重组人血小板生成素联合糖皮质激素治疗成人原发免疫性血小板减少症的临床观察

The Treatment of Newly Diagnosed Primary Immune Thrombocytopenia by Recombinant Human Thrombopoietin Combined with Glucocorticoid

目的:评价重组人血小板生成素(rh TPO)联合糖皮质激素治疗新诊断成人原发免疫性血小板减少症(ITP)的有效性和安全性。方法:选取2018年9月-2019年10月新诊断ITP患者34例,男11例、女23例,中位年龄52(20-76)岁,分为试验组(17例)和对照组(17例)。试验组给予rhTPO 300 IU/(kg·d)联合糖皮质激素治疗;对照组给予rhTPO(15 000 IU/d)联合糖皮质激素治疗。比较两组患者治疗后血小板数、血小板增幅以及总有效率,观察药物的不良反应。结果:试验组治疗后d 14 PLT数及PLT增幅均明显高于对照组基线水平(P<0.05)。治疗后d 3、7试验组和对照组PLT数及PLT增幅差异均无统计学意义(P>0.05)。试验组与对照组在d 7、l4的完全缓解率、总反应率差异均无统计学意义(P>0.05)。试验组、对照组分别有13、12例患者进行了血小板输注。试验组出现轻度肝酶升高、轻微肌肉酸痛不适各1例,对症处理后恢复正常。结论:与常规剂量相比,足剂量rhTPO联合糖皮质激素治疗新诊断ITP患者,d 14血小板数、较基线PLT增幅更大,且具有良好的安全性。

Objective: To evaluate the efficacy and safety of recombinant human thrombopoietin(rhTPO) combined with glucocorticoid in treatment of newly diagnosed adult primary immune thrombocytopenia(ITP). Methods: Eleven male and 23 female patients with the diagnosis of primary ITP in our hospital from November 2018 to October 2019 were enrolled and randomly divided into test group(17 cases) and control group(17 cases), the median age was 52 y ears old(range: 20-76 years old). The patients in test group were treated with rhTPO 300 IU/(kg·d) combinedwith glucocorticoid, while the patients in control group were treated with rhTPO(15 000 IU/d) combined withg lucocorticoid. Platelet count, platelet increase, as well as the overall response rate were compared. At the same time,the drug tolerance and any adverse drug reactions were observed. Results: The platelet counts and platelet increase of the patients in the test group were significantly higher than those in control group(P<0.05). There was no significantd ifference in platelet counts and platelet increase between the patients in the test group and control group at day 3,7 after treatment. There was no significant difference in overall response rates and complete response rates at day 7,14 between the two groups either. In test group, there were 13 cases received platelet transfusion, while 12 cases inc ontrol group. The muscle aches occurred in one patient, and mild aminotransferase increased in another patient in test group which was self-recovery without treatment. Conclusion: RhTPO 300 U/(kg·d) combined with glucocorticoidc ould rapidly increase the platelet count with a lowincidence of tolerable adverse events compared with conventional dose rhTPO with glucocorticoid.