Moran Gregory J, De Anda Carisa, Das Anita F, Green Sinikka, Mehra Purvi, Prokocimer Philippe
Division of Infectious Diseases, Department of Emergency Medicine, Olive View-UCLA Medical Center, Sylmar, CA, USA.
MRL, Merck & Co., Inc., Kenilworth, NJ, USA.
Infect Dis Ther. 2018 Dec;7(4):509-522. doi: 10.1007/s40121-018-0211-4. Epub 2018 Sep 21.
Injection drug users (IDUs) often develop acute bacterial skin and skin structure infections (ABSSSI) and use emergency departments as their primary source for medical care.
A post hoc subgroup analysis of two randomized trials examined the efficacy and safety of tedizolid in the treatment of ABSSSI in IDUs. IDUs (n = 389) were identified from two pooled phase 3 trials (NCT01170221, NCT01421511) in patients with ABSSSI (n = 1333). Patients were randomly assigned to tedizolid phosphate (200 mg once daily, 6 days) or linezolid (600 mg twice daily, 10 days). Primary endpoint was ≥ 20% reduction in lesion area from baseline at 48 -72 h. Secondary endpoints included investigator-assessed clinical and microbiological response at the post-therapy evaluation (PTE).
Wound infection was more common in IDUs (52.2%), while cellulitis/erysipelas was more common in non-IDUs (55.9%). Most infections were due to Staphylococcus aureus (IDUs, 75.2%; non-IDUs, 85.6%), while oral pathogens were more prevalent in IDUs. Early clinical success rates for tedizolid and linezolid were 82.5% and 79.6% in IDUs and 81.3% and 79.3% for non-IDUs, respectively; responses at PTE were similar. Microbiological response per pathogen was similar between treatment groups. Rates of treatment-emergent adverse events (AEs) in IDUs were comparable between tedizolid (46.2%) and linezolid (47.8%) arms, while lower incidence of gastrointestinal AEs was observed with tedizolid (20.3%) than with linezolid (25.1%).
Efficacy and safety of tedizolid and linezolid in the treatment of ABSSSI was similar in IDUs and non-IDUs, supporting the use of oxazolidinones in treating ABSSSIs in IDUs.
Merck & Co., Inc., Kenilworth, NJ, USA.
注射吸毒者（IDU）常发生急性细菌性皮肤和皮肤结构感染（ABSSSI），并将急诊科作为其主要医疗保健来源。
两项随机试验的事后亚组分析考察了特地唑胺治疗IDU的ABSSSI的疗效和安全性。从两项合并的3期试验（NCT01170221、NCT01421511）的1333例ABSSSI患者中识别出389例IDU。患者被随机分配至磷酸特地唑胺组（200mg，每日1次，共6天）或利奈唑胺组（600mg，每日2次，共10天）。主要终点为48 - 72小时时病变面积较基线减少≥20%。次要终点包括研究者评估的治疗后评估（PTE）时的临床和微生物学反应。
伤口感染在IDU中更常见（52.2%），而蜂窝织炎/丹毒在非IDU中更常见（55.9%）。大多数感染由金黄色葡萄球菌引起（IDU中为75.2%；非IDU中为85.6%），而口腔病原体在IDU中更普遍。特地唑胺和利奈唑胺在IDU中的早期临床成功率分别为82.5%和79.6%，在非IDU中分别为81.3%和79.3%；PTE时的反应相似。各治疗组间每种病原体的微生物学反应相似。IDU中，特地唑胺组（46.2%）和利奈唑胺组（47.8%）的治疗中出现的不良事件（AE）发生率相当，而特地唑胺组（20.3%）的胃肠道AE发生率低于利奈唑胺组（25.1%）。
特地唑胺和利奈唑胺治疗IDU的ABSSSI的疗效和安全性在IDU和非IDU中相似，支持恶唑烷酮类药物用于治疗IDU的ABSSSI。
美国新泽西州肯尼沃思的默克公司。
