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目的探讨恩替卡韦联合细胞因子诱导的杀伤细胞(CIK)治疗HBeAg阳性慢性乙型肝炎(CHB)的临床疗效及安全性。方法 50例HBeAg阳性CHB患者,其中治疗组20例,采用恩替卡韦联合CIK治疗,对照组30例,单用恩替卡韦治疗。观察所有患者治疗前及治疗后第12、24、48周肝功能、HBV血清标志物和HBV DNA水平并进行统计学分析,同时对不良反应进行评估。数据处理均用SPSS17.0软件进行检验,两组均值比较采用t检验,定性资料采用χ2检验。结果治疗前两组各项指标基线水平均无明显差异(P>0.05)。治疗后第24周,两组患者ALT、AST均明显改善,ALT的复常率治疗组为80%,对照组83.3%,AST的复常率治疗组75%,对照组73.3%,两组比较差异均无统计学意义(P>0.05);治疗后第12、24、48周治疗组HBV DNA不可检测率分别为45%、65%、80%,对照组为40%、60%、76.7%,两组比较差异均无统计学意义(P>0.05);治疗后第48周HBeAg阴转率治疗组为60%、对照组33.3%,血清学转换率治疗组为45%、对照组16.7%,两组比较差异均有统计学意义(P<0.05)。在治疗过程中除治疗组15例患者出现一过性发热、轻度头痛或关节酸痛外,无其他明显不良反应,后续随访肾功能和血常规均无异常。结论本研究表明恩替卡韦联合CIK免疫治疗HBeAg阳性慢性乙型肝炎安全性好,较单用恩替卡韦疗效更佳。
Objective To investigate the clinical efficacy and safety of entecavir combined with cytokine-induced killer cells (CIK) in the treatment of HBeAg-positive chronic hepatitis B (CHB). Methods 50 cases of HBeAg positive CHB patients, including 20 cases of treatment group, the use of entecavir CIK treatment, control group of 30 patients treated with entecavir alone. All patients were observed before and after treatment 12,24,48 weeks of liver function, HBV serum markers and HBV DNA levels and statistical analysis, while adverse reactions were evaluated. The data processing was tested by SPSS17.0 software, t-test was used to compare the mean of the two groups, and χ2 test was used to determine the qualitative data. Results Before treatment, there was no significant difference in the baseline levels of each index (P> 0.05). At 24 weeks after treatment, the ALT and AST in both groups were significantly improved. The normalization rate of ALT was 80% in the treatment group, 83.3% in the control group, 75% in the normal control group and 73.3% in the control group (P> 0.05). The undetectable rates of HBV DNA in treatment group were 45%, 65% and 80% at the 12th, 24th and 48th week after treatment, respectively. The control group was 40%, 60% and 76.7% , No significant difference between the two groups (P> 0.05). After 48 weeks of treatment, HBeAg negative conversion rate was 60% in the treatment group, 33.3% in the control group, 45% in the seroconversion rate treatment group and 16.7% in the control group , The difference between the two groups was statistically significant (P <0.05). In the course of treatment, there were no other obvious side effects except 15 cases of transient fever, mild headache or joint ache in the treatment group, and no abnormalities in renal function and blood routine follow-up. Conclusion This study shows that entecavir combined with CIK immunotherapy is safe and effective in treating HBeAg-positive chronic hepatitis B, which is better than entecavir alone.