Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS)

被引：29
|
作者：
Sakurai, Kouichi [1 ]
Nagahara, Akihito [2 ]
Inoue, Kazuhiko [3 ]
Akiyama, Junichi [4 ]
Mabe, Katsuhiro [5 ]
Suzuki, Junichi [6 ]
Habu, Yasuki [7 ]
Araki, Akihiro [8 ]
Suzuki, Tsuyoshi [9 ]
Satoh, Katsuaki [10 ]
Nagami, Haruhiko [11 ]
Harada, Ryosaku [12 ]
Tano, Nobuo [13 ]
Kusaka, Masayasu [14 ]
Fujioka, Yasuhiko [15 ]
Fujimura, Toshikatsu [16 ]
Shigeto, Nobuyuki [17 ]
Oumi, Tsuneyo [18 ]
Miwa, Jun [19 ]
Miwa, Hiroto [20 ]
Fujimoto, Kazuma [21 ]
Kinoshita, Yoshikazu [22 ]
Haruma, Ken [23 ]
机构：
[1] Kumamoto Univ, Grad Sch Med Sci, Dept Gastroenterol & Hepatol, Kumamoto 8608556, Japan
[2] Juntendo Univ, Sch Med, Dept Gastroenterol, Tokyo 113, Japan
[3] Matsue Red Cross Hosp, Matsue, Shimane, Japan
[4] Int Med Ctr, Dept Gastroenterol, Tokyo, Japan
[5] Yamagata Prefectural Cent Hosp, Dept Internal Med, Yamagata, Japan
[6] KKR Sapporo Med Ctr, Dept Gastroenterol, Sapporo, Hokkaido, Japan
[7] Saiseikai Noe Hosp, Dept Gastroenterol, Osaka, Japan
[8] Tokyo Med & Dent Univ, Dept Gastroenterol & Hepatol, Grad Sch Med & Dent Sci, Tokyo, Japan
[9] Tokyo Metropolitan Police Hosp, Dept Gastroenterol, Tokyo, Japan
[10] Satoh Gastrointestinal Surg Hosp, Kurashiki, Okayama, Japan
[11] Nagami Clin, Unnan, Japan
[12] Gastrointestinal Div, Tosu, Saga, Japan
[13] Kyoritsu Hosp, Dept Internal Med, Kawanishi, Japan
[14] Kusaka Hosp, Bizen, Japan
[15] Fujioka Hosp, Saga, Japan
[16] Yamaguchi Hosp, Imari, Japan
[17] Tamano City Hosp, Dept Internal Med, Tamano, Japan
[18] Ooumi Clin, Tsuyama, Japan
[19] Toshiba Hosp, Dept Internal Med, Tokyo, Japan
[20] Hyogo Coll Med, Dept Internal Med, Nishinomiya, Hyogo 6638501, Japan
[21] Saga Med Sch, Dept Internal Med, Saga, Japan
[22] Shimane Univ, Sch Med, Dept Gastroenterol & Hepatol, Izumo, Shimane, Japan
[23] Kawasaki Med Sch, Dept Internal Med, Div Gastroenterol, Kurashiki, Okayama, Japan
来源：
BMC GASTROENTEROLOGY | 2012年 / 12卷
关键词：
Omeprazole; Famotidine; Mosapride; Teprenone; Uninvestigated upper gastrointestinal symptoms; DOMESTIC/INTERNATIONAL GASTROENTEROLOGY SURVEILLANCE; GASTROESOPHAGEAL-REFLUX DISEASE; QUALITY-OF-LIFE; HELICOBACTER-PYLORI; FUNCTIONAL DYSPEPSIA; UNINVESTIGATED DYSPEPSIA; ENDOSCOPIC FINDINGS; PROXIMAL STOMACH; ACID INFUSION; GUIDELINES;
D O I：
10.1186/1471-230X-12-42
中图分类号：
R57 [消化系及腹部疾病];
学科分类号：
摘要：
Background: In Japan, treatment guidelines are lacking for patients with upper gastrointestinal symptoms. We aimed to compare the efficacy of different drugs for the treatment of uninvestigated upper gastrointestinal symptoms. Methods: This was a randomized, open-label, parallel-group multicenter study. Helicobacter pylori-negative, endoscopically uninvestigated patients >= 20 years of age with upper gastrointestinal symptoms of at least moderate severity (Global Overall Symptom score [GOS] >= 4 on a 7-point Likert scale) were randomized to treatment with omeprazole (10 mg once daily), famotidine (10 mg twice daily), mosapride (5 mg three times daily) or teprenone (50 mg three times daily). The primary endpoint was sufficient relief of upper gastrointestinal symptoms after 4 weeks of treatment (GOS <= 2). UMIN clinical trial registration number: UMIN000005399. Results: Of 471 randomized patients, 454 were included in the full analysis set. After 4 weeks of treatment, sufficient symptom relief was achieved by 66.9% of patients in the omeprazole group, compared with 41.0%, 36.3% and 32.3% in the famotidine, mosapride and teprenone groups, respectively (all, p < 0.001 vs omeprazole). There were no treatment-related adverse events. Conclusions: The favorable efficacy and safety profiles of omeprazole in relieving uninvestigated upper gastrointestinal symptoms support its use as first-line treatment in this patient group in Japan. Patients who show no improvement in symptoms despite PPI use, and those with alarm symptoms (such as vomiting, GI bleeding or acute weight loss) should receive further investigation, including prompt referral for endoscopy.
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页数：12
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