在暴露于MDR结核病的儿童中使用利沃弗洛克萨辛预防治疗
Anneke C Hesseling1, Susan E Purchase1, Neil A Martinson1
1From the Department of Pediatrics and Child Health, Desmond Tutu TB Centre, Stellenbosch University, Stellenbosch (A.C.H., S.E.P., H.S.S., A.G.-P., E.B., A.-M.D., S.N., J.A.S., L. Frigati), the Perinatal HIV Research Unit (N.A.M.) and the Faculty of Health Sciences, Wits Research Health Institute (L. Fairlie), University of the Witwatersrand, and Isango Lethemba TB Research Unit, Port Elizabeth, Wits Health Consortium (F.C.), Johannesburg, and the Tuberculosis and HIV Investigative Network, Durban (S.S.) - all in South Africa; the Johns Hopkins Center for TB Research, Baltimore (N.A.M.); the Medical Research Council Clinical Trials Unit at University College London (J.B., D.M.G., C.M., C.L., R.T., T.D.) and the Department of Infectious Disease, Imperial College London (J.A.S.) - both in London; the Department of Pediatrics, School of Medicine and Public Health, University of Wisconsin-Madison, Madison (A.G.P.); and the Division of Microbiology, Department of Laboratory Medicine, Centre Hospitalier Universitaire Sainte-Justine, and the Department of Microbiology, Immunology, and Infectious Diseases, Faculty of Medicine, University of Montreal - both in Montreal (A.-M.D.).
利沃素在暴露于MDR结核病的儿童中显示出降低多药耐药结核病 (MDR TB) 的趋势,但结果在统计学上并不显著. 需要进一步的研究来确认其作为预防治疗的有效性.
科学领域:
- 儿童传染病 儿童传染病
- 结核病的研究研究.
- 临床试验方法论 临床试验方法论
背景情况:
- 耐多药结核病 (MDR-TB) 构成了严重的全球健康威胁,尤其对儿童来说,有效的预防治疗证据有限.
- 大约有200万15岁以下的儿童感染了MDR结核病,每年约有3万例新发病例.
研究的目的:
- 评估勒沃素作为预防性治疗暴露于多药耐药结核病 (MDR TB) 的儿童的疗效和安全性.
- 评估勒沃素对儿童群体结核病发病率的影响,家庭暴露于MDR结核病.
主要方法:
- 一个基于社区,多站点,双盲,集群随机化,安慰剂受控的试验在南非进行.
- 家庭暴露于细菌学证实的MDR肺结核的儿童每天接受利沃素或安慰剂,持续24周.
- 主要终点是48周发生的结核病;安全性被评估为3级或更高的不良事件.
主要成果:
- 结核病发生在1.1%的儿童接受levofloxacin对比2.6%接受安慰剂在48周 (危险比,0.44;95% CI,0.15至1.25).
- 利沃克萨辛和安慰剂组之间的结核病发病率差异在统计学上并不显著.
- 可能与治疗方案相关的3级或更高的不良事件发生在4名参与者中,其中4名参与者在勒沃富洛克萨辛组,8名参与者在安慰剂组.
结论:
- 与安慰剂相比,使用勒沃素的预防治疗并没有显著降低暴露于MDR结核病的儿童的结核病发病率.
- 虽然观察到发病率下降的趋势,但研究结果强调需要进一步研究儿童有效的MDRTB预防策略.
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