Jeong Seung-Yeon, Park Jung-Hwan, Lee Ye-Seul, Kim Youn-Sub, Park Ji-Yeun, Kim Song-Yi
Department of Anatomy and Acupoint, College of Korean Medicine, Gachon University, Seongnam 13120, Korea.
Department of BioNano Technology and Gachon BioNano Research Institute, Gachon University, Seongnam 13120, Korea.
Pharmaceutics. 2020 Nov 19;12(11):1113. doi: 10.3390/pharmaceutics12111113.
In recent years, a number of clinical trials have been published on the efficacy and safety of drug delivery using microneedles (MNs). This review aims to systematically summarize and analyze the current evidence including the clinical effect and safety of MNs. Three electronic databases, including PubMed, were used to search the literature for randomized controlled trials (RCTs) and clinical controlled trials (CCTs) that evaluated the therapeutic efficacy of MNs from their inception to 28 June 2018. Data were extracted according to the characteristics of study subjects; disorder, types, and details of the intervention (MNs) and control groups; outcome measurements; effectiveness; and incidence of adverse events (AEs). Overall, 31 RCTs and seven CCTs met the inclusion criteria. Although MNs were commonly used in skin-related studies, evaluating the effects of MNs was difficult because many studies did not provide adequate comparison values between groups. For osteoporosis treatment, vaccine, and insulin delivery studies, MNs were comparable to or more effective than the gold standard. Regarding the safety of MNs, most AEs reported in each study were minor (grade 1 or 2). A well-designed RCT is necessary to clearly evaluate the effectiveness of MNs in the future.
近年来，已经发表了一些关于使用微针（MNs）进行药物递送的疗效和安全性的临床试验。本综述旨在系统地总结和分析当前证据，包括微针的临床效果和安全性。使用包括PubMed在内的三个电子数据库检索文献，以查找从开始到2018年6月28日评估微针治疗效果的随机对照试验（RCT）和临床对照试验（CCT）。根据研究对象的特征、疾病、干预措施（微针）和对照组的类型及细节、结局测量、有效性以及不良事件（AE）的发生率提取数据。总体而言，31项RCT和7项CCT符合纳入标准。虽然微针常用于皮肤相关研究，但由于许多研究未提供组间充分的比较值，评估微针的效果很困难。对于骨质疏松症治疗、疫苗和胰岛素递送研究，微针与金标准相当或更有效。关于微针的安全性，每项研究中报告的大多数AE都很轻微（1级或2级）。未来需要精心设计的RCT来明确评估微针的有效性。
