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阿奇霉素治疗猫抓病的前瞻性随机双盲安慰剂对照评估

Prospective randomized double blind placebo-controlled evaluation of azithromycin for treatment of cat-scratch disease.

作者信息

Bass J W, Freitas B C, Freitas A D, Sisler C L, Chan D S, Vincent J M, Person D A, Claybaugh J R, Wittler R R, Weisse M E, Regnery R L, Slater L N

机构信息

Department of Pediatrics, Tripler Army Medical Center, Honolulu, HI 96859-5000, USA.

出版信息

Pediatr Infect Dis J. 1998 Jun;17(6):447-52. doi: 10.1097/00006454-199806000-00002.

Abstract

OBJECTIVE

To determine the efficacy of azithromycin in the treatment of patients with typical cat-scratch disease.

DESIGN

Prospective, randomized, double blind, placebo-controlled clinical trial.

SETTING

Large military medical center and its referring clinics.

PATIENTS

Active duty military members and their dependents with laboratory-confirmed, clinically typical cat-scratch disease.

INTERVENTION

Study participants assigned by randomization to treatment with oral azithromycin or placebo for 5 days.

OUTCOME MEASURES

Lymph node volume was calculated using three dimensional ultrasonography at entry and at weekly intervals. The ultrasonographer was blinded to the treatment groups. Endpoint evaluations were predetermined as time in days to 80% resolution of the initial total lymph node volume.

RESULTS

Demographic and clinical data showed that the azithromycin and placebo treatment groups were comparable at entry although the placebo group tended to be older. Eighty percent decrease of initial lymph node volume was documented in 7 of 14 azithromycin-treated patients compared with 1 of 15 placebo-treated controls during the first 30 days of observation (P = 0.026). After 30 days there was no significant difference in rate or degree of resolution between the two groups.

CONCLUSIONS

Treatment of patients with typical cat-scratch disease with oral azithromycin for five days affords significant clinical benefit as measured by total decrease in lymph node volume within the first month of treatment.

摘要

目的

确定阿奇霉素治疗典型猫抓病患者的疗效。

设计

前瞻性、随机、双盲、安慰剂对照临床试验。

地点

大型军事医疗中心及其转诊诊所。

患者

现役军人及其家属中实验室确诊的临床典型猫抓病患者。

干预措施

通过随机分组,研究参与者接受口服阿奇霉素或安慰剂治疗5天。

观察指标

在入组时及每周使用三维超声测量淋巴结体积。超声检查人员对治疗组情况不知情。终点评估预先设定为初始总淋巴结体积消退80%所需的天数。

结果

人口统计学和临床数据显示,阿奇霉素治疗组和安慰剂治疗组在入组时具有可比性,尽管安慰剂组患者年龄偏大。在观察的前30天内,14例接受阿奇霉素治疗的患者中有7例初始淋巴结体积减少了80%,而15例接受安慰剂治疗的对照组患者中只有1例出现这种情况(P = 0.026)。30天后,两组之间在消退率或消退程度上没有显著差异。

结论

对于典型猫抓病患者,口服阿奇霉素治疗5天可带来显著的临床益处,以治疗第一个月内淋巴结总体积减少来衡量。

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