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一项评估强化植物性黄油保湿霜治疗银屑病的真实世界、非干预性印度研究。

A Real-World, Non-interventional Indian Study Evaluating Intensive Plant-Based Butter Moisturizing Cream in Psoriasis.

作者信息

Jerajani Hemangi Rajiv, Thomas Jayakar, Gupta Alka, Netha Gurram Narasimha Rao, Chawla Ranju, Shaikh Rashid, Babu Ravindra, Williams Irene, Talathi Prajakta, Mehta Suyog C, Mittal Rajan, Acharya Shivani, Charugulla Sujeet N

机构信息

MGM Medical College and Hospital, Mumbai, India.

JT Skin Care Centre, Chennai, India.

出版信息

Dermatol Ther (Heidelb). 2019 Sep;9(3):537-546. doi: 10.1007/s13555-019-0307-0. Epub 2019 Jun 14.

Abstract

INTRODUCTION

Psoriasis is estimated to affect 0.44-2.8% of the Indian population. Moisturizers are a key adjuvant psoriasis treatment strategy, but data regarding their effectiveness, safety and compliance pattern in an Indian context are lacking. Hence, this real-world study on an intensive plant-based butter moisturizing cream (Venusia Max) was conducted among Indian patients with psoriasis.

METHODS

This was an observational, patient-reported outcomes (PRO) study in patients with psoriasis aged 18-75 years who were prescribed the cream in routine clinical practice, as per clinician's discretion, over 4 weeks. The primary outcome measure was improvement from baseline in quality of life assessed using the Dermatology Quality of Life Index (DLQI) at 4 weeks of the study period. The secondary outcome measures were improvement in dryness using the Dry Skin/Ichthyosis Area and Severity Index (DASI) score at 4 weeks, safety and compliance. The DLQI and DASI scores were recorded by the clinicians at baseline and after 2 (optional) and 4 weeks of starting the cream. Safety was assessed throughout the study.

RESULTS

The study included 400 patients from 9 outpatient dermatology centers across India. Of 400 patients, 384 completed the study. A significant reduction in both the mean DLQI score (66.7%; p < 0.001) and mean DASI score (84.6%; p < 0.001) was observed at week 4 after starting the cream vs. baseline in the overall population. Overall, the cream showed a good safety and compliance profile during the study period. There were no serious adverse events or deaths.

CONCLUSIONS

The evidence from the PRO study suggests that use of the intensive plant-based butter moisturizing cream in a real-world scenario has a noticeable impact on improving the quality of life and reducing the skin dryness associated with psoriasis over 4 weeks. The moisturizing cream may serve as a valuable adjuvant treatment option for the management of psoriasis.

TRIAL REGISTRATION NUMBER

CTRI/2017/03/008023.

FUNDING

Dr. Reddy's Laboratories Ltd.

摘要

引言

据估计,牛皮癣影响印度0.44%-2.8%的人口。保湿剂是牛皮癣治疗的关键辅助策略,但在印度背景下,关于其有效性、安全性和依从性模式的数据尚缺。因此,这项针对强化植物性黄油保湿霜(Venusia Max)的真实世界研究在印度牛皮癣患者中开展。

方法

这是一项观察性、患者报告结局(PRO)研究,研究对象为18-75岁的牛皮癣患者,根据临床医生的判断,在常规临床实践中为他们开具该保湿霜,疗程为4周。主要结局指标是在研究期4周时,使用皮肤病生活质量指数(DLQI)评估的生活质量较基线的改善情况。次要结局指标包括4周时使用干性皮肤/鱼鳞病面积和严重程度指数(DASI)评分评估的皮肤干燥改善情况、安全性和依从性。DLQI和DASI评分由临床医生在基线时以及开始使用保湿霜2周(可选)和4周后记录。在整个研究过程中评估安全性。

结果

该研究纳入了来自印度9个门诊皮肤科中心的400名患者。400名患者中,384名完成了研究。在开始使用保湿霜4周后与基线相比,总体人群的平均DLQI评分(66.7%;p<0.001)和平均DASI评分(84.6%;p<0.001)均显著降低。总体而言,该保湿霜在研究期间显示出良好的安全性和依从性。没有严重不良事件或死亡。

结论

PRO研究的证据表明,在真实世界场景中使用强化植物性黄油保湿霜对改善生活质量和减少与牛皮癣相关的皮肤干燥在4周内有显著影响。该保湿霜可能是牛皮癣管理中有价值的辅助治疗选择。

试验注册号

CTRI/2017/03/008023。

资金来源

雷迪博士实验室有限公司

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0241/6704203/9646447c719d/13555_2019_307_Fig1_HTML.jpg

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