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Efficacy and safety of oral solithromycin versus oral moxifloxacin for treatment of community-acquired bacterial pneumonia: a global, double-blind, multicentre, randomised, active-controlled, non-inferiority trial (SOLITAIRE-ORAL).
口服索利霉素与口服莫西沙星治疗社区获得性细菌性肺炎的疗效和安全性: 一项全球性、双盲、多中心、随机、主动对照、非劣效试验 (接龙-口头)。

摘要

BACKGROUND:Community-acquired bacterial pneumonia (CABP) is a leading cause of morbidity and mortality, and treatment recommendations, each with specific limitations, vary globally. We aimed to compare the efficacy and safety of solithromycin, a novel macrolide, with moxifloxacin for treatment of CABP.
METHODS:We did this global, double-blind, double-dummy, randomised, active-controlled, non-inferiority trial at 114 centres in North America, Latin America, Europe, and South Africa. Patients (aged ≥18 years) with clinically and radiographically confirmed pneumonia of Pneumonia Outcomes Research Team (PORT) risk class II, III, or IV were randomly assigned (1:1), via an internet-based central block randomisation procedure (block size of four), to receive either oral solithromycin (800 mg on day 1, 400 mg on days 2-5, placebo on days 6-7) or oral moxifloxacin (400 mg on days 1-7). Randomisation was stratified by geographical region, PORT risk class (II vs III or IV), and medical history of asthma or chronic obstructive pulmonary disease. The study sponsor, investigators, staff, and patients were masked to group allocation. The primary outcome was early clinical response, defined as an improvement in at least two of four symptoms (cough, chest pain, sputum production, dyspnoea) with no worsening in any symptom at 72 h after the first dose of study drug, with a 10% non-inferiority margin. The primary analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT-01756339.
FINDINGS:Between Jan 3, 2013, and Sept 24, 2014, we randomly assigned 860 patients to receive solithromycin (n=426) or moxifloxacin (n=434). Patients were followed up to days 28-35 after first dose. Solithromycin was non-inferior to moxifloxacin in achievement of early clinical response: 333 (78·2%) patients had an early clinical response in the solithromycin group versus 338 (77·9%) patients in the moxifloxacin group (difference 0·29, 95% CI -5·5 to 6·1). Both drugs had a similar safety profile. 43 (10%) of 155 treatment-emergent adverse events in the solithromycin group and 54 (13%) of 154 such events in the moxifloxacin group were deemed to be related to study drug. The most common adverse events, mostly of mild severity, were gastrointestinal disorders, including diarrhoea (18 [4%] patients in the solithromycin group vs 28 [6%] patients in the moxifloxacin group), nausea (15 [4%] vs 17 [4%] patients) and vomiting (ten [2%] patients in each group); and nervous system disorders, including headache (19 [4%] vs 11 [3%] patients) and dizziness (nine [2%] vs seven [2%] patients).
INTERPRETATION:Oral solithromycin was non-inferior to oral moxifloxacin for treatment of patients with CABP, showing the potential to restore macrolide monotherapy for this indication.
FUNDING:Cempra.

译文

背景: 社区获得性细菌性肺炎 (CABP) 是发病率和死亡率的主要原因,全球范围内的治疗建议各有不同。我们旨在比较新型大环内酯类索利霉素与莫西沙星治疗 CABP 的疗效和安全性。
方法: 我们在北美、拉丁美洲、欧洲的 114 个中心进行了这项全球性、双盲、双模拟、随机、主动对照、非劣效性试验, 和南非。患者 (年龄 ≥ 18 岁) 有临床和影像学证实的肺炎结局研究小组 (PORT) 风险等级 II 、 III 或 IV 被随机分配 (1:1), 通过基于互联网的中央区组随机程序 (区组大小为 4),接受口服索利霉素 (第一天 800 毫克,第 2-5 天 400 毫克,第 6-7 天安慰剂) 或口服莫西沙星 (第 1-7 天 400 毫克)。随机分组按地理区域、港口风险等级 (II vs III 或 IV) 以及哮喘或慢性阻塞性肺病病史进行分层。研究发起人、调查人员、工作人员和患者被掩盖在小组分配上。主要结果是早期临床反应,定义为四种症状 (咳嗽、胸痛、咳痰、呼吸困难) 中至少两种症状的改善在研究药物第一次给药后的 72 小时内,任何症状都没有恶化,非劣效率为 10%。主要分析是通过意向治疗。该试验在 ClinicalTrials.gov 注册,编号 NCT-01756339。
结果: 在 2013年1月3日至 2014 期间,我们随机分配了 860 名患者接受索利霉素 (n = 426) 或莫西沙星 (n = 434)。患者在首次用药后 28-35 天进行随访。在获得早期临床反应方面,索利霉素并不比莫西沙星差: 333 (338) 的患者在索利霉素组中有早期临床反应,而 () 的患者有早期临床反应莫西沙星组的患者 (差异 0 · 29,95% CI-5 · 5 至 6 · 1)。两种药物的安全性相似。43 (10%) 在索利霉素组的 155 次紧急治疗不良事件和 54 (13%) 在莫西沙星组的 154 次此类事件被认为与研究药物有关。最常见的不良反应,主要是轻微的严重程度,是胃肠疾病,包括腹泻 (18 [4%] 患者在索利霉素组和 28 [6%] 患者在莫西沙星组), 恶心 (15 [4%] vs 17 [4%] 患者) 和呕吐 (十 [2%]每组的患者); 和神经系统疾病,包括头痛 (19 [4%] vs 11 [3%] 患者) 和头晕 (9 [2%] vs 7 [2%] 患者)。
解释: 口服索利霉素在治疗 CABP 患者时并不劣于口服莫西沙星,显示了恢复大环内酯类单一疗法治疗该适应症的潜力。
资金来源: Cempra。

Moxifloxacin

呼吸 超广谱喹诺酮类药物 药物
概述  :  

指征和剂量 莫西沙星是一种超广谱喹诺酮类药物,抗菌谱比较广泛,覆盖了患者的全部呼吸道主要致病菌。在体外对革兰阳性菌和革兰阴性菌、厌氧菌、分歧杆菌、支原体、衣原体和军团菌均有抗菌作用。对β-内酰胺类和大环内脂类抗生素耐药的细菌,以及一些对其他喹诺酮类药物耐药的细菌仍对本品敏感。对细菌感染引起的慢性支气管炎急性发作、急性细菌性鼻窦炎和轻、中度社区获得性肺炎等有显著的临床效果。在青年耐多药肺结核的临床治疗上,莫西沙星的最低抑菌浓度显著低于左氧氟沙星,且其不易产生耐药性,不良反应小,

Moxifloxacin   /mɒksɪf'lɒkseɪsɪn/

释    义   莫西沙星

例    句   This drug is moxifloxacin made by Bayer and its advantage is that it is already widely used against bronchitis, so it is known to be safe. 这种药是拜耳的莫西沙星,它的优势在于已经被广泛的应用于治疗支气管炎,因而是安全的。

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