海曲泊帕联合泼尼松治疗原发免疫性血小板减少症的疗效分析

Efficacy Analysis of Hetrombopag Combined with Prednison in the Treatment of Primary Immune Thrombocytopenia

关键词:  海曲泊帕  泼尼松  原发免疫性血小板减少症  疗效分析

Key words:  hetrombopag  prednison  primary immune thrombocytopenia  efficacy analysis

摘要:

目的 探讨海曲泊帕联合小剂量泼尼松治疗对既往治疗无效/复发原发免疫性血小板减少症(primary immune thrombocytopenia，ITP)患者的疗效及安全性。方法 选择2021年7月— 2022年8月甘肃省人民医院血液科收治的对既往治疗无效/复发的ITP患者40例，采用随机对照试验的研究方法，根据治疗方案分为观察组与对照组，每组各20例，观察组应用海曲泊帕联合小剂量泼尼松治疗，对照组应用小剂量泼尼松单药治疗，比较2组疗效、不良反应。结果 治疗第6周，观察组血小板计数 (platelet count，PLT)≥50×10⁹·L^?1、 PLT ≥30×10⁹·L^?1患者比例均高于对照组[90%(18/20) vs 50%(10/20)，P＝0.006；90%(18/20) vs 65%(13/20)，P＝0.130]。观察组6周治疗期内至少1次 PLT ≥50×10⁹·L^?1的患者比例高于对照组[90%(18/20) vs 55%(11/20)，P＝0.147]。观察组治疗6周内第1次达到PLT≥50×10⁹·L^?1的中位时间为3周，与对照组相同。治疗6周后中位血小板计数观察组高于对照组[97.50(58.25~166.75)×10⁹·L^?1 vs 45.50(13.25~82.50)×10⁹·L^?1 ，P<0.05]。治疗后观察组第1~6周中位PLT计数均高于对照组，疗效显著。2组患者对该方案耐受良好，不良反应程度较轻，对症治疗后很快好转。结论 海曲泊帕联合小剂量泼尼松治疗对既往治疗无效/复发原发免疫性血小板减少症有效率高，疗效优于单独使用，不良反应可耐受，可在临床推广使用。

Abstract:

OBJECTIVE To investigate the efficacy and safety of hetrombopag combined with low-dose prednison in the treatment of patients with refractory/recurrent primary immune thrombocytopenia(ITP). METHODS A total of 40 patients with ITP who failed to respond to previous treatment or relapsed in the Department of Hematology of Gansu Provincial People’s Hospital From July 2021 to August 2022 were selected. Used randomized controlled trial research methods, according to the treatment plan, they were divided into observation group and control group, with 20 cases in each group. The control group was treated with low-dose prednison alone. The observation group was combined with hetrombopag treatment on this basis. The efficacy and adverse reactions were compared between the two groups. RESULTS Treatment 6 weeks, patients who's proportion of platelet counts(PLT) reached≥50×10⁹·L^?1 and ≥30×10⁹·L^?1 in observation group were higher than control group with statistically significant differences in both groups[90%(18/20) vs 50%(10/20), P＝0.006; 90%(18/20) vs 65%(13/20), P＝0.130]; The study also indicated a statistically significant difference in favour of observation group compared with control group in the odds of achieving the outcome of a PLT≥50×10⁹·L^?1at least once during 6-week treatment[90%(18/20) vs 55%(11/20), P＝0.147], was more than placebo-treated one. The median time of PLT ≥ 50×10⁹·L^?1 for the first time within 6 weeks of treatment in the observation group was 3 weeks, which was the same as that in the control group. After 6 weeks of treatment, the median platelet count in the observation group was higher than that in the control group[97.50(58.25?166.75)×10⁹·L^?1 vs 45.50(13.25?82.50)×10⁹·L^?1 , P<0.05]. The median PLT count in the observation group was higher than that in the control group at week 1?6 after treatment, and the curative effect was significant. The two groups of patients tolerated the regimen well, and the degree of adverse reactions was mild, which improved quickly after symptomatic treatment. CONCLUSION Hetrombopag combined with low-dose prednison has a high effective rate in the treatment of refractory/recurrent ITP, which is better than that of single use, and the adverse reactions are tolerable, so it can be widely used in clinical practice.