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目的 :比较生物治疗方案 [康莱特 +干扰素α 1b(IFNα 1b,赛若金 ) ]与EP方案 (VP 16 +DDP)对Ⅲb～Ⅳ期初治非小细胞肺癌 (NSCLC)患者的近期疗效、毒性及生活质量的改善情况。方法 :A组 (34例 ) :康莱特 10 0ml,静滴 ,第1～ 14天 ,IFNα 1b3× 10 6U ,皮下注射 ,每周 3次 ;B组 (38例 ) :VP 16 80mg/m2 ·d ,静滴 ,第 1～ 5天 ,DDP 30mg/m2 ·d ,静滴 ,第 1～ 3天。两组均以每 3周为一周期 ,重复 3个周期。客观疗效与毒性反应按WHO标准来评价 ,临床受益疗效按行为状态评分及体重变化来评价。结果 :A、B两组有效率 (CR +PR)分别为 2 0 .6 %和 2 8.9% ,P >0 .0 5。Ⅲ～Ⅳ级的血液学毒性、口腔粘膜毒性、呕吐、腹泻及脱发等毒性仅见于B组 ,短暂性寒战、发热症状以A组显著多见 ,行为状态及体重变化 (临床受益疗效 )阳性率A组均明显高于B组 (P <0 .0 5 )。结论 :康莱特加IFNα 1b方案治疗晚期NSCLC的客观疗效与EP方案比较无明显差异 ,但前者毒副反应小 ,患者生活质量明显改善
OBJECTIVE: To compare the short-term efficacy of the biotherapeutic regimen [Kanglaite + interferon alpha 1b (IFNα 1b) and EP 16 (VP 16 + DDP) for patients with newly diagnosed non-small cell lung cancer (NSCLC) Toxicity and quality of life improvement. Methods: Group A (34 cases): Kanglaite 10ml, intravenous drip, days 1-14, IFNα 1b3 × 10 6U, subcutaneous injection 3 times a week; group B (38 cases): VP 1680mg / m2 · d, intravenous drip, 1 to 5 days, DDP 30mg / m2 · d, intravenous drip, the 1st to 3 days. Both groups were every 3 weeks for a cycle, repeat 3 cycles. Objective efficacy and toxicity according to WHO criteria to evaluate the clinical benefit of treatment according to behavioral status scores and weight changes to evaluate. Results: The effective rates (CR + PR) of A and B groups were 20.6% and 29.9%, respectively, P> 0.05. Grade Ⅲ ~ Ⅳ hematological toxicity, oral mucosal toxicity, vomiting, diarrhea and hair loss and other toxic only found in group B, transient chills, fever symptoms were more common in group A, behavioral status and weight change (clinical benefit) positive rate A group were significantly higher than the B group (P <0. 05). CONCLUSION: The objective efficacy of KLT plus IFNα 1b regimen in the treatment of advanced NSCLC is similar to that of EP regimen, but the former has less toxic side effects and significantly improved quality of life