加味逍遥丸联合替诺福韦酯治疗肝郁脾虚型慢性乙肝的临床研究

目的探讨加味逍遥丸联合富马酸替诺福韦二吡呋酯片治疗肝郁脾虚型慢性乙肝的临床疗效。方法选取2016年9月—2017年9月青岛市海慈医院收治的肝郁脾虚型慢性乙肝患者116例,按照随机数字表法将患者分为对照组和治疗组,每组各58例。对照组口服富马酸替诺福韦二吡呋酯片,300 mg/次,1次/d。治疗组在对照组治疗的基础上口服加味逍遥丸,6 g/次,2次/d。两组患者均连续治疗9个月。观察两组患者临床疗效,比较治疗前后两组肝功能指标、乙肝标志物转阴率和T淋巴细胞亚群水平。结果治疗后,对照组和治疗组总有效率分别为79.31%、93.10%,两组比较差异具有统计学意义(P0.05)。治疗后,两组丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、总胆红素(TBIL)、碱性磷酸酶(ALP)水平均显著降低,同组治疗前后比较差异有统计学意义(P0.05);且治疗后治疗组肝功能指标水平显著低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,对照组和治疗组乙肝表面抗原(HBs Ag)转阴率分别为17.24%、32.76%,e抗原(Hbe Ag)转阴率分别为34.48%、53.44%,乙肝病毒的脱氧核糖核酸(HBV-DNA)转阴率分别为75.86%、89.66%,两组比较差异具有统计学意义(P0.05)。治疗后,治疗组CD3~+、CD4~+、CD4~+/CD8~+、CD56~+水平均显著升高,同组治疗前后比较差异有统计学意义(P0.05);且治疗后治疗组T淋巴细胞亚群水平显著高于对照组,两组比较差异具有统计学意义(P0.05)。结论加味逍遥丸联合替富马酸替诺福韦二吡呋酯片治疗肝郁脾虚型慢性乙肝具有较好的临床疗效,能改善患者肝功能,提高乙肝标志物转阴率,调节免疫功能,具有一定临床推广应用价值。     

暴露前预防:探索适合中国的HIV预防策略

暴露前预防(PrEP)是国际指南推荐预防HIV感染的主要方式之一,在我国受到越来越多的关注。2019年,恩曲他滨联合丙酚替诺福韦(F/TAF)在美国获批成为继恩曲他滨联合富马酸替诺福韦二吡呋酯(F/TDF)后,第二个可用于PrEP的药物。本文结合最新国际指南、PrEP临床研究数据和我国实际情况,讨论PrEP在我国临床运用中的考量和挑战,并对提高PrEP认知、可及性、可负担性及用药依从性提出具体建议。     

Effectiveness of Tenofovir Alafenamide in Chronic Hepatitis B Patients with Normal Alanine Aminotransferase and Positive Hepatitis B Virus DNA

Background and AimsWith an increasing understanding of hepatitis B, the antiviral indications have been broadening gradually. To evaluate the effectiveness of tenofovir alafenamide (TAF) in chronic hepatitis B (CHB) patients with normal alanine aminotransferase (ALT) and detectable hepatitis B virus (HBV) DNA, those who are ineligible for broader antiviral criteria from the Chinese CHB prevention guide (2019).MethodsA total of 117 patients were recruited and their data were collected from paper or electronic medical records. HBV DNA and liver function were measured at baseline and throughout the 24-week follow-up. The effectiveness endpoint was complete virological response. The safety endpoint was the first occurrence of any clinical adverse event during the treatment.ResultsAmong the 117 patients, 45 had normal ALT as well as detectable HBV DNA and they were not recommended for antiviral therapy according to Chinese Guidelines (2019). After TAF antiviral therapy, the rates of patients who achieved HBV DNA <20 IU/mL at 4, 12 and 24 weeks were 77.1%, 96.7% and 96.8% respectively. Among them, the undetectable rates of HBV DNA in patients with low baseline viral load at 4, 12 and 24 weeks were 92.3%, 100% and 100%, while the rates of those with high baseline viral load were 68.2%, 94.1% and 94.4%. Compared with 71.4%, 94.4% and 94.7% in the high baseline group, the undetectable rates of HBV DNA at 4, 12 and 24 weeks in the low baseline liver stiffness group were 85.7%, 100% and 100%. There was no statistical significance among the above groups.ConclusionsCHB patients who had normal ALT and detectable HBV DNA and did not meet “CHB prevention guide (2019)”, could achieve complete virological response in 24 weeks after antiviral treatment by TAF.     

Treatment of hepatitis B virus infection in children and adolescents

Hepatitis B virus (HBV) infection is one of the main causes of morbidity and mortality worldwide. Most children acquire the infection perinatally or during early childhood and develop a chronic hepatitis characterized by a high viral replication and a low-inflammation phase of infection, with normal or only slightly raised aminotransferases. Although a conservative approach in children is usually recommended, different therapies exist and different therapeutic approaches are possible. The main goals of antiviral treatment for children with chronic HBV infection are to suppress viral replication and to warn the disease progression to cirrhosis and hepatocellular carcinoma, although these complications are rare in children. Both United States Food and Drug Administration (US-FDA) and European Medicines Agency (EMA) have approved interferon alfa-2b for children aged 1 year and older, pegylated interferon alfa-2a and lamivudine for children aged 3 years and older, entecavir for use in children aged 2 years and older, and adefovir for use in those 12 years of age and older. Tenofovir disoproxil fumarate is approved by EMA for children aged 2 years and older and by US-FDA for treatment in children aged 12 years and older. Finally, EMA has approved the use of tenofovir alafenamide for treatment of children aged 12 years and older or for children weighing more than 35 kg independent of age. This narrative review will provide the framework for summarizing indications to antiviral therapy in the management of chronic HBV infection in children and adolescents.     

Entecavir versus tenofovir in patients with chronic hepatitis B: Enemies or partners in the prevention of hepatocellular carcinoma

Over the past several decades, entecavir (ETV) and tenofovir disoproxil fumarate (TDF) have remained the first-line antiviral agents in several international guidelines. These two antiviral agents have shown similar short to intermediate-term efficacy, including virologic, biochemical, serologic, and histologic responses. However, huge controversies regarding the antiviral efficacy of ETV and TDF in preventing the development of hepatocellular carcinoma (HCC) still exist. In this review, we summarized recent studies that compared the treatment efficacy of ETV and TDF in terms of HCC development.     

富马酸替诺福韦二吡呋酯片处方开发研究

目的：对富马酸替诺福韦二吡呋酯片的处方进行筛选,提取出最佳的处方配伍方案。方法参照国外上市片“VIREAD？”的处方工艺,对其稀释剂、崩解剂、粘合剂、润滑剂以及包衣工艺进行实验,并将自制样品与参比制剂在高温、高湿及光照条件下进行稳定性考察,筛选出合理的处方工艺。结果最终确定处方工艺为：富马酸替诺福韦二吡呋酯300mg;乳糖60mg;微晶纤维素165mg;预胶化淀粉100mg;交联羧甲基纤维素钠35mg;硬脂酸镁5mg;欧巴代薄膜包衣预混剂20mg;以纯化水为粘合剂。结论确定的处方工艺稳定,生产过程不苛刻,适合放大生产,稳定性研究结果与市售品性质相似,体外溶出行为相近,处方设计合理。     

Management of hepatitis B and C in special population

Chronic viral hepatitis is one of the leading causes of cirrhosis worldwide. Chronic hepatitis B is more common in the Asia-Pacific region due to the larger population and lower screening availability. Hepatitis C predominates in the west due to injection drug abuse. The discovery of (oral) direct-acting antiviral agents (DAAs) has changed the landscape of chronic hepatitis C (CHC) management. Nucleos(t)ide analogs (NUCs) have also changed the approach to the treatment of chronic hepatitis B (CHB). Oral NUCs and DAAs have excellent efficacy and patient acceptance as well as a lower risk of resistance. However, certain populations have no robust data and safety and efficacy of such oral drugs is still evolving. In this review, we provide an overview of the management of CHB and CHC in special populations, such as those with chronic kidney disease, pregnant women, healthcare workers, and those undergoing chemo- or immunosuppressive therapy.     

片仔癀胶囊联合替诺福韦治疗慢性乙型病毒性肝炎的临床研究

目的 探讨片仔癀胶囊联合富马酸替诺福韦二吡呋酯片治疗慢性乙型病毒性肝炎的临床疗效.方法 选择2017年4月—2020年4月在安阳市第五人民医院治疗102例慢性乙型病毒性肝炎患者,根据住院序号分成对照组(51例)和治疗组(51例).对照组患者口服富马酸替诺福韦二吡呋酯片,300 mg/次,1次/d;治疗组患者在对照组基础...