恩替卡韦治疗慢性重症乙型肝炎50例的随机对照研究

A randomized controlled study on the effect of entecavir in the treatment of 50 patients with chronic severe hepatitis B

目的：观察慢性重症乙型肝炎患者采用恩替卡韦治疗的临床效果及对外周血 T 细胞亚群、肝功能的影响。方法选择100例符合入组标准的慢性重症乙型肝炎患者作为研究对象，按随机数字表法分为治疗组50例和对照组50例，对照组患者进行常规保肝、退黄、支持、对症治疗，治疗组在对照组的基础上再口服恩替卡韦，0．5mg／次，1次／d，两组均观察24周，疗程结束后评估临床效果。结果治疗组和对照组治疗后CD4^＋[（40．65±5．06）％和（35．32±5．18）％]、CD4^＋／CD8^＋[（1．83±0．35）和（1．30±0．26）]较治疗前明显升高（t ＝7．762、5．192、6．319、3．392，均 P ＜0．05），治疗后 CD8^＋[（22．13±4．85）％和（27．24±4．66）％]，较治疗前明显降低（t ＝8．553、3．667，均 P ＜0．05），治疗组治疗后 CD4^＋、CD4^＋／CD8^＋明显高于对照组（t ＝3．479、5．413，均 P ＜0．05），CD8^＋明显低于对照组（t ＝3．551，P ＜0．05）。治疗组和对照组治疗后 ALT[（45±17）U ／L和（90±22）U ／L]、AST[（55±20）U ／L 和（86±25）U ／L]、HBV-DNA[（2．71±0．50）拷贝／mL 和（4．62±0．53）拷贝／mL]均较治疗前明显降低（t ＝10．568、6．773、9．935、7．035、6．339和3．448，均 P ＜0．05），治疗组治疗后ALT、AST、HBV-DNA 明显低于对照组（t ＝3．662、3．514、3．604，均 P ＜0．05）。结论恩替卡韦能够有效抑制慢性重症乙型肝炎患者乙肝病毒病毒复制，提高免疫功能，改善肝功能，且安全性良好，值得临床推广使用。

Objective To investigate the effect of entecavir in the treatment of chronic severe hepatitis B and the influence on peripheral blood T cell subsets and liver function.Methods 100 patients with chronic severe hepati-tis B were selected as research subjects,who met the inclusion criteria.The patients were randomly divided into the observation group（50 cases）and control group（50 cases）,then the clinical effects were assessed after treatment. Results The CD4^＋ ,CD4^＋ /CD8^＋ of the observation group and control group after treatment were （40.65 ±5.06）%and （35.32 ±5.18）%,（1.83 ±0.35）% and （1.30 ±0.26）%,which were significantly higher than before treat-ment,the differences were statistically significant（t =7.762 and 5.192,6.319 and 3.392,all P 〈0.05）,the CD8^＋ levels were （22.13 ±4.85）% and （27.24 ±4.66）%,which were significantly lower than before treatment,the differences were significant（t =8.553,3.667,all P 〈0.05）.The CD4^＋ ,CD4^＋ /CD8^＋ of the observation group were significantly higher than the control group,the differences were statistically significant（t =3.479,5.413,all P 〈0.05）,the CD8^＋ was significantly lower than the control group,the difference was significant（t =3.551,P 〈0.05）. The ALT,AST,HBV-DNA of the observation group and control group after treatment were （45 ±17）U /L and （90 ± 22）U /L,（55 ±20）U /L and （86 ±25 ）U /L,（2.71 ±0.50）copy/mL and （4.62 ±0.53）copy/mL,which were significantly lower than before treatment,the differences were statistically significant（t =10.568 and 6.773,9.935 and 7.035,6.339 and 3.448,all P 〈0.05）.The ALT,AST,HBV-DNA of the observation group were significantly lower than the control group,the differences were statistically significant（t =3.662,3.514,3.604,all P 〈0.05）. Conclusion Entecavir can effectively suppress viral replication,enhance immune function and improve liver func-tion,and has better security in the treatment of 50 patients with chronic severe hepatitis B,which is worthy of clinical use.