Clinical application of the Personal Dialysis Capacity (PDC) test: Serial analysis of peritoneal function in CAPD patients

Clinical application of the Personal Dialysis Capacity (PDC) test: Serial analysis of peritoneal function in CAPD patients.BackgroundPeritoneal damage has been reported since the beginning of CAPD therapy.MethodsTo clarify the change of peritoneal function in CAPD patients, we used the Personal Dialysis Capacity (PDC) test in 22 patients with 49 serial studies and 14 patients with single studies. The data were expressed at the condition of 2.5% (2.27g/dl of glucose), four times at 2,000 ml/day.ResultsIn the mass analysis, the urea generation rate, creatinine generation rate, PNA/PCR, and water removal via the peritoneum (PD) were kept at the same level for almost eight years, and then gradually decreased. Urine volume and residual renal creatinine clearance (CCr) became zero at six years. On the other hand, PD CCr increased gradually with the time course of CAPD, and therefore the total CCr remained at the level of 6.0ml/min even after six years. Weekly urea KT/V decreased gradually from almost 2.800 to 2.000. The protein loss remained approximately 7.0g/day for the initial five years, then became 6.0g/day, except in five patients who showed levels above 10.0g/day on the first test of PDC. Weekly urea KT/V was correlated with residual renal CCr (P < 0.005), and significantly correlated with total CCr (weekly urea KT/V = -0.2798 + 0.3720 × total CCr; r = 0.915, P < 0.001). In the serial analysis, when the first and the last tests were compared, the urea generation rate increased significantly (mean ± sd, 2.800 ± 3.204 vs. 3.882 ± 3.382; P < 0.0001); however, water removal via PD (1364 ± 887 vs. 813 ± 609; P = 0.021), total ultrafiltration (1762 ± 841 vs. 1124 ± 843; P = 0.042), and weekly urea KT/V (2.285 ± 0.486 vs. 2.112 ± 0.512; P = 0.026) decreased significantly. The delta water removal via PD/duration became negative (-10.03 ± 6.59 ml/week) in all 7 patients after more than four years, however, it was positive (+14.40 ± 7.84 ml/week) in 6 of 10 patients after less than one year.ConclusionThese results suggest that water removal via PD increases within one year, then decreases after four years. The PDC test is useful to evaluate the change of peritoneal function in mass and serial analyses

Safety analysis of EpzicomR (lamivudine/abacavir sulfate) in post-marketing surveillance in Japan

Purpose: To obtain safety and effectiveness data on a combined anti-HIV drug, Epzicom (abacavir 600mg/lamivudine 300mg), a post-marketing surveillance on Epzicom that was required by the Japanese regulatory authority was conducted between January 2005 and December 2010. Methods: A joint survey (HIV-related drug [HRD] survey) has been conducted involving manufacturers of drugs for treatment of HIV infection in Japan. Safety and effectiveness data from total 624 cases (1107.3person-years) registered to the HRD surveys and received Epzicom were obtained. Adverse drug reactions (ADRs) were defined as adverse events (AE) of which association with Epzicom could not be \u27ruled out\u27. Results: It was found that the incidence of ADR was 32.4% (202/624 cases) on the case basis. In addition, the frequently reported ADR included hyperlipidaemia (59 cases), hypertriglyceridaemia (21 cases), blood bilirubin increased (19 cases), gamma-glutamyltransferase increase (14 cases), blood triglyceride increase (14 cases) and rash (14 cases). Serious AEs were seen in 19 patients (30 events), including one death (no evident association with Epzicom). There were four cases (0.6%) of survey-defined \u27hypersensitivity\u27, and the incidence was 0.9% (4/445) among abacavir naive patients; none of which was reported as serious. No case of myocardial infarction was reported. One pregnant case who delivered a normal baby by caesarean section was reported to have experienced aggravation of anaemia and nausea. Conclusions: The post-marketing surveillance indicated that the incidence of both ischaemic heart disease and hypersensitivity associated with Epzicom was considerably low, suggesting that this drug can be safely used in the Japanese population

Safety analysis of ZiagenR (abacavir sulfate) in postmarketing surveillance in Japan

Purpose: Abacavir is a nucleoside reverse transcriptase inhibitor indicated for human immunodeficiency virus (HIV) infection. In Japan, ZiagenR (300-mg abacavir sulfate) has been marketed since 1999. To obtain safety data on Ziagen, a mandatory postmarketing surveillance was conducted between September 1999 and September 2009. Methods: A joint survey [HIV-related Drug Surveys (HRD)] has been conducted involving manufacturers of drugs for HIV treatment in Japan. Safety data from total 643 cases (1345.7person-years) registered to the HRD surveys and received Ziagen were obtained. Adverse drug reaction (ADR) was defined as adverse event of which association with abacavir could not be "ruled out." Results: It was found that the overall frequency of ADR was 47.6% (306/643); the common ADRs were "hyperlipidemia," "nausea," "increased γ-glutamyltransferase level," "increased blood triglycerides," "abnormal hepatic function," and so on. Serious adverse events were reported in 65 subjects; however, none of the three fatal cases were clearly associated with Ziagen use. The survey-defined hypersensitivity has been infrequently reported in 15 subjects (2.3%). Although some studies had indicated of the association between abacavir and myocardial infarction, no ischemic heart diseases were reported in the present survey. Two of the three pregnant cases delivered normal neonates (one induced abortion). Conclusions: During the mandatory postmarketing survey of Ziagen, there were no cases of ischemic heart diseases, and the incidence of hypersensitivity was considerably low. These indicated that abacavir can be safely used in Japanese HIV+ population. However, the safety profile of Ziagen should be continued to be monitored through pharmacovigilance

Gastric Cancer in younger patients of less than age 30

Twenty-five gastric cancer of less than 30 years of age were clinically evaluated in comparison with those of manhood. 1) Gastric cancers in younger patients were predominant in female, four times as frequent as in male and the most favorable location in the younger was the cardia of the stomach. 2) In terms of histologic findings, undifferentiated carcinoma of Borrmann IV type was common in younger patients. 3) Peritoneal dissemination and serosal invasion as an extension type of carcinoma were most common in younger patients although hepatic metastasis was very few. 4) Surgical outcome of curative operation was very favorable although that of noncurative one was very pessimistic

Differential Expression of Vascular Endothelial Growth Factor (VEGF) and VEGF Receptors in the Sequence of Hyperplastic Polyp, Serrated Adenoma and Adenocarcinoma of Colorectum

AIM: The aim of this study was to investigate the role for vascular endothelial growth factor (VEGF) and its receptors, VEGFR-1 and -2, in the hyperplastic polyp (HP)- serrated adenoma (SA)-adenocarcinoma (AC) sequence of the colorectum.Methods: Thirty-six HPs, 33 SAs and 7 ACs (which contained HP and/or SA) were immunohistochemically examined for the expression of VEGF, VEGFR-1, and VEGFR-2.Results: VEGF protein was expressed in the cytoplasm of SA and AC tumor cells, and VEGFR-1 and VEGFR-2 were expressed both in the cytoplasm and on the membrane of these tumors, while there was faint or no expression of VEGF, VEGFR-1 and VEGFR-2 in HPs. Immunohistochemical staining revealed that 8.3% (3 of 36) HPs, 87.9% (29 of 33) SAs and 100% (7 of 7) ACs were positive for VEGF; 2.8% (1 of 36) HPs, 97.0% (32 of 33) SAs and 100% (7 of 7) ACs were positive for VEGFR-1; 16.7% (6 of 36) HPs, 100% (33 of 33) SAs and 100% (7 of 7) ACs were positive for VEGFR-2. The expression of VEGF, VEGFR-1 or VEGFR-2 was statistically correlated with the sequence of HP, SA and AC (P < 0.0001, respectively) Conclusion: Our results suggest that the VEGF pathway may play an important role in the HP-SA-AC sequence

Chemotherapy on QOL and night sleep of CC patients

Background : The aim of this study was to investigate quality of life (QOL) and night-time sleep disturbance in colon cancer patients with middle risk chemotherapy for proper antiemetic therapy. Methods : The study enrolled 139 patients with colorectal cancer. All patients received oxaliplatin or irinotecan-based chemotherapy. Patients completed a questionnaire about chemotherapy-induced nausea and vomiting and sleep disturbance. Sleep disturbance was checked, and the relationship between sleep disturbance and nausea was analyzed. Results : The prevalence of nausea was 48.9% (68 / 139). The degree of the nausea was slight / moderate / severe in 51 / 11 / 6 patients, and 12 patients had vomiting. Appetite showed no change / slightly decreased / half / one-fourth / none in 51 / 34 / 33 / 6 / 7 patients. There were significant differences in the mental component summary (MCS) score and the role-social component score (RCS). (MCS : nausea(+) vs nausea(-) 46.4 ± 1.1 vs 54.1 ± 1.1 p < 0.01 RCS : nausea(+) vs nausea(-) 33.1 ± 2.1 vs 41.6 ± 2.1 p < 0.01). Using the MCS with a cut-off score of 50, patients were divided into two groups, and nausea was significantly correlated with a low MCS score. Furthermore, patients were divided into two groups using a Pittsburgh Sleep Quality Index cut-off score of 6, and sleep disturbance was correlated with old age and second-line chemotherapy. Conclusions : Nausea affects QOL and night-time sleep of colon cancer patients with middle risk chemotherapy

Attenuation Of Multiple Nef Functions In HIV-1 Elite Controllers

Background Impaired HIV-1 Gag, Pol, and Env function has been described in elite controllers (EC) who spontaneously suppress plasma viremia to &lt; 50 RNA copies/mL; however, activity of the accessory protein Nef remains incompletely characterized. We examined the ability of 91 Nef clones, isolated from plasma of 45 EC and 46 chronic progressors (CP), to down-regulate HLA class I and CD4, up-regulate HLA class II invariant chain (CD74), enhance viral infectivity, and stimulate viral replication in PBMC. Results In general, EC Nef clones were functional; however, all five activities were significantly lower in EC compared to CP. Nef clones from HLA-B*57-expressing EC exhibited poorer CD4 down-regulation function compared to those from non-B*57 EC, and the number of EC-specific B*57-associated Nef polymorphisms correlated inversely with 4 of 5 Nef functions in these individuals. Conclusion Results indicate that decreased HIV-1 Nef function, due in part to host immune selection pressures, may be a hallmark of the EC phenotype