1.Preparation of Guidelines for Medication Guidance Regarding Automobile Driving to Patients Based on “Japanese Adverse Drug Event Report” Database by Pharmaceuticals and Medical Devices Agency (PMDA) (Part 1)
Yukiko Okamoto ; Yasuhisa Hattori ; Yasuo Nakamura ; Kaoru Kamimoto ; Hiroshi Suzumura
Japanese Journal of Drug Informatics 2015;17(2):59-68
Objective: Incidents, such as disturbance of consciousness due to adverse reactions of medications during automobile driving, could cause a serious accident. Although automobile driving is indicated to be “prohibited” in the package inserts of many drugs, no explicit guidelines are available in Japan on specific guidance to patients. Therefore, we attempted to prepare guidelines for medication guidance regarding automobile driving.
Methods: We investigated the number of incidents involving traffic accidents and the disturbance of consciousness cases reported in “Japanese Adverse Drug Event Report” database by “Pharmaceuticals and Medical Devices Agency (PMDA).” We also analyzed descriptions regarding automobile driving found in package inserts and guidelines to determine a risk level for each medication.
Results: Guidelines for medication guidance were prepared based on four-level classification of drugs for which “prohibition” of automobile driving was indicated in their package inserts; these levels are “conform to pertinent guidelines,” “strictly prohibited,” “prohibited,” and “conditionally prohibited.” The contents of the guidance prepared for some drugs were different from their package inserts.
Conclusions: The guidelines prepared in this study can be expected to become a support tool to ensure close attention to cautions regarding automobile driving. Because some contents of the guidance are different from that described in the package inserts, it is desirable to obtain agreement with physicians in hospitals adopting these guidelines. In addition, guidelines based on a broader range of information should be prepared in the future.
2.Hospital-Wide Standardization of Warnings about Driving Motor Vehicles While Taking Drugs: An Example from Nagoya City East Medical Center (Part 2)
Yasuhisa Hattori ; Yukiko Okamoto ; Yasuo Nakamura ; Kaoru Kamimoto ; Hiroshi Suzumura
Japanese Journal of Drug Informatics 2015;17(3):164-168
Objective: When vehicular accidents occur as a result of impaired consciousness etc., because of adverse drug reactions, there is a risk that third parties may be harmed. Till date, at Nagoya City East Medical Center (hereinafter, our hospital), the warnings about driving motor vehicles while taking drugs has varied depending on the doctor or pharmacist who provides the guidance. Therefore, throughout our hospital, we aimed to standardize these warnings and to introduce measures to strictly enforce them.
Methods: Among all the drugs used at our hospital, we identified those with warnings on the package insert about driving motor vehicles and classified them in accordance with “The Drug Administration Guidance Criteria Regarding the Driving of Vehicles,” created by our hospital on the basis of descriptions on the package insert and the level of risk of taking drugs. We then standardized the warnings about driving motor vehicles while taking drugs, throughout our hospital.
Results: Of the 1,416 drugs used at our hospital, we identified 294 (21%) with warnings about driving motor vehicles on the package insert, and more than half of these (158 drugs) had warnings about the prohibition of driving motor vehicles on the package insert. As a result of classifying the drugs according to “The Drug Administration Guidance Criteria Regarding the Driving of Vehicles,” we identified 53 drugs with warnings about the prohibition of driving motor vehicles. By the classification of the level of risk of taking drugs while driving motor vehicles and the hospital-wide standardization of the warnings about driving motor vehicles while taking drugs, we are now able to provide drug administration guidance in the form of warnings that are customized to the level of risk of using each drug.
Conclusion: These measures have clarified the level of risk of taking each drug and warnings about driving motor vehicles while taking them. In the future, we intend to cooperate with local pharmacies to intervene in the prescription of drugs outside well as inside hospitals.
3.PREBIOTIC EFFECT OF DAILY FRUCTOOLIGOSACCHARIDE INTAKE ON WEIGHT GAIN AND REDUCTION OF ACUTE DIARRHEA AMONG CHILDREN IN A BANGLADESH URBAN SLUM: A Randomized Double-masked Placebo-controlled Study
Sadako Nakamura ; Shafiqul Alam Sarker ; Mohammad Abdul Wahed ; Yukiko Wagatsuma ; Tsuneyuki Oku ; Kazuhiko Moji
Tropical Medicine and Health 2006;34(3):125-131
Fructooligosaccharide (FOS) is a typical prebiotic agent. A randomized, double-masked, placebo-controlled study was performed to evaluate the prebiotic effect of daily intake of an isotonic solution containing FOS on body weight gain and the reduction of diarrhea in children in an urban slum in Bangladesh over six consecutive months. We enrolled a total of 150 children, aged 25-59 months. Sixty-four children in the FOS group received 50 mL of isotonic solution with 2 g of FOS added, and 69 children in the placebo group were given an identical solution with 1 g of glucose added, once a day. The measurement of body weight was carried out every other day; height and arm circumference were measured once a month; and the children‘s mothers were interviewed to obtain data about diarrhea, the consistency and constitution of stool, other symptoms, and antibiotic treatment. As a result, the body weight gain during the six-month period was 0.86±0.55 kg in the FOS group and 0.89±0.48 kg in the placebo group, while the increase in height and arm circumference were not significantly different between the two groups. The number of diarrhea episodes during the six-month period was not significantly different. A significant reduction in the duration of diarrhea days and of duration per episode was observed in the FOS group (p=0.039 and p=0.008, respectively). In conclusion, daily intake of FOS was associated neither with the children‘s growth nor with the number of diarrhea episodes, but a significant reduction in the duration of diarrhea days was observed. Further studies are needed to confirm the effects of FOS by changing the doses and eliminating the influence of antibiotics.
4.Lifestyle factors in the prevention of coronavirus disease 2019 (COVID-19)
W.Lange KLAUS ; Nakamura YUKIKO
Global Health Journal 2020;4(4):146-152
Confinement to the home and psychological distress due to the coronavirus disease 2019 (COVID-19) pandemic may lead to harmful health behaviors, such as overeating, sedentary behavior with reduced physical activity, elevated alcohol and tobacco use and increased screen time causing impaired sleep. All of these behaviors are associated with non-communicable diseases and can interfere with immunity. While no foods, single nutrients or dietary supplements are capable of preventing infection with COVID-19, a balanced diet containing sufficient amounts of macronutrients and diverse micronutrients is a prerequisite of an optimally functioning immune system. High-energy "Western" diets and obesity are major risk factors for a more severe course of COVID-19. Alcohol use and tobacco also have detrimental effects on the immune system. Therefore, population-wide body weight control, reduction of smoking rates and limitation of alcohol consumption are important preventive measures. Furthermore, sufficient restorative sleep is needed for adequate immune functioning. Appropriate lifestyle changes in regard to nutrition, exercise, sleep, smoking and alcohol intake may help shift the population distribution of infection risk and aid in preventing severe COVID-19 disease. Large-scale surveys should explore the effects of lifestyle changes, and the provision of reliable lifestyle information and effective interventions to individuals and communities during the pandemic is a pressing need.
6.Laparoscopic Round Ligament Psoas Minor Tendon-Hitching: Newly Developed Uterine Prolapse Operation
Koji SHIMABUKURO ; Tamami ODAI ; Takanori YOSHIDA ; Takafumi TSUKADA ; Yukiko NUSHI ; Yasuko NISHIDA ; Kaori TAKAGI ; Reiko NAKAMURA ; Sanae HATTORI ; Naoyuki MIYASAKA ; Maiko ICHIKAWA ; Seiichi ENDO ; Masae SAKAMOTO
Journal of the Japanese Association of Rural Medicine 2016;64(5):815-818
We have developed a new surgical procedure for uterine prolapse of round ligament suspension to the psoas minor tendon by the use of a laparoscope. Here, we describe the new technique and report the outcome of surgery in three cases. Operative procedure: The fundus of the uterus is lifted back up to its natural position by fixing the round ligament of the uterus to the psoas minor tendon after incising the peritoneum covering psoas. It is important to use the tendon as a stronger reattachment site in addition to the psoas major muscle. The round ligament is tacked to the tendon by a 2-0 nonabsorbable suture on bilateral sides. The second suture may be added if the uterus is not appropriately lifted up by the first suture. The retroperioneum is closed by a continuous 3-0 absorbable suture after fixation. Cases: Two patients with severe uterine prolapse and one patient with a mild condition went through the operation safely and have experienced no recurrence for 10 to 24 months. One severely ill patient complained about post -operative right inguinal pain early and another with the severe condition complained that something felt wrong with the right thigh. We propose the operation of laparoscopic round ligament psoas minor tendon-hitching as a safe and effective surgical treatment for uterine prolapse.
7.A Case of Erythropoietin-secreting Large Uterine Leiomyoma
Yasuko NISHIDA ; Seiichi ENDO ; Kaori TAKAGI ; Yukiko NUSHI ; Reiko NAKAMURA ; Tamami ODAI ; Sanae HATTOR ; Maiko ICHIKAWA ; Masae SAKAMOTO ; Koji SHIMABUKURO ; Chigusa NAGATA
Journal of the Japanese Association of Rural Medicine 2016;65(2):244-249
A 59-year-old woman, para 2, attended our hospital for an abdominal mass and atypical genital bleeding. Magnetic resonance imaging revealed a 30×25cm uterine myoma. A preoperative blood examination showed the following results: hemoglobin, 21g/dl; hematocrit, 71.5%; erythropoietin, 38.5mIU/ml; and estradiol, 29.9pg/ml. Abdominal total hysterectomy and bilateral salpingo-oophorectomy were performed, with an estimated blood loss of 1650ml. The weight of the uterus, including the myoma nodule, was 4740g, and the results of histology confirmed the diagnosis of leiomyoma. By postoperative day 28, her hemoglobin, erythropoietin, and estradiol levels had fallen to levels of 15.1g/dl, 6.0mIU/ml, and 5.8pg/ml, respectively, which are normal for a postmenopausal woman. The findings suggest that the leiomyoma secreted erythropoietin and induced erythrocytosis. Estradiol stimulates erythropoietin secretion and enlargement of the leiomyoma. Some studies have shown that erythropoietin is also a growth factor for leiomyoma. More than half of the erythropoietin-producing leiomyomas are detected after menopause. It was discovered that leiomyoma cells can produce aromatase, which transforms androstenedione into estradiol. Although estradiol secretion from the ovaries decreases in the postmenopausal period, the estradiol and erythropoietin autocrine/paracrine system in leiomyoma might promote its own growth after menopause.
8.A Case of Deep Venous Thrombosis and Pulmonary Thrombosis during Week 29 of Pregnancy
Sanae HATTORI ; Maiko ICHIKAWA ; Shiori OKIKURA ; Haruka MANAYAMA ; Kaori TAKAGI ; Yasuko NISHIDA ; Yukiko NUSHI ; Reiko NAKAMURA ; Tamami ODAI ; Seiichi ENDO ; Masae SAKAMOTO ; Koji SHIMABUKURO
Journal of the Japanese Association of Rural Medicine 2016;65(4):857-861
A major cause of pulmonary thromboembolism (PTE) is deep venous thrombosis (DVT). We report here a case of DVT in a 31-year-old woman during week 29 of her second pregnancy. At week 29, the patient noticed swelling of the left leg and pain in the groin after sitting. At almost week 30, walking became difficult due to pain and she was referred to hospital. Computed tomography (CT) revealed a thrombus from the left common iliac vein to the femoral vein and multiple thrombi in the right pulmonary artery. Blood testing showed elevated D-dimer (3.4μg/ml). Continuous intravenous unfractionated heparin was administered, and the dose was increased due to decreased activated partial thromboplastin time control. Despite conservative therapy for DVT, the thrombi showed no change since admission. At almost week 37, a temporary inferior vena cava filter (t-IVCF) was placed to prevent pulmonary thromboembolism, and she had an uneventful delivery of a baby by Caesarean section. Warfarin was administered postpartum. The t-IVCF was removed 4 days after delivery, and the patient was discharged 10 days after delivery. Within the field of obstetrics, the need for IVCF insertion should be considered on an individual case basis and should not be viewed as a standard option.
9.Utility of Dynamic CT in the Management of Laparoscopic Port-site Hematoma
Koji SHIMABUKURO ; Haruka MANEYAMA ; Tamami ODAI ; Takanori YOSHIDA ; Takafumi TSUKADA ; Shiori KOURI ; Yukiko NUSHI ; Yasuko NISHIDA ; Rie KITANO ; Maiko ICHIKAWA ; Seiichi ENDO ; Masae SAKAMOTO ; Reiko NAKAMURA
Journal of the Japanese Association of Rural Medicine 2017;65(5):1023-1026
We report a case of subcutaneous port-site hematoma developed on day 6 after laparoscopic left-sided salpingooophorectomy. To start the procedure, three ports were placed in the umbilicus and in each lower quadrant using bladeless trocars. No bleeding was observed at the trocar sites after insertion or withdrawal. The patient was discharged on postoperative day (POD) 3, but returned to the emergency outpatient department with acute left lower abdominal pain on POD 6. Dynamic CT revealed a port-site hematoma with active bleeding from a subcutaneous artery. Hemostasis was achieved easily by opening the trocar wound. Dynamic CT was useful to locate the bleeding vessel and enabled use of a minimally invasive procedure to control bleeding.
10.Preventive Effect of Neutral Positioning of Both Arms on Malposition-Related Hand Numbness after Gynecological Laparoscopic Surgery
Koji SHIMABUKURO ; Reiko NAKAMURA ; Tamami ODAI ; Takanori YOSHIDA ; Takafumi TSUKADA ; Yukiko NUSHI ; Haruka MANEYAMA ; Shiori KOHRI ; Yasuko NISHIDA ; Rie KITANO ; Maiko ICHIKAWA ; Seiichi ENDO ; Masae SAKAMOTO
Journal of the Japanese Association of Rural Medicine 2017;66(1):21-26
This retrospective study was carried out to clarify the preventive effect of neutral positioning of both arms on upper extremity neuropathy after gynecological laparoscopic surgery compared with right arm abduction positioning. In 93 cases of right arm abduction positioning >90°, with the left arm tucked in at the side, postoperative right hand numbness occurred in 6 cases (6.5%). In these 6 cases, symptoms disappeared in 4 cases after postoperative day (POD) 1, in 1 case after POD 21, and in the remaining case after POD 41. In 81 cases where both arms were in the neutral position tucked in at the sides with shoulder braces applied, upper extremity numbness was not experienced in any cases; however, shoulder pain developed in 4 cases (4.9%) and was thought to be related to using the shoulder braces. The pain disappeared in 2 cases after POD 1, in 1 case after POD 2, and in the remaining case after POD 3. In right arm abduction positioning without the use of shoulder braces, shoulder pain was not experienced in any cases. Neutral positioning of both arms in gynecological laparoscopic surgical patients was effective for the prevention of upper extremity neuropathy, but measures to alleviate the onset of shoulder pain after change in positioning need to be addressed in the future.