1.EFFECT OF TAURIN ON THE METABOLISM WITH EXERCISE (I)
MITSUTSUGU ONO ; MASAYUKI WATANABE ; NORIKI NAGAO ; MICHIAKI IKEDA ; TAKANOBU YAMAMOTO ; SHO ONODERA ; HIROYUKI TANAKA ; HIDEKI HARA ; KUMIKO MINATO ; MICHIO OHASHI
Japanese Journal of Physical Fitness and Sports Medicine 1980;29(4):191-204
Effects of 20km running uppn taking a low-carbohydrate, high-fat and protein diet on the changes in blood pressure, heart rate, body weight, skinf old thickness, blood components and urinary recordings in five healthy young men were investigated and the changes in these items which occured by taurine inducement were studied by double blind test method. The results were as follows:
1) As to the degree of decrease in body weight in 20km running, the case in taurine administration (T. A.) was more than in placebo administration (P. A.) .
2) As to the degree of increase in systolic pressure upon 20km running, T. A. was less than P. A. 3) The rate of creatine kinase isozyme (CK-MB) against creatine kinase (CK), which increased after 20km running in P. A., was possible to reduce by T. A.
4) T. A. was less than P.A. in the rate of increase in lactate dehydrogenase (LDH) on 20km running.
5) In P. A., triglyceride increased after 20km running, but in T. A., it decreased.
6) T. A, much influenced the rate of individual fatty acid composition on 20km running
7) T. A, was more than P. A. in the secretion of adrenaline on 20km running.
8) No changes were observed in other blood components and urinary kallikrein.
2.Information: Recommendations for developing postmarketing surveys and clinical investigations using SS-MIX standardized storage
Kiyoshi Kubota ; Daisuke Koide ; Akira Kokan ; Shigeru Kageyama ; Shinichiro Ueda ; Michio Kimura ; Ken Toyoda ; Yasuo Ohashi ; Hiroshi Ohtsu ; Kotonari Aoki ; Osamu Komiyama ; Koji Shomoto ; Takeshi Hirakawa ; Hidenori Shinoda ; Tsugumichi Sato
Japanese Journal of Pharmacoepidemiology 2013;18(1):65-71
The Standardized Structured Medical record Information eXchange (SS-MIX) was started in 2006 as the project supported by the Ministry of Health, Labour and Welfare (MHLW) for promoting the exchange of the standardized medical information. Free soft wares developed in the project allow the storage of medical information to receive HL7 messages for prescription, laboratory test results, diagnoses and patient demographics in the hospital information system (HIS). We encourage the use of the SS-MIX standardized storage for postmarketing surveys and clinical studies. The recommendations consist of the following 7 parts. [1] In surveys and clinical studies, the information of drugs and laboratory test results in the SS-MIX standardized storage can be directly transferred to the electronic questionnaire and the investigators may obtain the information with high accuracy and granularity. [2] The SS-MIX standardized storage works as the backup system for the HIS because it can provide the minimum information essential in patient care even under the disastrous condition like earthquake or unexpected network failure. [3] The SS-MIX standardized storage may be useful to conduct a good pharmacoepidemiology study not only because it provides the information in the storage efficiently but also it can be used to identify “new users” who started the drug after some period of non-use.The “new user” design is often essential to have the unbiased results. [4] When the drug company conducts postmarketing surveys according to the current regulation, the use of the SS-MIX standardized storage will facilitate the fast and efficient collection of data to develop the timely measure to minimize the drug-related risk. With the SS-MIX standardized storage, it is also expected that many types of study design can be employed and the quality of data is improved in the survey. [5] The SS-MIX standardized storage maybe also useful to evaluate the risk minimization action plan by comparing the prescription pattern or incidence of the targeted adverse event between two periods before and after the implementation of the action plan. [6] In planning clinical trials, the SS-MIX standardized storage may be used to estimate the size of eligible patients. The storage may also allow conducting cross-sectional studies to know characteristics of diseases or drug treatment. In addition, cohorts of those who had coronary artery angiography, new users of a drug and those with a rare disease may be readily identified. Using such cohorts, investigators can initiate a case-control study nested within the cohort, pharmacogenomic studies and comparative effectiveness researches. [7] The SS-MIX standardized storage may be used as the formal data source in clinical trials in the future when some conditions are satisfied. For instance, the formal agreement should be reached between industry, government and academia on the use of standards of data structure in Clinical Data Interchange Standards Consortium (CDISC) and on the operation of computerized system validation (CSV) in the clinical trials.