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    Home > Medical News > Latest Medical News > Vit D: an unexplored gold mine

    Vit D: an unexplored gold mine

    • Last Update: 2017-02-27
    • Source: Internet
    • Author: User
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    Since vitamin D (hereinafter referred to as VitD) was found in the 1920s and 1930s, it has been used in medicine and health care products for nearly a hundred years Recently, two large-scale meta-analysis results published have attracted the author's attention to this old variety again The first meta-analysis was jointly completed by 27 researchers from Austria, Norway, Germany, Switzerland, the United States, Ireland and other countries, and was published in plosone on February 16, 2017 The median age of 26916 subjects involved in the meta-analysis was 61.6 years old, and the median plasma concentration of 25 hydroxyvitd (hereinafter referred to as 25 - (OH) d) was 53.8 nmol / L, 58% of them were women During the median follow-up period of 10.5 years, 6802 subjects died Compared with the 25 - (OH) d plasma concentration of 75-99.99nmol/l, the adjusted mortality risk ratio (HR, 95% confidence interval) at different concentrations is shown in the figure below As can be seen from the above figure, the risk of death increases with the decrease of 25 - (OH) D concentration in the plasma Similar phenomena were observed in cardiovascular mortality, but there was no significant linear relationship between cancer mortality and 25 - (OH) D concentration, and even if 25 - (OH) D concentration increased to 125 nmol / L, there was no significant increase in mortality On the same day, researchers at Queen Mary's College in London published a comprehensive study on VitD in the journal BMJ, which found that regular supplementation of appropriate VitD reduced the risk of acute respiratory infection, including bronchitis and pneumonia, by 12% Although this study does not provide conclusive evidence and needs to be verified in controlled clinical practice, it undoubtedly provides original support for the development of new application fields of VitD A total of 25 randomized controlled trials involving 11321 subjects were included in the review According to the meta-analysis, the risk of acute respiratory infection in all subjects could be reduced by regular supplementation of VitD The adjusted odds ratio (or) was 0.88, 95% confidence interval: 0.81-0.96, and heterogeneity P < 0.001 According to the results of subgroup analysis, if VitD was given orally every day or every week without additional injection, the preventive effect could be observed (adjusted or was 0.81, 95% CI: 0.72-0.91) If it was given once or multiple times, the preventive effect could not be observed (adjusted or was 0.97, 0.86-1.10; P value of interaction was 0.05) Among the subjects who took VitD orally every day or every week, the adjusted or of subjects whose baseline 25 - (OH) d level was less than 25 nmol / l was 0.30 (95% CI: 0.17-0.53), and the preventive effect was better than that of subjects whose baseline 25 - (OH) d level was more than 25 nmol / L (adjusted or was 0.75, 95% CI: 0.60-0.95, P value of interaction was 0.006) VitD did not affect the proportion of subjects with at least one adverse event (adjusted or 0.98, 95% CI 0.80-1.20, P = 0.83) In addition to orthopedic applications, VitD and its derivatives are also used to treat secondary hyperparathyroidism In addition, in recent years, a large number of researchers are committed to expanding the clinical use of VitD, or to explore the regulatory effect of endogenous vitamins on human physiological function, and have also made rich research results They searched and sorted out the meta analysis literature related to VitD published since 2015 in PubMed The results are shown in the table below The author's Outlook - Some Thoughts on the new use and development of old drugs although vitamin D is compared to a gold mine that has not yet been fully explored, the author thinks that the excavation of the remaining "gold" will be an arduous task First, none of the above meta analysis indicates that the conclusions need to be verified by large-scale controlled clinical trials; second, the economic benefits brought by new adaptation development are difficult to be enjoyed by developers alone Enterprises are the main body of innovation, economic interests are the most original driving force of innovation, while market monopoly under patent protection is an effective guarantee of economic interests Different countries at home and abroad have different forms of patent protection, strength and difficulty in obtaining patent protection for pharmaceutical use inventions, which makes enterprises interested in developing old drugs and new ones have to consider whether there will be "a situation of digging a well and drinking everyone" As far as I know, there are some correlations between the new and old uses of old drugs The biggest difference between the new and old uses is tadalafil of Lilly company and thalidomide of Amgen company Tadalafil was first approved by FDA in March 2005 for the treatment of male erectile dysfunction, and then in May 2009 and October 2011 for the treatment of pulmonary hypertension and male prostatic hyperplasia However, the FDA orange book does not include patents related to the new indications, so the development of the new indications does not play a substantial role in extending the market monopoly of other dalafi for Lilly Thalidomide is the leading actor in the "thalidomide" event which caused a stir in the world in the 1960s, because it was found to have teratogenicity in the treatment of early pregnancy vomiting and withdrew from the market Later, Amgen developed its new indications, which was approved by FDA in July 1999 for the treatment of erythema nodosum in leprosy, and then approved for the treatment of multiple myeloma in May 2006 No patents related to these two new indications are included in the orange peel book of FDA Most of the patents included involve the drug administration methods in the taboo population, and none of them have obtained patent protection in China (except for one application for a Chinese patent which is deemed to be withdrawn, none of the patents have been applied for in China) Although a composition patent in the orange peel book has entered China and been authorized, and is within the validity period, it has been successfully evaded by many domestic enterprises, resulting in the listing of generic drugs in China China's patent law has strict restrictions on the conditions for patent protection of pharmaceutical use inventions First, the third paragraph of Article 25 of the patent law excludes the possibility of the diagnosis and treatment of diseases as the patent object Therefore, most of the licensing requirements for pharmaceutical use patents should be written in the form of "xxxx's use in the preparation of drugs for the treatment of xxxx's diseases"; second, China China's patent law also imposes stricter requirements on creativity than the United States It is very difficult for a patent for medical use to be authorized in China, or there is the risk of invalidation after authorization A typical recent example is the invalidation of imatinib's patent for medical use (click the blue word to see it) Original statement: This article is the original manuscript of yaozhi.com, welcome to reprint, reprint please indicate the source and author, thank you!
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