The effects of Argatroban, a selective thrombin inhibitor, in anticoagulation therapy following cardiovascular surgery is reported. The agent was administered in 28 patients by means of continuous intravenous infusion, adjusted to maintain the activated coagulation time at from 170 to 200 seconds. The activated coagulation time was well controlled at a mean rate of 0.482± 0.26μg/kg/min by intravenous drip infusion, and the dose of Argatroban reached a steady state within a few hours. Both the percent rate of prothrombin time and the activated partial thromboplastin time were significantly decreased to 49% and to 36% respectively by Argatroban, and recoverd to the normal range the day after cessation of the drug. Thrombin-antithrombin III complex, an index of coagulation activity, decreased from 35μg/l in the postoperative state to 14 μg/l 4 hours after the infusion of the drug, which demonstrated the good control of anticoagulation status. Clinically, no adverse reactions such as abnormal bleeding tendency was observed. We conclude that Argatroban is a safe and effective agent for anticoagulation therapy in the early postoperative phase.

Objective: The aim of this study was to analyze the factors influencing the addition of clinically significant adverse reactions (CSDR) section in drug package inserts in Japan.
Methods: The summaries of investigation results from August 2011 to July 2014 were evaluated.  The revisions were classified into revisions based only on case reports from Japan ([Revision Y]) and revisions based on other information and/or case reports from Japan ([Revision X]).  The revisions were classified into MedDRA system organ class (SOC).  As index of amount of information from domestic case reports, the number of accumulated cases ([Case A]), cases for which a causal relationship to the product could not be ruled out ([Case B]), and fatal cases ([Case C]) were used.  In each SOC, as index of causal relationship to the product, [Index B/A] ([Case B]/[Case A]) was calculated.  Relationship of [Index B/A] to [Revision X]/all revisions, or to the number of [Case A] in [Revision Y] were evaluated.  Deference of drug lag between [Revision X] and [Revision Y] was evaluated.
Results: Three hundreds twenty-three revisions with respect to the addition of CSDR section were identified.  [Revision Y] was 203 revisions (63%).  The number of [Case A], ([Case B], and ([Case C]) that were required for [Revision X] (120 revisions) were significantly lower than that were required for [Revision Y] (p<0.0001 for all comparisons).  [Index B/A] tended to inversely correlate with [Revision X]/all revisions (r=−0.52, p=0.066), and the number of [Case A] in [Revision Y] (r=−0.61, p=0.025).  Drug lag of [Revision X] was significantly longer than that of [Revision Y] (p<0.001).
Conclusions: In future, it would especially needed to pay attention to adverse reactions with a low [Index B/A] of which revisions relatively depend on other information.

A 59-year-old man presented with severe abdominal pain. CT scan showed a type A aortic dissection and pericardial effusion. As cardiac tamponade was present, emergency total arch replacement was performed. Because of his symptom, we added an exploratory laparotomy, which revealed intestinal necrosis. Therefore, necrotic intestine 4.5m in length was resected. After intensive care, he began oral feeding on the 25th day and was discharged on the 76th day postoperatively.

Methods: This study included 539 patients diagnosed with spinal metastasis from February 2009 to July 2018. The patients were categorized into four groups based on age: <59, 60–69, 70–79, and ≥80 years. Differences in trunk muscle composition among age groups and among groups were classified on the basis of survival (< or >3 months after spinal metastasis diagnosis) were evaluated. Results: In total, 515 patients (273 men, 242 women; mean age, 67.8 years) with complete medical records were included in the analysis. No significant differences were observed in the area of the psoas and paravertebral muscles among age groups in either sex. A significant trend toward a low muscle density with the increase in age was found for both sexes. Patients who survived less than 3 months had significantly smaller trunk muscle area than those who survived for more than 3 months in both sexes. Conclusions The results suggest that the reduction in muscle density is associated with advanced age, whereas a decreased muscle area is associated with pathology. Additionally, a small trunk muscle area was associated with a short overall survival. Further studies are needed to elucidate the underlying mechanisms of age- versus cancer-related changes in the muscle area and their influence on overall survival.

Preoperative definitive diagnosis of intradural lumbar disc herniation (ILDH) is difficult despite the availability of various neuroradiological investigative tools. We present a case of ILDH diagnosed preoperatively by discography and computed tomography-discography (disco-CT).The patient was a 63-year-old man with acute excruciating right leg pain. Discography and disco-CT demonstrated leakage of the contrast medium into the intradural space. Based on these findings, a right L5 nerve root disturbance caused by ILDH was diagnosed. A right L5 hemi-laminectomy and a dorsal durotomy were performed. The herniated disc was carefully dissected and then completely removed. Three months after surgery, the patient had fully recovered. This report highlights the importance of making a definitive diagnosis of ILDH preoperatively for better surgical planning and improved clinical outcomes. Furthermore, discography and disco-CT are both useful preoperative diagnostic tools for the diagnosis of ILDH.
Diagnosis ; Humans ; Intervertebral Disc Displacement ; Leg ; Middle Aged

STUDY DESIGN: A retrospective study. PURPOSE: To assess postoperative bone regrowth at surgical sites after lumbar decompression with >5 years of follow-up. Postoperative preservation of facet joints and segmental spinal instability following surgery were also evaluated. OVERVIEW OF LITERATURE: Previous reports have documented bone regrowth after conventional laminectomy or laminotomy and several factors associated with new bone formation. METHODS: Forty-nine patients who underwent microscopic bilateral decompression via a unilateral approach at L4–5 were reviewed. Primary outcomes included correlations among postoperative bone regrowth, preservation of facet joints, radiographic parameters, and clinical outcomes. Secondary outcomes included comparative analyses of radiographic parameters and clinical outcomes among preoperative diagnoses (lumbar spinal stenosis, degenerative spondylolisthesis, and degenerative lumbar scoliosis). RESULTS: The average value of bone regrowth at the latest follow-up was significantly higher on the dorsal side of the facet joint (3.4 mm) than on the ventral side (1.3 mm). Percent facet joint preservation was significantly smaller on the approach side (79.2%) than on the contralateral side (95.2%). Bone regrowth showed a significant inverse correlation with age, but no significant correlation was observed with facet joint preservation, gender, postoperative segmental spinal motion, or clinical outcomes. Subanalysis of these data revealed that bone regrowth at the latest follow-up was significantly greater in patients with degenerative lumbar scoliosis than in those with lumbar spinal stenosis. Postoperative segmental spinal motion at L4–L5 did not progress significantly in patients with degenerative spondylolisthesis or degenerative lumbar scoliosis compared with those with lumbar spinal stenosis. CONCLUSIONS: Microscopic bilateral decompression via a unilateral approach prevents postoperative spinal instability because of satisfactory preservation of facet joints, which may be the primary reason for inadequate bone regrowth. Postoperative bone regrowth was not related to clinical outcomes and postoperative segmental spinal instability.
Bone Development ; Decompression* ; Diagnosis ; Follow-Up Studies* ; Humans ; Laminectomy ; Minimally Invasive Surgical Procedures ; Osteoarthritis, Spine ; Osteogenesis ; Retrospective Studies ; Scoliosis ; Spinal Stenosis ; Spondylolisthesis ; Treatment Outcome ; Zygapophyseal Joint

1) All students but 1 correctly typed the ABO blood groups, but only 33.2% of students and 63.9% of physicians properly performed cross-matching.
2) Most failures in cross-matching were due to the inability to detect allogeneic antibodies, but 5.2% of students and 2.9% of physicians failed to detect ABO mismatching.
3) Although laboratory practice is suggested to help students to solidify knowledge and comprehend principles, achieving an official goal of residency - gaining competence in performing and interpreting cross-matching independently - appeared difficult.

Background/Aims: Golimumab (GLM) is an anti-tumor necrosis factor-α drug approved for treating moderate-to-severe active ulcerative colitis (UC). A 52-week post-marketing surveillance (PMS) was initiated to evaluate its safety and effectiveness in patients with UC in Japan. We present an interim report of the ongoing PMS. Methods: Patients received 200 mg of subcutaneous GLM at week 0, 100 mg at week 2, and 100 mg 4 weekly thereafter. The safety analysis set included 392 patients with UC, and the effectiveness analysis set 387 patients. Safety and effectiveness were assessed at week 6. Results: Adverse drug reactions (ADRs) were reported in 8.2% (32/392) and serious ADRs in 4.6% (18/392). The most frequent ADRs were infection and infestation (3.3%), with herpes zoster being the most common. ADRs were significantly higher in patients with concomitant corticosteroid use (odds ratio [OR], 3.45; 95% confidence interval [CI], 1.40–9.68). No significant difference in ADR incidence was observed between patients aged ≥65 and <65 years (OR, 1.23; 95% CI, 0.35–3.47). Six-week effectiveness of GLM was confirmed by a decrease in the partial Mayo score (–2.3; 95% CI, –2.6 to –2.1) and C-reactive protein levels (–0.64; 95% CI, –0.92 to –0.36), including in the biologics-experienced population. Conclusions The safety and effectiveness of GLM at week 6 in a real-world setting were demonstrated in patients with UC in Japan. ADR patterns were consistent with previous reports with no new safety signals. Concomitant corticosteroid use may be associated with increased ADR incidence. The final results of the ongoing PMS are necessary for further evaluation.

STUDY DESIGN: Retrospective case series. PURPOSE: To evaluate surgical outcomes and effectiveness of an autogenic rib graft for upper cervical fixation in pediatric patients. OVERVIEW OF LITERATURE: Autogenic bone grafts have long been considered the ‘gold standard’ bone source for posterior cervical fusion in pediatric patients. However, there are some unsolved problems associated with donor-site morbidity and amount of bone grafting. METHODS: We studied five consecutive pediatric patients who underwent atlantoaxial fixation or occipitocervical fixation (OCF) using an autogenic rib graft with at least 2 years of follow-up (mean age, 9.8 years; mean follow-up period, 73.0 months). Two patients underwent OCF without screw-rod constructs and three patients with screw-rod constructs. Autogenic rib grafts were used in all patients. We evaluated the surgical outcomes including radiographic parameter, bony union, and perioperative complications. RESULTS: The atlantoaxial interval (ADI) was corrected from 11.6 to 6.0 mm, and the C1–2 angle was corrected −14.8° to 7.8°. The C2–7 angle was reduced from 31° to 9° spontaneously. Two patients with OCF required revision surgery due to loss of correction. Patients did not experience any complication associated with the donor sites (rib bone grafts). Six months postoperation X-rays clearly showed regeneration of the rib at the donor sites. Bony fusion was achieved in all patients; however, bony fusion occurred more slowly in patients without screw-rod constructs compared with patients with screw-rod constructs. Bone regeneration of the rib was observed in all patients with no complications at the donor site. CONCLUSIONS: Autogenic rib grafts have advantages of potential bone regeneration, high fusion rate, and low donor-site morbidity. In addition, a screw-rod construct provides better bony fusion in pediatric patients with OCF and atlantoaxial fixation.