重组人血小板生成素治疗化疗相关性血小板减少的研究

Studies of Recombinant Human Thrombopoietin（rhTPO） on Thrombocytopenia Induced by Chemotherapy

目的 观察重组人血小板生成素（rhTPO）治疗肺癌患者化疗所致血小板减少的疗效和不良反应.方法 采用病例自身对照研究,对第一个周期（对照组）化疗后血小板（PLT）≤50×109/L的18例肺癌患者,在下一周期（治疗组）所有患者接受5次rhTPO 15,000u皮下注射（SC）,三次化疗前（第-3、-2、-1天）,两次化疗后（第1、8天）,两个周期化疗方案均为吉西他滨1.0g/m2第1、8天＋顺铂75m/m2第1天,监测两研究组血小板计数变化及毒副反应.结果 在化疗后3、6、9、12、15、18、21天,治疗组平均血小板计数均高于对照组,治疗组和对照组化疗后血小板最低时间分别出现在第15天和第12天,最低值分别为（56±13.0）×109/L和（33.8±14.0）×109/L,两组差异有统计学意义.对照组有4例患者输注血小板,而治疗组无一例.无明显不良反应发生.结论 通过合理的rhTP0使用方法（三次化疗前,两次化疗后）可以明显地降低化疗相关性血小板减少的发生,无明显不良反应.

Objective To investigate the effect and safety of domestically produced recombinant human for the treatment of chemotherapy induced thrombocytopenia. Methods A total of 18 NSCLC patients who developed chemotherapy-induced thrombocytopenia（≤50× 10^9/L） after the Cycle l（control group） of chemotherapy was studied by self-cross control.All patients received five doses of rhTPO at 15,000u in Cycle 2（treatment group）.rhTPO was given as three doses before （pre） and two doses after （post） chemotherapy （days -3,-2 ,-1, 1,and 8）,patients received a course of chemotherapy at the same doses in two group using the identical regimen（Gemcitabine 1,000mg/m2 on days 1,8 ＋ Cisplatin 75mg/m2 on day l）.The platelet counts and toxycity of two study groups were monitored. Results The mean platelet count of the patients after rhTPO treatment were higher at the time points of day 3,6,9, l 2,15,18,21 during the Cycle 2 of chemotherapy than that during the Cycle l.The early platelet nadir of Cycle 1 was on day 12 with the mean pletelet count of （33.8±14.0）×109/L., versus （56±13.0）Х 10^9/L on day 15 in Cycle 2（ P〈0.01）.4 patients in Cycle 1 received platelet transfusion, but not one case of the Cycle 2.No significant adverse effect relative to rhTPO treatment. Conclusion By optimizing the timing, five doses of rhTPO （three before and two after chemotherapy） were required to significantly reduce the severity of chemotherapy-related thrombocytopenia.No significant adverse effect.