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目的系统评价五酯胶囊(片)对他克莫司(FK506)血药浓度及药动学参数的影响。方法检索PubMed、中国生物医学文献数据库、中国知网、万方数据,五酯胶囊(片)与FK506合用治疗肝肾移植患者的随机对照试验,检索时限2004年1月—2014年1月。由2位评价员根据纳入与排除标准独立进行文献筛选、资料提取并质量评价后,采用RevMan 5.2软件进行Meta分析。结果纳入10个临床随机对照试验,共491例患者。根据干预时间的长短进行亚组分析,Meta分析结果显示:(1)干预1个月后:与FK506组相比,合用组血药浓度显著增加〔SMD=0.75,95%CI(0.54,0.97),P<0.001〕,FK506剂量减少〔SMD=-1.52,95%CI(-1.78,-1.26),P<0.001〕;(2)干预3个月后:合用组血药浓度显著增加〔SMD=0.44,95%CI(0.25,0.64),P<0.001〕,FK506剂量减少〔SMD=-1.71,95%CI(-1.95,-1.47),P<0.001〕;(3)药代动力学主要参数:峰浓度Cmax〔SMD=1.57,95%CI(0.26,2.09),P=0.002〕,药时曲线下面积(AUC0-12h)〔SMD=1.66,95%CI(1.10,2.23),P<0.001〕和达峰时间(tmax)〔SMD=1.03,95%CI(0.52,1.55),P<0.001〕有显著差异。结论五酯胶囊(片)对FK506组的血药浓度有显著影响,可提高其血药浓度,降低其用量,提高生物利用度。受限于纳入研究数量,上述结论尚需今后开展更多大样本、高质量的临床试验加以验证。
Objective To systematically evaluate the effect of Wuzhi Capsule on the plasma concentration and pharmacokinetic parameters of tacrolimus (FK506). Methods The randomized controlled trials of PubMed, China Biomedical Literature Database, CNKI, Wanfang Data, Wu-Zeng Capsule and FK506 combined with liver and kidney transplantation were searched. The search time was from January 2004 to January 2014. According to inclusion and exclusion criteria, two reviewers independently screened the data, extracted the data, and evaluated the quality. Meta-analysis was performed using RevMan 5.2 software. Results A total of 491 patients were enrolled in 10 randomized controlled trials. The results of Meta-analysis showed that: (1) After one month of intervention, the plasma concentration of combined group was significantly increased compared with FK506 group [SMD = 0.75, 95% CI (0.54, 0.97) , P <0.001], the dose of FK506 decreased (SMD = -1.52,95% CI -1.78, -1.26, P <0.001); (3) After 3 months of intervention, 0.44, 95% CI (0.25,0.64), P <0.001), and the dose of FK506 decreased (SMD = -1.71,95% CI -1.95, -1.47, P <0.001). (3) The main pharmacokinetic parameters (SMD = 1.57, 95% CI (0.26, 2.09), P = 0.002) and the area under the curve of the drug (AUC0-12h) [SMD = 1.66,95% CI (1.10,2.23), P <0.001 ] And peak time (tmax) [SMD = 1.03, 95% CI (0.52, 1.55), P <0.001]. Conclusion Wuzhi capsule has significant effect on plasma concentration of FK506 group, which can increase its plasma concentration, reduce its dosage and improve bioavailability. Due to the limited number of included studies, the above conclusions still need to be followed by more large samples and high quality clinical trials.