中华皮肤科杂志 ›› 2019, Vol. 52 ›› Issue (8): 537-541.doi: 10.3760/cma.j.issn.0412-4030.2019.08.005

• 论著 • 上一篇    下一篇

一种含青刺果油等提取物的润肤剂改善儿童特应性皮炎缓解期临床症状的多中心、随机、平行对照临床研究

路坦1    王珊1    王榴慧2    李萍3    舒虹4    申春平1    吴瑶2    罗珍3    缪丽敏4    王红兵5    焦磊1    田晶1    彭晓霞6    赵牧童1    刘盈1    聂晓璐6    马琳1    何黎5   

  1. 1首都医科大学附属北京儿童医院皮肤科  100045； 2复旦大学附属儿科医院皮肤科，上海  201102； 3深圳市儿童医院皮肤科  518038； 4昆明市儿童医院皮肤科  650000； 5昆明医科大学第一附属医院皮肤科  650032； 6首都医科大学附属北京儿童医院循证医学研究中心  100045
  • 收稿日期:2019-01-09 修回日期:2019-06-03 出版日期:2019-08-15 发布日期:2019-07-30
  • 通讯作者: 马琳；何黎 E-mail:bch_maleen@aliyun.com; drheli2662@126.com
  • 基金资助:
    国家自然科学基金（81673042）；北京市医院管理局儿科学科协同发展中心专项经费（XTZD20180502）；云南省科技计划重大科技专项（2018ZF005）；北京市优秀人才培养资助项目（2017000021469G248）

An emollient containing Prinsepia utilis Royle oil extracts and other extracts for the improvement of clinical symptoms among children aged 2 - 12 years with atopic dermatitis in the remission period: a multicenter, randomized, parallel-group, controlled clinical study

Lu Tan1, Wang Shan1, Wang Liuhui2, Li Ping3, Shu Hong4, Shen Chunping1, Wu Yao2, Luo Zhen3, Miao Limin4, Wang Hongbing5, Jiao Lei1, Tian Jing1, Peng Xiaoxia6, Zhao Mutong1, Liu Ying1, Nie Xiaolu6, Ma Lin1, He Li5   

  1. 1Department of Dermatology, Beijing Children′s Hospital, Capital Medical University, Beijing 100045, China;  2Department of Dermatology, Children′s Hospital of Fudan University, Shanghai 201102, China;  3Department of Dermatology, Shenzhen Children′s Hospital, Shenzhen 518038, China;  4Department of Dermatology, Kunming Children′s Hospital, Kunming 650000, China;  5Department of Dermatology, First Affiliated Hospital of Kunming Medical University, Kunming 650032, China;  6Center for Clinical Epidemiology and Evidence⁃Based Medicine, Beijing Children′s Hospital, Capital Medical University, Beijing 100045, China
  • Received:2019-01-09 Revised:2019-06-03 Online:2019-08-15 Published:2019-07-30
  • Contact: Ma Lin; He Li E-mail:bch_maleen@aliyun.com; drheli2662@126.com
  • Supported by:
    National Natural Science Foundation of China （81673042）; Special Fund of the Pediatric Medical Coordinated Development Center of Beijing Municipal Administration of Hospitals （XTZD20180502）; Major Science and Technology Projects of Yunnan Province of China （2018ZF005）; Talents Training Program in Beijing （2017000021469G248）

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摘要： 【摘要】 目的 观察一种含青刺果油等提取物的润肤剂（以下简称润肤剂）对2 ~ 12岁儿童特应性皮炎（AD）缓解期临床症状的改善作用及疾病复发的影响。方法 2017年12月至2018年9月采用多中心、随机、平行对照的研究方法，在全国5家医院纳入2 ~ 12岁中度AD患儿297例，按随机数字表法分为试验组（148例）及对照组（149例）。急性期时，两组均在皮损处外用糠酸莫米松乳膏每天1次，全身外用润肤剂每天2次，使用2 ~ 4周，直至访视时研究者整体评分（IGA） ≤ 1分，进入缓解期。缓解期时，试验组停用糠酸莫米松乳膏，继续全身使用润肤剂每天2次，而对照组停用药物和润肤剂。分别在缓解期第4、8、12周时评估患儿AD复发情况、湿疹面积及严重度指数（EASI）、儿童皮肤病生活质量指数（CDQOL）以及不良事件的发生情况。统计分析采用SAS 9.4软件，两组间正态分布的连续性资料比较采用t检验，组间无序分类资料差异分析采用χ2检验，生存率分析采用Kaplan?Meier法，不同治疗方案对AD患儿缓解期复发的影响采用Cox回归分析，采用Logistic回归分析试验组与对照组在缓解期第4周EASI和CDQOL评分分类的优势比（OR）。结果 297例AD患儿中，31例违反试验方案，266例纳入PPS集（试验组132例、对照组134例）。PPS集中试验组及对照组分别有114和106例完成随访，复发47（41.23%）和84例（79.25%），两组复发率差异有统计学意义（χ2 = 32.96，P < 0.001）。试验组复发时间（61.99 d ± 2.80 d）显著高于对照组（39.17 d ± 2.54 d），t = 6.03，P < 0.001。试验组复发风险显著低于对照组（Log rank检验，χ2 = 32.02，P < 0.001）。调整年龄、性别后进行Cox回归分析，发现试验组复发风险是对照组的0.35倍（HR = 0.35，95% CI：0.24 ~ 0.51，P < 0.01）。缓解期第4周时试验组EASI评分位于P50 ~ P75、P75 ~ P100的风险是对照组的0.42、0.25倍（95% CI分别为0.20 ~ 0.86、0.12 ~ 0.54，P = 0.02、 < 0.01）；第4周时试验组患者CDQOL值位于P75 ~ P100的风险是对照组的0.33倍（95% CI为0.17 ~ 0.65，P < 0.01）。两组间不良事件发生率差异无统计学意义（P > 0.05）。结论 含青刺果油等提取物的润肤维持治疗可以显著降低缓解期AD患儿复发风险，改善临床症状，提高生活质量。

关键词: 皮炎, 特应性； 儿童； 随机对照试验； 缓解期； 维持治疗； 润肤剂； 青刺果油

Abstract: 【Abstract】 Objective To evaluate the effect of an emollient containing Prinsepia utilis Royle oil extracts and other extracts on clinical symptoms and disease recurrence in children aged 2 - 12 years with atopic dermatitis （AD） in the remission period. Methods A multicenter, randomized, parallel-group, controlled clinical trial was conducted from December 2017 to September 2018. A total of 297 children aged 2 - 12 years with moderate AD were enrolled from 5 hospitals in China, and randomly divided into the test group （148 cases） and control group （149 cases）. In the acute stage, the two groups were both topically treated with mometasone furoate cream once a day on the skin lesions, and with an emollient containing Prinsepia utilis Royle oil extracts and other extracts twice a day throughout the whole body for 2 - 4 weeks. The children would be enrolled into the remission stage if their Investigator′s Global Assessment（IGA）score was ≤ 1 at following visits. In the remission stage, the test group was only topically treated with the emollient twice a day throughout the whole body, while mometasone furoate cream and the emollient were both withdrawn in the control group. At weeks 4, 8 and 12 in the remission stage, the recurrence of AD, eczema area and severity index（EASI）, children′s dermatology life quality index （CDQOL） and adverse events were evaluated. Statistical analysis was carried out with SAS 9.4 software by using t test for comparison of normally distributed continuous data between two groups, chi-square test for comparison of unordered categorical data, Kaplan-Meier method for analysis of survival rates, Cox regression analysis for evaluating the effect of different therapies on AD recurrence in children in the remission stage, and Logistic regression analysis for analysis of odds ratio （OR） of EASI or CDQOL at week 4 in the remission stage between the test group and control group. Results Of the 297 children with AD, 31 breached the clinical trial protocol, and 266 were included in the per protocol set （PPS）, including 132 in the test group and 134 in the control group. In the PPS, 114 and 106 patients completed the follow-up in the test group and control group respectively, and the recurrence rate was significantly lower in the test group （47, 41.23%） than in the control group （84, 79.25%; χ2 = 32.96, P < 0.001）. The time to recurrence was significantly longer in the test group（61.99 d ± 2.80 d）than in the control group（39.17 d ± 2.54 d, t = 6.03, P < 0.001）, and the recurrence risk was significantly lower in the test group than in the control group （Log rank test, χ2 = 32.02, P < 0.001）. After adjustment for age and gender, Cox regression analysis showed that the recurrence risk in the test group was 0.35 times that in the control group（HR = 0.35, 95% CI: 0.24 - 0.51, P < 0.01）. At week 4 in the remission stage, the EASI score at P50 - P75 and P75 - P100 in the test group were 0.42, 0.25 times that in the control group respectively （95% CI: 0.20 - 0.86, 0.12 - 0.54 respectively; P = 0.02, < 0.01 respectively）. Moreover, the CDQOL score at P75 - P100 in the test group was 0.33 times that in the control group （95% CI: 0.17 - 0.65, P < 0.01）. No significant difference in the incidence of adverse events was observed between the two groups（P > 0.05）. Conclusion Maintenance treatment with the emollient containing Prinsepia utilis Royle oil extracts and other extracts can markedly reduce the recurrence risk in AD children, improve clinical symptoms, and enhance the quality of life.

Key words: Dermatitis, atopic, Child, Randomized controlled trial, Remission period, Maintenance treatment, Emollients, Prinsepia utilis Royle oil