蛋白酶抑制剂的随机对照试验(saquinavir)结合齐多夫定在以前未经治疗的晚期艾滋病患者感染。

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维拉拉年代,Lazzarin, Carosi G, Sinicco, Armignacco O,安格拉诺克,Andreoni M, Tambussi G, Chiodera, Floridia M, Scaccabarozzi年代,Facey K,邓肯•我Boudes P, Bragman K

蛋白酶抑制剂的随机对照试验(saquinavir)结合齐多夫定在以前未经治疗的晚期艾滋病患者感染。

小红伞。1996年8月,1 (3):129 - 40。

PubMed ID

11322246 (在PubMed

]

文摘

本研究评估活动和艾滋病病毒蛋白酶抑制剂的耐受性,saquinavir,单独或结合齐多夫定。92以前未经治疗的感染艾滋病毒的患者CD4细胞计数< 300 / mm3参与并行,随机双盲研究。病人被随机分配接受5个治疗,每一天三次:600毫克的saquinavir;齐多夫定的200毫克;75、200或600毫克的saquinavir结合200毫克的齐多夫定。主要治疗期是16周,月度扩展的患者并没有显示出重大疾病进展或毒性。使用的治疗功效的主要措施是CD4细胞计数的变化在hiv - 1 RNA的浓度和等离子体(如由定量聚合酶链式反应)。600毫克剂量的saquinavir结合齐多夫定诱导1.6日志(4周后)和0.7日志(16周之后)值减少等离子体RNA浓度;这种降低是更大的比其他四个治疗组。600毫克的saquinavir与齐多夫定的组合也导致了更大、更持续改善CD4细胞计数比saquinavir或齐多夫定单一疗法或其他联合疗法。 In the group receiving 200 mg of saquinavir in combination with zidovudine, the maximal median change in CD4 cell count occurred at week 2 (85 cells/mm3), and by week 16 had fallen to 15 cells/mm3. In the group receiving 600 mg of saquinavir plus zidovudine, the median change in CD4 cell count remained high for the 16-week period (median change of 48 cells/mm3 at week 2 and 61 cells/mm3 at week 16). Saquinavir was safe and very well tolerated, either alone or in combination with zidovudine. The incidence of adverse events was greater in the four groups receiving zidovudine therapy, and all the most commonly reported adverse events have previously been associated with zidovudine therapy. Few changes in laboratory values occurred during the study, except for known zidovudine-associated toxicities. The most frequent abnormalities were raised aspartate aminotransferase and alanine aminotransferase levels, depressed calcium levels, and abnormally high or low phosphate levels. Despite the low oral bioavailability of saquinavir, combined virological and immunological data show definite antiviral activity in vivo for the combination of saquinavir at 600 mg plus zidovudine at 200 mg (each three times daily). The combination of drugs with different mechanisms of action represents an advance in the treatment of HIV infection.

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药物靶点

药物	目标	类	生物	药理作用	行动
Saquinavir	人类免疫缺陷病毒1型蛋白酶	蛋白质	人类免疫缺陷病毒1	是的	抑制剂	细节