Effect of telmisartan on histological activity and fibrosis of non-alcoholic steatohepatitis: A 1-year randomized control trial.
Effect of telmisartan on histological activity and fibrosis of non-alcoholic steatohepatitis: A 1-year randomized control trial.
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DOI：
10.4103/1319-3767.173762
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发表时间：
2016-01
期刊：
影响因子：
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通讯作者：
Alam AK
中科院分区：
文献类型：
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作者：
Alam S;Kabir J;Mustafa G;Gupta U;Hasan SK;Alam AK
替米沙坦可减轻非酒精性脂肪性肝炎（NASH）的二次发病机制。本研究旨在观察替米沙坦对NASH患者非酒精性脂肪性肝病（NAFLD）活动性评分（NAS）和纤维化评分的影响。共50例NASH患者接受随机分组;第1组中的35例接受替米沙坦40/80 mg每日一次治疗，同时进行生活方式调整（TL），第2组中的15例仅接受生活方式调整（L），持续1年。最后，对TL组20例和L组10例进行分析。显示NAS改善≥ 2或NAS改善≥ 1且纤维化改善≥ 1的患者被视为应答者。两组的基线丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）、胰岛素抵抗指数、代谢综合征组分、年龄和性别相似。研究结束时，TL组和L组的NAS改善分别为2.15 ± 1.66和1.10 ± 0.57（P = 0.017），纤维化改善分别为0.65 ± 0.93和-0.30 ± 0.48（P = 0.001）。TL组和L组分别有13例（65%）和2例（20%）患者NAS改善≥ 2，8例（40%）患者纤维化评分改善≥ 1，无患者。替米沙坦和生活方式改变可改善脂肪变性、气球样变、小叶炎症和纤维化。生活方式改变仅能改善气球样变，但纤维化恶化。回归分析显示TL组NAS和纤维化评分改善[P值：0.035;比值比（OR）=92.07，置信区间（CI）=1.39-6106]。体重减轻和代谢综合征的改善不影响反应。两组的轻微不良事件相似。替米沙坦改善NASH患者的NAS和纤维化评分，不良事件不显著。
Telmisartan can attenuate two hit pathogenesis of non-alcoholic steatohepatitis (NASH). This study aimed to observe the effect of Telmisartan on non-alcoholic fatty liver disease (NAFLD) activity score (NAS) and fibrosis score in NASH patients. A total of 50 NASH patients were randomized; 35 of group 1 were treated with Telmisartan 40/80 mg once daily with life style modification (TL) and 15 of group 2 underwent only life style modification (L) for 1 year. At the end, 20 of TL group and 10 of L group were analyzed. Those who showed NAS improvement ≥ 2 or NAS improvement ≥ 1 with fibrosis improvement ≥ 1 were considered as responders. Baseline alanine aminotransferase (ALT), aspartate aminotransferase (AST), insulin resistance index, components of metabolic syndrome, age, and sex were similar in both groups. At the end of study, NAS improvement in TL and L groups was 2.15 ± 1.66 and 1.10 ± 0.57 (P = 0.017) and fibrosis improvement was 0.65 ± 0.93 and –0.30 ± 0.48 (P = 0.001), respectively. NAS improved by ≥ 2 in 13 (65%) and 2 (20%) patients and fibrosis score improved by ≥ 1 in 8 (40%) patients and none of the patients in TL group and L group, respectively. Telmisartan and life style modification could improve steatosis, ballooning, lobular inflammation, and fibrosis. Life style modification could improve ballooning only, but fibrosis deteriorated. TL group showed improvement in NAS and fibrosis score [P value: 0.035; odds ratio (OR) =92.07, confidence interval (CI) =1.39–6106] to the level of response by regression analysis. Weight reduction and improvement of metabolic syndrome did not influence the response. There were similar minor adverse events in both groups. Telmisartan improved NAS and fibrosis score in NASH with insignificant adverse events.