Simultaneous Material and Chemical Recycling of Waste PET/PE Multi-layer Films under Hydrothermal Conditions.

Multi-layer plastic films are widely used in various fields especially for packaging, but due to complex composition, it is very difficult to recover single-material polymers or high-purity monomers from them after usage. In this study, we proposed a hydrothermal process for recycling PET/PE (PET: Polyethylene terephthalate; PE: Polyethylene) films. PET can be hydrolyzed to monomers of terephthalic acid (TPA) and ethylene glycol (EG). Using a hydrothermal system equipped with two filters, PE, TPA, and EG were collected separately, indicating the simultaneous material and chemical recycling of PET/PE films was firstly achieved. At 300 °C and 10 MPa for 60 min, PET conversion reached around 100%, and TPA yield of 83.0% was obtained with a high TPA purity of 96.1%. In addition, the effect of the holding time on PET conversion, TPA yield, EG yield, and TPA purity was studied. This research opened up a new and sustainable pathway to recycle multi-layer plastic films in both lab and industry.

[Successful Placement of Self-Expandable Metallic Stent for Malignant Gastrojejunostomy Obstruction Following Pancreatoduodenectomy - A Case Report].

A man in his 50 s, who had undergone subtotal stomach-preserving pancreatoduodenectomy with modified Child's reconstruction for pancreatic cancer 8 months back, was hospitalized because of vomiting and difficulty in feeding.Radiological and endoscopic studies revealed a malignant obstruction of the gastrojejunostomy site due to peritoneal recurrence of the cancer.Although a self-expandable metallic stent(SEMS)was placed in the anastomotic site, it slipped back into the stomach 3 days later.It was suggested that the migration was caused by antiperistalsis, because the SEMS was placed in the afferent loop.Although the SEMS was required to be placed in concordance with the peristaltic direction, it was impossible to pass a guidewire directly from the stomach into the efferent loop.Therefore, the guidewire was placed antidromically through a narrow site from the distal portion of the efferent loop via Braun anastomosis, and the SEMS was subsequently placed without any complication.This allowed the patient to maintain oral intake throughout his remaining life.Our antidromic approach for SEMS placement could be beneficial if performing a standard procedure is difficult.

Efficacy and safety of fixed-dose losartan/hydrochlorothiazide/amlodipine combination versus losartan/hydrochlorothiazide combination in Japanese patients with essential hypertension.

Japanese patients with uncontrolled essential hypertension received single-blind losartan 50 mg/hydrochlorothiazide 12.5 mg (L50/H12.5) for 8 weeks. Patients whose blood pressure (BP) remained uncontrolled were randomized double-blind to fixed-dose losartan 50 mg/hydrochlorothiazide 12.5 mg/amlodipine 5 mg (L50/H12.5/A5) or L50/H12.5 for 8 weeks followed by open-label L50/H12.5/A5 for 44 weeks. Adverse events were assessed. After 8 weeks, diastolic and systolic BP were reduced significantly more with L50/H12.5/A5 versus L50/H12.5 (both p < 0.001). Mean changes in diastolic and systolic BP were sustained for 44 weeks. L50/H12.5/A5 was well-tolerated and improved BP significantly versus L50/H12.5 in Japanese patients with uncontrolled essential hypertension.

[Gemcitabine in Combination with Cisplatin in Patients with Unresectable Advanced or Recurrent Biliary Tract Cancer--A Multicenter Prospective Observational Study in Fukuoka].

The standard chemotherapy for the treatment of unresectable advanced and recurrent biliary tract cancers is considered gemcitabine plus cisplatin (GC) on the basis of favorable results reported in the ABC-02 study from the UK and the BT22 study from Japan. However, the GC cohort of the BT22 study consisted of only 42 patients, and we considered it necessary to confirm the effectiveness and safety of GC chemotherapy in a multicenter prospective observational study in Fukuoka. Thirty-seven patients were enrolled in this study, including two patients with recurrent disease. The median patient age was 67.5 years (range, 43-84 years). Twelve patients had intrahepatic cholangiocarcinoma, 13 patients had extrahepatic cholangiocarcinoma, and 12 patients had gallbladder cancer. The median survival time (MST) was 14.9 months, the 1-year survival rate was 54.5%, and the median progression free survival (PFS) was 7.7 months. No chemotherapy-related deaths occurred, and Grade 3/4 adverse events were mainly hematological events including leucopenia in 13 (35.1%) patients and neutropenia in 12 (32.4%). The MST, 1-year survival rate, median PFS, and rate of Grade 3/4 adverse events in our study were similar to those of the BT22 study. In conclusion, this multicenter prospective observational study confirms the effectiveness and safety of GC chemotherapy for the treatment of unresectable advanced and recurrent biliary tract cancers.

[Survival benefits of chemotherapy for unresectable biliary tract cancer--a multicenter retrospective analysis].

There is no agreement on the standard chemotherapeutic regimen for biliary tract cancer(BTC), although multi-drug regimens such as gemcitabine and/or S-1 have been tested in clinical trials. This study retrospectively reviewed data from patients with BTC who were seen at hospitals in the Kitakyushu and Fukuoka areas between 2005 and 2006, and examined the effect of systemic chemotherapy regimen on survival benefits in patients with unresectable BTC. Chemotherapy may benefit patients with BTC any age group, regardless of the primary site.

[Phase I/II study of combination chemotherapy with gemcitabine and UFT for advanced pancreatic cancer in a multi-center trial].

The aim of this phase I/II study was to evaluate the tolerability and efficacy of combination chemotherapy with gemcitabine (GEM) and UFT for advanced pancreatic cancer. In phase I study UFT was given orally every day for 14 days and GEM was infused on day 1 and 8 at three dose levels (800, 900, 1,000 mg/m(2)/week) every 21 days. GEM 1,000 mg/m(2) and UFT 400 mg/m(2) did not reach the maximum tolerated dose. We decided that the recommended dose (RD) was GEM 1,000 mg/m(2)and UFT 400 mg/m(2). In phase II study 27 patients were enrolled and received GEM and UFT at RD. The tumor response rate was 17.6%, and the median survival was 221 days, which was very similar to that of GEM monotherapy. Due to adverse events, especially liver dysfunction, protocol therapy was discontinued in 12 patients. This study could not revealed the superiority of the GEM monotherapy.

An effective management regimen for laryngeal granuloma caused by gastro-esophageal reflux: combination therapy with suggestions for lifestyle modifications.

According to our previous study, lifestyle modification in combination with drug therapy is much more effective than drug therapy alone in cases of laryngopharyngeal reflux (LPR). Most patients with LPR will have chronic gastro-esophageal reflux diseases (GERD) and require long-term medical therapy for control, resulting in high total expenditure on pharmacologic agents. We combined pharmacologic management with lifestyle modifications for the management of GERD with successful outcomes in patients with GERD-related laryngeal granulomas. Although further studies are needed, guidance concerning lifestyle modifications in combination with PPI therapy may be not only a clinically effective but also a cost-effective method for the management of laryngeal granulomas caused by gastro-esophageal reflux.

Three-dimensional laryngeal model for planning of laryngeal framework surgery.

CONCLUSION: The three-dimensional prototype model was useful for planning of laryngeal framework surgery. OBJECTIVE: To discuss the usefulness of a three-dimensional laryngeal model for laryngeal framework surgery. MATERIALS AND METHODS: A three-dimensional laryngeal model was created based on the postoperative helical computed tomography (CT) data of the larynx (case 1) which underwent lateral cricoarytenoid muscle (LCA) pull surgery. LCA pull surgery is a kind of arytenoid adduction for unilateral vocal cord paralysis. A three-dimensional model of case 1 larynx was prototyped using a selective laser sintering method. In case 1, the patient's voice did not improve after LCA pull surgery. The three-dimensional model revealed that the original surgical procedure was not appropriate to obtain optimal arytenoid adduction. According to the analysis of this three-dimensional model, we changed the surgical approach and performed this new refined LCA pull surgery on another patient with unilateral vocal cord paralysis (case 2). RESULTS: We were able to pull LCA precisely in case 2. Three-dimensional CT of case 2 after refined LCA pull surgery allowed the correct pulling of LCA and complete adduction of arytenoid. The postoperative voice improved remarkably.

Direct pull of lateral cricoarytenoid muscle for unilateral vocal cord paralysis.

CONCLUSION: Lateral cricoarytenoid muscle-pull surgery (LCA pull) is a safe and effective method for the treatment of unilateral vocal cord paralysis. OBJECTIVE: To evaluate the results of an improved method of LCA pull for unilateral vocal cord paralysis. MATERIAL AND METHODS: Thirteen patients with unilateral vocal cord paralysis underwent LCA pull between April 2003 and January 2004. A small window was made in the posterior lower part of the thyroid cartilage and 2-3 mm in a cranial direction to the lower edge of the thyroid cartilage. The inner perichondrium was carefully removed to expose the LCA muscle. A 4-0 nylon suture placed through the LCA muscle was pulled to adduct the arytenoid and was tied to the anterior lower part of the thyroid cartilage. All cases were treated by LCA pull alone. In all cases, the maximum phonation time was measured and an auditory evaluation was performed using the grade, roughness, breathiness, asthenia and strain scale. The airflow rate was measured in five cases. RESULTS: Vocal improvement was obtained in 11/13 cases (85%). One of the unimproved cases had cricoarytenoid joint ankylosis. No complications were observed.

The relationship between esophagoscopic findings and total acid reflux time below pH 4 and pH 5 in the upper esophagus in patients with laryngopharyngeal reflux disease (LPRD).

OBJECTIVE: : To investigate the relationship between esophagoscopic findings and total acid reflux time in the upper esophagus in the patients of laryngopharyngeal reflux disease (LPRD), and to evaluate whether pH<5 holding time is appropriate for diagnosing LPRD. METHOD: : Esophagoscopy and 24-h pH monitoring in the upper esophagus were performed in 29 patients suspected of LPRD and 19 healthy volunteers participated as controls. The total acid reflux times below pH 4 and 5 in the upper esophagus were compared between the LPRD group and the controls. The LPRD group was divided into LPRD with reflux esophagitis (RE) and LPRD without RE, and the total acid reflux times below pH 4 and 5 of these two groups were compared. RESULTS: : Eight of the 29 (27.6%) LPRD patients had reflux esophagitis. The LPRD group showed a significantly longer acid reflux time than the control group at pH below 5 (P=0.009) but not at pH below 4 (P=0.48). The LPRD with RE had significantly longer acid reflux times below both pH 4 and 5 in the upper esophagus compared to those of the LPRD without RE. The P values using a cut-off value of pH 5 were smaller than that of pH 4 in all statistical results. CONCLUSION: : The LPRD patients showed significantly longer acid reflux time in the upper esophagus than the control group. In the LPRD group, the LPRD with RE patients had more frequent acid exposure in the upper esophagus than the LPRD without RE. A pH level of 5 could be appropriate as a cutoff level for the diagnosis of LPRD in upper esophagus pH monitoring.

Add-on effect of hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension uncontrolled with losartan 50 mg and amlodipine 5 mg.

This study assessed the antihypertensive efficacy of a triple combination, fixed-dose therapy of losartan 50 mg (L50)/hydrochlorothiazide 12.5 mg (H12.5)/amlodipine 5 mg (A5) versus co-administration of L50 plus A5 (L50+A5) in Japanese subjects with uncontrolled essential hypertension. Initially, all subjects received single-blind treatment with L50+A5 for 8 weeks. Subjects whose blood pressure (BP) remained stable within pre-specified limits during the last 4 weeks of L50+A5 administration were randomized (n =3 27) to double-blind treatment with L50/H12.5/A5 or L50+A5 for 8 weeks. Primary and secondary efficacy endpoints were mean change from baseline to Week 8 in trough diastolic BP (DBP) and trough systolic BP (SBP), respectively. Safety was assessed throughout the study. The treatment difference for L50/H12.5/A5 versus L50+A5 in mean change from baseline in DBP at Week 8 was -1.1 mm Hg (95% confidence interval (CI) -2.7, 0.6; P = 0.205). However, the treatment difference in mean change from baseline in SBP at Week 8 was -3.2 mm Hg (95% CI: -5.7, -0.8; P=0.011). A chance imbalance in the change in DBP before randomization between groups was identified in a post-hoc analysis as a major reason for the smaller-than-expected difference in DBP between groups. The overall safety profile was generally similar between groups. In conclusion, treatment with L50/H12.5/A5 for 8 weeks did not demonstrate a significant difference in DBP reduction, but demonstrated a nominally significant difference in SBP reduction, compared with L50+A5. L50/H12.5/A5 was well tolerated. (ClinicalTrials.gov identifier NCT01302691.).

Rapid prototyping of temporal bone for surgical training and medical education.

OBJECTIVE: The skills of ear surgery are best developed by dissecting a temporal bone. However, only a limited number of trainees can be afforded this opportunity because of the scarcity of available bones. The aim of this study was to investigate the validity of a prototype temporal bone model for surgical training and education. MATERIAL AND METHODS: A simulated 3D model of a human temporal bone was made using a selective laser sintering method. The powder layers were laser-fused based on detailed CT data and accumulated to create a 3D structure. Conventional surgical instruments were used to dissect the model under a microscope. RESULTS: The model was as hard as real bone and surface structures were accurately reproduced. The model could be shaved using a surgical drill, burr and suction irrigator in the same way as a real bone. The malleus and incus were reproduced. The semicircular canals and the oval and round window niches were identified. Cavity structures, such as the semicircular canal, vestibule, antrum and air cells, were filled with powder which had to be removed using a pick and suction irrigator during dissection. A magnified model was useful for educating medical students. CONCLUSION: This prototype 3D model made using selective laser sintering serves as a good educational tool for middle ear surgery.

Globus sensation caused by gastroesophageal reflux disease.

OBJECTIVES: This study was designed to examine whether or not gastro esophageal reflux disease (GERD) is implicated in globus sensation. METHODS: The subjects were 25 patients (16 men/9 women; mean age: 51, range 25-69 years) complaining of globus sensation with one or more of four laryngeal findings suspected of having GERD, such as pooling of saliva, erythema of posterior one-third of larynx, inter-arytenoids edema, and granuloma. All 25 patients were administrated a proton pump inhibitor (PPI) for a period of 8 weeks. All were given esophageal endoscopies, laryngoscopes, and questionnaire before and after PPI dosing. The questionnaire survey was conducted to investigate changes in globus sensation and three symptoms specific to GERD including heartburn, regurgitation, and belching. Subjective symptoms were totalled by the over all scores of the three subjective symptoms which served as an index of severity of GERD. RESULTS: Fifty-two percent (13/25) of patients had reflux esophagitis. The esophagitis were improved after PPI administration except one case. The incidences of GERD symptoms were high (heart burn 68% (17/25), belching 49% (10/25) and regurgitation 76% (19/25)), and most of these symptoms ameliorated by PPI administration. The laryngeal findings were improved in all patients. Subjective symptoms were improved in 68% (17/25) of globus patients. The improvement rate of total score (before PPI dosing/after PPI dosing) was compared between the two groups: one with improved globus sensation (17 patients) and the other without (8 patients). The improvement rate was significantly higher in the group with improved globus sensation (P<0.05). This means that globus sensation improved because of the improvement in GERD. CONCLUSION: GERD is therefore concluded to be an inducing factor of globus sensation.

[Multi-center trial of gemcitabine for 49 patients with advanced pancreatic cancer].

Forty-nine patients with unresectable pancreatic cancer (stage IV disease) received gemcitabine in a multi-center trial in the Fukuoka pancreatic cancer chemotherapy group, Japan. No complete remissions, 5 partial remissions (10%) and 25 no changes (51%) were obtained. Gemcitabine could maintain QOL. Main toxicities were hematologic, especially neutropenia. Neutropenia tended to appear in early administration. Non-hematologic toxicities were anorexia, nausea/vomiting, and skin rash. The mean overall survival period was 7.5 months. Carcinomatous ascites and/or pleural effusion resulted in a poor prognosis (average survival 3.1 months). Gemcitabine could be given without severe toxicities in outpatient clinics. These results suggested that gemcitabine is currently a first-line therapeutic agent for advanced pancreatic cancer.

[Rapid prototyping of the larynx for laryngeal frame work surgery].

A detailed understanding of the three-dimensional (3D) structure of the larynx is important for determining appropriate methods and approaches for laryngeal frame work surgery. In this study, a 3D laryngeal model was constructed based on postoperative helical CT data obtained after lateral cricoarytenoid muscle (LCA) pull surgery (Iwamura) for the treatment of unilateral vocal fold paralysis. The anatomical configurations of the arytenoid cartilages and the optimal approaches for laryngeal frame work surgery were then examined. A 3D model of the human larynx was prototyped using a selective laser sintering method. A compound powder of plastic nylon and an inorganic substance (glass beads) was used as the raw material. The cricoid cartilage and the arytenoid cartilages were prototyped, and the configurations of the arytenoid cartilages were evaluated. The results were similar to those of previous reports. The arytenoid cartilage of the unaffected side moved downward while adducting, and the vocal process moved inwards and downwards. On the other hand, the paralyzed arytenoid cartilage moved neither inward nor downward, and the vocal process was fixed at an outer and upper position. Next, the thyroid cartilage was added to the model to determine the optimal location of the window in the thyroid cartilage for the LCA pull surgery. The window after the first surgery was largened using a surgical drill. The 3D prototype model was useful for understanding the complex configurations of the laryngeal anatomy, and to determine the optimal approaches for laryngeal frame work surgery, etc.

Efficacy and safety of losartan 100 mg/hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension: two randomized, controlled trials.

Two randomized studies were designed to assess the safety, tolerability and efficacy of losartan 100 mg (L100) plus hydrochlorothiazide 12.5 mg (H12.5) in a single fixed-dose combination. In one study, subjects received losartan 50 mg (L50) plus H12.5 during an 8-week filter period. They were then randomized to either L100/H12.5 or L50/H12.5 for another 8 weeks, followed by L100/H12.5 for 44 weeks. The primary end point was safety of L100/H12.5 for 52 weeks. In the second study, subjects received L100 during an 8-week filter period. Subjects were then randomized to receive either L100/H12.5 or L100 for a further 8 weeks. The primary end point was change from baseline in sitting diastolic blood pressure (SiDBP) at week 8. Safety was assessed throughout both studies. L100/H12.5 reduced SiDBP and sitting systolic blood pressure (SiSBP) at 8 weeks, and when compared with L100, the differences were statistically significant for both measures (P<0.001). L100/H12.5 reductions SiDBP for 8 weeks were comparable to L50/H12.5. The efficacy of L100/H12.5 was maintained to week 52. Drug-related adverse events with an incidence ⩾ 2% in the L100/H12.5 group during the 52-week extension period were an increase in aspartate aminotransferase and in blood uric acid. Additionally, mean uric acid levels were reduced by 0.57 mg dl(-1) from baseline with long-term treatment with L100/H12.5 in subjects whose baseline uric acid level was >7.0 mg dl(-1). In conclusion, L100/H12.5 was shown to be more effective than L100 at reducing SiDBP and SiSBP and showed good tolerability in Japanese patients with essential hypertension.

Safety and exploratory efficacy of the novel thrombin receptor (PAR-1) antagonist SCH530348 for non-ST-segment elevation acute coronary syndrome.

AIM: A previous phase 2 study of patients undergoing non-urgent PCI treated with SCH530348 plus aspirin and clopidogrel tended to reduce MACE without increased bleeding. This study evaluated the safety of SCH530348 in Japanese patients with NSTE ACS. METHODS: Subjects (117), in whom PCI was planned, received standard-of-care (aspirin, ticlopidine, and heparin) and were randomized 4:1 to receive either SCH530348 (20 or 40 mg loading dose followed by 1 mg/d or 2.5 mg/d for 60 days) or placebo. The key safety endpoint was TIMI major and minor bleeding in the PCI cohort (n=92). The key exploratory efficacy endpoint was MACE and death within 60 days. Addition of SCH530348 to standard-of-care did not significantly increase the rate of TIMI major and minor bleeding (or non-TIMI bleeding) in the primary cohort. RESULTS: Incidence (non-MACE) and discontinuation of AEs were similar across groups. PCI subjects treated with SCH530348 plus standard-of-care experienced a significant reduction in periprocedural MI compared with standard-of-care alone (16.9% vs 42.9%, respectively; p=0.013). There were no deaths or any other MACE. CONCLUSION: SCH530348 added to standard-of-care did not result in excess bleeding in Japanese subjects with NSTE ACS but significantly reduced the incidence of periprocedural MI in subjects undergoing urgent PCI.

Basic and translational research on proteinase-activated receptors: antagonism of the proteinase-activated receptor 1 for thrombin, a novel approach to antiplatelet therapy for atherothrombotic disease.

Atherothrombotic disease is a leading public health problem. Although current antiplatelet agents, such as aspirin and adenosine diphosphate (ADP)-receptor antagonists, reduce the morbidity and mortality associated with atherothrombotic disease, the residual risk for ischemic events remains substantial. The high residual risk despite dual antiplatelet therapy can be attributed to the fact that platelets possess multiple pathways of activation that are not all inhibited by aspirin and ADP-receptor antagonists. Among these, binding of thrombin to the proteinase-activated receptor 1 (PAR(1)) is the most potent platelet activation pathway. In addition, the PAR(1) pathway does not appear to be essential for initiating hemostasis. Inhibition of the PAR(1) receptor thus offers a possible new therapeutic approach with a potentially improved benefit-to-risk profile for treatment of patients with atherothrombotic disease. Preclinical and clinical studies have confirmed that SCH 530348, a potent, orally active thrombin-receptor antagonist selective for PAR(1), does not increase bleeding liability when added to dual antiplatelet therapy. Currently, two large ongoing phase 3 clinical trials are evaluating the efficacy and safety of SCH 530348 in combination with the standard of care in patients with acute coronary syndromes as well as for secondary prevention in patients with previous history of atherothrombotic disease.

A comparison of voice quality ratings made by Japanese and American listeners using the GRBAS scale.

The GRBAS scale is a widely used method for perceptual evaluation of voice quality. Two linguistically diverse groups of listeners (Japanese and American) rated 35 voice samples using the GRBAS scale. The ratings obtained from the two groups were compared to determine if the different linguistic background affected the use of the GRBAS scale. Results show that there are no significant differences between the Japanese and American listeners in the use of the Grade, Roughness and Breathiness scales. Ratings on the Asthenia and Strain scales, however, were different between the two groups of listeners. Despite these discrepancies, the GRBAS scale may be an excellent tool for perceptual evaluation of voice quality by linguistically diverse groups.

Rapidly prototyped temporal bone model for otological education.

The anatomy of the temporal bone is extremely complicated. If a three-dimensional model could be simulated, it would greatly contribute to the stereoscopic understanding of anatomy and surgery. A simulated three-dimensional model of a human temporal bone was prototyped using the selective laser sintering method. The model could be shaved using a surgical drill in the same way as in real surgery. A magnified model was particularly useful for the instruction of anatomy and surgery. When a translucent area was selected, a bony labyrinth could be created together with an internal auditory meatus and facial nerve, which also contributed to the easy understanding of the inner ear structure. The three-dimensional prototyped model using selective laser sintering serves as a good educational material for middle ear anatomy and surgery.