Data from: Adjunctive clindamycin for cellulitis: clinical trial comparing flucloxacillin with or without clindamycin for the treatment of limb cellulitis

Objective: To compare flucloxacillin with clindamycin to flucloxacillin alone for the treatment of limb cellulitis. Design: Parallel, double-blinded, randomised controlled trial. Setting: Emergency department attendances and general practice referrals within 20 hospitals in England. Interventions: Flucloxacillin, at a minimum of 500 mg 4 times per day for 5 days, with clindamycin 300 mg 4 times per day for 2 days given orally versus flucloxacillin given alone. Main outcome measures: The primary outcome was improvement at day 5. This was defined as being afebrile with either a reduction in affected skin surface temperature or a reduction in the circumference of the affected area. Secondary outcomes included resolution of systemic features, resolution of inflammatory markers, recovery of renal function, reduction in the affected area, decrease in pain, return to work or normal activities and the absence of increased side effects. Results: 410 patients were included in the trial. No significant difference was seen in improvement at day 5 for flucloxacillin with clindamycin (136/156, 87%) versus flucloxacillin alone (140/172, 81%)—OR 1.55 (95% CI 0.81 to 3.01), p=0.174. There was a significant difference in the number of patients with diarrhoea at day 5 in the flucloxacillin with clindamycin allocation (34/160, 22%) versus flucloxacillin alone (16/176, 9%)—OR 2.7 (95% CI 1.41 to 5.07), p=0.002. There was no clinically significant difference in any secondary outcome measures. There was no significant difference in the number of patients stating that they had returned to normal activities at the day 30 interview in the flucloxacillin with clindamycin allocation (99/121, 82%) versus flucloxacillin alone (104/129, 81%)—adjusted OR 0.90 (95% CI 0.44 to 1.84). Conclusions: The addition of a short course of clindamycin to flucloxacillin early on in limb cellulitis does not improve outcome. The addition of clindamycin doubles the likelihood of diarrhoea within the first few days.

研究目的：比较氟氯西林（flucloxacillin）联合克林霉素（clindamycin）与单用氟氯西林治疗肢体蜂窝织炎（limb cellulitis）的疗效。
试验设计：平行组、双盲随机对照试验（double-blinded, randomised controlled trial）。
研究场景：英格兰境内20家医院的急诊就诊及全科转诊病例。
干预措施：口服氟氯西林（至少500mg，每日4次，疗程5天）联合克林霉素（300mg，每日4次，疗程2天），对比单用氟氯西林方案。
主要结局指标：主要结局为第5天时的症状改善，定义为体温恢复正常，且受累皮肤温度降低或受累区域周径减小。次要结局包括全身症状消退、炎症标志物恢复正常、肾功能恢复、受累区域缩小、疼痛缓解、恢复工作或正常活动，以及未出现不良反应加重的情况。
试验结果：本试验共纳入410例患者。氟氯西林联合克林霉素组第5天症状改善率为87%（136/156），单用氟氯西林组为81%（140/172），组间差异无统计学意义（优势比[OR] 1.55，95%置信区间[CI] 0.81~3.01，P=0.174）。氟氯西林联合克林霉素组第5天腹泻发生率为22%（34/160），显著高于单用氟氯西林组的9%（16/176）（OR 2.7，95%CI 1.41~5.07，P=0.002）。其余次要结局指标均无临床显著性差异。第30天随访时，氟氯西林联合克林霉素组恢复正常活动的患者占比为82%（99/121），单用氟氯西林组为81%（104/129），组间差异无统计学意义（校正后OR 0.90，95%CI 0.44~1.84）。
研究结论：在肢体蜂窝织炎早期治疗中，于氟氯西林基础上加用短疗程克林霉素并不能改善治疗结局，但会使患者在前几日出现腹泻的风险翻倍。