ASSESSMENT OF TOLERANCE OF AEROSOLIZED PENTAMIDINE IN PEDIATRIC PATIENTS

儿科患者雾化喷他脒的耐受性评估

• 批准号: 3853058
• 负责人: F P OGNIBENE
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3853058
• 关键词: HIV infections; Pneumocystis; Pneumocystis pneumonia; adenocarcinoma; bronchospasm; child (0-11); clinical trials; drug screening /evaluation; drug tolerance; heart rate; human subject; human therapy evaluation; image processing; liver neoplasms; metastasis; monoclonal antibody; neoplasm /cancer immunodiagnosis; neoplasm /cancer radionuclide diagnosis; nuclear medicine; oxygen tension; pediatric pharmacology; pentamidine; radioimmunoassay; radionuclide diagnosis; radionuclide imaging /scanning; radiotracer; respiratory reflex

There are (as of yet) no definitive data concerning the appropriate dose or the most tolerable delivery system for aerosolized pentamidine in pediatric patients with HIV infection who require prophylaxis against Pneumocystis carinii. Using a delivery and dosage regimen similar to that recommended for adult patients, we are assessing the tolerance of aerosolized pentamidine in children. All patients are receiving aerosolized pentamidine as prophylaxis based on a clinical indication of either sulfa intolerance or low CD4 counts. Specifically addressed in the assessment of tolerance are physiologic parameters, such as heart rate, respiratory rate, oxygen saturation, cough, and evidence of bronchospasm. Subjective assessment includes whether or not there was a bad taste or burning associated with the aerosolization of pentamidine. Tolerance data are being collected serially and chronologically on all HIV-infected children receiving this prophylaxis regimen in the MICU. To date, the major side effects have been bronchospasm that is reversible with bronchodilator aerosolization (5 of 22 patients) and coughing without oxygen desaturation (16 of 22 patients). Thus, preliminary data indicate good tolerance without serious side effects. This clinical project is ongoing.

(到目前为止)还没有关于适当剂量或 小儿最耐受雾化喷胺释药系统 需要预防肺孢子虫的HIV感染患者 卡里尼。使用与推荐方案相似的分娩和剂量方案 对于成年患者，我们正在评估雾化吸入的耐受性 儿童中的戊二胺类药物。所有患者都在接受雾化吸入 基于磺胺或磺胺的临床适应症的预防 不耐受或CD4细胞计数过低。 在耐受性评估中具体涉及的是生理学 参数，如心率、呼吸频率、血氧饱和度、咳嗽、 以及支气管痉挛的证据。主观评价包括是否 有一种难闻的味道或与雾化有关的灼热 五烷双胺。正在按顺序收集公差数据并 按时间顺序记录所有接受这种预防措施的艾滋病毒感染儿童 MICU里的养生法。到目前为止，主要的副作用是 雾化吸入支气管扩张剂可逆转的支气管痉挛(5/22 无氧减饱和咳嗽(22例中16例)。 因此，初步数据表明，耐受性良好，没有严重的副作用 效果。这个临床项目正在进行中。