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目的：观察国产拓扑替康单药二线治疗复发性小细胞肺癌（ small cell lung cancer, SCLC）和与顺铂联合方案治疗初治 SCLC的疗效及毒性。方法：采用多中心开放式研究方法，在 100例病例中有 97例符合入组条件，其中采用拓扑替康单药治疗的复发 SCLC 38例，用药方法为拓扑替康 1.25 mg/（ m2· d），连用 5天，每 3周一疗程；拓扑替康与顺铂联合用于初治 SCLC病例 59例，顺铂 80 mg/（ m2· d） d1，拓扑替康 1 mg/(m2· d)，连用 5天，每 3周一疗程。结果：拓扑替康单药用于复发 SCLC有效率为 37.5％，其中 CR 3.1％， PR 34.4％；与顺铂联合用于初治 SCLC有效率为 79.6％，其中 CR 22.4％， PR达 57.1％。主要的毒副作用为骨髓抑制，单药组 39 9％出现Ⅲ～Ⅳ度中性粒细胞缺乏，Ⅲ～Ⅳ度血小板下降 31.6％；而联合用药组Ⅲ～Ⅳ度中性粒细胞缺乏 61.0％，Ⅲ～Ⅳ度血小板下降 39.0％。非血液学毒性较轻。结论：拓扑替康是治疗 SCLC的有效药物之一，联合顺铂后可提高疗效。拓扑替康的主要毒副反应为血液学毒性。
OBJECTIVE: To observe the efficacy and toxicity of domestic topotecan in the treatment of relapsed small cell lung cancer (SCLC) and cisplatin in combination with cisplatin in the treatment of primary SCLC. METHODS: Using a multi-center, open-label study, 97 of the 100 cases met the enrollment criteria. 38 patients with relapsed SCLC treated with topotecan were treated with topotecan 1.25 mg/( m2 d ), once every 5 days for 3 days, topotecan combined with cisplatin for 59 cases of initial SCLC, cisplatin 80 mg/( m2 d) d1, topotecan 1 mg/(m2 d) , Use once every 5 days for 3 days. RESULTS: The effective rate of topotecan alone in relapsed SCLC was 37.5%, including CR 3.1% and PR 34.4%. The effective rate of combination with cisplatin in initial treatment of SCLC was 79.6%, of which CR 22.4% and PR were 57.1%. . The main toxic and side effects were myelosuppression. 39.9% of the patients in the monotherapy group had III to IV degree of neutrophil depletion, and III to IV degree of platelet decreased 31.6%; while in the combined treatment group, the III to IV degree of neutrophils were lacking in 61.0%. Grade III to IV platelets decreased by 39.0%. Non-hematological toxicity is lighter. Conclusion: Topotecan is one of the effective drugs for the treatment of SCLC. The combination of cisplatin can improve the efficacy. The main toxicity of topotecan is hematological toxicity.