薬理と治療
Volume 41, Issue 5, 2013
Volumes & issues:
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扉・目次
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TOPICS:第12 回CRC と臨床試験のあり方を考える会議2012 in 大宮
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【セッション5 /国際競争力を高める試験実施体制の整備】 第Ⅰ相臨床試験実施施設における,薬物動態測定のための採血,蓄尿,および心電図測定実施にあたっての工夫
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【セッション5 /国際競争力を高める試験実施体制の整備】 治験薬温度管理およびデータ管理業務の無人化-データの記録・送信者からデータの受信者へ
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【セッション7 /立ち見御免! ここから始まるIRB の電子化-あなたのIRB は大丈夫?】 IRB 資料の電子ファイル授受に関する製薬協の考え
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ORIGINAL ARTICLES
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動脈硬化性疾患予防ガイドライン 2012 年版におけるスタチンによるコレステロール管理の疫学研究
41巻5号(2013);View Description Hide DescriptionIn this study, we retrospectively analyzed the goals of achieving low-density lipoprotein cholesterol(LDL-C)control in clinical practice. Medical records from the databases of 15 Japanese hospitals, in accordance with the guidelines for LDL-C control which were revised in 2012, were used. In this study, a total of 6789 cases taking statins for ≧3 months between April 1 2009 and March 31 2012 were evaluated. The evaluation of LDL-C control goal achievement rates, categorized by the type of statin pre-scribed, revealed that rosuvastatin had the highest success rate for secondary prevention in category III groups. The evaluation of disease risk factors indicated that the LDL-C goal achievement rate in patients taking rosuvastatin improved in a high-risk coronary artery disease group, in which epidemiological research had previously determined the treatment to be insufficient. The increasing popularity of rosuvastatin and other strong statins, such as atorvastatin and pitavastatin, may have contributed to these results. However, this study confirmed that some patients did not achieve the target values set by the guidelines. Thus, it is important to improve awareness of these target values. -
治験における有害事象に関する調査研究―医師,CRC,CRA の認識の相違と改善策―
41巻5号(2013);View Description Hide DescriptionBackground The concept of an“adverse event”appeared in clinical trials of investigational drugs by the J-GCP(Good clinical practice in Japan)in Japan. However, the concept seems to be poorly understood between physician investigators, clinical research coordinators(CRCs)and clinical research associates(CRAs). The purpose of this study was to conduct a survey to clarify the difference in recognition of adverse event in clinical trials of investigational drugs between physician investigators, CRCs, CRAs and to improve the quality of the safety data of investigational drugs. Methods The questionnaire survey was carried out on the recognition about the adverse events for 53 physician investigators, 81 CRCs and 69 CRAs. Results The large variation was found in the recognition about the adverse events within each professional staff and between physician investigators, CRCs and CRAs. Conclusions The correct meaning of an adverse event is not well understood by professional staffs such as physician investigator, CRC and CRA. In order to improve the quality of the safety data in clinical trials of investigational drugs, it is necessary for physician investigator, CRC and CRA to reconfirm and to understand correctly the exact definition and meaning of adverse event. For this purpose, it is essentially necessary to increase an opportunity to communicate each other among the clinical trial professionals including a regulatory agency. -
わが国の治験における臨床開発モニター(CRA)に関する調査研究―勤務内容とストレスの実態―
41巻5号(2013);View Description Hide DescriptionObjectives This study was performed to clarify the actual situation of duty contents and the stress of clinical research associates(CRAs)in Japan. Methods The questionnaire survey was carried out for 167 CRAs belonging to Japanese contract research organization(CRO). Results The results showed that CRAs in Japan had a wide variety of work to raise quality and efficiency in clinical trials of investigational drugs, and it became clear that most CRA felt stress on the correspondence duties with communication such as“taking the appointment and the communication with principal physician investigators”, the documentation duties such as “the making of documents in conjunction with the contract and the payment”and the communication in English. Conclusions The results suggest that the documentation ability, the communicative competence and the linguistic ability are necessary for CRA in the future. Improving an ability to keep the balance between“strict”and“flexible”is essentially important for CRA, it is necessary to increase opportunities to communicate among other members so that CRA comes to have collaboration as a member of the teams for drug development and fostering. -
アジュバント関節炎ラットにおけるTriptolide の IL-1β 抑制作用
41巻5号(2013);View Description Hide DescriptionVarious extracts of the Chinese herbal medicine Tripterygium wilfordii Hook. f.(TWHF)have been reported to be therapeutically effective for rheumatoid arthritis(RA)in China, but their action mechanism has not been understood well. Although triptolide, a diterpenoid triepoxide from TWHF, suppresses the inflammatory cytokine production in vitro, the influence of triptolide on immune system is not fully understood well. The present study, therefore, was designed to examine the effects of triptolide on cytokines production in vitro and in vivo by using adjuvant arthritic rats. The first part of these experiments was designed to examine the effects of triptolide on arthritic rats. Adjuvant arthritis was induced in male Wistar rats by a single subcutaneous injection of 0.1 mL complete Freund’s adjuvant into the hind paw. Arthritic rats were injected intraperitoneally with various doses of triptlide once a day for 1 week, starting one week after adjuvant injection. The minimum concentration of tiptolide, which caused significant suppression of paw swelling, was 0.3 mg/kg. The second part of these experiments was carried out to measure the ability of cytokine production by splenocytes from the arthritis rats which were treated with triptolide. Triptolide caused suppression of IL-1β and IL-6 production in splenocytes which was activated by concanavalin A. These data suggest that the therapeutic effects of TWHF in RA are in part due to the novel chondroprotective effects of triptolide via suppression of IL-1β and IL-6 production. -
Behavioral Evidence for Beneficial Effects of Soy Peptide Supplementation on Higher Brain Function in Healthy Young Volunteers
41巻5号(2013);View Description Hide DescriptionRecent study has demonstrated that dietary supplementation of soy peptides, composed primarily of di- and tri-peptides(Hinute, Fuji Oil Co. Ltd), improved age-associated cognitive decline, such as delayed memory and immediate memory. Furthermore, soy peptide intake increased the levels of certain neuroactive amino acids in the adult mouse brain. In this study, we evaluated the effects of soy peptide supplementation on higher brain function in healthy young volunteers. A randomized, double-blind, placebo-controlled study was performed in 41 healthy male subjects aged between 20 and 22(soy peptide group:n=21, placebo group:n=20). Neuropsychological tests were performed at baseline and after 2-week supplementation of 8 g/day soy peptide or placebo. The task performance accuracy assessed by the Uchida-Kraepelin test was significantly higher in the soy peptide group than in placebo group. The recognition memory test for words showed significant improvement in the recognition memory performances of new items in the soy peptide group. Subjective evaluation by the visual analogue scale also demonstrated that soy peptide supplementation reduced fatigue and stress after the neuropsychological tests. These results suggest that soy peptide dietary supplementation could help reduce fatigue and stress and improve task-solving ability. -
投与経路別生物学的抗リウマチ薬選択についての研究―生物学的抗リウマチ薬使用患者投与方法アンケートから―
41巻5号(2013);View Description Hide DescriptionObjective To clarify the impact of patients’lifestyle such as age, work situation and travel time to clinic on their choice of biological disease modifying anti-rheumatic drugs(DMARDs)and on the preferred route of administration(intravenous:IV or subcutaneous:SC)in patients with rheumatoid arthritis(RA). Method A questionnaire comprising 19 questions including age, gender, travel time for an outpatient visit, and preference of route of administration was collected. Results Of the patients who received biological DMARDs and enrolled in this survey(151 patients)75% were female, 43% received tocilizumab, and 65% of SC treated patients injected themselves. There was no relationship between preferred route of administration and age, gender, working status, time of travel to clinic. On the other hand, when assuming that patients could choose the route of administration with same products, about 56% of patients who used IV products wanted to continue using them and 80% of patients who received SC products wanted to continue using them. The characteristic of the patient who wanted to change the administration routes from IV into SC was as follows;the patents who are young, who needed long time to travel to the hospital, and who needed long time to stay in the hospital. Conclusion These results indicate that biological DMARDs are not selected only according to patient’s lifestyle or user-friendliness in the real clinical practice. However, if more than one route of administration within the same product was available to RA patients and healthcare professionals, this would allow selection based on lifestyle and user-friendliness in the real clinical practice.
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REVIEW
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RA 治療における DMARDs のアドヒアランス
41巻5号(2013);View Description Hide DescriptionArticles on medication adherence to oral disease modifying anti-rheumatic drugs(DMARDs) among patients with rheumatoid arthritis were extracted from research available on the Pub-Med database from its inception to January 2013. Ninety six articles from PubMed were included if they addressed adherence in patient with rheumatoid arthritis and included a clear definition of the methods used to determine adherence and the determinants used. This literature review is limited to 7 articles with a patient count of ≧100 and an observation period of 1 year in longitudinal study. Adherence rate to oral DMARDs was suboptimal, ranging from 30% to 69%. Improving adherence to DMARDs therapy could dramatically improve the efficacy of drug therapy. No consistent risk factors were identified for nonadherence to oral DMARDs or other prescriptions;however, there was some evidence for self-efficacy, patient-health-care-provider relationships, patient beliefs about medications, patient support for educational intervention programs, and patient age as factors affecting adherence. Besides addressing practical barriers, healthcare providers should be sensitive to patients’ personal beliefs that may affect adherence, and should discuss with their patients any concerns that they raise about prescription medicines. Because beliefs and concerns are modifiable, there is hope that adherence can be improved.
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