作为艾滋病相关的毒性脑炎的预防药物,克林达米辛的毒性. 关于艾滋病的临床研究的社区计划
M A Jacobson1, C L Besch, C Child
1Department of Medicine, University of California, San Francisco.
Lancet (London, England)
|February 8, 1992
概括
针对艾滋病毒患者的毒性脑炎的克林达米辛预防导致显著更多的不良事件,包括腹和皮疹,导致试验中止. 在正在进行的研究中,甲胺预防继续进行.
科学领域:
- 传染性疾病 传染性疾病
- 临床药理学 临床药理学
- 艾滋病毒 医学 艾滋病毒 医学
背景情况:
- 毒素性脑炎 (TE) 是艾滋病毒感染患者的一种严重的机会性感染.
- 预防对于预防风险人群的TE至关重要.
- 现有的预防方案需要仔细评估安全性和有效性.
研究的目的:
- 为了比较克林达米辛与甲胺的安全性和有效性,用于艾滋病毒感染患者的TE预防.
- 评估与克林达米辛预防相关的不良事件的发生率.
- 根据临时安全数据确定是否需要提前终止试验.
主要方法:
- 进行了一项双盲,安慰剂控制的试验.
- 参与者是艾滋病毒感染患者,有毒素性脑炎的风险.
- 患者接受了克林达米辛,甲胺或安慰剂.
主要成果:
- 与安慰剂相比,克林达米辛治疗与需要药物停用不良事件的可能性增加了4.4倍.
- 腹 (31%) 和皮疹 (21%) 在克林达米辛组明显更频繁.
- 由于安全问题,该试验的克林达米辛分支被提前终止.
结论:
- 在艾滋病毒患者中,克林达米辛对TE的预防与高发生不良事件率有关.
- 观察到的不良事件需要提前终止克林达米辛治疗组.
- 目前正在对这种人群中皮里甲胺对TE的预防进行进一步的研究.
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