The modern scientific research increase old varieties Chinese traditional medicine research increase choice clinical medication

Author: YangJunJian

Medicine economic news

        China's Shanghai drug epidemiological and clinical rational drug use international seminar of new Huang safety monitoring research summing-up meeting after listing on China's first oral agents in real world research project "new Huang piece of real world research" project is summarized, and that new Huang piece of Chinese and western medicine as a combined formula, traditional Chinese medicine composition can effectively reduce poison efficiency, than use indomethacin more is safe and effective.

        Expert advice: encourage more old varieties of research, with modern scientific research means to replace the traditional medicine experience, do more traditional Chinese medicine old varieties and evaluation, the future payment reform clinical drugs of choice will play a crucial role.

        Along with the clinical medical research level of ascent, the focus of drug evaluation is gradually from clinical examination and approval before the listed again after large-scale evaluation tilt. As the clinical application of traditional Chinese medicine for many years old products listed again after the research, this project has already become one of the most important products to increase again way.

        New Huang piece of considerations

        New Huang slice to belong to combine traditional Chinese and western medicine drugs, swollen quarter by wind, notoginseng, artificial bezoar, shaw brahman flower, pearl powder, indomethacin layer of, has qingrejiedu, remove blood stasis, acetanilide detumescence effect. The public has nearly 40 years, more than 4 million people are currently in use, sales over one hundred million yuan.

        Traditional Chinese medicine factory Co., LTD xiamen many years ago about the basic research thinks, this product in the anti-inflammatory and analgesic and antipyretic has synergy, and side effects is far lower than the equal doses of indomethacin, this shows that Chinese native medicine ingredient to western medicine composition has reduced poison effect.

        The general manager of traditional Chinese medicine factory xiamen wall hair told reporters, with the expansion of the product coverage, and domestic drug consumption cognitive ability enhancement, clinical efficacy of drugs for accurate data requirement enhances unceasingly, but in the real drug use in the crowd, of new Huang the efficacy and safety of how to, but not enough authority of the clinical trial data to support. The lack of the clinical data that further growth of the products met "bottleneck".

        In order to solve this problem, in July 2009, xiamen traditional Chinese medicine factory the start "the new Huang piece of real world research" project, again on the clinical research, project by the Shanghai adverse drug reaction monitoring center organization.

        The project mainly to the Shanghai 67 hospitals related departments of the clinical application of new Huang monitoring, and the results showed that 96.66% of the patients after treatment condition improved, especially to the hair is excited wall, a total of 10137 patients with subjects only occurs adverse reactions in 41 cases and adverse reaction rate of 4.04%. (I see/Uncommom). And the foreign literature shows that indomethacin adverse reaction rate of 20% ~ 50% (very common/Verycommom).

        This powerful new Huang piece that the combination of Chinese and western medicine as formula, traditional Chinese medicine composition can effectively reduce poison efficiency, than use indomethacin more is safe and effective. This product also is home for the first time through the large sample study confirms union of Chinese and western medicine formula the effective value of samples.

        It is reported, the international information about the drug epidemiology of the latest research method is real world research (RWS), new Huang piece RWS project for two years, the investment of 970000 yuan. The wall hair says, this product is going to carry out more of the sample, and its target for 50000 to 100000 cases of cases, is expected to put into funds will be more than 5 million yuan.

        Traditional Chinese medicine to evaluation

        Shanghai adverse drug reaction monitoring center technical director DuWenMin think, RWS method of evaluation and new Huang achieve positive results, to combine traditional Chinese and western medicine formula of the traditional products and the subsequent development of clinical rational drug use also provides some reference evaluation method, and the traditional randomized double-blind, placebo-controlled clinical trial (RCTs), compared to the real world of Chinese medicine research more mining process, the characteristics of target treatment, is an important weapon in the future development of Chinese medicine.

        But, according to reporter understanding, at present the market sales of Chinese medicine old varieties most clinical application for a long time, people used widely, with extensive use of foundation, but again after work evaluation listed often does not get enterprise seriously enough.

        From clinical medicine, Chinese traditional medicine in old varieties used widely the effectiveness of the crowd, and with the same kind of efficacy of drugs is, use for a long time benefit, the new indications and clinical practice between the various factors may affect curative effect, the combination of the regimen, adverse reactions and long-term drug safety, all need to further perfect and described. The objective demand for traditional Chinese medicine old varieties of listed again after evaluation.

        And from the view point of product vitality, the wall that the hair, the traditional Chinese medicine for old varieties of research and exploration, whether to improve product quality and recognize that mechanism, clear more scientific clinical medication scheme are very necessary.

        According to the clinical needs, combined with the new research methods, and carry out the curative effect evaluation, safety study to evaluate research, drug economic evaluation, can improve method to medicine, provide regimen, improve the level of the rational use of drugs, avoid adverse reactions, find new indications. Evaluation and the products more closely related to the secondary development, enterprises can promote the upgrade technology, technology innovation, improve product vitality, this is our country the modernization of traditional Chinese medicine and the only way of industrialization.

        At present, many countries have or will gradually emphasis from the drug for examination and approval before listing to transfer listed evaluation. Our country related regulations gradually strengthen the drugs listed again after the evaluation, in recent years on traditional Chinese medicine ADR monitoring and proprietary Chinese medicine clinical evaluation work, such as traditional Chinese medicine injection of again evaluation.

        Some of the leading domestic enterprise of traditional Chinese medicine also gradually pay attention to ordinary old breed of safety, efficacy, and quality control issues, such as TianShiLi, kang pharmaceutical, wan west margin the brand such as traditional Chinese medicine pharmaceutical enterprise also in succession to the leading varieties was listed again after the evaluation.

        Expert proposal, encourage more old varieties of research, with modern scientific research results to replace the traditional medicine experience means, do more old varieties of traditional Chinese medicine and evaluation, the future payment reform clinical drugs of choice will play a crucial role.