Yelland M J
Department of Social and Preventive Medicine, University of Queensland, Inala.
Med J Aust. 1993 May 17;158(10):697-9. doi: 10.5694/j.1326-5377.1993.tb121918.x.
A double-blind, randomised clinical trial was conducted in Queensland general practices to evaluate the efficacy of oral doses of trimethoprim-sulfamethoxazole (cotrimoxazole) as an adjunct to Kenacomb ointment in the treatment of acute diffuse otitis externa.
One hundred and five patients with otitis externa agreed to enter the trial; 13 of these had bilateral otitis externa. Six symptoms and signs of otitis externa were rated on a scale of 1 (none) to 5 (severe) and then the scores were averaged to give an index of severity. Swabs from all infected ears were cultured and then the patients were treated with Kenacomb ointment. Patients were randomly assigned to take a five-day course of either oral cotrimoxazole or an oral placebo and were reassessed on Days 2-4 and Days 5-6 after presentation.
The mean duration (+/- standard deviation) of ear pain from the first visit for the cotrimoxazole and placebo groups was 3.1 (+/- 1.5) days and 3.1 (+/- 1.7) days respectively. The mean severity indices (+/- standard deviation) for these groups on presentation were 2.33 (+/- 0.59) and 2.37 (+/- 0.57). The respective reductions in these scores by the second visit were 0.72 and 0.69 and by the third visit 1.10 and 1.05. The principle pathogen isolated was Pseudomonas aeruginosa.
This suggests that oral cotrimoxazole is unlikely to be useful as an adjunct to Kenacomb ointment in the treatment of mild to moderate otitis externa.
在昆士兰州的普通诊所进行了一项双盲随机临床试验，以评估口服甲氧苄啶 - 磺胺甲恶唑（复方新诺明）作为辅助肯纳康软膏治疗急性弥漫性外耳道炎的疗效。
105例外耳道炎患者同意参加试验；其中13例为双侧外耳道炎。对外耳道炎的六种症状和体征按1（无）至5（严重）进行评分，然后将分数平均得出严重程度指数。对所有感染耳朵进行拭子培养，然后用肯纳康软膏治疗患者。患者被随机分配接受为期五天的口服复方新诺明或口服安慰剂疗程，并在就诊后的第2 - 4天和第5 - 6天进行重新评估。
复方新诺明组和安慰剂组首次就诊时耳痛的平均持续时间（±标准差）分别为3.1（±1.5）天和3.1（±1.7）天。这些组就诊时的平均严重程度指数（±标准差）分别为2.33（±0.59）和2.37（±0.57）。第二次就诊时这些分数的相应降低分别为0.72和0.69，第三次就诊时分别为1.10和1.05。分离出的主要病原体是铜绿假单胞菌。
这表明口服复方新诺明作为辅助肯纳康软膏治疗轻度至中度外耳道炎不太可能有用。
