Background : With a suppport from Ministry of Health and Welfare (MHW) Japan, we studied the feasibility of conducting event monitoring in Japan similar to Prescription-Event Monitoring in England. The manuscript presented is a report to MHW in 1996.
Methods : Means available in Japan to identify drug, patient and doctor are examined. In addition, any modification needed to make on a questionnaire sent to doctors in PEM conducted in Japan is examined.
Results and Conclusion : Monthly claims called as “Rezept” issued by individual hospitals and clinics and sent to insurers and outpatient prescriptions issued by hospitals to be dispensed by the pharmacies outside the hospitals are considered to be two available means to identify drug, patient and doctor. To have a sample representative of all drug users, the use of “Rezept” is needed as only a fraction of outpatient prescriptions are dispensed by independent pharmacies. However, the use of prescriptions dispensed by the independent pharmacies together with the cooperation of individual pharmacies is capable of finding a contemporary control which is a group of patients who have recently started “old” drugs comparable to the new “test drug”. In Japan no doctor may have a complete list of the hospitals and clinics a patient has visited and it is mandatory to ask doctors the last date when the patient visited the doctor. To clarify what problems arise when a PEM-like study is introduced to Japan, a pilot study is going to be done during 1997 and the feasibility will be examined further based on the results.

Anomalous origin of the coronary artery is rare. Various complications have been reported in patients with this anomaly undergoing heart valve surgery. We describe a case of aortic valve stenosis combined with an anomalous origin of the left coronary artery. An 84-year-old man with exertional dyspnea was referred for surgical treatment of severe aortic valve stenosis. Coronary angiography and computed tomography of the coronary artery revealed a coronary arterial anomaly : the left anterior descending coronary artery originated as a branch of the right coronary artery, and the left circumflex artery separately originated from the right coronary sinus and extended behind the aortic annulus. To prevent injury to the anomalous circumflex artery during surgery, the artery was separated from the fatty tissue around the aortic annulus and dissected free from the aortic wall before the performance of transverse aortotomy. The coronary artery exhibited a single orifice that was significantly enlarged. Whether antegrade infusion of the cardioplegic solution could be achieved was difficult to determine. To perform the retrograde infusion, the catheter tip was inserted directly into the coronary sinus from the epicardium because the orifice in the right atrium was lattice-like. Aortic valve replacement was successfully performed with supra-annular prosthesis insertion using a 19-mm Mosaic porcine valve (Medtronic, Minneapolis, MN, USA). The postoperative course was uneventful. When aortic valve replacement is performed for patients with an anomalous coronary artery, careful performance of operative procedures and postoperative observation are considered important for the prevention of specific perioperative complications, such as intraoperative coronary injury or postoperative myocardial ischemic events in patients with an anomalous left circumflex artery.

No abstract available.
Aneurysm ; Saphenous Vein

No abstract available.
Melanoma

No abstract available.
Acetylcysteine* ; Dermatitis, Atopic* ; Healthy Volunteers* ; Humans ; Skin* ; Water Loss, Insensible

No abstract available.
Humans ; Lupus Erythematosus, Discoid ; Mucins

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.

Essential thrombocythemia is considered one of the chronic myeloproliferative disorders resulting in arterial thromboembolism, venous thrombosis, and bleeding tendency. We report a case of left ventricular aneurysm with successful treatment of the complications of this disease. A 66-year-old man who suddenly experienced right upper limb paralysis was carried to a nearby hospital. Computed tomography revealed multiple cerebral infarctions. An electrocardiogram confirmed findings of old myocardial infarctions in the anteroseptal wall. Echocardiography indicated a left ventricular aneurysm with mobile thrombus. The blood tests showed an abnormally high platelet count of 120×104/μl. His left ventricular thrombus showed an increasing tendency regardless of heparin administration ; thus, he was transferred to our hospital. The resection of the aneurysm and left ventricular restoration was performed emergently to avoid re-embolism. There was a soft thrombus inside the aneurysm at its apex. During cardiopulmonary bypass, the activated clotting time was not prolonged easily. We gave additional heparin and antithrombin III. The patient had no problem with hemostasis or postoperative bleeding. We started low-molecular-weight heparin from the second postoperative day and he was diagnosed with essential thrombocythemia by bone marrow biopsy. We started warfarin and aspirin on the fifth day after surgery. The number of platelets increased to 183×104/μl on the 8th day ; thus, oral administration of hydroxycarbamide was started. His platelet count fell to less than 100×104/μl around 3 weeks after surgery and he was discharged on the 34th day without new embolisms.