国产卡铂的注射液与粉针剂对比的临床研究

目的：观察国产卡铂注射液的疗效及毒性，并与卡铂粉针剂比较，方法全组121例小细胞肺癌（SCLC）、非小细胞肺癌（NSCLC）及乳腺癌（BC）患者随机进入卡铂注射液组（验证组）及粉针剂组（对照组），分别予CE、CIE及CAF方案化疗，两组所用药物及剂量完全一致。结果验证组与对照组SCLC的有效率分别为83．7％与72．2％（P＞0．05），NSCLC分别为11．5％与22．2％（P＞0．05），BC分别为71．4％与66．7％（P＞0．05）。两组毒性反应主要为骨髓抑制及胃肠道反应。验证组与对照组白细胞下降分别为82．4％及88．2％，血小板下降分别为42．4％与55．95，血红蛋白下降分别为61．2％与73．5％，毒性多为Ⅰ-Ⅱ度，恶心呕吐发生率分别为88．2％和91．2％，其中Ⅲ-Ⅳ度仅占9．4％与8．8％，两组间差异无显著意义。结论国产卡铂注射液疗效确切，有效率和毒性反应均与粉针剂相当，临床使用方便，价格低于同类进口药物，值得临床应用。

A comparative clinical study of carboplatin solution and carboplatin powder

OBJECTIVE: To observe the efficacy and side effects of carboplatin solution in comparison with carboplatin powder. METHODS: A multicenter, open randomized controlled trial was carried out. A total of 121 patients with small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC) and breast cancer (BC) were randomized into carboplatin injection group (study group) and carboplatin powder group (control group), treated with CE, CIE and CAF protocol, respectively. The same drugs and dosage were used in the two groups. RESULTS: The response rate of the study group and the control group was 94% and 67% in SCLC (P > 0.05), 12% and 22% in NSCLC (P > 0.05) and 71.4% and 67% in BC (P > 0.05), respectively. The major side effects were myelosuppression and gastrointestinal reactions, the frequency and intensity of which were statistically not different in the 2 groups of patients. CONCLUSION: Carboplatin solution is as effective as carboplatin powder for the treatment of cancer.