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目的观察重组人白介素-11(rhIL-11)治疗化疗后血小板(PLT)减少的疗效和安全性,并探讨其作用机制。方法34例(76周期)化疗后PLT减少患者接受rhIL211治疗,25μg·kg-1·d-1,皮下注射,连用4~16d,或至PLT升高幅度≥50×109/L时停药。观察rhIL211的疗效及不良反应,以ELISA法检测用药前血清IL-11水平,以RT-PCR法检测单个核细胞表面IL-11受体α链mRNA(IL-11Rα)的表达,分析rhIL-11的疗效与血清IL-11水平及IL-11Rα表达的关系。结果第1和第2周期化疗前,PLT基础值分别为(135.0±54.3)×109/L和(259.4±64.5)×109/L;应用rhIL-11的天数分别为7~16d(中位时间12d)和4~10d(中位时间6d),第1和第2周期rhIL-11的应用天数相比,差异有统计学意义(P<0.05);化疗后PLT计数<50×109/L的持续天数分别为7~13d(中位时间10d)和3~8d(中位时间5d),第1和第2周期PLT降低的持续天数相比,差异有统计学意义(P<0.05)。有30个周期PLT计数最高值>300×109/L,PLT计数最高值出现在应用rhIL-11后第10~17天(中位时间14d)。用药前的血清IL-11水平与用药后PLT计数最高值呈负相关。主要不良反应为水肿、乏力、头晕头痛和肌肉、关节疼痛。结论rhIL-11治疗化疗引起的PLT减少安全有效,虽起效缓慢,但作用持久;检测用药前血清IL-11水平对预测rhIL-11
Objective To observe the efficacy and safety of recombinant human interleukin-11 (rhIL-11) in reducing platelet (PLT) after chemotherapy and to explore its mechanism. Methods Twenty-four patients (76 cycles) received rhIL211 treatment after treatment with PLT reduction. The patients were treated with 25 μg · kg-1 · d-1 subcutaneously for 4 ~ 16 days or until the PLT increase ≥50 × 109 / L. The therapeutic effect and adverse reaction of rhIL211 were observed. The level of IL-11 in serum before treatment was detected by ELISA. The expression of IL-11R mRNA on the surface of mononuclear cells was detected by RT-PCR. And its relationship with the level of serum IL-11 and the expression of IL-11Rα. Results The baseline values of PLT were (135.0 ± 54.3) × 109 / L and (259.4 ± 64.5) × 109 / L respectively before the first and the second cycles of chemotherapy. The days of rhIL-11 administration were 7-16 days 12d) and 4 ~ 10d (median time 6d), the first and second cycles of rhIL-11 compared to the number of days, the difference was statistically significant (P <0.05); after chemotherapy PLT count <50 × 109 / L The duration of days was 7 ~ 13d (median time 10d) and 3 ~ 8d (median time 5d), the first and second cycles PLT decreased compared to the number of days, the difference was statistically significant (P <0.05). The highest PLT count was> 300 × 109 / L in 30 cycles and the highest PLT count was observed in 10 ~ 17 days after rhIL-11 administration (median time 14 days). The level of serum IL-11 before treatment was negatively correlated with the highest PLT count after treatment. The main adverse reactions were edema, fatigue, dizziness, headache and muscle and joint pain. Conclusion The decrease of PLT induced by rhIL-11 is safe and effective, but it has a long-lasting effect.