臨床薬理
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
47 巻, 1 号
選択された号の論文の5件中1~5を表示しています
原著
  • 渡邉 達也, 成川 衛
    2016 年 47 巻 1 号 p. 3-10
    発行日: 2016/01/31
    公開日: 2016/02/11
    ジャーナル フリー
    Many pharmacists utilize the package insert as a fundamental source of drug information. After re-examination, the package insert describes the information obtained up to approval and the information obtained after approval. However, our survey showed that when referring to the package inserts, many pharmacists gave priority to post-marketing information (treatment outcome study). Also, differences in response to some questions were found between respondents with and those without clinical trial experience. Clinical trials for marketing approval are strictly controlled and conducted with support by clinical research coordinators and monitors. On the other hand, there is no such enforcement system for treatment outcome studies, and some issues regarding the process of case report generation and environment of data collection have been noted. Furthermore, there are many pharmaceuticals for which the rates of adverse drugs reaction at approval differ greatly from those at re-examination. Therefore, pharmacists are expected to provide safety information on pharmaceuticals based on proper understanding of the difference in data collection environment between pre-marketing and post-marketing studies without solely focusing on the figures in the package inserts.
  • Yasutoshi SAKAMOTO, Mami WAKISAKA, Mika MAEDA, Ildae SONG, Tomoe FUJIT ...
    2016 年 47 巻 1 号 p. 11-16
    発行日: 2016/01/31
    公開日: 2016/02/11
    ジャーナル フリー
    Acetaminophen is widely used as a common analgesic agent, but toxic liver injury is a well known side effect of acetaminophen when used long-term. Compared to the clinical doses of acetaminophen used in Western countries and in China, the clinical doses used in Japan have been lower, and the drug potency is not high. The clinical doses of acetaminophen in Japan were increased in 2011, but the incidence of toxic liver injury remains to be investigated. In this study, the pharmacokinetics of acetaminophen were compared between Chinese and Japanese subjects, given that both are Asians and acetaminophen has been prescribed at high doses with an average of approximately 1,000 mg for many years in both countries. A single oral dose of acetaminophen 1,000 mg was administered to healthy Japanese and Chinese volunteers (8 participants each), and the pharmacokinetic parameters and urinary excretion rates were measured. No differences in pharmacokinetics of acetaminophen were observed between Japanese and Chinese subjects, and no differences in 24-h urinary excretion rates of unchanged acetaminophen and acetaminophen glucuronide as well as 4-acetaminophen sulfate and 3-cysteinyl acetaminophen were found. The pharmacokinetics of acetaminophen were similar in Chinese and Japanese subjects, and the risk of developing drug-induced toxic liver injury associated with an increase in acetaminophen dose is predicted to be comparable in the two ethnic groups.
短報
  • 則武 秀尚, 松永 英里香, 太田 和義, 下山 真, 山﨑 哲, 千田 剛士, 川田 一仁, 小林 良正
    2016 年 47 巻 1 号 p. 17-20
    発行日: 2016/01/31
    公開日: 2016/02/11
    ジャーナル フリー
    The factors related to the beneficial effects of tolvaptan treatment for hepatic ascites remain unclear. In this retrospective study, 35 cirrhotic patients with ascites who did not respond sufficiently to conventional diuretics (furosemide used in 77% of patients and spironolactone in 86%) were given tolvaptan (initial dose of 7.5 mg/day in 46% of patients) as add-on therapy to conventional diuretics. The assessment of treatment response was based on the physician's comprehensive clinical evaluation. Twenty-three patients (66%) had a favorable response. Concurrent furosemide administration was identified as a factor associated with poor response to tolvaptan treatment (P=0.020). In addition, the average serum sodium concentrations on days 3 and 4 increased significantly (median, 132 to 136 mEq/L, P=0.002) after the initiation of treatment in patients with a favorable response, which was not observed in patients who lacked a response. This study suggests a possibility that the diuretic effect of tolvaptan may be enhanced when conventional loop diuretics are not used concomitantly.
  • Motoh IWASA, Ryosuke SUGIMOTO, Nagisa HARA, Rumi MIFUJI-MOROKA, Yoshiy ...
    2016 年 47 巻 1 号 p. 21-24
    発行日: 2016/01/31
    公開日: 2016/02/11
    ジャーナル フリー
    The relationship between cirrhosis-related hyponatremia and survival prognosis has been the subject of many reports, primarily in Western countries. In a study of 161 patients with cirrhosis, we reconfirmed hyponatremia as a significant predictor of poor prognosis in a Cox proportional hazards regression model that included serum sodium and creatinine levels, Child-Pugh score, and use of conventional diuretics as variables. Moreover, we investigated the relationship of serum sodium level with clinical findings, particularly renal function, and dosage of diuretics. We also analyzed the relationship between the factors associated with low sodium level and survival rate. Serum sodium was found to decrease with increase in dosage of diuretics and with worsening of renal function. Analysis of survival rate revealed serum creatinine ≥1 mg/dL and use of furosemide at ≥40 mg/day as factors significantly associated with poor survival outcome. Serum sodium level is closely related to renal function and diuretic use. The present findings showed that concurrent mild renal disorders and use of low-dose furosemide may contribute to worsening survival in cirrhotic patients. The usefulness of administering tolvaptan in these patients has to be investigated in the future.
REPORT
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