薬理と治療
Volume 47, Issue 4, 2019
Volumes & issues:
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扉・目次
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TOPICS 第18回CRCと臨床試験のあり方を考える会議 2018 in 富山
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- 受賞演題
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北海道大学病院におけるDelegation Log・Training Log の作成・保管・管理の取り組み
47巻4号(2019);View Description Hide Description -
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SERIES 機能性表示食品制度における届け出されたレビューの現状
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<第2 回> 機能性表示食品制度における届出されたシステマティック・レビューの報告の質―緒言(Introduction)部分における報告の現状と課題―
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<第3 回> 機能性表示食品制度における届出されたシステマティック・レビューの報告の質―適格基準と研究の選択・データ収集に関する記載の現状と課題―
47巻4号(2019);View Description Hide Description
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ORIGINAL ARTICLES
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電位依存性カルシウムチャネルα2δ—1 サブユニットを介したミロガバリンの鎮痛作用―α2δ—1(R217A)およびα2δ—2(R282A)変異マウスを用いた検討―
47巻4号(2019);View Description Hide DescriptionObjective To investigate whether mirogabalin induces analgesia via the α2δ-1 or α2δ-2 subunit of the voltage-gated calcium channels. Methods Mutant mice with α2δ-1(R217A; arginine-to-alanine mutation at amino acid 217) or α2δ-2(R282A; arginine-to-alanine mutation at amino acid 282)were generated and used with the littermate wild type mice. The mutations are known to decrease binding to gabapentinoids. The specific binding amount of[3H]-mirogabalin was measured in the cerebral cortex and cerebellum of the mice. The analgesic effect of mirogabalin was evaluated in the mice with neuropathic pain induced by partial sciatic nerve ligation. Results The binding amount of mirogabalin in the cerebral cortex, where α2δ-1 is mainly distributed, was significantly less in the α2δ-1(R217A), but not in the α2δ-2(R282A)mutant mice, compared with the wild type mice. On the other hand, the binding amount of mirogabalin in the erebellum, where α2δ-2 is mainly distributed, was significantly less in the α2δ-2 (R282A), but not in the α2δ-1(R217A)mutant mice, compared with the wild type mice. The analgesic effect of mirogabalin disappeared in the α2δ-1 (R217A)mutant mice, but was observed in the α2δ-2(R282A)mutant mice at the same level as the wild type mice. Conclusions These results suggest that the binding of mirogabalin to α2δ-1 may be necessary for its own analgesic effect. -
フィルグラスチム後続1 の安全性および有効性の検討―長期使用症例を含む特定使用成績調査結果―
47巻4号(2019);View Description Hide DescriptionBackground Filgrastim biosimilar 1 is a biosimilar of GRAN®, and has been used for the treatment of neutropenia, etc., due to cancer chemotherapy since May 2013. The results of a survey on clinical experience with this drug in such cases have already been reported. However, no post-marketing surveillance study of this drug used in patients with neutropenia, etc. (including long-term use cases), associated with myelodysplastic syndrome or aplastic anemia has been reported.Method A specific drug use-results survey based on central registration targeting 70 cases for safety analysis(including 15 cases receiving 6-month treatment as long-term use cases)was performed between August 2013 and March 2018. Results In total, 125 cases were registered, and 110 cases were analyzed for safety and efficacy. There were 19 long-term use cases. Although adverse drug reactions occurred at a frequency of 5.5%(6╱110), no immunogenicity was suspected in any of these cases. Also, there were no specific adverse reactions to the drug during long-term use. The efficacy rate determined by physiciansʼ comprehensive judgments was 71.8%(79╱110), and efficacy rates did not particularly differ between long-term and short-term use.Conclusion A specific drug use-results survey on filgrastim biosimilar 1 in cases with neutropenia, etc., associated with myelodysplastic syndrome or aplastic anemia, including long-term use cases, revealed no particular issues regarding either safety or efficacy, showing that this drug is clinically useful. -
S—アリルシステインの身体的な疲労感軽減効果―ランダム化二重盲検プラセボ対照クロスオーバー試験―
47巻4号(2019);View Description Hide DescriptionObjectives Physical activity in daily life often induces oxidative stress, which causes fatigue. Accordingly, antioxidants are candidate anti-fatigue substances. As S-allylcysteine has strong anti-oxidative effects, we investigated the ability of S-allylcysteine-containing capsules to attenuate the fatigue sensation induced by mild physical load in a randomized, double-blind, placebo-controlled crossover trial. Methods Twenty-four healthy volunteers were randomized to oral administration of either capsules containing 2.0 mg of S-allylcysteine(test food) or placebo for 4 weeks. Subjective fatigue sensation was examined using the visual analogue scale(VAS)during mild physical load and the recovery period. In addition, we measured changes in the autonomic nervous system by frequency analysis of a-a intervals on accelerated plethysmography(APG)waves to elucidate the mechanism of action. Results On the VAS, the test food group had a significantly lower fatigue sensation score during the recovery period after physical load than the placebo group. On the frequency analysis of a-a intervals on APG, the test food group had significantly higher parasympathetic nerve activity during the recovery period. Conclusions These results suggest that the capsules containing 2.0 mg of S-allylcysteine can improve fatigue sensation induced by mild physical load and correct the imbalance in autonomic nervous function accompanying fatigue. Therefore, we consider S-allylcysteine to be a useful substance to attenuate fatigue sensation after physical activity in daily life. -
茶花エキスおよび桑の葉エキス含有食品摂取による食後血糖値上昇抑制効果検証試験―無作為化二重盲験プラセボ対照クロスオーバー比較試験―
47巻4号(2019);View Description Hide DescriptionObjective The purpose of the present study was to investigate the suppression effect of the tea flower extract and mulberry leaf extract on the postprandial blood glucose levels in healthy subjects. Methods Forty healthy subjects(male and female)whose fasting blood glucose levels were less than 126 mg╱dL, HbA1c(NGSP)were less than 6.5%, postprandial blood glucose levels at 30 or 60 minutes after food intake were more than 140 mg╱dL and postprandial blood glucose levels at 120 minutes after food intake were less than 200 mg╱dL were enrolled in randomized, double-blind, placebo-controlled, cross over study. The subjects ate 200 g of rice after ingestion of the powder which contained 100 mg of tea flower extract and 250 mg of mulberry leaf extract(test food)with 150 mL of water, or placebo food with 150 mL of water. The blood glucose level was measured before, 30, 60, 90 and 120 minutes after rice intake. The primary endpoint was the AUC of postprandial blood glucose level. The secondary endpoints were the AUC of postprandial insulin level, blood glucose and insulin levels at 30, 60, 90 and 120 minutes after rice intake. Results The test food significantly suppressed the AUC of postprandial blood glucose and insulin levels. We also observed significant suppression of the blood glucose levels at 30 and 60 minutes, and insulin levels at 30, 60 and 120 minutes after rice intake with the test food. Conclusions These results suggest that the tea flower extract and mulberry leaf extract suppress the postprandial blood glucose level after rice intake in healthy subjects. -
松樹皮抽出物含有食品のLDL コレステロール低下作用確認試験―プラセボ対照ランダム化二重盲検並行群間比較試験―
47巻4号(2019);View Description Hide DescriptionObjectives The objective of this randomized, double-blind, placebo-controlled, parallel-group study was to evaluate the effect of a functional food containing pine bark extract(PBE) on low-density lipoprotein-cholesterol(LDL-C)levels in healthy subjects. Methods Hundred healthy subjects with LDL-C levels<140 mg╱dL whose body mass indexes(BMI)were≥18.5 and<30 were enrolled in the study. These subjects were randomly divided into two groups and ingested either a test food containing PBE or a placebo over a 12-week period. Levels of LDL-C(primary outcome), total cholesterol(TC), high-density lipoprotein-cholesterol (HDL-C), and triglyceride(TG)(secondary outcome)were determined at baseline and at 4, 8, and 12 weeks after ingestion. Physical examination, blood test, urinalysis, and physician conducted interviews were also performed at the same time points. Results LDL-C and TC levels were significantly decreased at week 12 in the test food group compared with the placebo group(P<0.05). No adverse events attributable to the test food were observed throughout the study period.Conclusions Overall, these results indicate that consumption of food containing PBE has LDL-C and TC lowering effects in healthy subjects. -
食後血清尿酸値に対する乳酸菌発酵豆乳上清の上昇抑制作用とその関与成分の検討
47巻4号(2019);View Description Hide DescriptionObjectives The aim of the study was to investigate the effect of soymilk fermented with lactic acid bacteria(FSM)on postprandial serum uric acid(UA) level and its active ingredients. Methods 1)We examined the effects of FSM on blood UA after loading of purine nucleotide in animal and human. The human study was conducted a randomized, open-label, crossover study with thirty-six healthy subjects. Subjects consumed control water and two doses of FSM with purine-rich foods. Serum UA was measured for 360 min after purine loading. 2)We examined the active ingredients of the inhibitory effect in FSM by in vitro assay and animal study. Results 1)In animal study, FSM lowered the plasma UA incremental areas under the curve (IAUC)(0-60 min)than control(P<0.05). In human study, high dose(equivalent to 300 mL)of FSM lowered the serum UA IAUC(0-360 min)than control(P<0.05). There was no effect on the serum UA IAUC(0︱360 min)in low dose(equivalent to 100 mL)of FSM.2)Inhibition of purine nucleotide metabolism was examined in vitro assay for various ingredients derived from FSM. Consequently phytic acid was the only component with strong activity as a single component. FSM and phytic acid were shown to have the inhibition effects on purine nucleotide metabolism with IC50 value of 90.8 mg╱mL and 9.4 mg╱mL, respectively. The inhibitory activity contribution rate of phytic acid in FSM was 30%. In animal study, middle dose(100 mg╱kg)and high dose (300 mg╱kg)of phytic acid lowered the plasma UA IAUC (0-60 min)than control(P<0.05). There was no effect on the plasma UA IAUC(0-60 min) in low dose (30 mg╱kg)of phytic acid. Conclusions These findings suggest that FSM contributed to control the postprandial UA level and phytic acid was the main active ingredient of the inhibitory effect in FSM. -
藤茶由来アンペロプシンおよびキトサン含有食品の単回摂取による食後血清尿酸値上昇抑制効果の検討―無作為化二重盲検プラセボ対照クロスオーバー試験―
47巻4号(2019);View Description Hide DescriptionObjective This study was aimed to verify that ingestion of supplement containing ampelopsin derived from vine tea extract and chitosan would reduce the postprandial serum uric acid level. Methods A randomized, placebo-controlled, cross-over study was conducted for 43 participants whose fasting serum uric acid levels were 5.0 mg╱dL to 7.0 mg╱dL. The subjects consumed either a test supplement containing 500 mg of vine tea extract which contained 150 mg of ampelopsin and 100 mg chitosan, or placebo with high purine food(4 g of yeast RNA). The serum uric acid levels were determined before, 1, 2, 3, and 4 hours after high purine food ingestion. The primary endpoint was the area under the curve(AUC)of postprandial serum uric acid and the secondary endpoints were each points of the changes of serum uric acid levels from before high purine food intake, urinary uric acid excretion, uric acid clearance, creatinine clearance, and fractional excretion of uric acid. Results No improve effect of test supplement was observed in neither the AUC of postprandial serum uric acid and secondary endpoints. The other hands, in subjects whose fasting serum uric acid levels were between 5.0 mg╱dL and 7.0 mg╱dL in both Intervention Ⅰ and Ⅱ, intake of test supplement was significantly suppressed the AUC of postprandial serum uric acid. We also observed significant suppression of the elevation of postprandial serum uric acid levels after ingestion of the high purine food. Conclusions These results suggest that intake of the supplement containing 500 mg of vine tea extract which contained 150 mg of ampelopsin and 100 mg chitosan suppress postprandial serum uric acid elevation.
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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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臨床試験を報告するための指針—CONSORT声明に準拠して論文を執筆するための15項目(薬理と治療2017;45:339-44.より再掲載)
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