国产卡铂的注射液与粉针剂对比的临床研究  

A comparative clinical study of carboplatin solution and carboplatin powder

作　　者：李青[1] 周际昌[1] 屈凤莲[1] 宋恕平[2] 王秀向[3] 

机构地区：[1]中国医学科学院中国协和医科大学肿瘤研究所肿瘤医院内科,北京100021 [2]山东省肿瘤医院 [3]山东医科大学附属医院肿瘤中心

出　　处：《中华肿瘤杂志》2001年第2期170-172,共3页Chinese Journal of Oncology

摘　　要：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 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), nonsmall 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>005), 12% and 22% in NSCLC (P>005) and 714% and 67% in BC (P>005), 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. [WT5”HZ]Conclusion Carboplatin solution is as effective as carboplatin powder for the treatment of cancer.

关 键 词：卡铂 注射液 粉针剂 抗癌药 对比研究 

分 类 号：R969[医药卫生—药理学]