目的 观察拓扑替康联合多西他赛治疗小细胞肺癌的临床疗效，并评价其有效性和安全性。方法 将2010年1月-2013年1月来高唐县人民医院就诊的小细胞肺癌患者100例，随机分为治疗组和对照组，各50例。对照组iv多西他赛注射液75 mg/（m²·d），治疗组在对照组的基础上注射用盐酸拓扑替康1.5 mg/（m²·d）；3周为一个周期，至少治疗4周期。治疗结束后，比较两组的临床疗效和不良反应。结果 治疗组和对照组的部分缓解率分别为36.0%、28.0%，疾病控制率分别为74.0%、58.0%，两组比较差异有统计学意义（P<0.05）。治疗组和对照组的中位生存时间分别为10.2、7.3个月，中位无进展生存时间分别为3.2、2.1个月，两组比较差异有统计学意义（P<0.05）。治疗过程中两组患者均可发生恶心、呕吐、腹泻、食欲不振、肝功能损害、肾功能损害、咳嗽、发热、皮疹、痤疮、白细胞减少、血小板减少、血红蛋白降低等不良反应。治疗组患者消化系统和血液系统的不良反应比较大，28.0%出现恶心，24.0%发生白细胞减少，28.0%血小板减少，与对照组比较差异有统计学意义（P<0.05）。其他不良反应与对照组比较没有统计学意义。结论 拓扑替康联合多西他赛治疗小细胞肺癌的疗效显著，安全有效，值得临床借鉴。

Objective To observe the clinical efficacy of topotecan combined with docetaxel in treatment of small cell lung cancer and to evaluate the efficacy and safety for clinic. Methods The patients (100 cases) with small cell lung cancer who came to Gaotang County People's Hospital from January 2010 to January 2013 were randomly divided into treatment and control groups, 50 cases in each group. The patients in the control group were treated with 75 mg/(m²·d) Docetaxel for Injection. On the basis of control group, the patients in the treatment group were given 1.5 mg/(m²·d) Topotecan Hydrochloride for Injection. One course was 3 weeks, and all patients accepted administration for at least four courses. The clinical efficacy and side effects of two groups were compared. Results The RR rates in the treatment and control groups were 36.0% and 28.0%; The DCR rates were 74.0% and 58.0%, with significant difference between two groups (P < 0.05). The median OS time was 10.2 and 7.3 months; The median PFS time was 3.2 and 2.1 months, with significant difference (P < 0.05). The patients in both groups had side effects such as nausea, vomiting, diarrhea, inappetence, abnormal liver function, abnormal renal function, cough, fever, rash, acne, reduced leukocyte, hemoglobin, and blood platelet. The patients in the treatment group had more serious adverse reactions in digestive and blood systems. Nausea (28.0%), reduced leukocyte (24.0%), and reduced blood platelet (28.0%) were higher than those in the control group with significant difference (P < 0.05). The remaining aspects adverse reactions in patients showed no significant difference between two groups. Conclusion Topotecan combined with docetaxel in the treatment of small cell lung cancer has good effect, and it is a safe and effective manner worthy of reference.

国家自然科学基金资助项目（30971307）