惠尔丁®产品具体描述惠尔丁®（通用性名恩曲他滨胶襄，英文名字emtricitabine capsules）是一种新式的核苷类逆转录酶抑止药，美国肝脏疾病指南（AASLD）[1]、欧州肝脏疾病指南（EASL）[2]、亚太地区肝脏疾病指南（APASL）[3]等国际性权威性慢性乙肝（CHB）治疗指南都将该药品列入乙肝病毒治疗药品，其有机化学构造与现阶段临床医学上普遍应用的别的核苷类似物不同点取决于5-碳部位上的氟基，其血液药物半衰期更长，且不会受到饮食搭配限定，抗病毒治疗特异性更强。2003年7月获美国FDA准许在美国发售，现阶段在我国恩曲他滨胶襄是國家限HIV医疗保险药物。恩曲他滨原研药为美国吉利德企业，河北医大农药厂于近年来进行科学研究，恩曲他滨开发设计科学研究新项目被得到科技进步发展二等奖，并根据国家药品药监局准许发售，现阶段归属于独家代理发售药物，其公司生产制造的恩曲他滨胶襄依据《中华共和国药品管理法》经国家药品药监局审批并根据得到《新药证书》。河北医大农药厂是我国恩曲他滨的产品规范的拟定企业。2005年惠尔丁得到CFDA授予的药物生产制造批文，但是因为专利权未到限期因此该产品一直等你2014年才宣布进到临床医学应用环节，中国权威性的肝炎病症权威人物协同公布了我国《恩曲他滨临床医学运用权威专家的共识》[4]，并且于2014年6月在《中华民族试验和临床医学感柒病杂志期刊》宣布公布。惠尔丁®（通用性名恩曲他滨胶襄，英文名字emtricitabinecapsules）与目前的核苷类抗乙肝dna产品拥有多方位的差别，主要内容以下：l 已列入中国艾滋病医疗保险药物；l 恩曲他滨具备很好的安全系数，是美国FDA准许的唯一可用以0岁左右少年儿童的产品[4]；l 该产品归属于怀孕B级药物，可用以怀孕期保护性母婴用品散播阻隔及活跃性携带者的抗乙肝dna治疗，除该产品外乙肝病毒治疗药品仅有二种怀孕B级药品[2][4]；l HIV/HBV合拼携带者如需另外开展抗HIV与HBV治疗，该产品被世界各国指南强烈推荐为一线服药，强烈推荐在基本的HAART治疗中添加恩曲他滨[1][2][4]。而且该产品治疗HIV适用范围时归属于国家医保乙类药物范畴；l 历经很多年治疗的慢性乙型肝炎患者抗药性率逐渐提升，该产品在世界各国肝脏疾病指南中都被列入抗药性患者拯救治疗的一线服药[1][2][3][4]；l 肝移植手术后防止HBV再发作，大中型国际性临床研究确认协同恩曲他滨是到目前为止唯一可减少打针乙肝病毒丙种球蛋白周期时间的治疗计划方案，提高患者便捷性，并大幅度降低因打针乙肝病毒丙种球蛋白所产生的副作用，世界各国有关指南均给予强烈推荐[2][4]。l 恩曲他滨可用以失偿还期肝硬化腹水的治疗，较传统式治疗计划方案安全系数高，副作用小[3][4]。l 高基线漂移病毒感染载量HBV患者，恩曲他滨协同替诺福韦抑止HBV功效显著好于替诺福韦单药制剂，为别的抗病毒的药抑止HBV 功效欠佳的患者出示一种新的治疗挑选[1][4]。产品基本资料：【药物名字】通用性名字：恩曲他滨胶襄产品名称：惠尔丁英文名字：Emtricitabine Capsules拼音字母：Enqutabin Jiaonang【特性】本产品內容物为乳白色或类乳白色颗粒物或粉末状。【适用范围】1、与别的抗病毒的药合用以成年人HIV-1感柒的治疗。患者为未历经逆转录酶缓聚剂治疗和历经逆转录酶缓聚剂治疗病毒感染已被抑止者。2、用以慢性乙型肝炎治疗。【规格型号】0.2g*7粒， 零售价234元， 重庆市挂网价：167.82元【使用方法使用量】成年人内服一日一次，一次0.2g，可与食材同屏。论文参考文献【1】： AASLDPRACTICE GUIDELINES -Chronic Hepatitis B: Update 2009（2009年美国肝脏疾病学好乙型肝炎医治指南l 內容节选：HEPATOLOGY, Vol. 50, No.3, 2009 第17页AdefovirResistance.………Thismay be related to a higher dose of tenofovir being used 300 mg versus adefovir10mg. However, serum HBV DNA remained detectable and adefovir-resistantmutations persist after switching to tenofovir monotherapy indicating thatthese two drugs are cross-resistant. By contrast, rescue therapy withcombination of lamivudine or emtricitabine and tenofovir resulted in suppression ofserum HBV DNA to undetectable levels. One case series reported that twopatients with adefovir-resistant HBV responded to entecavir with a decrease inserum HBV DNA to undetectable levels.【译文翻译】………恩曲他滨或拉米夫定协同替诺福韦是阿德福韦酯抗药性管理方法中可将血细胞HBV DNA减少至检验低限的拯救治疗计划方案………。l 內容节选二：HEPATOLOGY, Vol. 50, No.3, 2009 第19-20页1) Tenofovir (Viread) ………Efficacy inVarious Categories of Patients. ………At week 48, patients in the adefovir group were switchedto tenofovir, and patients in both groups who had detectable serum HBV DNA byPCR at week 72 received, in addition, emtricitabine. In the patients who were originally on adefovir, a further decreasein the proportion with undectable HBV DNA occurred such that by week 96, asimilar proportion of patients in the two treatment groups had undetectableserum HBV DNA (78% vs 78%), HBeAg seroconversion (26% vs 24%) and HBsAg loss(4% vs 5%).………………At week 48, patients in the adefovir group were switchedto tenofovir, and patients in both groups who had detectable serum HBV DNA byPCR at week 72 also received emtricitabine. As observed in the HBeAg-positive cohort, switching totenofovir resulted in further virus suppression in the patients originallytreated with adefovir such that by week 96, a similar percent of patients inthe two treatment groups had undetectable serum HBV DNA (91% vs 89%). However,none of the patients lost HBsAg.【译文翻译】………替诺福韦的III期申请注册实验资料显示，不论是E抗原阳型或呈阴性慢乙肝病毒患者，当治疗至72周，患者血细胞HBVDNA若仍高过检验低限者，立即再加恩曲他滨治疗至96周，不论是替诺福治疗组還是最开始应用阿德福韦酯的对照实验，其各类指标值的应答率均同样。………2) Tenofovir Resistance. ………………In the two phase IIIclinical trials, 7 patients were observed to have virologic breakthrough during96 weeks of treatment but tenofovir-resistant HBV mutations were not detectedin any of these patients. It should be emphasized that 17 patients who hadpersistent detection of serum HBV DNA at week 72 and were at the greatest riskof tenofovir resistance received additional treatment with emtricitabine . Therefore, data on resistance totenofovir monotherapy beyond 72 weeks cannot be determined from the two pivotaltrials. ………【译文翻译】………替诺福韦的III期申请注册实验资料显示，72周时若血细胞HBVDNA仍可检验，应立即再加恩曲他滨以减少抗药性产生的风险性。………l 內容节选三：HEPATOLOGY,Vol. 50, No. 3, 2009 第21页Other Therapies………Emtricitabine (Emtriva, FTC)is a potent inhibitor ofHIV and HBV replication. FTC hasbeen approved for HIV treatment as Emtriva (FTC only) and as Truvada (incombination with tenofovir as a single pill). Because of its structuralsimilarity with lamivudine (3TC), treatment with FTC selects for the same resistant mutants. In one study of248 patients (63% were HBeAg positive) FTC200 mg daily resulted in a significantly higher rate of histologic (62%vs 25%), virologic [undetectable HBV DNA by PCR assay] (54% vs 2%) andbiochemical (65% vs 25%) responses at week 48 compared to placebo but HBeAgseroconversion rates were identical—12% in the two groups. FTC-resistantmutations in the YMDD motif were detected in 13% of patients. ………【译文翻译】恩曲他滨是一种合理的hiv病毒和乙肝dna缓聚剂。美国FDA早已准许该产品治疗HIV感柒的二种溶液剂Emtriva（恩曲他滨单一中药制剂）和Truvada的(协同替诺福韦)。其构造与拉米夫定(3TC)类似,治疗时候挑选同样的抗药性株。在一项科学研究中,248名患者每天服食(63%是
