目的 对比分析重组人血小板生成素（rhTPO）、重组人白介素-11（rhIL-11）分别联合常规剂量糖皮质激素（地塞米松）治疗免疫性血小板减少性紫癜（ITP）的临床疗效。方法 选择安徽医科大学附属安庆第一人民医院2021年12月—2024年5月收治的85例ITP患者为研究对象，按随机数字表法分为rhTPO组（n＝42）与rhIL-11组（n＝43），rhTPO组给予rhTPO（15 000 U·d^-1） ＋地塞米松（10 mg·d^-1）； rhIL-11组给予rhIL-11（1200万U·d^-1） ＋予地塞米松（10 mg·d^-1），均连续治疗14 d，未达14 d但血小板已恢复正常则停用rhTPO或rhIL-11。观察两组疗效、血小板计数、出血评分、Th1细胞因子［白细胞介素-2（IL-2）、γ干扰素（IFN-γ）、肿瘤坏死因子-α（TNF-α）］、Th2细胞因子（IL-4、IL-5、IL-10）、不良反应。结果rhTPO组、rhIL-11组临床有效率差异无统计学意义（P＞0.05）。与治疗前比较，两组治疗后不同时间血小板计数均显著升高（P＜0.05），且rhTPO组的患者治疗后第4、7天的血小板计数均高于rhIL-11组（P＜0.05）。与治疗前比较，两组治疗后1 d出血评分开始降低，治疗后4、7 d两组出血评分均显著降低（P＜0.05），且rhTPO组的患者治疗后第4、7天的出血评分也均低于rhIL-11组（P＜0.05、0.01）。两组治疗后的IL-2、IFN-γ、TNF-α水平较治疗前均显著降低（P＜0.05），IL-4、IL-5、IL-10水平均显著升高（P＜0.05），但两组间比较差异无统计学意义（P＞0.05）。rhTPO组不良反应发生率低于rhIL-11组（P＜0.05）。结论 rhTPO联合常规剂量糖皮质激素、rhIL-11联合常规剂量糖皮质激素治疗ITP的疗效相当，且均可调节Th1、Th2免疫平衡，但rhTPO联合常规剂量糖皮质激素治疗时血小板恢复更快，不良反应更少。

Objective To compare and analyze the clinical efficacy of recombinant human thrombopoietin (rhTPO) and recombinant human interleukin-11 (rhIL-11) combined with conventional-dose glucocorticoid in the treatment of immune thrombocytopenic purpura (ITP). Methods A total of 85 patients with ITP in Anqing First People's Hospital Affiliated to Anhui Medical University from December 2021 to May 2024 were selected as the research subjects. According to the random number table method, they were divided into rhTPO group (n = 42) and rhIL-11 group (n = 43). The rhTPO group was given rhTPO (15 000 U·d^-1) + dexamethasone (10 mg·d^-1), while the·rhIL-11 group was given rhIL-11 (12 million U·d^-1) + dexamethasone (10 mg·d^-1), and both groups were continuously treated for 14 days, and rhTPO or rhIL-11 was discontinued when the platelet returned to normal level within 14 days. The efficacy, platelet count, bleeding score, Th1 cytokines (IL-2, IFN-γ, TNFα), Th2 cytokines (IL-4, IL-5, IL-10) and adverse reactions were observed in the two groups. Results There was no statistical significance in the clinical effective rate between rhTPO group and rhIL-11 group (P > 0.05). Compared with baseline, platelet counts in both groups significantly increased at all post-treatment time points (P < 0.05). Furthermore, platelet counts in the rhTPO group were significantly higher than those in the rhIL-11 group on posttreatment days 4 and 7 (P < 0.05). Compared with baseline, bleeding scores in both groups began to decrease on day 1 post-treatment, with significant reductions observed on days 4 and 7 (P < 0.05). Additionally, bleeding scores in the rhTPO group were significantly lower than those in the rhIL-11 group on post-treatment days 4 and 7 (P < 0.05, 0.01, respectively). After treatment, the levels of IL-2, IFN-γ and TNF-α in the two groups were decreased (P < 0.05); while the levels of IL-4, IL-5 and IL-10 were increased (P < 0.05), but there were no statistical differences between groups (P > 0.05). The incidence rates of adverse reactions in rhTPO group were lower than those in rhIL-11 group (P < 0.05). Conclusion The efficacy of rhTPO combined with conventional-dose glucocorticoid and rhIL- 11 combined with conventional-dose glucocorticoid in the treatment of ITP is comparable, and both drug regimens can regulate Th1 and Th2 immune balance, but rhTPO combined with conventional-dose glucocorticoid has faster platelet recovery and fewer adverse reactions.

R973

安徽省卫生健康委科研项目立项项目（AHWJ2021b067）