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目的系统评价干细胞治疗终末期肝病的疗效及安全性。方法采用Cochrane系统评价方法,检索Cochrane图书馆临床对照试验数据库、CNKI、EMbase、CBM、PubMed、万方数据库等电子资料库以及中文科技期刊数据库VIP。由2名评价者共同评价所纳入研究的质量,对同质研究进行Meta分析。结果共纳入11个研究、468例终末期肝病患者。其中3篇文献采用随机数字法分组并实施盲法,其余8篇文献未描述具体随机方法、未实施盲法。2篇文献采用信封分配隐藏方法,其余文献均未描述分配隐藏方法。按观察指标和观察时间进行亚组分析:①在降低Meld评分方面:治疗1个月、3个月、6个月后干细胞治疗组优于对照组,差异有统计学意义[WMD=-1.65,95%CI(-2.95,-0.35);WMD=-2.54,95%CI(-3.85,-1.23);WMD=-2.76,95%CI(-4.11,-1.40)];而治疗12个月时治疗组与对照组差异无统计学意义[WMD=0.20,95%CI(-1.76,2.16)]。②在降低Child-Pugh分级方面:治疗1个月、6个月时干细胞治疗组均优于对照组,差异有统计学意义[WMD=-2.0,95%CI(-2.55,-1.45);WMD=-0.90,95%CI(-1.39,-0.41)]。治疗3个月、12个月时干细胞治疗组与对照组差异无统计学意义[WMD=0.20,95%CI(-1.48,1.88);WMD=0.60,95%CI(-0.93,2.13)]。③在血清白蛋白升高方面:治疗1个月时,治疗组均优于对照组,差异均有统计学意义;治疗3个月时,2项研究显示治疗组优于对照组,1项研究显示对照组优于治疗组,差异均有统计学意义;治疗6个月时治疗组优于对照组,差异均有统计学意义;治疗12个月时,1项研究显示治疗组与对照组差异无统计学意义;1项研究对照组优于干细胞组,差异有统计学意义。④血清胆红素降低量:疗程1个月、3个月时,治疗组均优于对照组,差异均有统计学意义;治疗6个月、12个月时治疗组与对照组无统计学差异。⑤血清ALT降低量的变化:治疗1个月时2项研究显示治疗组优于对照组,差异有统计学意义,1项研究治疗组与对照组无统计学差异;3个月、6个月、12个月时均显示治疗组与对照组无统计学意义。⑥在生存率方面:治疗10周及6个月时研究显示干细胞治疗组优于对照组,差异均有统计学意义。结论现有研究显示,干细胞对终末期肝病患者的Child评分、Meld评分、血清白蛋白、血清胆红素、ALT有改善,且能改善患者的临床症状、提高患者短期的生存率,无严重不良反应,但其远期疗效及生存预后尚不确定,尚需更大量的文献进一步的研究报道。
Objective To evaluate the efficacy and safety of stem cells in the treatment of end-stage liver disease. Methods The Cochrane systematic review was used to search the Cochrane Central Register of Controlled Trials Database (CNKI), CNKI, EMbase, CBM, PubMed and Wanfang Database, as well as the Chinese Science and Technology Periodical Database VIP. Two reviewers jointly evaluated the quality of the included studies and conducted a meta-analysis of the homogeneous studies. Results A total of 11 studies were included, 468 patients with end-stage liver disease. Three of them were grouped by random number method and blinded. The remaining eight articles did not describe the specific random method and did not implement blind method. Two articles adopt the envelope distribution concealment method, and none of the other documents describe the distribution concealment method. According to the observation index and the observation time, the subgroup analysis was performed: ① In the aspect of decreasing Meld score: the stem cell therapy group was superior to the control group at 1 month, 3 months and 6 months after treatment, the difference was statistically significant [WMD = -1.65, WMD = -2.54, 95% CI (-3.85, -1.23); WMD = -2.76, 95% CI (-4.11, -1.40)]; while at 12 months of treatment There was no significant difference between the treatment group and the control group [WMD = 0.20, 95% CI (-1.76, 2.16)]. ②In the aspect of decreasing Child-Pugh classification, the treatment group at 1 month and 6 months were better than the control group (WMD = -2.0,95% CI -2.55, -1.45); WMD = -0.90, 95% CI (-1.39, -0.41)]. There was no significant difference between the treatment group and the control group at 3 months and 12 months (WMD = 0.20,95% CI -1.48,1.88; WMD = 0.60,95% CI -0.93,2.13). ③ In serum albumin increase: 1 month after treatment, the treatment group were better than the control group, the difference was statistically significant; 3 months of treatment, two studies showed that the treatment group was better than the control group, one study Showing that the control group is superior to the treatment group, the difference was statistically significant; the treatment group was superior to the control group at 6 months, the differences were statistically significant; at 12 months, one study showed that the difference between the treatment group and the control group No statistical significance; a study of the control group was better than the stem cell group, the difference was statistically significant. ④ serum bilirubin reduction: treatment 1 month, 3 months, the treatment group were better than the control group, the differences were statistically significant; treatment 6 months, 12 months when the treatment group and the control group no statistical difference. ⑤ serum ALT decreased changes: 1 month treatment at 2 months showed that the treatment group was better than the control group, the difference was statistically significant, a study treatment group and the control group no significant difference; 3 months, 6 months , 12 months mean treatment group and control group was not statistically significant. ⑥ Survival rate: 10 weeks and 6 months treatment showed that the stem cell treatment group was better than the control group, the differences were statistically significant. Conclusions The current research shows that the scores of Child, Meld, serum albumin, serum bilirubin and ALT in patients with end-stage liver disease are improved, and can improve the clinical symptoms and improve the short-term survival of patients with no serious adverse reactions Response, but its long-term efficacy and survival prognosis is uncertain, but a large amount of literature still need further research reports.