目的 研究重組人血小板生成素（rhTPO）聯(lián)合白介素-11衍生物（rhIL-11Ala10）治療化療所致血小板減少癥的臨床療效和安全性。方法 選取鄭州大學(xué)第一附屬醫(yī)院2012年6月—2013年6月接受化療期間出現(xiàn)血小板（Plt）≤50×109/L的實(shí)體瘤患者32例，采用自身交叉對(duì)照試驗(yàn)的方法將患者隨機(jī)分為AB、BA兩組，每組均接受兩階段治療。A療程為化療結(jié)束后12～24 h皮下注射rhTPO 1.5×104 U/次，1次/d，連續(xù)給藥2 d后換用rhIL-11Ala10皮下注射，1.5 mg/次，1次/d；B療程為化療結(jié)束后12～24 h單用rhIL-11Ala10皮下注射1.5 mg/次，1次/d。AB組第一階段為A療程，第二階段為B療程，BA組恰好相反。A、B療程的治療過程中當(dāng)Plt的絕對(duì)值升高≥50×109/L，或Plt≥100×109/L，或用藥達(dá)14 d即可停藥。監(jiān)測(cè)所有患者血小板生長情況和不良反應(yīng)。結(jié)果 聯(lián)合用藥與單一用藥相比，化療后血小板下降的最低值平均升高5×109/L，血小板恢復(fù)的最高值平均升高78×109/L，持續(xù)用藥的天數(shù)平均縮短了3.7 d，且不良反應(yīng)發(fā)生率低。結(jié)論 聯(lián)合應(yīng)用rhTPO和rhIL-11Ala10治療化療后血小板減少癥的臨床效果更優(yōu)，更經(jīng)濟(jì)，更安全。

Objective To observe the efficacy and adverse reactions of recombinant human thrombopoietin (TPO) combined with recombinant human interleukin-11 derivative (rhIL-11Ala10) in treatment of thrombocytopenia induced by chemotherapy. Methods In this randomized cross-over self-controlled clinical trial, 32 patients with malignant tumor in The First Affiliated Hospital of Zhengzhou University from June 2012 to June 2013 whose platelet count (Plt) was under or equal to 50 × 109 /L after chemotherapy were divided randomly into AB and BA groups. All the patients underwent two identical periods of therapy. In cycle A, rhTPO (1.5 × 104 U) was sc given once daily after 12—24 h of chemotherapy for 2 d consecutively, then rhIL-11Ala10 (1.5 mg) was sc given once daily. In cycle B, only rhIL-11Ala10 (1.5 mg) was sc given once daily after 12—24 h of chemotherapy. The Plt was recorded consecutively and the adverse reactions were observed. In AB group, the first period treated with cycle A and the second period with cycle B, while in BA group, the treatment was by contrast method. Both in the treatment of cycle A and B, if the Plt was improved to higher than 50 × 109 /L or reached 100 × 109 /L or even more or the patients had been treated for 14 d, the treatment should be stopped. The Plt was recorded and the adverse reactions were observed. Results Compared with cycle B, the mean minimum Plt was 5 × 109/L higher in cycle A and the maximum Plt was 78 × 109 /L. The period of medication in cycle A was 3.7 d shorter than cycle B, and the adverse reaction rate was lower. Conclusion It is more effective, economical, and safer for TPO combined with rhIL-11Ala10 in the treatment of thrombocytopenia induced by chemotherapy.