Baum M L, Anish D S, Chalmers T C, Sacks H S, Smith H, Fagerstrom R M
N Engl J Med. 1981 Oct 1;305(14):795-9. doi: 10.1056/NEJM198110013051404.
To evaluate the use of antibiotics given prophylactically of colon surgery, we examined 26 trials published from 1965 to 1980 in which patients given various antibiotic regiments were compared with controls given no antibiotic treatment. In 22 (85 per cent of these trials) antibiotics reduced postoperative wound infection (p less than 0.05 in 14). Combining the results of the trials published from 1965 to 1975 reveals a 95 per cent confidence interval from the true difference in infection rates of 14 +/- 6 per cent (36 per cent for control group vs. 22 per cent for treatment group) and the true difference in death rates of 6.7 +/- 4.4 per cent (11.2 per cent for control group vs 4.5 per cent for treatment group). Yet trials employing control groups given no treatment continue to be reported. Since the use of such controls is justified only when no effective alternative therapy exists, we believe that any further trials of antibiotic prophylaxis in colon surgery should employ a previously proved standard. However, steadily increasing efficacy of treatment means that comparisons of new therapies with standard therapies will become prohibitively expensive because of the large number of patients required.
为评估结肠手术预防性使用抗生素的情况，我们查阅了1965年至1980年发表的26项试验，这些试验将接受各种抗生素治疗方案的患者与未接受抗生素治疗的对照组进行了比较。在其中22项试验（占这些试验的85%）中，抗生素降低了术后伤口感染率（14项试验中P值小于0.05）。综合1965年至1975年发表的试验结果，感染率的真实差异的95%置信区间为14±6%（对照组为36%，治疗组为22%），死亡率的真实差异为6.7±4.4%（对照组为11.2%，治疗组为4.5%）。然而，仍有采用未接受治疗的对照组的试验不断被报道。由于只有在不存在有效的替代疗法时使用这样的对照组才合理，我们认为结肠手术中抗生素预防的任何进一步试验都应采用先前已证实的标准。然而，治疗效果的稳步提高意味着，由于需要大量患者，将新疗法与标准疗法进行比较的成本将高得令人望而却步。
