[A systematic review of decided litigated cases on adverse drug events in Japan: classification of decided cases appearing in law reports].

Much of the damage to health caused by drugs could be prevented by appropriate care. A well-defined duty of care and further information are required for healthcare professionals. Although there are many litigation cases to use as references, neither the extent of the duty of care nor the obligation to explain medication according to the type of drug prescribed has yet been fully established. Thus, we systematically collected decided cases of adverse drug events, and assessed the degree of the duties of care and information. Specifically, we collected decided cases in which physicians, dentists, pharmacists, nurses, or hospitals had been sued. Data were derived from Bessatsu Jurist Iryo-kago Hanrei Hyakusen, Hanrei Jihou, and Hanrei Times from 1989 to November 2013, and information on precedents in the records of the Supreme Court of Japan from 2001 to November 2013. We analyzed the cases, and assessed the following according to the type of drug: (1) standards and explanations when dealing with drugs that were critical issues in litigation, and (2) the degree of the physician's or pharmacist's duties of care and information. In total, 126 cases were collected. The number of drug categories classified was 27, and 9 were considered of practical importance. After this systematic review, we found a trend in the degree of the required level of care and information on several drugs. With respect to duties of care and information, the gap between the required level and actual practice suggests that healthcare professionals must improve their care and explanations.

Potential utility of a new ulcerative colitis segmental endoscopic index combining disease severity and the extent of inflammation.

GOAL: To investigate the potential utility of a new scoring system, the Ulcerative Colitis Segmental Endoscopic Index (UCSEI), which combines measures of disease severity and extent of inflammation. BACKGROUND: Intestinal mucosal healing (MH) is a new therapeutic goal for ulcerative colitis (UC). Discontinuous lesions are common in UC and endoscopic observation of the entire colon is important. STUDY: Patients with active mild-to-moderate UC received daily treatment with oral mesalazine (4 g/d) and mesalazine enemas (1 g/d) for 8 weeks. Endoscopic evaluations, using the UCSEI and Mayo Endoscopic Score (MES), were performed in 5 colonic segments at baseline and week 8. The UCSEI criteria included erythema, vascular pattern, friability, and erosion/ulcer. The sum of 5 subscores, determined for each segment, was calculated as the UCSEI. Disease activity was also assessed using the UC Disease Activity Index (UCDAI). MH was defined as MES=0 to 1. RESULTS: Of 58 patients, 51 completed the scheduled endoscopic evaluations. At week 8, the UCDAI score had significantly decreased from 6.63 (baseline) to 2.73 (P<0.001). The remission and MH rates were 35.3% and 55.3%, respectively. Segmental endoscopic evaluation, using UCSEI, showed that baseline inflammation tended to be more severe in the distal colon. The baseline UCSEI increased with the extent of disease, which was not seen in MES. Improvements in UCSEI were observed, even in the patients without decreases in the MES. CONCLUSIONS: UCSEI, reflecting disease severity and extent of inflammation, provides useful information for UC management that is not available with MES.

Dynamic nuclear polarization studies of redox-sensitive nitroxyl spin probes in liposomal solution.

Overhauser-enhanced magnetic resonance imaging (OMRI) studies of a membrane-permeable nitroxyl spin probe, (2)H-enriched 3-methoxycarbonyl-2,2,5,5-tetramethyl-pyrrolidine-1-oxyl (MC-PROXYL), used in simultaneous molecular imaging is reported. Phantom imaging was performed with liposomal solutions of MC-PROXYL at varying spin probe and liposome concentrations using a field-cycle mode, custom-built OMRI scanner. Dynamic nuclear polarization (DNP) spectra of the liposomal solution of the spin probe, measured at 14.529mT using a 5mT sweep of the electron paramagnetic resonance (EPR) irradiation field showed splitting of the low and high filed hyperfine lines. Spectral measurements using D(2)O and a spin broadening agent, K(3)Fe(CN)(6) confirmed that these peaks originated from water molecules in two different environments, compartmentalized with liposomes. The nuclear Overhauser enhancement measured at different EPR irradiation times and power levels showed reduction in water nuclear magnetic resonance (NMR) signal enhancement in liposomal membrane due to the reduction in the coupling constant, rho. This study illustrates that OMRI can be used to differentiate between the intra- and extra- membrane water by loading the liposome vesicles with a lipid-permeable nitroxyl spin probe.

[A resected case of non-invasive type of intraductal papillary mucinous carcinoma penetrating to the duodenum].

A 74-year-old man was admitted to a nearby clinic complaining of high fever. Abdominal CT showed a 10 mm diameter cystic mass in the head of pancreas and dilation of the pancreatic duct. Endoscopy revealed a fistula filled with mucin in the posterior wall of the duodenum. The patient was referred to our institution for a surgical resection. Endoscopic ultrasonography revealed dilation of the pancreatic duct and also mural nodules in the pancreatic duct, ERP demonstrated a fistula from the pancreatic duct to the duodenum. Biopsied specimen from the papillary nodule in the pancreatic duct showed adenoma. We performed pancreaticoduodenectomy for main-duct IPMN penetrating to the duodenum. Pathological findings showed a non-invasive type of IPMC. Furthermore, a cancer invasion to the duodenum was not detected. These findings suggest that the increased pressure within the pancreatic duct caused a fistula to the duodenum.

[Clinical evaluation of the effect of tamsulosin hydrochloride and cernitin pollen extract on urinary disturbance associated with benign prostatic hyperplasia in a multicentered study].

We evaluated the clinical efficacy and safety of tamsulosin hydrochloride and cernitin pollen extract in 243 patients with urinary disturbance associated with benign prostatic hyperplasia. They were assigned randomly to 3 groups, oral tamsulosin hydrochloride, cernitin pollen extract and their combination were administered for 12 weeks. The international prostate symptom score, post-voided residual urine and uroflowmetrogram were obtained before and after treatment. The international prostate symptom score improved in each group and then the maximum flow rate and average flow rate also increased significantly in the tamsulosin hydrochloride-administered groups. In conclusion, the administration of only tamsulosin hydrochloride and the combination of tamsulosin hydrochloride and cernitin pollen extract seemed more effective then the administration of only cernitin pollen extract in the treatment of urinary disturbance associated with benign prostatic hyperplasia.