自体骨髓干细胞经肝动脉移植治疗肝硬化失代偿期的Meta分析
发布时间：2018-08-27 13:06
【摘要】：目的:系统评价自体骨髓间充质干细胞(Bone marrow mesenchymal stem cells,BMSCs)经肝动脉移植治疗肝硬化失代偿期的疗效及安全性,以期为肝硬化失代偿期的治疗提供参考。方法:电子计算机检索近十年数据库,包括万方数据库(Wan FangDate),重庆维普(VIP),中国知网(CKNI)三大中文数据库;还有Cochrane Library,PubMed两大外文数据库。手工检索近十年与肝病研究有关的重要期刊,并根据研究需要结合纳入排除标准进行文献筛选,运用Revman 5.3分析软件进行Meta分析,结合GRADE评分进行质量等级评价。结果:(1)本次评价符合纳入要求的期刊文献共15篇,发表时间为2010年-2016年,研究总共纳入病例总数为1040例。纳入文章的证据质量评价包含3篇“高级”,8篇“中级”,4篇“低级”,主要影响文章质量的是隐藏、盲法、手术与非手术对照。总评价分析表明自体骨髓干细胞移植治疗肝硬化失代偿期的疗效优于西医常规对照治疗。(2)对症状的改善,腹水好转方面(MD=1.92,95%CI(1.43~2.57)P0.0001)、纳差减轻方面(MD=1.77,95%CI(1.41~2.23),P0.00001)、乏力改善方面(MD=1.74,95%CI(1.39~2.17),P0.00001)、腹胀减轻方面(MD=1.86,95%CI(1.45~2.37)P0.00001),干细胞移植治疗组与西医常规对照组比较具有统计意义,说明自体骨髓干细胞移植较西医常规治疗更明显改善肝硬化失代偿期的症状。(3)血清学指标方面,ALB(MD=5.22,95%CI(2.40~8.04),P=0.0003)、ALT(MD=-17.8,95%CI(-30.8~-4.8),P=0.0070.01)、TBIL(MD=-11.77,95%CI(-17.85~-5.7)P=0.00010.01)、PT(MD=-4.33,95%CI(-8.58~-0.08),P=0.05),干细胞移植治疗组与西医常规对照组比较具有统计意义,说明自体骨髓干细胞移植治疗肝硬化失代偿期对肝脏功能血清学改善优于西医常规对照治疗;但PTA(MD=19.31,95%CI(-2.72~41.34),P=0.090.05)说明干细胞移植治疗组与西医常规对照组对凝血酶原时间活动度的改善无统计意义,疗效相当。(4)对肝脏综合评分上,Child-Pugh评分(MD=-1.4,4,95%CI(-1.68~-1.21),P0.00001)、MELD评分(=-4.50,95%CI(-8.13~-0.86),P=0.020.05),两评分表明干细胞移植治疗组与西医常规对照组比较具有统计意义,说明干细胞移植治疗组患者的MELD评分比常规西医治疗更优,但样本量较少,或需要更大样本量进一步证明。(5)不良反应方面因缺乏统计学意义难评定,但所纳入文献均显示不良反应少,安全性高。结论:(1)Meta分析评价说明干细胞移植组在临床症状、肝功能、凝血功能、Child-Pugh评分、MELD评分的短期疗效(1-6个月)均优于对照组;并且不良反应少,安全性高,值得应用推广。(2)我国大部分进行干细胞移植患者均为病毒性肝炎所致肝硬化,已进行或正在进行抗病毒治疗;患者肝脏功能越好,疗效越显著。(3)对进行自体骨髓干细胞移植建议如下:采集骨髓量为100-200ml,分离纯化后单个核细胞数需达到108-1010/ml,干细胞检测达到106-109/ml,保证存活率达到75%,4℃冷藏不超4小时,术前可予促肝或G-CSF辅助,肝动脉介入移植疗效更佳,术后可结合中药或生长因子等促进干细胞归巢分化。
[Abstract]:OBJECTIVE: To evaluate the efficacy and safety of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via hepatic artery in decompensated cirrhosis in order to provide a reference for the treatment of decompensated cirrhosis. Vip (VIP), China Knowledgeable Network (CKNI) three Chinese databases; and Cochrane Library, PubMed two foreign language databases. Hand-searched in the past decade with liver disease research related important journals, and according to research needs combined with inclusion exclusion criteria for literature screening, using Revman 5.3 analysis software for meta-analysis, combined with GRADE score for quality. Results: (1) Fifteen articles were published from 2010 to 2016. The total number of cases included in the study was 1 040. The evaluation of the quality of evidence included three "advanced", "intermediate" and "low" articles. The main factors affecting the quality of the articles were concealment, blindness, surgery and non-hands. Total evaluation showed that the effect of autologous bone marrow stem cell transplantation on decompensated liver cirrhosis was better than that of routine western medicine treatment. (2) Symptom improvement, ascites improvement (MD = 1.92,95% CI (1.43-2.57) P 0 000 1), Na difference alleviation (MD = 1.77,95% CI (1.41-2.23), P 0 000 01), fatigue improvement (MD = 1.74,95% CI (1.39-2.17), P 0 0 0 0 01). In the aspect of reducing abdominal distension (MD = 1.86,95% CI (1.45-2.37) P 0.00001), the treatment group of stem cell transplantation had statistical significance compared with the routine control group of Western medicine, indicating that autologous bone marrow stem cell transplantation could significantly improve the symptoms of decompensated liver cirrhosis compared with the routine treatment of Western medicine. (3) In the aspect of serological indicators, ALB (MD = 5.22,95% CI (2.40-8.04), P = 0.0003, A LT (MD = - 17.8, 95% CI (- 30.8 ~ - 4.8), P = 0.0070.01), TBIL (MD = - 11.77, 95% CI (- 17.85 ~ - 5.7) P = 0.00010.01), PT (MD = - 4.33, 95% CI (- 8.58 ~ - 0.08), P = 0.05), stem cell transplantation treatment group compared with conventional Western medicine control group has statistical significance, indicating that autologous bone marrow stem cell transplantation for decompensated liver cirrhosis has better serological improvement than the conventional control group. However, PTA (MD = 19.31, 95% CI (-2.72-41.34), P = 0.090.05) showed that the improvement of prothrombin time activity in the stem cell transplantation group was not statistically significant compared with that in the control group. (4) Child-Pugh score (MD =-1.4, 4, 95% CI (-1.68-1.21), P 0.00001, MELD score (=-4.50, 95% C-95% C-1.21) was the same in the comprehensive liver score. I (- 8.13 ~ - 0.86), P = 0.020.05), the two scores showed that the stem cell transplantation treatment group compared with the conventional control group of Western medicine has statistical significance, indicating that the MELD score of stem cell transplantation treatment group is better than the conventional Western medicine treatment, but the sample size is smaller, or need a larger sample size to further prove. (5) Adverse reactions due to lack of statistical significance is difficult. Conclusion: (1) Meta-analysis showed that the short-term efficacy of stem cell transplantation group in clinical symptoms, liver function, coagulation function, Child-Pugh score and MELD score (1-6 months) were better than that of the control group; moreover, it had less adverse reactions and high safety, and was worth popularizing in China. (2) Most of the stem cell transplantation group were improved. Stem cell transplantation patients are all cirrhosis caused by viral hepatitis, have been or are undergoing antiviral treatment; the better the liver function, the more significant the effect. (3) For autologous bone marrow stem cell transplantation recommendations are as follows: the amount of bone marrow collected is 100-200 ml, the number of mononuclear cells after isolation and purification must reach 108-1010/ml, stem cell detection reaches 10. 6-109/ml, the survival rate was 75%. The cryopreserved temperature was not more than 4 hours. Hepatic stimulation or G-CSF could be used before operation. Hepatic artery interventional transplantation was more effective. After operation, the stem cells could be homing and differentiated by combining traditional Chinese medicine or growth factor.
【学位授予单位】：广西中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R575.2
本文编号：2207383
[Abstract]:OBJECTIVE: To evaluate the efficacy and safety of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via hepatic artery in decompensated cirrhosis in order to provide a reference for the treatment of decompensated cirrhosis. Vip (VIP), China Knowledgeable Network (CKNI) three Chinese databases; and Cochrane Library, PubMed two foreign language databases. Hand-searched in the past decade with liver disease research related important journals, and according to research needs combined with inclusion exclusion criteria for literature screening, using Revman 5.3 analysis software for meta-analysis, combined with GRADE score for quality. Results: (1) Fifteen articles were published from 2010 to 2016. The total number of cases included in the study was 1 040. The evaluation of the quality of evidence included three "advanced", "intermediate" and "low" articles. The main factors affecting the quality of the articles were concealment, blindness, surgery and non-hands. Total evaluation showed that the effect of autologous bone marrow stem cell transplantation on decompensated liver cirrhosis was better than that of routine western medicine treatment. (2) Symptom improvement, ascites improvement (MD = 1.92,95% CI (1.43-2.57) P 0 000 1), Na difference alleviation (MD = 1.77,95% CI (1.41-2.23), P 0 000 01), fatigue improvement (MD = 1.74,95% CI (1.39-2.17), P 0 0 0 0 01). In the aspect of reducing abdominal distension (MD = 1.86,95% CI (1.45-2.37) P 0.00001), the treatment group of stem cell transplantation had statistical significance compared with the routine control group of Western medicine, indicating that autologous bone marrow stem cell transplantation could significantly improve the symptoms of decompensated liver cirrhosis compared with the routine treatment of Western medicine. (3) In the aspect of serological indicators, ALB (MD = 5.22,95% CI (2.40-8.04), P = 0.0003, A LT (MD = - 17.8, 95% CI (- 30.8 ~ - 4.8), P = 0.0070.01), TBIL (MD = - 11.77, 95% CI (- 17.85 ~ - 5.7) P = 0.00010.01), PT (MD = - 4.33, 95% CI (- 8.58 ~ - 0.08), P = 0.05), stem cell transplantation treatment group compared with conventional Western medicine control group has statistical significance, indicating that autologous bone marrow stem cell transplantation for decompensated liver cirrhosis has better serological improvement than the conventional control group. However, PTA (MD = 19.31, 95% CI (-2.72-41.34), P = 0.090.05) showed that the improvement of prothrombin time activity in the stem cell transplantation group was not statistically significant compared with that in the control group. (4) Child-Pugh score (MD =-1.4, 4, 95% CI (-1.68-1.21), P 0.00001, MELD score (=-4.50, 95% C-95% C-1.21) was the same in the comprehensive liver score. I (- 8.13 ~ - 0.86), P = 0.020.05), the two scores showed that the stem cell transplantation treatment group compared with the conventional control group of Western medicine has statistical significance, indicating that the MELD score of stem cell transplantation treatment group is better than the conventional Western medicine treatment, but the sample size is smaller, or need a larger sample size to further prove. (5) Adverse reactions due to lack of statistical significance is difficult. Conclusion: (1) Meta-analysis showed that the short-term efficacy of stem cell transplantation group in clinical symptoms, liver function, coagulation function, Child-Pugh score and MELD score (1-6 months) were better than that of the control group; moreover, it had less adverse reactions and high safety, and was worth popularizing in China. (2) Most of the stem cell transplantation group were improved. Stem cell transplantation patients are all cirrhosis caused by viral hepatitis, have been or are undergoing antiviral treatment; the better the liver function, the more significant the effect. (3) For autologous bone marrow stem cell transplantation recommendations are as follows: the amount of bone marrow collected is 100-200 ml, the number of mononuclear cells after isolation and purification must reach 108-1010/ml, stem cell detection reaches 10. 6-109/ml, the survival rate was 75%. The cryopreserved temperature was not more than 4 hours. Hepatic stimulation or G-CSF could be used before operation. Hepatic artery interventional transplantation was more effective. After operation, the stem cells could be homing and differentiated by combining traditional Chinese medicine or growth factor.
【学位授予单位】：广西中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R575.2
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