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单剂量强力霉素治疗成人霍乱的随机双盲试验。

Randomised double blind trial of single dose doxycycline for treating cholera in adults.

作者信息

Alam A N, Alam N H, Ahmed T, Sack D A

机构信息

International Centre for Diarrhoeal Disease, Research, Bangladesh, Dhaka.

出版信息

BMJ. 1990 Jun 23;300(6740):1619-21. doi: 10.1136/bmj.300.6740.1619.

Abstract

OBJECTIVE

To compare the efficacy of a single dose of doxycycline (200 or 300 mg) with the standard multiple doses of tetracycline in patients with cholera.

DESIGN

Randomised double blind controlled trial. Patients were given a single 200 mg dose of doxycycline, a single 300 mg dose of doxycycline, or multiple doses of tetracycline (500 mg, six hourly intervals).

SETTING

Hospital in Bangladesh treating diarrhoea.

PATIENTS

261 Patients aged over 15 admitted to the hospital with severe dehydration due to acute watery diarrhoea associated with Vibrio cholerae. All vibrios isolated from the stools and rectal swabs of patients, including those patients with prolonged excretion of vibrios, were sensitive to tetracycline. The stools of all patients at admission were negative for shigella and salmonella.

INTERVENTIONS

All patients received rapid intravenous acetate solution for the first four hours after admission to hospital. They were then entered in the study and randomised. Oral rehydration was started immediately after the intravenous treatment. If signs of severe dehydration reappeared during oral treatment patients were given rapid intravenous acetate solution until dehydration was fully corrected.

MAIN OUTCOME MEASURES

Stool output in first 24 hours and till diarrhoea stopped, total intake of oral rehydration fluid, duration of diarrhoea, and excretion of vibrio after receiving antibiotic treatment.

RESULTS

The median stool outputs during the first 24 hours (275 ml/kg body weight) and till diarrhoea stopped (296 ml/kg body weight) were significantly higher in patients receiving 200 mg doxycycline as a single dose than in patients receiving either standard tetracycline (242 ml/kg body weight and 254 ml/kg body weight) or 300 mg doxycycline (226 ml/kg body weight and 255 ml/kg body weight). Similarly, median consumption of oral rehydration solution (18.45 l) was significantly higher in patients receiving 200 mg doxycycline than in patients receiving either 300 mg doxycycline (16.10 l) or standard tetracycline (14.80 l). Almost equal numbers of patients in each group required unscheduled intravenous acetate solution to correct dehydration during antibiotic treatment. Patients treated with doxycycline (low or high dose), however, had more prolonged excretion of bacteria.

CONCLUSIONS

A single 300 mg dose of doxycycline is as effective as the standard multiple dose tetracycline treatment for cholera in terms of stool output, duration of diarrhoea, vomiting, and requirement for oral rehydration solution.

摘要

目的

比较单剂量强力霉素(200或300毫克)与标准多剂量四环素治疗霍乱患者的疗效。

设计

随机双盲对照试验。患者分别接受单次200毫克强力霉素剂量、单次300毫克强力霉素剂量或多剂量四环素(500毫克,每6小时一次)治疗。

地点

孟加拉国一家治疗腹泻的医院。

患者

261名15岁以上因急性水样腹泻伴霍乱弧菌感染而严重脱水入院的患者。从患者粪便和直肠拭子中分离出的所有弧菌,包括弧菌排泄时间延长的患者,对四环素均敏感。所有患者入院时粪便志贺菌和沙门菌检测均为阴性。

干预措施

所有患者入院后前4小时接受快速静脉输注醋酸盐溶液。然后进入研究并随机分组。静脉治疗后立即开始口服补液。如果口服治疗期间再次出现严重脱水迹象,患者接受快速静脉输注醋酸盐溶液直至脱水完全纠正。

主要观察指标

抗生素治疗后24小时内及腹泻停止前的粪便排出量、口服补液总量、腹泻持续时间及弧菌排泄情况。

结果

单次服用200毫克强力霉素的患者,在治疗后24小时内(275毫升/千克体重)及腹泻停止时(296毫升/千克体重)的粪便排出量中位数,显著高于接受标准四环素治疗(242毫升/千克体重和254毫升/千克体重)或300毫克强力霉素治疗(226毫升/千克体重和255毫升/千克体重)的患者。同样,接受200毫克强力霉素治疗的患者口服补液溶液的中位数消耗量(18.45升),显著高于接受300毫克强力霉素治疗(16.10升)或标准四环素治疗(14.80升)的患者。每组中几乎相同数量的患者在抗生素治疗期间需要非计划静脉输注醋酸盐溶液来纠正脱水。然而,接受强力霉素(低剂量或高剂量)治疗的患者细菌排泄时间延长。

结论

就粪便排出量、腹泻持续时间、呕吐情况及口服补液需求而言,单次300毫克剂量的强力霉素与标准多剂量四环素治疗霍乱的效果相同。

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