診療と新薬 Web|Medical Consultation & New Remedies Web
診療と新薬:
検索結果 7件
  • 書誌情報
  • Abstract
    (English)
  • PDF

診療と新薬 2013;50(8):673-683

筋萎縮性側索硬化症に対するリルゾール(リルテックⓇ錠50)の特定使用成績調査(特別調査)

サノフィ株式会社 メディカル本部

Shinryo to Shinyaku (Med Cons New-Remed)2013;50(8):673-683

Specified Drug-use Survey in Patients with Amyotrophic Lateral Sclerosis

Medical Operations Division, Sanofi K.K.

診療と新薬 2013;50(8):673-683

筋萎縮性側索硬化症に対するリルゾール(リルテックⓇ錠50)の特定使用成績調査(特別調査)

サノフィ株式会社 メディカル本部

Shinryo to Shinyaku (Med Cons New-Remed)2013;50(8):673-683

Specified Drug-use Survey in Patients with Amyotrophic Lateral Sclerosis

Medical Operations Division, Sanofi K.K.

To investigate the efficacy and safety of riluzole in clinical practice, specified drug-use survey was conducted in patients with amyotrophic lateral sclerosis who satisfied the same criteria as those of the foreign Phase Ⅲ clinical trial in which efficacy was confirmed. The primary efficacy endpoint was the nonincidence rate of the events of "death" or "respirator insertion with tracheostomy" at 18 months after treatment, while the main secondary efficacy endpoint was the nonincidence rate of abasia. The safety endpoint was the incidence of side effects, including clinical test value abnormality.
The nonincidence rate of the events of "death" or "respirator insertion with tracheostomy" at 18 months after treatment as the primary efficacy endpoint was higher at 64.9% as compared to 56.8% observed in the foreign Phase Ⅲ trial. Additionally, the nonincidence rate of abasia as the secondary endpoint was 41.4%.
Side effects were reported in 232 of 826 patients (28.09%) in the safety analysis set. Although a significant difference was found between "inpatients" and "outpatients" in background factors thought to affect safety, no characteristic bias or clinically significant side effects were observed in the tendency of the incidence of side effects in inpatients and outpatients. It was therefore considered that no particularly notable features were observed with respect to safety. From the results of the reexamination based on the special drug use surveillance and the drug use surveillance conducted concurrently, it was notified that the indication, dosage, and method of administration of riluzole were the same as those approved in March 2012.

Key Words: riluzole, amyotrophic lateral sclerosis, specified drug-use survey

診療と新薬 2013;50(8):673-683

筋萎縮性側索硬化症に対するリルゾール(リルテックⓇ錠50)の特定使用成績調査(特別調査)

Shinryo to Shinyaku (Med Cons New-Remed)2013;50(8):673-683

Specified Drug-use Survey in Patients with Amyotrophic Lateral Sclerosis

PDF

PDF:327 KB

左のアイコンをクリックすると、PDF が表示されます。
When you click on the icon to the left, you will see the PDF.

  • 書誌情報
  • Abstract
    (English)
  • PDF

診療と新薬 2013;50(8):684-697

筋萎縮性側索硬化症に対するリルゾール(リルテックⓇ錠50)の使用成績調査

サノフィ株式会社 メディカル本部

Shinryo to Shinyaku (Med Cons New-Remed)2013;50(8):684-697

Drug Use-result Survey of Riluzole in Patients with Amyotrophic Lateral Sclerosis

Medical Operations Division, Sanofi K.K.

診療と新薬 2013;50(8):684-697

筋萎縮性側索硬化症に対するリルゾール(リルテックⓇ錠50)の使用成績調査

サノフィ株式会社 メディカル本部

Shinryo to Shinyaku (Med Cons New-Remed)2013;50(8):684-697

Drug Use-result Survey of Riluzole in Patients with Amyotrophic Lateral Sclerosis

Medical Operations Division, Sanofi K.K.

Drug use surveillance of riluzole was conducted in patients with amyotrophic lateral sclerosis to investigate the unknown side effects, incidence of side effects in clinical practice, and factors affecting the safety and efficacy of the drug. The study cohort comprised patients who did not satisfy the inclusion and exclusion criteria for the specified drug-use survey that was conducted simultaneously to investigate the efficacy of riluzole with the criteria which are the same as those of the foreign Phase Ⅲ clinical trial in which efficacy was confirmed. The safety endpoint was to detect the incidence of side effects, including clinical test value abnormality, while the efficacy endpoint was the duration of time from the start of treatment until either death or respirator insertion with tracheostomy.
Side effects were observed in 567 of 1997 patients (28.39%) and unknown side effects were observed in 164 of 1997 patients (8.21%) in the safety analysis set; this incidence rate of side effect was lower than that observed in clinical trials during development (68.37%). In the incidence rate of side effects categorized by background factors, a significant difference was observed between "inpatients and outpatients", "WFN diagnostic criteria", "severity", and "duration of disease". In incidence tendency of side effects, however, no characteristic tendency was observed according to background factors, and no clinically significant side effect of riluzole was observed.
With respect to efficacy, the nonincidence rate of the events of "death" or "respirator insertion with tracheostomy" was 54.6% at 18 months. A significant difference in the nonincidence rate of events was observed in background factors of "elderly patients and nonelderly patients", "disease type", "duration of disease", and "FVC before treatment".
This study was an investigation in daily clinical settings for patients with amyotrophic lateral sclerosis except those undergoing the specified drug-use survey, which was being conducted concurrently, and the tolerability of riluzole was confirmed to be consistent with findings from a Phase Ⅲ trial in Japan. From the results of the reexamination based on the postmarketing surveillance and the Special drug use surveillance, it was notified that the indication, dosage, and method of administration of riluzole were the same as those approved in March 2012.

Key Words: riluzole, amyotrophic lateral sclerosis (ALS), drug use-result survey

診療と新薬 2013;50(8):684-697

筋萎縮性側索硬化症に対するリルゾール(リルテックⓇ錠50)の使用成績調査

Shinryo to Shinyaku (Med Cons New-Remed)2013;50(8):684-697

Drug Use-result Survey of Riluzole in Patients with Amyotrophic Lateral Sclerosis

PDF

PDF:332 KB

左のアイコンをクリックすると、PDF が表示されます。
When you click on the icon to the left, you will see the PDF.

  • 書誌情報
  • 要旨
  • PDF

診療と新薬 2013;50(8):698-704

新たな選択的ジペプチジルペプチダーゼ-4(DPP-4)阻害薬であるTeneligliptinの血管内皮機能に及ぼす亜急性効果

1)防衛医科大学校集中治療部,2)入間ハート病院

Shinryo to Shinyaku (Med Cons New-Remed)2013;50(8):698-704

Subacute Effect of a Novel Dipeptidyl Peptidase-4 Inhibitor Teneligliptin on Endothelial Function in Humans

1)National Defense Medical College, Department of Intensive Care Medicine,2)Iruma Heart Hospital

診療と新薬 2013;50(8):698-704

新たな選択的ジペプチジルペプチダーゼ-4(DPP-4)阻害薬であるTeneligliptinの血管内皮機能に及ぼす亜急性効果

1)防衛医科大学校集中治療部,2)入間ハート病院

Shinryo to Shinyaku (Med Cons New-Remed)2013;50(8):698-704

Subacute Effect of a Novel Dipeptidyl Peptidase-4 Inhibitor Teneligliptin on Endothelial Function in Humans

1)National Defense Medical College, Department of Intensive Care Medicine,2)Iruma Heart Hospital

ジペプチジルペプチダーゼ-4(DPP-4)阻害薬は,心合併症等を伴った高齢者2型糖尿病患者の有効な治療薬として注目されている。DPP-4阻害薬は血糖のコントロールのみならず,抗動脈硬化作用が期待されているためである。DPP-4阻害薬の血管内皮機能に及ぼす影響に関する臨床研究は,結果の異なった報告が散見され,DPP-4阻害薬間による血管内皮機能への影響に差がある可能性も示唆される。そこで,新規DPP-4阻害薬であるTeneligliptinの血管内皮機能に及ぼす影響を,EndoPAT2000測定法と上腕動脈血流依存性血管拡張反応測定法(flow-mediated vasodilatation; FMD)の2つの測定法により検討した。
方法:虚血性心疾患合併例や高齢者を含む2型糖尿病患者11症例(73±11歳)を対象に,Teneligliptinの亜急性効果を検討する目的で,Teneligliptin(20 mg/日)の2週間投与前後でのEndoPAT2000およびFMD測定法により血管内皮機能の変化を検討した。
結果:Teneligliptin投与により,血糖値(HbA1c)は有意に改善した(7.9±1.1 vs. 7.7±1.0%,P<0.01)。また,EndoPAT2000およびFMD測定法によるそれぞれの指標であるRHIおよびFMDはどちらも有意に改善した(RHI;1.64±0.35 vs. 1.87±0.45,P<0.05,FMD;4.61±2.62 vs. 8.11±5.05%,P<0.01)。
結語:心合併症等を伴った高齢者2型糖尿病患者において,新規DPP-4阻害薬Teneligliptinは,投与2週間で血管内皮機能を改善する可能性が示唆された。

Key words:Teneligliptin, Flow-mediated vasodilatation,EndoPAT2000,2型糖尿病,血糖値

診療と新薬 2013;50(8):698-704

新たな選択的ジペプチジルペプチダーゼ-4(DPP-4)阻害薬であるTeneligliptinの血管内皮機能に及ぼす亜急性効果

Shinryo to Shinyaku (Med Cons New-Remed)2013;50(8):698-704

Subacute Effect of a Novel Dipeptidyl Peptidase-4 Inhibitor Teneligliptin on Endothelial Function in Humans

PDF

PDF:260 KB

左のアイコンをクリックすると、PDF が表示されます。
When you click on the icon to the left, you will see the PDF.

  • 書誌情報
  • 要旨
  • Abstract
    (English)
  • PDF

診療と新薬 2013;50(8):705-711

エスワンメイジⓇ配合カプセルT25のヌードマウスを用いたヒト胃癌細胞皮下移植モデルにおける抗腫瘍効果の検討

Meiji Seikaファルマ株式会社

Shinryo to Shinyaku (Med Cons New-Remed)2013;50(8):705-711

Anti-tumor Effects of S-1meijiⓇCombination Capsules T25 in Nude Mice Implanted with Human Gastric Cancer-derived Cells

Meiji Seika Pharma, Co., Ltd.

診療と新薬 2013;50(8):705-711

エスワンメイジⓇ配合カプセルT25のヌードマウスを用いたヒト胃癌細胞皮下移植モデルにおける抗腫瘍効果の検討

Meiji Seikaファルマ株式会社

Shinryo to Shinyaku (Med Cons New-Remed)2013;50(8):705-711

Anti-tumor Effects of S-1meijiⓇCombination Capsules T25 in Nude Mice Implanted with Human Gastric Cancer-derived Cells

Meiji Seika Pharma, Co., Ltd.

Meiji Seikaファルマ株式会社が開発したエスワンメイジⓇ配合カプセルT25(以下,S-1Meiji)について,先発医薬品である大鵬薬品工業株式会社のティーエスワンⓇ配合カプセルT25(以下,TS-1)を比較対照に,ヌードマウス皮下移植ヒト胃癌細胞に対する抗腫瘍効果並びに造血器及び小腸への影響を検討した。
MKN45ヒト胃癌細胞を6週齢の雌ヌードマウスの背部皮下に移植し,移植の11日後より,S-1Meiji及びTS-1ともに各々10 mg/kgの用量を1日1回の頻度で9日間,強制経口投与した。投与期間終了後,動物は継続して12日間の観察期間を設けた。投与及び観察期間中に腫瘍径を測定した。サテライト群として一部の動物は両製剤の10 mg/kgを9日間強制経口投与後に解剖し,全採血を行い,造血器への影響を検討するため白血球数を計測した。また,これらの動物の小腸について病理組織学的に投与の影響を検討した。
その結果,S-1Meiji投与群では媒体対照群と比較して有意な腫瘍増殖抑制効果が観察された。S-1Meijiの平均腫瘍体積の推移を標準製剤であるTS-1投与群と比較すると,ほぼ同様の抑制傾向が示され,S-1MeijiとTS-1の薬効はほぼ同様であると考えられた。
サテライト群では,媒体対照群と比較して両製剤群に有意な白血球数の減少が観察されたが,両製剤群間では差はなかった。また,小腸陰窩上皮細胞に軽度の単細胞壊死とTUNEL染色陽性のアポトーシスの増加が両製剤ともにみられたが,これらの程度は両製剤間で差はみられなかった。
以上より,エスワンメイジⓇ配合カプセルT25の薬効並びに造血器及び小腸への影響は,標準製剤であるティーエスワンⓇ配合カプセルT25とほぼ同様と考えられた。

キーワード:フルオロウラシル,テガフール,ギメラシル,オテラシルカリウム,胃癌,抗腫瘍効果,後発医薬品

診療と新薬 2013;50(8):705-711

エスワンメイジⓇ配合カプセルT25のヌードマウスを用いたヒト胃癌細胞皮下移植モデルにおける抗腫瘍効果の検討

Meiji Seikaファルマ株式会社

Shinryo to Shinyaku (Med Cons New-Remed)2013;50(8):705-711

Anti-tumor Effects of S-1meijiⓇCombination Capsules T25 in Nude Mice Implanted with Human Gastric Cancer-derived Cells

Meiji Seika Pharma, Co., Ltd.

S-1MeijiⓇCombination Capsules T25 (test formulation) developed by Meiji Seika Pharma, Co., Ltd. was examined on its anti-tumor effects in comparison with TS-1 combination capsuleⓇT25 (Taiho Pharmaceutical Co., Ltd.; standard formulation) that have been mainly used in treatment of gastric cancer. We used female nude mice (CAnN.Cg-Foxn1nu/CrlCrlj) subcutaneously implanted with the human gastric cancer cell lines, MKN45. After 11 days of tumor cell transplantation, mice were administered orally with test or standard formulation at dose of 10 mg/kg daily for 9 days, respectively. After the treatment with the two formulations, all animals were observed for 12 days. The size of the tumor was measured for comparison from the start of treatment to the end of the study. Leukocyte counts and intestinal mucosal injury were examined in the additional three groups of mice treated with two formulations at dose of 10 mg/kg for 9 days.
As a result, a tendency of tumor growth inhibition by the test formulation was observed during a period of 9 days treatment. Thereafter, tumors in the test formulation group significantly decreased in volume throughout the observation period of 12 days. Similar antitumor effects for tumor growth during the study period were seen for the test and standard formulation.
Leukocyte counts in two groups of formulations were significantly decreased. Furthermore, intestinal mucosal damage in both groups was not clearly evident, however, single-cell necroses or apoptotic cells stained with TUNEL in the crypts were mildly observed in the groups.
The degree of decrease in leukocyte counts and the change of crypt cells of small intestine by the test formulation were comparable to those induced by the standard formulation.
The results concluded that the test formulation is expected to exert therapeutic effects in humans as in the case of standard formulation.

Key words: 5-fl uorouracil, tegafur, gimeracil, oteracil potassium, gastric cancer, anti-tumor effect, generic drug

診療と新薬 2013;50(8):705-711

エスワンメイジⓇ配合カプセルT25のヌードマウスを用いたヒト胃癌細胞皮下移植モデルにおける抗腫瘍効果の検討

Shinryo to Shinyaku (Med Cons New-Remed)2013;50(8):705-711

Anti-tumor Effects of S-1meijiⓇCombination Capsules T25 in Nude Mice Implanted with Human Gastric Cancer-derived Cells

PDF

PDF:321 KB

左のアイコンをクリックすると、PDF が表示されます。
When you click on the icon to the left, you will see the PDF.

  • 書誌情報
  • PDF

診療と新薬 2013;50(8):715-719

外用抗真菌薬のアドヒアランスの向上をめざして─レオロジーと使用感に関する調査・研究─

明治薬科大学微生物学教室

Shinryo to Shinyaku (Med Cons New-Remed)2013;50(8):715-719

診療と新薬 2013;50(8):715-719

外用抗真菌薬のアドヒアランスの向上をめざして─レオロジーと使用感に関する調査・研究─

PDF

PDF:188 KB

左のアイコンをクリックすると、PDF が表示されます。
When you click on the icon to the left, you will see the PDF.

  • 書誌情報

診療と新薬 2013;50(8):720-721

【国際学会報告】重度肝機能障害(Child-Pugh分類B,C)を有する進行肝細胞癌患者に対するソラフェニブ投与の安全性の評価~肝細胞癌の国際試験“GIDEON”の最終解析結果より~

Shinryo to Shinyaku (Med Cons New-Remed)2013;50(8):720-721

  • 書誌情報

診療と新薬 2013;50(8):722-727

【座談会】一歩先行く認知症治療~糖尿病の関わりから~

1)ばんどうクリニック,2)横浜市立大学附属病院 臨床統計学,3)横浜市立大学大学院 医学研究科 神経内科・脳卒中医学,4)横浜医療センター神経内科,5)タグチクリニック,6)横浜栄共済病院 代謝内分泌内科

Shinryo to Shinyaku (Med Cons New-Remed)2013;50(8):722-727