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环丙沙星在儿科患者中的安全性和有效性——综述

Safety and efficacy of ciprofloxacin in paediatric patients--review.

作者信息

Kubin R

机构信息

Bayer AG, Pharma-Forschungszentrum, Wuppertal, Germany.

出版信息

Infection. 1993 Nov-Dec;21(6):413-21. doi: 10.1007/BF01728929.

Abstract

Like all fluoroquinolones, ciprofloxacin causes articular damage in juvenile animals. Consequently, this drug was not recommended for children or pregnant women. However, due to its antibacterial effectiveness and convenience of oral administration, ciprofloxacin is now increasingly used for the treatment of certain infectious conditions in children and adolescents aged less than 18 years. In this paper the published literature on this subject is reviewed. Up to now, data are available on more than 1,500 paediatric patients who were given ciprofloxacin, two-thirds of whom were suffering from acute infectious bronchopulmonary exacerbations of cystic fibrosis, mainly due to Pseudomonas aeruginosa. The effectiveness of oral ciprofloxacin for this indication compared well to that of standard intravenous combination regimens. The majority of the remaining published trials was conducted in children with multiresistant typhoid fever; the administration of ciprofloxacin was successful in up to 100% of the cases. The safety profile of ciprofloxacin in children and adolescents was very similar to that observed in adult patients. Adverse events were noted in 5-15%, with gastrointestinal, skin and central nervous system reactions being the most common. Reversible arthralgia occurred in 36 out of 1,113 patients with cystic fibrosis, and in no case could cartilage damage be demonstrated by radiographic procedures. Thus, publication data clearly suggest that the administration of ciprofloxacin to children is effective and safe, but there is a need for further prospective, well-controlled clinical trials.

摘要

与所有氟喹诺酮类药物一样,环丙沙星会对幼年动物造成关节损伤。因此,该药物不推荐用于儿童或孕妇。然而,由于其抗菌效果和口服给药的便利性,环丙沙星现在越来越多地用于治疗18岁以下儿童和青少年的某些感染性疾病。本文对关于该主题的已发表文献进行了综述。到目前为止,已有超过1500名接受环丙沙星治疗的儿科患者的数据,其中三分之二患有囊性纤维化的急性感染性支气管肺加重,主要由铜绿假单胞菌引起。口服环丙沙星用于该适应症的有效性与标准静脉联合治疗方案相当。其余大多数已发表的试验是在多重耐药伤寒热患儿中进行的;环丙沙星给药在高达100%的病例中取得成功。环丙沙星在儿童和青少年中的安全性与在成年患者中观察到的非常相似。不良事件发生率为5%-15%,最常见的是胃肠道、皮肤和中枢神经系统反应。1113名囊性纤维化患者中有36人出现可逆性关节痛,影像学检查未发现任何一例软骨损伤。因此,发表的数据清楚地表明,给儿童使用环丙沙星是有效且安全的,但仍需要进一步进行前瞻性、严格对照的临床试验。

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