Chen Jun, Zhao Shu-Shan, Liu Xiao-Xiao, Huang Ze-Bing, Huang Yan
Department of Infectious Diseases, Xiangya Hospital, Central South University, Changsha, China; Key Laboratory of Viral Hepatitis, Hunan, China.
Department of Orthopedics, Xiangya Hospital, Central South University, Changsha, China.
Clin Ther. 2017 Sep;39(9):1870-1880. doi: 10.1016/j.clinthera.2017.07.015. Epub 2017 Aug 7.
This study aimed to compare the efficacy between tenofovir disoproxil fumarate (TDF) and TDF plus entecavir (ETV) combination therapy in patients with chronic hepatitis B (CHB) with a poor response to ETV.
We searched the China National Knowledge Infrastructure (CNKI), PubMed, EMBASE, and SCOPE libraries for articles using the keywords chronic hepatitis B virus or CHB or HBV, entecavir or ETV, and tenofovir or TDF.
Five studies (from CNKI and PubMed) with a total of 408 patients met the inclusion criteria: 212 patients in the TDF group and 196 patients in the TDF plus ETV group. The rates of viral suppression between the 2 groups were comparable at weeks 24 and 48 of treatment (P = 0.546 vs P = 0.818). In addition, the subanalysis revealed that no significant differences were observed in the rates of viral suppression between the 2 groups at week 24 (subgroup 1 [partial response to ETV]: P = 0.822; subgroup 2 [resistance to ETV]: P = 0.294) and week 48 (subgroup 1: P = 0.797; subgroup 2: P = 0.545). No significant differences were found in alanine aminotransferase normalization, hepatitis B e antigen loss, hepatitis B e antigen seroconversion, virologic breakthrough, and tolerability between the 2 groups at weeks 24 and 48. Therefore, the results suggest that TDF monotherapy should be chosen for patients with CHB with a poor response to ETV for reasons of economy and convenience.
We conclude that TDF monotherapy is comparable to TDF-ETV combination therapy for patients with a poor response to ETV; thus, TDF monotherapy may be a better choice for these patients. However, because of the limited citations in this meta-analysis, complete and systematic evidence is needed to evaluate the differences in efficacy and tolerability between TDF and TDF-ETV. Larger and longer randomized clinical trials and further studies should be conducted to verify the results.
本研究旨在比较替诺福韦酯（TDF）与TDF联合恩替卡韦（ETV）对恩替卡韦应答不佳的慢性乙型肝炎（CHB）患者的治疗效果。
我们在中国知网（CNKI）、PubMed、EMBASE和SCOPE数据库中检索了使用关键词慢性乙型肝炎病毒或CHB或HBV、恩替卡韦或ETV以及替诺福韦或TDF的文章。
5项研究（来自CNKI和PubMed）共408例患者符合纳入标准：TDF组212例患者，TDF联合ETV组196例患者。治疗24周和48周时两组的病毒抑制率相当（P = 0.546对比P = 0.818）。此外，亚组分析显示，在第24周（亚组1[对ETV部分应答]：P = 0.822；亚组2[对ETV耐药]：P = 0.294）和第48周（亚组1：P = 0.797；亚组2：P = 0.545）两组的病毒抑制率无显著差异。在第24周和48周时，两组在谷丙转氨酶正常化、乙肝e抗原消失、乙肝e抗原血清学转换、病毒学突破和耐受性方面均未发现显著差异。因此，结果表明，出于经济和便利性考虑，对于恩替卡韦应答不佳的CHB患者应选择TDF单药治疗。
我们得出结论，对于恩替卡韦应答不佳的患者，TDF单药治疗与TDF-ETV联合治疗效果相当；因此，TDF单药治疗可能是这些患者的更好选择。然而，由于本荟萃分析中的引用有限，需要完整和系统的证据来评估TDF与TDF-ETV在疗效和耐受性方面的差异。应进行更大规模、更长时间的随机临床试验和进一步研究以验证结果。
