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口服环丙沙星治疗小儿囊性纤维化假单胞菌感染加重:使用磁共振成像扫描进行临床疗效和安全性评估

Oral ciprofloxacin in the treatment of pseudomonas exacerbations of paediatric cystic fibrosis: clinical efficacy and safety evaluation using magnetic resonance image scanning.

作者信息

Redmond A, Sweeney L, MacFarland M, Mitchell M, Daggett S, Kubin R

机构信息

Royal Belfast Hospital for Sick Children, UK.

出版信息

J Int Med Res. 1998 Dec;26(6):304-12. doi: 10.1177/030006059802600604.

Abstract

Ciprofloxacin is effective for treating pulmonary infection in adult cystic fibrosis patients, and demonstrates excellent efficacy against Pseudomonas aeruginosa, but its use in paediatric cystic fibrosis patients has been limited because quinolone-induced cartilage toxicity has been observed in juvenile animals and has been considered a potential risk for children. Children with cystic fibrosis (n = 26; aged 6-16 years), with proven P. aeruginosa colonization of their sputum, were enrolled into a 14-day, open, non-comparative study. Patients were assigned to twice-daily treatment with oral ciprofloxacin 250 mg, 500 mg or 750 mg, depending on their body weight. None of the patients exhibited any signs or symptoms of arthropathy, as assessed by magnetic resonance imaging of the right knee, during or immediately after treatment, or at the 3-month post-therapy assessment. Cough, sputum production and sputum purulence were improved in more than 70% of patients. Patients showed a mean weight increase of 0.4 kg (95% confidence interval 0.1 to 0.7 kg) over the study period. Only one patient required a repeat chest radiograph, which showed no resolution of the abnormal radiographic appearances. Three patients reported adverse events during the trial, none of which were considered to be related to the study treatment.

摘要

环丙沙星对治疗成年囊性纤维化患者的肺部感染有效,且对铜绿假单胞菌显示出卓越疗效,但由于在幼年动物中观察到喹诺酮类药物引起的软骨毒性,且该毒性被认为是儿童面临的潜在风险,因此其在儿科囊性纤维化患者中的应用受到限制。对痰液中已证实有铜绿假单胞菌定植的26名囊性纤维化儿童(年龄6至16岁)进行了一项为期14天的开放性非对照研究。根据体重,患者被分配接受每日两次口服250毫克、500毫克或750毫克环丙沙星的治疗。在治疗期间、治疗刚结束时或治疗后3个月的评估中,通过右膝磁共振成像评估,没有患者表现出任何关节病的体征或症状。超过70%的患者咳嗽、痰液产生和痰液脓性有所改善。在研究期间,患者平均体重增加了0.4千克(95%置信区间为0.1至0.7千克)。只有一名患者需要重复进行胸部X光检查,结果显示异常影像学表现未得到缓解。三名患者在试验期间报告了不良事件,但均被认为与研究治疗无关。

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