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克林霉素与复方新诺明治疗单纯性伤口感染的随机试验

A Randomized Trial of Clindamycin Versus Trimethoprim-sulfamethoxazole for Uncomplicated Wound Infection.

作者信息

Talan David A, Lovecchio Frank, Abrahamian Fredrick M, Karras David J, Steele Mark T, Rothman Richard E, Krishnadasan Anusha, Mower William R, Hoagland Rebecca, Moran Gregory J

机构信息

Department of Emergency Medicine.

Division of Infectious Diseases, Department of Medicine, Olive View-UCLA Medical Center, David Geffen School of Medicine at UCLA.

出版信息

Clin Infect Dis. 2016 Jun 15;62(12):1505-1513. doi: 10.1093/cid/ciw177. Epub 2016 Mar 29.

Abstract

BACKGROUND

With the emergence of community-associated methicillin-resistant Staphylococcus aureus (MRSA) in the United States, visits for skin infections greatly increased. Staphylococci and streptococci are considered predominant causes of wound infections. Clindamycin and trimethoprim-sulfamethoxazole (TMP-SMX) are commonly prescribed, but the efficacy of TMP-SMX has been questioned.

METHODS

We conducted a randomized, double-blind, superiority trial at 5 US emergency departments. Patients >12 years of age with an uncomplicated wound infection received oral clindamycin 300 mg 4 times daily or TMP-SMX 320 mg/1600 mg twice daily, each for 7 days. We compared the primary outcome, wound infection cure at 7-14 days, and secondary outcomes through 6-8 weeks after treatment, in the per-protocol population.

RESULTS

Subjects had a median age of 40 years (range, 14-76 years); 40.1% of wound specimens grew MRSA, 25.7% methicillin-susceptible S. aureus, and 5.0% streptococci. The wound infection was cured at 7-14 days in 187 of 203 (92.1%) clindamycin-treated and 182 of 198 (91.9%) TMP-SMX-treated subjects (difference, 0.2%; 95% confidence interval [CI], -5.8% to 6.2%; P = not significant). The clindamycin group had a significantly lower rate of recurrence at 7-14 days (1.5% vs 6.6%; difference, -5.1%; 95% CI, -9.4% to -.8%) and through 6-8 weeks following treatment (2.0% vs 7.1%; difference, -5.1%; 95% CI, -9.7% to -.6%). Other secondary outcomes were statistically similar between groups but tended to favor clindamycin. Adverse event rates were similar.

CONCLUSIONS

In settings where MRSA is prevalent, clindamycin and TMP-SMX produce similar cure and adverse event rates among patients with an uncomplicated wound infection. Further study evaluating differential effects of antibiotics on recurrent infection may be warranted.

CLINICAL TRIALS REGISTRATION

NCT00729937.

摘要

背景

随着美国社区获得性耐甲氧西林金黄色葡萄球菌(MRSA)的出现,因皮肤感染而就诊的人数大幅增加。葡萄球菌和链球菌被认为是伤口感染的主要病因。克林霉素和甲氧苄啶-磺胺甲恶唑(TMP-SMX)是常用的处方药物,但TMP-SMX的疗效受到质疑。

方法

我们在美国的5个急诊科进行了一项随机、双盲、优效性试验。年龄大于12岁且患有单纯性伤口感染的患者,分别接受每日4次、每次300mg的口服克林霉素治疗,或每日2次、每次320mg/1600mg的TMP-SMX治疗,疗程均为7天。我们在符合方案人群中比较了主要结局(7至14天伤口感染治愈情况)以及治疗后6至8周的次要结局。

结果

受试者的中位年龄为40岁(范围14至76岁);40.1%的伤口标本培养出MRSA,25.7%培养出甲氧西林敏感金黄色葡萄球菌,5.0%培养出链球菌。在接受克林霉素治疗的203名受试者中,有187名(92.1%)在7至14天伤口感染得到治愈;在接受TMP-SMX治疗的198名受试者中,有182名(91.9%)在7至14天伤口感染得到治愈(差异为0.2%;95%置信区间[CI],-5.8%至6.2%;P =无统计学意义)。克林霉素组在7至14天以及治疗后6至8周的复发率显著更低(分别为1.5%对6.6%;差异为-5.1%;95%CI,-9.4%至-0.8%;以及2.0%对7.1%;差异为-5.1%;95%CI,-9.7%至-0.6%)。其他次要结局在两组之间无统计学差异,但克林霉素组有优势倾向。不良事件发生率相似。

结论

在MRSA流行的环境中,对于患有单纯性伤口感染的患者,克林霉素和TMP-SMX的治愈率和不良事件发生率相似。可能有必要进一步研究评估抗生素对复发性感染的不同影响。

临床试验注册号

NCT00729937。

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