Daum Robert S, Miller Loren G, Immergluck Lilly, Fritz Stephanie, Creech C Buddy, Young David, Kumar Neha, Downing Michele, Pettibone Stephanie, Hoagland Rebecca, Eells Samantha J, Boyle Mary G, Parker Trisha Chan, Chambers Henry F
From the University of Chicago Hospitals, Chicago (R.S.D., N.K.); Harbor-UCLA Medical Center and Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center, Los Angeles (L.G.M., S.J.E.), and University of California, San Francisco-San Francisco General Hospital, San Francisco (D.Y., M.D., H.F.C.); Morehouse School of Medicine and Emory University-Grady Memorial Hospital and Children's Healthcare of Atlanta, Atlanta (L.I., T.C.P.); Washington University School of Medicine-Barnes-Jewish Hospital and St. Louis Children's Hospital, St. Louis (S.F., M.G.B.); Vanderbilt University School of Medicine and Vanderbilt University Medical Center, Nashville (C.B.C.); EMMES Corporation, Rockville, MD (S.P.); and Cota Enterprises, Meriden, KS (R.H.).
N Engl J Med. 2017 Jun 29;376(26):2545-2555. doi: 10.1056/NEJMoa1607033.
Uncomplicated skin abscesses are common, yet the appropriate management of the condition in the era of community-associated methicillin-resistant Staphylococcus aureus (MRSA) is unclear.
We conducted a multicenter, prospective, double-blind trial involving outpatient adults and children. Patients were stratified according to the presence of a surgically drainable abscess, abscess size, the number of sites of skin infection, and the presence of nonpurulent cellulitis. Participants with a skin abscess 5 cm or smaller in diameter were enrolled. After abscess incision and drainage, participants were randomly assigned to receive clindamycin, trimethoprim-sulfamethoxazole (TMP-SMX), or placebo for 10 days. The primary outcome was clinical cure 7 to 10 days after the end of treatment.
We enrolled 786 participants: 505 (64.2%) were adults and 281 (35.8%) were children. A total of 448 (57.0%) of the participants were male. S. aureus was isolated from 527 participants (67.0%), and MRSA was isolated from 388 (49.4%). Ten days after therapy in the intention-to-treat population, the cure rate among participants in the clindamycin group was similar to that in the TMP-SMX group (221 of 266 participants [83.1%] and 215 of 263 participants [81.7%], respectively; P=0.73), and the cure rate in each active-treatment group was higher than that in the placebo group (177 of 257 participants [68.9%], P<0.001 for both comparisons). The results in the population of patients who could be evaluated were similar. This beneficial effect was restricted to participants with S. aureus infection. Among the participants who were initially cured, new infections at 1 month of follow-up were less common in the clindamycin group (15 of 221, 6.8%) than in the TMP-SMX group (29 of 215 [13.5%], P=0.03) or the placebo group (22 of 177 [12.4%], P=0.06). Adverse events were more frequent with clindamycin (58 of 265 [21.9%]) than with TMP-SMX (29 of 261 [11.1%]) or placebo (32 of 255 [12.5%]); all adverse events resolved without sequelae. One participant who received TMP-SMX had a hypersensitivity reaction.
As compared with incision and drainage alone, clindamycin or TMP-SMX in conjunction with incision and drainage improves short-term outcomes in patients who have a simple abscess. This benefit must be weighed against the known side-effect profile of these antimicrobials. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00730028 .).
单纯性皮肤脓肿很常见，但在社区获得性耐甲氧西林金黄色葡萄球菌（MRSA）时代，对该病的恰当管理尚不清楚。
我们进行了一项多中心、前瞻性、双盲试验，纳入门诊成年和儿童患者。患者根据是否存在可手术引流的脓肿、脓肿大小、皮肤感染部位数量以及是否存在非化脓性蜂窝织炎进行分层。纳入直径5厘米或更小的皮肤脓肿患者。在脓肿切开引流后，参与者被随机分配接受克林霉素、甲氧苄啶 - 磺胺甲恶唑（TMP - SMX）或安慰剂治疗10天。主要结局是治疗结束后7至10天的临床治愈情况。
我们纳入了786名参与者：505名（64.2%）为成年人，281名（35.8%）为儿童。共有448名（57.0%）参与者为男性。从527名参与者（67.0%）中分离出金黄色葡萄球菌，从388名（49.4%）中分离出MRSA。在意向性治疗人群中，治疗10天后，克林霉素组参与者的治愈率与TMP - SMX组相似（分别为266名参与者中的221名[83.1%]和263名参与者中的215名[81.7%]；P = 0.73），且每个活性治疗组的治愈率均高于安慰剂组（257名参与者中的177名[68.9%]，两组比较P均<0.001）。可评估患者人群的结果相似。这种有益效果仅限于金黄色葡萄球菌感染的参与者。在最初治愈的参与者中，随访1个月时新感染在克林霉素组（221名中的15名，6.8%）比TMP - SMX组（215名中的29名[13.5%]，P = 0.03）或安慰剂组（177名中的22名[12.4%]，P = 0.06）更少见。克林霉素的不良事件比TMP - SMX（261名中的29名[11.1%]）或安慰剂（255名中的32名[12.5%]）更频繁；所有不良事件均无后遗症地得到解决。一名接受TMP - SMX的参与者发生了过敏反应。
与单纯切开引流相比，克林霉素或TMP - SMX联合切开引流可改善单纯脓肿患者的短期结局。这种益处必须与这些抗菌药物已知的副作用相权衡。（由美国国立卫生研究院资助；ClinicalTrials.gov编号，NCT00730028。）
