Infektionsabteilung Med Klinik und Poliklinik IV, University Hospital of Munich, Munich, Germany.
Adv Ther. 2013 Jun;30(6):630-43. doi: 10.1007/s12325-013-0038-z.
ARTOS was an international, prospective, non-interventional, non-controlled observational study designed to determine the effectiveness, safety, and tolerability of moxifloxacin under daily-life conditions in patients with complicated skin and skin structure infections (cSSSIs) treated in Europe, the Middle East, and Asia-Pacific region.
Eligible patients included males and females who were hospitalized patients or outpatients requiring antibiotic therapy for cSSSIs and for whom the treating physician had elected to begin moxifloxacin therapy in accordance with its approved indications. Patients were assessed before therapy and then at one or two follow-up visits. Effectiveness was assessed with respect to improvement and resolution of signs and symptoms of cSSSIs and safety with respect to the nature and frequency of adverse events and adverse drug reactions.
A total of 6,594 patients were enrolled of whom 5,444 had data available for analysis; 4,692 patients received sequential intravenous/oral (IV/PO) moxifloxacin and 752 exclusively IV therapy. A majority of patients were aged between 40 and 79 years and had one or more comorbid conditions. Post-surgical wound infection, skin abscess, and diabetic foot infection were the cSSSIs most frequently diagnosed and treated with moxifloxacin, with almost 90% of infections rated moderate or severe. Treating physicians chose sequential moxifloxacin 400 mg for most patients, switching from IV to PO after 3-4 days. On average, treatment was maintained for 10 days. Treatment with moxifloxacin was associated with rapid relief in symptoms, with 93.2% of patients experiencing either complete resolution of symptoms or improvement at follow-up. Moxifloxacin was well tolerated with adverse drug reactions occurring in only 2% of patients.
This study, conducted in a 'real-world' setting, confirms the effectiveness and safety of moxifloxacin in the treatment of a wide spectrum of cSSSIs seen in routine clinical practice.
ARTOS 是一项国际性、前瞻性、非干预性、非对照观察性研究，旨在确定莫西沙星在欧洲、中东和亚太地区患有复杂性皮肤和皮肤结构感染（cSSSIs）的患者的日常生活条件下的有效性、安全性和耐受性。
符合条件的患者包括男性和女性住院患者或门诊患者，他们需要抗生素治疗 cSSSIs，且治疗医生根据其批准的适应症选择开始莫西沙星治疗。患者在治疗前进行评估，然后在一次或两次随访中进行评估。有效性根据 cSSSIs 的体征和症状的改善和消退来评估，安全性根据不良事件和药物不良反应的性质和频率来评估。
共纳入 6594 例患者，其中 5444 例患者的数据可用于分析；4692 例患者接受序贯静脉/口服（IV/PO）莫西沙星治疗，752 例患者仅接受 IV 治疗。大多数患者年龄在 40 至 79 岁之间，并有一种或多种合并症。手术后伤口感染、皮肤脓肿和糖尿病足感染是最常诊断和治疗的 cSSSIs，几乎 90%的感染为中度或重度。大多数患者的治疗医生选择莫西沙星 400mg 序贯治疗，在 3-4 天后从 IV 转为 PO。平均治疗时间为 10 天。莫西沙星治疗迅速缓解症状，93.2%的患者在随访时症状完全缓解或改善。莫西沙星具有良好的耐受性，仅 2%的患者发生药物不良反应。
这项在“真实世界”环境中进行的研究证实了莫西沙星在治疗广泛的 cSSSIs 中的有效性和安全性，这些感染在常规临床实践中很常见。
