消化性潰瘍治療剤「タケプロン®カプセル15」、「タケプロン®OD錠15」（一般名：ランソプラゾール）が、「非ステロイド性抗炎症薬投与時における胃潰瘍又は十二指腸潰瘍の再発抑制」の効能追加承認を取得しました。どの程度の効果なのか？臨床論文を確認しました。
・ピロリ菌がなく、潰瘍の既往歴がある537名の患者が12週間後の潰瘍が発生していない人の割合
| placebo | 51% (95% CI, 41.1%-61.3%) |
| 800microg misoprostol | 93% (95% CI, 87.2%-97.9%) |
| 15-mg lansoprazole | 80% (95% CI, 72.5%-87.3%) |
| 30-mg lansoprazole | 82% (95% CI, 75.0%-89.6%) |
・ミソプロストール群は、早期の中断例が有意に高かった。
・ランソプラゾールのようなプロトンポンプ阻害剤は、ミソプロストールよりも優れた有効性はなかったが、NSAIDSの再発性潰瘍を予防する。ミソプロストールのコンプライアンスの低さや潜在的な副作用も勘案すると、プロトンポンプ阻害剤は、ミソプロストールの最大投与量と臨床的には同価値である。
気づき）
・ランソプラゾールは15,30mgで差がないので、今回の適応も15mgなわけだ。
・ミソプロストールを採用するよりは、PPIの方が安全（他のPPI、ジェネリックの適応追加はいつ？）
・オーダリングなどの処方運用の検討をしないと
Arch Intern Med. 2002 Jan 28;162(2):169-75.
Ulcer prevention in long-term users of nonsteroidal anti-inflammatory drugs: results of a double-blind, randomized, multicenter, active- and placebo-controlled study of misoprostol vs lansoprazole.
BACKGROUND: Studies that report prevention of ulcer recurrence among long-term users of nonsteroidal anti-inflammatory drugs (NSAIDs) that do not stratify for Helicobacter pylori status may not be generalizable to the large population of individuals without H pylori.
METHODS: This was a prospective, double-blind, multicenter, active- and placebo-controlled study among 537 patients without H pylori who were long-term users of NSAIDs and who had a history of endoscopically documented gastric ulcer. Patients were randomized to receive placebo, 200 microg of misoprostol 4 times a day, or 15 or 30 mg of lansoprazole once daily for 12 weeks. Ulcer status was determined by endoscopy at 4, 8, and 12 weeks.
RESULTS: Patients receiving lansoprazole (15 or 30 mg) remained free from gastric ulcer longer than those who received placebo (P<.001) but for a shorter time than those who received misoprostol. By week 12, the percentages of gastric ulcer-free patients were as follows: placebo, 51% (95% confidence interval [CI], 41.1%-61.3%); misoprostol, 93% (95% CI, 87.2%-97.9%); 15-mg lansoprazole, 80% (95% CI, 72.5%-87.3%); and 30-mg lansoprazole, 82% (95% CI, 75.0%-89.6%). A significantly higher proportion of patients in the misoprostol group reported treatment-related adverse events and early withdrawal from the study. When the impact of withdrawals on ulcer development was considered (as failures), therapy was successful for 69% for each of the active treatment groups and 35% for the placebo group.
CONCLUSIONS: Proton pump inhibitors such as lansoprazole are superior to placebo for the prevention of NSAID-induced gastric ulcers but not superior to misoprostol, 800 microg/d. When the poor compliance and potential adverse effects associated with misoprostol are considered, proton pump inhibitors and full-dose misoprostol are clinically equivalent.
これから）
ＡＣＣのエイズ研修＠国立国際医療研究センター病院エイズ治療・研究開発センターで薬剤師コース２日間の研修。薬局のハードディスクがクラッシュとの連絡（ピンチ！）、休日なしでずっと外にでているな。
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