Chinese Journal of Tissue Engineering Research ›› 2013, Vol. 17 ›› Issue (18): 3374-3380.doi: 10.3969/j.issn.2095-4344.2013.18.020
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Gu Jin-yang1, 2, Shi Xiao-lei1, 2, Ren Hao-zhen1, Xiao Jiang-qiang1, Ding Yi-tao1, 2
Received:
2012-10-19
Revised:
2013-01-21
Online:
2013-04-30
Published:
2013-04-30
Contact:
Ding Yi-tao, Chief physician, Professor, Doctoral supervisor, Department of Hepatobiliary Surgery, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing 210008, Jiangsu Province, China; Jiangsu Clinical Center of Hepatobiliary Disease, Nanjing 210008, Jiangsu Province, China
dingyitao@yahoo.com.cn
About author:
Gu Jin-yang☆, Doctor, Attending physician, Department of Hepatobiliary Surgery, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing 210008, Jiangsu Province, China; Jiangsu Clinical Center of Hepatobiliary Disease, Nanjing 210008, Jiangsu Province, China
gjynyd@126.com
CLC Number:
Gu Jin-yang, Shi Xiao-lei, Ren Hao-zhen, Xiao Jiang-qiang, Ding Yi-tao. Systematic evaluation of extracorporeal bioartificial liver support system for the treatment of liver failure[J]. Chinese Journal of Tissue Engineering Research, 2013, 17(18): 3374-3380.
2.1 文献检索结果 在PubMed数据库共检索到2 812篇文章,Cochrane数据库检索到10篇论文。其中3篇因非英语论文被排除,另有2 778篇研究为摘要、评论、综述、动物实验或非相关研究。剩余41篇相关研究经进一步筛选后,发现尚有9项研究由于数据不足而无法纳入,1篇为重复发表论文,故最终共有31篇文献纳入本项研究。 2.2 纳入研究特征 纳入的研究及患者特征详见表1。 其中美国14项[11-12, 14-22, 24, 28-29, 31],中国5项[23, 33, 35, 39-40],意大利4项[19, 30, 32, 38],德国3项[26, 36-37],荷兰3项[27, 34, 41],英国和法国各1项[13,25]。"
2项随机对照试验进行了有关ELAD和HepatAssist研究[13, 24]。除去以上4项研究,剩余29篇文献均为BAL安全性和有效性的观察。共10种BAL装置应用于临床研究,分别为HepatAssist[11-12, 14-18,22, 24-25,32],ELAD[13, 20-21,29],TECA-HALSS[23, 33, 35, 40],AMC-BAL[27, 34, 41],LSS[26, 36],BLSS[28, 31],RFB[30, 38],MELS[37],HBL和BHS[19,39]。481例患者的年龄范围从21-56岁,男女比例为1∶1.35,大部分患者有脑病分期(26/31),Ⅲ期和Ⅳ期比例分别为21.62% 和33.47%。31项研究中肝脏疾病的类型有:急性肝衰竭[11, 13, 17, 19, 23-24, 26-27, 30-31, 33-34, 36, 39, 41],爆发性肝衰竭[11-12, 14-16, 18, 20-22, 25, 28-30, 32, 38],肝移植后无功 能 [14-15, 30, 37],慢加急性肝衰竭和重症肝炎[14-15, 31-32, 35]。 2.3 BAL治疗情况 见表2。"
大多数患者接受了一二次BAL治疗,最多者接受了9次治疗[24]。每次治疗时间根据不同的系统,3-168 h不等。不同的系统使用的细胞数量也不同,如HepatAssist系统使用了5×109个细胞,而MELS则需要470 g细胞,一般来说以10×109到 20×109个肝脏细胞数为最多见。在细胞类型选择方面,大多数的BAL系统选择新鲜分离的猪肝细胞,除此之外,还有使用低温冻存的猪肝细胞、低温冻存或新鲜分离的人肝细胞及C3A肝细胞株等。 2.4 BAL治疗结果 大多数作者描述了临床和生化指标、肝移植过渡期、存活率和不良反应事件,以评估BAL治疗效果。大体而言,上述指标均有不同程度改善,包括转氨酶、血氨、总胆红素、凝血酶原时间、国际标准化比值、颅内压和脑灌注压。大部分患者神经系统的功能状态也得到了改善或稳定。其中肝移植过渡期从3 h到8 d不等。值得一提的是,两项随机对照试验结果不尽如人意。Ellis等[13]报道了生物人工肝联合原位肝移植治疗组与单纯原位肝移植手术组在生存期方面统计并无明显差异。Demetriou等[24]报道了在使用HepatAssist系统治疗的患者中,只有因过量摄入对乙酰氨基酚引起急性肝衰竭这一亚组的患者,他们的生存率才有明显改善。另外,5个BAL系统报道发生了不良反应,其中暂时性低血压最为常见。BAL治疗效果列于表3。"
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