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目的观察重组人干扰素α-2b联合利巴韦林治疗肝硬化的临床疗效及安全性。方法将186例肝硬化随机分为对照组93例和试验组93例。对照组予以口服利巴韦林颗粒0.8~1.2 g qd;试验组在对照组治疗的基础上,第1个月予以肌内注射重组人干扰素α-2b 5×106U qd,之后予以相同剂量,qod。2组患者均治疗12个月。比较2组患者的临床疗效、水通道蛋白8(AQP8)和AQP9指标、肠道生理功能,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为72.04%(67/93例)和45.16%(42/93例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的AQP8表达量分别为(0.53±0.08),(0.39±0.13)copy·μL~(-1);AQP9表达量分别为(0.52±0.11),(0.40±0.11)copy·μL~(-1);排气体积分别为(1.52±0.05),(1.13±0.14)L;排便次数分别为(2.05±0.16),(1.46±0.05)次;粪便质量分别为(1.06±0.23),(0.50±0.08)kg;短链脂肪酸含量分别为(8.01±1.13),(7.28±1.47)mg·g-1;肠道内厌氧菌数量分别为(1.15±0.06),(3.19±0.15)lg CFU·g-1,差异均有统计学意义(P<0.05)。试验组发生的药物不良反应主要有精神障碍和免疫反应,对照组发生的药物不良反应主要有精神障碍和自体性免疫肝炎。试验组与对照组的药物不良反应发生率分别为18.28%和10.75%,差异无统计学意义(P>0.05)。结论重组人干扰素α-2b联合利巴韦林治疗肝硬化的临床疗效显著,能促进肝硬化患者AQP8和AQP9蛋白的表达,改善患者的肠道生理功能,且不增加药物不良反应的发生率。
Objective To observe the clinical efficacy and safety of recombinant human interferon α-2b combined with ribavirin in the treatment of liver cirrhosis. Methods A total of 186 cases of cirrhosis were randomly divided into control group (n = 93) and experimental group (n = 93). The control group received orally administered ribavirin 0.8-1.2 g qd. On the basis of the control group, the experimental group was given intramuscular injection of recombinant human interferon α-2b 5 × 106U qd on the first month, qod. Two groups of patients were treated for 12 months. Clinical efficacy, AQP8 and AQP9, intestinal physiological function, and adverse drug reactions were compared between the two groups. Results After treatment, the total effective rate was 72.04% (67/93 cases) and 45.16% (42/93 cases) respectively in the experimental group and the control group, the difference was statistically significant (P <0.05). After treatment, the expression of AQP8 was (0.53 ± 0.08) and (0.39 ± 0.13) copies · μL -1 respectively in the experimental and control groups, and the expression of AQP9 was (0.52 ± 0.11) and (0.40 ± 0.11) (1.52 ± 0.05) and (1.13 ± 0.14) L, respectively. The numbers of defecation were (2.05 ± 0.16) and (1.46 ± 0.05) times respectively. The stool quality were (1.06 ± 0.23) and (0.50 ± 0.08) kg, respectively. The contents of short chain fatty acids were (8.01 ± 1.13) and (7.28 ± 1.47) mg · g-1, ± 0.15) lg CFU · g-1, the differences were statistically significant (P <0.05). Adverse drug reactions occurred in the experimental group mainly mental disorders and immune responses, adverse reactions occurred in the control group are mainly mental disorders and autoimmune hepatitis. The incidence of adverse drug reactions in the experimental group and the control group were 18.28% and 10.75%, respectively, with no significant difference (P> 0.05). Conclusion The clinical efficacy of recombinant human interferon α-2b combined with ribavirin in the treatment of liver cirrhosis is significant. It can promote the expression of AQP8 and AQP9 protein in patients with liver cirrhosis and improve the intestinal physiological function in patients without increasing the incidence of adverse drug reactions .