核苷酸类似物治疗对慢性乙型肝炎健康相关生存质量的影响
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摘要
背景和目的：乙型肝炎病毒(HBV)感染呈世界性流行,据世界卫生组织报道,全球慢性乙肝感染者约有4亿人,每年死于乙型肝炎及其相关疾病者约有100万人。大约15-40%的HBV感染者可发生肝硬化、肝功能衰竭或肝癌。我国为乙肝中度流行区,据最新发布的流行病学统计数字,我国自然人群的总体HBsAg阳性率为7.18%,部分地区高于8%。
慢性乙型肝炎在严重危害人体健康的同时,造成严重的经济负担和精神负担。Min等[’]研究发现慢性乙型肝炎患者每个病人每年的经济费用在北京和广州分别为1636美元和1452美元。慢性乙型肝炎患者的健康相关生存质量明显下降,姚光弼等[2]研究发现拉米夫定治疗能够有效改善慢性乙型肝炎的生存质量。李雯雯等研究证实乙肝肝硬化患者的生存质量与健康人群比较明显下降,短期综合治疗可以改善乙肝肝硬化患者的生存质量[3,41。
目前,恩替卡韦与阿德福韦酯均为公认的有效的治疗慢性乙型肝炎的核苷酸类似物,能够抑制HBV复制、控制炎症进展、延缓疾病进程。本研究旨在借助于简明的生存质量量表(SF-36中文版)探讨核苷酸类似物恩替卡韦与阿德福韦酯抗病毒治疗对患者的生存质量的影响及其相关因素分析。
方法：将120例慢性乙型肝炎患者随机分为ETV组(60例)与ADV组(60例),分别给予ETV 0.5mg/d、ADV 10mg/d抗病毒治疗。分别在基线、治疗24周、治疗48周记录患者的一般资料、生化学及病毒学指标,并采用简明生存质量量表(SF-36中文版)测定生存质量评分。
应用重复测量数据方差分析对治疗前后生存质量进行对照分析。计算48周与基线之间各维度、生理健康方面(Physical Component Summary, PCS)、心理健康方面(Mental Component Summary, MCS)及总评分差值,以差值>0作为生存质量改善的标准,将其划分为二分类变量作为因变量,6个因素：年龄、性别、户籍、文化程度、48周ALT、48周HBV DNA作为自变量,进行卡方检验、Logistic逐步回归分析,探索生存质量的影响因素。P<0.05有统计学意义。
结果：
基线时,与健康人群相比较[5],慢性乙型肝炎患者除了机体疼痛(Bodily Pain,BP)及心理健康(Mental Health, MH)方面差别较小之外,其余各维度得分均明显降低,尤其以社会功能(Social Functioning, SF)最为显著,降低了20.6。除了BP及MH之外,其余各维度差异均具有统计学意义(P<0.05)。
经ETV、ADV治疗24、48周后,伴随生化学和病毒学指标的改善,除了BP之外,生存质量其余维度的评分均明显升高,主要集中在心理健康方面,其中躯体角色限制(Role Physical, RP)和情感角色限制(Role Emotional, RE)于48周时分别提高了17.68分,14.67分。并且重复测量数据方差分析显示,除了BP之外,其余各维度3个时间点的评分,差异均具有统计学意义。
非参数检验进行两两比较发现,治疗48周后,HBV DNA转阴组较未转阴组生存质量的改善在以下维度具有明显差别：BP(T=-0.259,P=0.010)、总的健康状况(General Health, GH,T=-2.246, P=0.025)、VT (T=-2.443, P=0.015)、SF (T=-3.252, P=0.001)、MH (T=-3.351, P=0.00l)、PCS (T=-2.567, P=0.010)、MCS (T=-3.560,P=0.000)、总评分(T=-3.433,P=0.001)。
对抗病毒治疗48周时单个维度评分及PCS、MCS评分提高具有统计学影响的因素是HBV DNA转阴,影响维度主要集中于心理健康方面为,包括活力(Vitality, VT)(χ2值=8.1,P值=0.00)、SF(χ2值=6.0,P值=0.01)、MH(χ2值=6.1,P值=0.01)、PCS(χ2值=4.8,P值=0.03)、MCS(χ2值=7.9,P值=0.01)。
单因素分析显示,在治疗48周时生存质量总评分的改善率方面,HBV DNA转阴组明显高于未转阴组(83.8% vs 63.0%,χ2=6.6,P=0.010),而其余5个因素分组间无明显统计学差别。
Logistic逐步回归分析显示,HBV DNA转阴为48周生存质量各维度、PCS及MCS评分提高的独立影响因素,主要集中于与心理健康方面,为：VT(P=0.002,OR=4.022,95%CI:1.675～9.661). SF (P=0.016, OR=2.694,95%CI:1.207-6.013)、MH (P=0.020, OR=2.576,95%CI:1.157～5.733)、PCS (P=0.020, OR=2.993, 95%CI:1.192～7.517)、MCS (P=0.005, OR=3.901,95%CI:1.519～10.018)。
以48周生存质量总评分与基线总评分差值为因变量进行回归分析,发现HBV DNA转阴为独立的影响的因素,其OR值为3.665(95%CI：1.416～9.488,P=0.007)。
结论：
(1)慢性乙型肝炎患者与健康人群相比,生存质量明显降低。
(2)应用核苷酸类似物抗病毒治疗后,慢性乙型肝炎患者生存质量显著提高。
(3) HBV DNA转阴是生存质量提高的独立影响因素。
[BACKGROUND] Hepatitis B virus (HBV) infection is a serious global health problem. According to the World Health Organization report, there were 4 billion people infected with HBV worldwide and 1 million people per year died by chronic hepatitis and the related diseases. Approximately 15-40% of HBV infected patients will develop cirrhosis, liver failure, or hepatocellular carcinoma. China is one of the high endemic areas of the hepatitis B. According to the latest epidemiological statistics data, the positive Rate of HBsAg for the general population in china was 7.18% and in some areas of China was more than 8%.
The disease burden caused by chronic hepatitis B includes not only impairment in health status and mental status, but also enormous economic expenses. Hu Min, et al found that the total annual cost per patient for CHB was US＄1636 in Beijing and US＄1452 in Guangzhou. Health-related quality of life (HRQOL) of chronic hepatitis B patients decrease obviously. Yao Guang bi, et al found that Patients with chronic hepatitis B have significant improvement in quality of life after treatment with lamivudine. Li Wenwen, et al indicated HRQOL of patients with liver cirrhosis was impaired obviously and could be improved by short-term treatment.
[OBJECTIVE] Now, entecavir (ETV) and adefovir (ADV) are nucleoside analogues which can inhibit HBV replication, control the progress of liver inflammation, and delay disease progression. The aim of this study is to explore the effect of the treatment of entecavir or adefovir on health-related quality of life (HRQOL) in chronic hepatitis B patients and analyze factors associated with improvement of HRQOL with the short-form 36 (SF-36) health survey.
[METHODS] 120 chronic hepatitis B patients were randomized divided into two groups:group ETV (60 patients, ETV 0.5mg/d) and group ADV (60 patients, 10mg/d). The general information of all patients, the data of liver function, indexes of hepatitis B virus were collected at baseline, and week 24,48 during treatment. All patients completed the SF-36 assessments at baseline and week 24,48 during treatment. The HRQOL were compared between before and after the treatment to assess the effect by analysis of variance for repeated measures Data. The differences in value of all the domains of SF-36, Physical Component Summary (PCS), Mental Component Summary (MCS), and the total score of SF-36 between baseline and week 48 during treatment were set as dependent variable. Age, gender, household register, level of education, ALT at 48 weeks of treatment, HBV DNA at 48 weeks of treatment were set as independent variable. Factors associated with HRQOL were evaluated by univariate analysis and multivariate analysis.
[RESULTS] Except Bodily pain (BP) and Mental Health(MH), the scores of other domains of SF-36 in chronic hepatitis B significantly decreased than that of healthy people at baseline. For both of patients treated with entecavir and adefovir, except Bodily pain (BP), the scores of other domains and the total score of SF-36 were statistically increased from baseline,24 weeks and 48 weeks (P<0.05) and the improvement of HRQOL mainly concentrated in mental components. Non-parametric tests showed that at 48 weeks of treatment the improvement rate of HRQOL was statistically different between HBV DNA negativity group than HBV DNA positive group in the following domains:BP (T=-0.259, P=0.010), General Health (GH) (T=-2.246, P=0.025), VT (T=-2.443, P=0.015), SF (T=-3.252, P=0.001), MH (T=-3.351, P=0.001), PCS (T=-2.567, P=0.010), MCS (T=-3.560, P=0.000), the total score (T=-3.433, P=0.001). Univariate analysis discovered that HBV DNA negativity was associated with the increase of score of the single domains including Vitality(VT,χ2=8.1, P=0.00), Social Functioning (SF,χ2=6.0, P=0.01), Mental Health (MH,χ2 =6.1, P=0.01), and PCS (χ2=4.8, P=0.03) and MCS (χ2=7.9, P=0.01). The improvement rate of the total score of HRQOL at 48 weeks of treatment was statistically higher in HBV DNA negativity group than in HBV DNA positive group (83.8% vs 63.0%,χ2=6.6, P=0.010).Logistic regression showed HBV DNA negativity was independent factor associated with improvement of HRQOL which mainly concentrated in mental components:VT(P=0.002, OR=4.022,95%CI:1.675～9.661); SF (P=0.016, OR=2.694,95%CI: 1.207～6.013); MH (P=0.020, OR=2.576,95%CI: 1.157～5.733); PCS (P=0.020, OR=2.993,95%CI:1.192～7.517); MCS (P=0.005, OR=3.901,95%CI: 1.519～10.018); the total score (P=0.007,OR=3.665,95%CI: 1.416～9.488).
[CONCLUSION] HRQOL of chronic hepatitis B significantly decreased than that of healthy people. HRQOL of chronic hepatitis B patients can be significantly improved by antiviral treatment with nucleoside analogues. HBV DNA negativity was independent factor associated with improvement of HRQOL.
慢性乙型肝炎在严重危害人体健康的同时,造成严重的经济负担和精神负担。Min等[’]研究发现慢性乙型肝炎患者每个病人每年的经济费用在北京和广州分别为1636美元和1452美元。慢性乙型肝炎患者的健康相关生存质量明显下降,姚光弼等[2]研究发现拉米夫定治疗能够有效改善慢性乙型肝炎的生存质量。李雯雯等研究证实乙肝肝硬化患者的生存质量与健康人群比较明显下降,短期综合治疗可以改善乙肝肝硬化患者的生存质量[3,41。
目前,恩替卡韦与阿德福韦酯均为公认的有效的治疗慢性乙型肝炎的核苷酸类似物,能够抑制HBV复制、控制炎症进展、延缓疾病进程。本研究旨在借助于简明的生存质量量表(SF-36中文版)探讨核苷酸类似物恩替卡韦与阿德福韦酯抗病毒治疗对患者的生存质量的影响及其相关因素分析。
方法：将120例慢性乙型肝炎患者随机分为ETV组(60例)与ADV组(60例),分别给予ETV 0.5mg/d、ADV 10mg/d抗病毒治疗。分别在基线、治疗24周、治疗48周记录患者的一般资料、生化学及病毒学指标,并采用简明生存质量量表(SF-36中文版)测定生存质量评分。
应用重复测量数据方差分析对治疗前后生存质量进行对照分析。计算48周与基线之间各维度、生理健康方面(Physical Component Summary, PCS)、心理健康方面(Mental Component Summary, MCS)及总评分差值,以差值>0作为生存质量改善的标准,将其划分为二分类变量作为因变量,6个因素：年龄、性别、户籍、文化程度、48周ALT、48周HBV DNA作为自变量,进行卡方检验、Logistic逐步回归分析,探索生存质量的影响因素。P<0.05有统计学意义。
结果：
基线时,与健康人群相比较[5],慢性乙型肝炎患者除了机体疼痛(Bodily Pain,BP)及心理健康(Mental Health, MH)方面差别较小之外,其余各维度得分均明显降低,尤其以社会功能(Social Functioning, SF)最为显著,降低了20.6。除了BP及MH之外,其余各维度差异均具有统计学意义(P<0.05)。
经ETV、ADV治疗24、48周后,伴随生化学和病毒学指标的改善,除了BP之外,生存质量其余维度的评分均明显升高,主要集中在心理健康方面,其中躯体角色限制(Role Physical, RP)和情感角色限制(Role Emotional, RE)于48周时分别提高了17.68分,14.67分。并且重复测量数据方差分析显示,除了BP之外,其余各维度3个时间点的评分,差异均具有统计学意义。
非参数检验进行两两比较发现,治疗48周后,HBV DNA转阴组较未转阴组生存质量的改善在以下维度具有明显差别：BP(T=-0.259,P=0.010)、总的健康状况(General Health, GH,T=-2.246, P=0.025)、VT (T=-2.443, P=0.015)、SF (T=-3.252, P=0.001)、MH (T=-3.351, P=0.00l)、PCS (T=-2.567, P=0.010)、MCS (T=-3.560,P=0.000)、总评分(T=-3.433,P=0.001)。
对抗病毒治疗48周时单个维度评分及PCS、MCS评分提高具有统计学影响的因素是HBV DNA转阴,影响维度主要集中于心理健康方面为,包括活力(Vitality, VT)(χ2值=8.1,P值=0.00)、SF(χ2值=6.0,P值=0.01)、MH(χ2值=6.1,P值=0.01)、PCS(χ2值=4.8,P值=0.03)、MCS(χ2值=7.9,P值=0.01)。
单因素分析显示,在治疗48周时生存质量总评分的改善率方面,HBV DNA转阴组明显高于未转阴组(83.8% vs 63.0%,χ2=6.6,P=0.010),而其余5个因素分组间无明显统计学差别。
Logistic逐步回归分析显示,HBV DNA转阴为48周生存质量各维度、PCS及MCS评分提高的独立影响因素,主要集中于与心理健康方面,为：VT(P=0.002,OR=4.022,95%CI:1.675～9.661). SF (P=0.016, OR=2.694,95%CI:1.207-6.013)、MH (P=0.020, OR=2.576,95%CI:1.157～5.733)、PCS (P=0.020, OR=2.993, 95%CI:1.192～7.517)、MCS (P=0.005, OR=3.901,95%CI:1.519～10.018)。
以48周生存质量总评分与基线总评分差值为因变量进行回归分析,发现HBV DNA转阴为独立的影响的因素,其OR值为3.665(95%CI：1.416～9.488,P=0.007)。
结论：
(1)慢性乙型肝炎患者与健康人群相比,生存质量明显降低。
(2)应用核苷酸类似物抗病毒治疗后,慢性乙型肝炎患者生存质量显著提高。
(3) HBV DNA转阴是生存质量提高的独立影响因素。
[BACKGROUND] Hepatitis B virus (HBV) infection is a serious global health problem. According to the World Health Organization report, there were 4 billion people infected with HBV worldwide and 1 million people per year died by chronic hepatitis and the related diseases. Approximately 15-40% of HBV infected patients will develop cirrhosis, liver failure, or hepatocellular carcinoma. China is one of the high endemic areas of the hepatitis B. According to the latest epidemiological statistics data, the positive Rate of HBsAg for the general population in china was 7.18% and in some areas of China was more than 8%.
The disease burden caused by chronic hepatitis B includes not only impairment in health status and mental status, but also enormous economic expenses. Hu Min, et al found that the total annual cost per patient for CHB was US＄1636 in Beijing and US＄1452 in Guangzhou. Health-related quality of life (HRQOL) of chronic hepatitis B patients decrease obviously. Yao Guang bi, et al found that Patients with chronic hepatitis B have significant improvement in quality of life after treatment with lamivudine. Li Wenwen, et al indicated HRQOL of patients with liver cirrhosis was impaired obviously and could be improved by short-term treatment.
[OBJECTIVE] Now, entecavir (ETV) and adefovir (ADV) are nucleoside analogues which can inhibit HBV replication, control the progress of liver inflammation, and delay disease progression. The aim of this study is to explore the effect of the treatment of entecavir or adefovir on health-related quality of life (HRQOL) in chronic hepatitis B patients and analyze factors associated with improvement of HRQOL with the short-form 36 (SF-36) health survey.
[METHODS] 120 chronic hepatitis B patients were randomized divided into two groups:group ETV (60 patients, ETV 0.5mg/d) and group ADV (60 patients, 10mg/d). The general information of all patients, the data of liver function, indexes of hepatitis B virus were collected at baseline, and week 24,48 during treatment. All patients completed the SF-36 assessments at baseline and week 24,48 during treatment. The HRQOL were compared between before and after the treatment to assess the effect by analysis of variance for repeated measures Data. The differences in value of all the domains of SF-36, Physical Component Summary (PCS), Mental Component Summary (MCS), and the total score of SF-36 between baseline and week 48 during treatment were set as dependent variable. Age, gender, household register, level of education, ALT at 48 weeks of treatment, HBV DNA at 48 weeks of treatment were set as independent variable. Factors associated with HRQOL were evaluated by univariate analysis and multivariate analysis.
[RESULTS] Except Bodily pain (BP) and Mental Health(MH), the scores of other domains of SF-36 in chronic hepatitis B significantly decreased than that of healthy people at baseline. For both of patients treated with entecavir and adefovir, except Bodily pain (BP), the scores of other domains and the total score of SF-36 were statistically increased from baseline,24 weeks and 48 weeks (P<0.05) and the improvement of HRQOL mainly concentrated in mental components. Non-parametric tests showed that at 48 weeks of treatment the improvement rate of HRQOL was statistically different between HBV DNA negativity group than HBV DNA positive group in the following domains:BP (T=-0.259, P=0.010), General Health (GH) (T=-2.246, P=0.025), VT (T=-2.443, P=0.015), SF (T=-3.252, P=0.001), MH (T=-3.351, P=0.001), PCS (T=-2.567, P=0.010), MCS (T=-3.560, P=0.000), the total score (T=-3.433, P=0.001). Univariate analysis discovered that HBV DNA negativity was associated with the increase of score of the single domains including Vitality(VT,χ2=8.1, P=0.00), Social Functioning (SF,χ2=6.0, P=0.01), Mental Health (MH,χ2 =6.1, P=0.01), and PCS (χ2=4.8, P=0.03) and MCS (χ2=7.9, P=0.01). The improvement rate of the total score of HRQOL at 48 weeks of treatment was statistically higher in HBV DNA negativity group than in HBV DNA positive group (83.8% vs 63.0%,χ2=6.6, P=0.010).Logistic regression showed HBV DNA negativity was independent factor associated with improvement of HRQOL which mainly concentrated in mental components:VT(P=0.002, OR=4.022,95%CI:1.675～9.661); SF (P=0.016, OR=2.694,95%CI: 1.207～6.013); MH (P=0.020, OR=2.576,95%CI: 1.157～5.733); PCS (P=0.020, OR=2.993,95%CI:1.192～7.517); MCS (P=0.005, OR=3.901,95%CI: 1.519～10.018); the total score (P=0.007,OR=3.665,95%CI: 1.416～9.488).
[CONCLUSION] HRQOL of chronic hepatitis B significantly decreased than that of healthy people. HRQOL of chronic hepatitis B patients can be significantly improved by antiviral treatment with nucleoside analogues. HBV DNA negativity was independent factor associated with improvement of HRQOL.
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