Cost-effectiveness analysis of once-yearly injection of zoledronic acid for the treatment of osteoporosis in Japan.

Model-based economic evaluation was performed to assess the cost-effectiveness of zoledronic acid. Although zoledronic acid was dominated by alendronate, the incremental quality-adjusted life year (QALY) was quite small in extent. Considering the advantage of once-yearly injection of zoledronic acid in persistence, zoledronic acid might be a cost-effective treatment option compared to once-weekly oral alendronate. INTRODUCTION: The purpose of this study was to estimate the cost-effectiveness of once-yearly injection of zoledronic acid for the treatment of osteoporosis in Japan. METHODS: A patient-level state-transition model was developed to predict the outcome of patients with osteoporosis who have experienced a previous vertebral fracture. The efficacy of zoledronic acid was derived from a published network meta-analysis. Lifetime cost and QALYs were estimated for patients who had received zoledronic acid, alendronate, or basic treatment alone. The incremental cost-effectiveness ratio (ICER) of zoledronic acid was estimated. RESULTS: For patients 70 years of age, zoledronic acid was dominated by alendronate with incremental QALY of -0.004 to -0.000 and incremental cost of 430 USD to 493 USD. Deterministic sensitivity analysis indicated that the relative risk of hip fracture and drug cost strongly affected the cost-effectiveness of zoledronic acid compared to alendronate. Scenario analysis considering treatment persistence showed that the ICER of zoledronic acid compared to alendronate was estimated to be 47,435 USD, 27,018 USD, and 10,749 USD per QALY gained for patients with a T-score of -2.0, -2.5, or -3.0, respectively. CONCLUSION: Although zoledronic acid is dominated by alendronate, the incremental QALY is quite small in extent. Considering the advantage of annual zoledronic acid treatment in compliance and persistence, zoledronic acid may be a cost-effective treatment option compared to alendronate.

Long-term health status as measured by EQ-5D among patients with metastatic breast cancer: comparison of first-line oral S-1 and taxane therapies in the randomized phase III SELECT BC trial.

PURPOSE: The goal of chemotherapy for metastatic breast cancer (MBC) is to prolong survival and maintain health-related quality of life. This study aimed to evaluate long-term health status of patients with MBC who participated in the phase III randomized SELECT BC trial. METHODS: In the SELECT BC trial, patients were randomly allocated to the S-1 or taxane (paclitaxel or docetaxel) arm. Health status was assessed by EQ-5D at pre-treatment, 3 and 6 months after randomization, and every 6 months thereafter to the extent possible. Least square mean scores were assessed to compare EQ-5D index values between groups. Time to deterioration analysis was also performed by defining the minimally important difference of EQ-5D as 0.05 or 0.1. RESULTS: The number of patients for EQ-5D analysis was 175 and 208 in the taxane and S-1 arms, respectively. Least square mean EQ-5D index values up to 60 months were 0.741 (95 % CI [0.713-0.769]) in the taxane arm and 0.748 [0.722-0.775] in the S-1 arm. The EQ-5D index value during PFS up to 12 months in the S-1 was superior to the corresponding index value in the taxane (0.812 [0.789-0.834] vs. 0.772 [0.751-0.792], P = 0.009). Time to deterioration analysis also revealed that S-1 significantly delayed the deterioration of EQ-5D index value during the period before progression (P = 0.002 and 0.003). CONCLUSIONS: Our findings suggest that the EQ-5D index value was higher in patients treated with S-1 during first-line chemotherapy. Considering non-inferiority of S-1 in terms of OS, obtained quality-adjusted life years may be greater in the S-1 arm.

Recovery oriented phosphorus adsorption process in decentralized advanced Johkasou.

Decentralized advanced wastewater treatment using adsorption and desorption process for recovery and recycling oriented phosphorus removal was developed. Adsorbent particles made of zirconium were set in a column, and it was installed as subsequent stage of BOD and nitrogen removal type Johkasou, a household domestic wastewater treatment facility. The water quality of the effluent of adsorption column in a number of experimental sites was monitored. The effluent phosphorus concentration was kept below 1 mg l(-1) during 90 days at all the sites. Furthermore, over 80% of the sites achieved 1 mg l(-1) of T-P during 200 days. This adsorbent was durable, and deterioration of the particles was not observed over a long duration. The adsorbent collected from each site was immersed in alkali solution to desorb phosphorus. Then the adsorbent was reactivated by soaking in acid solution. The reactivated adsorbent was reused and showed almost the same phosphorus adsorption capacity as a new one. Meanwhile, the desorbed phosphorus was recovered with high purity as trisodium phosphate by crystallization. It is proposed as a new decentralized system for recycling phosphorus that paves the way to high-purity recovery of finite phosphorus.

[The malignant tumor of the pulmonary artery; report of a case].

Primary sarcoma of the pulmonary artery is rare. Diagnosis is difficult and often delayed; pulmonary embolism is part of the differential diagnosis. We treated a 46-year-old woman with progressive dyspnea. Computed tomography showed a lesion occupying the main pulmonary artery and peripheral branches on both sides. The pulmonary artery tumor, resected under cardiopulmonary bypass, was diagnosed pathologically as intimal sarcoma. Two weeks after the operation, the patient was feeling well and discharged from our hospital. Although the prognosis of pulmonary artery sarcoma is poor, early diagnosis and resection may prolong survival.

[Emergency operation due to complications of cardiac catheterization].

From January 2001 to July 2005, 4,741 cardiac catheterizations were performed on adult patients at our institute. Five of them underwent emergency operation due to complications of cardiac catheterization. The causes of operations were acute coronary occlusion due to coronary arterial dissection in 3 patients and bleeding due to perforation of the coronary artery in 2. Intra-aortic balloon pumping was used preoperatively in 4 patients and percutaneous cardio-pulmonary support in 2. Coronary artery bypass grafting was performed on all patients. Perforation sites of the coronary arteries were closed. One patient died 4 months after surgery, due to neurological damage, but the other 4 patients recovered and have been doing well. As coronary artery disruption is one of the main complications of cardiac catheterization, it is necessary to recognize the risk of hemodynamic derangement and to give prompt and appropriate treatment.

[Ventricular free wall re-rupture after surgical treatment of ventricular free wall rupture due to acute myocardial infarction; report of a case].

An in-hospital 72-year-old male with complaint of anterior chest pain was presented with shock. Pericardial effusion was confirmed by echocardiography, and therefore, he was brought to the operating room immediately with diagnosis of ventricular free wall rupture. The repair was performed using fibrin glue, fibrin sheet, and pericardial patch. His post-operative course was uneventful until massive bleeding came through the chest tube on the 5th day from the initial surgery. The emergency sternotomy was made again for hemostasis. In the re-operation, an approximately 20 mm laceration along the proximal circumflex artery was found and this was successfully repaired with 2 pledgetted horizontal mattress sutures. It is important and necessary to treat a postoperative patient taking care of re-rupture.

[A case report of aneurysm of the ductus arteriosus combined with mitral regurgitation].

A case with the giant aneurysm of the ductus arteriosus combined with severe mitral regurgitation is reported. 58-year-old male underwent MVR and patch closure of the ductal orifice for staged operation. The first operation was MVR and patch closure of the PDA orifice of the pulmonary artery end using retrograde cerebral perfusion (RCP) with deep hypothermic circulatory arrest (DHC). The second operation was performed on 3 months after the first operation using left thoracotomy approach, and patch closure of the ductal orifice via the aorta using RCP with DHC was performed. Upon following-up examination, the patient is now doing well 20 months after the initial surgery.

Transbrachial selective pulmonary angiography using a new 4 Fr curved pigtail catheter and hydrophilic-coated guidewire.

We have employed a new 4 Fr curved pigtail catheter with a hydrophilic-coated guidewire for transbrachial, selective pulmonary angiography using digital subtraction imaging. Eighteen patients and 27 pulmonary arteries were catheterized and selective pulmonary digital subtraction angiography was performed. Clinical diagnosis included lung cancer in 14 patients, thymoma in 1, bronchogenic cyst in 1, and pulmonary embolism in 2. Selective pulmonary arteriograms were obtained in all patients. No catheter-related complication occurred, although occasional premature ventricular contractions were noted. The high-flow injection rate of the contrast material resulted in clear visualization of the pulmonary arteries in all cases. This newly developed pigtail catheter combined with a hydrophilic-coated guidewire allowed easier and exact transbrachial selective pulmonary angiography to be performed. This technique does not require bedrest after the procedure and thus can be used in outpatients. It can also be used in patients who have thrombi along the transfemoral route.

[Neoplastic angioendotheliosis with Roth's spots].

A 81-year-old woman was admitted with fever, anemia and an elevation of serum LDH on September, 1995. She had anasarca and various abnormalities of the ocular fundus including Roth's spots. Skin eruption and psycho-neurological abnormalities were not seen. Laboratory data exhibited Hb 7.6g/dl, Plt 9.3 x 10(4)/microliters, WBC 6,300/microliters and LDH 1932 IU/l. Antibiotics, antituberculotic drugs and steroids were not effective and she died on October, 1995 with heart failure. An autopsy revealed that the small vessels of lungs, kidneys and the mucosa of the bladder and the gastrointestinal tract were filled with large mononuclear cells. Immunohistochemically these cells were positive in LCA and L26 stains, and negative in UCHL-1 stains. There fore this case was finally diagnosed as neoplastic angioendotheliosis (NAE). Although there has been no case report of NAE with Roth's spots previously, there is the possibility that Roth's spots appeared as a sign of vascular occlusion due to NAE. Roth's spots may be noteworthy as a sign of NAE that has few clinical features.

[Histological study of the tracheal adventitia, perichondrium and annular ligament].

The trachea begins at the lower border of the cricoid cartilage and passes down to bifurcate into the left and right mainstem bronchi. The presence of tracheal invasion is crucial factor influencing the prognosis for patients with cancers of the thyroid gland, hypopharynx, esophagus, etc. In order to understand the manner of invasion of the above tumors, precise knowledge of the normal tracheal structure is indispensable. This study was undertaken to clarify the normal microscopic structure of the trachea. Five normal tracheal specimens obtained at surgery were examined histologically and immunohistochemically. The loose connective tissue around the trachea, known as adventitia, was divided into a loose outer and a dense inner layer by hematoxylin and eosin (HE) staining. This two-layer pattern was clearly seen near the annular ligament but was obscured away from it. The connective tissue of the inner layer ran obliquely to joint the connective tissue of the annular ligament and ended in the submucosal layer. This arrangement of connective fibers seems to play a role in allowing the trachea to stretch and bend. Tracheal cartilage is covered with a dense fibrous membrane known as the perichoundrium. Between the superficial fibrous membrane and mature cartilage cells lies zone of immature cartilage made up of oval or spindle cells, and the inclusion of this zone in the perichondrium has long been a subject of controversy. In our study, the zone was homogeneously stained red by the elastica van Gieson's stain and was clearly distinguished from other structures. Immunohistochemical staining revealed a wide distribution of type I and type III collagen on the fibrous membrane and the zone of immature cartilage cells, while mature cartilage cells did not show such collagen. Based on these findings, we conclude that the zone of immature cartilage cells belongs to the periochondrium, which thus contains two layers, an outer fibrous layer and an inner transitional layer of immature cartilage cells. Our conclusions are as follows: 1. Tracheal adventitia is divided into two layers, an outer loose and an inner dense fibrous layer. 2. Tracheal perichondrium also consists of two layers, an outer fibrous layer and an inner transitional layer. 3. The fibrous bundle originating from the adventitia joins the connective tissue of the annular ligament, probably in order to allow the trachea to stretch and bend.

[Parasagittal meningioma growing in the superior sagittal sinus presenting intracranial hypertension: a case report].

Parasagittal meningiomas often invade the superior sagittal sinus (SSS), but rarely grow inside the SSS as a primary tumor. The authors report a case of parasagittal meningioma growing mainly inside the SSS and presenting papilledema. The SSS is invisible behind the tumor end on the right carotid angiogram but still patent on the left carotid angiogram. The superficial cortical vein on the opposite side works as a collateral pathway. The tumor may have originated from the right wall of the SSS, grew inside the sinus and covered the entrances of the right ascending cerebral veins. V-P shunt was performed after removal of the mass outside the sinus for resolving headache and visual symptoms.

[A case of pulmonary thrombosis associated with primary antiphospholipid syndrome].

A 23-year-old man was admitted because of an attack of chest pain and dry cough. Chest roentogenogram showed a solitary pulmonary nodule in the left upper lobe. Chest CT showed a nodule and a small pleural effusion on the same side. Pulmonary thrombosis was diagnosed by pulmonary Ventilation/perfusion scintigraphy and pulmonary arteriography. Deep vein thrombosis was not detected except in a distal pulmonary artery. The solitary nodule disappeared spontaneously without thrombolytic therapy. An anticardiolipin antibody (IgG) test was positive. Primary antiphospholipid syndrome was diagnosed, because of the absence of physical findings suggesting other collagen vascular diseases. Patients with antiphospholipid syndrome have a high frequency of pulmonary complications that include pulmonary hypertension and pulmonary embolism. Most of the patients with pulmonary embolism have deep vein thrombosis, and pulmonary vessel thrombosis as seen in the present case is a rare complication.

[Cardiac operations in nine patients aged 80 years or older].

Nine patients aged 80 years or older underwent cardiac operations with cardiopulmonary bypass. Seven patients underwent coronary artery bypass surgery, one modified Bentall's operation and another patch closure of ventricular septal perforation. One patient died soon after operation (11 POD) and operative mortality was 11%. One died 7 months after operation because of rupture of dissecting thoracic aortic aneurysm. Seven patients are still alive within physical status of New York Heart Association Classes I or II. We conclude that cardiac operations should not be excluded in octogenarians because of their chronological age alone.

[A case of diffuse alveolar hemorrhage accompanied by mesangial proliferative glomerulonephritis with positive perinuclear anti-neutrophil cytoplasmic antibody].

A 62-year-old man was admitted to our hospital because of low-grade fever and hemoptysis. Chest roentgenogram revealed diffuse infiltrative shadows with air bronchograms. Bronchoalveolar lavage fluid demonstrated bloody fluid, including many hemosiderin-laden macrophages. In addition, his laboratory data on admission revealed elevation of serum creatinine and BUN, and proteinuria and hematuria on urinalysis. Renal needle biopsy showed atrophic glomeruli and mesangial proliferative glomerulonephritis without crescent formation. A history of wheezing and slight eosinophila was also present, and we therefore suspected allergic granulomatous angitis. We performed airway sensitivity and reversibility tests, which were positive, and so we judged that he had an asthmatic component. Perinuclear antineutrophil cytoplasmic antibody (P-ANCA) was positive (x 1000) with ELISA. We diagnosed diffuse alveolar hemorrhage with mesangial proliferative glomerulonephritis and bronchial asthma. His general condition improved with oral administration of corticosteroid (50 mg/day) and immunosuppressive agent (cyclophosphamide; 50 mg/day), and his major symptoms disappeared within a few days.

[Identification of the most appropriate time for lung transplantation in the patients with idiopathic interstitial pneumonitis].

In order to identify the most appropriate time for lung transplantation, we examined the natural courses of eight patients who died of idiopathic interstitial pneumonitis (IIP). Five of eight patients died within two years after they were diagnosed as IIP and six died within one year after the last admission. As the disease progressed, arterial oxygen pressure tended to decrease and serum LDH level to increase. But no parameter was able to predict the natural courses of patients. We conclude that it is very difficult to identify the most appropriate time for lung transplantation and the prognosis of IIP patient is very poor. Therefore as soon as patients are diagnosed as IIP, it is mandatory to assess their eligibility for lung transplantation.

[Bronchial arterial hemodynamics after thoracic irradiation therapy in lung cancer patients].

We evaluated bronchial arterial hemodynamics after thoracic irradiation therapy. We performed bronchial arteriography in 9 patients (8 males and 1 female) with lung cancer who received thoracic irradiation (58-72 Gy). Three patients had adenocarcinoma, 3 squamous cell carcinoma, 2 small cell carcinoma and 1 large cell carcinoma. Their clinical stages were 6 in stage IIIB and 3 in stage IV. Eight of these cases also received chemotherapy by intra-bronchial arterial infusion of anti-cancer agents (Carboplatin and/or Cisplatin). The bronchial arterial supply was patent except in the one complete remission case (small cell carcinoma of stage IIIB). In the five cases developing radiation pneumonitis, bronchial arteries demonstrated angiogenesis in the radiation fields, despite which pulmonary arteriography and/or pulmonary perfusion scintigrams showed a decreased pulmonary arterial supply. Bronchial arterial hemodynamics demonstrated no significant damage in the bronchial arteries by the thoracic irradiation therapy and/or bronchial arterial infusion of anti-cancer agents. It is suggested that patent bronchial arteries after radiation therapy promote local recurrences of lung cancer. In 5 cases, including 2 local relapsed cases and 3 cases showing no remarkable response to radical radiation therapy, we performed bronchial arterial infusion of anti-cancer agents after radiation therapy, with good responses obtained. We conclude that thoracic irradiation did not damage bronchial arteries as compared with pulmonary arteries, and that in local relapsed and radio-resistant cases bronchial arterial infusion of anti-cancer agents after radiation therapy is a useful approach.