氯尼达明联合NP方案治疗30例晚期非小细胞肺癌

目的:观察氯尼达明片联合长春瑞滨+ 顺铂（NP）治疗晚期非小细胞肺癌（NSCLC ）的有效性和安全性。方法:将2006年2 月～2007年6 月在大连医科大学第二临床学院肿瘤科确诊的30例符合入组条件的NSCLC 患者随机分为试验组和对照组，试验组采用国产NVB+DDP方案化疗联合口服氯尼达明片（LND ），第1～2 天，150mg/次，1 次/天，第3～4 天，150mg/次，2 次/天，第5～21天，150mg/次，3 次/天，饭后口服，连续服用至试验结束或肿瘤进展，21天为1 个周期。对照组单用国产NVB+DDP方案化疗，同时口服LND 模拟片，剂量及用法同治疗组。每个周期观察其不良反应，每2 个周期评价疗效。研究的终点目标是有效率（RR）、临床获益率（CBR ）、肿瘤进展时间（TTP）、生存状况（ECOG 评分）以及安全性。结果:23例可评价疗效的患者中，试验组和对照组的近期有效率（CR+PR）分别为36.4% 和33.3%（P<0.05）；临床获益率（CR+PR+SD ）分别为100% 和91.7%（P>0.05），试验组略高于对照组，但差异无统计学意义；肿瘤中位进展时间（TTP）分别为4 个月和3.75个月，差异无统计学意义（P>0.05）；治疗后，两组白细胞下降、胃肠道反应等方面的发生率，差异无统计学意义（P 均>0.05）；在血色素下降、乏力、便秘等不良反应的发生率试验组要略高于对照组（P 均<0.05）；而在血小板下降程度方面试验组较对照组轻（P<0.05）；治疗前后ECOG 评分，差异有统计学意义（P<0.05），试验组优于对照组。结论:国产NVB+DDP治疗非小细胞肺癌疗效确切，患者耐受性一般，同时口服氯尼达明片能增强疗效，并有改善患者生存质量的趋势，具有较好的临床应用前景，但尚需进一步临床试验评价。 

LND and NP Regimen Treatment for Advanced Non-small Cell Lung Cancer

Objective: To compare the response rate and safety in patients with advanced non-small cell lung cancer (NSCLC) when treated with LND plus vinorelbine and cisplatin (NP) or placebo plus NP. Methods:A total of 30NSCLC pa -tients seen in our hospital between February 2006and June2007were collected and randomly assigned to the trial group or the control group. The trial group was treated with LND plus NP. Vinorelbine was administered intravenously on days
1-8, with 25mg/m2and cisplatin on days 1-3, with 80-100 mg/m2, every 3 weeks for at least 3 cycles. LND was administered orally after meal for the first 1-2 days, 150 mg/time, once a day, the first3-4 days, 150 mg/time, twice a day, the first5-21 days, 150 mg/time, 3 times a day, taking a row to the end of the trial or tumor progression. The treatment was repeated ev-ery 21days. Patients in the control group received placebo plus NP, at the same dose and route of administration as the tri-al group. The efficacy and side effects were observed. The trial endpoints included response rate (RR), clinical benefit rate (CBR), time to progression (TTP), quality of life and safety. Results: Of the 23assessable patients, the overall response rate was 36.4% in the trial group and 33.3% in the control group (P<0.05). The clinical benefit rate was 100 % in the trial group and 91.7% in the control group (P>0.05). The median TTP was 4 months and3.75months, respectively ( P>0.05). No significant difference was found in adverse effects between the two groups. After treatment, the incidence of thrombocy-topenia, anemia, constipation and fatigue was lower in the trial group ( P<0.05). The ECOG PS score in the trial group was lower than that in the control group ( P<0.05). Conclusion:NVB + DDP is safe and effective for non-small cell lung cancer. LND plus NP enhance efficacy and improve the quality of life, indicating good prospects for clinical application. Further eval-uation in clinical trials is warranted.