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替诺福韦二吡呋酯片联合自体骨髓干细胞移植治疗肝硬化失代偿的临床研究

Clinical trial of tenofovir disoproxil fumarate tablets combined with autologous bone marrow stem cell transplantation in the treatment of decompensation of liver cirrhosis
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摘要 目的观察替诺福韦二吡呋酯片联合自体骨髓干细胞移植治疗肝硬化失代偿的临床疗效及安全性。方法将138例肝硬化失代偿患者随机分为对照组和试验组,每组69例。对照组予以替诺福韦二吡呋酯片每次300 mg,qd,口服;试验组在对照组治疗的基础上,于口服替诺福韦二吡呋酯片1个月后予以自体骨髓干细胞移植治疗。2组患者均治疗12周。比较2组患者的Child-Pugh评分、终末期肝病模型(MELD)评分、肝功能、肝纤维化指标,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的Child-Pugh评分分别为(5.32±0.63)和(7.55±1.06)分,MELD评分分别为(18.66±2.32)和(25.69±3.01)分,谷丙转氨酶分别为(32.48±3.49)和(51.16±6.54)U·L^(-1),谷草转氨酶分别为(45.47±5.43)和(64.28±8.12)U·L^(-1),Ⅲ型前胶原肽分别为(97.46±11.15)和(115.65±12.23)μg L^(-1),Ⅳ型胶原分别为(107.53±13.65)和(129.99±14.12)μg L^(-1),差异均有统计学意义(均P<0.05)。2组患者的药物不良反应均以恶心、头痛和疲劳为主。试验组和对照组的总药物不良反应发生率分别为14.49%和10.14%,差异无统计学意义(P>0.05)。结论替诺福韦二吡呋酯片联合自体骨髓干细胞移植治疗肝硬化失代偿的临床疗效确切,其能明显改善患者的肝功能,减轻肝纤维化程度,且不增加药物不良反应的发生率。 Objective To observe the clinical efficacy and safety of tenofovir disoproxil fumarate tablets combined with autologous bone marrow stem cell transplantation in the treatment of decompensation of liver cirrhosis. Methods A total of 138 patients with decompensation of liver cirrhosis were randomly divided into control and treatment groups with 69 cases per group. Control group was given tenofovir disoproxil fumarate tablets 300 mg per time,qd,orally. Treatment group was given autologous bone marrow stem cell transplantation after 1 months treatment with tenofovir disoproxil fumarate tablets,on the basis of control group. Two groups were treated for 12 weeks. The Child-Pugh scores,end-stage liver disease model( MELD) scores,liver function,liver fibrosis indexes and adverse drug reactions were compared between two groups. Results After treatment,the main indexes in treatment and control groups were compared: Child-Pugh scores were( 5. 32 ± 0. 63) and( 7. 55 ± 1. 06)points,MELD scores were( 18. 66 ± 2. 32) and( 25. 69 ± 3. 01) points, alanine aminotransferase were( 32. 48 ± 3. 49) and( 51. 16 ± 6. 54) U·L^(-1),aspartate aminotransferase were( 45. 47 ± 5. 43) and( 64. 28 ± 8. 12)U·L^(-1),type Ⅲ procollagen peptide were( 97. 46 ± 11. 15) and( 115. 65 ± 12. 23) μg L^(-1),type Ⅳ collagen were( 107. 53 ± 13. 65) and( 129. 99 ± 14. 12) μg L^(-1),the differences were statistically significant( all P 0. 05). The adverse drug reactions of two groups were nausea,headache and fatigue. The total incidences of adverse drug reactions in treatment and control groups were 14. 49% and 10. 14% without significant difference( P 0. 05). Conclusion Tenofovir disoproxil fumarate tablets combined with autologous bone marrow stem cell transplantation have a definitive clinical efficacy in the treatment of decompensation of liver cirrhosis,which can significantly improve the liver function,reduce the degree of liver fibrosis,without increasing t
作者 冯玉 张钦 张运涛 郭义锦 林亚发 FENG Yu;ZHANG Qin;ZHANG Yun-tao;GUO Yi-jin;LIN Ya-fa(Department of Digestive,Fourth People's Hospital of Haikou,Haikou 571100,China)
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2018年第15期1773-1775,共3页 The Chinese Journal of Clinical Pharmacology
基金 海南省卫生厅医学科研立项基金资助项目(琼卫2012 PT-94)
关键词 替诺福韦二吡呋酯片 自体骨髓干细胞移植 肝硬化失代偿 安全性 tenofovir disoproxil fumarate tablet autologous bone marrow stem cell transplantation decompensation of liver cirrhosis safety
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