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Butylphthalide Project Elected as The Most Internationally-Influential Medical News in 2009
(2010-5-27)
 

 

Recently, the China Medical Tribune Newspaper selected out the most internationally-influential medical news of 2009.The multicenter, randomized double-blind, double dummy case control study result of Butylphthalide & Sodium Chloride parenteral solution phase Ⅲ clinical trial was revealed and listed as the 2009 annual neurology research advancement, and elected as the 19th place of China Medical News. It is learned that this election was based on casting ballots of general audience through mail, telegraph, electronic mail, website and SMS, and which was ultimately determined after the evaluation and confirmation of the China Medical Tribune Newspaper Commission.
                                               A clinical trial targeting market promotion
As early as in 2006, when the protocol for Butylphthalide & Sodium Chloride parenteral solution phase Ⅲ clinical trial was developed, it adopt 90 mRS as the ultimate evaluation indicator, and made prophase preparation for the 3-year later update of SFDA evaluation standards. This trial took the central random grouping method. The patients were divided into groups by computers in the single WHO clinical data management center in China. It ensured that the patients with similar time period and similar severity could be evenly grouped. It is currently the largest-scale clinical registration study in the process of domestic neurology new medicine research and development and made a couple of innovations through the research.
When the Butylphthalide & Sodium Chloride parenteral solution phase Ⅲ clinical trial launched, it gave a view to the market promotion. The positive control medicine was selected with repeated study and research and got the support of experts. It used the traditional Chinese medicine as basic medicine, and avoided the risk that SFDA will require this medicine to be used combined with the traditional Chinese medicine.
In order to enhance the authority of Butylphthalide & Sodium Chloride parenteral solution phase Ⅲ clinical trial, the company simultaneously organized the pharmacoecomonics research, and provided data basis for the independently pricing of Butylphthalide & Sodium Chloride parenteral solution. The subgroup research was developed at the same time, obtained advanced iconography study result, enriched the research results extensively, and provided beneficial support for the market promotion.
                                             Creating golden formula for cerebral stroke cure
Both Butylphthalide soft capsule and parenteral solution are medicine used during the acute period of cerebral stroke. In the phase Ⅲ clinical study of Butylphthalide & Sodium Chloride parenteral solution, it also made the clinical research of injecting Butylphthalide parenteral solution in the acute period and administering capsule in the recovery period. The study result revealed that this cure protocol is superior to the unitary injection of Butylphthalide parenteral solution.

 
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