The Effect of General Anesthesia Immunosuppressive on Hepatitis B Virus Replication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- HBV-DNA
研究概览
简要总结
The purpose of this study is to determine whether the general anesthesia immunosuppressive could effect hepatitis B Virus replication
详细描述
The change of immune state can influence HBV replication or elimination, it has been reported that a certain degree of immunosuppression occured after general anesthesia. In this study we detect the cytotoxic T lymphocyte(CTL) count and activity, interferon-γ(IFN-γ) and HBV-DNA content form the HBV patient who will accept general anesthesia. Our purpose is to evaluate the influence of general anesthesia immunosuppressive on HBV replication. If the results show that HBV-DNA quantity increases, so the patients might be given anti-HBV drugs or immune enhancer; otherwise it is indicated the general anesthesia immunosuppressive don't influence HBV replication.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists（ASA） Ⅰ - Ⅱ;
- •ability to compliance the research plan;
- •volunteered and signed for the study ;
- •HBsAg positive, no serious system disease (heart: New York Heart Association（NYHA） class Ⅰ - Ⅱ, lung: vital capacity（VC）% or maximal voluntary ventilation（MVV）%>71, forced expiratory volume at one second（FEV1.0）%>61, arterial oxygen saturation（SaO2）%>94, arterial partial pressure of oxygen（PaO2）>75 mmHg, arterial carbondioxide partial pressure（PaCO2）<45mmHg, liver:child-pugh class A - B and kidney: chronic kidney disease（CKD）stage 1-3);
- •receive under general anesthesia (including gynecology, orthopedics,general surgery and urology department).
排除标准
- •tumor patients
- •can't collaborate;
结局指标
主要结局
HBV-DNA
时间窗: with in the first 5 days after surgery
collect blood samples 4 times with in the first 5 days after surgery: the first time：before initiation of anesthesia; the second time：the first day after surgery; the third time：the third day after surgery; the forth time：the fifth day after surgery. And outcome measure will be assessed with in 3 months when all the samples collected, and will be presented with in 2 months when outcome measure assessed .
次要结局
未报告次要终点
研究者
Lu KZ
Southwest Hospital
Southwest Hospital, China