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The Safety, Toleration, and Pharmacokinetics Comparison of Two Intravenous Voriconazole Formulations in Healthy Chinese Volunteers after Three Ascending Doses 三次上升剂量后两种伏立康唑静脉注射制剂在中国健康志愿者中的安全性、耐受性和药代动力学比较
Pub Date : 1900-01-01 DOI: 10.23880/apct-16000193
Jin Wang
Voriconazole is a triazole antifungal agent with potent activity against a broad spectrum of clinically significant pathogens to treat infections and invasive aspergillosis and immunocompromised patients as prophylactic drug. The large variability of plasma exposure of voriconazole for injection is related with adverse drug reactions (ADRs), including visual impairment, rash and abnormal liver function test. Because the poorly dissolution of voriconazole in aqueous media, the toxicity of the excipient accumulation of sulfobutyl ether-beta-cyclodextrin sodium salt (SBECD) contained in the intravenous voriconazole may occur in renally impaired patients. The Betadex sulfobutyl ether sodium and SBECD as a solubilizer in the new formulation of intravenous voriconazole injection may improve the related ADRs. The present article evaluate the safety, toleration, and pharmacokinetics (PKs) comparison of two intravenous voriconazole injection formulations after three ascending dose administrations in healthy Chinese subjects by a randomized, double-blind, placebo- and positive-controlled trial.
伏立康唑是一种三唑类抗真菌药物,对广泛的临床重要病原体具有有效活性,可作为预防药物治疗感染、侵袭性曲霉病和免疫功能低下患者。注射用伏立康唑血浆暴露的大变异性与药物不良反应(adr)有关,包括视力损害、皮疹和肝功能检查异常。由于伏立康唑在水溶性较差,静脉注射伏立康唑时所含的磺基丁基醚- β -环糊精钠盐(SBECD)的赋形物积累可能对肾功能受损患者产生毒性。Betadex磺基丁基醚钠和SBECD作为新剂型静脉伏立康唑注射液的增溶剂可改善相关不良反应。本文通过随机、双盲、安慰剂和阳性对照试验,评价了两种伏立康唑静脉注射制剂在三次递增剂量后的安全性、耐受性和药代动力学(PKs)的比较。
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引用次数: 0
Dermatology Prescriptions by Abulcasis Al-Zahrawi (C.936-C.1013) 阿布卡西斯·扎赫拉维(C.936-C.1013)的皮肤病处方
Pub Date : 1900-01-01 DOI: 10.23880/apct-16000175
L. M. Arvide Cambra
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引用次数: 0
Local Perception of Coronavirus and Disease Care in Southwestern Nigeria 尼日利亚西南部当地对冠状病毒的认知和疾病护理
Pub Date : 1900-01-01 DOI: 10.23880/apct-16000179
Aderemi Sa
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引用次数: 0
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Advances in Pharmacology & Clinical Trials
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