Over 40 years, Post-maketing surveillance (PMS) studies have been conducted as a legal obligation in Japan. Though the contribution of these studies to the better use of the drug has been acknowledged, there are criticisms that these PMS studies have been stereotyped and need to be improved. The ICH-E2E guideline entitled as "Pharmcovigilance Planning", agreed in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has been implemented in the concerned countries. The legislation of the guideline in Japan in 2005 seems to have urged drug companies and regulatory agency to review the current PMS practices in contrast with the today's highest scientific standard. We investigated the theoretical and practical aspects of pharmacoepidemiology required when the drug company evaluates safety specification prior to developing the pharmacovigilance plan and designs a PMS study along the lines stipulated in the ICH-E2E guideline. To meet this end, we evaluated the profiles of the drug, summarized "Important identified risks", "Important potential risks" and "Important missing information" to be identified and examined the pharmacovigilance plan suggested by the regulatory agency and that proposed and implemented by the drug company. We examined those aspects for 6 new products selected from 168 drugs newly approved during the period between January 2004 and October 2006. In 5 of 6 cases, we judged that the use of a comparator group would have been appropriate to asses the association between the drug and adverse events of interest. In addition, in one half (3) of 6 cases, it would have been preferable to use the database for the patient registration and/or other types of databases. The issues of relevant legislation and the infrastructure and funding for the investigations needed to develop a desirable study design and conduct a good pharmacoepidemiology study are however beyond a single company's capacity and should be set as a national strategy. The issues of post-marketing safety in the nation is becoming more and more important as the data in the countries outside Japan are being used more often for the processes of marketing authorization application of a new drug and its approval. It is urgent to secure the practice of pharmacoepidemiology to achieve the effective post-approval pharmacovigilance studies.

It has been made known that there isn't any significant regional difference in the frequencies of cases of viral hepatitis C by subtypes in our country. In the present study we investigated the subtypes in hepatitis C virus carring patients without blood transfusion history in the southern region of Ibaraki Prefecture to clarify the occurrence ratio of each subtype of the virus. The results of interferon therapy were also examined in those patients with chronic hepatitis C. The frequencies of subtypes 2, 3 and 4 were found to be 71%, 16% and 10%, respectively. Although these ratios were the same as the national average, a significantly high frequency (P>0.01) of subtype 3 was observed in the patients from Tsuchiura in the region, suggesting that there may have existed some particular source of infection other than blood transfusion. The effectiveness of interferon therapy was significantly higher (P>0.01) in the patients with subtype 3 (75%) than in those patients with subtypes 2 and 4 (23% and 43%, raspectively), suggesting that interferon is a remedy specific to subtype 3.

OBJECTIVETo explore the effects of mandibular implant junction on the growth of immature bone.

METHODSEight Beagle dogs were randomly divided into three groups: control, unjunction and junction. Twelve implants were produced on the mandible of unjunction experimental group and junction experimental group. At three months after implanting, radiographic examination was performed.

RESULTSThree months after implanting, all implants were integrated with bone. None implants was mobile or got off. Radiographic examination demonstrated that the bone lose difference was no significant in junction and unjunction group.

CONCLUSIONMandibular implant connection wasn't effect on the growth of bone.

Animals ; Bone Development ; Dental Implants ; Dogs ; Mandible ; Osseointegration ; Prostheses and Implants ; X-Rays

PURPOSE: Thoracic dumbbell tumors are relatively rare, usually arising from neurogenic elements. Methods for surgical removal thereof remain controversial. The purpose of this study was to evaluate the surgical results of a single-stage posterior approach with laminectomy and costotransversectomy only for the management of thoracic dumbbell tumors. MATERIALS AND METHODS: Eight cases of thoracic large dumbbell tumor were analyzed retrospectively: seven men and one woman (mean age, 49 years). Pathologic findings included schwannoma in five patients, neurofibroma in two patients (Recklinghausen in one patient), and ganglioneuroma in one patient. All patients underwent single-stage removal of dumbbell tumors by a posterior approach followed by laminectomy and costotransversectomy combined with instrumentation. Clinical and radiologic outcomes were reviewed, thereafter. RESULTS: Operative time ranged from 185 to 420 minutes (mean, 313 minutes), with estimated blood loss ranging from 71 to 1830 mL (mean, 658 mL). Postoperative complications included atelectasis in one case. All patients had tumors successfully removed with no neurological deterioration. Spinal deformities were not observed in any patients at the last follow-up (mean, 52 months), with instrumentation. CONCLUSION: Single-stage surgery with laminectomy and costotransversectomy may be useful for removing thoracic dumbbell tumors without a combined anterior approach.
Adolescent ; Adult ; Aged ; Female ; Humans ; Laminectomy ; Male ; Retrospective Studies ; Thoracic Neoplasms/*surgery ; Thoracic Vertebrae/*surgery

Background/Aims: Asymptomatic esophageal eosinophilia (aEE) is considered to be a potential precursor of eosinophilic esophagitis (EoE). However, there are few clinical parameters that can be used to evaluate the disease. Therefore, we aimed to clarify the factors involved in the symptoms of EoE by examining the clinicopathological differences between aEE and EoE. Methods: We reviewed 41 patients with esophageal eosinophilia who underwent endoscopic ultrasonography and high-resolution manometry. They were divided into the aEE group (n=16) and the EoE group (n=25) using the Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease score. The patients’ clinicopathological findings were collected and examined. Results: The median Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease score was 3.0 in the aEE group and 10.0 in the EoE group. There was no significant difference in patient characteristics, endoscopic findings and pathological findings. The cutoff value for wall thickening was 3.13 mm for the total esophageal wall thickness and 2.30 mm for the thickness from the surface to the muscular layer (total esophageal wall thickness: 84.0% sensitivity, 75.0% specificity; thickness from the surface to the muscular layer: 84.0% sensitivity, 68.7% specificity).The high-resolution manometry study was abnormal in seven patients (43.8%) in the aEE group and in 12 (48.0%) in the EoE group. The contractile front velocity was slower in the EoE group (p=0.026). Conclusions The esophageal wall thickening in the lower portion of the esophagus is an important clinical factors related to the symptoms in patients with EoE.