Primary prophylaxis of variceal hemorrhage: a randomized controlled trial comparing band ligation, propranolol, and isosorbide mononitrate
| Autor: | Hock F. Lui, Peter C. Hayes, W.Stuart Hislop, Alastair MacGilchrist, Rajiv Jalan, Ewan Forrest, Adrian J. Stanley, Niall D.C. Finlayson, Peter R. Mills |
|---|---|
| Rok vydání: | 2002 |
| Předmět: |
Male
Randomization Vasodilator Agents Isosorbide Dinitrate Esophageal and Gastric Varices law.invention Esophageal varices Randomized controlled trial law Nadolol medicine Isosorbide mononitrate Secondary Prevention Humans Ligation Antihypertensive Agents Hepatology business.industry Esophageal disease Gastroenterology Middle Aged medicine.disease Prognosis Propranolol Confidence interval Anesthesia Drug Therapy Combination Female Varices business Gastrointestinal Hemorrhage medicine.drug |
| Zdroj: | Gastroenterology. 123(3) |
| ISSN: | 0016-5085 |
| Popis: | Background & Aims: This randomized controlled trial compared variceal band ligation (VBL), propranolol (PPL), and isosorbide-5-mononitrate (ISMN) in the prevention of first esophageal variceal bleed. Methods: Over a 6-year period, 172 patients with cirrhosis, grade II or III esophageal varices that had never bled, were recruited; 44 into VBL, 66 into PPL, and 62 into ISMN. Baseline patient characteristics: age, 55 +/- 11 years; Child-Pugh score, 8 +/- 2; 65% alcohol-induced cirrhosis; follow-up period, 19.7 +/- 17.6 months (range, 0.13-72.1 months), were comparable in the 3 groups. Results: On intention-to-treat analysis, variceal bleeding occurred in 7% of patients randomized to VBL, :14% to PPL, and 23% to ISMN. The 2-year actuarial risks for first variceal bleed were 6.2% (95% confidence interval [CI], 0.0%-15.0%) for VBL, 19.4% (95% CI, 0.1%-32.4%) for PPL, and 27.7% (95% CI, 14.2%-41.2%) for ISMN. A significant number of patients reported side effects with drug treatment (45% PPL and 42% ISMN vs. 2% VBL; P = 0.00), resulting in withdrawal from treatment in 30% of PPL and 21% of ISMN patients. There were no statistically significant differences in mortality rates in the 3 groups. In as-treated analysis, there was a statistically significant difference in actuarial risk for bleeding at 2 years between VBL and ISMN (7.5%, 95% CI, 2.5%-10.6% vs. 33.0%, 95% CI, 15%-49%, respectively, log rank test P = 0.03) but not between VBL and PPL. Conclusions: VBL was equivalent to PPL and superior to ISMN in preventing first variceal bleed. The side-effect profile for pharmacotherapy was considerable. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|