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莫西沙星治疗普通科门诊鼻窦炎患者的疗效和耐受性:上市后监测研究结果。

Efficacy and tolerability of moxifloxacin in patients with sinusitis treated in general practice : results of a post-marketing surveillance study.

机构信息

Hals-, Nasen-, Ohrenklinik, Städtische Kliniken Bielefeld gGmbH, Bielefeld, Germany.

出版信息

Clin Drug Investig. 2004;24(8):431-9. doi: 10.2165/00044011-200424080-00001.

Abstract

OBJECTIVE

To assess the efficacy, safety and tolerability of moxifloxacin, an 8-methoxy fluoroquinolone, in patients with respiratory tract infections (RTIs) treated in general practice in Germany. Different RTIs were analysed separately, and this paper focuses on patients with acute sinusitis. METHODS, DESIGN AND PATIENTS: This was an open-label, prospective, uncontrolled, post-marketing surveillance study undertaken between October 2001 and June 2002. Symptoms of sinusitis (fever, cough, nasal obstruction, nasal secretion and headache) were assessed at baseline and at follow-up visits, and classified as 'absent', 'mild' or 'severe' by the attending physician.

RESULTS

Altogether 9036 patients were treated with moxifloxacin, of whom 2405 adult men and women had sinusitis. Sinusitis symptoms were improved or cured in at least 92% of patients. Moxifloxacin produced significant improvements after only 3 days (71.6% of patients); 96.2% of patients were improved after 5 days. Most patients (89.5%) had recovered by day 8 and 97.3% by day 10. Physicians rated moxifloxacin therapy as 'good' or 'very good' in 96.6% of patients and almost all favoured prescribing moxifloxacin in the future. Very few adverse events were reported with moxifloxacin (<0.4%), and were mostly gastrointestinal disturbances.

CONCLUSIONS

Moxifloxacin is a very effective and safe treatment for patients with acute sinusitis in general practice and is highly regarded by both physicians and patients because of rapid symptom improvement and good tolerability.

摘要

目的

评估莫西沙星(一种 8-甲氧基氟喹诺酮)在德国普通实践中治疗呼吸道感染(RTI)患者的疗效、安全性和耐受性。分别分析了不同的 RTI,本文重点关注急性鼻窦炎患者。

方法、设计和患者:这是一项在 2001 年 10 月至 2002 年 6 月之间进行的、开放标签、前瞻性、非对照、上市后监测研究。在基线和随访时,由主治医生评估鼻窦炎的症状(发热、咳嗽、鼻塞、鼻分泌物和头痛),并将其分类为“无”、“轻度”或“重度”。

结果

共有 9036 名患者接受了莫西沙星治疗,其中 2405 名成年男女患有鼻窦炎。至少 92%的患者的鼻窦炎症状得到改善或治愈。莫西沙星在第 3 天(71.6%的患者)后产生显著改善;第 5 天,96.2%的患者改善。大多数患者(89.5%)在第 8 天恢复,97.3%在第 10 天恢复。医生对莫西沙星治疗的评价为“好”或“非常好”,在 96.6%的患者中,几乎所有患者都赞成未来开莫西沙星处方。莫西沙星的不良反应很少见(<0.4%),主要是胃肠道紊乱。

结论

莫西沙星是一种非常有效的治疗急性鼻窦炎的方法,在普通实践中安全可靠,并且由于症状改善迅速和良好的耐受性而受到医生和患者的高度评价。

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