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A组链球菌咽炎患者两种青霉素V治疗方案的比较
作者:小柯机器人 发布时间:2019/10/10 10:50:12

瑞典公共卫生署G Skoog Ståhlgren研究小组在研究中取得新进展。他们提出应采用每日4次青霉素V、持续5天来治疗A组链球菌咽炎患者,而非每日3次、持续10天的方案。相关论文2019年10月4日在线发表于《英国医学杂志》。

2015年9月至2018年2月,研究组在瑞典的17个初级保健中心进行了一项开放标签、随机对照的非劣效性研究。共招募了433例参与者,年龄均大于6岁,患有A组链球菌咽炎,且符合3-4个Centor标准(发烧超过38.5℃,淋巴结疼痛,扁桃体渗出,无咳嗽)。随机将其分为两组,其中215例服用青霉素V 800mg,每日4次,治疗5天(共16g);218例服用青霉素V 1000mg,每日3次,治疗10天(共30g)。

治疗结束5-7天后,5天组的临床治愈率为89.6%,10天组为93.3%。5天组的细菌清除率为80.4%,10天组为90.7%。5天组中有8例患者复发,6例出现新的扁桃体炎;10天组中有7例复发,4例出现并发症,13例新的扁桃体炎。与10天组相比,5天组症状缓解的时间更短。治疗过程中发生的不良反应主要为腹泻、恶心和外阴疾病,其中10天组的不良反应发生率较高,且持续时间较长。

总之,对A组链球菌咽炎患者进行连续5天每天4次青霉素V的临床疗效,并不低于目前推荐的连续10天每天3次青霉素V,且未显著增加复发率和并发症,可作为一种替代方案。

附:英文原文

Title: Penicillin V four times daily for five days versus three times daily for 10 days in patients with pharyngotonsillitis caused by group A streptococci: randomised controlled, open label, non-inferiority study

Author: Gunilla Skoog Sthlgren, Mia Tyrstrup, Charlotta Edlund, Christian G Giske, Sigvard Mlstad, Christer Norman, Karin Rystedt, Pr-Daniel Sundvall, Katarina Hedin

Issue&Volume: 2019/10/04

Abstract: 

Objective To determine whether total exposure to penicillin V can be reduced while maintaining adequate clinical efficacy when treating pharyngotonsillitis caused by group A streptococci.

Design Open label, randomised controlled non-inferiority study.

Setting 17 primary healthcare centres in Sweden between September 2015 and February 2018.

Participants Patients aged 6 years and over with pharyngotonsillitis caused by group A streptococci and three or four Centor criteria (fever ≥38.5°C, tender lymph nodes, coatings of the tonsils, and absence of cough).

Interventions Penicillin V 800 mg four times daily for five days (total 16 g) compared with the current recommended dose of 1000 mg three times daily for 10 days (total 30 g).

Main outcome measures Primary outcome was clinical cure five to seven days after the end of antibiotic treatment. The non-inferiority margin was prespecified to 10 percentage points. Secondary outcomes were bacteriological eradication, time to relief of symptoms, frequency of relapses, complications and new tonsillitis, and patterns of adverse events.

Results Patients (n=433) were randomly allocated to the five day (n=215) or 10 day (n=218) regimen. Clinical cure in the per protocol population was 89.6% (n=181/202) in the five day group and 93.3% (n=182/195) in the 10 day group (95% confidence interval −9.7 to 2.2). Bacteriological eradication was 80.4% (n=156/194) in the five day group and 90.7% (n=165/182) in the 10 day group. Eight and seven patients had relapses, no patients and four patients had complications, and six and 13 patients had new tonsillitis in the five day and 10 day groups, respectively. Time to relief of symptoms was shorter in the five day group. Adverse events were mainly diarrhoea, nausea, and vulvovaginal disorders; the 10 day group had higher incidence and longer duration of adverse events.

Conclusions Penicillin V four times daily for five days was non-inferior in clinical outcome to penicillin V three times daily for 10 days in patients with pharyngotonsillitis caused by group A streptococci. The number of relapses and complications did not differ between the two intervention groups. Five day treatment with penicillin V four times daily might be an alternative to the currently recommended 10 day regimen.

DOI: 10.1136/bmj.l5337

Source: https://www.bmj.com/content/367/bmj.l5337

期刊信息

BMJ-British Medical Journal:《英国医学杂志》,创刊于1840年。隶属于BMJ出版集团,最新IF:27.604
官方网址:http://www.bmj.com/
投稿链接:https://mc.manuscriptcentral.com/bmj