1.A Survey of the Conditions on Pharmacoeconomic Studies at the Pharmaceutical Companies in Japan
Hiroyuki SAKAMAKI ; Nobuyasu HIROMORI ; Yumiko ABURAYA ; Keiko NAKAMURA
Japanese Journal of Pharmacoepidemiology 2001;6(1):49-58
Objective : To identify the issues in conducting pharmacoeconomics (PE) studies at pharmaceutical companies in Japan.
Methods : A questionnaire survey on the conditions of PE studies was conducted for the pharmaceutical companies that are members in the Pharmaceutical Manufacturers Association of Tokyo. Seventy-seven of 94 member companies participated, an 82% response rate. The survey covered the following topics with regard to the companies : the number of applications of PE data for the new drug pricing process, the timing and phases to conduct a PE analysis, a recognition of the necessity for PE analysis, and issues for conducting optimum PE analysis.
Results : Out of 77 responding companies, 36 companies (47%) answered that they conduct PE analysis at their regulatory affair department in order to submit supplemental applications for the drug pricing process to the Ministry of Health, Labor and Welfare. However, only 42% companies of approved drugs since April 1997 were actually submitted with PE data for the drug pricing review. Seventy-seven percent of companies recognized the necessity for PE analysis for the drugs. On the other hand, they did not perceive PE as a useful tool for negotiating drug prices with the Japanese government. Major issues for PE analysis to be conducted are ; lack of Japanese guidelines and epidemiological databases, lack of transparency in the method which reflects the data for the policy making, and lack of companies'initiative.
Conclusion : Establishment of a Japanese guideline for PE studies will be important for companies to conduct accurate and reliable PE studies. The Japanese government should disclose the process of using the PE data for policy making. At the same time, it is necessary for the companies to be more spontaneous in their PE studies.
2.A Survey of Pharmacoeconomic Data in Applications for NHI New Drug Price Listing in Japan
Hiroyuki SAKAMAKI ; Nobuyasu HIROMORI ; Yumiko ABURAYA ; Ken KUBOTA ; Keiko NAKAMURA
Japanese Journal of Pharmacoepidemiology 2001;6(2):83-100
Objectives : Pharmaceutical companies in Japan can attach pharmacoeconomic (PE) data to their application for new drug prices covered by the National Health Insurance (NHI) system since 1992. To examine the present state of PE studies in Japan by investigating the situation of PE data attachments and their details and also to identify problems concerning how to reflect the PE information in new drug pricing, a questionnaire-based survey of pharmaceutical companies was conducted.
Method : The survey covered 115 drugs filed by the members of the Japanese Pharmaceutical Manufacturers Association (JPMA), which are among the 137 drugs listed between June 20, 1997, when the NHI drug price formula was published, and November 17, 2000. Questionnaires were returned on 114 of the 115 drugs studied and the response rate was 99%.
Results : PE data was attached to 37 of the 114 drugs (32%) at the time of application. The ratio of applications accompanied by PE data tended to be decreased from 1998. No significant relation was observed between a premium for a drug and the attachment of PE data. The most common method used in the attached PE data was cost-effective analysis (14 of 37 drugs ; 38%), followed by cost-benefit analysis (7 drugs) and cost-minimization analysis (6 drugs). Cost-utility analysis was not applied to any of the 37 drugs.
Discussion : Compared with overseas PE studies, Japanese studies were found to be less comparable with one another due to the lack of a uniform system of research and reporting results. Other problems observed included insufficient epidemiological data for analysis and difficulty in the cost data collection. The questionnaire-based survey revealed that Japan needs to set guidelines for PE studies and to establish epidemiological and cost databases for these research activities. It also suggested the necessity of reviewing the present method of clinical tests so that economic parameters for PE analysis and QOL may be obtained from these tests.
3.A Case Study of Acute Aortic Dissection, Which Occurred in a Mother and Daughter with Marfan Syndrome on the Same Day
Hiromasa Nakamura ; Hiroyuki Nakajima ; Atsushi Nagasawa ; Atsushi Shimizu
Japanese Journal of Cardiovascular Surgery 2009;38(2):151-155
Case 1 was a 48-year-old mother who was under observation for Marfan syndrome and thoracic aortic dilation. She was brought to the hospital with chest pain, and a CT scan revealed acute aortic dissection (Stanford A). Aortic incompetence was also observed, and an emergency Bentall procedure was performed. Case 2, her daughter, was a 26 years old and 39 weeks pregnant. She did not meet the diagnostic criteria for Marfan syndrome. She experienced severe back pain on the same day that her mother was admitted for aortic dissection. Because the patient did not agree to the use of a contrast agent due to concern about its effect on the fetus, emergency cesarean section was performed. Subsequently, a CT scan performed on the patient showed acute aortic dissection (Stanford B). Accordingly, antihypertensive therapy was commenced. In both cases, the patients were discharged after they recovered. Although case 2 did not meet criteria for Marfan syndrome, because of the hereditary disposition, we strongly suspect this was a Marfan syndrome pregnancy. This type of case is included in the case literature on cesarean and vigilant perinatal care is thought to be necessary.
4.Clinical Status of the Late Stage after Valvulectomy without Prosthetic Replacement.
Tomoji SHIMASAKI ; Hiroyuki ORITA ; Chiharu NAKAMURA ; Masahiko WASHIO
Japanese Journal of Cardiovascular Surgery 1992;21(5):469-473
We have experienced 3 cases of valvulectomy without prosthetic replacement. All patients had active infective endocarditis. Clinical states of the patient who received pulmonary valvulectomy and of the other who received partial tricuspid valvulectomy are stable in the late phase. They have no cardiomegaly. The patient who received total tricuspid valvulectomy has progressive cardiomegaly. It seems that the volume overload due to the regurgetant flow in the tricuspid position causes the dilatation of the right heart. Tricuspid valvuloplasty with remained tissue or with pericardial patch may be more recommendable.
5.Active Learning through an Integrated Curriculum: Making Use of Human Anatomy Practice
Hiroyuki Ichijo ; Tomoya Nakamura ; Yuichi Takeuchi ; Masahumi Kawaguchi
Medical Education 2016;47(6):343-351
Students always have many questions and problems during active participation. Here, we report an active learning course (AL) based on problems that medical students encountered in gross anatomy practice. This AL was implemented after the practice, consisting of a lecture, group discussions, resource hours, and presentation session to ensure exploratory learning. Based on a questionnaire survey, 75.1% of the students evaluated the AL as very valuable or valuable, indicating its usefulness. The AL not only complemented the anatomy course, but also directed the students toward other forms of basic and clinical learning. The results indicate that by making use of gross anatomy practice, the AL functions as a hub for horizontal and vertical integrations in medical education.
6.Usefulness of a Video-Recording System Using Four Video Cameras in Objective Structured Clinical Examinations.
Kaei WASHINO ; Yuzo TAKAHASHI ; Kazuhiko FUJISAKI ; Yasuhiko SUZUKI ; Hiroyuki NIWA ; Hiroyuki NAKAMURA
Medical Education 2002;33(4):253-260
We propose a new video system with four cameras aimed in different directions for use in objective structured clinical examinations (OSCEs) to 1) minimize the examiner's burden and 2) standardize the examiner's evaluation. The system consists of four charge-coupled device video cameras, several microphones, and a video tape recorder. The OSCE of each student was recorded with four cameras simultaneously aimed in different directions so that the student's performance could be viewed and evaluated at the examiner's convenience. Two trials for this system were undertaken at different times. More than 80% of those participating in the trials thought that this system was useful for examining the basic skills of medical students as part of the OSCE, and more than 70% thought that the system would increase educational efficacy. This system may improve the reliability and efficiency of OSCE.
7.A criterion for evaluation of obesity based on the relationship between percent body fat and medical examination parameters.
HIROYUKI IMAMURA ; MASA MATSUBARA ; MASAHIRO MINAYOSHI ; MASARU IMAI ; KAZUHIRO KUNIKATA ; SHIN NAKAMURA ; DAIKICHI KOBATA ; HIROYUKI MORII
Japanese Journal of Physical Fitness and Sports Medicine 1992;41(1):70-78
A study was conducted to examine the relationship between percent body fat (%fat) and medical examination parameters. The subjects were 250 women aged 17 to 68 years, who neither drank nor smoked. The results obtained were as follows:
After controlling for the effects of age and maximal oxygen intake per kilogram body weight (VO2max/wt), %fat showed a significant correlation with high-density lipoprotein cholesterol (HDL-C), total cholesterol/HDL-C ratio (TC/HDL-C), β-lipoprotein (β-L), glutamic oxaloacetic transaminase (GOT), glutamic pyruvic tansaminase (GPT), uric acid (UA), white blood cell count (WBC), red blood cell count (RBC), systolic blood pressure (SBP), and diastolic blood pressure (DBP) . Values of %fat calculated from each regression equation when HDL-C=38mg/dl, TC/HDL-C=4.9, β-L=500 mg/dl, GOT=41mu/ml, GPT=46 mu/ml, UA=5.7mg/dl, WBC=8500/mm3, RBC=520×104/mm3, SBP=159 mmHg, and DBP=94 mmHg were 32.2%, 31.9%, 30.8%, 35.4%, 36.4%, 31.8%, 30.7%, 35.0%, 33.8% and 32.6%, respectively.
The subjects were then divided into 2 groups, above (above group) or below (below group) 30%, 31%, 32%, 33%, 34% or 35% body fat. Wherever the subjects were divided into 2 groups at these values of %fat, the above group showed a significantly higer occurrence of abnormal values for medical parameters than the below group.
The subjects were further divided into 3 groups: 154 subjects with %fat below 29.9% (N group), 47 subjects with %fat between 30% and 34.9% (MO group), and 49 subjects with %fat above 35% (O group) . The O group showed significantly higher occurrence of abnormal values for medical parameters than the MO and N groups. The O group also showed a significantly higher mean value of DBP than the MO and N groups. Furthermore, the O group showed a significantly lower mean value of HDL-C and significantly higher mean values of TC/HDL-C, UA, GOT, GPT, SBP, FBS than the N group. There was no significant difference between the N and MO groups in the occurrence of abnormal values for medical parameters. However, the MO group showed a significantly lower mean value of HDL-C and significantly higher mean values of TC/HDL-C, UA and β-L.
These results suggest that the values of medical parameters become poorer when %fat exceeds 30%, a level widely used in Japan as a criterion for evaluation of obesity.
The subjects were further divided into 3 groups: 50 subjects who were non-obese and fit (NF group) ; 104 subjects who were non-obese and unfit (NU group) ; 88 subjects who were obese and unfit (OU group) . There were significant differences in the occurrence of abnormal values for medical parameters among these groups. The NF group showed the lowest values, followed by the NU and OU groups. Thus, it seems preferable to evaluate individuals using a combination of %fat and VO2max/wt.
8.A criterion for evaluation of obesity in men based on the relationships between percent body fat and clinical parameters.
HIROYUKI IMAMURA ; MASA MATSUBARA ; MASAHIRO MINAYOSHI ; MASARU IMAI ; KAZUHIRO KUNIKATA ; SHIN NAKAMURA ; DAIKICHI KOBATA ; HIROYUKI MORII
Japanese Journal of Physical Fitness and Sports Medicine 1992;41(3):322-329
A study was conducted to derive a criterion for evaluation of obesity based on relationships between percent body fat (%fat) and clinical parameters. The subjects were 457 men aged 18 to 73 years. The results obtained were as follows:
After controlling for the effects of age, maximal oxygen intake per kilogram body weight (VO2max/wt), alcohol intake and cigarette smoking, %fat showed significant correlations with high-density lipoprotein cholesterol (HDL-C), total cholesterol/HDL-C ratio (TC/HDL-C), fasting blood sugar (FBS), glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), γ-glutamyl transpeptidase (γ-GTP), white blood cell count (WBC), red blood cell count (RBC), systolic blood pressure (SBP), and diastolic blood pressure (DBP) . Values of %fat estimated from borderline values of these clinical parameters ranged from 17.9% to 20.4%.
When the subjects were divided into 11 groups from a below 12% fat group to an above 22% fat group, the 18%, 20%, 21% and above 22% fat groups showed significantly higher occurrence of abnormal values for clinical parameters than the below 12% fat group.
When the subjects were divided into 2 groups, i, e, above (above group) or below (below group) 18%, 19%, 20%, or 21% body fat, the above group always showed a significantly higher occurrence of abnormal values for clinical parameters than the below group.
The subjects were further divided into 3 groups: 250 subjects with %fat below 17.9% (N group), 63 subjects with %fat between 18% and 19.9% (MO group), and 144 subjects with %fat above 20% (O group) . The O group showed the highest occurrence of abnormal values for clinical parameters, followed in order by the MO and N groups. These differences were significant. The O group showed a significantly lower mean value of HDL-C and significantly higher mean values of TC, TC/HDL-C, TG, GPT, SBP, DBP and FBS than the N group. The O group also showed significantly higher mean values for WBC and RBC than the MO and N groups. The O and MO groups showed significantly higer mean values of β-L, γ-GTP and UA than the N group.
From these results and the fact that a value above 20% fat is widely used as a criterion for evaluation of obesity, men with a %fat range of 18.0% to 19.9% are defined as mildly obese, whereas those with above 20% fat are defined as obese.
The subjects were further divided into 3 gooups: %fat below (non-obese) or above (obese) 20%, and VO2max/wt above (fit) or below (unfit) values recommended by the Ministry of Public Welfare for each age group. One hundred fifty-one subjects were non-obese and fit (NF group), 142 subjects were non-obese and unfit (NU group) and 107 subjects were obese and unfit (OU group) . The NF group showed the lowest occurrence of abnormal values for clinical parameters, followed in order by the NU and OU groups. These differences were significant. Thus, it seems appropriate to evaluate obesity by using a combination of %fat and VO2max/wt.
9.Tuberculous Abdominal Aortic Aneurysm. A Case Report.
Mitsuhiro Yano ; Kunihide Nakamura ; Masakazu Matsuyama ; Eisaku Nakamura ; Hiroyuki Nagahama ; Toshio Onitsuka ; Kazuki Nabeshima
Japanese Journal of Cardiovascular Surgery 2002;31(1):55-57
A 52-year-old woman who had been treated for miliary pulmonary tuber culosis complained of left flank pain. Abdominal aortic angiography revealed a saccular type aneurysm in the supra-renal abdominal aorta. We resected the aneurysm and reconstructed the aorta by arificial graft patch under partial extracorporeal circulation. The left renal artery was reconstructed by an artificial graft. During the operation, the superior mesenteric artery and the bilateral renal arteries were perfused by blood from the extracorporeal circuit. On pathological examination, it was shown that the aneurysm was caused by tuberculosis.
10.Development of a Pseudoaneurysm of the Thoracic Aorta at the Cannulation Site : Our Experience with Three Cases
Yuichiro Hirata ; Satoru Tobinaga ; Hiroyuki Saisho ; Kumiko Wada ; Tomokazu Ohno ; Eiji Nakamura ; Yukio Hosokawa ; Shinichi Hiromatsu ; Hidetoshi Akashi ; Hiroyuki Tanaka
Japanese Journal of Cardiovascular Surgery 2013;42(4):320-323
A pseudoaneurysm of the thoracic aorta after cardiac surgery is a rare complication, but can be life-threatening when it is ruptured. The pseudoaneurysm itself presents no symptoms in many cases, or may be similar to an atherosclerotic aortic aneurysm. Therefore, it is usually found incidently during imaging studies. We encountered 3 cases of pseudoaneurysm of the thoracic aorta that developed during the long-term follow-up after congenital cardiac surgery. None of the patients experienced specific symptoms associated with the pseudoaneurysm, and were diagnosed by chest roentgenograms and computed tomography. Most patients who undergo surgery for congenital heart defects as adolescents are free from medical treatment, and do not regularly see a doctor after the surgery. It is important to consider the possibility of a pseudoaneurysm in patients having a history of cardiac surgery.