Objective: To evaluate the efficacy and safety of recombinant human thrombopoietin (rhTPO) treatment for primary immune thrombocytopenia (ITP) patients during the perioperative period. Methods: Adult ITP patients who were refractory to first-line glucocorticoid therapy and underwent selective surgery were enrolled to be treated with rhTPO at the dosage of 1.5×10(4)U/d subcutaneously during the perioperative period. rhTPO treatment would not be terminated until one of the following conditions occurred: ①Platelet counts met the requirement of surgery; ②Platelet counts were ≥100×10(9)/L; ③Completed the 14 days of therapy. End points of the study were surgery rate, rhTPO therapy response rate, rescue therapy rate and adverse responses. Results: 42 patients were enrolled from Jan. 1, 2016 to Jun. 30, 2018. 14 were male and 28 were female. The median age was 60 (25-73) years old. There were no newly diagnosed patients. 5 patients were persistent and 37 were chronic. 27 patients completed selective surgery. The surgery rate was 64.3% (27/42) . Among them, 13 patients were under local anesthesia and 14 under general anesthesia. Of 42 cases receiving rhTPO therapy. 31 patients achieved responses, The overall response rate was of 73.8%. Among them, 24 patients achieved CR. The CR ratio was 77.4% (24/31) . 7 achieved response. The response ratio was 22.6% (7/31) . 11 patients did not respond to rhTPO therapy. The non-response rate was 26.2% (11/42) . The median time to reach CR was 7 (3-16) days. The median time to reach the peak of platelet counts were 10 (3-21) days. rhTPO was used for a median of 7 (3-14) days. The median platelet counts of patients undergoing surgery before rhTPO therapy, before surgery and at day 7 after surgery were 33 (20-89) ×10(9)/L, 125 (78-245) ×10(9)/L and 72 (30-250) ×10(9)/L, respectively. The median peak of platelet counts was 149 (101-466) ×10(9)/L. No infection, bleeding, thromboembolism and therapy-related adverse responses occurred in the patients. Conclusion: rhTPO for ITP patients during the perioperative period is safe and effective.
目的： 观察成人原发免疫性血小板减少症（ITP）患者围手术期应用rhTPO的疗效和安全性。 方法： 对拟接受择期手术的一线糖皮质激素治疗无效的ITP患者在围手术期应用重组人血小板生成素（rhTPO）1.5×10(4) U/d皮下注射，直至符合下列任何一个条件则停止：①血小板计数达到手术要求；②PLT≥100×10(9)/L；③疗程达14 d。 结果： ①2016年1月1日至2018年6月30日共入组42例患者，男14例，女28例，中位年龄60（25~73）岁，持续性ITP 5例，慢性ITP 37例。②中位rhTPO疗程7（3~14）d。完全反应24例，有效7例，无效11例。达到完全反应的中位时间为7（3~16）d，血小板计数达峰值中位时间为10（3~21）d。③27例（64.3%）完成手术（全麻手术14例，局麻手术13例）。④手术患者rhTPO治疗前、手术前、手术后第7天中位血小板计数分别为33（20~89）×10(9)/L、125（78~245）×10(9)/L、72（30~250）×10(9)/L，中位峰值血小板计数为149（101~466）×10(9)/L。⑤未发生感染、出血、血栓和rhTPO相关不良事件。 结论： rhTPO可作为ITP患者择期手术围手术期提升血小板水平的备选方案。.
Keywords: Perioperative period; Thrombocytopenia; Thrombopoietin.