Relationship Between Neurological Degenerative Disorders and a Blood Deficiency Using ki-ketsu-sui Score / 日本東洋医学雑誌

We evaluated body constituents patterns of 74 consecutive patients with neurological degenerative disorders. They comprise Parkinson's disease (n = 38), amyotrophic lateral sclerosis (n = 19), and multiple system atro­phy (n = 17). We compared body constituents patterns between them and 149 consecutive patients with other neurological diseases of the same age. We used ki-ketsu-sui scores to evaluate body constituents patterns in all cases. Ki-ketsu-sui scores measure six factors : qi deficiency (kikyo), qi stagnation (kiutsu), qi counterflow (kigyaku), blood deficiency (kekkyo), blood stasis (oketsu), and fluid retention (suitai). As a result of multi­variate analysis, neurological degenerative disorders had large weight of blood deficiency, fluid retention and qi stagnation. Their adjusted odds ratios (95% confidence interval) were 3.02 (1.43-­6.48), 2.37 (1.13-­5.11), 2.33 (1.01-­5.44), respectively. Most relevant factor to neurological degenerative disorders was a blood defi­ciency. Taking into consideration a prescription of “shimotsuto rui” may contribute to alleviate patient's suf­fering. In addition to subjective symptoms, we need an oriental medicine scale such as pulse, tongue, and ab­dominal examinations to judge a therapeutic effect of Kampo medicine.

Characterization of the Body Constituent Patterns for Symptomatic Acute Cerebral Infarction Using qi-ketsu-sui Score / 日本東洋医学雑誌

We evaluated body constituent patterns of 130 consecutive patients with symptomatic acute cerebral infarction. They comprise lacunar infarction (n = 47), atherothrombotic infarction (n = 70), cardiogenic embolism (n = 11), and other type of infarction (n = 2). We compared body constituent patterns between them and 93 consecutive patients with other neurological diseases of the same age. We used qi-ketsu-sui scores to evaluate body constituent patterns in all cases. Qi-ketsu-sui scores measure six factors : qi deficiency (kikyo), qi stagnation (kiutsu), qi counterflow (kigyaku), blood deficiency (kekkyo), blood stasis (oketsu), and fluid retention (suitai). As a result of multivariate model analysis, symptomatic acute cerebral infarction had the largest weight of blood stasis and an adjusted odds ratio (95% confidence interval) was 4.6 (2.45-8.91). Even when gender as a confounding factor was adjusted by stratified analysis, adjusted odds ratios of blood stasis (95% confidence interval) were 7.46 (3.02-20.25) for males and 2.63 (1.02-7.11) for females, and those were maximum. The point (median, interquartile range) of blood stasis was more severe in acute cerebral infarction (24 points, 18-33 points) than other neurological diseases (16 points, 9-23 points). We examined relationships between body constituent patterns and clinical disease type, severity at hospitalization, and sex in patients with symptomatic acute cerebral infarction. Ratio of blood stasis was the largest in any clinical disease type, severity and sex. Blood stasis seemed to be the most important factor in symptomatic acute cerebral infarction.

Intermediate educational activity report of "Clinical Research Management human resources development program" / 医学教育

<p>　Clinical research skills to answer clinical questions arising in daily clinical practice are necessary to improve the quality of medical care. Since 2014, we have been developing a clinical research educational program including clinical research fellowships for doctors, nurses, and pharmacists at the Department of Clinical Research and Quality Management. This paper reports intermediate educational activities and evaluations.</p>

<b>Information: Recommendations for developing postmarketing surveys and clinical investigations using SS-MIX standardized storage </b> / 薬剤疫学

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.

<b>Roles of the Data Storage System in Clinical Trials and Observational Cohort Studies </b> / 薬剤疫学

Appropriate observational studies with sufficient external validity are apparently warranted to assess comparative effectiveness and safety of treatment with approved drugs in real world clinical practice. This kind of study must register patients consecutively without any arbitrariness, assess outcome carefully, (e.g. cardiovascular events) and automatically extract clinical data including results from laboratory tests and prescribed drugs. Clinical trials for the assessment of efficacy of newly developing drugs may also need such patients' registry. Data storage system by SS-MIX may be appropriate for this purpose. (Jpn J Pharmacoepidemiol 2013；18(1)：31-34)