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利塞膦酸钠治疗食管静脉曲张和肝硬化患者的安全性和有效性:一项非随机临床试验。

Safety and efficacy of risedronate for patients with esophageal varices and liver cirrhosis: a non-randomized clinical trial.

机构信息

Internal Medicine Department, Gastroenterology Division - São Paulo State University (UNESP), Botucatu Medical School, São Paulo, Brazil.

Public Health Department, São Paulo State University (UNESP), Botucatu Medical School, São Paulo, Brazil.

出版信息

Sci Rep. 2019 Dec 12;9(1):18958. doi: 10.1038/s41598-019-55603-y.

DOI:10.1038/s41598-019-55603-y
PMID:31831865
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6908659/
Abstract

Despite the high prevalence of osteoporosis in liver cirrhosis, the indication of bisphosphonates for patients with esophageal varices has been avoided due to risk of digestive mucosal damage. Therefore, this study aimed to evaluate the safety profile of risedronate treatment for patients with osteoporosis, liver cirrhosis and esophageal varices with low risk of bleeding. A total of 120 patients were allocated into two groups according to their bone mineral density measured by dual-energy X-ray absorptiometry. In the intervention group, 57 subjects with osteoporosis received oral risedronate at 35 mg weekly plus daily calcium and vitamin D supplementation. In the control group, 63 subjects with osteopenia received only calcium and vitamin D. The groups received the treatment for one year and underwent surveillance endoscopies at six and 12 months, as well as a control dual-energy X-ray absorptiometry after a 12-month follow-up. The study received Institutional Review Board approval. The groups had not only comparable Model for End-stage Liver Disease score and esophageal varices degree, but also similar incidence of digestive adverse effects. A significant improvement was achieved in the intervention group in the lumbar spine T score (p < 0.001). The results suggest that risedronate may be safely used in liver cirrhosis and esophageal varices with low bleeding risk under endoscopic surveillance, thus allowing bone mass recovery.

摘要

尽管肝硬化患者中骨质疏松症的患病率很高,但由于存在消化道黏膜损伤的风险,双膦酸盐在食管静脉曲张患者中的应用指征一直被回避。因此,本研究旨在评估利塞膦酸钠治疗低出血风险肝硬化合并食管静脉曲张伴骨质疏松症患者的安全性。共 120 例患者根据双能 X 线吸收法测量的骨密度分为两组。在干预组中,57 例骨质疏松症患者接受每周口服利塞膦酸钠 35mg 加每日钙和维生素 D 补充治疗。在对照组中,63 例骨量减少患者仅接受钙和维生素 D 治疗。两组均接受治疗 1 年,并在 6 个月和 12 个月时进行内镜监测,在 12 个月随访后进行控制双能 X 线吸收法检查。该研究获得了机构审查委员会的批准。两组患者不仅终末期肝病模型评分和食管静脉曲张程度相当,而且消化道不良反应的发生率也相似。干预组的腰椎 T 评分显著改善(p<0.001)。结果表明,在接受内镜监测的低出血风险的肝硬化和食管静脉曲张患者中,利塞膦酸钠可能是安全的,可以恢复骨量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1368/6908659/e2067357de80/41598_2019_55603_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1368/6908659/75222d1954e3/41598_2019_55603_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1368/6908659/0bcf7b41dd4b/41598_2019_55603_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1368/6908659/e2067357de80/41598_2019_55603_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1368/6908659/75222d1954e3/41598_2019_55603_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1368/6908659/0bcf7b41dd4b/41598_2019_55603_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1368/6908659/e2067357de80/41598_2019_55603_Fig3_HTML.jpg

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