Smith C R, Baughman K L, Edwards C Q, Rogers J F, Lietman P S
N Engl J Med. 1977 Feb 17;296(7):349-53. doi: 10.1056/NEJM197702172960701.
Amikacin or gentamicin was used to treat 174 patients with suspected severe gram-negative infections in a prospective, randomized, double-blind trial. Enteric gram-negative bacilli were pathogenic in 71 cases (39 treated with amikacin, and 32 with gentamicin). Amikacin was effective in 10 to 12 bacteremias, 21 of 24 urinary-tract infections, two of five pneumonias and four of six other serious tissue infections. The toal favorable response rate was 77 per cent for amikacin and 78 per cent for gentamicin. Nephrotoxicity and auditory toxicity could be evaluated in 124 and 67 cases respectively. Definite nephrotoxicity developed in five of 62 (8 per cent) receiving amikacin and seven of 62 (11 per cent) given gentamicin, and possible nephrotoxicity developed in four patients in both groups. Definite ototoxicity developed in four patients in both groups. Definite otoxicity developed in two of 34 (6 per cent) and three of 30 (10 per cent) respectively. These differences were not statistically significant (by chisquare analysis, P greater than 0.05). The results indicate that amikacin is effective against severe gram-negative infections and is not more and not less ototoxic or nephrotoxic than gentamicin.
在一项前瞻性、随机、双盲试验中,使用阿米卡星或庆大霉素治疗了174例疑似严重革兰氏阴性菌感染的患者。肠道革兰氏阴性杆菌在71例患者中致病(39例用阿米卡星治疗,32例用庆大霉素治疗)。阿米卡星对10至12例菌血症、24例尿路感染中的21例、5例肺炎中的2例以及6例其他严重组织感染中的4例有效。阿米卡星的总有效率为77%,庆大霉素为78%。分别对124例和67例患者评估了肾毒性和耳毒性。接受阿米卡星的62例患者中有5例(8%)出现明确的肾毒性,接受庆大霉素的62例患者中有7例(11%)出现明确的肾毒性,两组均有4例患者出现可能的肾毒性。两组均有4例患者出现明确的耳毒性。分别在34例中的2例(6%)和30例中的3例(10%)出现明确的耳毒性。这些差异无统计学意义(经卡方分析,P大于0.05)。结果表明,阿米卡星对严重革兰氏阴性菌感染有效,其耳毒性和肾毒性与庆大霉素相当。