Neurology, Peking University Third Hospital, Beijing, China.
Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, China.
BMJ Open. 2019 Apr 8;9(4):e025722. doi: 10.1136/bmjopen-2018-025722.
Painful diabetic peripheral neuropathy (PDN) is a growing public health problem in China. Despite recent progress in treatment, there has been no nationwide study evaluating current medical practices and compliance with treatment guidelines. The primary aims of this study are to investigate the clinical characteristics and treatment practices for PDN and associated anxiety and depression in China.
Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnts is a cross-sectional, multicentre registry study with a target sample size of approximately 1500 people experiencing PDN. People with PDN will be treated according to current guidelines and local practices. The demographics, medical histories, Visual Analogue Scale pain scores, Patient Health Questionnaire-9 results, Generalised Anxiety Disorder-7 scores and therapies will be recorded to evaluate clinical characteristics of PDN and current treatment practices for pain, anxiety and depression.
Ethical approval has been obtained from the Peking University Third Hospital Medical Science Research Ethics Committee (2018-182).The results of this study will be disseminated through peer-reviewed publications and scientific presentations.
NCT03520608.
在中国，疼痛性糖尿病周围神经病变（PDN）是一个日益严重的公共卫生问题。尽管最近在治疗方面取得了进展，但仍没有全国性的研究评估当前的医疗实践和治疗指南的遵守情况。本研究的主要目的是调查中国 PDN 患者的临床特征和治疗实践以及相关的焦虑和抑郁情况。
中国门诊疼痛性糖尿病周围神经病患者研究是一项横断面、多中心登记研究，目标样本量约为 1500 名患有 PDN 的患者。根据当前的指南和当地的实践，对 PDN 患者进行治疗。将记录患者的人口统计学、病史、视觉模拟量表疼痛评分、患者健康问卷-9 结果、广泛性焦虑症-7 评分和治疗情况，以评估 PDN 的临床特征以及疼痛、焦虑和抑郁的当前治疗实践。
本研究已获得北京大学第三医院医学科学研究伦理委员会的批准（2018-182）。研究结果将通过同行评议的出版物和科学演讲进行传播。
NCT03520608。
