【摘要】 背景：异基因造血干细胞移植是治疗恶性血液病的重要手段，术后血小板植入延迟是常见并发症，严重影响患者生存质量，然而，目前并无标准方案来提高血小板植入率和预防血小板植入延迟。目的：对比分析口服海曲泊帕与皮下注射重组人血小板生成素促进恶性血液病患者单倍体造血干细胞移植后血小板植入的安全性及有效性。方法：回顾性分析2016年1月至2022年10月进行单倍体造血干细胞移植的163例恶性血液病患者的临床资料。+2 d开始皮下注射重组人血小板生成素的患者共72例，归为重组人血小板生成素组；+2 d开始口服海曲泊帕的患者共27例，归为海曲泊帕组；未应用海曲泊帕及重组人血小板生成素的64例患者归为空白对照组。对3组植入情况、100 d内Ⅱ-Ⅳ度急性移植物抗宿主病发生率、1年生存率、1年复发率及安全性进行分析。结果与结论：(1)中位随访时间52(12-87)个月，空白对照组、重组人血小板生成素组、海曲泊帕组患者中性粒细胞植入时间分别为(12.95±3.88) d,(14.04±3.71) d,(13.89±2.74) d，差异无显著性意义(P=0.352)；血小板植入时间分别为(15.16±6.27) d,(17.67±6.52) d,(17.00±4.75) d，差异无显著性意义(P=0.287);(2)空白对照组、重组人血小板生成素组、海曲泊帕组第60天血小板完全植入率分别为64.06%,90.28%,92.59%，差异有显著性意义(P <0.001)；亚组分析显示，空白对照组与重组人血小板生成素组比差异有显著性意义(P <0.001)，空白对照组与海曲泊帕组比差异有显著性意义(P=0.004)，重组人血小板生成素组与海曲泊帕组比差异无显著性意义(P=0.535);(3)空白对照组、重组人血小板生成素组、海曲泊帕组100 dⅡ-Ⅳ度急性移植物抗宿主病发生率分别为25.00%,30.56%,25.93%，差异无显著性意义(P=0.752);(4)巨细胞病毒血症、巨细胞病毒肺炎、肝功能损伤发生率在3组间无显著性差异(P> 0.05);(5)随访期内，3组患者均未发生血栓事件；(6)结果表明，重组人血小板生成素、海曲泊帕均可提高恶性血液病患者单倍体造血干细胞移植后血小板的植入率，疗效相当且安全性良好。更多还原

【Abstract】 BACKGROUND: Allogeneic hematopoietic stem cell transplantation is an important treatment for malignant hematological diseases, and delayed postoperative platelet implantation is a common complication that seriously affects the quality of patient survival; however, there are no standard protocols to improve platelet implantation rates and prevent platelet implantation delays.OBJECTIVE: To compare the safety and efficacy of oral Herombopag Olamine versus subcutaneous recombinant human thrombopoietin for promoting platelet implantation in patients with malignant hematological diseases undergoing haploid hematopoietic stem cell transplantation. METHODS: Clinical data of 163 patients with malignant hematological diseases who underwent haploidentical hematopoietic stem cell transplantation from January 2016 to October 2022 were retrospectively analyzed. A total of 72 patients who started to subcutaneously inject recombinant human thrombopoietin at +2 days were categorized into the recombinant human thrombopoietin group; a total of 27 patients who started to orally take Herombopag Olamine at +2 days were categorized into the Herombopag Olamine group; and 64 patients who did not apply Herombopag Olamine or recombinant human thrombopoietin were categorized into the blank control group. The implantation status, incidence of acute graft-versus-host disease of degree II-IV within 100 days, 1-year survival rate, 1-year recurrence rate, and safety were analyzed in the three groups.RESULTS AND CONCLUSION:(1) The average follow-up time was 52(12-87) months. The implantation time of neutrophils in the blank control group, recombinant human thrombopoietin group, and Herombopag Olamine group was(12.95±3.88) days,(14.04±3.71) days, and(13.89±2.74) days, respectively, with no statistically significant difference(P=0.352); the implantation time of platelets was(15.16±6.27) days,(17.67±6.52) days, and(17.00±4.75) days, with no statistically significant difference(P=0.287).(2) The complete platelet implantation rate on day 60 was 64.06%, 90.28%, and 92.59%, respectively, and the difference was statistically significant(P < 0.001). The subgroup analysis showed that the difference between the blank control group and the recombinant human thrombopoietin group was statistically significant(P < 0.001), and the difference between the blank control group and the Herombopag Olamine group was statistically significant(P=0.004). The difference was not statistically significant between the recombinant human thrombopoietin group and Herombopag Olamine group(P=0.535).(3) 100-day II-IV degree acute graft-versus-host disease incidence in the blank control group, recombinant human thrombopoietin group, and Herombopag Olamine group were 25.00%, 30.56%, and 25.93%, respectively, and the difference was not statistically significant(P=0.752).(4) The incidence of cytomegalovirus anemia, cytomegalovirus pneumonia, and hepatic function injury had no statistical difference among the three groups(P > 0.05).(5) During the follow-up period, there was no thrombotic event in any of the three groups of patients.(6) The results showed that recombinant human thrombopoietin and Herombopag Olamine could improve the platelet implantation rate of malignant hematological disease patients after haploidentical hematopoietic stem cell transplantation, with comparable efficacy and good safety.更多还原