Freires Irlan Almeida, Rosalen Pedro Luiz
Department of Physiological Sciences, Piracicaba Dental School, University of Campinas (UNICAMP), 901 Limeira Ave., 13414-018, Piracicaba, SP, Brazil.
Pharm Res. 2016 Jun;33(6):1311-7. doi: 10.1007/s11095-016-1905-5. Epub 2016 Mar 14.
Despite the high number of studies on the biological effects of natural products (NP) and molecules isolated therefrom, only a small part of them reach the clinical phase and become commercially available. In this perspective we make an analysis on how plant research has impacted oral health care over the last 15 years.
Sixteen major clinical trial registry databases across the globe were searched for completed randomized clinical trials of herbal/natural product interventions (RCTHI) in theperiod 2000-2015.
There was a considerable increase in the number of RCTHI, which points out an interest of academia and industry in the development of novel NP-based therapeutics. There is a trendfor greater heterogeneity of targeted dental conditions, mostly oral mucositis, periodontitis and dental caries. Topical application rather than systemic use predominated in the dental scope as mouthwashes, toothpastes, oral patches and gels have been the most commonly tested pharmaceutical forms. Today, despite the high number of in vitro, in vivo and clinical studies testing NP and/or NP-isolated molecules, only 11% (n = 9) of them are phase IV clinical trials assessing commercially available herbal products. This may be a result of poorly designed, superficial basic research that does not provide evidence to support the clinical testing of NP and derived molecules.
As of now, plant research is promising although still accounts for a modest participation in the oral health care industry due to limited investment and incomplete or inconsistent information from preclinical and clinical testing.
尽管对天然产物(NP)及其分离出的分子的生物学效应进行了大量研究,但其中只有一小部分进入临床阶段并实现商业化。从这个角度出发,我们分析了过去15年植物研究对口腔保健的影响。
检索全球16个主要临床试验注册数据库,以查找2000年至2015年期间完成的草药/天然产物干预随机临床试验(RCTHI)。
RCTHI的数量有了显著增加,这表明学术界和产业界对开发新型基于NP的疗法很感兴趣。针对的牙科疾病有更大的异质性趋势,主要是口腔黏膜炎、牙周炎和龋齿。在牙科领域,局部应用而非全身应用占主导地位,漱口水、牙膏、口腔贴片和凝胶是最常测试的药物剂型。如今,尽管有大量体外、体内和临床研究测试NP和/或NP分离分子,但其中只有11%(n = 9)是评估市售草药产品的IV期临床试验。这可能是由于基础研究设计不佳、不够深入,无法为NP及其衍生分子的临床测试提供证据。
截至目前,植物研究前景广阔,不过由于投资有限以及临床前和临床试验信息不完整或不一致,其在口腔保健行业中的参与度仍然不高。