1.Comparative Study of the Safety Information in the Private Import through the Internet of the Melatonin from which a Classification between Drugs and Food Differs in Japan and the United States
Kuniko Otsuka ; Yasuyuki Nomura ; Naoki Uchida ; Hajime Yasuhara ; Shinichi Kobayashi
Japanese Journal of Social Pharmacy 2014;33(1):21-29
Classification of food and pharmaceutical products are different. In the proper use of pharmaceutical products, it is essential for a medical consumer to receive the drug information about effectiveness, safety and quality of it. On the other hand, since legal classification between medicines and dietary supplements was based their cultures, the classification of each drug is different in each country. Melatonin is a hormone produced by the pineal gland and used for improvement of the jet lag. We searched melatonin product information of Japan and the United States by using Internet search mainly and investigated the relationship between amount of product information and product classification. Melatonin is classified as a dietary supplement in the United States, the product information of efficacy and safety is displayed as “Supplement Facts” and the use of melatonin in children is not recommended. On the other hand, melatonin is classified as a pharmaceutical product in Japan, but is not produced in Japan. Therefore, it is difficult to have it for Japanese customers, and then they personally import using the Internet with their self-responsibility. However it is difficult to obtain its appropriate information for consumers, because of the regulation of the Pharmaceutical Affairs Law. It has been reported that the poisoning accident by the excessive intake of melatonin already. It will increase the risk of the health problem to purchase melatonin through the Internet more. Therefore, we concluded that Internet purchase of Medicines had a high risk for Japanese customers since there was not sufficient drug information.
3.The Epidemiological Study of Venous Thromboembolism and Bleeding Events Using a Japanese Healthcare Database
Takuhiro Yamaguchi ; Takeshi Fuji ; Masao Akagi ; Yasuyuki Abe ; Mashio Nakamura ; Norikazu Yamada ; Eisei Oda ; Daisuke Matsubayashi ; Kaori Ota ; Masafumi Kobayashi ; Daiju Matsui ; Jumpei Kaburagi ; Yasuyuki Matsushita ; Atsushi Harada
Japanese Journal of Drug Informatics 2015;17(2):87-93
Objective: The aim of this study was to establish the proper definitions of venous thromboembolism (VTE) and bleeding events for a healthcare database in Japan.
Study Design: Validation study.
Methods: The study comprised patients with VTE or who had undergone orthopedic surgery of the lower extremities and whose outpatient or inpatient medical information from April 1, 2008 to September 30, 2013 was available. The source population of the database was derived from 100 acute-care hospitals. The endpoints were VTE events (deep venous thrombosis [DVT], pulmonary thromboembolism [PE]) and bleeding events (bleeding requiring blood transfusion, intracranial hemorrhage, intraocular hemorrhage, upper gastrointestinal [GI] bleeding, and lower GI bleeding). The frequent events with laboratory data were randomly extracted and evaluated, while all the infrequent events with laboratory data were extracted and evaluated. Positive predictive value (PPV) was defined as the proportion of events judged to be clinical by medical experts of all the extracted events. First, we conducted a test with a small number of cases and then revised the definitions of events. Second, we extracted and evaluated data in 50 patients for VTE and bleeding events patients, based on which we defined the target PPV level between 60 and 70%.
Results: Of the 5,044,743 patients in the database, 36,947 patients underwent orthopedic surgeries of the lower extremities and 3,578 patients experienced a VTE event. The PPV at the first evaluation was 80.0% (8/10) for DVT, 57.1% (4/7) for PE, and 27.3% (6/22) for bleeding events. At the second evaluation using the revised definitions, the PPV were 75.0% (42/56) for VTE and 73.3% (33/45) for bleeding events. Overall, the PPVs for VTE and bleeding events were over 70%. The PPV of the VTE events were 76.9% (30/39) for DVT and 70.6% (12/17) for PE. The PPVs of each type of bleeding event were over 70% except for intracranial hemorrhage (44.4%, 4/9).
Conclusion: The PPV was high for VTE events (75.0%) and bleeding events (73.3%). The definitions used in this study are rational for the identification of VTE, DVT, PE, and bleeding events in the healthcare database in Japan. The definition for each type of bleeding event should be investigated in further studies.
4.Complications and Outcome of Free Flap Transfers for Oral and Maxillofacial Reconstruction
Masashi Yamashiro ; Kazuki Hasegawa ; Narikazu Uzawa ; Yasuyuki Michi ; Junichi Ishii ; Hiroyuki Yoshitake ; Junji Kobayashi ; Kazuhiro Yagihara ; Sadao Okabe ; Teruo Amagasa
Oral Science International 2009;6(1):46-54
Microvascular free flap transfers have become a preferred reconstructive technique; however, rare complications may still prove devastating. This study reviewed 213 consecutive free-tissue transfers in order to assess the incidence and causes of complications in patients undergoing microvascular free flap reconstruction in the oral and maxillofacial region. In most cases, reconstruction was undertaken after resection of a malignant tumor. The flap donor sites were the radial forearm (n=111), rectus abdominis (n=88), scapula (n=13), and latissimus dorsi (n=1). The superior thyroid artery and the external jugular vein were commonly used as recipient vessels for anastomosis. The overall flap success rate was 99%. There were 7 cases of postoperative vascular thrombosis (6 venous and 1 arterial), constituting 3.3% of the entire series. Five flaps were salvaged, representing a 71.4% successful salvage rate in cases of vascular complications. Most of the successful salvage attempts were made within 24 hours of the end of the initial operation, and the successful salvage rate for re-exploration was 100%. Finally, the total flap loss rate was 0.9% and the partial flap loss rate was 2.3%. We conclude that early re-exploration should be the first choice for management of vascular compromised flaps. Complications at the donor site occurred in 17 cases (8.0%), the most common complication of which was partial skin graft loss after harvesting a radial forearm flap (n=10; 9.0%). Recipient and donor site morbidity was limited and considered acceptable.
5.A Case of Breast Carcinoma with Multiple Bone Metastases Intervened by Palliative Care Preceding Chemotherapy
Hiroaki SHIBAHARA ; Satoshi KOBAYASHI ; Ei SEKOGUCHI ; Yasuyuki FUKAMI ; Akira ITO ; Sakura ONISHI ; Akihiro TOMITA ; Ryo SHIRATSUKI ; Akira KANAMORI ; Kei MIYAMURA ; Yasuhiro KURUMIYA ; Daisaku NISHIMURA
Journal of the Japanese Association of Rural Medicine 2013;62(1):26-30
This case is a 56-year-old woman. With multiple bone metastases, she was referred to the Department of Palliative Care on the same day as core needle biopsy had just been performed in the Department of Surgery. Aggressively increased oxycodone was administered to relieve her significantly severe pains by bone metastases. After relief of the pains, cancer chemotherapy of EC and weekly PTX regimens were performed parallel to palliative care. In this case, chemotherapy could be performed after the pains had been sufficiently relieved with closer cooperation between the palliative care doctor and the attending surgeon. It is important for patient-focused medical care to be delivered by both the attending doctor administering cancer treatment and the palliative care doctor working for relief of the symptoms, while they are striving to foster their tie-up.
6.Loiasis in a Japanese Traveler Returning from Central Africa
Tetsuro Kobayashi ; Kayoko Hayakawa ; Momoko Mawatari ; Makoto Itoh ; Nobuaki Akao ; Rie R. Yotsu ; Jun Sugihara ; Nozomi Takeshita ; Satoshi Kutsuna ; Yoshihiro Fujiya ; Shuzo Kanagawa ; Norio Ohmagari ; Yasuyuki Kato
Tropical Medicine and Health 2015;43(2):149-153
We encountered a probable case of loiasis in a returned traveler from Central Africa. A 52-year-old Japanese woman presented to our hospital complaining of discomfort in her eyes and skin. She reported having frequently visited Central Africa over many years and having been extensively exposed to the rainforest climate and ecosystem. Although no microfilariae were found in her blood, there was an elevated level of IgG antibodies against the crude antigens of Brugia pahangi, which have cross-reactivity with Loa loa. She was treated with albendazole for 21 days, after which the antigen-specific IgG level decreased and no relapse occurred.
7.Post-polio Syndrome
Yoichiro AOYAGI ; Satoru SAEKI ; Koshiro SAWADA ; Yasuyuki MATSUSHIMA ; Megumi TOKI ; Emiko WADA ; Atsushi KINOSHITA ; Nobuyuki KAWATE ; Hirotaka KOBAYASHI ; Izumi KONDO ; Eiich SAITOH
The Japanese Journal of Rehabilitation Medicine 2015;52(10):625-633
Post-polio syndrome (PPS) is the term used to describe the symptoms that may develop many years after acute paralytic poliomyelitis( APP). In the case of PPS, the symptoms and signs include progressive muscle wasting and weakness, limb pain, and/or fatigue, occurring one or more decades after maximal recovery from APP. An overuse of enlarged motor units is suspected to cause the deterioration of some nerve terminals or the loss of the motor units themselves. This could in turn induce PPS symptoms such as new muscle weakness and atrophy. Electromyography (EMG) is often a strong tool to diagnose and evaluate PPS. Some studies have shown that mild to moderate intensity muscular strengthening has a positive effect in patients affected by PPS. Rehabilitation for PPS patients should utilize a multiprofessional and multidisciplinary approach. PPS patients should be advised to avoid both inactivity and overuse of the affected muscles. Finally, patient evaluation is often required to access the need of orthoses and assistive devices.
8.Guidance for Post-polio Syndrome (PPS)
Yoichiro Aoyagi ; Koshiro Sawada ; Fumi Toda ; Yasuyuki Matsushima ; Atsushi Kinoshita ; Emiko Wada ; Megumi Toki ; Nobuyuki Kawade ; Hirotaka Kobayashi ; Akiko Hachisuka ; Satoru Saeki ; Izumi Kondo ; Eiichi Saitoh
The Japanese Journal of Rehabilitation Medicine 2017;54(2):140-144
9.Loiasis in a Japanese traveler returning from Central Africa
Tetsuro Kobayashi ; Kayoko Hayakawa ; Momoko Mawatari ; Makoto Itoh ; Nobuaki Akao ; Rie Roselyne Yotsu ; Jun Sugihara ; Nozomi Takeshita ; Satoshi Kutsuna ; Yoshihiro Fujiya ; Shuzo Kanagawa ; Norio Ohmagari ; Yasuyuki Kato
Tropical Medicine and Health 2015;advpub(0):-
We encountered a probable case ofloiasis in a returned traveler from Central Africa. A 52-year-old Japanese womanpresented to our hospital complaining of discomfort in her eyes and skin. She reportedhaving frequently visited Central Africa over many years and having been extensivelyexposed to the rainforest climate and ecosystem. Although no microfilariae werefound in her blood, there was an elevated level of IgG antibodies against thecrude antigens of Brugia pahangi,which have cross-reactivity with Loa loa.She was treated with albendazole for 21 days, after which the antigen-specificIgG level decreased and no relapse occurred.
10.The 2020 Japan Society of Gynecologic Oncology guidelines for the treatment of ovarian cancer, fallopian tube cancer, and primary peritoneal cancer
Hideki TOKUNAGA ; Mikio MIKAMI ; Satoru NAGASE ; Yoichi KOBAYASHI ; Tsutomu TABATA ; Masanori KANEUCHI ; Toyomi SATOH ; Yasuyuki HIRASHIMA ; Noriomi MATSUMURA ; Yoshihito YOKOYAMA ; Kei KAWANA ; Satoru KYO ; Daisuke AOKI ; Hidetaka KATABUCHI
Journal of Gynecologic Oncology 2021;32(2):e49-
The fifth edition of the Japan Society of Gynecologic Oncology guidelines for the treatment of ovarian cancer, fallopian tube cancer, and primary peritoneal cancer was published in 2020. The guidelines contain 6 chapters—namely, (1) overview of the guidelines; (2) epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer; (3) recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer; (4) borderline epithelial tumors of the ovary; (5) malignant germ cell tumors of the ovary; and (6) malignant sex cord-stromal tumors. Furthermore, the guidelines comprise 5 algorithms—namely, (1) initial treatment for ovarian cancer, fallopian tube cancer, and primary peritoneal cancer; (2) treatment for recurrent ovarian cancer, fallopian tube cancer, and primary peritoneal cancer; (3) initial treatment for borderline epithelial ovarian tumor; (4) treatment for malignant germ cell tumor; and (5) treatment for sex cord-stromal tumor. Major changes in the new edition include the following: (1) revision of the title to “guidelines for the treatment of ovarian cancer, fallopian tube cancer, and primary peritoneal cancer”; (2) involvement of patients and general (male/female) participants in addition to physicians, pharmacists, and nurses; (3) clinical questions (CQs) in the PICO format; (4) change in the expression of grades of recommendation and level of evidence in accordance with the GRADE system; (5) introduction of the idea of a body of evidence; (6) categorization of references according to research design; (7) performance of systematic reviews and meta-analysis for three CQs; and (8) voting for each CQ/recommendation and description of the consensus.