外用强效糖皮质激素联合中、低剂量口服糖皮质激素治疗大疱性类天疱疮的疗效与安全性评价(1)
摘 要 目的：比较使用单纯外用强效糖皮质激素与再联合中、低剂量口服糖皮质激素治疗大疱性类天疱疮患者的疗效及其相关影响因素。方法：对2009—2013年间收治的54例大疱性类天疱疮患者，先评估疾病严重程度，然后随机分成两组治疗：单纯外用0.05%丙酸卤米松乳膏(根据皮损范围给予15 ～ 60 g/d治疗)组和外用0.05%丙酸卤米松乳膏联合口服中、低剂量泼尼松[轻、中度患者剂量为0.2 mg/(kg·d)、重度患者剂量为0.4 mg/(kg·d)]组。记录患者的每天新发水疱数、疾病控制天数、复发次数、不良反应和死亡率，对患者的外周血嗜酸性粒细胞(eosinophil， EOS)计数、血清白蛋白和总免疫球蛋白E水平与临床症状的相关性进行分析，并进一步对影响患者疾病严重程度和治疗疗效的相关因素进行评价。结果：在单纯外用组，治疗3周后，患者的每天新发水疱数和血EOS计数明显减少；在联合口服组，治疗2周后，患者的每天新发水疱数即明显减少，血EOS计数在3周后也明显减少。在单纯外用组和联合口服组，患者的血EOS计数与每天新发水疱数都呈正相关性；在联合口服组，患者的血清白蛋白水平与每天新发水疱数呈负相关性。治疗3周内，联合口服组的疾病控制率远大于单纯外用组；对轻、中度患者，联合口服组的复发率也较单纯外用组低；不同疾病严重程度的患者在联合口服组和单纯外用组的不良事件发生率无明显差异。结论：与使用单纯外用糖皮质激素相比，再联合中、低剂量口服糖皮质激素治疗大疱性类天疱疮可较快地控制疾病、降低复发率，而不良反应发生率没有明显增加。在治疗过程中，患者的外周血EOS计数和临床症状呈正相关性，故可作为疗效的观察指标；总免疫球蛋白E水平升高、低龄是疾病严重的危险因素。
关键词 类天疱疮 外用糖皮质激素 疗效
中图分类号：R977.11； R758.66 文献标识码：B 文章编号：1006-1533(2016)09-0014-06
Evaluation of the efficacy and safety of topical potent glucocorticoid combined with low or middle dose of systemic glucocorticoid in the treatment of patients with bullous pemphigoid*
XU Muchi1，2**， PAN Meng1***， ZHU Haiqin2， LI Weiping1， YE Yafen1， XU Jing1， ZHENG Jie1(1. Department of Dermatology， Ruijin Hospital affiliated to School of Medicine， Shanghai Jiao Tong University， Shanghai 200025， China； 2. Department of Dermatology， North Ruijin Hospital affiliated to School of Medicine， Shanghai Jiao Tong University， Shanghai 201801， China)
ABSTRACT Objective： To evaluate the efficacy of topical potent glucocorticoid combined with low or middle dose of oral glucocorticoid in the treatment of patients with bullous pemphigoid (BP) and analyze the factors that influence the outcome and prognosis. Methods： Fifty-four BP patients enrolled in this study were randomly divided into a control group receiving topical 0.05% halometasone propionate cream (15 ～ 60 g/d according to lesion area) and an observation group receiving topical glucocorticoid combined with oral prednisone [the dosage was 0.2 mg/(kg·d) for those with moderate disease or 0.4 mg/(kg·d) for those with extensive disease] based on the severity of their diseases (moderate or extensive). The daily newly appeared bullae， the days for disease controlled， the times for recurrence， adverse reactions and mortality rate were recorded and the correlation among peripheral blood eosinophil count and the levels of albumin and total immunoglobin E and clinical severity were analyzed， and furthermore， the related factors affecting the severity of disease and the efficacy of therapy were evaluated. Results： The number of newly appeared bullae and eosinophil count were significantly reduced in the control group after 3 week treatment and in the observation group after 2 or 3 week treatment. There was a positive correlation between the number of newly appeared bullae and eosinophil count in both groups and a negative correlation between the serum albumin level and the number of newly appeared bullae in the observation group. Disease control rate was significantly higher in the observation group than the control group and recurrence rate was much lower in the observation group than the control group for the patients with mild to moderate disease. There were no significantly differences between two groups in the incidence of adverse event in the patients with different severity of disease. Conclusion： Topical glucocorticoid combined with low dose of oral glucocorticoid is effective for the treatment of BP and can fast control disease and decrease the relapse rate without a significant increase of adverse reaction. There is a positive correlation between the peripheral blood eosinophil count and the clinical symptoms， which can be used as an observation indicator for efficacy. High level of total immunoglobin E and low age are the risk factors for severity of BP. (徐牧迟 潘萌 朱海琴 李卫平 叶亚芬 徐静 郑捷)
关键词 类天疱疮 外用糖皮质激素 疗效
中图分类号：R977.11； R758.66 文献标识码：B 文章编号：1006-1533(2016)09-0014-06
Evaluation of the efficacy and safety of topical potent glucocorticoid combined with low or middle dose of systemic glucocorticoid in the treatment of patients with bullous pemphigoid*
XU Muchi1，2**， PAN Meng1***， ZHU Haiqin2， LI Weiping1， YE Yafen1， XU Jing1， ZHENG Jie1(1. Department of Dermatology， Ruijin Hospital affiliated to School of Medicine， Shanghai Jiao Tong University， Shanghai 200025， China； 2. Department of Dermatology， North Ruijin Hospital affiliated to School of Medicine， Shanghai Jiao Tong University， Shanghai 201801， China)
ABSTRACT Objective： To evaluate the efficacy of topical potent glucocorticoid combined with low or middle dose of oral glucocorticoid in the treatment of patients with bullous pemphigoid (BP) and analyze the factors that influence the outcome and prognosis. Methods： Fifty-four BP patients enrolled in this study were randomly divided into a control group receiving topical 0.05% halometasone propionate cream (15 ～ 60 g/d according to lesion area) and an observation group receiving topical glucocorticoid combined with oral prednisone [the dosage was 0.2 mg/(kg·d) for those with moderate disease or 0.4 mg/(kg·d) for those with extensive disease] based on the severity of their diseases (moderate or extensive). The daily newly appeared bullae， the days for disease controlled， the times for recurrence， adverse reactions and mortality rate were recorded and the correlation among peripheral blood eosinophil count and the levels of albumin and total immunoglobin E and clinical severity were analyzed， and furthermore， the related factors affecting the severity of disease and the efficacy of therapy were evaluated. Results： The number of newly appeared bullae and eosinophil count were significantly reduced in the control group after 3 week treatment and in the observation group after 2 or 3 week treatment. There was a positive correlation between the number of newly appeared bullae and eosinophil count in both groups and a negative correlation between the serum albumin level and the number of newly appeared bullae in the observation group. Disease control rate was significantly higher in the observation group than the control group and recurrence rate was much lower in the observation group than the control group for the patients with mild to moderate disease. There were no significantly differences between two groups in the incidence of adverse event in the patients with different severity of disease. Conclusion： Topical glucocorticoid combined with low dose of oral glucocorticoid is effective for the treatment of BP and can fast control disease and decrease the relapse rate without a significant increase of adverse reaction. There is a positive correlation between the peripheral blood eosinophil count and the clinical symptoms， which can be used as an observation indicator for efficacy. High level of total immunoglobin E and low age are the risk factors for severity of BP. (徐牧迟 潘萌 朱海琴 李卫平 叶亚芬 徐静 郑捷)