薬理と治療
Volume 38, Issue 1, 2010
Volumes & issues:
-
シリーズ
-
- 「いろいろな臨床試験のケースレポート: 温泉のRCTから看護のSRまで」
-
-
-
DRUG PROFILE SERIES
-
-
-
ORIGINAL ARTICLES
-
-
CRC 業務遂行上の不安緊張傾向と関与する要因
38巻1号(2010);View Description Hide DescriptionBackground Clinical research coordinators(CRCs)in Japan often have to respond flexiblyto changing situations of daily work. Anxiety−provoking stressful situations and factors associatedwith such anxiety were investigated. Relationships between anxiety and various factorssuch as medical qualifications, CRC experience, and CRC certification/accreditation wereanalyzed.Methods A total of 174 currently active CRCs were asked via questionnaire to name workrelatedsituations that caused tension and anxiety during the previous week. Anxiety levelwas measured using the State Trait Anxiety Inventory(STAI)and Visual Analogue Scale(VAS). Stressful situations were classified into 15 categories, and the relationship of eachcategory to STAI score, VAS level, medical qualifications, CRC experience, and CRC certification/accreditation was analyzed.Results The mean state anxiety level(measured by STAI)was high, and a tendency to behighly anxious was shown in all CRC respondents. Stress and anxiety levels were significantlyhigher in CRCs with 1−2 years’experience than in those with 3−4 years’experience.The most commonly−named stressful situations were“communication with subjects, andschedule management”for pharmacist and nurse CRCs, and“liaison and coordination withinvestigators”for clinical technologist CRCs. CRCs working in Site Management Organization(SMO)named“clinical study pre−commencement duties”significantly more frequently thanCRCs working in medical institutions. State anxiety level was lower in CRCs with CRC certification/accreditation than in those without.Conclusions In CRCs, perceived stressful situation and anxiety depend on medical qualifications,affiliated institution, length of experience, and certification/accreditation. A cooperativeapproach and support systems will reduce anxiety levels.(Jpn Pharmacol Ther 2010;38:69−80)KEY WORDS CRC, Anxiety, Stress -
胃炎に対する胃腸薬 SAG−030 の有効性,安全性および有用性の検討
38巻1号(2010);View Description Hide DescriptionObjective To evaluate the clinical efficacy, safety and usefulness of SAG−030, a digestivemedicine in patients with gastritis.Design Phase III, multicenter, open−label, non−comparative study.Setting Seventeen clinics in Japan.Participants One hundred seventy three patients who had more than two typical uppergastrointestinal symptoms and were diagnosed acute gastritis or acute exacerbation phase ofchronic gastritis by stomach X−ray test or gastroscopy.Interventions One pack of SAG−030 administered orally three times a day for 2 weekscontained troxipide 100 mg, sodium azulene sulfonate 2 mg, scopolia extract powder(×3)30mg and precipitated calcium carbonate 228 mg, magnesium silicate 240 mg and sodium hydrogencarbonate 320 mg.Main outcome measure Final global improvement rate(FGIR)based on the change ofoverall subjective symptoms as primary endpoint, improvement rate by the symptoms and bythe endoscopic findings as secondary endpoints.Results One hundred sixty five patients were eligible for efficacy and 173 for safety. Theproportion of patients showed marked or moderate improvement on FGIR was 86.1%(142/165). Marked or moderate improvement rate by the symptoms were 89.1% in epigastricpain, 86.2% in a sensation of discomfort in the upper abdomen, 91.1% in stomach heaviness,88.9% in a feeling of fullness, 87.1% in sitting heavy on the stomach, 96.6% in nauseousfeeling, 87.4% in heartburn, 77.0% in belching and 88.6% in a sensation of chest oppression.Marked or moderate improvement rate by the gastroscopic findings were 100.0% in gastrichemorrhage, 57.1% in gastric erosion, 51.0% in redness(erythema)of the gastric mucosaand 76.2% in edema of the gastric mucosa. Incidence of adverse events was 6.9%(12/173)and most of them were mild and transient.Conclusion Two week treatment of SAG−030 for acute gastritis or acute exacerbationphase of chronic gastritis was very effective, safe and useful.(Jpn Pharmacol Ther 2010;38:81−93)KEY WORDS SAG−030, Troxipide, Acute gastritis, Acute exacerbation phase of chronicgastritis, Upper gastrointestinal symptom, Gastroscopic finding
-