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用于治疗蓝氏贾第鞭毛虫引起的腹泻的新型抗感染药物评估。美国传染病学会和美国食品药品监督管理局。

Evaluation of new anti-infective drugs for the treatment of diarrhea caused by Giardia lamblia. Infectious Diseases Society of America and the Food and Drug Administration.

作者信息

Cooperstock M, DuPont H L, Corrado M L, Fekety R, Murray D M

机构信息

Department of Pediatrics, University of Missouri Medical School, Columbia.

出版信息

Clin Infect Dis. 1992 Nov;15 Suppl 1:S244-8. doi: 10.1093/clind/15.supplement_1.s244.

DOI:10.1093/clind/15.supplement_1.s244
PMID:1477237
Abstract

Giardia lamblia is a flagellate protozoan that produces symptoms by infecting the small bowel and biliary tract in the trophozoite form. Diagnosis is currently established by microscopic visualization of the organism in appropriate intestinal contents (stool, small-bowel contents, or biopsy specimen). Adult patients with diarrhea and one or more enteric symptoms may be enrolled in clinical trials of new drugs for the treatment of giardial disease. A randomized, double-blind, active-concurrent-control design is recommended. Post hoc stratification by age, immune status, chronicity of disease, and ease of establishing diagnosis (organism load) may be performed. Microbiological assessment 48 hours to 7 days after the completion of therapy is paramount for determining final outcome.

摘要

蓝氏贾第鞭毛虫是一种鞭毛虫原生动物,其滋养体形式感染小肠和胆道会产生症状。目前通过在适当的肠道内容物(粪便、小肠内容物或活检标本)中显微镜观察该生物体来进行诊断。有腹泻及一种或多种肠道症状的成年患者可纳入治疗贾第虫病新药的临床试验。推荐采用随机、双盲、活性同期对照设计。可根据年龄、免疫状态、疾病慢性程度以及诊断确立的难易程度(病原体负荷)进行事后分层。治疗结束后48小时至7天的微生物学评估对于确定最终结果至关重要。

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