重组人血小板生成素治疗化疗相关血小板减少的临床价值

Value of recombinant human thrombopoietin in the treatmeat of chemotherapy-induced thrombocytopenia in patients with solid tumor

目的评价国产重组人血小板生成素（rhTPO）治疗实体瘤患者化疗后血小板（PLT）减少的临床疗效和安全性。方法采用非随机、平行对照的研究方法对化疗后PLT〈75×10^9／L的72例患者进行观察治疗。治疗组35例，采用国产rhTPO治疗，15000U／d，皮下注射；对照组37例，采用重组人白细胞介素11（rhIL-11）治疗，3mg／d，皮下注射。结果用药后，治疗组和对照组PLT的最低值分别为（46．2±20．3）×10^9／L和（37．2±16．7）×10^9／L，PLT恢复的最高值分别为（250．2±159．0）×10^9／L和（160．5±96．4）×10^9／L，两组差异均有统计学意义（均P〈0．05）。治疗组Ⅲ、Ⅳ度PLT减少的发生率和持续时间均明显低于对照组（均P〈0．05）。治疗组PLT输注4例，对照组PLT输注11例。治疗组不良反应的发生率（11．4％）明显低于对照组（78．4％，P〈0．001），且程度较轻。结论国产rhTPO能明显地减少PLT降低的程度和持续时间，更快地促进PI｜T恢复，且患者不良反应轻，安全性好。

Objective To evaluate the efficacy and safety of domestically manufactured recombinant human thrombopoietin （rhTPO） in the treatment for chemotherapy-induced thrombocytopenia in patients with solid tumors. Methods A non-randomized controlled study was conducted. Seventy-two patients with platelet count 〈 75×10^9/L after chemotherapy were enrolled into this study according to the standard criteria of NCI-CTC toxicity stratification. Thirty-five patients in the treatment-group received subcutaneous injection of rhTPO at a dose of 15 000 U/d, another 37 patients in the control group received subcutaneous injection of rhIL-11 a at a dose of 3 mg/d as the paralleled control. Results The mean minimal platelet count after rhTPO treatment was （46.2 ±20.3 ） ×10^9/L in the treatment-group versus （37.2 ±16.7 ） ×10^9/L in the control-group （ P 〈 0.05 ）, while the mean maximal platelet count was （250.2 ±159.0） ×10^9/L versus （160.5 ±96.4）×10^9/L （P 〈0.05）. The incidence rate of adverse effects and duration of grade Ⅲ and Ⅳ thrombocytopenia in the treatment-group was also significantly lower than those in the control-group. Furthermore, the patients receiving platelet transfusion were 4/35 in the treatment-group versus 11/37 in the control-group （ P 〉 0.05）. The side-effect rate in the treatment-group was significantly lower than that in the control-group （ 11.4% versus 78.4% , P 〈 0.01 ）. Conclusion Compared with rhIL-11, administration of rhTPO after chemotherapy is safe and effective with mild adverse effects in reducing the degree and duration of thrombocytopenia.