重组人干扰素α-2b注射剂联合利巴韦林颗粒治疗肝硬化的临床研究

Clinical trial of recombinant human interferon α-2b injection combined with ribavirin granules in the treatment of liver cirrhosis

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 combinant human interferon α -2b the clinical efficacy and safety of re- combined with ribavirin in the treat- ment of liver cirrhosis. Methods One hundred and eighty - six patients with liver cirrhosis were randomly divided into control group （n = 93） and treatment group （ n = 93 ）. Control group was given oral ribavirin granules 0. 8 - 1.2 g qd. On the basis of control group, the treatment group was given intramuscular injection of recombinant human interferon alpha -2b 5 × 10^6 U qd in the first month, followed by the same dose, qod. Two groups of patients were treated for 12 months. The clinical effi- cacy, AQP8 and AQP9 index, intestinal physiological function, and the occurrence of adverse drug reactions were compared between the 2 groups. Results After treatment, the total effective rates of treatment and control groups were 72.04% （67/93） and 45.16% （42/93） with significant difference （P 〈0.05 ）. After treatment, the main indexes in treatment and control groups were compared： AQP8 were （0.53 ± 0.08）, （0.39 ＋0. 13） copy-μL-＇; AQP9 were （0.52 ±0.11）, （0.40 ±0.11） copy · μL-l; exhaust volume were （1.52±0.05）, （1.13±0.14）L; defecation times were （2.05± 0.16）, （1.46 ± 0.05）times; defecation weight were （1.06 ± 0.23）, （0.50 ±O. 08）kg; short chain fatty acid were （8.01 ±1.13） , （7.28 ± 1.47）mg · g-1 ; intestinal anaerobic bacteria were （1.15 ± 0.06）, （3.19 ±0. 15 ）lg CFU · g-l, there were statistically significant difference （P 〈 O. 05 ）. The adverse drug reactions were based on mental disorder and immune response in treatment groups, which was mental disorders and autoimmune hepatitis in control group. The incidence of adverse drug reactions in the treatment and control groups were 18.28% and 10.75% , without statistically significant difference （ P 〉 O. 05 ）. Conclusion Recombinant human interferon α -2b combined with ribavirin have a definitive clinical efficacy for the treatment of liver cirrhosis, which can improve the expression of AQP8 and AQP9, and intestinal physiological function, without increasing the incidence of adverse drug reactions.