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目的探讨大剂量托瑞米芬增敏长春瑞滨和顺铂(NP方案)对非小细胞肺癌(NSCLC)的化疗及逆转肺癌多药耐药的效果。方法入组患者随机分为两组。治疗组采用大剂量托瑞米芬+NP方案治疗。对照组仅用NP方案治疗。治疗组患者在口服托瑞米芬后第2天和第8天抽血测定托瑞米芬血清浓度。结果治疗组PR 8例,SD 14例,PD 2例,有效率为33.3%。对照组PR 2例,SD19例,PD 3例,有效率为8.3%。治疗组与对照组相比,有效率差异有显著性(P<0.05)。治疗组中位生存期9.4个月,对照组为6.3个月,两组中位生存期差异有显著性(P<0.05)。治疗组1年生存率41.7%,对照组为20.8%,两组差异无显著性(P>0.05)。两组不良反应差异无显著性。托瑞米芬血清浓度在第2天和第8天均超过5μmol/L。结论通过随机对照研究证实,大剂量托瑞米芬能增敏长春瑞滨和顺铂对NSCLC的化疗及逆转肺癌多药耐药,联合NP方案治疗NSCLC安全有效。
Objective To investigate the effect of high-dose toremifene-sensitized vinorelbine and cisplatin (NP) chemotherapy on non-small cell lung cancer (NSCLC) and to reverse multidrug resistance in lung cancer. Methods Patients were randomly divided into two groups. The treatment group with high dose toremifene + NP treatment. The control group only treated with NP regimen. Patients in the treatment group were given toremifene serum concentrations on the second and eighth day after oral administration of toremifene. Results The treatment group PR 8 cases, SD 14 cases, PD 2 cases, the effective rate was 33.3%. The control group PR 2 cases, SD19 cases, PD 3 cases, the effective rate was 8.3%. The treatment group and the control group, the effective rate difference was significant (P <0.05). The median survival time was 9.4 months in the treatment group and 6.3 months in the control group, with significant difference between the two groups (P <0.05). The 1-year survival rate was 41.7% in the treatment group and 20.8% in the control group, with no significant difference between the two groups (P> 0.05). There was no significant difference in adverse reactions between the two groups. Toremifene serum concentrations exceeded 5 μmol / L on days 2 and 8. Conclusions Randomized controlled trials confirm that high dose toremifene can sensitize vinorelbine and cisplatin to chemotherapy of NSCLC and reverse multidrug resistance in lung cancer. It is safe and effective to treat NSCLC with NP regimen.