Pigmentary retinopathy of ALS/PDC in Kii.
Explore the source record for details and available documents.
Amyotrophic Lateral Sclerosis↗
Biomedical subjects
Kunio Ito
Publications and source records attributed to Kunio Ito.
[Example of safety measures for antineoplastic agents immediately after market launch--a case of TS-1 capsule all example use result investigation that executes safety monitoring--].
As a measure to ensure safe use of TS-1 during the early marketing period, a drug use investigation was conducted on an all-case basis. Extra safety monitoring,rarely included in the use investigation,was also planned for patients who began therapy with this agent. Of the 4,177 subjects registered during the year beginning in March 1999, 3,882 started TS-1 therapy. Aside from 74 dropouts, 3,808 cases were evaluable for safety. The overall incidence of adverse reactions, with high frequencies of myelosuppression and gastrointestinal disorders, was 74.3%: a result similar to an incidence of 77.5% (100/129) found in the early phase II trial with gastric cancer patients. Safety monitoring made it possible to check if a given patients was eligible for proper use before treatment is begun. During TS-1 administration,collaboration was formed between physicians and medical representatives to ensure regular laboratory testing and to check the test findings. Measures were considered necessary to secure the safe use of drugs with manifest risk of serious adverse reactions, such as antineoplastic agents, during the initial period of market introduction. Our present approach proved effective as one of such measures.
Antimetabolites, Antineoplastic↗
Japanese nationwide post-marketing survey of S-1 in patients with advanced gastric cancer.
BACKGROUND: It is likely that there are some discrepancies in the safety and efficacy results for anticancer agents between those shown in registration studies for approval and those shown in clinical practice after market release. The aim of this survey was to confirm the safety and efficacy of S-1 for advanced gastric cancer after market release. METHODS: After the approval of S-1 in 1999, all patients had to be registered with the manufacturer for a post-marketing survey, according to the government recommendation. All patients were monitored for safety and survival. The data for all registered patients were updated 1 year after each registration. RESULTS: During this survey, a total of 4177 patients with advanced gastric cancer were registered. The incidences of all adverse events and of grade 3 or worse adverse events in the 3808 patients evaluable for safety were 74.3% and 25.0%, respectively. In patients with lower creatinine clearance at baseline, the incidences of adverse reactions were higher for all grades combined, as well as for grades 3 or worse. There were 90 (2.4%) early deaths (within 30 days of the initiation of the treatment) and 5 (0.1%) deaths possibly related to the treatment. The median survival time and the 1-year survival rate for all patients evaluable for efficacy (n = 3801) were 8.3 months (95% confidence interval [CI], 8.0-8.6 months) and 33.3% (95% CI, 31.8-34.9%), respectively. CONCLUSION: This nationwide survey confirmed that the safety and efficacy profiles of S-1 were similar to those seen in the registration study. These results have proven the utility of this post-marketing survey in assessing the reproducibility of the safety and efficacy results obtained from prior clinical studies.
Aged↗
New gonioscopy system using only infrared light.
PURPOSE: To describe an infrared gonioscopy system designed to observe the anterior chamber angle under natural mydriasis in a completely darkened room. METHODS: An infrared light filter was used to modify the light source of the slit-lamp microscope. A television monitor connected to a CCD monochrome camera was used to indirectly observe the angle. RESULTS: Use of the infrared system enabled observation of the angle under natural mydriasis in a completely darkened room. CONCLUSION: Infrared gonioscopy is a useful procedure for the observation of the angle under natural mydriasis.
Anterior Chamber↗
Evaluation of eyes with relative pupillary block by indentation ultrasound biomicroscopy gonioscopy.
PURPOSE: To investigate changes in anterior chamber angle configuration with indentation ultrasound biomicroscopy gonioscopy of relative pupillary block (RPB). DESIGN: Cross-sectional study. METHODS: This study included 26 eyes of 26 patients with RPB. We determined angle opening distance 500 and angle recess area using indentation ultrasound biomicroscopy gonioscopy and compared a small-sized standard eye cup with a new eye cup with an area for inducing pressure. RESULTS: Indentation ultrasound biomicroscopy images documented concavity of the iris in eyes with RPB. Both the new and the small standard eye cups widened the anterior chamber angle significantly (P <.0001) without causing corneal damage. Angle changes were significantly greater for the new eye cup design. CONCLUSIONS: Indentation ultrasound biomicroscopy gonioscopy is a useful technique for observation and diagnosis of RPB. Using a small standard or the newly designed eye cup, the procedure can be performed easily and without causing corneal damage.
Aged↗
Evaluation and comparison of indentation ultrasound biomicroscopy gonioscopy in relative pupillary block, peripheral anterior synechia, and plateau iris configuration.
PURPOSE: To evaluate and compare the findings and changes of the anterior chamber angle configuration with indentation ultrasound biomicroscopy (UBM) gonioscopy in relative pupillary block (RPB), peripheral anterior synechia (PAS), and plateau iris configuration (PIC). METHODS: This study included 73 eyes of 52 patients with RPB (n = 26), PAS (n = 21), or PIC (n = 26). First, a conventional UBM scan was performed using a normal size standard eye cup before indentation. Then, for indentation UBM gonioscopy, scans were performed using a new eye cup that we designed. For evaluation of the angle, angle opening distance 500 and angle recess area were recorded and evaluated with regard to the effect of expansion on the anterior chamber angle. RESULTS: Indentation UBM gonioscopy showed the characteristic images in each of the eyes. The angle of all examined eyes was significantly widened with indentation (P < 0.01). The angle changes in eyes with RPB were significantly greater than in eyes with PAS or PIC (P < 0.01). CONCLUSION: Indentation UBM gonioscopy is a very useful method for observing the angle and diagnosis of RPB, PAS, and PIC.
Aged↗
Ophthalmomyiasis-like pigmentary retinopathy in ALS/PDC in the Kii peninsula of Japan.
Explore the source record for details and available documents.
Aged↗
Supraciliochoroidal fluid in the eyes indicates good intraocular pressure control despite absence of obvious filtering bleb after trabeculectomy.
PURPOSE: To examine the presence of supraciliochoroidal fluid (SCF) by ultrasound biomicroscopy in posttrabeculectomy eyes that show good intraocular pressure (IOP) control despite the absence of an obvious filtering bleb. PATIENTS AND METHODS: Eyes were selected retrospectively according to the following criteria: IOP < 15 mm Hg, no antiglaucoma medication, no filtering bleb or a flattened bleb without microcystic spaces, and no ophthalmoscopic choroidal detachment after trabeculectomy with mitomycin C. The SCF was examined using 50-MHz ultrasound biomicroscopy (Zeiss-Humphrey). RESULTS: Ultrasound biomicroscopy detected SCF in five (63%) of eight eyes that met the study criteria. The extent of SCF in two of the eyes was four quadrants and one or two quadrants in three eyes. CONCLUSION: The presence of the SCF may explain increased uveoscleral outflow and may represent an IOP-lowering mechanism after trabeculectomy with mitomycin C, especially when IOP control is good and a filtering bleb is not obvious.
Anterior Eye Segment↗
Studies of rapidly disintegrating tablets in the oral cavity using co-ground mixtures of mannitol with crospovidone.
We attempted the development of rapid oral disintegration tablets by direct compression using co-ground mixture of D-mannitol and crospovidone. The co-ground mixture was prepared with a vibration rod mill. The tablets were formed by compression using a single punch-tableting machine after addition of the co-ground mixture to non-ground D-mannitol, crospovidone and magnesium stearate. Regarding the properties of tablets, hardness and the time of disintegration were measured. The particle diameter and specific surface area of the co-ground mixture were measured. The tablets manufactured from a physical mixture of 30% (w/w) co-ground mixture of D-mannitol and crospovidone (mixed ratio 9 :1) with 65.5% (w/w) of non-ground mannitol, 4% (w/w) of crospovidone, and 0.5% (w/w) of magnesium stearate had good properties for rapidly disintegrating tablets in the oral cavity. They showed the hardness of 4.9 kg and disintegration time of 33 s. We found that adding co-ground mixture of D-mannitol and crospovidone is useful in enhancing hardness of the tablets that could not be achieved by addition of their individually ground mixture. The improvement in the hardness of the tablets was also observed when other saccharides and disintegrants were used. This method was proved to be applicable in the manufacture of tables of ascorbic acid, a water-soluble drug and nifedipine, a slightly water soluble drug; and the dissolution rate of nifedipine from the tablets in water was remarkably improved. The particle sizes of D-mannitol in the co-ground mixture were smaller than that of the individually ground mixture, resulting in a larger specific surface area of the co-ground mixture than that of the individually ground mixture. Therefore, it was presumed that crospovidone acted as a grinding assistant for D-mannitol in the co-grinding process, enhancing the hardness of tablets by increasing the contact area among powder particles.
Mannitol↗
Effects of haloperidol on K(+) currents in acutely isolated rat retinal ganglion cells.
PURPOSE: Effects of haloperidol on K(+) currents (IKs) of rat retinal ganglion cells (RGCs) were examined, with the hypothesis that its alteration of IKs explains alterations in the pattern electroretinogram (PERG). METHODS: Fast blue was injected into superior colliculi of rats (3-8 days old) to identify RGCs under epifluorescence illumination after retrograde transport to retinas. Retinas were dissected, treated enzymatically, and dissociated with trituration. Effects of haloperidol on membrane currents at -70 mV, voltage-dependent IK, and Ca(2+)-dependent K(+) currents (K(Ca)) were examined by whole-cell patch voltage clamp. Na(+) currents were abolished by tetrodotoxin (1 microM; TTX). Voltage-gated IKs were isolated by Ca(2+)-free perfusate. Persistent and transient components of the voltage-sensitive IKs were isolated by prepulses, and sensitivity of each component to tetraethylammonium (TEA, 20 mM) and 4-aminopyridine (5 mM) was tested. K(Ca) was identified by its response to TEA, charybdotoxin (CTX), and apamin. Haloperidol (0.01-100 microM) was instilled into the perfusate dissolved in dimethyl sulfoxide (DMSO). RESULTS: Currents recorded at -70 mV were not affected by haloperidol, whereas the persistent component of the voltage-dependent IK was reversibly reduced by haloperidol, with a dose dependence fitted with the Hill equation (median inhibitory concentration [IC(50)] = 4.2 microM). The transient component of the voltage-gated IK was less sensitive to haloperidol. Haloperidol (10 nM) blocked the apamin-sensitive K(Ca) but not the CTX-sensitive K(Ca). CONCLUSIONS: Haloperidol reduced voltage-dependent IKs in RGCs, but at a higher concentration than that needed to antagonize dopamine receptors. Haloperidol (10 nM) blocked the apamin-sensitive K(Ca) which modulates the firing rate of RGCs and may contribute to the alteration of PERG.
Animals↗
Switch to latanoprost monotherapy from combined treatment with beta-antagonist and other antiglaucoma agents in patients with glaucoma or ocular hypertension.
PURPOSE: To investigate the effects on intraocular pressure (IOP) and the occurrence of adverse events upon switching directly to latanoprost monotherapy from multiple drug therapy, including a beta-antagonist, for glaucomatous eyes. METHODS: Patients with primary open-angle glaucoma or ocular hypertension and receiving long-term therapy with two or three topical ocular hypotensive drugs (including one topical beta-antagonist) were switched to latanoprost monotherapy for 12 weeks without any intervening washout period. Observations were performed before switching (baseline) and at weeks 4, 8, and 12 after switching to latanoprost monotherapy. RESULTS: Of the 29 enrolled patients, 26 (90%) completed this protocol. Three patients had excessive IOP elevation, and these patients were withdrawn. The switch to latanoprost monotherapy was followed by a significant ( P < 0.0001) mean reduction of 3.9 mmHg at week 12 in per-protocol cases ( n = 26) and a significant ( P = 0.0016) mean reduction of 2.8 mmHg at last postswitch visit in patients in the intent-to-treat analysis group ( n = 29). Adverse ocular events other than IOP elevation were mild. CONCLUSIONS: The switch to latanoprost monotherapy in glaucoma patients receiving multiple drug therapy resulted in an additional, significant IOP reduction.
Administration, Topical↗
Symmetry analysis for detecting early glaucomatous changes in ocular hypertension using optical coherence tomography.
PURPOSE: To compare symmetry analysis of the retinal nerve fiber layer (RNFL) in ocular-hypertensive, normal, and glaucomatous eyes using optical coherence tomography (OCT). METHODS: Thirty-three consecutive ocular-hypertensive patients (33 eyes), 25 normal volunteers (25 eyes), and 35 open-angle glaucoma patients (35 eyes) were enrolled in this study. Circular OCT scans were obtained using a diameter of 3.4 mm around the optic disc. RNFL thickness was measured, and a symmetry analysis was performed using symmetry ratios. To calculate the symmetry ratios, the circle was divided into the superior and inferior hemiretina. The superior hemiretina was further subdivided into three (area I, temporal 45 degrees; area II, superior 90 degrees; and area III, nasal 45 degrees ) or five (with areas 1-5, each spanning 36 degrees ) zones. The symmetry ratios were defined as the ratios comparing the RNFL thickness within each of the zones with that in the analogous zone in the inferior hemiretina. RESULTS: RNFL thickness measurements could distinguish glaucomatous eyes from other groups, but could not distinguish ocular-hypertensive from normal eyes. However, the symmetry analysis revealed differences between ocular-hypertensive and normal eyes in area II (mean +/- SD, 0.77 +/- 0.16 vs. 0.85 +/- 0.12, P = 0.0379). CONCLUSIONS: Early glaucomatous RNFL changes might exist in some areas of ocular-hypertensive eyes, and a symmetry analysis may be a useful method for detecting these changes.
Adult↗
Supraciliochoroidal fluid at an early stage after trabeculectomy.
PURPOSE: To detect the presence of supraciliochoroidal fluid (SCF) by ultrasound biomicroscopy (UBM) at an early stage after trabeculectomy. METHODS: Trabeculectomy with mitomycin C was performed on 14 patients (15 eyes) with medically uncontrolled glaucoma. The ciliary bodies were observed using UBM testing, which was conducted preoperatively and within 2 weeks after the procedure. RESULTS: SCF was detected postoperatively in 6 eyes. One eye also had choroidal detachment (CD), as seen with an indirect ophthalmoscope; and 5 eyes (33%) had SCF without intraocular inflammatory clinical signs, postoperative changes of the anterior chamber depth, or obvious CD. The SCF in 4 eyes disappeared within 4 weeks after the trabeculectomy. The intraocular pressure (IOP) was 6.4 +/- 3.4 mm Hg (mean +/- SD) when SCF was detected and it rose to 13.2 +/- 7.2 mm Hg when the SCF disappeared. The IOP was 11.4 +/- 4.0 mm Hg in the eyes without SCF, which was significantly higher than that seen in the eyes with SCF. CONCLUSIONS: At an early stage after trabeculectomy, SCF without subclinical CD was detected in some cases by UBM. Compared with the reported frequency of SCF after 3 or 6 months, our study revealed that SCF was present more frequently at an early stage after trabeculectomy. Our results may indicate that the presence of SCF is related to the early low IOP after trabeculectomy and that the disappearance of SCF induces the elevation of IOP.
Aged↗