Cystic Fibrosis Center, Anna Meyer Children's University Hospital, University of Florence, Florence, Italy.
Department of Health Sciences, University of Florence, Florence, Italy.
PLoS One. 2019 Mar 22;14(3):e0213497. doi: 10.1371/journal.pone.0213497. eCollection 2019.
Few studies, based on a limited number of patients using non-uniform therapeutic protocols, have analyzed Methicillin-resistant Staphylococcus aureus (MRSA) eradication.
In a randomized multicenter trial conducted on patients with new-onset MRSA infection we evaluated the efficacy of an early eradication treatment (arm A) compared with an observational group (B). Arm A received oral rifampicin and trimethoprim/sulfamethoxazole (21 days). Patients' microbiological status, FEV1, BMI, pulmonary exacerbations and use of antibiotics were assessed.
Sixty-one patients were randomized. Twenty-nine (47.5%) patients were assigned to active arm A and 32 (52.5%) patients to observational arm B. Twenty-nine (47.5%) patients, 10 patients in arm A and 19 in arm B, dropped out of the study. At 6 months MRSA was eradicated in 12 (63.2%) out of 19 patients in arm A while spontaneous clearance was observed in 5 (38.5%) out of 13 patients in arm B. A per-protocol analysis showed a 24.7% difference in the proportion of MRSA clearance between the two groups (z = 1.37, P(Z>z) = 0.08). Twenty-seven patients, 15 (78.9%) out of 19 in arm A and 12 (92.3%) out of 13 in arm B, were able to perform spirometry. The mean (±SD) FEV1 change from baseline was 7.13% (±14.92) in arm A and -1.16% (±5.25) in arm B (p = 0.08). In the same period the BMI change (mean ±SD) from baseline was 0.54 (±1.33) kg/m2 in arm A and -0.38 (±1.56) kg/m2 in arm B (p = 0.08). At 6 months no statistically significant differences regarding the number of pulmonary exacerbations, days spent in hospital and use of antibiotics were observed between the two arms.
Although the statistical power of the study is limited, we found a 24.7% higher clearance of MRSA in the active arm than in the observational arm at 6 months. Patients in the active arm A also had favorable FEV1 and BMI tendencies.
少数研究基于使用非统一治疗方案的有限数量患者，分析了耐甲氧西林金黄色葡萄球菌（MRSA）的清除情况。
在一项针对新发 MRSA 感染患者的随机多中心试验中，我们评估了早期清除治疗（A 组）与观察组（B 组）的疗效。A 组接受口服利福平加甲氧苄啶/磺胺甲噁唑（21 天）。评估患者的微生物学状态、FEV1、BMI、肺部恶化情况和抗生素使用情况。
共 61 名患者被随机分配。29 名（47.5%）患者被分配到主动 A 组，32 名（52.5%）患者被分配到观察组 B 组。29 名（47.5%）患者，10 名 A 组患者和 19 名 B 组患者退出了研究。6 个月时，A 组 19 名患者中有 12 名（63.2%）MRSA 清除，B 组 13 名患者中有 5 名（38.5%）自然清除。方案分析显示两组间 MRSA 清除率的差异为 24.7%（Z=1.37，P(Z>Z)=0.08）。27 名患者，A 组 19 名患者中有 15 名（78.9%），B 组 13 名患者中有 12 名（92.3%）能够进行肺活量测定。A 组从基线到治疗的 FEV1 变化的平均值（±SD）为 7.13%（±14.92），B 组为-1.16%（±5.25）（p=0.08）。同期 A 组从基线到治疗的 BMI 变化（平均值±SD）为 0.54（±1.33）kg/m2，B 组为-0.38（±1.56）kg/m2（p=0.08）。6 个月时，两组间肺部恶化次数、住院天数和抗生素使用天数无统计学差异。
尽管研究的统计效能有限，但我们发现 6 个月时主动治疗组 MRSA 清除率比观察组高 24.7%。A 组的患者的 FEV1 和 BMI 也有较好的改善趋势。
