薬理と治療
Volume 37, Issue 7, 2009
Volumes & issues:
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TOPICS
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- 第15回浜名湖セミナー
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- 臨床試験と医学の進歩
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ORIGINAL ARTICLES
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スギ花粉症患者由来 CD14 陽性細胞からのTh2 T 細胞遊走因子産生に及ぼす塩酸エピナスチン(アレジオン )の効果
37巻7号(2009);View Description Hide DescriptionObjective The purpose of the present study was to examine the influence of epinastinehydrochloride(EP)on the production of both thymus−and activation−regulated chemokine(TARC)and macrophage−derived chemokine(MDC)from human CD14+cells induced by antigenicstimulation with Japanese cedar pollen(Cry j1)in vitro.Methods CD14+cells(1×105cells/mL)obtained from 5 patients with pollinosis against Japanesecedar pollen were stimulated with 100 ng/mL Cry j1 in the absence or presence of EP.TARC and MDC levels in 6−day culture supernatants were assayed by ELISA. We also examinedthe influence of EP on mRNA expression and transcription factor, NF−κB, activation in24−hour cultured cells by RT−PCR and ELISA, respectively.Results EP could inhibit the production of both TARC and MDC from CD14+cells afterCry j1 stimulation. The minimum concentrations that caused significant suppression were 25ng/mL for TARC and 10 ng/mL for MDC. EP also exerted the suppressive effects on chemokinemRNA expression and NF−κB activation, which are enhanced by Cry j1 stimulation.Conclusion The present results strongly suggest that EP inhibits Th2 type helper T cellmigration into the sites of allergic immune responses and results in attenuation of clinical conditionsof allergic diseases, including pollinosis.(Jpn Pharmacol Ther 2009;37:569−76)KEY WORDS Epinastine hydrochloride, CD14+cells, Cry j1, CC chemokine, Suppression -
カルペリチド(ヒト心房性ナトリウム利尿ペプチド)の急性腎不全に対する有効性と安全性の検討
37巻7号(2009);View Description Hide DescriptionObjectives Efficacy and safety of the Carperitide(α−human atrial natriuretic peptide)wereinvestigated in patients with acute renal failure for exploratory purposes multicenter prospectivestudy.Methods Thirty−three acute renal failure patients with pre−defined criteria of high serumcreatinine and low creatinine clearance were enrolled into this study. Carperitide was administeredat a start dose of 0.05μg・kg−1・min−1 by continuous intravenous infusion for maximumof 7 days.Results Infusion of Carperitide increased the creatinine clearance significantly and suppressedthe further increase in serum creatinine. In the oliguric acute renal failure patients,defined as<30 mL・hr−1 at the baseline, increase of urine volume were observed. The mortalityrate at day 21 was 10.0%. The probability of dialysis and dialysis−free survival rate atday 21 were 6.3% and 84.4%, respectively. For safety, the decrease of blood pressureoccurred in 15 patients(45.5%), however, these events did not result in serious problemsclinically. Additionally, worsening renal function associated with the decrease in blood pressurewas not observed.Conclusions These results suggested that infusion of Carperitide in patients with acuterenal failure showed improvement of the renal functions, favorable prognosis and no significantadverse events.(Jpn Pharmacol Ther 2009;37:577−85)KEY WORDS Acute renal failure, Atrial natriuretic peptide, Carperitide, Clinical trial -
高トリグリセリド血症を伴う高コレステロール血症患者におけるピタバスタチンカルシウムとデキストラン硫酸ナトリウムの併用成績
37巻7号(2009);View Description Hide DescriptionEffective and safe therapy has not been established for patients with mixedhyperlipidemia. We conducted two clinical studies in order to clarify significance of combinationtherapy with pitavastatin calcium(hereinafter called PIT)and dextran sulfate sodium sulfur18(hereinafter called DS)and accumulate clinical results of this therapy as supportivedata for daily medical practice. We conducted study 1, comparing three therapies with PIT 2mg QD, DS 300 mg TID and combination of them. Each mono therapy demonstrated reductionin serum triglyceride levels no less than existing reports. On the other hand, efficacy ofcombination therapy of them on that reduction was not significant, which was considered dueto patient back grounds, compliance, and so forth. To improve them, we conducted study 2,adding DS 300 mg QD on PIT 2 mg QD having administered over two months. There wasobserved an additional reduction in triglyceride levels by add−on of DS. In conclusion, it wassuggested that combination therapy with PIT and DS should be positioned with high priorityas an option of pharmacotherapy for patients with mixed hyperdyslipidemia, which is difficultto be managed in daily medical practice.(Jpn Pharmacol Ther 2009;37:587−96)KEY WORDS Mixed hyperlipidemia, Pitavastatin calcium, Dextran sulfate sodium, Multicenterclinical trial, Combination therapy -
「MSM および鶏軟骨抽出物含有食品」の変形性膝関節症改善作用に関するヒト臨床評価
37巻7号(2009);View Description Hide DescriptionObjectives To evaluate the effectiveness and safety of food containing methylsulfonylmethane(MSM), a analgesic/anti−inflammatory agent, and chicken cartilage extract consisting primarilyof typeII collagen on knee osteoarthritis.Methods A randomized, double−blind, parallel, placebo−controlled trial was conducted in 24subjects(male/female:6/18, age:55.6±1.3)with slight pain or discomfort in their kneejoints and Kellgren−Lawrence osteoarthritis scale rating of 0 or 1 on x ray. Intervention waseither placebo or a test compound of MSM 1820 mg and chicken cartilage extract 2820 mgtaken in two doses each day for 8 weeks. Subjective symptoms of knee pain, stiffness and discomfortwere evaluated by a visual analogue scale(VAS)registered daily. Range of motion(ROM)in both knees were assessed at 0(start of treatment), 4 and 8 weeks post−treatment.Safety was assessed by medical examinations at 0, 4 and 8 weeks, and laboratory tests at 0and 8 weeks post−treatment.Results Compared with placebo, MSM and chicken cartilage extract compound induced significantimprovement in VAS scores for knee pain, stiffness and/or discomfort when gettingup in the morning, going up and down the stairs, and sitting with legs folded underneath asearly as 2 to 3 weeks post−treatment. No significant difference in ROM was observedbetween the two groups. No significant abnormal laboratory results or adverse events relatedto the treatments were detected during the study period.Conclusion MSM and chicken cartilage extract compound rapidly and safely reduced thesubjective symptoms of pain and discomfort from knee osteoarthritis.(Jpn Pharmacol Ther 2009;37:597−610)KEY WORDS Methylsulfonylmethane, MSM, Chicken cartilage extract, Osteoarthritis -
機能性食品の市販後調査研究
37巻7号(2009);View Description Hide DescriptionObjectives Recently, compounds of collagen, glucosamine, chondroitin and methylsulfonylmethane(MSM), considered effective for knee osteoarthritis(OA), have been marketed asfunctional foods. However, practically no study has been done to examine the safety of thesefoods, which are used mainly by middle− to advanced−aged people many of whom may bereceiving treatments for‘lifestyle−related diseases’. We thus investigated the clinical safetyof one of these marketed functional foods, particularly taking drug interactions into account.Methods Subjects were outpatients of internal medicine with knee OA pain. Two differentmethods were employed to assess the safety of the compound:a detailed study conducted ina small number of patients comparing their conditions before and after a 12−week intakeperiod;and a simple survey with a questionnaire sent out together with the compound to alarge number of patients, and collected after a 4−week intake period.Results Of the 44 subjects in the detailed study, adverse events were noted in 3 cases(dermatologicalsymptoms(1);epigastric discomfort, inappetence(1);constipation(1)). Therewere no abnormal values in the laboratory test results. Of the 210 subjects in the simplequestionnaire survey, there were 12 cases of gastrointestinal symptoms, 5 cases of dermatologicalsymptoms, and 10 other cases(pain in the lower extremity, lassitude(3);frequent urination(2);headache(1);unknown symptoms(4)). No drug interactions were detected ineither study.Conclusions The results suggested that the functional food used in this study was safeeven for outpatients of internal medicine with‘lifestyle−related diseases’.(Jpn Pharmacol Ther 2009;37:613−8)KEY WORDS Safety, Collagen, Glucosamine, Chondroitin sulfate, MSM, Patients
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