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1.
目的:评价不同种类干扰素与利巴韦林联用治疗慢性丙型肝炎(CHC)的疗效,为CHC患者抗病毒治疗方案的选择提供依据。方法:将96例CHC初治患者随机分成治疗组(50例)和对照组(46例);治疗组患者予聚乙二醇干扰素α-2b,对照组患者(46例)予国产重组人干扰素α-2b,两组患者均予利巴韦林联用治疗;疗程结束后随访24周,评价两组患者病毒学应答情况。结果:经治疗和测试,治疗组基因Ⅰ型患者为32例,其快速病毒学应答率(RVR)、早期病毒学应答率(EVR)、治疗终点病毒学应答率(ETVR)和持续病毒学应答率(SVR)显著高于对照组(29例),两组资料经比较其差异有统计学意义(P〈0.05);治疗组非基因Ⅰ型患者为18例,其RVR、EVR、ETVR和SVR略高于对照组(17例),经比较其差异无统计学意义(P〉0.05)。结论:对于基因Ⅰ型CHC患者,治疗组患者经治疗后,其SVR显著优于对照组,而对于非基因Ⅰ型CHC患者予国产重组人干扰素α-2b与利巴韦林联用治疗,更符合我国国情。  相似文献   

2.
目的 评价长疗程聚乙二醇干扰素联合利巴韦林治疗慢性丙型肝炎的临床疗效。方法45例接受聚乙二醇干扰素α-2b联合利巴韦林治疗未能达到快速应答(rapidvirological response,RVR)的慢性丙型肝炎患者被随机分成两组,分别完成聚乙二醇干扰素联合利巴韦林48周治疗(普通疗程组)和72周治疗(长疗程组),在完成治疗后继续随访24周,并观察药物副反应。结果普通疗程组和长疗程组在治疗结束时病毒应答(endtreatment virological response,ETVR)分别为(52.1%对77.2%,P〉0.05),但是长疗程组持续病毒学应答(sustained virological response,SVR)显著高于普通疗程组(72.7%对34.7%,P〈0.05)。结论长疗程聚乙二醇干扰素能够显著提高无快速应答慢性丙肝患者的SVR,副反应随疗程增加未见增加。  相似文献   

3.
目的:观察干扰素α1b对慢性丙型肝炎(CHC)患者甲状腺功能的影响。方法:回顾性收集CHC患者90例,按是否合并甲状腺疾病分为甲亢组、甲减组、CHC组,各30例。3组患者均使用重组人干扰素α1b 40μg,qod,联合利巴韦林0.1 g,tid,进行抗病毒治疗。所有患者均给予常规保肝及稳定甲状腺功能治疗。治疗前后,观察3组患者快速病毒学应答(RVR)、早期病毒学应答(EVR)、治疗结束时病毒学应答(ETVR)、持续病毒学应答(SVR)效果及甲亢组、甲减组患者三碘甲状腺原氨酸(T3)、甲状腺素(T4)、游离三碘甲状腺原氨酸(FT3)、游离甲状腺素(FT4)、促甲状腺激素(TSH)水平变化。结果:治疗后,3组患者RVR、EVR、ETVR、SVR率均显著升高,与治疗前比较,差异有统计学意义(P<0.05)。治疗后,3组患者RVR、EVR、ETVR、SVR组间比较,差异无统计学意义(P>0.05);治疗后甲亢组、甲减组患者T3、T4、FT3、FT4、TSH水平与治疗前比较,差异无统计学意义(P>0.05)。结论:干扰素α1b联合利巴韦林治疗CHC合并甲状腺疾病可以获得良好的抗病毒效果且不加重原有甲状腺疾病。  相似文献   

4.
目的:观察聚乙二醇干扰素α-2b联合利巴韦林治疗血友病合并慢性丙型肝炎的疗效及安全性。方法:血友病合并慢性丙型肝炎患者52例分为两组,治疗组29例患者予聚乙二醇干扰素α-2b联合利巴韦林,对照组23例患者予重组人干扰素α-2b联合利巴韦林,观察病毒学应答、白细胞、血小板数量变化及出血情况。结果:治疗组患者快速病毒学应答(RVR)、早期病毒学应答(EVR)、治疗结束时病毒学应答(ETVR)、第24周时持续病毒学应答(SVR24)、分别为57.1%、64.2%、64.2%、57.1%。对照组患者RVR、EVR、ETVR、SVR24分别为54.5%、68.2%、63.6%、54.5%,两组比较差异无统计学意义(P>0.05)。不良反应中,治疗组白细胞下降、血小板下降、出血发生率、严重出血发生率分别为68.9%、24.1%、51.7%、3.4%,对照组为65.2%、26.1%、56.5%、4.3%,治疗组白细胞下降、血小板下降、出血发生率、严重出血发生率与对照组相当,两组比较差异无统计学意义(P>0.05)。结论:对于血友病合并慢性丙型肝炎患者,聚乙二醇干扰素α-2b联合利巴韦林与普通干扰素α-2b联合利巴韦林治疗的疗效和安全性相当,但需要严密监控患者出血情况,并及时处理。  相似文献   

5.
聚乙二醇干扰素α-2a治疗慢性丙型肝炎疗效观察   总被引:1,自引:0,他引:1  
目的:观察聚乙二醇干扰素α-2a(PEG-IFNα-2a)治疗慢性丙型肝炎的临床疗效和安全性。方法:85例慢性丙型肝炎患者随机分为两组,观察组(43例)予PEG-IFNα-2a180μg,皮下注射,每周1次,同时口服利巴韦林900~1200mg·d-1;对照组(42例)接受普通干扰素α-2b500MU,皮下注射,1周3次,利巴韦林用法同观察组。48周治疗结束后随访24周,检测基线及治疗4,12,48周及治疗结束后24周时的血清HCVRNA和ALT水平,比较两组快速病毒学应答(RNA)率、早期病毒学应答(EVR)率、治疗终点病毒学应答(ETVR)率、持续病毒学应答(SVR)率以及ALT复常率与不良反应。结果:EVR、ETVR、SVR观察组分别为76.7%、86.0%和79.1%,明显高于对照组的54.8%、66.7%和57.1%,差异有统计学意义(P<0.05)。观察组治疗12周及48周时ALT复常率分别为81.4%和90.7%,明显高于对照组(P<0.05)。观察组白细胞计数下降和血小板减少的发生率高于对照组(P<0.05),中性粒细胞计数减少的发生率明显高于对照组(P<0.01),其他不良反应两组相近,未出现与聚乙二醇干扰素α-2a相关的新的不良反应。结论:PEG-IFNα-2a对慢性丙型肝炎患者的疗效优于普通干扰素,并具有较好的安全性和耐受性。  相似文献   

6.
王海燕  邓群 《河北医药》2016,(22):3378-3381
目的:探讨HBV/HCV合并感染患者的临床特征以及对聚乙二醇干扰素α-2a( PEGIFNα-2a)联合利巴韦林的抗病毒疗效。方法选取收治的HBV/HCV合并感染患者45例( A组),单纯HBV感染患者49例( B组),单纯HCV感染患者38例( C组),比较病毒感染和抗病毒疗效。结果 A组与B组HBeAg阳性率、HBV DNA阳性率、HBV DNA平均值以及HBV DNA量的患者分布差异有统计学意义( P <0貂.05);A组与C组HCV RNA平均值差异无统计学意义( P >0.05),HCV RNA量的患者分布差异有统计学意义( P <0.05);A组与C组基因型分布、HCV RNA和ALT差异无统计学意义( P >0.05),PLT、WBC、PTA和Alb差异具有统计学意义( P <0.05);Ⅰ基因型中,A组与C组pEVR、ETVR以及复发率差异有统计学意义( P <0.05),RVR、cEVR以及SVR差异无统计学意义( P >0.05);非Ⅰ基因型中,RVR、cEVR、pEVR、ETVR、SVR以及复发率差异均无统计学意义( P >0.05);A组与C组不良反应例数以及WBC和PLT减少例数差异有统计学意义( P <0.05),溶血以及甲状腺功能减退差异无统计学意义( P >0.05);未获得SVR患者和获得SVR患者阳转率差异具有统计学意义( P <0.05)。结论丙型和乙型肝炎合并感染患者以HCV为优势病毒株为主,HBV复制受抑制。合并感染Ⅰ基因型患者复发率、部分早期病毒学应答和治疗结束时病毒学应答高于单纯HCV感染患者,持续病毒学应答相似,但合并感染对非基因Ⅰ型病毒学应答率无影响。  相似文献   

7.
目的探讨抗病毒治疗在丙型肝炎失代偿期肝硬化患中的临床应用效果。方法选择2014年1月至2016年6月于我院住院治疗的失代偿期丙型肝炎肝硬化脾功能亢进行脾栓塞术患者85例,根据治疗方法不同分为治疗组(45例)和对照组(40例)。同时选取40名同期于我院行健康查体者作为健康对照组。所有患者均给予保肝退黄、降转氨酶等对症治疗,同时给予脾动脉栓塞术达到抗病毒标准后,治疗组给予聚乙二醇干扰素联合利巴韦林抗病毒治疗,对照组给予利巴韦林抗病毒治疗,2组治疗周期均为24周。比较2组患者一般资料、肝功能指标及Child-Pugh评分变化、抗病毒疗效及不良反应发生情况。采用放射性免疫法检测各组瘦素表达水平,采用酶联免疫吸附法检测各组脂连蛋白表达水平。结果经治疗后,2组丙氨酸转氨酶(ALT)和ChildPugh评分均较治疗前显著降低(P<0.05)。且治疗组改善程度显著优于对照组(P<0.05)。治疗组白蛋白、总胆红素(TBiL)和凝血酶原活动度(PTA)均较治疗前显著改善(P<0.05)。对照组治疗后白蛋白、TBiL和PTA虽较治疗前略改善,但差异无统计学意义(P>0.05)。2组患者病毒应答率比较差异具有统计学意义(P<0.05)。治疗组非基因Ⅰ型快速病毒学应答(RVR)、早期病毒学应答(EVR)、治疗结束时病毒学应答(ETVR)及持续病毒学应答(SVR)与对照组非基因Ⅰ型的SVR率均显著高于相应的基因Ⅰ型(P<0.05)。2组基因Ⅰ型RVR、EVR、ETVR及SVR率比较差异均具有统计学意义(P<0.05)。2组非基因Ⅰ型RVR、EVR、ETVR及SVR率比较差异具有统计学意义(P<0.05)。治疗期间不良反应均可耐受,经对症处理后症状缓解。治疗组和对照组治疗前瘦素和脂连蛋白水平显著高于健康对照组(P<0.05)。治疗组治疗后瘦素和脂连蛋白水平较治疗前显著下降(P<0.05)。对照组治疗后2项指标虽有下降,但与治疗前比较差异无统计学意义(P>0.05)。结论失代偿期丙型肝炎肝硬化合并脾功能亢进患者行脾栓塞术后给予聚乙二醇干扰素联合利巴韦林抗病毒治疗可有效抑制患者肝功能进一步恶化,抑制病毒复制,延缓肝病进展,且不良反应小,安全性良好,可在临床推广应用,瘦素和脂连蛋白在丙型肝炎肝硬化患者中呈高表达,提示其可作为丙型肝炎肝硬化病情程度评估的有效指标。  相似文献   

8.
目的:观察不同类型干扰素治疗慢性丙型肝炎的临床疗效。方法:将94例患者随机分为治疗组52例和对照组42例,治疗组应用上海罗氏制药有限公司的PegIFNα-2a注射液(派罗欣)180mg,每周1次皮下注射,对照组使用北京凯因生物技术有限公司普通α-2b注射液(凯因益生)5000000U,隔日1次肌注,两组疗程均为1年,所有患者按体重给利巴韦林片,体重≥75kg者给1200mg/d口服,体重〈75kg者给1000mg/d口服,观察治疗过程中不同时间点的病毒学应答,评价疗效并观察药物不良反应。结果:治疗组在快速病毒学应答(RVR)、早期病毒学应答(EVR)、治疗结束时病毒学应答(ETVR)、持续病毒学应答(SVR)、无应答率及复发率上分别为75%、84%、84%、75%、5%、10%,明显优于对照组的55%、60%、66%、57%、19%、32%。结论:持续1年的PegIFN联合RBV治疗丙型肝炎优于普通干扰素联合RBV。  相似文献   

9.
目的 探讨艾尔巴韦格拉瑞韦片治疗继发性丙型肝炎病毒感染的效果观察。方法 选取某院2021年1月~2022年6月纳入的124例继发性丙型肝炎病毒感染患者,按照抽签法分为对照组(n=62)和观察组(n=62),其中对照组采用聚乙二醇干扰素-α联合恩替卡韦治疗,观察组采用艾尔巴韦格拉瑞韦片治疗。评估两组患者肝功能、临床疗效、不同病毒基因型感染者病毒学应答率、不良反应发生情况及生活质量。结果 与治疗前对比,治疗后两组患者的血清ALT、AST及TBil水平均降低,观察组ALT及AST水平明显低于对照组(P <0.05),但观察组TBil水平与对照组差异无统计学意义(P> 0.05);两组患者早期病毒学应答(EVR)、治疗结束时病毒学应答(ETVR)及持续病毒学应答(SVR)对比,差异均无统计学意义(P> 0.05);两组非HCVⅠ型感染者EVR、ETVR和SVR均高于HCVⅠ型感染者(P <0.05);与对照组的不良反应发生率19.35%相比,观察组不良反应发生率6.45%明显更低(P <0.05);与治疗前相比,治疗后两组患者的生活质量评分均升高,且观察组高于对照...  相似文献   

10.
目的观察聚乙二醇化干扰素α-2a(PEGIFNα-2a)联合利巴韦林治疗慢性丙肝的临床疗效。方法 56例患者随机分为两组,治疗组应用PEGIFNα-2a180μg,皮下注射,每周一次;对照组给予α-2b干扰素5MIU,肌肉注射,隔日一次,两组均按体重口服利巴韦林片900~1200mg/d。疗程为48周。治疗后4、12、24、48周分别检测谷丙转氨酶(ALT)和HCV-RNA病毒量评价临床疗效,并密切观察药物的不良反应。结果 56例患者均完成治疗,12周时治疗组的EVR为76.7%,对照组为46.7%,两组差异有统计学意义(P〈0.05)。48周ETVR及随访24周时SVR,治疗组为90.0%和83.8%,对照组为53.8%和42.3%,两组比较差异有统计学意义(P〈0.05)。治疗组ALT复常率在48周达93.3%,高于对照组的69.2%。结论 PEGIFNα-2a联合利巴韦林治疗慢性丙肝可取得较好的临床疗效。  相似文献   

11.
目的:探讨大剂量利巴韦林联合干扰素治疗慢性丙型肝炎快速病毒学应答不佳者的疗效。方法:收集2009年1月至2012年12月收治的132例慢性丙型肝炎快速病毒学应答不佳者,随机分为A、B、C3组,在干扰素治疗的基础上分别给以不同剂量利巴韦林,比较治疗后3组患者早期病毒学应答(early virological response,EVR)、治疗结束时病毒学应答(end of therapyvirological response,ETVR)、持续病毒学应答(sustained virological response,SVR)的差异。结果:治疗后,A组EVR应答26例,ETVR应答33例,SVR应答21例;B组EVR应答19例,ETVR应答26例,SVR应答21例;C组EVR应答14例,ETVR应答17例,SVR应答13例;3组患者在EVR、ETVR和SVR应答率等差异具有统计学意义,大剂量利巴韦林组(A组)疗效明显优于其他组(P<0.05)。结论:对于慢性丙型肝炎快速病毒学应答不佳者,使用大剂量利巴韦林联合干扰素治疗可以提高患者的EVR、ETVR和SVR率。  相似文献   

12.
聚乙二醇干扰素联合利巴韦林治疗慢性丙型肝炎疗效观察   总被引:1,自引:0,他引:1  
目的观察聚乙二醇干扰素(PEG-IFNα-2a)联合利巴韦林治疗慢性丙型肝炎的临床疗效。方法将53例慢性丙型肝炎患者随机分为2组,试验组28例给予PEG-IFNα-2a和利巴韦林治疗,对照组25例给予普通干扰素和利巴韦林治疗,疗程均为48周。随访24周,比较2组病毒学及生化应答情况。结果与对照组相比,试验组患者病毒学应答率明显升高,治疗结束病毒学应答(ETVR)和持续病毒学应答(SVR)率比较差异有统计学意义(P<0.05)。与治疗前相比,2组肝功能均明显改善;疗程结束及随访24周时,试验组仍保持较高的生化应答率(P<0.05)。结论 PEG-IFNα-2a联合利巴韦林治疗慢性丙型肝炎具有良好的病毒应答和生化应答,疗效优于普通干扰素。  相似文献   

13.
Dalgard O  Mangia A 《Drugs》2006,66(14):1807-1815
In the past 10 years, progress has been made in the management of patients with chronic hepatitis C. A sustained virological response (SVR) is achieved in 80-85% of patients infected with hepatitis C virus (HCV) genotype 2 or 3 after 24 weeks of treatment with peginterferon-alpha and ribavirin. Treatment durations <24 weeks have been investigated to determine whether shorter-term therapy reduces adverse effects and costs compared with longer-term therapy without compromising efficacy. Three studies involving only patients with HCV genotype 2 or 3, with different baseline patient characteristics have shown that 12-16 weeks of treatment can be as effective as 24 weeks of treatment. In all three trials, undetectable HCV RNA 4 weeks after the start of treatment was defined as rapid virological response (RVR), and only patients with RVR stopped treatment early.In the first trial, 75% of patients treated with peginterferon-alpha-2b and ribavirin achieved RVR; these rapid responders achieved an SVR rate of 90% after 14 weeks of treatment. In the second trial, 63% of patients achieved RVR after 4 weeks of treatment with peginterferon-alpha-2b and ribavirin, and 85% of patients with RVR achieved SVR after 12 weeks of treatment. In comparison, 91% of patients with RVR treated for 24 weeks had SVR. In the third study, 93% of the total study population achieved RVR and were randomly assigned to 16 or 24 weeks of treatment with peginterferon-alpha-2a and ribavirin. Among patients with RVR, 85% in the group treated for 16 weeks and 80% in the group treated for 24 weeks achieved SVR. Among patients with HCV genotype 2 or 3, achieving an RVR to interferon-based treatment is common and a criterion to reduce the duration of treatment. In patients with genotype 2 and RVR, 12 weeks of therapy with peginterferon-alpha and ribavirin is recommended. For patients with genotype 3, a univocal recommendation on treatment duration cannot be made. However, ongoing trials will probably clarify this aspect.  相似文献   

14.
OBJECTIVE: Combination therapy with pegylated interferon (Peg) and ribavirin (RBV) is the standard of care for the treatment of chronic hepatitis C virus (HCV) infection. This analysis compares the cost efficacy of treatment with pegylated interferon alfa-2b plus ribavirin (Peg-2b plus RBV) with pegylated interferon alfa-2a plus ribavirin (Peg-2a plus RBV) in hypothetical cohorts of 100 chronic HCV patients comprised 75% of genotype 1. METHODS: A decision analysis model was constructed from the viewpoint of a managed care organization to compare Peg-2b plus RBV (1.5 mcg per kilogram per week plus RBV 800 mg per day) and Peg-2a plus RBV (180 mcg per week plus RBV 1,000-1,200 mg per day) pursuant to the label dosing approved by the U.S. Food and Drug Administration. The model also included the so-called weight-based dosing regimen with Peg-2b plus RBV (1.5 mcg per kilogram per week plus RBV 10.6 mg/kg per day). Patient weight was assumed to be 80 kg. For purposes of this analysis, early virologic response (EVR), defined as viral negative or 2-log drop in viral load, was assessed at 12 weeks for only genotype 1 patients, and nonresponders were assumed to discontinue therapy. The positive predictive value (PPV) was calculated for each treatment group for genotype 1 patients, which is determined from the values for EVR and sustained viral response (SVR). Genotype 2 and genotype 3 patients were assumed to be treated for 24 weeks. Treatment duration and efficacy data were obtained from the published literature. Product pricing was based on average wholesale price, October 2004, and sensitivity analysis was performed using prices from the Federal Supply Schedule. Economic outcomes were determined from hypothetical 100-patient cohorts assumed to be comprised 75% of genotype 1 HCV. RESULTS: Taking into account both EVR and SVR, the PPV for genotype 1 patients was 0.63 and 0.57 for Peg-2b plus RBV and Peg-2a plus RBV, respectively. The proportion of treated patients achieving SVR would be nearly identical, (53.6%) and (53.8%) for Peg-2a plus RBV and Peg-2b plus flat RBV, respectively. For Peg- 2b plus weight-based RBV, the proportion of patients achieving SVR was higher (61.4%). Consequently, this leads to fewer overall treatment weeks for the Peg- 2b plus RBV cohorts. Therefore, the cost per successful treatment (defined as SVR) was 19.4% less (37,638 US dollars) for Peg-2b plus flat dosing of RBV as compared with Peg-2a plus RBV (46,717 US dollars). When Peg-2b plus RBV was dosed 1.5 mcg per kilogram per week plus RBV 10.6 mg/kg/day, then the cost per SVR was 39,045 US dollars. The cost for the 100-patient cohort was 2,024,846 US dollars for Peg-2b plus RBV, 2,397,529 US dollars for Peg-2b plus weight-based RBV, and 2,505,317 US dollars for Peg-2a plus RBV. This difference is due to a lower PPV in the Peg-2a plus RBV groups and hence more patients treated in spite of a low probability of achieving SVR. CONCLUSION: The results of this cost-efficacy analysis suggest that treating HCV genotype 1 patients with Peg-2b plus RBV may result in savings to a health care system because fewer of these patients are treated beyond 12 weeks when achieving sustained viral clearance is unlikely.  相似文献   

15.
目的 探讨老年慢性丙型肝炎患者抗病毒疗效的影响因素.方法 回顾性分析48例慢性丙型肝炎患者的临床资料,16例年龄≥60岁患者为老年组,32例年龄<60岁患者为中青年组.均给予干扰素联合利巴韦林联合抗病毒治疗,记录2组患者病毒学应答、生化学应答及不良反应发生情况,分析影响抗病毒疗效的可能因素.结果 老年组达快速病毒学应答(RVR)、早期病毒学应答(EVR)、持续病毒学应答(SVR)者分别占93.75% (15/16)、100.00% (16/16)、50.00% (8/16),中青年组达RVR、EVR、SVR者分别占90.63% (29/32)、100.00% (32/32)、78.13% (25/32),2组达SVR情况比较差异有统计学意义(P<0.05).老年组中发生乏力、中性粒细胞减少和贫血的患者比例均明显高于中青年组[93.75% (15/16)比59.38%(19/32),87.50% (14/16)比53.13% (17/32),56.25% (9/16)比21.88% (7/32)],2组比较差异有统计学意义(均P<0.05).2组生化学应答和其他不良反应发生情况比较差异均无统计学意义(P>0.05).中青年患者和使用长效干扰素联合利巴韦林抗病毒治疗的患者中达到SVR者明显多于老年患者和使用普通干扰素联合利巴韦林抗病毒治疗的患者[78.12% (25/32)比50.00%(8/16),80.00%(28/35)比38.46%(5/13)] (P <0.05).结论 老年慢性丙型肝炎患者SVR率明显下降,不良反应的发生率高.年龄和治疗方案的选择与慢性丙型肝炎患者抗病毒治疗效果有关.  相似文献   

16.
目的 探讨聚乙二醇干扰素α-2a联合利巴韦林治疗不同年龄慢性丙型肝炎患者的临床效果.方法 回顾性分析2010年1月~2014年1月本院收治的慢性丙型肝炎患者83例,根据年龄的不同将其分为<60岁组(n=43)和≥60岁组(n=40).两组患者均给予聚乙二醇干扰素α-2a联合利巴韦林治疗,观察比较两组的治疗效果及不良反应发生情况.结果 治疗48周后,<60岁组患者的快速病毒学应答(RVR)率(65.1%)、早期病毒学应答(EVR)率(72.1%)、治疗结束时病毒学应答(ETVR)率(69.8%)、持续病毒学应答(SVR)率(51.2%)均高于≥60岁组(分别为50.0%、57.5%、87.5%、40.0%),差异有统计学意义(P<0.05或P<0.01);两组复发率、无效率比较,差异无统计学意义(P>0.05).<60岁组患者中性粒细胞、血小板、血红蛋白下降率明显低于≥60岁组,差异有统计学意义(P<0.05或P<0.01);两组患者主要不良反应为恶心、呕吐、乏力、脱发不适症状,且<60岁组恶心、呕吐、乏力的发生率低于≥60岁组,差异有统计学意义(P<0.05).结论 老年慢性丙型肝炎患者抗病毒疗效较差,药物不良反应发生率较高,治疗上仍存在一定的难度,针对老年患者制订安全有效的抗病毒治疗方案,对于降低肝硬化、肝癌的发生率至关重要.  相似文献   

17.
BACKGROUND: Patients infected with chronic hepatitis C virus (HCV) genotype 1 are the least responsive to peginterferon (pegIFN) and ribavirin therapy. The monitoring of early virological response (EVR) is therefore an important tool for quickly identifying non-responders, permitting therapy discontinuation and avoiding adverse effects and costs. OBJECTIVE: To analyse the financial impact, in treatment-naive patients infected with HCV genotype 1, of two different measurement techniques for evaluating the EVR during pegIFN-alpha-2b plus ribavirin therapy, and to compare the results of a 48-week standard course of therapy with pegIFN-alpha-2b plus ribavirin without measuring EVR. METHODS: A budget impact model was constructed using a decision-tree analysis. EVR was defined as a >2 log decline in HCV RNA levels at week 12 either tested with two quantitative HCV RNA tests or undetectable HCV core antigen (HCV core Ag) protein levels at week 12 (one HCV core Ag test). Clinical data were taken from multicentre trials and costs from the published literature (euro, 2003 values). The analysis was carried out from the perspective of the Spanish healthcare system and therefore only direct costs were considered. The base-case scenario assumed that a potential study population of 18,504 people in Spain with chronic HCV genotype 1 would be eligible for treatment with pegIFN-alpha-2b plus ribavirin. RESULTS: In the base case, the most effective strategy was testing EVR by HCV core Ag. This resulted in 12,745 patients reaching a sustained virological response (SVR) at an overall cost of 243.98 million euro (19,142 euro per SVR). Conversely, quantitative HCV RNA testing resulted in 11,776 patients with an SVR at a cost of 232.73 million euro ( 19,763 euro per SVR). The incremental cost per successfully treated patient with HCV core Ag testing versus quantitative HCV RNA testing was 11,597 euro. One-way sensitivity analyses demonstrated that changes in the study parameters did not modify the outcomes, except when increasing the EVR or SVR of strategy 2 or when decreasing the EVR or SVR of strategy 3. CONCLUSION: This model suggests, with its underlying assumptions and data, that the assessment of EVR at week 12 by HCV core Ag testing in chronic HCV patients infected with genotype 1 permits identification of those patients expected to achieve an SVR with pegIFN-alpha-2b and ribavirin, resulting in a lower overall cost to the Spanish healthcare system than HCV RNA testing or no testing at all.  相似文献   

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