薬理と治療
Volume 49, Issue 6, 2021
Volumes & issues:
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扉・目次
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TOPIC 第20回CRCと臨床試験のあり方を考える会議 2020 in 長崎
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- 受賞演題
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がんゲノム医療におけるCRC の取り組みと役割
49巻6号(2021);View Description Hide Description2019 年6 月より代表的ながん遺伝子パネル検査(以下,パネル検査)として「OncoGuideTM NCC オンコパネルシステム」1)および「FoundationOne®CDx がんゲノムプロファイル」2)が保険収載となり,実臨床へ本格的に導入されている。がん患者にとってがんゲノム医療は“ 最後の砦” に位置するものと考えられているため,患者からの期待も大きい。しかしながら,パネル検査を受けたすべての患者に何らかの治療選択肢が提示できるかというとそうでもない。いくつかの国内外における報告では,ゲノム情報に適合する治療を受けた患者はパネル検査を受けた患者のうち約十数%以下で,がんゲノム医療における限界を指摘する声もある3 ~ 7)。岡山大学病院(以下,当院)は2018 年にがんゲノム医療中核拠点病院として指定され,近隣施設のがんゲノム拠点病院などの医療機関と連携し,がんゲノム医療の中心的役割を担っている。また役割の一つとしてエキスパートパネル(以下,EP)の開催が義務づけられており,専門知識を有する多職種のスタッフにより構成されたEP では個々の患者の出口戦略に関して活発な議論がなされている。パネル検査から治療候補に結び付く遺伝子病的バリアント(以下,変異等)が見つかった場合,治療選択肢として治験薬の使用があげられることも少なくない。そのため治験に関連した専門知識,分子標的治療薬や関連治験に関する情報等が必要とされているのが現状である。しかしながら,EP 構成員の指定要件にCRC は含まれておらず,がんゲノム医療におけるCRC の活動範囲や役割についてはほとんど認知されていない。当院では,CRC がEP に定期的に参加しており,パネル検査の出口戦略の検討を中心に行っている。本稿では,これまでの活動や対応事例からがんゲノム医療におけるCRC の役割を考察したので報告する。
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TOPIC
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「PRISMA 2020 声明: システマティック・レビュー報告のための更新版ガイドライン」の解説と日本語訳
49巻6号(2021);View Description Hide Description2009 年に公表されたシステマティック・レビュー(SR)とメタアナリシス(MA)の優先報告項目のステートメント(PRISMA statement)は,SR が行われた理由,著者が行ったこと,および発見したことを透過的に報告できるように設計された。過去10 年間で,SR の方法論と用語の進歩により,ガイドラインの更新が必要になった。PRISMA 2020 は2009 ステートメントに代わるものであり,研究を特定し,選択し,評価し,そして統合する方法の進歩を反映した新しい報告ガイダンスである。その項目の構造と表示は,実施を容易にするために更新された。本稿では,PRISMA2020 の27 項目のチェックリスト,各項目の報告に関する推奨事項を詳しく説明した拡張チェックリスト,PRISMA 2020 の抄録チェックリスト,およびオリジナルのSR とその更新に適合するために改訂されたフローチャートを紹介する。
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ORIGINAL ARTICLES
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Impact of Simple Suspension Method on the Number of Living Bacteria of Probiotics
49巻6号(2021);View Description Hide DescriptionThe simple suspension method(SSM)is a method in which tablets and capsules are disintegrated and suspended in warm water(55℃)as they are without being crushed or decapsulated, and then administered by tube. Recently, with the spread of the SSM, the problem of compounding change when multiple drugs are suspended at the same time has been pointed out. This time, the impact of antibiotics on simply suspended probiotics was tested in vitro. One gram of each probiotic and 1 tablet or 1 capsule of antibiotics were simultaneously placed in 20 mL of sterile water and suspended. Samples were obtained after 10 minutes and 60 minutes, respectively. The sample was sown on an agar medium. After culturing, the number of colonies was measured. The number of living E. faecalis bacteria was significantly reduced by mixing with Levofloxacin(P<0.05). The number of living C. butyricum bacteria decreased by mixing with Cefditoren Pivoxil(P<0.01)and Clarithromycin(P<0.001). The number of living B. longum bacteria was significantly reduced by mixing with Amoxicillin(P<0.001), and was not detected at all when mixed with Levofloxacin. This time, it was suggested that when administering mixed probiotics and antibiotics using the SSM, it is necessary to consider the combination of the probiotics and antibiotics. -
ラットにおける五苓散由来成分の体内動態
49巻6号(2021);View Description Hide DescriptionObjective Goreisan has long been used for treating impairments of regulation of body fluid homeostasis. This study aimed to investigate the pharmacokinetics of the major ingredients of Goreisan extract. The concentrations of the major ingredients of Goreisan extract in the plasma and brain tissue after the oral administration of Goreisan extract to rats were investigated. Methods Goreisan extract(1 g/kg)was orally administered to 7-week-old male Sprague-Dawley rat. Then, the concentrations of alisol A, alisol B, alisol C, alisol B O-23 acetate, alisol C O-23 acetate, atractylodin, atractylodin carboxylic acid, pachymic acid, tumulosic acid, cinnamic acid, and 2-methoxy cinnamic acid in the blood plasma and brain tissue were quantified. Liquid chromatography with tandem mass spectrometry was used for quantitative analysis, upon which pharmacokinetic parameters were calculated from those quantitative values. Results Alisol A, alisol B, atractylodin, atractylodin carboxylic acid, cinnamic acid, 2-methoxy cinnamic acid, pachymic acid, and tumulosic acid were detected in the blood plasma; and the Cmax values for each of these were 21.3, 20.5, 15.1, 14.9, 156, 85.7, 4.75, 364, and 85.7 ng╱mL, respectively. Alisol A, alisol B, alisol B O-23 acetate, atractylodin, atractylodin carboxylic acid, cinnamic acid, and 2-methoxy cinnamic acid were detected in the brain tissue; and the Cmax values for each of these were 7.23, 14.0, 1.11, 62.9, 0.432, 12.3, and 6.49 ng╱g, respectively. Atractylodin exhibited the highest level of migration into the brain. Conclusions This is the first study to demonstrate the pharmacokinetics of the major ingredients of Goreisan. Our results will be help for elucidating the pharmacological mechanism of Goreisan. -
Apoptosis Induction and Anticancer Effect of Pheophorbide a from a Decomposition Product of Chlorophyll a on Human Stomach Cancer KATO Ⅲ Cells
49巻6号(2021);View Description Hide DescriptionObjective In this study, we investigated the antiproliferative activity and induction of apoptosis by pheophorbide a on human stomach cancer KATO Ⅲ cells. Methods The growth inhibition of cancer cells was examined in MTT assay. The apoptotic morphological changes resulting from DNA fragmentation were observed by electrophoresis. Results The growth inhibition by pheophorbide a was much stronger than that by chlorophyll a. Morphological change showing apoptotic bodies was observed in the cells treated with pheophorbide a. The fragmentation by pheophorbide a of to oligonucleosomal sized fragments, that are characteristics of apoptosis, was observed to be concentration and time-dependent. Conclusions We demonstrated antiproliferative activity and induction of apoptosis by pheophorbide a on human stomach cancer KATO Ⅲ cells. These findings raise the possibility that pheophorbide a may have clinical value in cancer therapy and prevention. -
ワルファリンカリウムとアミオダロン塩酸塩併用患者のPT—INR に影響を与える要因の検索
49巻6号(2021);View Description Hide DescriptionBackground The anticoagulant drug warfarin potassium(WF)shows a number of interactions with other drugs that alter its anticoagulant effects. The oral antiarrhythmic drug amiodarone hydrochloride(AMD)is an inhibitor of cytochrome P450(CYP)2C9, the major enzyme responsible for metabolism of WF. Thus, the co-administration of AMD and WF has been known to increase the prothrombin time-international normalized ratio(PT-INR). However, the risk factors of PT-INR prolongation due to co-administration of AMD and WF are not clear. In this study, we investigated the risk factors of patients whose PT-INR was increased by the co-administration of AMD and WF. Methods We retrospectively reviewed the records of 20 WF-treated patients starting AMD treatment between April 2010 and March 2020 at Fukuoka University Hospital. To evaluate the influence of PT-INR due to AMD treatment, we calculated the time in the therapeutic range (TTR). Patients with a TTR<60% were defined as the poor control group, while those with a TTR≥60% were defined as the good control group. The creatinine clearance rate CCr)was estimated by the Cockcroft-Gault formula. Results There were no significant difference in the male-female ratio, body mass index or use of other concomitant drugs between the TTR<60%(n=11)and TTR≥60% groups(n=9). However, the CCr was significantly higher in the TTR<60% group than in the TTR≥60% group. Furthermore, the TTR<60% group tended to have a lower rate of chronic kidney disease than the TTR≥60% group. Conclusions The present findings suggest that the renal function may involved in the poor TTR control induced by the co-administration of AMD and WF. -
日本人2 型糖尿病患者を対象としたデュラグルチドの安全性および有効性の検討―デュラグルチド0.75 mg 特定使用成績調査中間報告―
49巻6号(2021);View Description Hide DescriptionBackground Dulaglutide is a long-acting, once weekly GLP-1 receptor agonist thatimproves glycemic control in patients with type 2 diabetes mellitus(T2DM)and has been widely used in T2DM patients since its 2015 approval in Japan. There is no need for dose escalation and frequent injections as compared with conventionally available GLP-1 receptor agonists. Dulaglutide is provided with a simple auto-injector device. The drug is further supported by having no restrictions with impaired kidney function and fewer restrictions with concomitant medications. However, there is limited information about long-term safety and effectiveness of the drug when administered to the Japanese T2DM patients in the real world setting. We are conducting a post-marketing special drug-use survey on dulaglutide, where 3265 T2DM patients were registered. We performed an interim analysis of patientsʼ data collected as of September 2020 to investigate the safety and effectiveness of the drug, specifically focusing on the switch to dulaglutide from previous treatments. Methods The patients were grouped according to the drug class types they received prior to the survey as switch from dipeptidyl peptidase-4 inhibitors(Group A), switch from other GLP-1 receptor agonists(Group B), and others(Group C). The long-term safety and efficacy of dulaglutide were then analyzed and assessed in the three groups. Results The mean period of dulaglutide administration was 565.5±353.5 days. The percentage of patients who remained on dulaglutide 360 days post-drug switch was 76.2% in the whole population, and 73.8% in Group A, 81.1% in Group B, and 76.1% in Group C, indicating a high drug continuation rate. Adverse drug reactions were reported in 7.21% of the whole population, and in 9.84%, 5.41% and 5.49% of the patients of Group A, B and C, respectively. Adverse drug reactions of gastrointestinal disorders were observed in 3.24% of the whole population, and in 4.53%, 2.07% and 2.54% of each patient group. HbA1c decreased significantly from baseline in the whole population as well as each group by 1 month following dulaglutide administration. Although HbA1c was lower at baseline and its decrease was smaller in Group B compared to the two other groups, the parameter showed a stable time-dependent profile similar to that of Group A and C at 3 months or later. Conclusions In this interim analysis, no new safety concerns were observed for dulaglutide regardless of prior medication types. This post-marketing surveillance is still ongoing and the long-term safety and efficacy data of dulaglutide will continue to be collected. -
2 型糖尿病患者に対するアナグリプチン・メトホルミン配合錠の安全性および有効性の検討― 一般使用成績調査 最終報告 ―
49巻6号(2021);View Description Hide DescriptionBackground and Objectives METOANA® LD/HD is a combination tablet containing 250 mg or 500 mg metformin hydrochloride and 100 mg anagliptin. A drug use results survey of METOANA® was conducted to examine its safety and efficacy after 24 weeks of treatment in real-world clinical settings. Methods Patients with type 2 diabetes who were newly treated with METOANA® were included in this study. Adverse events, efficacy endpoints and others were surveyed using a central registry system. Results The incidence of adverse drug reactions in safety analysis set(452 patients)was 3.98%(18 patients), including constipation(0.88%), acute myocardial infarction(0.44%), anaemia, hypoglycaemia, organising pneumonia, abdominal pain, abdominal pain upper, gastritis, nausea, diabetic nephropathy, renal impairment, oedema peripheral, blood triglycerides increased, and hepatic enzyme increased(0.22% each). Serious side effects included acute myocardial infarction in 2 patients(0.44%)and organising pneumonia in 1 patient(0.22%). The efficacy of this drug was maintained up to 24 weeks, and the mean change in HbA1c at the final evaluation was -0.42±1.08(SD)%. Conclusions No new safety or efficacy issues were observed during 24 weeks of use, suggesting that METOANA® LD╱HD is a useful treatment option for patients with type 2 diabetes. -
Immunological Benefits of Enterococcus faecalis 2001 in Healthy Volunteers
49巻6号(2021);View Description Hide DescriptionBackground Our previous studies showed that Enterococcus faecalis 2001(EF-2001)has various effects such as improvement of the intestinal environment and immune system, and antidementia- and antidepressant-like effects in mice. Methods In the present study, we conducted hematological and immunological tests to evaluate the safety and immunological benefit of EF-2001 in healthy people(age 54.3±5.6 y, six male and four female). Results After the subjects were administered EF-2001 for 4 weeks, the alanine aminotransferase level was decreased, while serum IgM was increased. There were no other changes in clinical values between before and after treatment. Conclusions These results suggest that EF-2001 may safely enhance immunological capacity in normal subjects. -
The Effect of Euglena Gracilis EOD—1 on the Age—related Decline of Testosterone Levels in Healthy Older Adults
49巻6号(2021);View Description Hide DescriptionEndogenous testosterone levels decrease with age, leading to the occurrence of menopause symptoms, various diseases, and low quality of life. Previous studies have shown that immunity and active oxygen influence changes in endogenous testosterone levels. However, there is a dearth of research on food ingredients that inhibit the decline of endogenous testosterone. Euglena gracilis EOD-1 is a micro-alga that is high in paramylon(β-1,3-glucan)and has been reported to have antioxidant ability and may contribute to immune function. Based on these features, we examined the impact of Euglena gracilis EOD-1 on changes in endogenous testosterone levels by conducting a double-blind, placebo-controlled, comparative study. In this study, healthy older adults aged between 65 and 75 years received Euglena gracilis EOD-1 for eight weeks. The participants completed a questionnaire, and the testosterone levels in their saliva were measured. The results indicated that consumption of Euglena gracilis EOD-1 reduced uneasiness. In addition, Euglena gracilis EOD-1 inhibited the decline of free testosterone in male participants. Consumption of Euglena gracilis EOD-1 may inhibit the age-related decline of endogenous testosterone levels. -
ハトムギ摂取による肝機能および肌バリア機能へ与える効果の検証研究―ランダム化二重盲検プラセボ対照並行群間比較試験―
49巻6号(2021);View Description Hide DescriptionObjective The aim of this study is to elucidate the effects of adlay tea intake on liver function and on skin barrier function. Methods A double-blind, placebo-controlled, randomized study was conducted to 69 healthy women. Participants were randomized into two groups: adlay tea(500 mL)group and barley tea(500 mL)group(placebo group). Participants took the assigned test food every day for 8 weeks. Before and after ingestion, serum liver enzyme levels were measured to evaluate liver function. Skin moisture content and transepidermal water loss(TEWL)were also measured to evaluate skin barrier function. Results The adlay tea group showed no significant difference in alanin aminotransferase (ALT), aspartate aminotransferase(AST)and γ-glutamyltransferase(γ-GTP)levels after 8 weeks of treatment compared with the placebo group. There was also no significant difference in skin moisture content levels or TEWL levels. Subgroup analysis showed that γ-GTP tends to decrease in adlay tea group with top half of γ-GTP before ingestion. Moreover, skin moisture content was significantly high both in the ≥40-year-old adlay tea group. No adverse event recorded in the study was judged to be related to the intervention by principal investigator. Conclusions The results showed that intake of adlay tea could be helpful for keeping skin mo content for ≥40-year-old women. In adlay tea, vanillic acid with anti-inflammatory effect is considered to be the major functional molecule for the moisturizing effect. (UMIN ID: 000041108) -
乳酸菌Lactobacillus delbrueckii subsp. delbrueckii TUA4408L により発酵させた発酵豆乳の摂取が便秘傾向の健康成人における便通および腸内細菌叢に及ぼす影響―ランダム化プラセボ対照二重盲検並行群間試験―
49巻6号(2021);View Description Hide DescriptionObjectives The purpose of this study was to verify the effect of continuous ingestion of a lactic fermented soymilk(LFS)by Lactobacillus delbrueckii subsp. delbrueckii TUA4408L on improving bowel movements, and to clarify whether or not the mechanism is through improvement of the intestinal flora. Methods In this study, we designed a randomized, placebo-controlled, double-blind, parallel-group study of 104 healthy adults with a tendency to constipation. The test food group(n=51)and placebo group(n=50)ingested LFS(TUA4408L count:6.0×108 CFU/120 g)or placebo(yogurt-like food without soymilk and TUA4408L, 120 g) once a day for 2 weeks, respectively. A primary endpoint was the amount of change in the number of bowel movements. Secondary endpoints were changes in the following items: days of defecation, volume of stool, characteristics of stool(shape, color, odor), sensation after defecation, gastrointestinal symptoms, occupancy of intestinal bacteria in Bifidobacterium, Lactobacillus and Clostridium. Results Number of defecations(LFS, 1.2±0.2;P, 0.3±0.1 times/week, P<0.001), numberof defecation days(LFS, 1.1±0.2;P, 0.2±0.1 days/week), P<0.001), and the stool shape score(LFS, 0.3±0.1;P, -0.1±0.1 points╱time, P<0.016)showed a significant increase, respectively. The amount of change in the occupancy rate of Clostridium was significantly reduced(LFS, -0.8±0.3;P, 0.3±0.3%, P<0.0077). Conclusions The number of defecations and days of defecation increased due to LFS intake, and the effect of improving constipation was observed. In the intestinal flora, there was no increase in Bifidobacterium or Lactobacillus, but a significant decrease in the occupancy rate of Clostridium. (UMIN ID: UMIN000042292) -
Effects of Black Soybean Seed Coat Extract on Attenuating Fatigue Sensation in Healthy Volunteers ―A Randomized, Double—blind, Placebo—controlled, Crossover Comparison Trial―
49巻6号(2021);View Description Hide DescriptionObjective According to the Survey on State of Employeesʼ Health by the Ministry of Health, Labour and Welfare in 2002, 72.2% of the working population answeredʻI am fatigued by my usual workʼ. Fatigue is defined as a state of impaired performance, resulting in social and economic losses. Daily activities, including usual work, induce oxidative stress, and stress causes fatigue. Antioxidants are candidate anti-fatigue substances. Black soybean seed coat extract (BE)includes abundant levels of polyphenols, such as procyanidins, which have strong anti-oxidative effects. The aim of this study was to investigate the effects of BE on attenuating fatigue sensation in healthy volunteers. Methods This study was a randomized, double-blind, placebo-controlled, crossover comparison trial. Twenty-four subjects were randomly assigned to either a group that received capsules containing 100 mg of BE(test food)or a group that was administered placebo for a 4-week intake period that was performed twice. As a fatigue-inducing mental task, the subjects performed a 30-min 2-back task and a 30-min advanced trail making test on two occasions(2-hour mental load)and then rested for 2 hours(recovery period)for examination of the start and the end of test food intake(0 weeks, 4 weeks). We evaluated fatigue sensation by visual analogue scale(VAS)as the primary outcome, and subjective sensation by VAS and the Jikaku-sho shirabe, cognitive function by CogEvo Ri, and autonomic nervous function by accelerated plethysmography as secondary outcomes respectively. Results The VAS score of fatigue sensation in the BE group was significantly lower than in the placebo group before load, after 1-hour load, and after 2-hour load at 4 weeks. Moreover, BE improved the feeling of eyestrain and sleepiness in the VAS, and the feelings of drowsiness and uneasiness in the Jikaku-sho shirabe. Furthermore, in the BE group, impaired time orientation and executive function was improved after 2-hour load and parasympathetic nervous activity was more dominant than sympathetic nervous activity during the recovery period. Conclusion BE attenuated fatigue sensation and improved feelings of eyestrain and sleepiness, drowsiness, and uneasiness in daily activity; moreover, it improved the impaired cognitive function induced by 2-hour load. These effects were thought to be caused by modulations of the autonomic nervous system related to the anti-oxidative effect of BE. These results show that intake of 100 mg of BE for 4 weeks attenuated daily physiological fatigue in healthy people.(UMIN ID: UMIN000041228) -
ガルシニアインディカ抽出物含有食品摂取による飲酒翌日の二日酔い症状軽減作用―プラセボ対照ランダム化二重盲検 トリプルクロスオーバー試験―
49巻6号(2021);View Description Hide DescriptionObjectives A randomized, double-blind, placebo-controlled, triple crossover study was conducted to evaluate the effect of food containing an extract of Garcinia indica on the alleviation of the symptom of a hangover on the next day of drinking alcohol.Methods Forty-two healthy participants were enrolled and randomly assigned to three groups. The two experimental groups ingested food containing G. indica extract(with 18.0 or 36.8 mg garcinol)while the third placebo group ingested unmodified food(without added G. indica extract)7 hours after consuming whisky diluted in water(0.75 g ethanol per kg body weight). Data regarding alcohol hangover symptoms were collected using questionnaires before alcohol consumption and at 1, 7, 8, 9, 10, and 11 hours after alcohol consumption. Results The ingestion of food containing G. indica extract after alcohol consumption significantly alleviated alcohol hangover symptoms(P<0.05), such as excessive thirst, fatigue, headache, dizziness, loss of appetite, stomachache, and nausea, on the day after alcohol consumption in the experimental groups compared to the placebo group. Moreover, no adverse events were observed during this study period, and this could be attributed to the ingestion of food containing G. indica extract. Conclusions The results indicate that the ingestion of food containing G. indica extract after alcohol consumption alleviates alcohol hangover symptoms and that it is well tolerated. (UMIN-CTR ID: UMIN000040996) -
睡眠に不満を感じている人におけるイクラオイル由来DHA・イクラオイル由来EPA・深海鮫肝油由来DAGE 含有油脂加工食品の睡眠の質改善と抗ストレス効果の検証―ランダム化二重盲検プラセボ対照並行群間比較試験―
49巻6号(2021);View Description Hide DescriptionObjectives This study aimed to evaluate the efficacy of a supplement product containing salmon roe oil-derived DHA and EPA and deep-sea shark liver oil-derived DAGE on the sleep quality and stress in healthy adults who have difficulties sleeping and stress. Methods A randomized, double-blind, placebo-controlled, parallel-group study was conducted in 80 participants(Age 20-64, Pittsburgh Sleep Quality Index≳6). Participants were randomly assigned to receive either the test product or placebo daily for 12 weeks. Daily intake of the test product contained salmon roe oil(DHA and EPA)and deep-sea shark liver oil (DAGE). Participants were assessed on their mood states and quality of sleep by sleep electroencephalogram measurement, Profile of Mood States 2nd Edition(POMS2), PSQI, Athens Insomnia Scale(AIS), International Physical Activity Questionnaire (IPAQ), and s-IgA secretion rate. Results The changes in the total time of non-REM sleep stage N1 and second sleep cycle at Week 12 were significantly lower in the test product group than in the placebo group. The proportion of non-REM sleep stage N3 and REM sleep stage R was significantly higher in the test product group than in the placebo group. In the participants group with POMS2 Vigor-Activity of less than 50, the daytime dysfunction by PSQI was significantly lower in the test product group than in the placebo group, Also, the POMS2 subscales of Depression -Dejection, Tension-Anxiety, Vigor-Activity, and Total Mood Disturbance were significantly lower in the test product group compared with the placebo group. Conclusions The increase in the proportion of non-REM sleep stage N3 and REM stage R suggests that the test product improves sleep quality. In addition, improvement of daytime sleepiness and anti-stress effect are expected in people with low vigor and activity. (UMIN ID: UMIN000041059) -
マンゴスチンエキス含有食品の抗糖化作用―プラセボ対照ランダム化二重盲検並行群間試験―
49巻6号(2021);View Description Hide DescriptionObjectives This randomized, double-blinded, placebo-controlled, parallel-group study aimed to evaluate the antiglycation effects of Garcinia mangostana extract. Methods This study included 90 healthy participants who were randomly assigned to a test food group and a placebo group. Participants in the test food group consumed a test food containing G. mangostana extract(160μg/day as rhodanthenone B), while those in the placebo group consumed a placebo food. Pentosidine level(primary outcome)and glycoalbumin and glycated hemoglobin levels(key secondary outcomes)were evaluated after 8 weeks of intervention. Results Pentosidine and glycoalbumin levels were significant lower in the test food group than in the placebo food group(P<0.05). During the study period, no adverse events attributable to the test food were observed. Conclusions Overall, the study findings indicate that the foods containing G. mangostana extract have an antiglycation effect in healthy participants. (UMIN-CTR ID: UMIN000039948)
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BRIEF COMMUNICATION
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Effect of Coadministration of Atorvastatin and Magnesium Oxide on the Rate of Change in LDL Cholesterol ―A Retrospective Clinical Study―
49巻6号(2021);View Description Hide DescriptionObjectives Atorvastatin(ATV)has potent low-density lipoprotein-cholesterol(LDL-C) lowering effect, and prevents cardiovascular events. However, although the ATV prescribing information in the United States cautions that area under the concentration-time curve(AUC) of ATV decreases approximately 33% when ATV and the magnesium-containing antacid Maalox® are coadministered, the effect on the rate of change in LDL︱C is unknown. Methods Patients newly prescribed ATV 10 mg at our hospital were divided into a group coadministered magnesium oxide (MgO)(ATV+MgO group)and a group not coadministered MgO(ATV group), and the rate of change in LDL︱C before and after administration of ATV 10 mg was investigated. Results The rate of change in LDL︱C after administration of ATV 10 mg was -45.8±15.8% in the ATV group and -38.3±17.9% in the ATV+MgO group, and no statistically significant difference was observed between the two groups(P=0.37). Conclusion Coadministration of ATV and MgO is considered to have little effect on the rate of change in LDL-C. However, the degree of difference observed in this study is an important interaction from the viewpoint of the risk of developing cardiovascular events. Therefore, pharmacists should regularly monitor LDL-C during coadministration of ATV and MgO.
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COLUMN
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前後比較デザインにおける群間比較の手法
49巻6号(2021);View Description Hide Description前後比較デザイン(Pre-post design)は,Box1 の上図のように示されます。ランダム化が入っていますが,そうでない観察研究であっても構いません。臨床試験の場合,前後だけでなく,途中に何回か測定が入った反復測定デザイン(Repeated measures design)が多いと思われます(Box 1 の下図)。 Box 2 に示した仮想的データに基づいて,解析実例と解説を加えます。これは3 群比較のデータです1)。縦軸に測定値,横軸に前後,群別のグラフをBox 3 に示しました。Post 値の平均値の比較なら分散分析(ANOVA)ですが,Pre 値が均一ではないので,それは誤った解析と思われます。何らかの方法でPre 値を補正する必要があるでしょう。
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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)
49巻6号(2021);View Description Hide Description -
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