Internal Medicine Department, Botucatu Medical School, Gastroenterology Division-São Paulo State University (UNESP), Rubião Júnior s/n, Botucatu, SP, CEP 18618-687, Brazil.
Public Health Department, Botucatu Medical School, São Paulo State University (UNESP), Botucatu, Brazil.
Hepatol Int. 2022 Dec;16(6):1458-1467. doi: 10.1007/s12072-022-10366-z. Epub 2022 Jun 29.
Bisphosphonates are the mainstay of osteoporosis treatment, but their use for patients with esophageal varices has been avoided due to the risk of esophagitis, which may cause variceal bleeding. Since most clinical trials assessing osteoporosis treatment last 2-3 years, this study aimed to evaluate a 2-year risedronate treatment for patients with esophageal varices and liver cirrhosis.
The study received Institutional Review Board approval, and the sample was divided into two groups according to bone mineral density (BMD). Cirrhosis severity and endoscopic findings at baseline were similar between the groups. The intervention group had 51 patients with osteoporosis, who received oral risedronate 35 mg weekly plus calcium and vitamin D supplements. The control group had 51 patients with osteopenia, receiving only the supplements. Scheduled esophagogastroduodenoscopies and BMD measurements were carried out.
The adjusted esophagitis risk was higher in the intervention group; however, none of the subjects had digestive bleeding. Lumbar spine BMD increased in the intervention group (- 3.06 ± 0.71 to - 2.33 ± 0.90; p < 0.001) and in the control group (- 1.38 ± 0.77 to - 1.10 ± 1.05; p = 0.012). Femoral neck BMD did not change in the intervention group (- 1.64 ± 0.91 to - 1.71 ± 0.95; p = 0.220), but tended to decrease in the control group (- 1.00 ± 0.74 to - 1.09 ± 0.82; p = 0.053).
Oral risedronate was effective and did not cause gastrointestinal bleeding in cirrhotic patients with esophageal varices under endoscopic surveillance.
双膦酸盐是骨质疏松症治疗的主要药物，但由于食管炎的风险，它们在食管静脉曲张患者中的使用受到了限制，因为这可能导致静脉曲张出血。由于大多数评估骨质疏松症治疗的临床试验持续 2-3 年，因此本研究旨在评估 2 年利塞膦酸钠治疗食管静脉曲张和肝硬化患者。
该研究获得了机构审查委员会的批准，并根据骨密度（BMD）将样本分为两组。两组患者的肝硬化严重程度和基线时的内镜检查结果相似。干预组有 51 例骨质疏松症患者，接受口服利塞膦酸钠 35mg 每周一次，同时补充钙和维生素 D。对照组有 51 例骨量减少症患者，仅接受补充剂治疗。定期进行食管胃十二指肠镜检查和 BMD 测量。
干预组调整后的食管炎风险较高；然而，没有患者出现消化道出血。干预组腰椎 BMD 增加（-3.06±0.71 至-2.33±0.90；p<0.001），对照组腰椎 BMD 也增加（-1.38±0.77 至-1.10±1.05；p=0.012）。干预组股骨颈 BMD 没有变化（-1.64±0.91 至-1.71±0.95；p=0.220），但对照组股骨颈 BMD 有下降趋势（-1.00±0.74 至-1.09±0.82；p=0.053）。
在食管静脉曲张患者中，在胃镜监测下，口服利塞膦酸钠对肝硬化患者是有效且不会引起胃肠道出血的。
