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目的比较不同剂量恩替卡韦治疗慢性乙型肝炎(CHB)的临床疗效。方法选取解放军第九五医院消化内科门诊2016年5—9月收治的CHB患者96例,随机将患者分为低、高剂量组和安慰剂组,各32例。低、高剂量组分别予以剂量分别是0.5 mg·次~(-1·d~(-1)和1.0 mg·次~(-1·d~(-1)恩替卡韦治疗,安慰剂组给予安慰剂片治疗,3组均连续治疗9个月。比较3组患者治疗3个月、6个月、9个月后丙氨酸氨基转移酶(ALT)复常率、HBV-DNA阴转率,治疗前后ALT、天冬氨酸氨基转移酶(AST)和总胆红素(TBil),观察3组患者不良反应发生情况。结果治疗3个月、6个月、9个月后3组患者ALT复常率、HBV-DNA阴转率比较,差异有统计学意义(P<0.05),其中高剂量组、低剂量组ALT复常率、HBV-DNA阴转率高于安慰剂组(P<0.05);高剂量组ALT复常率、HBV-DNA阴转率高于低剂量组(P<0.05)。治疗前3组血清ALT、AST及TBil水平比较,差异无统计学意义(P>0.05);治疗后3组患者ALT、AST及TBil水平比较,差异有统计学意义(P<0.05);其中低、高剂量组患者血清ALT、AST及TBil水平低于安慰剂组,且高剂量组低于低剂量组(P<0.05)。3组患者疲劳、恶心、眩晕、头痛和腹部不适发生率及总发生率比较,差异无统计学意义(P>0.05)。结论恩替卡韦治疗CHB的临床疗效确切,其中高剂量恩替卡韦的抗病毒作用更强,对患者肝功能改善更明显,且具有较高的安全性。
Objective To compare the clinical efficacy of different doses of entecavir in the treatment of chronic hepatitis B (CHB). Methods Ninety-six CHB patients admitted to the Department of Gastroenterology, the 95th Hospital of PLA, from May 2016 to September 2016, were randomly divided into two groups: low dose, high dose group and placebo group, with 32 cases in each group. The low and high dose groups were treated with entecavir 0.5 mg · d -1 and -1.0 d · -1 d -1, respectively. The placebo group was given placebo Treatment, three groups were continuous treatment for 9 months.Comparison of three groups of patients treated 3 months, 6 months, 9 months after alanine aminotransferase (ALT) normalization rate, HBV-DNA negative conversion rate, treatment ALT, AST and TBil were observed before and after treatment.Results The ALT complex in 3 groups, 6 months and 9 months after treatment were significantly higher than those in control group (P <0.05). The normalization rate of ALT and HBV-DNA negative conversion rate in high-dose group and low-dose group were higher than those in placebo group (P <0.05) ), The ALT normalization rate and the HBV-DNA negative conversion rate in the high-dose group were higher than those in the low-dose group (P <0.05) .There was no significant difference in serum ALT, AST and TBil levels between the three groups before treatment ; The levels of ALT, AST and TBil in the three groups after treatment were significantly different (P <0.05). The serum levels of ALT, AST and TBil in the low and high dose groups were lower than those in the placebo group and the high dose group In the low-dose group (P <0.05), the three groups were fatigue and nausea The incidence of vertigo, headache and abdominal discomfort were not statistically significant (P> 0.05) .Conclusion The clinical efficacy of entecavir in the treatment of CHB is definite, and the antiviral effect of high dose entecavir is stronger and the liver function is improved More obvious, and with higher security.