巻号一覧
46 巻 (2015)
- 6 号 p. 253-
- 5 号 p. 225-
- 4 号 p. 179-
- 3 号 p. 115-
- 2 号 p. 55-
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46 巻, 4 号
選択された号の論文の5件中1～5を表示しています
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原著
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田中 雅幸, 妹尾 健, 西山 徳人, 藤井 良平 , 打谷 和記, 米山 雅紀, 荻田 喜代一, 廣田 育彦2015 年 46 巻 4 号 p. 179-184
発行日: 2015/07/31
公開日: 2015/08/19
ジャーナル フリーBackground: There is no established surrogate indicator for the efficacy and safety of dabigatran. Although activated partial thromboplastin time (APTT) may be an index of safety for dabigatran, the risk factors for the development of prolonged APTT while taking dabigatran is unclear. The purpose of this study was to find risk factors contributing to prolonged APTT.
Methods and Results: 394 plasma samples from 108 patients (67±9 years of age, 70 men) with non-valvular atrial fibrillation (NVAF) at our hospital were analyzed. Median APTT in patients taking dabigatran 220 mg/day was 39.4 seconds (range 19.9-88.6), with a positive correlation between APTT and age (R2=0.04, p<0.01) and a negative correlation between APTT and creatinine clearance (Ccr) (R2=0.07, p<0.01). Median APTT in patients taking dabigatran 300 mg/day was 39.8 seconds (range 24.8-66.6), with a negative correlation between APTT and Ccr (R2=0.09, p<0.01). In multivariable analysis, significant associations were found between APTT and the following risk factors: age ≥70 years, gender, weight, Ccr, and dose of dabigatran. Twelve patients (11%) developed bleeding complication. In receiver operating characteristic analysis, the cut-off value of APTT for bleeding-related adverse effects was 50.4 seconds. In multivariate analysis, Ccr and P-glycoprotein inhibitor were significant risk factors associated with prolongation of APTT to 50 seconds.
Conclusions: We identified the risk factors contributing to prolonged APTT during dabigatran treatment in NVAF patients.抄録全体を表示PDF形式でダウンロード (888K) -
森 恵里奈, 金子 真之, 成川 衛2015 年 46 巻 4 号 p. 185-189
発行日: 2015/07/31
公開日: 2015/08/19
ジャーナル フリーIn Japan, with the increasing use of overseas clinical data in clinical data packages submitted for new drug application, the amount of Japanese clinical data used in new drug application has been decreasing. Reports have shown that all-case surveillance studies have been conducted for a relatively large number of new drugs approved recently. While surveillance studies serve as one of the useful tools in the monitoring of postmarketing safety, all-case surveillance studies impose an additional burden on pharmaceutical companies and medical institutions. Therefore, their operation has to be improved. With this background, we examined the recent status of all-case surveillance study in Japan and factors influencing the judgment of its necessity. Eighty-two of 261 new drugs approved between 2006 and 2013 were required to conduct all-case surveillance studies for a certain period after launching. Orphan drugs and antineoplastic agents account for a large proportion of these drugs. Significant safety concern is considered to be a factor necessitating the conduct of all-case surveillance study. Also, accumulation of safety data on previously approved similar drugs and comparability of the new drug with the preceding drugs affect the judgment on the necessity of all-case surveillance study.抄録全体を表示PDF形式でダウンロード (671K) -
Miyoko NAGANUMA, Tsuyoshi SHIGA, Takehiko NAGAO, Kagari MURASAKI, N ...2015 年 46 巻 4 号 p. 191-197
発行日: 2015/07/31
公開日: 2015/08/19
ジャーナル フリーBackground: Japanese physicians tend to empirically maintain lower-intensity prothrombin time-international normalized ratios (PT-INR) of 1.6-2.6 for most non-valvular atrial fibrillation (NVAF) patients taking warfarin. However, the optimal anticoagulant intensity in Japanese patients with low CHADS2 (Congestive heart failure, Hypertension, Age ≥75, Diabetes, Stroke [doubled]) scores is not clear. This study aimed to evaluate the clinical outcome and anticoagulant intensity in Japanese NVAF patients aged ≥65 years with CHADS2 scores of 0-1 and taking warfarin.
Methods: We included 382 consecutive NVAF patients aged ≥65 years with CHADS2 scores of 0-1, who took warfarin between 2001 and 2006 (median age, 68 years; 29.8% women). This study included a median follow-up period of 54 months (1-154 months). The occurrence of thromboembolic events including ischemic stroke, transient ischemic attack and other systemic embolism, as well as major bleeding events were validated through a medical record review.
Results: The incidence of thromboembolic and major bleeding events was both 0.9 per 100 patient-year. All thromboembolic events occurred in patients with a PT-INR <2.00. The incidence of major bleeding events increased markedly in patients with a PT-INR ≥3.00. A HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly and concomitant Drugs/alcohol) score ≥3 was a risk for major bleeding (hazard ratio 4.8, 95% confidence interval 1.6-14.4). A PT-INR of 2.00-2.99 predicted a low incidence of thromboembolic and major bleeding events.
Conclusions: Our results showed that a PT-INR of 2.00-2.99 was associated with a low incidence of both thromboembolism and major bleeding in Japanese NVAF patients aged ≥65 years with CHADS2 score of 0-1 and taking warfarin.抄録全体を表示PDF形式でダウンロード (624K) -
津谷 喜一郎, 小出 宏, 中野 重行2015 年 46 巻 4 号 p. 199-210
発行日: 2015/07/31
公開日: 2015/08/19
ジャーナル フリーInternet surveys were performed in 2003 and 2013 to investigate the knowledge of the general public on clinical trials and placebo and their attitudes of participation in clinical trials. In both surveys, the term ‘clinical trial’ was recognized by many participants, and clinical trial advertisement was acknowledged by nearly one-half of the survey participants in 2003. Approximately 30 to 40% of the survey participants responded that they wished to participate in clinical trials for relatively mild diseases such as common cold or gastric ulcer, whereas 50 to 60% would participate in the case of gastric cancer. When the possibility to receive placebo was 50%, the rate of ‘yes’ response decreased by 10 to 20%. The proportions of responders who knew the term ‘placebo’ were 14% (females) and 23% (males) in 2003, and increased to 27% (females) and 31% (males) in 2013, although the rates were still less than one-third. The term ‘An-i-zai (安慰剤)’ was the most preferred Japanese translation for ‘placebo’ in both surveys. The environment for clinical trials has been improved by many measures and policies implemented during the decade between these surveys. However, educational activities on clinical trials targeting the general public remain insufficient. In order to familiarize and establish clinical trials in Japan, more proactive measures should be taken to provide information on clinical trial and placebo, and educate the general public to obtain their cooperation in participating as subjects. In that regard, it is important to enrich the sources of information such as the database of people's experience in clinical trials hosted by DIPEx-Japan. As for the Japanese translation of ‘placebo’, it is desirable to use ‘An-i-zai (安慰剤)’, ‘Ki-yaku (喜薬)’ or ‘Gi-yaku (擬薬)’ rather than ‘Gi-yaku (偽薬)’ which is widely used inappropriately.抄録全体を表示PDF形式でダウンロード (1075K) -
―脳内タウイメージング用放射性薬剤［11C]PBB3 の多施設連携研究での経験から―栗原 千絵子, 堀口 隆司, 鈴木 和子, 須原 哲也2015 年 46 巻 4 号 p. 211-224
発行日: 2015/07/31
公開日: 2015/08/19
ジャーナル フリーEthical Guidelines for Medical Research Involving Human Subjects have been enforced since April 2015 by the Ministry of Health, Labour and Welfare and the Ministry of Education, Science and Technology. According to the guidelines, a research project categorized as interventional or invasive clinical study that starts from October 2015 or later should implement monitoring and if necessary audit. Several study groups have issued guidelines on monitoring and audit, which seem to be appropriate for large-scale drug clinical trials, but a quality assurance system for other kinds of research is needed, especially for exploratory clinical research. We developed a scheme for exploratory clinical research, which we have been using even before monitoring and audit become mandatory. This scheme is composed of: (1) a questionnaire-based check sheet; (2) letter for site visit; (3) site visit protocol; and (4) site visit check sheet. We found that the scheme which we have implemented is useful for human subject protection and quality assurance of clinical research. This scheme can be applied flexibly according to the type and characteristics of other research projects.抄録全体を表示PDF形式でダウンロード (4627K)
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