Du Mengmeng, Zhang Yudong, Shi Xiaohua, Liu Ming
First Clinical Medical College, Shandong University of Traditional Chinese Medicine.
Department of Peripheral Blood Vessel, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong.
Medicine (Baltimore). 2020 Nov 20;99(47):e23386. doi: 10.1097/MD.0000000000023386.
Lipodermatosclerosis (LDS) is a severe skin change accompanied by the development of chronic venous disease of the lower extremities. Its main clinical manifestations are erythema, induration, hyperpigmentation, and rough and thickened skin. It may also eventually lead to refractory ulcers, skin necrosis and even cancer. Conventional treatment methods mainly include the intake of oral anabolic hormones or androgen and pressure therapy. However, patients often refuse due to their drug resistance and intolerance. As a clinical irreplaceable treatment method for LDS, traditional Chinese medicine (TCM) has not been compared of the safety and effectiveness so far. Therefore, we cannot wait to use a method to compare the efficacy of TCM for LDS systematically, such as network meta-analysis (NMA).
We will retrieve the relevant Chinese and English databases comprehensively. All the randomized controlled trials of TCM for LDS from January 2015 to September 2020 will be included. Under the guidance of inclusion criteria, 2 researchers will screen the literature, then assess the risk of bias and extract data. We will use Bayesian NMA to evaluate all available evidence in STATA 14.0 and WinBUGS software.
This study will use Bayesian NMA to evaluate the efficacy and safety of TCM for LDS.
This study provide a reliable theoretical basis for the clinical application of TCM in the treatment of LDS, and contribute to the formulation of treatment guidelines for LDS.
脂膜炎性硬化症（LDS）是一种严重的皮肤病变，伴有下肢慢性静脉疾病的发展。其主要临床表现为红斑、硬结、色素沉着以及皮肤粗糙增厚。它最终还可能导致难治性溃疡、皮肤坏死甚至癌症。传统治疗方法主要包括口服合成代谢激素或雄激素以及压力疗法。然而，患者常常因耐药性和不耐受性而拒绝接受治疗。作为治疗LDS的一种临床不可替代的方法，迄今为止，中医药（TCM）尚未在安全性和有效性方面进行比较。因此，我们迫不及待地要采用一种方法来系统地比较中医药治疗LDS的疗效，比如网状Meta分析（NMA）。
我们将全面检索相关的中英文数据库。纳入所有2015年1月至2020年9月期间中医药治疗LDS的随机对照试验。在纳入标准的指导下，由2名研究人员筛选文献，然后评估偏倚风险并提取数据。我们将使用贝叶斯NMA在STATA 14.0和WinBUGS软件中评估所有可用证据。
本研究将使用贝叶斯NMA评估中医药治疗LDS的疗效和安全性。
本研究为中医药治疗LDS的临床应用提供了可靠的理论依据，并有助于制定LDS的治疗指南。
