Second Percutaneous Transluminal Angioplasty Versus Surgical Reconstruction for Hemodialysis Access Failure Within a Short Time Period.

BACKGROUND: The purpose of this study was to compare patency and nonabandonment rates for second percutaneous transluminal angioplasty (PTA) and surgical reconstruction for the treatment of failing vascular access due to restenosis or reocclusion in a short time after initial PTA. METHODS: Seventy two consecutive patients who underwent second treatment within 90 days after the initial PTA were evaluated retrospectively. The patency (time to corrective procedure) and access abandonment were compared among patients who underwent a second PTA (n = 35) and those who underwent surgical reconstruction (n = 37). Univariate and multivariate analyses were performed to determine independent predictors of patency and access abandonment at 1 year after the treatment. RESULTS: At 1 year after the treatment, the patency rates were 35.1% and 11.4% (P = 0.02) and nonabandonment rates were 64.9% and 77.1% (P = 0.25) for surgical reconstruction and second PTA, respectively. The Kaplan-Meier survival analysis showed that the surgical reconstruction group had better patency probability (P = 0.02), but there was no difference in the nonabandonment probability between the groups (P = 0.29). Shorter time to retreatment was associated with good patency. The female gender was likely to be associated with access abandonment. CONCLUSIONS: The access abandonment between the 2 procedures had no difference, although surgical reconstruction provided better patency than second PTA.

Two-year outcomes of low-exposure extended-release tacrolimus and mycophenolate mofetil regimen in de novo kidney transplantation: A multi-center randomized controlled trial.

BACKGROUND: Once-daily extended-release tacrolimus (TACER) is commonly administered following kidney transplantation (KTx); however, its optimal dosage remains unknown. METHODS: In this multi-center, randomized controlled trial, 62 living donor KTx recipients were assigned to either standard-exposure (SE; n = 32) or low-exposure (LE; n = 30) TACER (Graceptor®, Astellas Pharm Inc.) groups. All patients received basiliximab and mycophenolate mofetil (MMF). The primary outcomes were acute rejection, graft/patient survival, and the secondary outcomes were incidence of cytomegalovirus infection, and de novo donor-specific antibodies (dnDSA) production. RESULTS: The tacrolimus trough level and estimated area under the blood concentration-time curve (eAUC) were significantly higher in SE than in LE (SE vs. LE; 1 year: 5.0 ± 0.9 ng/ml and 206.9 ± 26.8 ng h/ml vs. 3.4 ± 1.0 ng/ml and 153.9 ± 26.4 ng h/ml; 2 years: 4.8 ± 1.0 ng/ml and 204.9 ± 30.1 ng h/ml vs. 3.8 ± 0.9 ng/ml and 164.4 ± 27.0 ng h/ml). In contrast, the dosage and eAUC of MMF did not differ between groups. Two-year graft and patient survival rates were 100% in both groups, and acute rejection rates were 0% and 10% in the SE and LE, respectively (p = 0.11). The mean estimated glomerular filtration rates did not differ between the groups. Cytomegalovirus infection was slightly lower in the LE (SE: 12.5% and LE: 6.7%, p = 0.37). In the LE, four cases of dnDSA were noted within 2 years of transplantation; no case was observed in the SE (p = 0.034). CONCLUSIONS: Although the LE TACER regimen showed similar rates of acute rejection, as well as graft and patient survival compared with SE after KTx, LE was significantly more associated with dnDSA. Further investigation of its long-term effect on graft survival is warranted. (University Hospital Medical Information Network Clinical Trials Registry ID: UMIN000033089).

Long-term impact of baseline serum uric acid levels on living kidney donors: a retrospective study.

BACKGROUND: Preoperative characteristics of living kidney donors are commonly considered during donor selection and postoperative follow-up. However, the impact of preoperative uric acid (UA) levels is poorly documented. The aim of this study was to evaluate the association between preoperative serum UA levels and post-donation long-term events and renal function. METHODS: This was a single-center retrospective analysis of 183 living kidney donors. The donors were divided into high (≥5.5 mg/dl) and low (< 5.5 mg/dl) UA groups. We analyzed the relationship between preoperative UA levels and postoperative estimated glomerular filtration rate (eGFR), as well as adverse events (cardiovascular events and additional prescriptions for hypertension, gout, dyslipidemia, and diabetes mellitus), over 5 years after donation. RESULTS: In total, 44 donors experienced 52 adverse events over 5 years. The incidence of adverse events within 5 years was significantly higher in the high UA group than in the low UA group (50% vs. 24%, p = 0.003); this was true even after the exclusion of hyperuricemia-related events (p = 0.047). UA emerged as an independent risk factor for adverse events (p = 0.012). Donors with higher UA levels had lower eGFRs after donation, whereas body mass index, hemoglobin A1c, blood pressure, and low-density lipoprotein cholesterol did not have any impact on the eGFR. CONCLUSIONS: The findings suggest that preoperative UA levels should be considered during donor selection and postoperative follow-up.

Prediction model of compensation for contralateral kidney after living-donor donation.

BACKGROUND: Compensation of contralateral kidney function after living-donor kidney donation is well known, and many predictive factors have been proposed. However, no prediction model has been proposed. This study was performed to establish a tool with which to estimate the degree of compensation of the contralateral kidney after living-donor kidney donation. METHODS: We retrospectively analyzed 133 living donors for renal transplantation in our institution. We defined a favorable compensation as a post-donation estimated glomerular filtration rate (eGFR) at 1 year (calculated by the Chronic Kidney Disease Epidemiology Collaboration equation) of > 60% of the pre-donation eGFR. We analyzed the living donors' clinical characteristics and outcomes. RESULTS: The median (range) donor age was 59 (24-79) years, median (range) body mass index was 22.9 (16.8-32.7) kg/m2, and median (range) body surface area was 1.6 (1.3-2.0) m2. All donors were Japanese, and 73% of the donors were biologically related. The median (range) donor pre-donation eGFR was 108.7 (82-144) ml/min/1.73 m2, and the median (range) post-donation eGFR at 1 year was 86.9 (43-143) ml/min/1.73 m2. Eighty-six percent of donors had compensatory hypertrophy. In the univariate analysis, age, female sex, history of hypertension, body surface area, and pre-donation eGFR were significantly associated with hypertrophy (p < 0.05). In the multivariate analysis, age, female sex, history of hypertension, and ratio of the remnant kidney volume to body weight were significantly associated with hypertrophy (p < 0.05). Based on these results, we created a compensation prediction score (CPS). The median (range) CPS was 8.7 (1.1-17.4). Receiver operating characteristic analysis showed strong diagnostic accuracy for predicting favorable compensation (area under the curve, 0.958; 95% confidence interval, 0.925-0.991, p < 0.001). The optimal cut-off value of the CPS was 5.0 (sensitivity, 92.0%; specificity, 89.5%). The CPS had a strong positive correlation with the post-donation eGFR (R = 0.797, p < 0.001). CONCLUSION: The CPS might be useful tool with which to predict a favorable compensation of the contralateral kidney and remnant kidney function. If the CPS is low, careful management and follow-up might be necessary. Further investigations are needed to validate these findings in larger populations.

Novel curved balloon catheter for dilating postoperative angled lesions associated with congenital heart disease.

OBJECTIVES: This study aimed to analyze the surface stress generated by a novel curved balloon and assess its efficacy for treating angular lesions associated with congenital heart disease. BACKGROUND: Obstructions at the anastomosis of aortopulmonary shunts and cavopulmonary connections may occur postoperatively. Catheter interventions are often performed for such lesions; however, acute angulation may cause balloon slippage or inappropriate stress on the vessel wall. METHODS: We dilated the curved balloon in a curved vessel model and measured the resultant wall stress and its distribution. Clinical evaluations were performed using this balloon in angled lesions. RESULTS: In the curved vessel model, curved balloons generated uniform stress on the lesser and greater curvatures (curved type, lesser/greater = 0.343 MPa/0.327 MPa; P = 0.61), whereas straight balloons caused disproportionate stress (straight type, lesser/greater = 0.358 MPa/0.254 MPa; P = 0.19). However, the difference in average stress was not statistically significant. Furthermore, the stress was uniform along the entire length of the curved balloon, but differed between the mid and end portions of the straight balloon. Curved balloon dilations were performed for 10 lesions in 7 patients. The curved balloon conformed well to the angulated lesion without slipping. The median percent change in the minimal lumen diameter (MLD) was 64% (range, 0-206%). In 5 lesions, MLD increased by ≥50%. Oxygen saturation increased by 5% (0-9%). CONCLUSIONS: Although further clinical evaluation is necessary, this novel curved balloon may be a reasonable alternative in angled lesions, providing better conformability and preventing excessive stress to the vessel wall adjacent to the stenosis.

Calcific tendinitis of the shoulder induced by an mRNA vaccine for COVID-19: A case report.

Coronavirus disease 2019 (COVID-19) vaccines have been widely used and have been shown to be effective in combating the pandemic. However, various side effects have been reported following vaccination. For instance, a condition called 'shoulder injury related to vaccine administration' (SIRVA) is characterized by shoulder pain and limited range of motion after intramuscular injection of a vaccine into the deltoid muscle of the shoulder. Despite an increase in SIRVA cases, the exact incidence of the disease is unclear, and there are a few reports of SIRVA about the COVID-19 vaccine. Here, we report a rare case of an 83-year-old woman who was diagnosed with calcification in her left shoulder 1 year ago and developed calcific tendinitis after receiving an mRNA vaccine for COVID-19 (Pfizer-BioNTech). Radiographs showed calcification of the supraspinatus tendon, and magnetic resonance images showed continuous inflammatory findings from the subdeltoid bursa to the subacromial bursa. We treated the patient with celecoxib and acetaminophen, and she recovered after about 2 months. In order to prevent SIRVA, the presence of shoulder joint disease should be carefully asked during a pre-vaccination assessment. The puncture point should be chosen with the median point of the deltoid muscle or the anterior-posterior axillary line as landmarks because the more cephalad the puncture position, the greater the chance of causing SIRVA.

Hepatic toxicity and prognosis in hepatitis C virus-infected patients with diffuse large B-cell lymphoma treated with rituximab-containing chemotherapy regimens: a Japanese multicenter analysis.

The influence of hepatitis C virus (HCV) infection on prognosis and hepatic toxicity in patients with diffuse large B-cell lymphoma in the rituximab era is unclear. Thus, we analyzed 553 patients, 131 of whom were HCV-positive and 422 of whom were HCV-negative, with DLBCL treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (RCHOP)-like chemotherapy. Survival outcomes and hepatic toxicity were compared according to HCV infection. The median follow-up was 31 and 32 months for patients who were HCV-positive and HCV-negative, respectively. HCV infection was not a significant risk factor for prognosis (3-year progression-free survival, 69% vs 77%, P = .22; overall survival, 75% vs 84%, P = .07). Of 131 patients who were HCV-positive, 36 (27%) had severe hepatic toxicity (grade 3-4), compared with 13 of 422 (3%) patients who were HCV-negative. Multivariate analysis revealed that HCV infection was a significant risk factor for severe hepatic toxicity (hazard ratio: 14.72; 95% confidence interval, 6.37-34.03; P < .001). An exploratory analysis revealed that pretreatment transaminase was predictive of severe hepatic toxicity. HCV-RNA levels significantly increased during immunochemotherapy (P = .006). These results suggest that careful monitoring of hepatic function and viral load is indicated during immunochemotherapy for HCV-positive patients.

Cell adhesion and glistening formation in hybrid copolymer intraocular lenses.

The purpose of this study is to investigate the cell adhesion and glistening formation properties of various foldable intraocular lenses (IOLs) in vitro. Three conventional hydrophobic methacrylate acrylic (MA) IOLs, a hydrophilic hydroxyethyl methacrylate (HEMA) IOL and a hybrid MA/HEMA copolymer IOL were investigated for immunologically activated cell adhesion and for formation of glistenings resulting from cavitation, by analysis of digital images using NIH Image J PC software. The MA IOLs exhibited a low level of adhering cells but a high level of glistening formation, the HEMA IOL exhibited the reverse tendency, and the MA/HEMA IOL exhibited a low level of both, thus indicating that hybrid MA/HEMA IOLs are less susceptible than HEMA IOLs to cell adhesion and less susceptible than MA IOLs to glistening formation.

Glecaprevir/Pibrentasvir and Renal Dysfunction in Deceased Donor Renal Transplantation: A Case Report.

BACKGROUND: Glecaprevir/pibrentasvir is a novel anti-hepatitis C virus (HCV) drug, and it is currently the only drug available for patients with severe renal impairment. Here we report a case with renal dysfunction after an administration of glecaprevir/pibrentasvir. CASE REPORT: The case was 66-year-old Japanese man who turned out to be HCV-positive 14 years ago at the time of his second deceased renal transplantation. He had no prior history of HCV treatment. HCV genotype was serogroup 1, and baseline HCV-RNA was 5.3 LOG IU/mL. Since glecaprevir/pibrentasvir became available, he started to take it for treatment of HCV. His immunosuppressants were tacrolimus (trough levels 4.3∼6.5 ng/mL) and 5 mg of prednisolone. His baseline renal function was serum creatinine (Cr) 2.1 mg/dL and urine protein (-). Shortly after starting glecaprevir/pibrentasvir, the serum Cr started to increase. Serum Cr reached up to 2.92 mg/dL and urine protein was (+) at day 36. Right pleural effusion was observed while cardiac function was normal. His liver function had been consistently normal. We concluded glecaprevir/pibrentasvir was the cause of renal dysfunction as no other drugs were added. Immediately after discontinuation of glecaprevir/pibrentasvir at day 36, serum Cr decreased to 1.9 mg/dL and urine protein turned negative at day 64. Although the patient completed a half course of glecaprevir/pibrentasvir, HCV-RNA turned to be negative at day 36. CONCLUSIONS: We experienced a case with renal dysfunction after the initiation of glecaprevir/pibrentasvir in deceased donor renal transplant recipient. Renal dysfunction caused by glecaprevir/pibrentasvir has not been reported so far.

Anterior capsule coverage and rotational stability of an acrylic toric intraocular lens.

PURPOSE: To investigate factors related to the rotational stability of an acrylic toric intraocular lens (IOL). SETTING: Four ophthalmic surgical sites in Japan. DESIGN: Prospective case series. METHODS: The study included 120 eyes of 120 patients undergoing phacoemulsification and implantation of a toric IOL (AcrySof IQ, Alcon Laboratories, Inc.). At 1 hour postoperatively, the area of continuous curvilinear capsulorhexis (CCC) was measured, and the state of anterior capsule coverage on the IOL optic (total on or partial on) was recorded. The toric IOL axis orientation was assessed at the end of surgery and at 1 hour, 1 week, 1 month, and 6 months postoperatively. Multiple regression analysis was performed to explore any clinical factors relevant to IOL rotation from the end of surgery to 6 months postoperatively. The explanatory variables included age, anterior chamber depth preoperatively, axial length, type of corneal astigmatism (with-the-rule, against-the-rule, or oblique astigmatism), area of CCC, state of anterior capsule overlap on IOL optic (total coverage vs partial coverage), and surgical sites (surgeons). RESULTS: The multiple regression analysis in 110 eyes of 110 patients indicated that anterior capsule overlap on the IOL optic was the only variable associated with IOL rotation at 6 months postoperatively (P = .0482). The mean absolute rotation at 6 months was 1.96 ± 1.81 degrees in the total on group and 3.79 ± 3.12 degrees in the partial on group (P = .0004). CONCLUSIONS: Rotational stability of a single-piece, acrylic toric IOL was better in eyes with total anterior capsule coverage than that in those with partial anterior capsule coverage on the IOL optic.

Substantial hysteresis in emergent temperature sensitivity of global wetland CH4 emissions.

Wetland methane (CH4) emissions ([Formula: see text]) are important in global carbon budgets and climate change assessments. Currently, [Formula: see text] projections rely on prescribed static temperature sensitivity that varies among biogeochemical models. Meta-analyses have proposed a consistent [Formula: see text] temperature dependence across spatial scales for use in models; however, site-level studies demonstrate that [Formula: see text] are often controlled by factors beyond temperature. Here, we evaluate the relationship between [Formula: see text] and temperature using observations from the FLUXNET-CH4 database. Measurements collected across the globe show substantial seasonal hysteresis between [Formula: see text] and temperature, suggesting larger [Formula: see text] sensitivity to temperature later in the frost-free season (about 77% of site-years). Results derived from a machine-learning model and several regression models highlight the importance of representing the large spatial and temporal variability within site-years and ecosystem types. Mechanistic advancements in biogeochemical model parameterization and detailed measurements in factors modulating CH4 production are thus needed to improve global CH4 budget assessments.

Efficacy and safety of topical travoprost with sofzia preservative for Japanese glaucoma patients.

The purpose of this study is to evaluate the intraocular pressure (IOP) -lowering effect and safety of topical travoprost with sofzia and without benzalkonium chloride on Japanese patients with glaucoma. Topical travoprost (0.04%) was used on 39 glaucoma patients with no prior use of topical prostaglandin F2alpha analogues (Beginning group). The IOP, number of conjunctival follicules, degrees of conjunctival hyperemia, and degrees of superficial punctate keratitis (SPK, AD-classification) were determined at the beginning of the treatment and after 1 month and 3 months. 37 other patients who were using 0.005% topical latanoprost were switched to 0.04% topical travoprost and analyzed in the same way (Switched group). For the Beginning group, the IOP was significantly decreased after 3 months (p < 0.0001). The conjunctival follicule score was decreased significantly (p = 0.033). Both the SPK area score and density score for the cases with SPK at the baseline decreased significantly (p = 0.034 and p = 0.024). In the switched group, the IOP was not changed significantly at 3 months after the switch (p = 0.118). Both the conjunctival follicule and hyperemia score were significantly decreased at 3 month (p = 0.0074 and p = 0.0047). The SPK area score for the cases with SPK at the time of switch decreased significantly (p = 0.013). Travoprost with sofzia preservative had an equal effect in reducing the IOP as latanoprost. It had low toxicity on the ocular surface of Japanese glaucoma patients.

HbA1c and Aortic Calcification Index as Noninvasive Predictors of Pre-Existing Histopathological Damages in Living Donor Kidney Transplantation.

We previously reported that allografts from living donors may have pre-existing histopathological damages, defined as the combination of interstitial fibrosis (ci), tubular atrophy (ct), and arteriolar hyalinosis (ah) scores of ≧1, according to the Banff classification. We examined preoperative characteristics to identify whether the degree of these damages was related to metabolic syndrome-related factors of donors. We conducted a single-center cross-sectional analysis including 183 living kidney donors. Donors were divided into two groups: chronic change (ci + ct ≧ 1 ∩ ah ≧ 1, n = 27) and control (n = 156). Preoperative characteristics, including age, sex, blood pressure, hemoglobin A1c (HbA1c), aortic calcification index (ACI), and psoas muscle index (PMI), were analyzed. Comparing the groups, the baseline estimated glomerular filtration rate was not significantly different; however, we observed a significant difference for ACI (p = 0.009). HbA1c (p = 0.016) and ACI (p = 0.006) were independent risk factors to predict pre-existing histopathological damages, whereas PMI was not. HbA1c correlated with ct scores (p = 0.035), and ACI correlated with ci (p = 0.005), ct (p = 0.021), and ah (p = 0.017). HbA1c and ACI may serve as preoperative markers for identifying pre-existing damages on the kidneys of living donors.

Optimizing Intraoperative Blood Pressure to Improve Outcomes in Living Donor Renal Transplantation.

BACKGROUND: Adequate renal perfusion at the time of unclamping is important because it has been known to affect outcomes in renal transplantation. Nevertheless, the ideal intraoperative systolic arterial pressure (SAP) has not been well defined. METHODS: We performed a retrospective analysis of 106 living donor renal transplants performed at our center from June 2010 to May 2019. We divided the cohort into 2 groups according to our center's goal SAP of ≥150 mm Hg: 57 patients had SAP ≥150 mm Hg and 49 patients had SAP <150 mm Hg. We analyzed pretransplant characteristics, intraoperative measurements, and postoperative laboratory values to validate our center's target SAP at the time of reperfusion. This study strictly complied with the Helsinki Congress and the Istanbul Declaration regarding donor sources. RESULTS: Patients with SAP ≥150 mm Hg had been on dialysis for a significantly shorter duration before transplant compared with those who had SAP <150 mm Hg. In the SAP ≥150 mm Hg group, urinary sodium excretion normalized earlier, and they had a significantly smaller stroke volume variation, higher cardiac output and cardiac index, earlier initial urination, and higher intraoperative urine output. There were no differences in intraoperative volume repletion, central venous pressure, or postoperative estimated glomerular filtration rate. CONCLUSION: Achieving SAP ≥150 mm Hg at the time of reperfusion may be associated with early stabilization of graft function. Nevertheless, our data suggested that recipients with a prolonged dialysis history are less likely to achieve SAP ≥150 mm Hg at the time of unclamping in living donor renal transplantation.

Is the Living Donor Kidney Profile Index Valuable in Japanese Patients?

INTRODUCTION: The Living Kidney Donor Profile Index (LKDPI) was recently proposed in the United States to evaluate living donor quality. Japan has a largely different renal transplant circumstance, such as a high ABO incompatibility rate. The aim of this study was to validate the LKDPI among the Japanese population and adjust the score. METHODS: We performed a retrospective analysis of 133 living donors in renal transplant in our institution. We analyzed the clinical characteristics and outcomes, and created a modified LKDPI score considering the favorable ABO incompatible kidney transplant outcomes in Japan. RESULTS: Median (interquartile range [IQR]) donor age was 59 (51 to 65) and median (IQR) body mass index was 22.9 kg/m2 (20.9 to 25.2). ABO incompatibility rate was 28.5%. Median (IQR) donor estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration equation) was 108.7 mL/min/1.73 m2 (99.9 to 115.5). The 1-year graft survival rate was 98.5%, and the 3-year graft survival rate was 97%. The incidence of antibody mediated rejection was 5.2%. The median (IQR) LKDPI score was 30.2 (11.8 to 46.8). This was significantly higher than the previously reported score in the United States, which was 12.8 (-0.8 to 27.2). The modified LKDPI (mLKDPI) score was 23.2 (4.1 to 35.1). LKDPI and mLKDPI did not show a diagnostic value in graft survival; however, LKDPI and mLKDPI showed significant diagnostic value in eGFR at 1 year (area under the curve [AUC]=0.627, P = .017; and AUC=0.673, P = .01). CONCLUSION: Our outcomes had better survival even though with higher ABO incompatibility rate. According to original LKDPI, our donor pool is higher than the general US population. In this study, lower LKDPI tended to be associated with good allograft function, and mLKDPI has better diagnostic value than LKDPI. To compare internationally, an adjusted model for Japan might be necessary based on the outcomes of a large population.

Impact of Very Low-Dose Trimethoprim-Sulfamethoxazole on Serum Creatinine after Renal Transplantation: A Retrospective Study.

BACKGROUND: It is well known that high-dose trimethoprim, through its effect of inhibiting creatinine secretion, increases serum creatinine levels without changes in real glomerular filtration rate. However, there has been no report regarding the effect of very low-dose trimethoprim on serum creatinine levels after renal transplantation. METHODS: We retrospectively investigated 76 renal transplantation recipient outpatients who completed their course of initial prophylaxis at our institution. Twelve patients who experienced events that might affect their serum creatinine levels were excluded. Fifty-one patients who required readministration of trimethoprim-sulfamethoxazole to prevent a possible outbreak of pneumocystis jirovecii pneumonia and 13 patients who did not receive readministration (control) were analyzed. Dosage was 80 mg/400 mg (per tablet), administered as 3 tablets per week for 30.6 ± 13.5 days. This study strictly complied with the Helsinki Congress and the Istanbul. Declaration regarding donor source. RESULTS: All patients completed readministration without adverse events. Serum creatinine increased significantly in the readministration group (1.40 ± 0.64 mg/dL to 1.48 ± 0.70 mg/dL, P < .01) while not in the control group. The higher the initial serum creatinine level, the greater the increase of Δ serum creatinine (R = 0.59, P < .001). Sex, baseline urine protein level, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use, donor type, and time after renal transplantation did not affect Δ serum creatinine. Serum creatinine returned to baseline levels after cessation. CONCLUSIONS: Very low-dose trimethoprim-sulfamethoxazole prophylaxis significantly raised serum creatinine reversibly by 6% after renal transplantation.

A pharmacokinetic study evaluating the relationship between treatment efficacy and incidence of adverse events with thalidomide plasma concentrations in patients with refractory multiple myeloma.

BACKGROUND: Multiple myeloma (MM) is a clonal disorder of plasma cells, accounting for 10% of hematologic malignancies. Relapsed or refractory MM has a poor prsognosis. Thalidomide has been reported to be effective for these patients; however, high-dose thalidomide has induced many adverse events, including in the nervous, gastrointestinal, and hematopoietic systems in approximately 20%-50% of patients. Recently, low-dose thalidomide therapy has been used in many countries in order to reduce these adverse events. The objective of this study was to determine whether plasma concentration of thalidomide is related to the efficacy and the development of adverse events in patients with refractory MM treated with low-dose thalidomide plus low-dose dexamethasone. PATIENTS AND METHODS: A total of 66 patients (age range, 40-74 years) presenting with progressive disease after previous treatments were treated with low-dose thalidomide and low-dose dexamethasone. Thalidomide was administered orally at 100 mg/day for the first week. When severe adverse events did not develop, the dose was increased to 200 mg/day in the second week and was continued until progression. Dexamethasone was administered at a dose of 4 mg/day for the first 4 weeks, then decreased by 1 mg every week, and finally maintained at 1 mg/day. Plasma trough concentration of thalidomide 3 days after thalidomide treatment was analyzed by high-performance liquid chromatography in 45 patients (age range, 42-74 years) who agreed to participate in this study of thalidomide concentration analysis. RESULTS: The mean concentrations at 100 mg/day and 200 mg/day were 0.343 microg/mL (range, 0.05-1.45 microg/mL) and 0.875 microg/mL (range, 0.19-2.09 microg/mL), respectively. The overall response rate (near-complete response + partial response + minimal response) of this treatment was 73%. Five had stable disease, and 3 patients experienced progressive disease. There was no relationship between the concentration of thalidomide in the plasma and the efficacy (P > .8). Severe adverse events, including grade > 2 nonhematologic and grade > 3 hematologic adverse events, were observed in 21 patients (46.6%). There was no significant difference in the concentration of thalidomide between the patients with and without severe adverse events (P > .843). CONCLUSION: The thalidomide concentration in the plasma does not predict treatment efficacy and the development of adverse events.

Blue light-filtering and violet light-filtering hydrophobic acrylic foldable intraocular lenses: Intraindividual comparison.

PURPOSE: To compare the clinical outcomes after cataract surgery and implantation of a blue light-filtering IOL (AcrySof IQ SN60WF) or a violet light-filtering intraocular lens (IOL) (OptiBlue ZCB00V). SETTING: Four surgical sites in Japan. DESIGN: Prospective case series. METHODS: One eye of patients with bilateral cataract was randomly allocated to the blue light-filtering IOL and the fellow eye to the violet light-filtering IOL. Visual acuity and contrast sensitivity were assessed over 3 months. The incidence of cyanopsia was evaluated using the neutralization method. RESULTS: The study enrolled 110 eyes of 55 patients. There was no significant difference in visual acuity between the two IOLs. Based on the neutralization results 1 week postoperatively, 15 cases (27.8%) with the light-filtering IOL and 8 cases (14.8%) with the violent light-filtering IOL had cyanopsia; the difference reached statistical significance (P = .049). After 2 weeks, the difference in the incidence of cyanopsia was not significant. Postoperative contrast sensitivity under photopic condition at 1 week and 3 months and contrast sensitivity under mesopic conditions at 3 months were significantly better with the violet light-filtering IOL than with the blue light-filtering IOL (P < .05). CONCLUSIONS: The violet light-filtering IOL yielded highly satisfactory clinical outcomes, including reduction of cyanopsia and a potential improvement in contrast sensitivity. The different chromophores of the IOL and its different material and design might have contributed.

Influence of surface light scattering and glistenings of intraocular lenses on visual function 15 to 20 years after surgery.

PURPOSE: To assess the long-term influence of surface light scattering and glistenings of hydrophobic acrylic (Acrysof), silicone, and poly(methyl methacrylate) (PMMA) intraocular lenses (IOLs) on visual function. SETTING: Eleven surgical sites, Japan. DESIGN: Retrospective case series. METHODS: Patients who had cataract surgery with implantation of a hydrophobic acrylic, silicone, or PMMA IOL from 1994 to 2000 were examined. Silicone and PMMA IOLs were not restricted to specific manufacturers or models. Patients were included if their corrected distance visual acuity (CDVA) within 3 months postoperatively (baseline CDVA) was 20/25 or better. The CDVA, contrast sensitivity, degree of surface light scattering measured with Pentacam densitometry, and glistening grades were recorded at the patient's latest visit. RESULTS: Of the eyes, 31 had a hydrophobic acrylic IOL, 37 a silicone IOL, and 30 a PMMA IOL. Surface light scattering and glistenings were significantly greater with the hydrophobic acrylic IOL than with silicone and PMMA IOLs (P < .0001). The CDVA at the latest visit as well as the changes in CDVA from the baseline to the latest visit did not differ between the IOLs and was unaffected by surface light scattering and glistenings, as was the contrast sensitivity. CONCLUSIONS: The hydrophobic acrylic IOL was associated with a significantly greater level of surface light scattering and glistenings than the silicone IOLs and PMMA IOLs 15 to 20 years postoperatively. However, the optical phenomena within the optics of the hydrophobic acrylic IOL did not influence the patients' visual function.

Treatment of acute myeloid leukemia patients aged more than 75 years: results of the E-AML-01 trial of the Japanese Elderly Leukemia and Lymphoma Study Group (JELLSG).

The feasibility and effects of combination chemotherapy for very elderly patients with acute myeloid leukemia was examined in 65 patients (including previous myelodysplastic syndrome) aged 76 years or morewith a performance status of 0 - 3. Induction chemotherapy was performed with 30 mg/m2 daunorubicin on days 1 - 3, 150 mg/m2 behenoyl cytosine arabinoside on days 1 - 7, and 70 mg/m2 6-mercaptopurine with 300 mg allopurinol taken orally on days 1 - 7 (BHAC-DM). The complete remission (CR) rate was 38.5%, whereas overall survival at 2 and 5 years was 22.0% and 4.7%, respectively. Two- and 5-year survival of CR patients was 41.8% and 11.2%, respectively. The relapse rate of the 25 CR patients was 64.0% and disease-free survival at 2 and 5 years was 21.0% and 11.2%, respectively. The therapy-related mortality rate at induction was 13.8%. BHAC-DM is feasible and effective for selected very elderly acute myeloid leukemia patients.