| 冯永亮,韩雨洁,姚添,王建民,柳红婷,郭红萍,柴国伟,刘黎明,王富珍,王素萍.慢性肾脏病患者不同免疫方案接种乙型肝炎疫苗的免疫效果及影响因素分析[J].中华流行病学杂志,2022,43(2):241-247 |
| 慢性肾脏病患者不同免疫方案接种乙型肝炎疫苗的免疫效果及影响因素分析 |
| Immunogenicity and influencing factors of hepatitis B vaccination based on different vaccination schedules among chronic kidney disease patients |
| 收稿日期:2021-08-07 出版日期:2022-02-16 |
| DOI：10.3760/cma.j.cn112338-20210807-00618 |
| 中文关键词: 慢性肾脏病 乙型肝炎疫苗 免疫方案 免疫效果 影响因素 |
| 英文关键词: Chronic kidney disease Hepatitis B vaccine Vaccination schedules Immunogenicity Influencing factor |
| 基金项目:国家科技重大专项（2018ZX10721202） |
| 作者 | 单位 | E-mail | | 冯永亮 | 山西医科大学公共卫生学院流行病学教研室, 太原 030001 | | | 韩雨洁 | 山西医科大学公共卫生学院流行病学教研室, 太原 030001 | | | 姚添 | 山西医科大学公共卫生学院流行病学教研室, 太原 030001 | | | 王建民 | 临汾市中心医院肾内科, 临汾 041000 | | | 柳红婷 | 运城市中心医院肾内科, 运城 044000 | | | 郭红萍 | 临汾市人民医院肾内科, 临汾 041081 | | | 柴国伟 | 侯马市人民医院肾内科, 侯马 043011 | | | 刘黎明 | 临汾市中心医院肾内科, 临汾 041000 | | | 王富珍 | 中国疾病预防控制中心免疫规划中心, 北京 100050 | | | 王素萍 | 山西医科大学公共卫生学院流行病学教研室, 太原 030001 | supingwang@sxmu.edu.cn |
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| 中文摘要: |
| 目的 分析不同免疫方案对慢性肾脏病（CKD）患者接种乙型肝炎（乙肝）疫苗的免疫效果及影响因素。方法 研究对象为2019年5月至2020年7月在山西省4家医院参加随机对照试验的CKD患者273例。按1∶1∶1比例采用区组随机分为3组（每组91例），分别接受0-1-6月20 μg、0-1-2-6月20 μg、0-1-2-6月60 μg乙肝疫苗接种，在全程接种后1个月和6个月随访期采用化学发光微粒子免疫分析法进行乙型肝炎表面抗体（抗-HBs）的定量检测，采用χ2检验、方差分析、非条件logistic回归的统计学方法分析其阳性率、强阳性率和几何平均浓度（GMC）及影响因素。结果 273例CKD患者中，全程接种后1个月随访期，0-1-2-6月20 μg和0-1-2-6月60 μg组的抗-HBs阳性率［92.96%（66/71）和93.15%（68/73）］及抗-HBs GMC（2 091.11 mIU/ml和2 441.50 mIU/ml）明显高于0-1-6月20 μg组［81.69%（58/71）及1 675.21 mIU/ml］（均P<0.05）；全程接种后6个月随访期，0-1-2-6月60 μg组抗-HBs阳性率（94.83%，55/58）明显高于0-1-6月20 μg组（78.79%，52/66）（P<0.05），0-1-2-6月60 μg组抗-HBs GMC（824.28 mIU/ml）明显高于0-1-2-6月20 μg组（755.53 mIU/ml）和0-1-6月20 μg组（639.74 mIU/ml）（P<0.05）。控制潜在混杂因素后，全程接种后1个月和6个月随访期，按0-1-2-6月接种60 μg乙肝疫苗的抗-HBs阳性的概率分别是0-1-6月20 μg组的3.19（95%CI：1.02~9.96）和5.32（95%CI：1.27~22.19）倍，不服用激素/免疫抑制剂者的抗-HBs阳性的概率分别是服用者的3.33（95%CI：1.26~8.80）和4.78（95%CI：1.47~15.57）倍。结论 0-1-2-6月20 μg和0-1-2-6月60 μg免疫方案均可提高CKD患者乙肝疫苗免疫效果，且0-1-2-6月60 μg方案对该人群抗-HBs水平的维持有积极作用。服用激素/免疫抑制剂的CKD患者乙肝疫苗免疫效果不佳。 |
| 英文摘要: |
| Objective To explore the immunogenicity and influencing factors of hepatitis B vaccination based on different vaccination schedules among chronic kidney disease (CKD) patients.Methods CKD patients who participated in randomized controlled trials in four hospitals in Shanxi province and completed three doses of 20 μg vaccination (at months 0, 1 and 6) and four doses of 20 μg or 60 μg vaccination (at months 0, 1, 2, and 6) were surveyed from May 2019 to July 2020.According to the ratio of 1∶1∶1, 273 CKD patients were divided into 3 groups randomly. Quantification of the anti-hepatitis B surface antigen-antibody (anti-HBs) in serum samples was performed using chemiluminescent microparticle immunoassay at months 1 and 6 after the entire course of the vaccinations. The positive rate, high-level positive rate, geometric mean concentration (GMC) of anti-HBs, and the influencing factors were analyzed by χ2 tests, analysis of variance, unconditional logistic regression analysis. Results A total of 273 CKD patitents were participants.The positive rates in the CKD patients with four doses of 20 μg vaccination (92.96%,66/71) or 60 μg vaccination (93.15%, 68/73) were higher than that in the CKD patients with three doses of 20 μg vaccination (81.69%, 58/71) at month one after the full course of the vaccinations (P<0.05). The GMCs of anti-HBs showed similar results (2 091.11 mIU/ml and 2 441.50 mIU/ml vs. 1 675.21 mIU/ml) (P<0.05). The positive rate was higher in the CKD patients with four doses of 60 μg vaccination (94.83%,55/58) than in those with three doses of 20 μg vaccination (78.79%,52/66) (P<0.05) at month six after the full course of the vaccinations. And the GMC of anti-HBs in the patients with four doses of 60 μg vaccination (824.28 mIU/ml) was significantly higher than those in the patients with 3 or 4 doses of 20 μg vaccination (639.74 mIU/ml and 755.53 mIU/ml) (P<0.05). After controlling the confounding factors, the positive rate in the CKD patients with four doses of 60 μg vaccination were 3.19 (95%CI: 1.02-9.96) and 5.32 (95%CI: 1.27-22.19) times higher than those in the patients with three doses of 20 μg vaccination at months 1 and 6 after the full course of the vaccinations, respectively. The positive rate in CKD patients without immune suppression or hormone therapy was 3.33 (95%CI: 1.26-8.80) and 4.78 (95%CI: 1.47-15.57) times higher than those in the patients with such therapy, respectively. Conclusions Four doses of 20 μg or 60 μg hepatitis B vaccination could improve the immunogenicity in patients with CKD. And four doses of 60 μg vaccination might play a positive role in maintaining anti-HBs in this population. The immunogenicity in the CKD patients with immune suppression or hormone therapy was poor. |
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