薬理と治療
Volume 43, Issue 5, 2015
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扉・目次
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GUIDELINE
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TOPICS:システマティック・レビュー/メタアナリシスの結果は信じてよいか
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メタアナリシスの変遷と今後の課題
43巻5号(2015);View Description Hide DescriptionMeta-analysis emerged in 1976 and the first application in medicine was published in 1985. This article reviews the evolution of meta-analysis and future challenges. Three events having advanced meta-analysis were first discussed. Those are Cochrane collaboration, evidence-based medicine, and comparative effectiveness research. These events contributed to move forward the application of meta-analysis. Network meta-analysis may be a breakthrough to allow for indirect comparisons that are necessary to conduct the comparative effectiveness research. Methodological advances and educational tools were also briefly reviewed. Four controversies related to the results of meta-analysis were demonstrated. Finally, the author recalled careful evaluation using checklists since similar meta-analyses have been published. -
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メタアナリシスのエビデンスを正しく読み解くために−アカデミアの生物統計家の立場から
43巻5号(2015);View Description Hide DescriptionMeta-analysis has been one of important research methods of modern evidence-based medicine. However, exploring critical reviews in this field, many studies have pointed out its weakness of scientific validity and reproducibility. For example, LeLorier et al. (N Engl J Med 1997; 337: 536-42) systematically reviewed discordances of results among meta-analyses and their following large randomized trials, and reported that many discordant results have been found even in papers published in the leading medical journals(BMJ, JAMA, Lancet, New England Journal of Medicine). Following these critical discussions, Feinstein(J Clin Epidemiol 1995; 48: 71-9) noted meta-analysis is “statistical alchemy for the 21st century.” In this article, we briefly review these critical discussions and how readers should interpret the evidences obtained by meta-analyses. Also, we review the developments of methodologies and systems for preventing the misleading evidences. -
ネットワークメタアナリシスの医薬品のComparative Effectiveness 評価への利用−企業の立場から
43巻5号(2015);View Description Hide Description -
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TOPICS:第14 回CRC と臨床試験のあり方を考える会議2014 in 浜松
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- 事前登録セミナー③/体験プログラム
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ORIGINAL ARTICLES
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腎機能低下被験者におけるトピロキソスタット経口投与時の薬物動態および薬力学の検討
43巻5号(2015);View Description Hide DescriptionObjectives This study evaluated the pharmacokinetics and pharmacodynamics of topiroxostat in subjects with moderate renal impairment. Methods Topiroxostat was orally administered at a dose of 80 mg to fasting male subjects that were classified as ones with normal renal function(inulin clearance(Cin)≧90 mL/ min/1.73 m2), mild renal impairment group(60≦Cin<90 mL/min/1.73 m2), and moderate renal impairment groups(30≦Cin<60 mL/min/1.73 m2). Thereafter, plasma and urinary concentrations of topiroxostat, its metabolites, and uric acid were determined. Results After topiroxostat administration, the plasma concentrations of unchanged drug exhibited a similar course in each group and reached Tmax at 0.67-1 h, and decreased with T1/2 of 6.7-8.4 hours. As for the pharmacokinetic parameters, there were no significant differences between the mild and moderate renal impairment groups and the normal group. Urinary excretion rate of topiroxostat was<0.1% of the dose in each group within 24 h post dosing. As for plasma concentrations and urinary excretion of metabolites(N-oxide form, N1-glucuronide conjugate, and N2-glucuronide conjugate)after dosing, no remarkable variations were observed in each group. The level of plasma uric acid decreased approximately 1 mg/dL at 24 h after dosing. In addition, the profile of plasma uric acid reduction was similar in each group. Twenty-four hour urinary excretion amounts(Ae0-24)of uric acid decreased from pre-dose values(Ae-24-0)in subjects without renal function. Conclusion Mild and moderate renal impairment affected neither pharmacokinetics nor pharmacodynamics of topiroxostat. -
ラット肝障害に対する霊芝の予防効果
43巻5号(2015);View Description Hide DescriptionWe investigated the effect of oral administration of Ganoderma lucidum(Reishi) extract at doses of 500 or 1000 mg/kg on hepatic injuries experimentally induced by D-galactosamine in male rats, an animal model of viral hepatitis. Oral administration of Reishi extract showed significant improvement on the serum-biochemical and histopathological suppressions in D-galactosamine-induced hepatic injury. In the D-galactosamine-treated rats, Reishi extract significantly prevented the increases in serum aspartate aminotransferase(GOT), alanine aminotransferase(GPT)and alkaline phosphatase(ALP)activities in a dose-dependent manner, and also apparently improved hepatic cell necrosis. In addition, the Reishi extract showed the antagonizing effect on the increase of lipid peroxide and the decrease of triglyceride contents in serum. These findings suggest that oral administration of Reishi extract may have an ameliorating effect on hepatic dysfunction -
社会不安障害患者におけるParoxetine 塩酸塩水和物(パキシル(R) 錠)の長期使用における安全性および有効性の評価-特定使用成績調査結果-
43巻5号(2015);View Description Hide DescriptionWe conducted a special drug use investigation to evaluate the safety and effectiveness in long-term treatment of paroxetine in patients with social anxiety disorder(SAD)in clinical practice. The incidence of adverse drug reactions (ADRs)was 27.4%(252/920)in the safety analysis set with 378 ADRs reported. The common ADRs of“nausea”,“ somnolence”,“ constipation”, “insomnia”,“ malaise”,“ headache”and“dizziness”were known. No new safety issue in long-term treatment was observed based on the time to onset of the ADRs and analysis of specific AE groupings of interest. The efficacy rate(“very much improved”or“much improved”in global improvement)was 62.3%(497/798)in the efficacy analysis set. Continuous improvement trend was confirmed until 12 months later in comparison with the point of start, in other effective scales /evaluation items, the Japanese version of the Liebowitz Social Anxiety Scale(including sub-score analysis), severity of illness, SAD-related somatic symptoms(“trembling of hands, feet and voice”“, palpitation or breathing difficulty”and“perspiration”)and disturbance of daily activities. From this investigation, paroxetine appears to be efficacious and generally well tolerated for the long-term treatment of SAD. -
DHA・EPA 入り魚肉ソーセージの2 年間の摂取による日本人高齢者の認知機能に対する効果-ランダム化二重盲検プラセボ比較試験-
43巻5号(2015);View Description Hide DescriptionObjectives We aimed to examine the effects of daily dietary docosahexaenoic acid(DHA)and eicosapentaenoic acid(EPA)supplementation on cognitive functions in this 2-year randomized, double-blind, placebo-controlled trial. Methods Healthy elderly Japanese aged 57 years or over(n=111, 72.4±7.7 years)were randomized to active and placebo groups. The active group consumed fish sausages containing 1720 mg DHA and 407 mg EPA daily for 24 months;the placebo group consumed fish sausages containing olive oil daily for the first 12 months and fish sausages containing DHA and EPA daily for the next 12 months. Results The plasma and erythrocyte plasma membrane DHA and EPA levels significantly increased in the active group at 6 and 12 months. Further, the mean changes in some of cognitive function test scores from the baseline to month 6 and month 12 were significantly higher in the active group. The mean changes in cognitive function test scores from the baseline to month 12 were positively correlated with plasma membrane DHA level and EPA levels, and negatively correlated with n-6/n-3 polyunsaturated fatty acid ratio. Conclusion Long-term daily dietary DHA and EPA supplementation seems to have beneficial effects against age-related cognitive decline in healthy elderly Japanese with very mild dementia. -
クリルオイル摂取による血中脂質への影響
43巻5号(2015);View Description Hide DescriptionObjectives The purpose of this study was to explore the effect of 8 weeks daily krill oil supplementation on serum triglyceride(TG)and lipid metabolism in the Japanese men and women. Methods This clinical study was designed as an open test. The soft capsules of krill oil(1 g/day)was administered daily for 8 weeks to 139 healthy subjects. Blood samples, physical measurements and the dietary survey were taken at before/after intake of the krill oil. Results The 78 subjects with more than 150 mg/dL TG levels were significant decrease in serum TG with krill oil intake. On the other hand, the 61 subjects with the standard value of TG levels were not changed in serum TG level with krill oil intake. Conclusions The present study strongly suggests that krill oil is effective for reducing serum TG in the Japanese men and women, especially in subjects who have the borderline high or high fasting TG levels. -
Effects of Intake of Sesame Oil(Kadoya Pure Sesame Oil)on the Level of Serum Cholesterol in Volunteers with Slightly Higher Serum Cholesterol-A Randomized, Double—blind, Parallel—group, Placebo—controlled Study-
43巻5号(2015);View Description Hide DescriptionBackground Sesame seed contains nutraceutical ingredients. Sesame lignans, represented by sesamin, are postulated to have favorable functions such as hypocholesterolemic, hypotensive, and anti-oxidative effects. We have been producing for many years sesame oil designated“Kadoya Pure Sesame Oil”,which contains sesamin and other related lignans. Objective The aim of this study was to investigate the effect of intake of Kadoya Pure Sesame Oil on serum cholesterol levels in humans. Methods/study design We conducted a randomized, double-blind, parallel-group, placebo-controlled study with volunteers with slightly higher level of serum cholesterol. Subjects(108 persons aged from 23 to 64)were randomly allocated to 3 groups:placebo, low-dose test food(10 g daily), and high-dose test food(14 g daily). The period of intake was 12 weeks. After excluding data for 5 subjects from plausible reasons, data obtained with 103 persons were subjected to analysis for efficacy. Results There were significant decreases in serum low density lipoprotein(LDL)-cholesterol levels(estimated using the Friedewald formula)in subjects in both low-dose and high-dose groups at the 8th and 12th weeks when compared to the levels in placebo group(P=0.02-0.043 by Student's t-test). No serious adverse event was observed during this study. Discussion/conclusion Our investigation demonstrates that intake of Kadoya Pure Sesame Oil is effective in lowering serum LDL-cholesterol level in populations with slightly higher serum cholesterol level. -
プロアントシアニジン含有食品の育毛効果
43巻5号(2015);View Description Hide DescriptionObjective We evaluated the hair growth effect of ingesting a food containing proanthocyanidin. Methods An open-label study consisting of 16 weeks was conducted. 29 healthy volunteers including 15 males and 14 females participated in this study. In each one-day of a study period, all subjects ingested a test food containing proanthocyanidin and tocotrienol. The dermatologist's evaluation for severity of hair loss, score of the scalp condition, and general improvement degree with photographic evaluation at the parietal region, and a subjective evaluation including sensory questions were conducted. Results In the male group, 5 indexes of score of the scalp condition(inflammation, rash, amount of dandruff, pore-clogging, and sebum capacity)showed significant improvement compared with week 0 at week 16. There was no significant change in the Hamilton-Norwood scale. In the female group, severity of hair loss score, two indexes of score of the scalp condition(rash and amount of dandruff)showed significant improvement compared with week 0 at week 16. The subjective evaluation was improved significantly in the both groups compared with week 0 at week 16. No adverse effects were observed after the ingestion of the test food. Conclusion These results implied that the test food was effective against the hair loss and pointed to its safety. -
乳酸菌Streptococcus thermophilus strain 9618 の風邪症候群予防効果-ランダム化並行群間比較試験-
43巻5号(2015);View Description Hide DescriptionObjective We performed this study in order to clarify whether Streptococcus thermophilus strain 9618 yogurt supplementation possess beneficial effects on Influenza infection or Cold Syndrome. Methods A randomized parallel-group trial was performed in nursing homes, located in Sapporo area. One hundred elderly subjects, who permanently reside in nursing homes, were administrated with Streptococcus thermophilus strain 9618 yogurt or placebo food for 5 months. Subjects were monitored for prevalence of Influenza and Cold Syndrome in between intake periods. As secondly endpoints, QOL and subjective symptoms in daily life were monitored by care persons and by a questionnaire. Results Prevalence of Cold Syndrome was significantly reduced in the Streptococcus thermophilus strain 9618 yogurt group, compared to placebo group(P=0.0265). Co-primary endpoints, prevalence of Influenza appeared not to be significantly influenced. The result of the secondly endpoints' analysis showed that symptoms related to Cold Syndrome tended to be improved by the intakes of Streptococcus thermophilus strain 9618 yogurt. Conclusions Streptococcus thermophilus strain 9618 yogurt supplementation may be an effective strategy in protection against Cold Syndrome.
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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)
43巻5号(2015);View Description Hide Description
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