恩替卡韦治疗慢性乙型肝炎患者的临床疗效及其生存质量评价

Assessment of clinical curative effect and quality of life for entecavia treatment in patients with chronic hepatitis B

目的:评价恩替卡韦对慢性乙型肝炎(CHB)患者临床疗效和生存质量(QOL)的影响。方法:对200例CHB患者进行前瞻性研究,采用美国医学结局研究组的普适性测定量表(SF-36)进行生存质量调查,根据患者的意愿分为对照组(常规用甘草酸二胺护肝治疗,77例)和恩替卡韦治疗组即试验组(在常规护肝基础上加用恩替卡韦抗病毒治疗,123例)。观察各组患者治疗前、治疗后26周、52周的临床症状、肝功能、HBV DNA、生存质量指数,并进行对照分析,综合评价恩替卡韦的疗效。结果:两组患者在基线时年龄、性别、肝功能、HBV DNA水平和生存质量指数等方面均无统计学差异(P>0.05)。与对照组相比,试验组在治疗后26周和52周的肝功能复常率(26周:90.08%Vs 28.95%,P=0.000;52周:97.44%Vs 26.03%,P=0.000)、HBV DNA阴转率(26周:68.60%Vs0.00%,P=0.000;52周:86.32%Vs 1.37%,P=0.000)均优于对照组,差异有显著性意义(P<0.05)。治疗26周后和52周后,试验组患者的QOL在除PF(躯体功能)、BP(肌体疼痛)以外的多个纬度的得分均高于治疗前(P<0.05);对照组患者的QOL在治疗26周和52周时与治疗前比较,未见明显改善。结论:恩替卡韦能改善CHB患者的临床客观指标,提高患者的生存质量。

Objective： To evaluate the clinical curative effect and quality of life for entecavir treatment in patients with chronic hepatitis B. Methods：A prospective study based on 200 patients with chronic hepatitis B were divided into two groups, received diammonium glycyrrhizinate （ n = 77 ） and entecavir associated with diammonium glyeyrrhizinate （ n = 123 ） respectively. The effects of the two groups on the symptom, liver function, level of HBV DNA were examined, and the health-related quality （QOL） of life were evaluated by the SF-36. Results：On the baseline of treatment, two groups of patients in age, gender, liver function and HBV DNA levels and QOL index and so on were no statistical difference （ P 〉 0. 05 ）. At 26 weeks and 52 weeks, the group of enteeavir associated with diammonium glycyrrhizinate was significant higer than the group of diammonium glycyrrhizinate alone on the ratio of liver function return to nomorl （ Week 26 ： 90. 08% Vs 28.95%, P = 0. 000 ; Week 52 ： 97.44% Vs 26. 03 % , P = 0. 000 ） and negative conversion ratio of HBV DNA （ Week 26 ： 68.60% Vs 0. 00% , P = 0. 000 ; Week 52 ： 86. 32% Vs 1.37% ,P =0. 000）. At 26 weeks and 52 weeks, the group of enteeavia associated with diammonium glyeyrrhizinate on the marks of SF-36 in many domains was significant higer than at baseline（P 〈0. 05） , except PF and BP. Otherwise, At 26 weeks and 52 weeks, the control group on the marks of SF-36 was as same as at baseline （ P 〉 0. 05 ）. Conclusion： Entecavir treatment can improve the clinical curative effect and quality of life ＇for Entecavir treatment for patients with chronic hepatitis B.