Adverse Drug Reaction Relief System in Japan: From Clinical Perspective.

Adverse drug reaction (ADR) relief system in Japan is comprehensively described in this article. Particularly, review process during ADR relief evaluation is focused from clinical perspective. The significance of clinical review process and roles of a physician medical reviewer in the ADR relief system in Japan are also discussed.

The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.

The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials.

A rare case of focal multiple medullary venous malformations with ipsilateral cerebral surface varix.

We report here a rare case of focal multiple venous malformations (VMs) in the white matter, via a draining vein arising from each VM, connecting with an ipsilateral cerebral surface venous varix. The male teen was asymptomatic neurologically. A diagnostic process using of MRI/MRDSA in this extremely rare entity is important as the more incidental discovery is expected with increasing opportunities of performing brain CT/MRI for various indications.

Intrafractional setup errors in patients undergoing non-invasive fixation using an immobilization system during hypofractionated stereotactic radiotherapy for lung tumors.

Intrafractional setup errors during hypofractionated stereotactic radiotherapy (SRT) were investigated on the patient under voluntary breath-holding conditions with non-invasive immobilization on the CT-linac treatment table. A total of 30 patients with primary and metastatic lung tumors were treated with the hypofractionated SRT with a total dose of 48-60 Gy with four treatment fractions. The patient was placed supine and stabilized on the table with non-invasive patient fixation.

Stereotactic body radiotherapy for metachronous multisite oligo-recurrence: a long-surviving case with sequential oligo-recurrence in four different organs treated using locally radical radiotherapy and a review of the literature.

Stereotactic body radiotherapy (SBRT) for oligometastases represents a recent trend in radiation oncology. While abundant data are available regarding the use of SBRT for the treatment of lung or liver oligometastases from various retrospective series and prospective trials, relatively little information has been accumulated for the treatment of oligometastases at sites other than the lungs and liver, particularly for sequential oligometastases in multiple organs. Oligometastases with primary lesions controlled is called "oligo-recurrence.

Collapse of Viabahn stent-graft secondary to rheolytic thrombectomy: a rare complication of the AngioJet device.

There is increased use of percutaneous mechanical thrombectomy for treatment of occluded dialysis access. The AngioJet rheolytic thrombectomy device is one such device available. Reports have shown safety and efficacy of these techniques with relatively few complications.

Renal pseudoaneurysm following laser lithotripsy: endovascular treatment of a rare complication.

Hemorrhagic complications of renal transplantation can be life threatening and require prompt and timely intervention. This brief report describes the exceedingly rare formation of an extrarenal pseudoaneurysm of a transplant renal artery following laser lithotripsy for nephrolithiasis in a teenage male. The pseudoaneurysm ruptured into the renal collecting system.

Transfer of regulatory T cells generated ex vivo modifies graft rejection through induction of tolerogenic CD4+CD25+ cells in the recipient.

Certain CD4+CD25+ T cells can induce and maintain T-cell non-responsiveness to donor alloantigens and have therapeutic potential in solid organ transplantation. Peripheral CD4+CD25- cells alloactivated with IL-2 and transforming growth factor beta (TGF-beta) ex vivo express the transcription factor FoxP3, and become potent antigen-specific CD4+CD25- suppressor cells. Here we report that the transfer of TGF-beta-induced regulatory CD4+ and CD8+ T cells (Tregs) co-incident with transplantation of a histoincompatible heart resulted in extended allograft survival.

Transforming growth factor-beta/interleukin-2-induced regulatory CD4+ T cells prolong cardiac allograft survival in rats.

Background: Treatment of naive CD4+ T cells in vitro with transforming growth factor-beta (TGF-beta) or TGF-beta/interleukin-2 (IL-2), combined with stimulation in a mixed lymphoid culture (MLC), has been shown to generate CD4+ CD25+ regulatory T cells. However, little is known about the effect of these regulatory T cells on cardiac allograft survival in vivo.

Methods: CD4+ CD25+ T cells were generated from Lewis (LEW) rat spleen through a primary MLC with TGF-beta (10 ng/ml) or TGF-beta/IL-2 (10 U/ml).

BCR/ABL P190 transgenic mice develop leukemia in the absence of Crkl.

The Bcr/Abl fusion protein directly causes chronic myelogenous leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia. Multiple independent studies have implicated Crkl, a small adapter protein, in transduction of oncogenic signals of Bcr/Abl and Crkl tyrosine-phosphorylation is used as a diagnostic tool for Philadelphia-positive leukemia. To evaluate the contribution of Crkl to this type of leukemia, we generated mutant mice that lack Crkl expression.