西他滨1 000 mg/m2（d1、d8）＋奈达铂80 mg/m2（d1）。21 d为1个周期,治疗2个周期后评价有效率（RR）、疾病控制率（DCR）、药品不良反应。对于稳定期和有效的患者继续给予化疗2-4个周期直至疾病进展,随访生存时间。结果：观察组RR为33.3%,显著高于对照组的8.3%,差异有统计学意义（P〈0.05）;观察组DCR为87.5%,高于对照组的70.8%,但差异无统计学意义（P〉0.05）;观察组与对照组的中位生存时间分别为14、11个月,两组生存曲线比较观察组优于对照组（P〈0.05）。在不良反应方面两组差异无统计学意义（P〉0.05）。结论：重组人血管内皮抑制素联合吉西他滨和奈达铂序贯给药方案可提高患者的临床疗效及生存期,安全性好。

OBJECTIVE： To observe therapeutic efficacy and safety of sequential dosage regimen of recombinant human end- ostatin combined with gemcitabine and platinum in the treatment of advanced non-small cell lung cancer （NSCLC）. METHODS： 48 NSCLC patients were randomly divided into observation group and control group. Observation group received sequential dosage regimen： recombinant human endostatin 7.5 mg/m2 on dl-d14, gemcitabine 1 000 mg/m2 on dl and dll and platinum 80 mg/m2 on d4. Control group received chemotherapy alone： gemcitabine 1 000 mg/m2 on ld and 8 d, platinum 80 mg/m2 on dl. A treatment course lasted for 21 days. Response rate （RR）, disease control rate （DCR） and ADR were evaluated after 2 courses of treatment. The patients on the stable and effective phase continued to accept 2-4 courses until disease progression, and survival time was tbl- lowed up. RESULTS： RR of observation group was 33.3%, which was significantly higher than that （8.3%） of control group; there was statistical significance （P〈0.05）. DCR of observation group was 87.5%, which was significantly higher than that （70.8%） of control group; there was no statistical significance （P〉0.05）. The median survival time of 2 groups were 14 months and 11 months, respectively; the survival curve of observation group was better than that of control group （P〈0.05）. There was no statistical signifi- cance in the occurrence of ADR between 2 groups （P〉0.05）. CONCLUSIONS： Sequential dosage regimen of recombinant human endostatin combined with gemcitabine and platinum can improve clinical efficacy and survival time with good safety.