1.Pregnancy outcome following first trimester exposure to Terbinafine Hydrochloride : A case series survey
MASAHIRO HAYASHI ; RITSUKO YAMANE ; MASA TANAKA ; KAYOKO HISHINUMA ; KAYOKO OGAWA ; IKUKO YOKOO ; HIROAKI KITAGAWA
Japanese Journal of Drug Informatics 2009;11(1):31-34
Objective: Treatment of tinea unguium with topical drugs alone is difficult, and medication with oral terbinafine hydrochloride is necessary in many cases. Since Trychophyton infects the nails in not only men but also women at a reproductive age, the influence on a fetus of the drug ingested during early pregnancy is a matter of concern of many women. The objective of this study was to investigate the influence of oral terbinafine hydrochloride on fetuses.
Methods: The outcomes were investigated in pregnant women who ingested terbinafine hydrochloride and visited the ‘Outpatient Services for Consultation on Pregnancy and Drugs (Teratology Information Services)’ of Toranomon Hospital, and cases were collected.
Results: Fifteen pregnant women ingested the drug during the organogenic period, in which the teratogenic risk is the highest. All 15 pregnant women gave birth to healthy babies.
Conclusion: This is the first survey concerning newborns delivered by women who ingested terbinafine hydrochloride during pregnancy in Japan. All investigated women gave birth to healthy babies, and the incidence of congenital abnormalities did not markedly exceed that in the general population. Since the number of cases was small, it is necessary to perform a cohort study to investigate details of the safety for fetuses.
2.Survey regarding pregnant women receiving novel antipsychotic agents
RITSUKO YAMANE ; MASAHIRO HAYASHI ; MASA TANAKA ; KAYOKO HISHINUMA ; KAYOKO OGAWA ; IKUKO YOKOO ; HIROAKI KITAGAWA
Japanese Journal of Drug Informatics 2009;11(1):35-38
Objective: Novel antipsychotic agents less frequently cause extrapyramidal side effects compared to conventional antipsychotic agents, contributing to improvement in the QOL. Recently, these agents have also been increasingly prescribed to females who may become pregnant. In Japan, no epidemiological survey regarding the application of novel antipsychotic agents in pregnant women has been published. In this study, we investigated the influence on fetuses in pregnant women receiving novel antipsychotic agents.
Methods: In pregnant women on novel antipsychotic agents who consulted the Pregnancy and Drug Consultation Outpatient Clinic of Toranomon Hospital, the outcome of pregnancy was confirmed.
Results: Twenty-nine pregnant women took novel antipsychotic agents in the organogenesis phase, in which the risk of teratogenicity is the highest. The agents consisted of olanzapine in 8 patients, risperidone in 11, quetiapine fumarate in 7, and perospirone hydrochloride hydrate in 4. The outcomes of pregnancy were full-term delivery in 24 patients, premature delivery in 1, spontaneous abortion in 2, and artificial abortion in 2. Of the 29 patients, 15 (60%) had continuously taken these agents until delivery. All 25 neonates were healthy without malformation.
Conclusion: This report describes the first prospective survey in Japan regarding infants delivered by pregnant women receiving novel antipsychotic agents. All patients delivered healthy neonates; the incidence of congenital anomalies did not exceed that in the general population. This survey included a small number of patients; cohort studies should be conducted to evaluate the safety in fetuses.
3.Effects of Edaravone on Prevention of Paraplegia Caused by Ischemic Spinal Cord
Kiyoshi Chiba ; Haruo Makuuchi ; Hiroshi Murakami ; Kayoko Tanaka ; Shigeko Ohnuma ; Mamoru Tadokoro
Japanese Journal of Cardiovascular Surgery 2008;37(2):82-90
Spinal cord injury after successful operation of the thoraco-abdominal aorta is an unpredictable complication which negatively affects the patient's quality of life. The main cause of spinal cord injury has been reported to be peroxidation of lipids. Edaravone, a free radical scavenger, has been used in the acute phase of cerebral infarction to ameliorate the brain damage. The aim of the present study was to evaluate the protective effect of edaravone on the neurological and histological outcome, and to examine the method of its administration so as to obtain the better effect, using animal models with ischemic spinal cord. Three groups of rabbits underwent surgical exposure of the abdominal aorta that was clamped for 20min to achieve spinal cord ischemia. Group A (n=6, control group) was given no medication. In group B (n=6), edaravone (3mg/ml saline/kg body weight) was administered intravenously 30min after reperfusion. In group C (n=6), the same dose of edaravone was administered at 30min, 24h and 48h after reperfusion. Neurological status was clinically assessed, using Tarlov's score, at 24h, 48h and 1week after reperfusion. Somatosensory evoked potential was measured preoperatively, at 20min after ischemia, at 30min after reperfusion, and at 24h, 48h and 1week after operation. Spinal cord sections were examined histologically to determine the degree of neuronal damage given by ischemic-reperfusion. Group A presented paraplegia with marked neuronal necrosis. Groups B and C maintained better neurogical function than Group A (p<0.001), and Group C was much better than Group B (p<0.05). In the model rabbits with 20min of ischemia-reperfusion, systemic repetitious administration of edaravone was found to have a more protective effect than a single administration on the spinal cord neurons and glia cells both neurologically and histologically.
4.Effect of Edaravone on Cerebral Protection during Aortic Arch Surgery
Yousuke Kitanaka ; Haruo Makuuchi ; Hiroshi Murakami ; Makoto Ono ; Takashi Ando ; Kayoko Tanaka ; Shigeko Onuma
Japanese Journal of Cardiovascular Surgery 2011;40(2):48-53
Edaravone is an agent developed as a free radical scavenger, and is useful in functional recovery of the brain after cerebral infarction. However, to the best of our knowledge no experimental studies have been made regarding the effect of edaravone on cerebral protection during aortic arch surgery. We investigated the pharmacological effect of edaravone experimentally, through selective cerebral perfusion under deep hypothermia. Twelve adult dogs (body weight 14.8±2.0 kg) were used, and selective cerebral perfusion was performed under hypothermic circulatory arrest of 20°C for 120 min at 5 mg/kg/min, which was half the usual flow volume of cerebral perfusion. Group E (n=6) received 3 mg/kg edaravone for 30 min at the start of both selective cerebral perfusion and rewarming of the body, while Group C (n=6) received no drugs. Somatosensory evoked potential (SEP) was measured, and so were blood pressure, body temperature, pH level, oxygen partial pressure, and blood flow in the cerebral tissue. Histopathological investigations were also performed. In Group E, complete SEP recovery was observed in all dogs, while in Group C, complete SEP recovery was observed in only 2 dogs (33%) (p=0.014). A statistically significant difference was also observed in cerebral tissue pressure (p=0.014), but not in pH level, oxygen partial pressure, or cerebral tissue blood flow. On histopathological investigation, Group C demonstrated reduced staining of Nissl granules in neurons of the cerebral cortex, and many of them presented the appearance of acute circulatory impairment while Group E demonstrated no reduction in staining of Nissl granules. In the present experimental study of selective cerebral perfusion under deep hypothermia below the safety threshold flow, edaravone was effective in cerebral protection.
5.A Comprehensive Study of Outcome of Bilateral Cataract Surgery Performed on Patients Living on Remote Islands, Postoperative Management at their Homes and Postoperative Complications
Koji KAWAMOTO ; Yumiko YAMASHITA ; Mitsue KAWANO ; Kayoko YASUI ; Misato OKAIRI ; Miho NOMURA ; Kyouko SAGAWA ; Ayako FUJII ; Yoko IWASHIGE ; Miyuki OKAMURA ; Hiroki OKIDA ; Makoto KENJO ; Makoto FUJIKAWA ; Miho NINOMIYA ; Hiroyuki TANAKA ; Takahiko KUBO ; Hiroyuki NISHIHARA ; Toru HAYASHI ; Jyunichi MURAKAMI
Journal of the Japanese Association of Rural Medicine 2010;59(4):493-499
Purpose: We examined the safety and efficacy of cataract surgery and postoperative management in our hospital and at the homes of the patients who live on medically underserved remote.
Patients and methods: A total of 27 patients (54 eyes), who were followed in our hospital or at their homes were enrolled in this study. Cataract surgery was performed on them between January 2009 and January 2010 and we could follow up six months postoperatively. We divided these patients into two groups:group I (GI) consisted of 13 patients who could come to our hospital regularly during both preoperative and postoperative periods, and group II (GII) consisted of 14 patients who could not come to our hospital regularly during either preoperative or postoperative periods. Cataract surgeries were performed on all the patients in GI and GII in our hospital. The patients in GI were hospitalized for three days and those in GII were for seven days. After cataract surgery, the patients in GI had their eyes checked regularly in our hospital and those in GII were in their homes where the doctor visited. Postoperative ophthalmic clinical tests were conducted to examine visual acuity, intraocular pressure and fundus.
Results: GI comprised three males and 10 females. Their age averaged 79.3. GII comprised four males and 10 females. Their age averaged 82.6. Preoperative ophthalmic examinations found that preoperative average visual acuity (LogMAR and decimal visual acuity in parentheses) and spherical equivalent in GI and GII were 0.69 (0.41), 0.80 (0.33) and -0.43 dioptors, -0.42 dioptors respectively, showing no significant differences between the two groups. Postoperative ophthalmic examinations found that, best corrected visual acuity (LogMAR) was significantly increased to 0.36 (0.66) and 0.44 (0.53) in GI and GII respectively, showing no significant differences either.
Conclusions: We concluded that we could get safe and efficient cataract surgery and postoperative management combined with prolonged hospitalization and house calls on the patients who live in the isolated islands.
6.5. The 2022 Revision of the Model Core Curriculum for Medical Education in Japan and the Common Achievement Test Being Made an Official Requirement / Participatory Clinical Clerkship
Makoto TAKAHASHI ; Kayoko MATSUSHIMA ; Akiteru TAKAMURA ; Naoko HASUNUMA ; Hiroyuki KOMATSU ; Rika MORIYA ; Masonori ISOBE ; Takeshi KONDO ; Junichi TANAKA ; Akira YAMAMOTO
Medical Education 2023;54(2):164-170
Following the revision of the structure and content of the Model Core Curriculum for Medical Education to be more outcome-based and the legal status of the medical practice performed by medical students in the clinical clerkship, we have revised the Guideline for Participatory Clinical Clerkship. The following items were revised or newly described : significance of enhancing the participatory clinical clerkship, scope of medical practice, confidentiality, patient consent, patient consultation and support service, objectives of the clinical clerkship, simulation education, departments where the clinical clerkship is conducted, assessment in the clinical practice setting, CC-EPOC, and entrustable professional activities. A foundation has been established to promote seamless undergraduate and postgraduate medical education. However, future work is needed to examine the specific level of performance expected at the end of the clinical clerkship and department-specific clinical practice goals and educational strategies.