直接抗病毒药物治疗慢性丙型肝炎的疗效调查
发布时间：2018-07-25 08:42
【摘要】：目的:为了解中国慢性丙型肝炎患者口服直接抗病毒药物(DAAs)的病毒学应答率,观察该药物对汉族人群的疗效及副作用,分析其疗效与病毒基因型、治疗方案、病变程度间是否存在相关性。方法:选取2015年3月至2017年4月在山西医科大学第一医院传染科门诊及住院部就诊并且口服DAA治疗的慢性丙型肝炎111例患者(包括既往干扰素治疗及初治病人)作为研究调查对象。收集患者治疗前,治疗过程中及治疗结束后的HCV-RNA、肝肾功能、血常规检查结果、影像学检查及病毒基因分型等资料。根据病毒基因型、不同治疗方案及初治或经治进行分组。运用统计学方法分析不同组间的疗效。统计各治疗组患者在治疗2周、4周、12周时HCV-RNA转阴率及停药后12周、24周时HCV RNA的持久阴转率。同时分析山西丙肝患者病毒的基因型分布情况及其与患者肝脏病变严重程度间是否存在相关性。结果:1.在基因1b型患者中,接受SOF+DAL治疗方案者的2w转阴率为97.7%(42/43)、4w、12w转阴率均为100%(43/43),在SOF+LED治疗方案中,患者2w转阴率为89.4%(42/47),4w、12w转阴率均为100%(47/47)。在2a型患者中,2w、4w、12w转阴率均为100%(21/21)。2.由于不同治疗方案在治疗4w及12w时的HCVRNA的阴转率均为100%,故我们比较了SOF+DAL与SOF+LED在治疗2w时HCV-RNA转阴率(97.7%vs89.4%),两种治疗方案的2w转阴率无明显差异(P=0.248,大于0.05)。1b基因型经治患者与初治患者治疗2w时的转阴率进行比较(卡方检验),结果显示为P=0.875,大于0.05,即初治及经治患者2w转阴率无明显差异。3.在1b基因型患者中,SOF+DAL治疗组疗程结束后12w HCV RNA持续转阴率(SVR12)为96.9%(32/33),SOF+LED治疗组SVR12为95.7%(22/23),SOF/PEG-INF/RBV治疗组SVR12为100%(4/4)。在基因型2a型患者中,接受SOF+RBV方案治疗者SVR12为100%(12/12)。运用卡方检验对SOF+DAL及SOF+LED方案的SVR12进行比较,P=0.657,大于0.05,即两种治疗方案无明显差异。4.1b型患者疗程结束后24w HCV RNA持续转阴率(SVR24)为95.3%(41/43),其中SOF+DAL治疗患者SVR24为95.8%(23/24),SOF+LED治疗患者SVR24为93.3%(14/15),SOF/PEG-INF/RBV方案的SVR24为100%(4/4),运用卡方检验对SOF+DAL及SOF+LED方案的SVR24进行比较,P=0.628,大于0.05,即两种治疗方案无明显差异。接受SOF+RBV方案治疗的2a基因型患者SVR24为100%(6/6)。5.158例丙肝患者的HCV基因分型检测结果,主要分布为1b和2a型,1b型123例(77.9%),2a型30例(19.0%),其他基因型5例(3.1%)。结论:1.DAAs药物治疗2w HCV-RNA转阴率为89.4%~100%,4w、12w均为100%。2.疗程结束后12w持续病毒学应答率高达95.7%~100%;疗程结束后24w的持续病毒学应答率93.3%~100%。3.DAAs抗病毒治疗副作用少,对血常规、肾功能无明显影响,并能够快速改善肝功。4.山西省丙型肝炎基因分型主要分布为1b及2a型,1b型占77.9%,2a型占19%。5.丙型肝炎基因分型分布与肝脏病变严重程度之间无明显关联性。
[Abstract]:Objective: to investigate the virological response rate of Chinese patients with chronic hepatitis C (CHC) by oral direct antiviral drug (DAAs), to observe the efficacy and side effects of the drug, to analyze its efficacy, viral genotype and therapeutic regimen. Whether there is a correlation between the degree of lesion. Methods: from March 2015 to April 2017, 111 patients with chronic hepatitis C (including previous interferon therapy and initial treatment) were selected from the Department of Infectious Diseases, Department of Infectious Diseases, first Hospital of Shanxi Medical University, and treated with oral DAA. As the subject of investigation. The data of HCV-RNAs, liver and kidney function, blood routine examination, imaging examination and virus genotyping were collected before, during and after treatment. According to the virus genotypes, different treatment schemes and initial treatment or treatment were divided into groups. The effect of different groups was analyzed by statistical method. The rate of HCV-RNA turning negative at 2 weeks, 4 weeks and 12 weeks after treatment, and the rate of persistent negative change of HCV RNA at 12 weeks and 24 weeks after withdrawal were analyzed in each treatment group. At the same time, the distribution of hepatitis C virus genotypes in Shanxi province and its correlation with the severity of liver disease were analyzed. The result is 1: 1. In patients with type 1b gene, the rate of negative conversion at 2 weeks was 97.7% (42 / 43) in patients with SOF DAL regimen, and 100% (43 / 43) in patients with SOF LED regimen for 4 weeks (43 / 43). In patients with SOF LED regimen, the negative conversion rate was 89.4% (42 / 47) in 4 weeks and 100% (47 / 47) in 4 weeks. In 2a patients, the negative rate was 100% (21 / 21). Since the negative conversion rate of HCVRNA was 100 at 4 and 12 weeks after treatment, we compared the negative conversion rate of HCV-RNA between SOF DAL and SOF LED at 2 weeks (97.7 vs 89.4%), and there was no significant difference between the two groups (P0. 248, > 0. 05) .1b genotypes were treated. The results of chi-square test showed that there was no significant difference in the rate of negative conversion between the patients treated at 2 weeks and the patients treated at 2 weeks (P < 0. 05, P < 0. 05), that is to say, there was no significant difference between the two groups in the rate of negative conversion at 2 weeks after treatment (P < 0. 05, P < 0. 05). In 1b genotype patients, the HCV RNA persistent negative rate (SVR12) was 96.9% (32 / 33) 12 weeks after the treatment of SOF DAL. The SVR12 of the SOF LED group was 95.7% (22 / 23). The SVR12 of the treatment group was 100% (4 / 4). SVR12 was 100% (12 / 12) in patients with genotype 2 a treated with SOF RBV regimen. The SVR12 of SOF DAL and SOF LED regimen was compared by chi-square test. The results showed that there was no significant difference between the two treatment regimens. The SVR24 was 95.3% (41 / 43) at 24 weeks after the end of treatment, and SVR24 was 95.8% (23 / 24) in SOF DAL patients. The SVR24 of the SOF / PEG-INFR / RBV regimen was 93. 3% (14 / 15). The SVR24 of the regimen was 100% (4 / 4). The SVR24 of SOF DAL and SOF LED regimen was compared by chi-square test. There was no significant difference between the two treatments. The results of HCV genotyping in 2a genotype patients treated with SOF RBV regimen were 100% (6 / 6). 5.158 cases of hepatitis C patients. The main distribution was 1b and 2a genotype 1b (77.9%), 2a genotype (30 cases (19.0%), other genotypes (5 cases (3.1%). Conclusion: 1. The conversion rate of HCV-RNA to negative for 2 weeks after drug treatment was 89. 4% and 100% and 12 weeks after drug treatment, it was 100. 2. The continuous virological response rate of 93.3%~100%.3.DAAs was as high as 95.770 / 100 at 12 weeks after the end of the course of treatment, and the 93.3%~100%.3.DAAs antiviral response rate at 24 weeks after the course of treatment had little side effects, had no obvious effect on blood routine and renal function, and could quickly improve liver function. 4. The main genotypes of hepatitis C in Shanxi Province were 1b and 2a / 1b, which accounted for 77.9% and 19.5% respectively. There was no significant correlation between the genotyping distribution of hepatitis C and the severity of liver disease.
【学位授予单位】：山西医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R512.63
本文编号：2143261
[Abstract]:Objective: to investigate the virological response rate of Chinese patients with chronic hepatitis C (CHC) by oral direct antiviral drug (DAAs), to observe the efficacy and side effects of the drug, to analyze its efficacy, viral genotype and therapeutic regimen. Whether there is a correlation between the degree of lesion. Methods: from March 2015 to April 2017, 111 patients with chronic hepatitis C (including previous interferon therapy and initial treatment) were selected from the Department of Infectious Diseases, Department of Infectious Diseases, first Hospital of Shanxi Medical University, and treated with oral DAA. As the subject of investigation. The data of HCV-RNAs, liver and kidney function, blood routine examination, imaging examination and virus genotyping were collected before, during and after treatment. According to the virus genotypes, different treatment schemes and initial treatment or treatment were divided into groups. The effect of different groups was analyzed by statistical method. The rate of HCV-RNA turning negative at 2 weeks, 4 weeks and 12 weeks after treatment, and the rate of persistent negative change of HCV RNA at 12 weeks and 24 weeks after withdrawal were analyzed in each treatment group. At the same time, the distribution of hepatitis C virus genotypes in Shanxi province and its correlation with the severity of liver disease were analyzed. The result is 1: 1. In patients with type 1b gene, the rate of negative conversion at 2 weeks was 97.7% (42 / 43) in patients with SOF DAL regimen, and 100% (43 / 43) in patients with SOF LED regimen for 4 weeks (43 / 43). In patients with SOF LED regimen, the negative conversion rate was 89.4% (42 / 47) in 4 weeks and 100% (47 / 47) in 4 weeks. In 2a patients, the negative rate was 100% (21 / 21). Since the negative conversion rate of HCVRNA was 100 at 4 and 12 weeks after treatment, we compared the negative conversion rate of HCV-RNA between SOF DAL and SOF LED at 2 weeks (97.7 vs 89.4%), and there was no significant difference between the two groups (P0. 248, > 0. 05) .1b genotypes were treated. The results of chi-square test showed that there was no significant difference in the rate of negative conversion between the patients treated at 2 weeks and the patients treated at 2 weeks (P < 0. 05, P < 0. 05), that is to say, there was no significant difference between the two groups in the rate of negative conversion at 2 weeks after treatment (P < 0. 05, P < 0. 05). In 1b genotype patients, the HCV RNA persistent negative rate (SVR12) was 96.9% (32 / 33) 12 weeks after the treatment of SOF DAL. The SVR12 of the SOF LED group was 95.7% (22 / 23). The SVR12 of the treatment group was 100% (4 / 4). SVR12 was 100% (12 / 12) in patients with genotype 2 a treated with SOF RBV regimen. The SVR12 of SOF DAL and SOF LED regimen was compared by chi-square test. The results showed that there was no significant difference between the two treatment regimens. The SVR24 was 95.3% (41 / 43) at 24 weeks after the end of treatment, and SVR24 was 95.8% (23 / 24) in SOF DAL patients. The SVR24 of the SOF / PEG-INFR / RBV regimen was 93. 3% (14 / 15). The SVR24 of the regimen was 100% (4 / 4). The SVR24 of SOF DAL and SOF LED regimen was compared by chi-square test. There was no significant difference between the two treatments. The results of HCV genotyping in 2a genotype patients treated with SOF RBV regimen were 100% (6 / 6). 5.158 cases of hepatitis C patients. The main distribution was 1b and 2a genotype 1b (77.9%), 2a genotype (30 cases (19.0%), other genotypes (5 cases (3.1%). Conclusion: 1. The conversion rate of HCV-RNA to negative for 2 weeks after drug treatment was 89. 4% and 100% and 12 weeks after drug treatment, it was 100. 2. The continuous virological response rate of 93.3%~100%.3.DAAs was as high as 95.770 / 100 at 12 weeks after the end of the course of treatment, and the 93.3%~100%.3.DAAs antiviral response rate at 24 weeks after the course of treatment had little side effects, had no obvious effect on blood routine and renal function, and could quickly improve liver function. 4. The main genotypes of hepatitis C in Shanxi Province were 1b and 2a / 1b, which accounted for 77.9% and 19.5% respectively. There was no significant correlation between the genotyping distribution of hepatitis C and the severity of liver disease.
【学位授予单位】：山西医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R512.63
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