Marchant C D, Carlin S A, Johnson C E, Shurin P A
Department of Pediatrics, New England Medical Center, Boston, MA 02111.
J Pediatr. 1992 Jan;120(1):72-7. doi: 10.1016/s0022-3476(05)80601-8.
In randomized, double-blind trials of antibiotic therapy for acute otitis media that determined both clinical and bacteriologic outcomes, clinical success rates were (93%) 236 of 253 for patients with bacteriologic success, (62%) 25 of 40 for those with bacteriologic failure, and (80%) 124 of 155 for those with nonbacterial acute otitis media. These rates were used to calculate the effectiveness of three strategies for assessing drug efficacy: (1) tympanocentesis and culture before and during therapy (bacteriologic efficacy), (2) tympanocentesis before therapy and assessment of clinical efficacy in bacterial acute otitis media, and (3) no tympanocentesis and assessment of clinical efficacy in clinical (total) acute otitis media. For a drug with a bacteriologic efficacy of 100%, calculated clinical efficacy was 93% for bacterial acute otitis media and 89% for clinical acute otitis media. For a drug with bacteriologic efficacy of 27%, a rate consistent with no antibacterial therapy, efficacy was 71% for bacterial acute otitis media and 74% for clinical acute otitis media. We conclude that if efficacy is measured by symptomatic response, drugs with excellent antibacterial activity will appear less efficacious than they really are and drugs with poor antibacterial activity will appear more efficacious than they really are. The predominant phenomenon is that drugs with poor antibacterial activity will appear to be clinically effective in the treatment of acute otitis media.
在针对急性中耳炎的抗生素治疗进行的随机双盲试验中，该试验确定了临床和细菌学结果，细菌学检查成功的患者临床成功率为（93%），即253例中的236例；细菌学检查失败的患者临床成功率为（62%），即40例中的25例；非细菌性急性中耳炎患者临床成功率为（80%），即155例中的124例。这些比率被用于计算三种评估药物疗效策略的有效性：（1）治疗前和治疗期间进行鼓膜穿刺和培养（细菌学疗效）；（2）治疗前进行鼓膜穿刺并评估细菌性急性中耳炎的临床疗效；（3）不进行鼓膜穿刺并评估临床（总体）急性中耳炎的临床疗效。对于一种细菌学疗效为100%的药物，计算得出细菌性急性中耳炎的临床疗效为93%，临床急性中耳炎的临床疗效为89%。对于一种细菌学疗效为27%（与不进行抗菌治疗的比率一致）的药物，细菌性急性中耳炎的疗效为71%，临床急性中耳炎的疗效为74%。我们得出结论，如果通过症状反应来衡量疗效，具有优异抗菌活性的药物看起来比其实际疗效要低，而抗菌活性差的药物看起来比其实际疗效要高。主要现象是抗菌活性差的药物在治疗急性中耳炎时似乎具有临床疗效。
