In this report, we introduce the importance of a system for sharing information about cancer molecular-targeted medicines from trial to the clinic by the department of knowledge education research, department of breast surgical oncology, department of cardiovascular internal medicine and department of dermatology at St. Luke’s International Hospital in Japan.  At present, information regarding the side effect(s) of a study drug does not reach doctors who are not members of the department in charge of the clinical trial.  The reason for this is because clinical trials are conducted under the legal constraints of GCP (Good clinical practice), and while safety information about any adverse events (side effects) is reported, it is limited to the level of an Institutional Review Board.  When there was an enquiry about a known side effect that had occurred to patients taking molecular-target medicine from a doctor who was not a member of the department in charge of the clinical trial, it became clear that information regarding the clinical trial medicine and non-approved medicine was not reaching the clinic.  We developed an original reporting system for such information that would offer the information using the same format as the clinical trial itself, as well as the department in which the side effect was treated, to resolve the problem of access to side effect information outside of the clinical trial itself.  We show that the reporting of such information leads to resolution of this problem.  We believe that this will relieve the patient and contribute to the clinical trial as well as to the department that deals with such side effects.

1) This study involved an educational evaluation of preclinical practice with simulated patients (SPs) by students in the departments of nursing, physiotherapy, and occupational therapy. The scores were highly correlated with the usefulness of SPs, the conviction and the realism of the performances of SPs, and feedback from SPs. Students required SPs to accurately mimic symptoms and to give them critical feedback. Follow-up sessions are required regarding performance as SPs.
2) Preclinical practice with SPs helped students grasp the reality of practice, enhance preparations, and help them recognize their role as professionals based on feedbacks from SPs.

Renal damage caused by hemolysis during cardiopulmonary bypass (CPB) was investigated, and the preventive effects of haptoglobin in regard to this condition was also evaluated. Nineteen patients who underwent open heart surgery were divided into two groups: a control group (n=11) and a haptoglobin group (n=8). In the control group, the level of plasma-free hemoglobin increased significantly after CPB (p<0.01), and this level was strongly correlated with renal tubular leaking enzymes: NAG (r=0.76) and γ-GTP (r=0.81), in the Intensive Care Unit or on the first day after surgery. On the contrary, in the haptoglobin group, in which 4, 000 units of haptoglobin was added in the priming solution of CPB, no increased level of plasma free hemoglobin was observed. Furthermore, leak age of renal tubular enzymes were statistically less (p<0.05). It was concluded that free hemoglobin was a cause of renal damage during CPB and the damage was preventable by the administration of haptoglobin.

We performed coronary artery bypass operation on 258 patients from July 1974 to February 1993, of whom 10 underwent a total of 11 reoperations. These 10 patients were not significantly different from the other patients with respect to gender, coronary risk factors and number of grafts used in the first operation, aside from older age and lower LVEF. The interval between the two operations was <1 year (early) or about 10 years (late) in most instances. The most common reasons for reoperation were graft failure from technical problems in early and time-related alterations in graft and progression of original disease in late cases. The outcome of reoperation was less than satisfactory, with 2 operative deaths, IABP required in 5, reoperation for bleeding needed in 3 and severe sternal wound infection of the patent vein graft postoperatively, of which atheromatous debris released from the atherosclerotic vein graft was strongly suspected to be the cause. The old vein graft should be immediately ligated at the beginning of CPB in cases with diffuse atherosclerotic vein graft in which more than several years have passed since initial operation. In reoperation, arterial graft is preferable, especially GEA graft can be used advantageously even with a left thoracotomy approach. Bypass reoperation for occlusion of LAD or Cx should be performed by a left thoracotomy approach.