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葡萄糖酸洗必泰和盐酸苄达明口腔喷雾剂对链球菌性扁桃体咽炎患者临床症状及生活质量的影响:多中心、前瞻性、随机、双盲、安慰剂对照研究

Effect of chlorhexidine gluconate and benzydamine hydrochloride mouth spray on clinical signs and quality of life of patients with streptococcal tonsillopharyngitis: multicentre, prospective, randomised, double-blinded, placebo-controlled study.

作者信息

Cingi C, Songu M, Ural A, Erdogmus N, Yildirim M, Cakli H, Bal C

机构信息

Department of Otorhinolaryngology, Osmangazi University Medical Faculty, Eskisehir, Turkey.

出版信息

J Laryngol Otol. 2011 Jun;125(6):620-5. doi: 10.1017/S0022215111000065. Epub 2011 Feb 11.

DOI:10.1017/S0022215111000065
PMID:21310101
Abstract

OBJECTIVE

To assess the effect of chlorhexidine gluconate and benzydamine hydrochloride mouth spray, used in conjunction with antibiotic treatment, on the intensity of clinical signs and quality of life of patients with group A streptococcal tonsillopharyngitis.

METHODS

Patients (n = 147) with streptococcal tonsillopharyngitis were recruited and randomly allocated to either the treatment group (penicillin plus chlorhexidine and benzydamine; n = 72) or control group (penicillin plus placebo; n = 75). Blinded assessments were conducted before and after 10 days' treatment, using an intensity rating scale for clinical sign severity, a visual analogue scale for subjective health state, the Short Form 36 Health Questionnaire for quality of life, and a customised questionnaire for side effects.

RESULTS

The treatment group showed a statistically significant reduction in the intensity of clinical signs, compared with the control group. On treatment day 7, there was no significant difference in quality of life between the treatment and control groups. The treatment drugs were well tolerated, and no serious adverse events were observed.

CONCLUSION

Chlorhexidine gluconate and benzydamine hydrochloride mouth spray, added to standard antibiotic treatment, significantly alleviate the intensity of clinical signs in patients with streptococcal pharyngitis. Further research is needed using larger sample sizes or alternative control groups.

摘要

目的

评估葡萄糖酸洗必泰和盐酸苄达明口腔喷雾剂联合抗生素治疗对A组链球菌性扁桃体咽炎患者临床症状严重程度及生活质量的影响。

方法

招募147例链球菌性扁桃体咽炎患者,随机分为治疗组(青霉素加洗必泰和苄达明;n = 72)和对照组(青霉素加安慰剂;n = 75)。在治疗10天前后进行盲法评估,使用临床症状严重程度强度评分量表、主观健康状态视觉模拟量表、36项简短健康调查问卷评估生活质量,以及一份定制的副作用调查问卷。

结果

与对照组相比,治疗组临床症状强度有统计学意义的降低。在治疗第7天,治疗组和对照组的生活质量无显著差异。治疗药物耐受性良好,未观察到严重不良事件。

结论

在标准抗生素治疗基础上加用葡萄糖酸洗必泰和盐酸苄达明口腔喷雾剂,可显著减轻链球菌性咽炎患者的临床症状强度。需要使用更大样本量或替代对照组进行进一步研究。

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