Hayward Gail Nicola, Hay Alastair D, Moore Michael V, Jawad Sena, Williams Nicola, Voysey Merryn, Cook Johanna, Allen Julie, Thompson Matthew, Little Paul, Perera Rafael, Wolstenholme Jane, Harman Kim, Heneghan Carl
Nuffield Department of Primary Care Health Sciences, University of Oxford, United Kingdom.
Centre for Academic Primary Care, NIHR School for Primary Care Research, School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom.
JAMA. 2017 Apr 18;317(15):1535-1543. doi: 10.1001/jama.2017.3417.
Acute sore throat poses a significant burden on primary care and is a source of inappropriate antibiotic prescribing. Corticosteroids could be an alternative symptomatic treatment.
To assess the clinical effectiveness of oral corticosteroids for acute sore throat in the absence of antibiotics.
DESIGN, SETTING, AND PARTICIPANTS: Double-blind, placebo-controlled randomized trial (April 2013-February 2015; 28-day follow-up completed April 2015) conducted in 42 family practices in South and West England, enrolled 576 adults recruited on the day of presentation to primary care with acute sore throat not requiring immediate antibiotic therapy.
Single oral dose of 10 mg of dexamethasone (n = 293) or identical placebo (n = 283).
Primary: proportion of participants experiencing complete resolution of symptoms at 24 hours. Secondary: complete resolution at 48 hours, duration of moderately bad symptoms (based on a Likert scale, 0, normal; 6, as bad as it could be), visual analog symptom scales (0-100 mm; 0, no symptom to 100, worst imaginable), health care attendance, days missed from work or education, consumption of delayed antibiotics or other medications, adverse events.
Among 565 eligible participants who were randomized (median age, 34 years [interquartile range, 26.0-45.5 year]; 75.2% women; 100% completed the intervention), 288 received dexamethasone; 277, placebo. At 24 hours, 65 participants (22.6%) in the dexamethasone group and 49 (17.7%) in the placebo group achieved complete resolution of symptoms, for a risk difference of 4.7% (95% CI, -1.8% to 11.2%) and a relative risk of 1.28 (95% CI; 0.92 to 1.78; P = .14). At 24 hours, participants receiving dexamethasone were not more likely than those receiving placebo to have complete symptom resolution. At 48 hours, 102 participants (35.4%) in the dexamethasone group vs 75 (27.1%) in the placebo group achieved complete resolution of symptoms, for a risk difference of 8.7% (95% CI, 1.2% to 16.2%) and a relative risk of 1.31 (95% CI, 1.02 to 1.68; P = .03). This difference also was observed in participants not offered delayed antibiotic prescription, for a risk difference of 10.3% (95% CI, 0.6% to 20.1%) and a relative risk of 1.37 (95% CI, 1.01 to 1.87; P = .046). There were no significant differences in any other secondary outcomes.
Among adults presenting to primary care with acute sore throat, a single dose of oral dexamethasone compared with placebo did not increase the proportion of patients with resolution of symptoms at 24 hours. However, there was a significant difference at 48 hours.
isrctn.org Identifier: ISRCTN17435450.
急性咽痛给初级医疗保健带来了沉重负担，也是抗生素不恰当使用的一个源头。皮质类固醇可能是一种替代性的对症治疗方法。
评估在不使用抗生素的情况下口服皮质类固醇治疗急性咽痛的临床疗效。
设计、设置和参与者：双盲、安慰剂对照随机试验（2013年4月 - 2015年2月；2015年4月完成28天随访）在英格兰南部和西部的42家家庭诊所进行，纳入了576名因急性咽痛在就诊当日被招募到初级医疗保健机构且不需要立即使用抗生素治疗的成年人。
单次口服10毫克地塞米松（n = 293）或相同的安慰剂（n = 283）。
主要指标：24小时时症状完全缓解的参与者比例。次要指标：48小时时症状完全缓解、中度不良症状持续时间（基于李克特量表，0为正常；6为可能的最严重程度）、视觉模拟症状量表（0 - 100毫米；0表示无症状，100表示可想象到的最严重症状）、医疗保健就诊情况、工作或学习缺勤天数、延迟使用抗生素或其他药物的情况、不良事件。
在565名被随机分组的符合条件的参与者中（年龄中位数为34岁[四分位间距，26.0 - 45.5岁]；75.2%为女性；100%完成干预），288人接受了地塞米松治疗；277人接受了安慰剂治疗。在24小时时，地塞米松组65名参与者（22.6%）和安慰剂组49名参与者（17.7%）症状完全缓解，风险差为4.7%（95%置信区间，-1.8%至11.2%），相对风险为1.28（95%置信区间；0.92至1.78；P = 0.14）。在24小时时，接受地塞米松治疗的参与者症状完全缓解的可能性并不比接受安慰剂治疗的参与者更高。在48小时时，地塞米松组102名参与者（35.4%）和安慰剂组75名参与者（27.1%）症状完全缓解，风险差为8.7%（95%置信区间，1.2%至16.2%），相对风险为1.31（95%置信区间，1.02至1.68；P = 0.03）。在未接受延迟抗生素处方的参与者中也观察到了这种差异，风险差为10.3%（95%置信区间，0.6%至20.1%），相对风险为1.37（95%置信区间，1.01至1.87；P = 0.046）。在任何其他次要结局方面均无显著差异。
在因急性咽痛就诊于初级医疗保健机构的成年人中，与安慰剂相比，单次口服地塞米松在24小时时并未增加症状缓解患者的比例。然而，在48小时时存在显著差异。
isrctn.org标识符：ISRCTN17435450。
