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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 12 1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 ) ,分别给予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 0 5 ) ,NSCLC分别为 11 5 %与 2 2 2 % (P >0 0 5 ) ,BC分别为 71 4%与 6 6 7% (P >0 0 5 )。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 5 5 9% ,血红蛋白下降分别为 6 1 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。
Objective To observe the curative effect and toxicity of domestic carboplatin injection and compare with carboplatin injection. Methods 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 (test group) and injection group (control group) , CIE and CAF regimen chemotherapy, the two groups of drugs and dosage exactly the same. Results The effective rates of SCLC in the validation group and control group were 83 7% and 72 2% respectively (P 0.05). The NSCLC rates were 115% and 122% respectively (P 0 05) 4% and 66.7% (P> 0.05). Two groups of toxic reactions mainly bone marrow suppression and gastrointestinal reactions. The leukopenia in the experimental group and the control group were 82 4% and 88 2% respectively, and the platelet counts were 42 4% and 55 9% respectively. The hemoglobin decreased 6 12% and 73 5% . The incidence of nausea and vomiting were 88.2% and 91.2%, respectively, of which Ⅲ ~ Ⅳ degrees accounted for only 94% and 8 8%, no significant difference between the two groups. Conclusion The domestic carboplatin injection is effective, effective and toxic reactions are comparable with the injection, the clinical convenience, the price is lower than similar imported drugs, it is worth clinical application.