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环丙沙星缓释片与环丙沙星每日两次给药治疗伤寒的疗效和耐受性的开放性研究。

Open study on efficacy and tolerability of ciprofloxacin XR compared with ciprofloxacin BID in the treatment of typhoid fever.

作者信息

Chen Khie, Pohan Herdiman T

机构信息

Division of Tropical and Infectious Diseases, Department of Internal Medicine, Faculty of Medicine, University of Indonesia-dr. Cipto Mangunkusumo Hospital, Jakarta.

出版信息

Acta Med Indones. 2007 Jan-Mar;39(1):22-6.

Abstract

AIM

To compare the efficacy and tolerability of ciproflaxin extended-release and ciproflaxin intermediate release in the treatment of typhoid fever.

METHODS

A prospective, open labelled, clinical trial, comparing the safety and efficacy of extended-release ciprofloxacin 1000 mg once daily (Ciprofloxacin XR) and ciprofloxacin intermediate release 500 mg two times daily (Ciprofloxacin bid) was performed in adult with typhoid fever. Diagnosis for typhoid fever was based on Widal serology test, blood culture and Polymerase Chain Reaction (PCR) for Salmonella typhi. A two-sided student t-test and chi-square or Fisher's exact test were used for the analysis of clinical responses.

RESULTS

Good clinical responses were obtained in 32 subjects (14 with Intermediate release ciprofloxacin and 18 with Extended-release ciprofloxacin) and there were no failure case (0%). Day to reach defervescence in Ciprofloxacin BID (mean 3.28 days) was similar to Ciprofloxacin XR group (mean 3.72 days) with p=0.43. Mild side effects were noted in 7.1% of subjects who received Ciprofloxacin BID compared by 22.2% in subjects who received Ciprofloxacin XR, with p=0.29. There were no moderate or severe side effects on both drugs.

CONCLUSION

Clinical outcomes were similar for the two treatments and both treatments were well tolerated. Once daily ciprofloxacin XR was safe, effective, and non-inferior to twice-daily ciprofloxacin IR in the treatment of typhoid fever.

摘要

目的

比较环丙沙星缓释制剂和环丙沙星中释制剂治疗伤寒热的疗效和耐受性。

方法

进行了一项前瞻性、开放标签的临床试验,比较每日一次服用1000mg环丙沙星缓释制剂(环丙沙星XR)和每日两次服用500mg环丙沙星中释制剂(环丙沙星bid)在成人伤寒热患者中的安全性和疗效。伤寒热的诊断基于肥达氏血清学试验、血培养以及伤寒沙门氏菌的聚合酶链反应(PCR)。采用双侧学生t检验和卡方检验或Fisher精确检验分析临床反应。

结果

32名受试者(14名使用环丙沙星中释制剂,18名使用环丙沙星缓释制剂)获得了良好的临床反应,无失败病例(0%)。环丙沙星bid组达到退热的天数(平均3.28天)与环丙沙星XR组(平均3.72天)相似,p=0.43。接受环丙沙星bid的受试者中有7.1%出现轻度副作用,而接受环丙沙星XR的受试者中这一比例为22.2%,p=0.29。两种药物均未出现中度或重度副作用。

结论

两种治疗方法的临床结果相似,且耐受性良好。在治疗伤寒热方面,每日一次的环丙沙星XR安全、有效,且不劣于每日两次的环丙沙星IR。

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