3.1. Practical Use of the Open Japanese Adverse Drug Event Report Database (JADER)
Japanese Journal of Pharmacoepidemiology 2014;19(1):14-22
As for spontaneous case reports of suspected adverse drug reactions, the following problems are known, a part of phenomenon actually recognized to be side effects in clinical site is reported, moreover, the thing which report bias which fluctuate produces by a factor with the various rates exists, since an appearance ratio is incalculable, it cannot be adapted in the analysis technique for common side-effects data. Therefore, the search algorithm analyzing method of signal detection has been established. Japanese Adverse Drug Event Report database (abbreviation; JADER) is exhibited from Pharmaceuticals and Medical Devices Agency (abbreviation; PMDA) to April 2012, and can use anyone now without restrictions. It is expected that the quality of research of pharmacoepidemiology will improve by practical use of JADER. However, as for the present condition, there are few reports of the practical use example in a pharmaceutical company as a subject which tends to attract attention from “signal detection” as the practical use method, consequently regulatory agency should cope with. Although the pharmacoepidemiology group of the author Japanese Society for Biopharmaceutical Statistics is not comprehensive before public presentation of JADER, the list obtained by “case report line list search with which side effects are suspected” which PMDA offers was collected and put in a database, and practical use in a pharmaceutical company has been tried by referring to the examination method of pharmacoepidemiology. This paper explains the processing method of the JADER data for enabling signal detection. Using this method, application to the subject of much pharmacoepidemiology is performed actively, and it expects to contribute to improvement in the quality of research of pharmacoepidemiology.
6.Clinical Characteristics and Prognosis of Malignant Melanoma Treated in Our Hospital
Journal of the Japanese Association of Rural Medicine 2003;52(5):831-836
This paper describes the clinical characteristics of 14 cases of malignant melanoma treated in our department during a period of five years from 1997 to 2001 and their prognosis. Excluding one case whose stage could not be defined, five cases recognized at the early stage have survived, and six cases out of eight at the progressive stages were dead within one year after their first visit. When it came to the clinical characteristics, nine cases were primary cutaneous melanomas and five cases were metastatic carcinomas. Acral lentiginous melanomas, histopathologically the most common type of melanoma in Japan, were found in seven cases of the total 14 (50%). Most of the patients were aware of the primary lesions but left them untreated. Generally speaking, malignant melanoma grow rapidly and prognosis is poor because the cure rate by chemotherapy is low. To realize earlier detection and treatment, we thought it is crucial to educate the public, have the general practitioners understanding more about the malignancy of the skin neoplasm and to build up a collaborative relationship between medical professionals.
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9.Mechanism of acupuncture-induced gastric motility
Journal of the Japan Society of Acupuncture and Moxibustion 2003;53(4):484-497
Effects of acupuncture on gastric motility in anesthetized rats
Acupuncture has been used to treat gastrointestinal symptoms in. China for more than 3, 000 years. However, the mechanism of the beneficial effects of acupuncture remains mysterious. Strain gage transducers were implanted on the serosal surface of the stomach to record circular muscle contractions in thiobutabarbialanesthetized rats. Acupuncture on the right lower abdomen caused a transient relaxation of the stomach. Acupuncture-induced gastric relaxations were abolished by guanethidine, propranolol, splanchnic ganglionectomy, spinal cord transection, and spino-medullary transection. In contrast, NG-nitro-L-arginine, phentolamine, truncal vagotomy and ponto-medullary transection had no effect. Acupuncture increased the number of c-Fos immunopositive cells at the rostral ventrolateral medulla (RVLM). It is concluded that acupuncture-induced gastric relaxations are mediated via somato-sympathetic reflex. Its afferent limb is composed of abdominal cutaneous and muscle afferent nerves. Its efferent limb is the gastric sympathetic nerve and the reflex center is within the medulla. RVLM neurons may play an important role in mediating this reflex.
Effects of acupuncture on gastric motility in conscious rats
Of 35 rats studied, 60% showed no cyclic groupings of strong contractions (type A) and 10 rats (40%) showed the cyclic phase III-like contractions (type B) in conscious rats. In 73 % of type A rats, acupuncture on the hind limb (ST36), but not on the back, produced strong cyclic contractions lasting for more than 3 hrs. Acupuncture failed to produce phase III-like contractions in type A rats treated with atropine, hexamethonium and vagotomy. Pretreatment with naloxone significantly shortened the duration of enhanced phase III-like contractions. In 60 % of type B rats, acupuncture suppressed phase III-like contractions. These results suggest that the acupuncture on the ST36 induces dual effects, either stimulatory or inhibitory effects, on gastric motility. The stimulatory effects of acupuncture on the hind limb are mediated via wagal efferent pathway and opioid pathway.
Effects of acupuncture on vasopressin-induced emesis in conscious dogs
Arginine vasopressin (AVP) is a posterior pituitary hormone and recent evidence implies an involvement of AVP in vomiting and nausea of humans and animals. Vasopressin was intravenously infused at a dose of 0.1U/kg/min. Number of retching and vomiting were visually counted during the experiment. Intravenous administration of vasopressin induced retching and vomiting in all dogs tested. Retrograde peristaltic contractions (RPCs) occurred before the retching and vomiting.
Electro-acupuncture (EA) of 10 HZ at PC6 decreased the number of retching and vomiting induced by vasopressin. EA also suppressed the RPCs. EA at the PC6 significantly reduced the number of episodes of retching and vomiting to 20-30 % compared to that without EA, while EA at BL21 had no significant effects on the number of episodes of retching and vomiting induced by vasopressin.
To investigate whether opioid pathway is involved in EA-induced anti-nociceptive effects, naloxone was administered before EA and vasopressin infusion. EA at PC6 had no more inhibitory effects on vasopressininduced nausea and vomiting when naloxone was given. This suggests that anti-emetic effects of acupuncture is mediated via (central) opioid pathway.
Effects of acupuncture on EGG in healthy volunteers
The point of PC6 and ST36 are the common points for the treatment of gastric symptoms. We compared the effect of EA between PC6 and ST36 on gastric myoelectrical activity using surface electrogastrography (EGG). Eight healthy volunteers were fasted for 12 hours. On the separate days, four sessions of EA (1 Hz, 30 min) were randomly performed to each subject. The percentage of normal slow waves and tachygastria, peak dominant frequency (PDF) and peak dominant power
10.A case of nail destruction as a possible side effect of anabolic androgenic steroid doping.
Japanese Journal of Physical Fitness and Sports Medicine 1994;43(1):66-74
I report a case of scalp hair loss and nail destruction as possible side effects of anabolic androgenic steroid (AAS) doping in a Japanese athlete. The patiet, a 27-year-old man, was an amateur bodybuilder who won the championship in a bodybuilding contest. However, he tested positive in a doping test for drostanolone and stanozolol, and was deprived of his championship.
In Japan, positive results in doping tests are very rare. The patient suffered from loss of scalp hair and destruction of the nails before the contest. In addition, he presented with hoarseness and soft tumors of the lower extremities. Laboratory data showed hypotestos-onemia caused by AAS doping. However, a hCG test revealed that he still had positive of sex function capacity. Therefore the patients natural course was observed without medical treatment, and the symptoms were resolved within four months after the contest. This is considered to be the first case of nail destruction caused by AAS doping reported in the world.