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

机译:克林霉素辅助治疗蜂窝组织炎:氟氯西林与克林霉素联合治疗或不联合克林霉素治疗肢体蜂窝组织炎的临床试验

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摘要

To compare flucloxacillin with clindamycin to flucloxacillin alone for the treatment of limb cellulitis.Parallel, double-blinded, randomised controlled trial.Emergency department attendances and general practice referrals within 20 hospitals in England.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. 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.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).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.
机译:比较氟氯西林和克林霉素与氟氯西林单独治疗肢体蜂窝组织炎的平行,双盲,随机对照试验在英格兰的20家医院中进行急诊就诊和全科医生转诊氟氯西林,每天至少4次,每次500μgmg连续5天,与口服氟氯西林相比,口服克林霉素300mg每天2次,每天4次。主要结果是在第5天改善。这被定义为发热,即受影响的皮肤表面温度降低或受影响区域的周长降低。次要结果包括全身特征的消退,炎症标志物的消退,肾功能的恢复,患病区域的减少,疼痛的减轻,恢复工作或正常活动以及无增加的副作用。该试验包括410名患者。与克林霉素相比,氟氯西林在第5天的改善(136 / 156,87%)与单独使用氟氯西林(140 / 172,81%)的改善无明显差异,或1.55(95%CI 0.81至3.01),p = 0.174。分配克林霉素的氟氯西林(34/160,22%)与单独使用氟氯西林(16/176,9%)的第5天有腹泻的患者数量有显着差异-或2.7(95%CI 1.41至5.07 ),p = 0.002。在任何次要结局指标中,临床上均无显着差异。在调整后的第30天接受氟氯西林分配克林霉素治疗的患者(99 / 121,82%)与单独使用氟氯西林治疗的患者(104 / 129,81%)恢复正常活动的患者人数没有显着差异或0.90(95%CI 0.44至1.84)。在肢体蜂窝组织炎早期向氟氯西林中添加短疗程的克林霉素不能改善预后。添加克林霉素在头几天内会使腹泻的可能性加倍。

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