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普萘洛尔与泼尼松龙对比联合治疗婴幼儿血管瘤的随机对照研究。

Effect of propranolol vs prednisolone vs propranolol with prednisolone in the management of infantile hemangioma: a randomized controlled study.

机构信息

Department of Pediatric Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

J Pediatr Surg. 2013 Dec;48(12):2453-9. doi: 10.1016/j.jpedsurg.2013.08.020.

Abstract

AIMS AND OBJECTIVES

The purpose of this study was to compare the efficacy of orally administered propranolol versus prednisolone versus both in the treatment of potentially disfiguring or functionally threatening infantile hemangiomas.

MATERIAL AND METHODS

A prospective study of 30 patients aged 1 week-8 months was randomized into three equal groups. These were as follows: A, propranolol (2-3 mg/kg/d); B, prednisolone (1-4 mg/kg/d); and C, receiving both for a minimum duration of 3 months. Dimensions, color, consistency, ultrasonography, photographic documentation based on Visual Analogue Scale (VAS) were recorded before and periodically after starting treatment. A minimum 75% improvement was considered as success with no regrowth up to 1 month of stopping treatment.

RESULTS

Mean initial response time (days) in A (4.1±3.3 SD) and C (4.7±3.4SD) was significantly lower than B (9.78±7.8SD) (p<0.047). Significant change in consistency was noted very early in A (24 hours) compared to B and C (8 days). VAS results are as follows: (a) color fading--significant reduction in A within 48 hours compared to B and C (p=0.025), (b) flattening--more significant and earlier in A and C than B (p<0.05), and (c) mean reduction in size: significant in A and C at 3 months (p=0.005, p=0.005), 6 months (p=0.005, p=0.008), 12 months (p=0.005, p=0.008), and 18 months (p=0.02, p=0.04), whereas in B, it was seen only at 6 months (p=0.008).

CONCLUSIONS

Propranolol had a consistent, rapid therapeutic effect compared to prednisolone. A combination of the two had a comparable but not higher efficacy than propranolol alone. Prednisolone was associated with a higher number of complications, thereby decreasing patient compliance.

摘要

目的和目标

本研究的目的是比较口服普萘洛尔与泼尼松龙治疗潜在毁容或功能威胁性婴儿血管瘤的疗效。

材料和方法

对 30 名年龄在 1 周至 8 个月的患者进行前瞻性研究,随机分为三组。如下所示:A 组,普萘洛尔(2-3mg/kg/d);B 组,泼尼松龙(1-4mg/kg/d);C 组,至少接受 3 个月的联合治疗。在开始治疗前和定期记录尺寸、颜色、质地、超声检查、基于视觉模拟量表(VAS)的照片记录。治疗停止后 1 个月内无复发且改善达 75%以上被认为是成功。

结果

A(4.1±3.3SD)和 C(4.7±3.4SD)的平均初始反应时间(天)明显低于 B(9.78±7.8SD)(p<0.047)。A 组的质地变化在 24 小时内就很明显,而 B 组和 C 组则在 8 天内才有变化。VAS 结果如下:(a)颜色消退——A 组在 48 小时内与 B 组和 C 组相比有显著减少(p=0.025),(b)变平——A 组和 C 组比 B 组更早且更显著(p<0.05),(c)大小平均减少:A 组和 C 组在 3 个月(p=0.005,p=0.005)、6 个月(p=0.005,p=0.008)、12 个月(p=0.005,p=0.008)和 18 个月(p=0.02,p=0.04)时显著,而 B 组仅在 6 个月时(p=0.008)显著。

结论

与泼尼松龙相比,普萘洛尔具有一致、快速的治疗效果。两者联合使用的疗效与单独使用普萘洛尔相当,但并不更高。泼尼松龙相关并发症较多,从而降低了患者的依从性。

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