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透明质酸酶联合倍他米松局部治疗包茎是否能提高疗效?一项随机双盲临床试验。

Does the addition of hyaluronidase to betamethasone in topical treatment of phimosis improves results? - A randomized double-blind clinical trial.

机构信息

Faculty of Medical and Health Sciences of Juiz de Fora (FCMS/JF - SUPREMA), Brazil.

Federal University of Juiz de Fora (UFJF), Brazil.

出版信息

J Pediatr Urol. 2024 Oct;20(5):898-903. doi: 10.1016/j.jpurol.2024.06.039. Epub 2024 Jul 10.

DOI:10.1016/j.jpurol.2024.06.039
PMID:39079875
Abstract

INTRODUCTION

Phimosis is defined as the inability to retract the foreskin, preventing partial or complete exposure of the glans.

OBJECTIVES

To compare the efficacy of topical treatment with betamethasone alone and in combination with hyaluronidase, evaluate systemic absorption of cortisol, and identify factors that predispose the success of topical treatment of phimosis in children aged 3-10 years.

METHODS

This randomized double-blinded clinical trial involved 152 participants (3-10 years old) with phimosis. The children were divided into two groups: betamethasone associated with hyaluronidase (betamethasone valerate 2.5 mg + hyaluronidase 150 UTR; Group A) and betamethasone (betamethasone valerate 2.5 mg; Group B). Parents were instructed on how to use the ointment (twice a day, after hygiene, for 60 days) and on collecting salivary cortisol measurements at 11pm and 9am, before and after treatment. Participants were evaluated after 30 and 60 days. Fisher's exact test and paired t-test were used to analyze the data.

RESULTS

Ninety children (69.77%) were successfully treated with the proposed treatment, with the success rate for Group A being 75.38% versus 64.06% for Group B, p = 0.18). Systemic absorption evaluated by salivary cortisol did not show differences after the intervention (p > 0.05), indicating that there was no systemic absorption when using ointments with or without hyaluronidase. The factors of age (OR = 0.98 - CI: 0.97-1.00), adherence (OR = 1.49 - CI: 0.53-4.16), balanoposthitis (OR = 1.85 - CI: 0.47-7.19), and previous use of corticosteroids (OR = 1.21 - CI: 0.53-2.72) also did not show influenced results CONCLUSION: Topical therapy for true phimosis with betamethasone 0.2% + hyaluronidase, despite showing no differences when compared with betamethasone 0.2% alone, for a period of up to 60 days, proved to be safe, effective, and with good results. The variables analyzed could not predict the expected clinical response.

REBEC

RBR-76bhgyb.

摘要

引言

包茎是指无法回缩包皮,导致龟头部分或完全无法外露。

目的

比较单独使用倍他米松和联合使用透明质酸酶治疗包茎的疗效,评估皮质醇的全身吸收,并确定导致 3-10 岁儿童包茎局部治疗成功的相关因素。

方法

这是一项随机、双盲的临床试验,共纳入 152 名(3-10 岁)包茎患儿。将患儿分为两组:倍他米松联合透明质酸酶(倍他米松戊酸 2.5mg+透明质酸酶 150UTR;A 组)和倍他米松(倍他米松戊酸 2.5mg;B 组)。指导家长如何使用软膏(每天两次,在卫生后使用,共 60 天),并在治疗前后的晚上 11 点和早上 9 点收集唾液皮质醇测量值。在 30 天和 60 天时对参与者进行评估。使用 Fisher 确切检验和配对 t 检验对数据进行分析。

结果

90 名儿童(69.77%)成功接受了所提议的治疗,A 组的成功率为 75.38%,B 组为 64.06%,p=0.18。通过唾液皮质醇评估的全身吸收在干预后没有差异(p>0.05),这表明使用含有或不含有透明质酸酶的软膏时没有全身吸收。年龄(OR=0.98-CI:0.97-1.00)、依从性(OR=1.49-CI:0.53-4.16)、龟头炎(OR=1.85-CI:0.47-7.19)和之前使用皮质类固醇(OR=1.21-CI:0.53-2.72)等因素也未显示出影响结果的作用。

结论

对于真正的包茎,使用 0.2%倍他米松+透明质酸酶进行局部治疗,尽管与单独使用 0.2%倍他米松相比,在长达 60 天的时间内,结果并无差异,但被证明是安全、有效且结果良好。分析的变量不能预测预期的临床反应。

REBEC

RBR-76bhgyb。

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