直接抗病毒藥物治療慢性丙型肝炎的療效調(diào)查
發(fā)布時(shí)間：2018-07-25 08:42
【摘要】：目的:為了解中國(guó)慢性丙型肝炎患者口服直接抗病毒藥物(DAAs)的病毒學(xué)應(yīng)答率,觀察該藥物對(duì)漢族人群的療效及副作用,分析其療效與病毒基因型、治療方案、病變程度間是否存在相關(guān)性。方法:選取2015年3月至2017年4月在山西醫(yī)科大學(xué)第一醫(yī)院傳染科門診及住院部就診并且口服DAA治療的慢性丙型肝炎111例患者(包括既往干擾素治療及初治病人)作為研究調(diào)查對(duì)象。收集患者治療前,治療過程中及治療結(jié)束后的HCV-RNA、肝腎功能、血常規(guī)檢查結(jié)果、影像學(xué)檢查及病毒基因分型等資料。根據(jù)病毒基因型、不同治療方案及初治或經(jīng)治進(jìn)行分組。運(yùn)用統(tǒng)計(jì)學(xué)方法分析不同組間的療效。統(tǒng)計(jì)各治療組患者在治療2周、4周、12周時(shí)HCV-RNA轉(zhuǎn)陰率及停藥后12周、24周時(shí)HCV RNA的持久陰轉(zhuǎn)率。同時(shí)分析山西丙肝患者病毒的基因型分布情況及其與患者肝臟病變嚴(yán)重程度間是否存在相關(guān)性。結(jié)果:1.在基因1b型患者中,接受SOF+DAL治療方案者的2w轉(zhuǎn)陰率為97.7%(42/43)、4w、12w轉(zhuǎn)陰率均為100%(43/43),在SOF+LED治療方案中,患者2w轉(zhuǎn)陰率為89.4%(42/47),4w、12w轉(zhuǎn)陰率均為100%(47/47)。在2a型患者中,2w、4w、12w轉(zhuǎn)陰率均為100%(21/21)。2.由于不同治療方案在治療4w及12w時(shí)的HCVRNA的陰轉(zhuǎn)率均為100%,故我們比較了SOF+DAL與SOF+LED在治療2w時(shí)HCV-RNA轉(zhuǎn)陰率(97.7%vs89.4%),兩種治療方案的2w轉(zhuǎn)陰率無明顯差異(P=0.248,大于0.05)。1b基因型經(jīng)治患者與初治患者治療2w時(shí)的轉(zhuǎn)陰率進(jìn)行比較(卡方檢驗(yàn)),結(jié)果顯示為P=0.875,大于0.05,即初治及經(jīng)治患者2w轉(zhuǎn)陰率無明顯差異。3.在1b基因型患者中,SOF+DAL治療組療程結(jié)束后12w HCV RNA持續(xù)轉(zhuǎn)陰率(SVR12)為96.9%(32/33),SOF+LED治療組SVR12為95.7%(22/23),SOF/PEG-INF/RBV治療組SVR12為100%(4/4)。在基因型2a型患者中,接受SOF+RBV方案治療者SVR12為100%(12/12)。運(yùn)用卡方檢驗(yàn)對(duì)SOF+DAL及SOF+LED方案的SVR12進(jìn)行比較,P=0.657,大于0.05,即兩種治療方案無明顯差異。4.1b型患者療程結(jié)束后24w HCV RNA持續(xù)轉(zhuǎn)陰率(SVR24)為95.3%(41/43),其中SOF+DAL治療患者SVR24為95.8%(23/24),SOF+LED治療患者SVR24為93.3%(14/15),SOF/PEG-INF/RBV方案的SVR24為100%(4/4),運(yùn)用卡方檢驗(yàn)對(duì)SOF+DAL及SOF+LED方案的SVR24進(jìn)行比較,P=0.628,大于0.05,即兩種治療方案無明顯差異。接受SOF+RBV方案治療的2a基因型患者SVR24為100%(6/6)。5.158例丙肝患者的HCV基因分型檢測(cè)結(jié)果,主要分布為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%)。結(jié)論:1.DAAs藥物治療2w HCV-RNA轉(zhuǎn)陰率為89.4%~100%,4w、12w均為100%。2.療程結(jié)束后12w持續(xù)病毒學(xué)應(yīng)答率高達(dá)95.7%~100%;療程結(jié)束后24w的持續(xù)病毒學(xué)應(yīng)答率93.3%~100%。3.DAAs抗病毒治療副作用少,對(duì)血常規(guī)、腎功能無明顯影響,并能夠快速改善肝功。4.山西省丙型肝炎基因分型主要分布為1b及2a型,1b型占77.9%,2a型占19%。5.丙型肝炎基因分型分布與肝臟病變嚴(yán)重程度之間無明顯關(guān)聯(lián)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.
【學(xué)位授予單位】：山西醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R512.63
本文編號(hào)：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.
【學(xué)位授予單位】：山西醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R512.63
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