Real-World Safety, Tolerability and Effectiveness of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis: Final Report of Post-marketing Surveillance in Japan.

Introduction: Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fibrotic interstitial pneumonia, which is characterised by progressive worsening of dyspnoea and lung function. Nintedanib treatment is recommended to slow IPF disease progression. The aim of this post-marketing surveillance (PMS) study was to evaluate the safety and effectiveness of nintedanib over 24 months in patients with IPF in a real-world setting in Japan.

Stent Graft Placement for Injured Visceral Artery.

Injury of the visceral artery is a potentially fatal complication of iatrogenic procedures, trauma, and tumors. A stent graft can achieve rapid exclusion of the injured arterial portion and minimize the risk of ischemic complications by preserving arterial flow to organs. Although various types of stent grafts are available worldwide, Viabahn has only been approved for visceral arterial injury in Japan.

O80 in Healthy Cattle: Absence of Shigatoxigenic and Enteropathogenic O80:H2 and (Phylo) Genomics of Non-Clonal Complex 165 O80.

The origin of human and calf infections by Shigatoxigenic (STEC) and enteropathogenic (EPEC) O80:H2 is still unknown. The aim of this study was to identify O80 in healthy cattle with an emphasis on melibiose non-fermenting O80:H2. Faecal materials collected from 149 bulls at 1 slaughterhouse and 194 cows on 9 farms were tested with O80 antigen-encoding gene PCR after overnight growth in enrichment broths.

Fibrin Glue in Interventional Radiology: How to Use It.

A fibrin glue kit consists of separate solutions of fibrinogen and thrombin that instantly coagulate when mixed together and can be used as an embolic agent and tissue adhesive in several interventional procedures, such as the closure of enterocutaneous, postoperative pancreatic, and bronchopulmonary fistulas, embosclerosis of biloma, and portal vein embolization. Separate and simultaneous injections of fibrinogen and thrombin solutions at the target site are necessary; therefore, insertion of two catheters or a balloon catheter with multiple lumen is required. The combined use of metallic coils is also effective for a large fistula as the coils can provide a matrix for retaining the fibrin glue, in addition to partially occluding the fistulous tract.

Excretion of Necrotic Hepatocellular Carcinoma Tissues into Hepatic Lymphatic Vessels after Conventional Transarterial Chemoembolization.

We report a case of necrotic hepatocellular carcinoma tissue excretion into the hepatic lymphatic system after conventional transarterial chemoembolization (cTACE) in an 80-year-old man with liver cirrhosis. A tumor measuring 19 mm in diameter in segment 5 was successfully treated with superselective cTACE. Hepatic lymphatic vessels were not opacified with iodized oil during the procedure.

Percutaneous sclerotherapy using a 4 F pigtail catheter and 40 milliliters of 5% ethanolamine oleate for symptomatic large hepatic cysts.

PURPOSE We retrospectively evaluated the efficacy of percutaneous sclerotherapy using a 4 F catheter and 40 mL of 5% ethanolamine oleate (EO) for symptomatic large hepatic cysts. METHODS Twenty-four patients, including 10 with polycystic liver disease (PLD), were eligible. The mean long- and short-axis diameters of the cyst on computed tomography (CT) were 145.

Efficacy of Superselective Conventional Transarterial Chemoembolization Using Guidance Software for Hepatocellular Carcinoma within Three Lesions Smaller Than 3 cm.

The indication of transarterial chemoembolization (TACE) has advanced to hepatocellular carcinoma (HCC) of Barcelona Clinic Liver Cancer (BCLC) stage A when surgical resection (SR), thermal ablation, and bridging to transplantation are contraindicated; however, TACE for small HCC is frequently difficult and ineffective because of less hypervascularity and the presence of tumor portions receiving a dual blood supply. Here, we report outcomes of superselective conventional TACE (cTACE) for 259 patients with HCCs within three lesions smaller than 3 cm using guidance software. Automated tumor feeder detection (AFD) functionality was applied to identify tumor feeders on cone-beam computed tomography during hepatic arteriography (CBCTHA) data.

Cerebral Embolism as a Rare Complication of Balloon-Occluded Retrograde Transvenous Obliteration for Gastric Varices: A Case Report.

We report a case of cerebral embolism caused by balloon-occluded retrograde transvenous obliteration (BRTO) for gastric varices in a 77-year-old woman with liver cirrhosis. Balloon-occluded retrograde venography demonstrated multiple collaterals between the efferent and systemic veins, and some of them could not be embolized with metallic coils. Therefore, they were embolized with ethanol, 50% glucose solution, gelatin sponge particles, and ethanolamine oleate, and BRTO was completed.

Usefulness of virtual parenchymal perfusion software visualizing embolized areas to determine optimal catheter position in superselective conventional transarterial chemoembolization for hepatocellular carcinoma.

Aim: To determine the optimal catheter position during superselective conventional transarterial chemoembolization (cTACE) for hepatocellular carcinoma (HCC) using virtual parenchymal perfusion software.

Methods: Patients who had newly developed HCC nodules ≤6 cm and five or fewer lesions were eligible. The virtual catheter tip was placed on a tumor-feeder identified by TACE guidance software using cone-beam computed tomography during hepatic arteriography to minimize the virtual embolized area (VEA), including the tumor with a safety margin.

Transarterial Interventional Therapy for Non-functioning Hemodialysis Access.

Transarterial vascular access interventional therapy (VAIVT) for non-functioning hemodialysis access has advantages over the venous approach because natural venous outflow through the fistula as well as the stump at the fistula site in total occlusion can be observed, and most strictures and/or occlusions can be treated via one access route. The brachial arterial approach is essential, but the radial arterial approach at the wrist is also necessary for certain patients. The transarterial approach can be applied to all VAIVTs; however, additional venous access is necessary in cases requiring a large device and those with unsuccessful traversal of the occluded segment via the arterial route.

Intraoperative Bile Duct Disruption Treated Using Intrahepatic Biliary Ablation with Ethanol: A Report of Two Cases.

We report two cases of intraoperative bile duct disruption. In case 1, an isolated bile duct in the remnant of the anterosuperior liver segment after right hepatic lobectomy for cholangiocarcinoma caused bile leakage. In case 2, bile leakage continued from a disrupted accessory hepatic duct during pancreaticoduodenectomy for pancreatic carcinoma.

Blood supply to the caudate lobe of the liver from the right inferior phrenic artery: observation by cone-beam computed tomography during arteriography.

Purpose: To retrospectively evaluate blood supply to the caudate lobe of the liver from the right inferior phrenic artery (RIPA) using cone-beam computed tomography during arteriography (CBCTA-RIPA).

Methods: CBCTA-RIPA examinations during transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) were collected from 2448 procedures in 787 patients. The exclusion criteria were (1) major artifacts, (2) TACE of hepatic arterial branches before performing CBCTA-RIPA, and (3) repeated CBCTA-RIPA studies in the same patient.

Long-Term Safety and Effectiveness of Linagliptin in Japanese Patients with Type 2 Diabetes and Renal Dysfunction: a Post-Marketing Surveillance Study.

Introduction: International clinical trials have shown that linagliptin significantly improves glycemic control and can be used at a single dose regardless of renal function in patients with type 2 diabetes (T2D). However, to date, no studies have evaluated the use of linagliptin in Japanese patients with T2D by renal function in routine clinical care.

Methods: This was a subgroup analysis of data from a prospective observational post-marketing surveillance (PMS) study of linagliptin conducted in Japan that evaluated the safety and effectiveness of linagliptin in routine clinical care for 3 years in Japanese patients with T2D.

Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: interim analysis from a post-marketing surveillance study.

: Sodium-glucose cotransporter-2 (SGLT2) inhibitors are effective treatments for type 2 diabetes mellitus (T2DM). We present the interim findings of an ongoing post-marketing surveillance (PMS) study in Japanese patients with T2DM receiving empagliflozin.: This 3-year, prospective, observational, multicenter PMS evaluated the safety and effectiveness of empagliflozin in Japanese clinical practice.

Long-Term Safety and Effectiveness of Linagliptin in Japanese Patients with Type 2 Diabetes Mellitus: A 3-Year Post-Marketing Surveillance Study.

Introduction: Clinical trials of linagliptin in Japanese patients conducted to date have had limited observational periods; therefore, there is a need for additional longer-term real-world data. The aim of this study was to investigate the long-term safety and effectiveness of linagliptin in routine clinical practice.

Methods: This was a prospective, observational, post-marketing surveillance study conducted over 156 weeks in patients with type 2 diabetes mellitus who started linagliptin monotherapy.

Correction to: Real-world treatment of over 1600 Japanese patients with EGFR mutation-positive non-small cell lung cancer with daily afatinib.

The original article can be found online.

Real-world treatment of over 1600 Japanese patients with EGFR mutation-positive non-small cell lung cancer with daily afatinib.

Background: This prospective, post-marketing observational study in Japanese patients aimed to evaluate the safety and effectiveness of daily afatinib use in general practice.

Methods: This non-interventional study (NCT02131259) enrolled treatment-naïve and pre-treated patients with inoperable/recurrent EGFR mutation-positive NSCLC, eligible for afatinib treatment as per the afatinib label in Japan. Patients received afatinib at the approved dose (20, 30, 40, or 50 mg/day; physician decision), and were observed following treatment initiation for 52 weeks or until premature discontinuation.

Outcomes of conventional transarterial chemoembolization for hepatocellular carcinoma ≥10 cm.

Aim: To retrospectively evaluate the outcomes of conventional transarterial chemoembolization (cTACE) for hepatocellular carcinoma (HCC) ≥10 cm.

Methods: Twenty-five patients with naïve HCC ≥10 cm (mean maximum tumor diameter, 130 ± 27.6 mm; single [n = 12], 2-9 [n = 6], and ≥10 [n = 7]) without extrahepatic spread treated with cTACE were eligible.

Preferential prescribing of linagliptin in type 2 diabetes patients in an expanded post-marketing surveillance study in Japan.

Aims/introduction: To evaluate linagliptin prescribing in type 2 diabetes mellitus patients with different comorbidities, an expanded Japanese post-marketing surveillance also collected baseline data for patients initiating other glucose-lowering drugs.

Materials And Methods: Patients initiating linagliptin monotherapy were enrolled, then the next patient starting monotherapy with another glucose-lowering drug was enrolled (2012-2014). Baseline data were collected and analyzed by the Medical Dictionary for Regulatory Activities system organ class.

Outcomes of Patients with Hepatocellular Carcinoma Treated with Conventional Transarterial Chemoembolization Using Guidance Software.

Purpose: To evaluate the outcomes of conventional transarterial chemoembolization using guidance software for hepatocellular carcinoma (HCC) patients.

Materials And Methods: One hundred two patients with treatment-naïve HCC with ≤ 7-cm and ≤ 5 lesions treated with conventional transarterial chemoembolization using guidance software were selected. Technical success was classified into 3 grades by computed tomography performed 1 week after transarterial chemoembolization: (i) A, complete embolization with a safety margin; (ii) B, entire tumor embolization without a safety margin; and (iii) C, incomplete embolization.

Validation of an LC-MS/MS Method for the Determination of Propofol, Midazolam, and Carbamazepine in Rat Plasma: Application to Monitor Their Concentrations Following Co-administration.

Propofol (PRO) is a hypnotic used to induce and maintain general anesthesia. A risk of drug-drug interactions exists in cases of clinical co-administration of PRO and midazolam (MDZ) or carbamazepine (CBZ). Therefore a sensitive and rapid assay is needed to monitor these drugs.

Quantitative and antioxidative behavior of Trolox in rats' blood and brain by HPLC-UV and SMFIA-CL methods.

Trolox, a water-soluble vitamin E analogue has been used as a positive control in Trolox equivalent antioxidant capacity and oxygen radical antioxidant capacity assays due to its high antioxidative effect. In this study, the ex vivo antioxidative effects of Trolox and its concentration in blood and brain microdialysates from rat after administration were evaluated by newly established semi-microflow injection analysis, chemiluminescence detection and HPLC-UV. In the administration test, the antioxidative effect of Trolox in blood and brain microdialysates after a single administration of 200 mg/kg of Trolox to rats could be monitored.

Association of BDNF Val66Met polymorphism with HPA and SAM axis reactivity to psychological and physical stress.

Background: Decreased expression of brain-derived neurotrophic factor (BDNF) is implicated in enhanced stress responses. The BDNF Val66Met polymorphism is associated with psychological changes; for example, carriers of the Met allele exhibit increased harm avoidance as well as a higher prevalence of depression and anxiety disorder.

Methods: To analyze the effects of BDNF Val66Met on stress responses, we tested 226 university students (88 women and 138 men) using a social stress procedure (Trier Social Stress Test [TSST]) and an electrical stimulation stress test.