薬理と治療
Volume 39, Issue 1, 2011
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扉・目次
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DRUG PROFILE SERIES
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睡眠-覚醒リズムに働きかけ生理的な睡眠導入効果をもたらすメラトニン受容体アゴニストラメルテオン(ロゼレム)錠 8 mg の基礎と臨床
39巻1号(2011);View Description Hide Description
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SERIES
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一流誌にアクセプトされる医学論文執筆のポイント[第4回]結果の書き方
39巻1号(2011);View Description Hide Description結果Resultsは「この研究で何を発見したのか」を記載するセクションである1)。ここでは,図・表・文章を用いて論理的な順序で得られた結果を報告する2)。臨床研究の場合は,① 研究参加者の内訳,②研究参加者の追跡期間(縦断研究の場合),③研究参加者の背景因子,④アウトカムの解析結果を順に示すのが一般的である3, 4)。多くの医学雑誌は,論文に掲載可能な図表の数に制限を設けるか,論文全体の単語数や文字数に制限を設けたうえで図表1枚を何単語(または何文字)として換算するかを規定している。このため,原稿を作成する前に必ず投稿規定を確認し,図表を用いて示すデータを決定した後に文章を書き始めたほうが効率的である。これらを踏まえたうえで,結果に示すべき情報を以下に整理する。
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REVIEW
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臨床研究の計画・実施・報告・評価に関する現状および論点
39巻1号(2011);View Description Hide DescriptionClinical research involves several steps initiating from the planning. This article dealswith survey and some discussions on the designing, conducting, reporting, and evaluating ofclinical researches. In designing a research, four issues of PROBE, composite endpoints, preregistration,and non-inferiority trials were discussed based on the current status. In conducting,practical issues were discussed to make success a clinical research. In reporting, authorship,CONSORT, pre-specified analysis, role of academic statisticians, and sponsorship weresurveyed and discussed. In evaluating, Cochrane collaboration developed in UK was firstintroduced followed by a newly developed J-CLEAR non-profit organization in Japan. Finally,it put emphasis on the critical appraisal by each investigator with an example.
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ORIGINAL ARTICLES
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閉経後骨粗鬆症モデルラットにおけるカタセ マグの骨粗鬆症および脂質異常症に及ぼす効果
39巻1号(2011);View Description Hide DescriptionObjectives Dietary effects of CATASE MAG and Ca-containing formulation A on osteoporosisand dyslipidemia were examined using ovariectomized rats.Methods Six-week-old female Wistar rats were ovariectomized(OVX)or sham-operated.At 8 weeks of age, each rat was assigned to one of the following 6 groups:Sham-operatedgroup and OVX-control group fed the control diet(Ca 0.4%, Mg 0.05%, vitaminD32400 IU/kg), OVX-CATASE MAG group fed the control diet supplemented with CATASE MAG(Ca1.2%, Mg 0.48%, vitaminD37970 IU/kg), OVX-Ca-containing formulation A group fedthe control diet supplemented with Ca-containing formulation A(Ca 1.2%, Mg 0.05%, vitaminD37970 IU/kg), OVX-low Ca group fed the low Ca diet(Ca 0.08%, Mg 0.05%, vitaminD32400 IU/kg), and OVX-low Mg group fed the low Mg diet(Ca 0.4%, Mg 0.01%, vitaminD32400 IU/kg). The diets and distilled water were available ad libitum during the 16 weeksof the experimental period.Results Increases in the total-cholesterol and the atherosclerotic index were observed inthe OVX-control, the OVX-low Ca and the OVX-low Mg groups as compared with thesham-operated group. A tendency of increases in the serum triglyceride was also observedin these three OVX groups. In the OVX-CATASE MAG group, the hyperlipidemic changes,i. e., the inceased levels of the serum triglyceride, total-cholesterol and atherosclerotic index,were remarkably improved, while in the OVX-Ca-containing formulation A group only theserum triglyceride was improved. The signs of osteoporosis, i. e., decreases in the trabecularbone mineral density and the trabecular number, and increases in the trabecular space andthe star volume(V*m・space),were observed in the OVX-control group. The osteoporotic signs tended to be more severe in the OVX-low Ca and the OVX-low Mg groups. The bone parameters were improved in both the OVX-CATASE MAG and the OVX-Ca-containing formulation A groups, although the improvement was more marked in the OVX-CATASE MAG group.Conclusion These results strongly suggest the preventive effect of CATASE MAG on the post-menopausal symptoms and diseases including osteoporosis, dyslipidemia, and resultant atherosclerosis. -
アシノン錠改良製剤の生物学的同等性試験
39巻1号(2011);View Description Hide DescriptionBackground Nizatidine Tablets are used to treat gastric/duodenal ulcer, esophageal inflammation,acute gastritis, and acutely exacerbated chronic gastritis. However, the surface of tabletsslightly varies in shade of color in open air condition, improved tablet was developed toprevent the coloring.Method Twenty-five healthy male Japanese volunteers who met both inclusion and exclusioncriteria were enrolled in a non-blind cross-over study;twenty of these candidateswere administered Z-121 150 mg Tablet and Nizatidine Tablet 150 mg in a randomized orderwith a 7-day washout period. The plasma concentrations of unchanged Nizatidine were examinedat ten points in 24 hours after administration.Result No discrepancy were found in the level of AUC0-24h, Cmax, Tmax and t1/2 in both Z-121 150 mg Tablet and Nizatidine Tablet 150 mg. In addition, the 90% confidence intervals ofAUC0-24h and Cmax were log(1.003)to log(1.087)and log(0.899)to log(1.104), respectively,both of which were within the range stipulated in the guidelines for bioequivalence studies.Conclusion Z-121 Tablet was biologically equivalent to Nizatidine Tablet. -
ベザフィブラート後発医薬品の製剤学的および治療学的同等性試験
39巻1号(2011);View Description Hide DescriptionObjectives The use of generic drugs is recommended in order to reduce medical costs.However, many doctors and pharmacists do not trust the quality, efficacy and safety of somegeneric drugs. BezatorSR containing bezafibrate is widely used for the treatment of hyperlipidemia,and besastarSR is the generic drug of bezatorSR. We herein compared the pharmaceuticaland therapeutic equivalence of besastarSR with those of bezatorSR.Methods The elution rate of bezafibrate from besastarSR was compared to that of bezatorSR. In addition, the clinical data of the patients treated with besastarSR at FukuokaMemorial Hospital were compared with those treated with bezatorSR at Fukuoka UniversityChikushi Hospital.Results One of six lots of besastarSR did not satisfy the standards of elution ofbezafibrate. However, the effect of besastarSR on the blood triglyceride concentration after4-12 weeks was equivalent to that of bezatorSR. In addition, in a manner similar to that ofbezatorSR, besastarSR did not induce hematopoietic injury, hepatic dysfunction, renal dysfunctionor rhabdomyolysis during the period from 4-12 weeks after the initiation oftreatment.Conclusions Although besastarSR is not 100% pharmaceutically equivalent to bezatorSR, the efficacy and safety of this generic drug are considered to be equivalent to those ofbezatorSR. -
β-グルカン強化型大麦食品の継続摂取による耐糖能異常改善効果および安全性の検討
39巻1号(2011);View Description Hide DescriptionObjectives We investigated the effect of β-glucan enriched barley flour on Impaired GlucoseTolerance and safety of the product on the subjects at high risk of diabetes for 12 weeks.Methods The double-blind study with 2 parallel groups was designed and examined. Atotal of 66 subjects were assigned to 1 of 2 groups;test powder‘Barley β-glucan Powder’(3.6 g/pack)’containing 1.0 g β-glucan or test powder‘Mugikogashi(roast barley flour)(3.6g/pack)’containing 0.1 g β-glucan. The subjects in both groups took the assigned powder 1pack a day for 12 consecutive weeks. Blood tests, including 75 g OGTT, urine test and bodymeasurement were carried out before and after the test period.Results In both groups, significant decreases of blood glucose levels were observed at 0-min and 60-min of glucose tolerance test, and also significant decreases of blood insulin levelwere observed at 60-min and 120-min of glucose tolerance test. In addition, significantincreases of high-molecular-weight adiponectin were observed in both groups. No statisticalsignificant differences were found in both groups. No adverse event was found after continuousintake of barely β-glucan, and therefore, safety was confirmed.Conclusions Clear significant differences were not confirmed between the groups;however,there is a possibility that improvement of insulin resistance in both groups wereobserved due to increases of high-molecular-weight adiponectin.
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