背景：相对于健康个体，患有慢性肾脏疾病的患者对于乙肝病毒疫苗会表现出典型的免疫应答受损。许多遗传或后天获得的因素多少都会在这个减少的免疫应答中有所表现。一些作者表示应用佐剂可为提高现存的乙肝病毒疫苗的免疫原性提供有利因素。目的：评价在慢性肾脏疾病患者中应用乙肝病毒疫苗佐剂的有效性和安全性。方法：（这次研究）仅选取有前瞻性的、随机对照试验（RCT）。我们应用包含异质性和亚组分析的DerSimonian 和Laird随机效应模型。首要的研究点是注射基因工程疫苗加入佐剂（实验组）相对于单独应用基因工程疫苗（对照组）的血清保护率的不同。结果：我们挑选了包括了1228名独立慢性肾脏疾病患者的总共10个研究。混合后的研究结果并没有表现出研究组的血清保护率高于对照组；混合后的血清保护率的比值比为1.47.（95% Cl：0.88；2.46，NS）。在注射乙肝疫苗后（实验组vs对照组），并依据最新的佐剂系统，血清应答率的总比值比在亚组研究中没有变化（例如，HBV-AS04或HBV-AS02),总比值比是2.22 (95% CI, 0.72; 6.78 ),Q检验异质性10.819。结论：我们的META分析表明应用乙肝病毒疫苗佐剂并没有明显增加肾功能不全患者的血清保护率。在这类高危人群中，研究结果不支持，应用佐剂来增加现有乙肝基因工程疫苗免疫原性的方法。

BACKGROUND: Patients with chronic kidney disease typically show an impaired immune response to hepatitis B virus vaccine compared with healthy individuals.A variety of inherited or acquired factors have been implicated in this diminished response.Some authors suggested a benefit with adjuvantation to improve the immunogenicity of existing HBV vaccines.AIM: To evaluate the efficacy and safety of adjuvantation for hepatitis B virus vaccine in patients with chronic kidney disease.METHODS: Only prospective, randomized clinical trials (RCTs) were included. We used the random effects model of DerSimonian and Laird with heterogeneity and subgroups analyses. The primary end-point of interest was the seroprotection rate after HBV vaccination with recombinant vaccine plus adjuvants (study group) versus recombinant vaccine alone (control group).RESULT: We identified ten studies involving 1228 unique patients with chronic kidney disease. Pooling of study results did not show a significant increase in seroprotection rate among study (HBV recombinant vaccine plus adjuvants) versus control (HBV recombinant alone) patients; the pooled odds ratio of seroprotection rate was 1.47 (95% CI: 0.88; 2.46, NS). (P=0.004).The pooled OR for seroresponse rate after HBV vaccine (adjuvanted recombinant vaccine versus recombinant vaccine alone) did not change in the subgroup of studies based on novel adjuvant systems (i.e., HBV-AS04 or HBV-AS02), the pooled OR was 2.22 (95% CI, 0.72; 6.78,NS). Q-test for heterogeneity being 10.819. CONCLUSIONS: Our meta-analysis showed that adjuvanted hepatitis B vaccine did not significantly improve the seroprotection rate in patients with renal insufficiency. These results do not support adjuvantation as an approach to increase the immunogenicity of existing recombinant vaccines towards HBV in this high-risk population.

点击下载 在慢性肾脏疾病患者中应用乙肝病毒疫苗：佐剂是否可以增加免疫原性？一项随机对照试验的荟萃分析