康莱特联合吉西他滨、顺铂治疗晚期非小细胞肺癌的临床疗效及安全性评价

Clinical efficacy and safety of Kanglaite combined with gemcitabine and cisplatinum chemotherapy in the treatment of advanced non-small cell lung cancer

目的评价康莱特联合吉西他滨＋顺铂方案治疗晚期非小细胞肺癌的临床疗效和安全性及其对T淋巴细胞亚群的影响。方法将69例晚期非小细胞肺癌患者随机分为对照组36例和试验组33例。对照组给予1000 mg·m^-2吉西他滨,第1,8天＋80 mg·m^-2顺铂,第2天,3周为1个周期,连续化疗2个周期;试验组在对照组的基础上,联合静脉点滴康莱特200 m L,10 d为1个周期,随化疗连续应用2个周期。2个化疗周期结束后,进行2组的临床疗效、T淋巴细胞亚群（CD3,CD4和CD8）活性及不良反应评价。结果治疗后,对照组客观有效率为22.22%略低于试验组27.27%（P〉0.05）。治疗后,试验组T淋巴细胞亚群CD3、CD4和CD8值显著高于对照组（P〈0.05）。2组患者主要不良反应为骨髓抑制和胃肠道反应,试验组Ⅲ~Ⅳ级不良反应发生率显著低于对照组（P〈0.05）。结论康莱特联合西他滨和顺铂治疗晚期非小细胞肺癌可提高患者T淋巴细胞亚群比例,降低化疗相关不良反应发生率。

Objective To evaluate the clinical efficacy, safety and affection for T lymph cell subgroup by gemcitabine and cisplatinum chemotherapy combined with Kanglait in the treatment of advanced nonsmall cell lung carcinoma. Methods Sixty -nine non -small lung cancer patients were included in this study and randomly divided into control group （n = 36） and treatment group （n = 33 ）. The patients in the control group were treated with gemcitabine 1000 mg·m^-2 day 1, 8 ＋ cisplatinum 80 mg ·m^-2, day 2, three weeks per cycle with 2 cycles treatment. Patients in the treatment group were treated with basis on control group, plus Kanglaite injection 200 mL for 2 cycles with the chemotherapy regimen. After qd x 10 days per cycle 2 cycles chemo treatment, the clinical efficacy, chemotherapy related toxicity therapy and T lymph cell subgroup were analyzed between the two groups. Results The objective response rate were 22.22% and 27.27% for the control and treatment group respectively without statistical difference （P 〉 0. 05 ）. The T lymph cell subgroup in treatment group was signifi- cant higher than in the control group （P 〈 0.05）. The main chemotherapy related toxicity were bone marrow depression and gastrointestinal reaction with no statistical difference between the two groups （P 〉 0. 05）. Conclusion Gemcitabine ＋ cisplatinum chemotherapy combined with Kanglait can elevate the T lymph cell subgroup and decrease the chemotherapy toxicity.