Aledort L M, Salama A, Kovaleva L, Robak T, Newland A C, Nugent D J, Brenner B, Zenker O
University Clinics Charite, Berlin, Germany.
Hematology. 2007 Aug;12(4):289-95. doi: 10.1080/10245330701383908.
This Phase III study examined the efficacy and safety of Rhophylac (CSL Behring AG, Bern, Switzerland), a highly pure, liquid-stable anti-D preparation, in chronic immune thrombocytopenic purpura (ITP).
Ninety-eight patients (96 adults, two adolescents) with chronic ITP and platelet counts < 30 x 10(9)/l received a single intravenous injection of 50 microg/kg bodyweight Rhophylac.
A response (defined as an increase in platelet count by >or= 20 x 10(9)/l to >or= 30 x 10(9)/l in the first 15 days after treatment) was seen in 66% of patients. Mean time to response was 3.1 +/- 3.0 days, and mean duration of response was 19.2 +/- 1.1 days for responders. The most frequent drug-related adverse events were chills, pyrexia, an increase in bilirubin, and headache; events were mainly mild or moderate. there was no severe hemolysis or renal failure.
rhophylac is well tolerated and efficacious in chronic itp.
本III期研究考察了高纯度、液体稳定的抗D制剂罗菲莱克（瑞士伯尔尼CSL贝林公司）治疗慢性免疫性血小板减少性紫癜（ITP）的疗效和安全性。
98例慢性ITP患者（96例成人，2例青少年），血小板计数<30×10⁹/L，接受单次静脉注射50μg/kg体重的罗菲莱克。
66%的患者出现反应（定义为治疗后前15天内血小板计数增加≥20×10⁹/L至≥30×10⁹/L）。有反应者的平均反应时间为3.1±3.0天，平均反应持续时间为19.2±1.1天。最常见的与药物相关的不良事件为寒战、发热、胆红素升高和头痛；这些事件主要为轻度或中度。未出现严重溶血或肾衰竭。
罗菲莱克在慢性ITP中耐受性良好且有效。
