安全性和有效性的第一行依氟鸟氨酸锥虫属brucei gambiense昏睡病在苏丹:队列研究。
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Priotto G, Pinoges L, Fursa IB,伯克B, Nicolay N, Grillet G, Hewison C, Balasegaram M
安全性和有效性的第一行依氟鸟氨酸锥虫属brucei gambiense昏睡病在苏丹:队列研究。
BMJ。2008年3月29日,336 (7646):705 - 8。doi: 10.1136 / bmj.39485.592674.BE。Epub 2008 3月5。
- PubMed ID
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18321960 (在PubMed]
- 文摘
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目的:评估依氟鸟氨酸的安全性和有效性作为第一线治疗非洲人类锥虫病。设计:队列研究。Ibba设置:控制项目,苏丹南部。参与者:1055名成人和儿童在第二阶段新诊断为16个月。主要结果测量:死亡、严重的药物反应,治疗24个月。结果:1055名患者接受依氟鸟氨酸为14天(400毫克/公斤/天成人和600毫克/公斤/天的96名儿童)。每个病人总体而言,2824年药物反应(2.7)发生在住院期间,1219年第一周后(43.2%)。严重影响反应138例(13.1%)患者(主要是癫痫、发烧、腹泻、和细菌感染),导致15人死亡。严重反应的危险因素包括脑脊液白细胞计数> = 100 x10 (9) / l(成人:优势比为2.6,95%可信区间1.5到4.6),癫痫(成人:5.9,2.0 - 13.3),和昏迷(孩子:9.3,2.5,34.2)。儿童接受高剂量没有经验增加毒性。 Follow-up data were obtained for 924 (87.6%) patients at any follow-up but for only 533 (50.5%) at 24 months. Of 924 cases followed, 16 (1.7%) died during treatment, 70 (7.6%) relapsed, 15 (1.6%) died of disease, 403 (43.6%) were confirmed cured, and 420 (45.5%) were probably cured. The probability of event free survival at 24 months was 0.88 (0.86 to 0.91). Most (65.8%, 52/79) relapses and disease related deaths occurred after 12 months. Risk factors for relapse included being male (incidence rate ratio 2.42, 1.47 to 3.97) and cerebrospinal fluid leucocytosis: 20-99x10(9)/l (2.35, 1.36 to 4.06); > or =100x10(9)/l (1.87, 1.07 to 3.27). Higher doses did not yield better effectiveness among children (0.87 v 0.85, P=0.981). Conclusions Eflornithine shows acceptable safety and effectiveness as first line treatment for human African trypanosomiasis. Relapses did occur more than 12 months after treatment. Higher doses in children were well tolerated but showed no advantage in effectiveness.
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