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71.
72.
Kasai T; Ohe Y; Nishio K; Kunitoh H; Tamura T; Sekine I; Kubota K; Yamamoto N; Nakamura Y; Shinkai T; Kodama T; Saijo N 《Japanese journal of clinical oncology》1998,28(3):214-221
BACKGROUND: It is important to minimize the incidence of ineligible cases
to improve the quality of clinical trials. To determine factors which may
influence the incidence of ineligible cases, the incidence of and reasons
for ineligibility in clinical trials were retrospectively analyzed.
METHODS: We retrospectively examined the incidence of and reasons for
ineligibility for inclusion in eight clinical trials conducted by the Lung
Cancer Chemotherapy Study Group of the Japan Clinical Oncology Group and
four trials financed by trust funds from a pharmaceutical company. RESULTS:
In these 12 clinical studies, the incidence of ineligibility was 4.2%
(32/762) (range 0-10.6%). Specific factors that might influence the
incidence of ineligible cases were then analyzed. There was a significant
difference in the incidence of ineligibility between the methods of
registration (P < 0.05). The incidences using a central registration and
without using a central registration system were 2.8% (9/322) and 5.2%
(23/440) respectively. We also analyzed ineligible cases in clinical
studies published in the Journal of Clinical Oncology. In clinical studies
published in the Journal of Clinical Oncology recently and 10 years ago,
the incidences of ineligible cases were 5.0% (942/18 878) and 4.1%
(206/4995) respectively. In clinical studies on lung cancer published in
the Journal of Clinical Oncology from 1984 to 1995, the incidence of
ineligible cases was 4.7% (900/19,116). There was no significant difference
in the incidence of ineligible cases between our 12 studies and the Journal
of Clinical Oncology clinical studies by the chi 2 test (P > 0.05).
CONCLUSIONS: We conclude that the incidence of ineligible cases in our
studies is similar to that in clinical trials published in the Journal of
Clinical Oncology. Central registration systems are useful for checking for
ineligibility, and to increase the quality of clinical trials.
相似文献
73.
Association of Loss of Heterozygosity at the p53 Locus with Chemoresistance in Osteosarcomas 总被引:4,自引:0,他引:4
Akiteru Goto Hiroaki Kanda Yuichi Ishikawa Seiichi Matsumoto Noriyoshi Kawaguchi Rikuo Machinami Yo Kato Tomoyuki Kitagawa 《Cancer science》1998,89(5):539-547
Although the osteosarcoma is considered to be among the most chemosensitive malignancies and preoperative chemotherapy is commonly applied, an appreciable proportion of cases are in fact quite insensitive. Predictive markers for chemosensitivity are therefore desirable in order to develop effective treatment strategies. Thirty-two cases of conventional osteosarcomas treated at the Cancer Institute Hospital, Tokyo, were analyzed. The sensitivity to preoperative chemotherapy was investigated with reference to loss of heterozygosity (LOH) at the 17p13 ( p 53) and 13q14 ( Rb ) loci and expression of the cell-cycle associated proteins, p53, Rb, p21/Waf-1, mdm-2 and Ki-67, as detected immunohistochemically. LOH was detected by analyzing polymerase chain reaction products at marker microsatellite loci. The efficacy of chemotherapy was evaluated both radiologically and histologically. LOH at p 53 or Rb loci was seen in 54% (13/24) and 58% (14/24) of cases, respectively. Only 15% of osteosarcomas with LOH at the p 53 locus were sensitive to preoperative chemotherapy, as compared to 64% of tumors without such loss ( P <0.05). A similar but much less distinct tendency was observed with LOH at the Rb locus. No relationship was evident between chemosensitivity and immunohistochemical staining patterns for p53, Rb, p21/Waf-1, mdm-2 or Ki-67. The results suggest that p 53 gene deletion, but not the other parameters investigated, may be useful for predicting chemoresistance of osteosarcomas. 相似文献
74.
Conjugated linoleic acid supplementation reduces adipose tissue by apoptosis and develops lipodystrophy in mice 总被引:47,自引:0,他引:47
Tsuboyama-Kasaoka N Takahashi M Tanemura K Kim HJ Tange T Okuyama H Kasai M Ikemoto S Ezaki O 《Diabetes》2000,49(9):1534-1542
Conjugated linoleic acid (CLA) is a naturally occurring group of dienoic derivatives of linoleic acid found in beef and dairy products. CLA has been reported to reduce body fat. To examine the mechanism(s) of CLA reduction of fat mass, female C57BL/6J mice were fed standard semipurified diets (10% fat of total energy) with or without CLA (1% wt/wt). Terminal deoxynucleotidyl transferase-mediated dUTP-biotin nick endlabeling (TUNEL) and DNA fragmentation analysis revealed that fat-mass decrease by CLA was mainly due to apoptosis. Tumor necrosis factor (TNF)-alpha and uncoupling protein (UCP)-2 mRNA levels increased 12- and 6-fold, respectively, in isolated adipocytes from CLA-fed mice compared with control mice. Because it is known that TNF-alpha induces apoptosis of adipocytes and upregulates UCP2 mRNA, a marked increase of TNF-alpha mRNA with an increase of UCP2 in adipocytes caused CLA-induced apoptosis. However, with a decrease of fat mass, CLA supplementation resulted in a state resembling lipoatrophic diabetes: ablation of brown adipose tissue, a marked reduction of white adipose tissue, marked hepatomegaly, and marked insulin resistance. CLA supplementation decreased blood leptin levels, but continuous leptin infusion reversed hyperinsulinemia, indicating that leptin depletion contributes to the development of insulin resistance. These results demonstrate that intake of CLA reduces adipose tissue by apoptosis and results in lipodystrophy, but hyperinsulinemia by CLA can be normalized by leptin administration. 相似文献
75.
Ohno T Ikebuchi E Henomatsu K Kasai K Nakagome K Iwanami A Hiramatsu K Hata A Fukuda M Honda M Miyauchi M 《Psychiatry research》2000,100(3):155-167
Social skill deficits in schizophrenia profoundly affect patients' life-long outcome, although the profile of the underlying cognitive dysfunction still remains a matter of debate. In the present study, we investigated the relationship between social skills and event-related potentials (ERPs) in an auditory selective attention task, in addition to the neurocognitive indices obtained from the degraded-stimulus continuous performance test (CPT) and clinical indices, such as Brief Psychiatric Rating Scale (BRPS) and global assessment of function (GAF) scores. Social skills were assessed using a Japanese version of the structured role play test. Fourteen persons with schizophrenia participated in the study. Non-verbal skills showed a positive correlation with GAF, the performance level, N1 and N2b amplitude in the ERP task, and hit rate in the CPT, and a negative correlation with reaction time in the CPT. Verbal communication skills showed a positive correlation with GAF, the performance level and N2b amplitude in the ERP task, and hit rate in the CPT, and a negative correlation with reaction time in the CPT. Processing skills showed a positive correlation with the performance level and N1 amplitude in the ERP task and a negative correlation with reaction time in the CPT. These findings suggested that the social skill deficits of persons with schizophrenia were related to the vigilance level and controlled stimulus detection processing. 相似文献
76.
Naomi Morita Hiroyuki Kusuhara Yoshitane Nozaki Hitoshi Endou Yuichi Sugiyama 《Drug metabolism and disposition》2005,33(8):1151-1157
Rat organic anion transporter 2 (rOat2, Slc22a7) is a sinusoidal multispecific organic anion transporter in the liver. The role of rOat2 in the hepatic uptake of drugs has not been thoroughly investigated yet. rOat2 substrates include nonsteroidal anti-inflammatory drugs, such as ketoprofen, indomethacin, and salicylate. In the present study, the uptake of ketoprofen, indomethacin, and salicylate by freshly isolated rat hepatocytes was characterized. The uptake of ketoprofen, indomethacin, and salicylate by hepatocytes was sodium-independent, and the rank order of their uptake activities was indomethacin > ketoprofen > salicylate. Kinetic analysis based on Akaike's Information Criterion suggested that the uptake of ketoprofen and indomethacin by hepatocytes consists of two saturable components and one nonsaturable one. The K(m) and V(max) values for the high- and low-affinity components for ketoprofen uptake were 0.84 and 97 microM and 35 and 1800 pmol/min/mg protein, respectively, whereas those for indomethacin were 1.1 and 140 microM and 130 and 16,000 pmol/min/mg protein, respectively. The K(m) values of the high-affinity component were similar to those for rOat2 (3.3 and 0.37 microM for ketoprofen and indomethacin, respectively). The uptake of ketoprofen by hepatocytes was significantly inhibited by probenecid and rOat2 inhibitors (indocyanine green, indomethacin, glibenclamide, and salicylate). Other inhibitors of rOatps (taurocholate and pravastatin) and rOat3 (pravastatin and p-aminohippurate) had a slight effect, but digoxin had no effect. These results suggest that rOat2 accounts partly for the hepatic uptake of ketoprofen and, presumably, indomethacin as a high-affinity site and that other transporters, such as rOatps, but not rOatp2, and rOat3, are also involved. 相似文献
77.
Shin-ichi Fukumoto Naoko Yamauchi Hisashi Moriguchi Yoshitaka Hippo Akira Watanabe Junji Shibahara Hirokazu Taniguchi Shumpei Ishikawa Hirotaka Ito Shogo Yamamoto Hiroko Iwanari Mitsugu Hironaka Yuichi Ishikawa Toshiro Niki Yasunori Sohara Tatsuhiko Kodama Masaharu Nishimura Masashi Fukayama Hirotoshi Dosaka-Akita Hiroyuki Aburatani 《Clinical cancer research》2005,11(5):1776-1785
PURPOSE: Squamous cell carcinoma (SCC) and adenocarcinoma of the lung are currently subject to similar treatment regimens despite distinct differences in histology and epidemiology. The aim of this study is to identify a molecular target with diagnostic and therapeutic values for SCC. EXPERIMENTAL DESIGN: Genes specifically up-regulated in SCC were explored through microarray analysis of 5 SCCs, 5 adenocarcinomas, 10 small cell lung carcinomas, 27 normal tissues, and 40 cancer cell lines. Clinical usefulness of these genes was subsequently examined mainly by immunohistochemical analysis. RESULTS: Seven genes, including aldo-keto reductase family 1, member B10 (AKR1B10), were identified as SCC-specific genes. AKR1B10 was further examined by immunohistochemical analysis of 101 non-small cell lung carcinomas (NSCLC) and its overexpression was observed in 27 of 32 (84.4%) SCCs and 19 of 65 (29.2%) adenocarcinomas. Multiple regression analysis showed that smoking was an independent variable responsible for AKR1B10 overexpression in NSCLCs (P < 0.01) and adenocarcinomas (P < 0.01). AKR1B10 staining was occasionally observed even in squamous metaplasia, a precancerous lesion of SCC. CONCLUSION: AKR1B10 was overexpressed in most cases with SCC, which is closely associated with smoking, and many adenocarcinoma cases of smokers. These results suggest that AKR1B10 is a potential diagnostic marker specific to smokers' NSCLCs and might be involved in tobacco-related carcinogenesis. 相似文献
78.
Shunsuke Ogata Yoshito Ishii Keiichiro Asano Erena Kobayashi Shun Kubota Keita Takahashi Yosuke Miyaji Yuichi Higashiyama Hideto Joki Hiroshi Doi Michiaki Koga Hideyuki Takeuchi Fumiaki Tanaka 《Internal medicine (Tokyo, Japan)》2022,61(11):1757
Guillain-Barré syndrome (GBS) has occasionally occurred in people who have received coronavirus disease 2019 (COVID-19) vaccines. Dysgeusia is rare symptom of GBS. We herein report a rare case of sensory ataxic GBS with dysgeusia just after the second dose of the Pfizer-BioNTech COVID-19 vaccine. Although autoantibodies against glycolipids were not detected, immunotherapy with intravenous immunoglobulin and methylprednisolone pulse therapy effectively ameliorated the symptoms. Our report suggests that the COVID-19 vaccine may induce various clinical subtypes of GBS, including a rare variant with sensory ataxia and dysgeusia. 相似文献
79.
Junichi Mazaki Kenji Katsumata Tetsuo Ishizaki Noritoshi Fukushima Ryutaro Udo Tomoya Tago Kenta Kasahara Hiroshi Kuwabara Masanobu Enomoto Yuichi Nagakawa Akihiko Tsuchida 《Medicine》2022,101(27)
Anastomotic leakage (AL) after colorectal surgery is a serious complication. This study aimed to evaluate the effectiveness of the EEA™ circular stapler, a new triple-row circular stapler (TCS), relative to a conventional, double-row circular stapler (DCS).A total of 285 patients who underwent anastomosis with the double stapling technique at the Tokyo Medical University Hospital between 2017 and 2021 were included in this nonrandomized clinical trial with historical controls using a propensity score (PS) analysis. The primary endpoint was the risk of AL.We performed a 1:2 PS matching analysis. Before case matching, AL occurred in 15 (7.4%) and 2 (2.4%) patients in the DCS and TCS groups, respectively, with no significant difference (P = .17). After case matching, AL occurred in 13 patients (11.6%) and 1 patient (1.8%) in the DCS and TCS groups, respectively, revealing a significant difference (P = .04). Cox models were created by applying PS to adjust for group differences via regression adjustment. Odds ratios for AL in the DCS group versus the TCS group were 0.31 (95% confidence interval [CI]: 0.07–1.38) in the entire cohort, 0.15 (95% CI: 0.02–0.64) in the regression adjustment cohort, and 0.14 (95% CI: 0.02–1.09) in the 1:2 PS-matched cohort.PS analysis of clinical data suggested that the use of TCS contributes to a reduced risk of AL after colorectal anastomosis CTwith the double stapling technique. 相似文献
80.
Chiaki Imai Hiromi Saeki Kohei Yamamoto Ayano Ichikawa Makoto Arai Akinobu Tawada Takaaki Suzuki Yuichi Takiguchi Toyoyuki Hanazawa Itsuko Ishii 《Oncology Letters》2022,23(5)
Clinical trials have not fully demonstrated the efficacy and safety of radiotherapy plus cetuximab for locally advanced squamous cell head and neck cancer (LA-SCCHN) in patients with cisplatin-ineligible renal dysfunction. Patients who received radiotherapy plus cetuximab for LA-SCCHN at Chiba University Hospital (Chiba, Japan) between July 2013 and October 2018 were retrospectively reviewed. Background characteristics and locoregional control and overall survival rates were compared between patients with and without renal dysfunction. Survival was examined using Kaplan-Meier analysis and an adjusted Cox proportional hazards model. Kaplan-Meier analysis demonstrated that overall survival was shorter in patients with creatinine clearance of <45 ml/min (P=0.041; log-rank test). However, there was no difference in the locoregional control rate (P=0.477; log-rank test). Adjusted Cox analysis revealed that the risk of death was increased by 2.52-fold (hazard ratio, 2.52; 95% confidence interval, 1.01-6.30; P=0.048) if creatinine clearance was <45 ml/min. Moderate to severe renal dysfunction did not affect the locoregional control rate in patients with LA-SCCHN treated with radiotherapy plus cetuximab but was an adverse prognostic factor. 相似文献