RheothRx (poloxamer 188) injection for the acute painful episode of sickle cell disease: A pilot study
RheothRx (poloxamer 188) injection for the acute painful episode of sickle cell disease: A pilot study
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DOI：
10.1182/blood.v90.5.2041
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发表时间：
1997-09-01
期刊：
影响因子：
20.3
通讯作者：
Emanuele, M
中科院分区：
文献类型：
--
作者：
AdamsGraves, P;Kedar, A;Emanuele, M
RheothRx（Glare Wellcome Inc，三角研究园，北卡罗来纳州；泊洛沙姆 188）注射液是一种非离子表面活性剂，具有血液流变学特性，表明它可能有助于治疗镰状细胞病 (SCD) 的急性疼痛发作（血管闭塞危象）。我们进行了一项随机、双盲、安慰剂对照的初步研究，以评估泊洛沙姆（RheothRx 注射液）对 50 名 SCD 患者的安全性和有效性。需要肠外镇痛药的中度至重度疼痛发作的患者被随机分配接受 48 小时输注 RheothRx 或安慰剂。每 4 小时评估一次疼痛。功效终点包括：（1）疼痛发作持续时间，（2）住院天数，（3）使用的镇痛药数量，以及（4）疼痛强度评分。根据研究药物输注的实际持续时间和疼痛评分数据收集的完整性，考虑对三个患者亚组进行疗效分析。与安慰剂相比，根据亚组的不同，RheothRx 治疗的患者疼痛发作持续时间减少 16% 至 45%，住院时间减少 1 至 2 天，镇痛需求减少三至五倍，72 小时平均疼痛强度评分减少 1 分（使用 5 分制）。 RheothRr 耐受性良好；在不良经历或其他安全措施方面，治疗之间没有观察到临床显着差异。此外，治疗组之间复发性疼痛发作的发生率没有差异。在这项研究中，RheothRr 显着减少了镇痛药的总使用量和疼痛强度，并显示出疼痛发作持续时间和住院总天数缩短的趋势。对于中度至重度血管闭塞性疼痛的患者，RheothRx 是安全的，并且可能提供治疗益处。 (C) 1997 年，美国血液学会。
RheothRx (Glare Wellcome Inc, Research Triangle Park, NC; poloxamer 188) Injection is a nonionic surfactant with hemorrheologic properties that suggest it may be useful in treating acute painful episodes (vasoocclusive crises) of sickle cell disease (SCD). We conducted a randomized, double-blind, placebo-controlled pilot study to evaluate the safety and efficacy of poloxamer, formulated as RheothRx Injection, in 50 patients with SCD. Patients with moderate to severe painful episodes requiring parenteral analgesics were randomized to receive a 48-hour infusion of either RheothRx or placebo. Pain was assessed every 4 hours. Efficacy endpoints included: (1) painful episode duration, (2) days of hospitalization, (3) quantity of analgesics used, and (4) pain intensity scores. Three subgroups of patients were considered for efficacy analyses based on the actual duration of the study drug infusion and the completeness of pain score data collection. Compared with placebo and depending on the subgroup, RheothRx-treated patients showed a 16% to 45% decrease in duration of painful episodes, a 1- to 2-day reduction in hospital stay, a threefold to fivefold reduction in analgesic requirements, and a 1-point reduction (using a 5-point scale) in average pain intensity scores at 72 hours. RheothRr was well tolerated; no clinically significant differences were observed between treatments with respect to adverse experiences or other safety measures. In addition, there were no differences between treatment groups in the incidence of recurrent painful episodes. In this study, RheothRr significantly reduced total analgesic use and pain intensity and showed trends to shorter duration of painful episodes and total days of hospitalization. In patients with moderate to severe vasoocclusive pain, RheothRx was safe and may offer a therapeutic benefit. (C) 1997 by The American Society of Hematology.