1.4. Safety Risk Evaluation Methodology in Detecting the Medicine Concomitant Use Risk which might Cause Critical Drug Rash
Yutaka SUSUTA ; Yukio TAKAHASHI
Japanese Journal of Pharmacoepidemiology 2014;19(1):39-49
The new practical use example of the JADER datasets from Japanese Adverse Drug Event Report database opened by Independent Administrative Agency Pharmaceuticals and Medical Devices Agency in April, 2012 and afterwards will be reported. The purpose of this study is to examine the evaluating method of medicine concomitant use risk by the frequency at which two or more medicines were reported simultaneously, being assumed the possibility of the influence of drug interactions to be the concomitant use risk in an adverse drug event onset. In order to estimate the potential degree of the safety risk at the time of the concomitant use, the methodology was estimated by the following procedures. 1) For considering that two suspicion medicine targeted is one medicine, the statistical signal index which means those of medicines with use in the case where they both are indicated in one report, the index of the concomitant use, is computed. 2) The statistical signal index about two target suspicion medicines is computed individually. 3) The case where the ratio of the index of the concomitant use to the index obtained individually exceeds 2 also in any of two suspicion medicines is judged as there being the concomitant use risk. The Proportional Reporting Ratio (PRR) and the Reporting Odds Ratio (ROR) were used as a statistical signal index. In order to check the validity of this method, Stevens-Jonson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) which are known for the adverse events of critical drug rash reported in JADER were taken up, and the causality of medical supplies limited to the medicine with which they were reported as a suspicion medicine. As for the combination of the suspicion medicine which fulfills the conditions of the concomitant use risk, 10 kinds of candidates out of 159 combinations for SJS and 22 kinds of candidates out of 111 combinations for TEN were detected, respectively. Although this approach for the concomitant use risk was considered to be an effective means in showing the above results, some issues about the ratio of the index of the concomitant use and criteria in the report numbers of the medicine to be chosen, the effective calculation method for combinations in more than 3 medicines, etc. will be required for the further examination.
2.The role of laparoscopic hepatectomy for the hepatic metastases from colorectal cancer
Innovation 2014;8(4):144-145
Background: The glissonean pedicle approach was introduced by Couinaud
and Takasaki in the early 1980s. The key of the glissonean pedicle approach is
clamping the pedicle first, secondly confirming the territory, and finally dissecting
the liver parenchyma. In this presentation, we introduced our recent refinements
of glissonean pedicle approach for liver resection.
“Approach to the glissonean pedicles at the hepatic hilus” Couinaud described
three approaches to the hepatic hilus. 1) Intra-fascial access (Control method):
The conventional dissection at the hilus or within the sheath is referred to as intrafascial
access However, dissection performed under the hilar plate is dangerous
and surgeons have to consider any variations of the hepatic artery and bile ducts.
2) Extra-fascial access (Glissonean pedicle approach): The glissonean pedicle is
dissected from the liver parenchyma at the hepatic hilus before dissecting the
liver parenchyma. This procedure prevents intrahepatic metastasis of HCC, which
spreads along the portal vein and improves the overall survival after surgery.
3) Extra-fascial and transfissural access: If the main portal fissure or the left
suprahepatic fissure is opened after dissecting the liver parenchyma, the surgeon
can confirm the pedicles that arise from the hilar plate or the umbilical plate.
“Operative techniques” 1) Preoperative 3D simulation of the precise anatomy
of portal vein, hepatic artery and bile duct at hepatic hilus should be performed.
2) Right glissonean pedicle: The hilar plate is detached from the quadrate lobe.
The assistant pulls the liver parenchyma cranially and the operator conversely
pulls the hepatoduodenal ligament caudally. Mayo scissors are inserted along the
liver parenchyma between the liver parenchyma and glissonean capsule (Fig.1).
Then forceps are inserted in the same way and the right main pedicle is taped
(Fig.2). The right anterior and posterior glissonean pedicles are taped as well. 3)
Left glissonean pedicle: The hilar plate is detached from the liver parenchyma.
Then, the Arantius duct is confirmed and the left pedicle is dissected along the left
pedicle at the ventral side of the Arantius duct.
“Pitfall of glissonean pedicle approach” The right pedicle should be dissected
in the liver side as much as possible to prevent the injury of left hepatic duct.
If possible, the right pedicle is recommended to be dissected at the level of the
second branches separately (Fig.3). The right posterior hepatic duct sometimes
branches from the left hepatic duct and the Arantius duct is confirmed and the left
pedicle should be dissected along the left pedicle at the ventral side of the Arantius
duct because the right posterior hepatic duct branches from the left hepatic duct
at the dorsal side of Arantius’ duct. In addition, the intraoperative cholangiogram
should be used in the case with the abnormal anatomy of bile duct.
Conclusions: Any anatomical hepatectomy can be performed using “glissonean
pedicle approach” which allows simple, safe and easy liver resection.
5.Studies on the Pharmacological Effects of Crocus(Crocus sativus LINNE). Changes in Prostaglandin Levels, Platelet Aggregation, Blood Viscosity and Laboratory Data throughout the Menstrual Cycle.
Yuji SHIOTANI ; Yutaka SHIMADA ; Harumi MATSUDA ; Kouzou TAKAHASHI ; Katsutoshi TERASAWA
Kampo Medicine 1995;45(4):823-831
In order to determine the pharmacological effects of Crocus (traditionally classified as an herb helpful in eliminating Blood Stagnation), the 11-dehydro TXB2, platelet aggregation, blood viscosity and laboratory data of 12 healthy sexually mature females were examined during the menstrual, follicle and corpus luteum phases before the test substance was administered. Compared with the follicle or corpus luteum phases, higher levels of 11-dehydro TXB2 and increased mean cell volume (MCV) were found during the menstrual phases. This suggested that the increase in blood viscosity may be due to a lowering of erythrocyte deformation resulting from increased mean cell volume. From the fact that the highest endometrial PGE2 value was exhibited during the menstrual Phase, PGE2 was thought to be involved in the MCV increase. Next, plain hot water was administered to the six cases in the control group (for four weeks), and Crocus infusion administered to the other six cases (for four weeks), after which a comparative study was made of their indicators. The significant lowering of the MCV and blood viscosity during the menstrual phase upon Crocus administration suggested that an improvement in erythrocyte deformation brought about by decreased MCV played a role in the reduction of blood viscosity. Moreover, a decrease in 11-dehydro TXB2 was observed during the low blood estrogen follicle phase. It has been reported that there is an overall increase in blood viscosity and acceleration of platelet and thrombin synthesis associated with the disease state known as “Blood Stagnation”. From the clear effects of Crocus upon these indicators, its effectiveness as an herb useful in eliminating Blood Stagnation in healthy sexually mature females was indicated.
6.A Study of the Relationship between the Fur of the Tongue and Dysfunction of Ki, Blood, Body Fluids, Spleen and Stomach.
Yutaka SHIMADA ; Kazufumi KOHTA ; Naotoshi SHIBAHARA ; Kouzou TAKAHASHI ; Katsutoshi TERASAWA
Kampo Medicine 1995;45(4):841-847
The relationship between the fur of the tongue and dysfunctions of Ki, Blood, Body Fluids, Spleen and Stomach was investigated in 167 cases by analyzing both subjective and objective symptoms. The mean score of Ki-deficiency increased with the degree of both thickness and yellowness of the tongue fur. The mean score of upper gastrointestinal tract symptoms also increased with the degree of thickness of the tongue fur. These results suggest that when examining the tongue fur during Oriental Medical diagnosis, it is important to keep in mind its relationship with dysfunction of the Spleen and Stomach and Ki-deficiency.
7.Shoulder injuries caused by throwing during water polo.
SHIGEHIRO SUZUKI ; YUKINORI TOMODA ; YUTAKA MIYANAGA ; GORO TAKAHASHI ; ISAO SAKATA ; HITOSHI SHIRAKI
Japanese Journal of Physical Fitness and Sports Medicine 1990;39(1):60-68
A study was conducted to investigate the influence on the shoulder joint of throwing during water polo. One hundred sixty-seven water polo players were interviewed about injuries caused by water polo, and 70 players claimed to have had shoulder pain.
In 21 players, clinical examinations were performed, and in 31 players, assessment of external rotation stability was made. Then three-dimensional analysis of hand-to-hand shoot motion was performed in 7 players.
The results were as follows;
1. The painful phases of the throwing motion were the take-back phase and the acceleration phase, the pain being present at the anterior and lateral portions of the shoulder joint,
2. Assessment of stability revealed that the external rotation displacement on the affected side was significantly larger than that on the control side in the injured players.
3. Analysis of hand-to-hand shoot motion revealed that the external rotation angle in the acceleration phase was significantly larger in non-injured subjects than in the injured.
4. The external rotation angle after ball contact was increased in the injured, but decreased in the non-injured.
5. To prevent injury, it appears important to catch and throw the ball using the upper extremity and rotation of the trunk in a high body position in the water, and to strengthen the muscles of the shoulder.
8.A Successful Operation Case of Budd-Chiari Syndrome.
Akiyuki TAKAHASHI ; Syuuji SHIRAKATA ; Satoshi NIU ; Yutaka KANKI ; Yukio WADA ; Kouichi OGA ; Takahiro OKA
Japanese Journal of Cardiovascular Surgery 1991;20(7):1294-1298
A case of Budd-Chiari syndrome in which direct surgical intervention was successfully performed is reported. A 43-year-old female who had had a history of hepatic coma was pointed out complete obstruction of inferior vena cava (IVC) between the right atrium and diaphragma, associated with hepatic dysfunction and esophageal varices. At operation, the IVC lesion was visualized directly by thoracotomy through midsternal incision and by laparotomy through right hypochondrial oblique incision, with the liver retracted. Under partial extracorporeal circulation with suction of blood from hepatic vein, the IVC was incised, 3cm in length, and membranous tissue causing obstruction was resected. The defect of the IVC wall was repaired with ringed EPTFE patch. Postoperatively, both central venous and portal pressure were decreased, 21 mmHg to 10mmHg and 26cm H2O to 21cm H2O, respectively, with good patency of the IVC on venogram. Now the patient is up and well, 11 months after operation. Thus, complete removal of obstruction under direct vision is thought to be important for surgical treatment of Budd-Chiari syndrome.
9.Introduction of collaborative drug therapy management (CDTM) into a community healthcare system in Japan
Takehiro Ogawa ; Akira Matsushita ; Toshihiro Nakashima ; Hiroko Moriyasu ; Kenichi Shimada ; Takashi Egawa ; Yutaka Gomita ; Masashi Takahashi ; Yoichiro Takami
An Official Journal of the Japan Primary Care Association 2013;36(4):302-307
Introduction : As one of the strategies for the introduction of collaborative drug therapy management (CDTM) into a community healthcare system in Japan, we constructed a ‘positive list’ which was agreed by a family physician in advance, and subsequently validated the effects on healthcare insurance fees, the number of prescription question and the changes of utilization rate for generic drugs.
Methods : The items that replaced prescription questions with regard to ex post facto approval were defined as ‘Resolved Questions’ in our constructed positive list. By adopting the ‘Resolved Questions’, we then examined the effect on healthcare insurance fees, prescription questions and the changes of utilization rates for generic drugs.
Results : Among all prescription questions accepted from January through May 2012 inclusive, 178 (22.7%) were ‘Resolved Questions’, without there being change in the therapeutic strategies by the prescribing physicians. During this period, 17,455 healthcare insurance fees were reduced. In addition, the utilization rate for generic drugs were increased up to 46.6%.
Conclusion : The reduction of healthcare insurance fees, prescription questions and the increased utilization rates of generic drugs were facilitated by prudent pharmacist judgements based on ‘Resolved Questions’.
10.Total Removal of a Contaminated Pacemaker under Cardiopulmonary Bypass in a Case of MRSA Septicemia.
Yutaka Hasegawa ; Susumu Ishikawa ; Akio Otaki ; Yasushi Sato ; Kazuhiro Sakata ; Toru Takahashi ; Motoi Kano ; Tetsuya Koyano ; Masao Suzuki ; Yasuo Morishita
Japanese Journal of Cardiovascular Surgery 1995;24(5):347-350
A 78-year-old man underwent successful removal of a contaminated pacemaker in a case of methicillin-resistant Staphylococcus aureus (MRSA) septicemia. Septicemia was due to a subcutaneous abscess at the site of old cut electrodes. Following debridement of the infected pacemaker pocket, residual leads and the pacemaker system were removed under cardiopulmonary bypass. Bacterial examination of arterial blood and vegetation attached to the leads showed septicemia caused by MRSA. After the operation, antibiotic therapy with vancomycin, arbekacin and minocycline was performed for several weeks. His postoperative course was uneventful without the recurrence of infection. In cases of pacemaker contamination, with septicemia, total removal of the pacemaker system and adequate antibiotic therapy are necessary.