Centre of Evidence-Based Dermatology, University of Nottingham, Nottingham, United Kingdom.
N Engl J Med. 2013 May 2;368(18):1695-703. doi: 10.1056/NEJMoa1206300.
Cellulitis of the leg is a common bacterial infection of the skin and underlying tissue. We compared prophylactic low-dose penicillin with placebo for the prevention of recurrent cellulitis.
We conducted a double-blind, randomized, controlled trial involving patients with two or more episodes of cellulitis of the leg who were recruited in 28 hospitals in the United Kingdom and Ireland. Randomization was performed according to a computer-generated code, and study medications (penicillin [250 mg twice a day] or placebo for 12 months) were dispensed by a central pharmacy. The primary outcome was the time to a first recurrence. Participants were followed for up to 3 years. Because the risk of recurrence was not constant over the 3-year period, the primary hypothesis was tested during prophylaxis only.
A total of 274 patients were recruited. Baseline characteristics were similar in the two groups. The median time to a first recurrence of cellulitis was 626 days in the penicillin group and 532 days in the placebo group. During the prophylaxis phase, 30 of 136 participants in the penicillin group (22%) had a recurrence, as compared with 51 of 138 participants in the placebo group (37%) (hazard ratio, 0.55; 95% confidence interval [CI], 0.35 to 0.86; P=0.01), yielding a number needed to treat to prevent one recurrent cellulitis episode of 5 (95% CI, 4 to 9). During the no-intervention follow-up period, there was no difference between groups in the rate of a first recurrence (27% in both groups). Overall, participants in the penicillin group had fewer repeat episodes than those in the placebo group (119 vs. 164, P=0.02 for trend). There was no significant between-group difference in the number of participants with adverse events (37 in the penicillin group and 48 in the placebo group, P=0.50).
In patients with recurrent cellulitis of the leg, penicillin was effective in preventing subsequent attacks during prophylaxis, but the protective effect diminished progressively once drug therapy was stopped. (Funded by Action Medical Research; PATCH I Controlled-Trials.com number, ISRCTN34716921.).
腿部蜂窝织炎是一种常见的皮肤和皮下组织细菌感染。我们比较了小剂量青霉素预防和安慰剂预防复发性蜂窝织炎的效果。
我们在英国和爱尔兰的 28 家医院进行了一项双盲、随机、对照试验，纳入了两次或两次以上腿部蜂窝织炎发作的患者。根据计算机生成的代码进行随机分组，中央药房分发研究药物（青霉素[250mg，每日两次]或安慰剂，持续 12 个月）。主要结局是首次复发的时间。参与者的随访时间最长为 3 年。由于 3 年内复发风险并非恒定不变，因此仅在预防阶段检验主要假设。
共纳入 274 名患者。两组的基线特征相似。青霉素组首次复发蜂窝织炎的中位时间为 626 天，安慰剂组为 532 天。在预防阶段，青霉素组 136 名参与者中有 30 人（22%）复发，安慰剂组 138 名参与者中有 51 人（37%）（风险比为 0.55；95%置信区间[CI]为 0.35 至 0.86；P=0.01），即预防一次复发需要治疗的人数为 5 人（95%CI 为 4 至 9）。在无干预随访期间，两组首次复发率无差异（两组均为 27%）。总体而言，青霉素组的复发次数少于安慰剂组（119 次比 164 次，P=0.02 趋势）。两组参与者不良事件的数量无显著差异（青霉素组 37 例，安慰剂组 48 例，P=0.50）。
在复发性腿部蜂窝织炎患者中，青霉素在预防治疗期间有效预防了后续发作，但一旦停止药物治疗，保护作用逐渐减弱。（由行动医学研究基金资助；PATCH I 对照试验。com 编号，ISRCTN34716921。）
