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一项双盲、随机、安慰剂对照临床试验,旨在评估莫匹罗星钙软膏消除医院工作人员鼻腔金黄色葡萄球菌携带的安全性和有效性。

A double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of mupirocin calcium ointment for eliminating nasal carriage of Staphylococcus aureus among hospital personnel.

作者信息

Fernandez C, Gaspar C, Torrellas A, Vindel A, Saez-Nieto J A, Cruzet F, Aguilar L

机构信息

Preventative Medicine Department, San Carlos University Hospital, Madrid, Spain.

出版信息

J Antimicrob Chemother. 1995 Mar;35(3):399-408. doi: 10.1093/jac/35.3.399.

Abstract

Sixty-eight health care workers were enrolled in a double-blind clinical trial and randomized to receive either mupirocin calcium ointment or placebo, intranasally bid for 5 days. Nasal cultures were taken immediately before starting treatment, 1 and 2 during treatment, at the end of treatment, 3 days later, weekly for 1-5 weeks and then monthly for 2-6 months after treatment. Mupirocin eliminated nasal carriage with Staphylococcus aureus in 58% of subjects within two days and 86.7% subjects by the end of therapy compared to 9.4% subjects at the end of treatment with placebo (P < 0.001). Post-treatment colonization rates of 43%, 56% and 67% were attained after 1 month, 2-4 and 6 months treatment with mupirocin respectively and recolonisation with the same strain of S. aureus that had been isolated before treatment was noted in 32%, 40% and 48%. No resistance to mupirocin developed and the drug was well tolerated. Mupirocin is safe and effective in suppressing nasal carriage of S. aureus.

摘要

68名医护人员参与了一项双盲临床试验,随机分为两组,分别接受莫匹罗星钙软膏或安慰剂治疗,每天两次经鼻给药,持续5天。在开始治疗前、治疗期间第1天和第2天、治疗结束时、治疗结束3天后、治疗后1 - 5周每周以及治疗后2 - 6个月每月采集鼻拭子培养。与安慰剂治疗结束时9.4%的受试者相比,莫匹罗星在两天内消除了58%受试者的金黄色葡萄球菌鼻腔定植,治疗结束时消除了86.7%受试者的鼻腔定植(P < 0.001)。分别在莫匹罗星治疗1个月、2 - 4个月和6个月后,治疗后定植率分别达到43%、56%和67%,并且观察到在治疗前分离出的同一株金黄色葡萄球菌重新定植的比例分别为32%、40%和48%。未出现对莫匹罗星的耐药性,且该药物耐受性良好。莫匹罗星在抑制金黄色葡萄球菌鼻腔定植方面安全有效。

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