苦参素对维持性血液透析患者微炎症状态的影响：随机对照试验

背景：维持性血液透析（maintenance hemodialysis，MHD）患者体内普遍存在微炎症状态。它严重影响MHD患者长期生存率，改善MHD患者微炎症状态具有重要意义。目的：观察苦参素对MHD患者微炎症状态的影响，探讨苦参素对MHD患者微炎症的治疗作用。设计、场所、对象和干预措施：选择2008年6～9月在武汉市第一医院血液净化中心进行规律性维持血液透析治疗的60例慢性肾衰竭患者，随机分为治疗组和对照组，每组各30例。治疗组给予苦参素胶囊0．4g口服，1次／d，连续服用3个月，对照组不用药。主要结局指标：检测治疗前及治疗3个月后血清超敏C反应蛋白（high-sensitivity C-reactive protein，hs-CRP）、白细胞介素1β（interleukin-1β，IL—1β）、肿瘤坏死因子α（tumor necrosis factor—α，TNF—α）、血清白蛋白（albumin，Alb）、血清前白蛋白（pre-albumin，PAB）、总胆固醇（total cholesterol，TC）和三酰甘油（triglyceride，TG）浓度。结果：治疗组3例服药后当天出现胃痛，其中2例退出，1例经停药观察后症状消失，继续服药后胃痛未再次出现。治疗组2例服药第2天出现皮疹，经停药观察后症状消失，继续服药后未再次出现皮疹。其他患者均未发现不良反应，共58例完成观察。与治疗前比较，治疗组治疗后hs-CRP、IL-1β和TNF-α水平降低（P〈0.01），Alb，PAB、TC及TG水平升高（P〈0．01），与对照组比较，差异亦有统计学意义（P〈0．01，P〈0．05）。结论：苦参素能够改善MHD患者的微炎症状态。

Effects of oxymatrine on microinflammatory state in patients undergoingcontinuous hemodialysis: a randomized controlled trial

Background： Chronic microinflammatory state is common in the patients undergoing maintenance hemodialysis （MHD）, which seriously affects the long-term survival rate of MHD patients. It is important to improve the microinflammatory state in MHD patients.
Objective： To investigate the effects of oxymatrine on continuous hemodialysis.
Design, setting, participants and interventions： Sixty MHD Hospital, from June to September 2008, were randomized microinflammatory state in patients undergoing patients in Blood Purification Center, Wuhan No. 1 nto treatment group （30 cases） and control group （30 cases）. Oxymatrine Capsule was orally administered to the patients in the treatment group 0. 4 g once a day for 3 months, while the patients in the control group were not given oxymatrine.
Main outcome measures： The serum concentrations of high-sensitivity C-reactive protein （hs-CRP）, interleukin-13 （IL-13）, tumor necrosis factor-α （TNF-α）, albumin （Alb）, pre-albumin （PAB）, total cholesterol （TC） and triglyceride （TG） were detected before and after 3-month treatment.
Results： Three patients in the treatment group had a stomachache on the first day of treatment, and two out of the three quitted the trial. The stomachache disappeared in one patient after stopping taking the drug, and did not recur after continuing to receive the intervention. Two patients in the treatment group had skin rash with pruritus on the second day of treatment. The rash disappeared after the patients stopped taking the drug, and did not recur after continuing to receive the intervention. A total of 58 cases accessed to the statistical analysis, while 2 cases were excluded. In the treatment group, the concentrations of hs-CRP, IL-1β and TNF-α significantly decreased （P〈0.01） and the mean values of AIb, PAB, TC and TG significantly increased after the treatment as compared with those before the treatment （P〈0.01）, but there were no significant differences in all parameters between before and after treatment in the control group. There were significant differences in all parameters between the treatment group and the control group after treatment （P〈0. 01, P〈0. 05）.
Conclusion： Oxymatrine can improve the microinflammatory state in the patients undergoing continuous hemodialysis.