薬理と治療
Volume 40, Issue 6, 2012
Volumes & issues:
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扉・目次
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TOPICS:第11 回CRC と臨床試験のあり方を考える会議 2011 in 岡山
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- シンポジウム6 / CRC 業務とその魅力
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- パネルディスカッション3 /これからの時代を担うIRB の機能と責務-中央IRB(共同IRB を含む)の普及に向けて-
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【講演4】 中央IRB 等への移行過程で生じた課題とその解決に向けた取り組み
40巻6号(2012);View Description Hide Description大学病院臨床試験アライアンスではいわゆる中央IRBのあり方について検討を行うとともに,千葉大学,信州大学,新潟大学による中央IRBの審議を2010 年7 月より試験的に一試験について開始した。本稿では大学病院臨床試験アライアンスで実施している中央IRB検討ワーキンググループ(以下WG)およびその上部組織である推進室での議論,さらに欧州の中央IRBのあり方をふまえたIRBのあるべき姿と,実際の取り組みについて述べるものである。また,この内容については,筆者らの私見にもとづいており,各大学でのコンセンサスを得られた段階に至っていない。
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DRUG INFORMATION:アレルギー性鼻炎の新治療
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ORIGINAL ARTICLES
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拘束ストレス誘発性瘀血モデルに対する桂枝茯苓丸の影響
40巻6号(2012);View Description Hide DescriptionObjectives It is a common well known fact that blood flow stasis or stagnation induces pain and organ dysfunctions. Blood fluidity is an essential factor in the circulation system. The stagnation of blood fluidity is called“oketsu”in the oriental medicine, and“oketsu”is known to cause pain and equivocal symptom frequently. Keishibukuryogan(KB)is the representative Chinese medicine to improve oketsu. We previously demonstrated how stressors impair blood fluidity. In this study, we observed whether the Japanese herbal medicine, KB, used by “oketsu”patients, improves low blood flow induced by restraint stress. Methods We tested on SPF 8 weeks old male Wistar rats weighing 250 g. They were treated with the KB for 1 week. The rats were randomly divided into four medication groups Restraint-Normal feed group(RN), Restraint-0.3% or 3% KB mixing feed group(RKB-0.3/RKB-3), and Non restraint(control)-Normal feed group(CN). Blood fluidity was measured with a Micro Channel Array Flow Analyzer(MC-FAN). Platelet aggregation was examined by a platelet aggregometer(PA-20). P-Selectin level in plasma was examined using commercially available enzyme linked-immunosorbent assay(ELISA)kits. Results In the RN, platelet aggregation and P-Selectin level were increased, while blood fluidity was decreased compared with the CN and RKB.Conclusion The results of this study suggest that KB improves blood fluidity to reduce platelet activity. -
アジュバント関節炎ラットにおけるメロキシカム誘起胃損傷の増悪に対するイルソグラジンの効果
40巻6号(2012);View Description Hide DescriptionWe previously reported that gastric ulcerogenic responses to non-steroidal anti-inflammatory drugs(NSAIDs)and highly selective cyclooxygenase-2(COX-2)inhibitors were markedly increased in arthritic rats. In the present study, we examined the effect of irsogladine on aggravation of gastric damage induced by meloxicam, a preferential COX-2 inhibitor, in adjuvant arthritic rats. Arthritis was induced in male DA rats by a plantar injection of Freund’s complete adjuvant. Two weeks after the adjuvant injection, the animals were given meloxicam (3 and 10 mg/kg, p.o.), and 4 h later the gastric mucosa was examined for damage, myeloperoxidase(MPO)activity, and lipid peroxidation. In normal rats, meloxicam at 3 mg/kg did not cause any damage in the stomach but at 10 mg/kg produced only slight damage. In arthritic rats, however, this agent provoked apparent damage in the stomach even at 3 mg/kg and at 10 mg/kg produced severe hemorrhagic damage. The severity of meloxicam-induced gastric damage in arthritic rats was ameliorated by irsogladine, in a dose-dependent manner. Similar effect was also observed by omeprazole and teprenone. Likewise, the increase in MPO activity and lipid peroxidation after the administration of meloxicam was significantly suppressed by irsogladine, omeprazole, and teprenone. These findings suggest that meloxicam, a preferential COX-2 inhibitor, although showed only minimum gastric ulcerogenecity in normal rats,caused severe hemorrhagic damage in the arthritic rat stomach. Irsogladine prevented meloxicam-induced gastric damage in arthritic rats, similar to omeprazole and teprenone. It is assumed that irsogladine can be used as a prophylactic against meloxicam-induced gastric toxicity in arthritic patients. -
ブロッコリー抽出加工食品(ブロリコ)の継続摂取によるヒトの自然免疫賦活作用に関する試験
40巻6号(2012);View Description Hide DescriptionObjectives A broccoli extract processed food product has been shown to activate natural immunity in animals, and this study was conducted to examine the natural immunity activating action of continued consumption of this food product in humans and to confirm its safety. Methods Twenty healthy individuals(8 men and 12 women with an average age of 57.5±11.6)consumed 20 mL of a broccoli extract(brolico)drink every day for 4 weeks. Samples of their blood were collected before and after consumption of the extract, and the activity of NK cells and other cells involved in immunity was measured. Results One subject stopped consuming the extract in the middle of trial because it was unpalatable for him. Four subjects could not come to the examination after consumption. Therefore, 16 subjects(6 men and 10 women with an average age of 58.2±10.8)were examined the effect of consumption of the extract. It was observed that through continued administration of the trial extract neutrophil phagocytic capacity and NK cell activity in the blood tended to increase. No serious side effects that could be thought of as having been caused by the trial extract were seen during the period of consumption. Conclusions The results of this trial suggest that continued consumption of this broccoli extract drink increases human natural immunity, but randomized clinical trials on a larger number of subjects are now required. -
肥満者に対するケルセチン配糖体(酵素処理イソクエルシトリン)配合緑茶飲料の体脂肪低減作用および安全性の検証
40巻6号(2012);View Description Hide DescriptionObjectives The objective of this study was to evaluate the effect of long-term consumption of green tea containing quercetin glucoside on body fat accumulation and the safety in obese subjects. Methods We performed a randomized double-blind, placebo-controlled trial on subjects(81men and 119 women)aged from 20 to 65 years old with 25≦ body mass index(BMI)<30 kg/m2. They were randomly assigned into two groups and consumed the beverages containing 0mg or 110 mg of quercetin glucoside for 12 weeks. Results Both total fat area and visceral fat area were significantly reduced in test group compared with placebo group. No adverse effect related to the test beverage containg quercetin glucoside was observed in this study. Conclusions The results of this study suggest that the long-term consumption of green tea containing quercetin glucoside reduced body fat in safe, and could be useful for prevention and amelioration of obesity and metabolic syndrome. -
ケルセチン配糖体(酵素処理イソクエルシトリン)配合緑茶飲料の肥満者を含む健康成人に対する過剰摂取時の安全性
40巻6号(2012);View Description Hide DescriptionObjective A randomized double-blind placebo-controlled study for 4 weeks was conducted on 48 subjects to evaluate the safety of the green tea beverage containing quercetin glycoside (enzymatically modified isoquercitrin) in the case of excessive intake in healthy adults include obesity persons(body-mass index:25-30 kg/m2). Methods The subjects(male=24, female=24, mean 38.8±8.2 years old)were randomly divided into two groups, one is test group and the other is placebo group. The test group ingested daily 1 bottle of test beverage(500 mL/bottle), which contained 480 mg of quercetin glycoside, for 4 weeks. On the other hand, the placebo group ingested the same amount of placebo beverage for the same duration. Results Changes in the body weight, BMI, body fat percentage, vital sign, blood parameters and urine parameters were thought to be no clinically concerning changes during intake period. No adverse event attributed to the test beverage was found in the study. Conclusions Thus, these results indicated the safety of the green tea beverage containing quercetin glycoside(enzymatically modified isoquercitrin)in healthy adults include obesity persons in the case of excessive intake. -
骨欠損を伴う感染性頭部皮膚難治性潰瘍でのメロペネム水和物混入リン酸カルシウム骨ペーストの使用経験
40巻6号(2012);View Description Hide DescriptionWe treated a 61-year-old male who had an infected scalp ulcer due to Pseudomonas aeruginosa with a bone defect. We performed cranioplasty using calcium phosphate bone cement with meropenem hydrate(MEPM-CPC). Prior to the operation, we investigated the mechanical strength of MEPM-CPC. CPC with low consistency containing 5% wt antibiotics showed a strength of about 30 MPa. Clinical follow-up 10 months later indicated excellent, results with no bony resorption or fragmentation. Consequently, MEPM-CPC was found to be safe and effective in the treatment of cranium osteomyelitis in the weightless-bearing region and infections caused effective MEPM.
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