薬理と治療
Volume 46, Issue 7, 2018
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扉・目次
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TOPICS 第17回CRCと臨床試験のあり方を考える会議 2017 in 名古屋
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- シンポジウム5/小児臨床開発の現状と課題,推進に向けた取り組み~未来を担う子どもたちのために~
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- 教育セッション3/開発が困難な希少疾病・難病領域における臨床研究,新薬開発の産学患の取り組み
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患者団体等が主体的に運用する疾患横断的な情報基盤プラットフォームの運用およびそれを用いたQOL 調査研究実施
46巻7号(2018);View Description Hide Description
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ORIGINAL ARTICLES
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日本人2 型糖尿病患者に対するミチグリニドカルシウム水和物のインスリン製剤との併用療法における有効性および安全性の検討(続報)―製造販売後臨床試験―
46巻7号(2018);View Description Hide DescriptionObjective Followed by a placebo-controlled, randomized, double-blind clinical trial, an open-label clinical trial was conducted to examine the long-term efficacy and safety of concomitantly administering mitiglinide(Glufast tablets)to type 2 diabetes mellitus patients without adequate glycemic control, despite receiving long-acting insulin only or a combination of long-acting insulin and an oral hypoglycemic agent with diet therapy. Methods During the double-blind clinical trial period, in addition to monotherapy with long-acting insulin or a combination therapy of long-acting insulin and an oral hypoglycemic agent, one tablet of mitiglinide(10 mg)or placebo was administered three times a day before meals for 16 weeks. During the open-label clinical trial period, in addition to insulin therapy for the double-blind clinical trial period, one tablet of mitiglinide(10 mg)was administered three times a day before meals for 36 weeks. This trial was registered in Clinical-Trials. gov (NCT02154347).Results A significant decrease in HbA1c level from baseline was observed at any evaluation point after the initiation of treatment with mitiglinide. Adverse drug reactions to mitiglinide were observed in 31 out of 175 patients. Hypoglycemia occurred in 25 patients; however, severe hypoglycemia and treatment discontinuation case were not observed. Conclusions Mitiglinide appears to be clinically useful as a combination therapy with long-acting insulin in patients with type 2 diabetes mellitus. -
トラボプロスト点眼液(トラバタンズ® 点眼液0.004%)の日常診療下における長期使用時の安全性と有効性―使用成績調査の最終解析結果報告―
46巻7号(2018);View Description Hide DescriptionObjective We carried out a drug use results survey(hereafter“this survey”)to confirm the safety and efficacy of travoprost ophthalmic solution(TRAVATANZ(R) 0.004% ophthalmic solution) with long-term use in routine clinical practice. Methods This survey was carried out between July 14, 2008, and May 20, 2014 in patients with glaucoma or ocular hypertension recorded in a central registry. The standard follow-up period per patient(duration of use)was 24 months, and safety was investigated primarily by evaluating the development of adverse reactions and tabulating data on four priority survey items that were established in adverse. Efficacy was investigated by evaluating the response rate and reduction in intraocular pressure. Results The safety analysis for this survey included 4326 patients, and the efficacy analysis included 4142 patients. The incidence of adverse reactions was 33.1%(1432╱4326 patients). Broken down by system organ class, the most common category was eye disorders, which accounted for 30.3%. Total of adverse reactions were reported 2601 cases. The main adverse reactions were hypertrichosis in 552 cases, blepharal pigmentation in 484, ocular hyperaemia in 416, iris hyperpigmentation in 347, conjunctival hyperaemia in 286, and punctate keratitis in 76. In 4045 of the 4142 patients included in the efficacy analysis(excluding 97 patients whose efficacy assessment was not recorded), 75.2%(3040╱4045 patients)of patients were assessed as“effective”. Ocular pressure decreased significantly compared with baseline at all follow-up time-points from Month 1 to Month 24 after the start of administration in all the patients included in the efficacy analysis, patients newly treated with Travatanz(R) alone, and normal tension glaucoma patients(P<0.0001 at all follow-up time-points). Conclusions The results of this survey confirmed the safety and efficacy of long-term routine clinical use of Travatanz(R). -
コーヒー豆由来クロロゲン酸の正常高値血圧者とⅠ度高血圧者の日本人成人に対する血圧への効果―ランダム化比較試験のIndividual Participant Dataメタアナリシス―
46巻7号(2018);View Description Hide DescriptionBackground/Objective Coffee chlorogenic acid has been showed to reduce blood pressure. This individual participant data(IPD)meta-analysis was to assess the overall effect of coffee chlorogenic acid supplementation on gradeⅠ hypertension and high-normal blood pressure. Design Systematic review and meta-analysis of individual participant data(IPD)from randomized, double-blind, placebo-controlled trials. Data sources Medline(PubMed), JDreamⅢ and University hospital Medical Information Network Clinical Trials Registry(UMIN-CTR)from inception to May 2018. Eligibility criteria for selecting studies Randomized, double-blind, placebo-controlled trials of ingestion of coffee chlorogenic acid for 12 or more weeks were eligible for inclusion if data of blood pressure were collected. Results Three eligible randomized controlled trials(total 450 participants)were identified. IPD were obtained for 432 participants. Coffee chlorogenic acid reduced blood pressure in grade 1 hypertension and high-normal blood pressure participants(systolic blood pressure -7.3 mmHg, 95% confidence interval -8.3 to -6.3; diastolic blood pressure -4.2 mmHg, 95% confidence interval -5.2 to -3.2). In the subgroup analysis, chlorogenic acid reduced blood pressure(systolic blood pressure -8.6 mmHg, 95% confidence interval -10.3 to -6.8; diastolic blood pressure -4.8 mmHg, 95% confidence interval -6.3 to -3.3)in gradeⅠhypertension participants and reduced blood pressure(systolic blood pressure -6.7 mmHg, 95% confidence interval -7.8 to -5.6; diastolic blood pressure -4.3 mmHg, 95% confidence interval -5.6 to -2.9)in high-normal blood pressure participants. Adverse effects caused by coffee chlorogenic acid were not observed. Conclusions Coffee chlorogenic acid has a blood pressure lowering effect in gradeⅠ hypertension and high-normal blood pressure Japanese adults(. UMIN-CTR ID:UMIN000032524) -
ルチン高含有ダッタンソバ粉を含むソフトカプセルの継続摂取による血流改善効果―プラセボ対照ランダム化二重盲検並行群間比較試験―
46巻7号(2018);View Description Hide DescriptionObjective We evaluated the effects of 12 weeks ingestion of dietary supplement containing rutin-rich Tartary buckwheat“Dattan Soba Seikatsu”on the blood pressure and blood flow in this randomized, double-blind, placebo-controlled, parallel-group study. Methods Fifty healthy Japanese people with the conditions of a)and╱or b)were divided into active test and placebo groups. a)SBP is≥130 mmHg and<160 mmHg or DBP is≥85 mmHg and<100 mmHg. b)Home SBP is≥125 mmHg and<155 mmHg or home DBP is≥80 mmHg and<95 mmHg. Subjects ingested active test dietary supplement(containing 4.8 mg rutin)or placebo dietary supplement(not containing rutin)daily for 12 weeks. Physical, and blood examinations and medical interviews were conducted at weeks 0, 4, 8, and 12. Results Blood pressure did not significantly differ between the groups. However, blood flow at rest significantly differed between groups at 12weeks. Moreover, in the subgroup with normal blood pressure and relatively severe chillness of hands and feet, blood flow at rest significantly differed between groups at 12weeks and chillness of hands and feet were improved at 12weeks relative to 0week in the active test group. There were no adverse events related to the intake of the test foods. No medical changes or safety concerns were observed with physical and blood examinations nor reported during medical interviews during the trial. Conclusion Dietary supplement containing rutin-rich Tartary buckwheat improved blood flow of the finger and chillness of hands and feet(. UMIN-CTR ID:000026254) -
BCAA 含有飲料「百白糀」摂食に伴う急性期筋肉疲労軽減効果の検討―ランダム化オープン・プラセボ対照クロスオーバー試験―
46巻7号(2018);View Description Hide DescriptionObjectives HYAKUBYAKUKOJI is a milk fermented by koji mold containing branched-chain amino acids(BCAA). Herein we investigate the anti-fatigue effect associated with the ingestion of HYAKUBYAKUKOJI in healthy adults with the habit of exercising. Methods In a randomized, open-placebo-controlled crossover study, healthy subjects were assigned to 2 groups(preceding ingestion of HYAKUBYAKUKOJI or control food). As an exercise tolerance test, subjects underwent total 4 hours of body workload using a bicycle ergometer. After every 1 hour of body workload, subjects took a break of 10 min and ingested the test food. We evaluated the physical performances of the subjects by 10-s high-power test, measured subjective fatigue by visual analogue scale and modified Borg scale, blood collection and urinalysis-related fatigue before and after body workload, after 4-h break, and the next day, and also performed blood amino acids analysis. Results Ingestion of HYAKUBYAKUKOJI showed improvement in physical performance and reduced subjective fatigue compared with the control food. Moreover, blood BCAA concentration was maintained at the post-body workload in HYAKUBYAKUKOJI ingestion group. Conclusions In this study, we concluded that ingestion of HYAKUBYAKUKOJI before exercise produces anti-fatigue effect on the acute phase fatigue for healthy adults who routinely exercise(. UMIN000024254) -
ピセアタンノール摂取による肌の水分や弾力へ及ぼす効果―ランダム化二重盲検プラセボ対照並行群間比較試験―
46巻7号(2018);View Description Hide DescriptionObjectives The aim of this study was to investigate the effect of a dietary supplement containing piceatannol on skin in healthy subjects with dry skin. Methods A randomized, double blind, placebo-controlled parallel-group, comparison study was conducted in 36 healthy subjects(30-60 years old)with dry skin. They were randomly divided into two groups and ingested either the test product(125 mL drink containing 10 mg piceatannol derived from passion fruit seed extract)or the control product(placebo drink)three packs per day for 8 weeks. The outcomes about skin condition were evaluated using moisture content of horny layer, Trans-epidermal Water Loss(TEWL)and viscoelasticity of the face. This study was registered in UMIN-CTR(UMIN000030491). Results The water content and elastic recovery from the pretrial were significantly increased at 8 week in the test product containing piceatannol compared to the placebo group. Conclusions These result suggested that the daily supplementation of piceatannol derived from passion fruit seed extract is effective for skin moisture. -
加熱殺菌体Lactobacillus acidophilus L—92 株を含有する食品の健常人に対する過剰摂取時の安全性―ランダム化プラセボ対照二重盲検並行群間比較試験―
46巻7号(2018);View Description Hide DescriptionA randomized, placebo-controlled, double-blind, parallel-group comparison study on 24 healthy subjects(11 males and 13 females, 38.1±8.7 years old)was conducted to evaluate the safety of excessive intake of tablets containing Lactobacillus acidophilus strain L-92(L-92). Subjects were randomly divided into two groups. Each group ingested tablets containing either L-92 at 11 times of recommended daily intake or the placebo tablets, without L-92, for 4 consecutive weeks. No abnormal change was observed during the physical examination, blood analysis and urinalysis after 2 and 4 weeks of intake in the test groups. No adverse event attributed to the test tablets was found in this study. In conclusion, these results demonstrated that tablets containing L-92 were safe for consumption by healthy subjects with or without symptoms of mild perennial allergic rhinitis. -
Association Between Patients’ Communication Motivation and Physicians’ Past Reactions/Attitudes Regarding Complementary and Alternative Medicine Use in Japan
46巻7号(2018);View Description Hide DescriptionObjective This study aimed to elucidate the perspective of patients with chronic diseases on the relationship between their motivation to communicate regarding complementary and alternative medicine(CAM)use and past reactions of physicians(negative or supportive). Methods A questionnaire was administered to 428 patients about their experiences of disclosing CAM use to physicians, the physiciansʼ reaction, and patientsʼ motivation to communicate regarding CAM in the future. Results In total, 277 patients(65.3%)had discussed CAM with their physicians, with 83 (30.2%)experiencing a negative reaction(i. e., denial of therapy efficacy, with no reason╱information provided)and 217(79.2%) experiencing a supportive reaction(i. e., empathy). Furthermore, 175 patients (63.6%)wished to communicate to the physician regarding CAM in the future. Logistic regression analysis of factors related to the patient willingness to communicate was performed, with physiciansʼ reactions as an additional independent variable. Results indicated that patientsʼ communicative and critical health literacy(P=0.030, OR=1.61)and physiciansʼ empathic reaction(P=0.033, OR=1.33)were significantly associated with willingness to communicate. Conclusion Patients who had higher communicative and critical health literacy and experienced an empathic reaction by the physician were more likely to wish to communicate with a physician about CAM use in the future. While it is necessary to educate patients to enhance their communicative and critical health literacy, an empathic reaction by the physician may enhance the patientsʼ willingness to communicate about CAM, contributing to good communication.
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SERIES
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INFORMATION
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CONSORT 2010声明―ランダム化並行群間比較試験報告のための最新版ガイドライン―(薬理と治療2010;38:939-49. より再掲載)
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