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在接受妥布霉素和哌拉西林联合治疗的发热性中性粒细胞减少患者中替考拉宁与万古霉素的双盲比较:对环孢素A相关肾毒性的影响

Double-blind comparison of teicoplanin versus vancomycin in febrile neutropenic patients receiving concomitant tobramycin and piperacillin: effect on cyclosporin A-associated nephrotoxicity.

作者信息

Kureishi A, Jewesson P J, Rubinger M, Cole C D, Reece D E, Phillips G L, Smith J A, Chow A W

机构信息

Division of Infectious Diseases, University of British Columbia, Vancouver, Canada.

出版信息

Antimicrob Agents Chemother. 1991 Nov;35(11):2246-52. doi: 10.1128/AAC.35.11.2246.

DOI:10.1128/AAC.35.11.2246
PMID:1839490
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC245367/
Abstract

A prospective, randomized, and double-blind study comparing teicoplanin with vancomycin in the initial management of febrile neutropenic patients was conducted. Teicoplanin was administered at 6 mg per kg of body weight every 24 h (q24h) intravenously (i.v.) after initial loading at 6 mg/kg q12h for three doses. Vancomycin was administered at 15 mg/kg q12h i.v. Patients also received piperacillin (3 g q4h i.v.) and tobramycin (1.5 to 2.0 mg/kg q8h i.v.). Of 53 patients enrolled, 50 were judged to be evaluable. Among these, 25 received teicoplanin and 25 received vancomycin. At enrollment, both groups were comparable in age, sex, renal function, underlying hematologic condition, and concurrent therapy. Both groups had similar sites of infection and microbial pathogens. Empirical antimicrobial therapy resulted in the cure of or improvement in 23 (92%) teicoplanin patients and 21 (84%) vancomycin patients (P = 0.67). Failures occurred with two vancomycin patients but no teicoplanin patients. Clinical response was indeterminate for two patients in each group. Adverse reactions occurred significantly more often in the vancomycin group than in the teicoplanin group (P = 0.01), and these reactions required the termination of the study regimens of 6 vancomycin versus 0 teicoplanin patients (P = 0.02). Nephrotoxicity was observed more frequently in the vancomycin group (10 versus 2 patients; P = 0.02). Subgroup analysis revealed a significant deterioration of renal function when vancomycin and cyclosporin A, but not teicoplanin and cyclosporin A, were used concurrently (P = 0.02). Among patients who received vancomycin and amphotericin B or teicoplanin and amphotericin B concurrently, deterioration in renal function was equivalent in both groups. Teicoplanin in the dosage employed was tolerated better than vancomycin in the empirical treatment of fever and neutropenia in our patient population.

摘要

进行了一项前瞻性、随机、双盲研究,比较替考拉宁与万古霉素在发热性中性粒细胞减少患者初始治疗中的效果。替考拉宁初始负荷剂量为6mg/kg,每12小时一次,共3剂,之后每24小时静脉注射6mg/kg。万古霉素每12小时静脉注射15mg/kg。患者还接受哌拉西林(每4小时静脉注射3g)和妥布霉素(每8小时静脉注射1.5至2.0mg/kg)。在纳入的53例患者中,50例被判定为可评估。其中,25例接受替考拉宁,25例接受万古霉素。入组时,两组在年龄、性别、肾功能、基础血液学状况和同时进行的治疗方面具有可比性。两组的感染部位和微生物病原体相似。经验性抗菌治疗使23例(92%)接受替考拉宁的患者和21例(84%)接受万古霉素的患者治愈或病情改善(P = 0.67)。2例接受万古霉素的患者治疗失败,但接受替考拉宁的患者无治疗失败情况。每组各有2例患者的临床反应不确定。万古霉素组的不良反应发生率显著高于替考拉宁组(P = 0.01),这些反应导致6例接受万古霉素的患者终止研究方案,而接受替考拉宁的患者无此情况(P = 0.02)。万古霉素组更频繁地观察到肾毒性(10例对2例;P = 0.02)。亚组分析显示,当同时使用万古霉素和环孢素A时,肾功能显著恶化,但同时使用替考拉宁和环孢素A时则不然(P = 0.02)。在同时接受万古霉素和两性霉素B或替考拉宁和两性霉素B的患者中,两组的肾功能恶化情况相当。在我们的患者群体中,在发热和中性粒细胞减少的经验性治疗中,所用剂量的替考拉宁比万古霉素耐受性更好。

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本文引用的文献

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Retrospective study of the toxicity of preparations of vancomycin from 1974 to 1981.1974年至1981年万古霉素制剂毒性的回顾性研究。
Antimicrob Agents Chemother. 1983 Jan;23(1):138-41. doi: 10.1128/AAC.23.1.138.
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Empiric use of vancomycin during prolonged treatment-induced granulocytopenia. Randomized, double-blind, placebo-controlled clinical trial in patients with acute leukemia.在长期治疗引起的粒细胞减少症期间经验性使用万古霉素。针对急性白血病患者的随机、双盲、安慰剂对照临床试验。
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Gram-positive infections and the use of vancomycin in 550 episodes of fever and neutropenia.革兰氏阳性菌感染以及万古霉素在550例发热伴中性粒细胞减少症病例中的应用。
Ann Intern Med. 1988 Jan;108(1):30-5. doi: 10.7326/0003-4819-108-1-30.
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Vancomycin, ticarcillin, and amikacin compared with ticarcillin-clavulanate and amikacin in the empirical treatment of febrile, neutropenic children with cancer.在对发热性中性粒细胞减少的癌症儿童进行经验性治疗时,将万古霉素、替卡西林和阿米卡星与替卡西林-克拉维酸和阿米卡星进行比较。
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Plasmid-mediated resistance to vancomycin and teicoplanin in Enterococcus faecium.粪肠球菌中质粒介导的对万古霉素和替考拉宁的耐药性
N Engl J Med. 1988 Jul 21;319(3):157-61. doi: 10.1056/NEJM198807213190307.
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Teicoplanin: a new glycopeptide antibiotic complex.替考拉宁:一种新型糖肽类抗生素复合物。
Drug Intell Clin Pharm. 1988 Mar;22(3):218-26. doi: 10.1177/106002808802200309.
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A multicentre open clinical trial of teicoplanin in infections caused by gram-positive bacteria.替考拉宁治疗革兰氏阳性菌感染的多中心开放性临床试验。
J Antimicrob Chemother. 1988 Jan;21 Suppl A:61-7. doi: 10.1093/jac/21.suppl_a.61.
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Teicoplanin in empirical combined antibiotic therapy of bacteraemias in bone marrow transplant patients.替考拉宁在骨髓移植患者菌血症经验性联合抗生素治疗中的应用
J Antimicrob Chemother. 1988 Jan;21 Suppl A:105-11. doi: 10.1093/jac/21.suppl_a.105.
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Early termination of a prospective, randomized trial comparing teicoplanin and flucloxacillin for treating severe staphylococcal infections.一项比较替考拉宁和氟氯西林治疗严重葡萄球菌感染的前瞻性随机试验的提前终止。
J Infect Dis. 1987 Feb;155(2):187-91. doi: 10.1093/infdis/155.2.187.
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Molecular epidemiology of nosocomial, multiply aminoglycoside resistant Enterococcus faecalis.医院内多重氨基糖苷类耐药粪肠球菌的分子流行病学
J Antimicrob Chemother. 1989 Aug;24(2):121-30. doi: 10.1093/jac/24.2.121.