异甘草酸镁治疗抗结核药致肝损害疗效和安全性的Meta-分析
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摘要
目的系统评价异甘草酸镁治疗抗结核药物所致肝损害的疗效和安全性。方法检索PubMed、EMbase、Cochrane图书馆、Medline、中国学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、万方数据库和维普数据库,收集国内外关于异甘草酸镁治疗抗结核药致肝损害的临床随机对照研究(RCTs),评价纳入研究的质量并提取数据,使用RevMan 5.3软件进行Meta-分析。结果共纳入14篇RCTs,包括1 202名抗结核药致肝损害患者。Meta-分析结果显示:异甘草酸镁在治疗抗结核药致肝损害总有效率[RR=1.38,95%CI(1.24,1.54),P<0.000 01]、降低丙氨酸氨基转移酶(ALT)[MD=-25.98, 95%CI (-34.68,-17.29), P<0.000 01]、天冬氨酸氨基转移酶(AST)[MD=-20.21,95%CI(-24.49,-15.93),P<0.000 01]、总胆红素(TB)[MD=-9.92,95%CI(-16.41,-3.43),P=0.003]、碱性磷酸酶(ALP)[MD=-13.91,95%CI(-26.03,-1.79),P=0.02]方面均优于对照组,差异有统计学意义,同时不良反应发生率低于对照组[RR=0.51,95%CI(0.27,0.96),P=0.04]。结论异甘草酸镁治疗抗结核药致肝损害临床疗效较好,可显著降低患者血清ALT、AST、TB和ALP水平,同时具有较高安全性,但本研究纳入文献多为较低质量的小样本研究,尚需更多高质量、大样本的随机对照试验进一步支持。
Objective To evaluate the efficacy and safety of magnesium isoglycyrrhizinate in the treatment of liver injury caused by anti-tuberculosis drugs. Methods PubMed, EMbase, Cochrane Database, Medline, CNKI, the Chinese Biomedical Database(CBM), Wanfang Database and WIP Database were searched to collecte the randomized controlled trials(RCTs) on liver injury patients caused by anti-tuberculosis drugs treated with magnesium isoglycyrrhizin. After screening the literatures, the quality of the included studies and extracted data was evaluated by using the RevMan 5.3 software for meta-analysis. Results A total of 14 RCTs were selected, including 1 202 patients with liver injury caused by anti-tuberculosis drugs. The total effective rate [RR=1.38, 95%CI(1.24, 1.54), P < 0.000 01], the reduced ALT [MD=-25.98, 95%CI(-34.68),-17.29), P < 0.000 01], AST [MD=-20.21, 95%CI(-24.49,-15.93), P < 0.000 01], TB [MD=-9.92, 95%CI(-16.41,-3.43), P = 0.003], ALP [MD=-13.91, 95%CI(-26.03,-1.79), P = 0.02]were superior to the control group, the difference was statistically significant, and the incidence of adverse reactions was lower than that of the control group [RR = 0.51, 95%CI(0.27, 0.96), P =0.04]. Conclusion Magnesium glycyrrhizinate has a good clinical effect in the treatment of liver injury caused by anti-tuberculosis drugs, which can significantly reduce the serum levels of ALT, AST,TB and ALP, and has a higher safety. However, the less quantity of samples, more high-quality and large-sample RCTs are needed to further support.
Objective To evaluate the efficacy and safety of magnesium isoglycyrrhizinate in the treatment of liver injury caused by anti-tuberculosis drugs. Methods PubMed, EMbase, Cochrane Database, Medline, CNKI, the Chinese Biomedical Database(CBM), Wanfang Database and WIP Database were searched to collecte the randomized controlled trials(RCTs) on liver injury patients caused by anti-tuberculosis drugs treated with magnesium isoglycyrrhizin. After screening the literatures, the quality of the included studies and extracted data was evaluated by using the RevMan 5.3 software for meta-analysis. Results A total of 14 RCTs were selected, including 1 202 patients with liver injury caused by anti-tuberculosis drugs. The total effective rate [RR=1.38, 95%CI(1.24, 1.54), P < 0.000 01], the reduced ALT [MD=-25.98, 95%CI(-34.68),-17.29), P < 0.000 01], AST [MD=-20.21, 95%CI(-24.49,-15.93), P < 0.000 01], TB [MD=-9.92, 95%CI(-16.41,-3.43), P = 0.003], ALP [MD=-13.91, 95%CI(-26.03,-1.79), P = 0.02]were superior to the control group, the difference was statistically significant, and the incidence of adverse reactions was lower than that of the control group [RR = 0.51, 95%CI(0.27, 0.96), P =0.04]. Conclusion Magnesium glycyrrhizinate has a good clinical effect in the treatment of liver injury caused by anti-tuberculosis drugs, which can significantly reduce the serum levels of ALT, AST,TB and ALP, and has a higher safety. However, the less quantity of samples, more high-quality and large-sample RCTs are needed to further support.
引文
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[9]邓敏,宣华,余晓,等.异甘草酸镁联合谷胱甘肽治疗抗结核药物所致中度以上肝损害疗效观察[J].浙江实用医学,2013,18(3):177-178.
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[13]吴小霞,辛朝雄,李晓云,等.异甘草酸镁治疗抗结核药引起的药物性肝炎的疗效分析[J].现代诊断与治疗,2015(6):1272-1274.
[14]熊晓晴.异甘草酸镁治疗抗结核药物性肝损害71例[J].江西中医药,2015,46(11):53-54.
[15]陈丽虹,王健华,李春明.异甘草酸镁治疗抗结核药引起的药物性肝炎临床效果观察[J].白求恩医学杂志,2016,14(3):317-318.
[16]蒋利,易星.异甘草酸镁治疗抗结核药致药物性肝损伤临床疗效观察[J].中国现代药物应用,2016,10(5):117-118.
[17]杨惠卫,李冬雷,李润浦,等.抗痨药物致药物性肝损伤患者应用异甘草酸镁治疗的临床疗效[J].现代消化及介入诊疗,2016,21(4):578-580.
[18]薄湘晖.异甘草酸镁治疗抗结核药引起的药物性肝炎临床疗效[J].中国现代药物应用,2017,11(18):97-98.
[19]赵刚.异甘草酸镁治疗抗结核药引起的药物性肝炎临床疗效分析[J].中外医疗,2017(4):137-139.
[20]李在亮.异甘草酸镁治疗抗结核药引起的药物性肝炎临床疗效[J].世界最新医学信息文摘,2017,17(32):79.
[21]Golichenari B,Velonia K,Nosrati R,et al.Label-free nano-biosensing on the road to tuberculosis detection[J].Biosens Bioelectron,2018,113:124-135.
[22]Cao J,Mi Y,Shi C,et al.First-line anti-tuberculosis drugs induce hepatotoxicity:A novel mechanism based on a urinary metabolomics platform[J].Biochem Biophys Res Commun,2018,497(2):485-491.
[23]蒋博峰,马晨晨,陈阳贵.抗结核药物不良反应发生率及其影响因素分析[J].中华疾病控制杂志,2017,21(2):160-163.
[24]金雯彦,于锋.异甘草酸镁防治药物性肝损伤的药理及临床研究进展[J].药学进展,2013,37(4):161-166.
[2]沈弢,黄昕,王誉雅,等.我国药物性肝损伤流行病学研究现状[J].临床肝胆病杂志,2018,34(6):1152-1155.
[3]李卫,钟洪兰,温秀珍,等.抗结核药物致肝损伤的发病机制及预防和治疗药物研究进展[J]现代医院,2015,15(9):9-12.
[4]杨亚君,张俊霞,徐平,等.22例抗结核药物所致肝功能衰竭的临床观察与护理[J].中国肝脏病杂志:电子版,2016,8(3):112-115.
[5]Huang X L,Qin J J,Lu S.Magnesium isoglycyrrhizinate protects hepatic L02 cells from ischemia/reperfusion induced injury[J].Int J Clin Exp Pathol,2014,7(8):4755-4764.
[6]Vinod R,Subramanian S.Systematic reviews and metaanalysis demystified[J].J Rheumatol,2015,10(2):89-94.
[7]李仁仙.异甘草酸镁治疗药物性肝炎50例临床分析[J].亚太传统医药,2011,7(8):75-76.
[8]周艳,曹雪霞.异甘草酸镁治疗抗结核患者的肝功能损伤60例疗效观察[J].医学信息,2011(8):3994-3995.
[9]邓敏,宣华,余晓,等.异甘草酸镁联合谷胱甘肽治疗抗结核药物所致中度以上肝损害疗效观察[J].浙江实用医学,2013,18(3):177-178.
[10]郭新枝,陈裕,程俊伟,等.异甘草酸镁注射液治疗抗结核药物所致急性肝损伤的临床研究[J].微生物与感染,2013,8(3):157-162.
[11]高卫红,邵伟杰,雷涛.异甘草酸镁治疗抗结核药物性肝损害45例[J].中国药业,2013,22(11):122-123.
[12]熊延军,李东方,孙红.异甘草酸镁治疗抗结核药物性肝损害的效果分析[J].中国当代医药,2014,21(5):68-69.
[13]吴小霞,辛朝雄,李晓云,等.异甘草酸镁治疗抗结核药引起的药物性肝炎的疗效分析[J].现代诊断与治疗,2015(6):1272-1274.
[14]熊晓晴.异甘草酸镁治疗抗结核药物性肝损害71例[J].江西中医药,2015,46(11):53-54.
[15]陈丽虹,王健华,李春明.异甘草酸镁治疗抗结核药引起的药物性肝炎临床效果观察[J].白求恩医学杂志,2016,14(3):317-318.
[16]蒋利,易星.异甘草酸镁治疗抗结核药致药物性肝损伤临床疗效观察[J].中国现代药物应用,2016,10(5):117-118.
[17]杨惠卫,李冬雷,李润浦,等.抗痨药物致药物性肝损伤患者应用异甘草酸镁治疗的临床疗效[J].现代消化及介入诊疗,2016,21(4):578-580.
[18]薄湘晖.异甘草酸镁治疗抗结核药引起的药物性肝炎临床疗效[J].中国现代药物应用,2017,11(18):97-98.
[19]赵刚.异甘草酸镁治疗抗结核药引起的药物性肝炎临床疗效分析[J].中外医疗,2017(4):137-139.
[20]李在亮.异甘草酸镁治疗抗结核药引起的药物性肝炎临床疗效[J].世界最新医学信息文摘,2017,17(32):79.
[21]Golichenari B,Velonia K,Nosrati R,et al.Label-free nano-biosensing on the road to tuberculosis detection[J].Biosens Bioelectron,2018,113:124-135.
[22]Cao J,Mi Y,Shi C,et al.First-line anti-tuberculosis drugs induce hepatotoxicity:A novel mechanism based on a urinary metabolomics platform[J].Biochem Biophys Res Commun,2018,497(2):485-491.
[23]蒋博峰,马晨晨,陈阳贵.抗结核药物不良反应发生率及其影响因素分析[J].中华疾病控制杂志,2017,21(2):160-163.
[24]金雯彦,于锋.异甘草酸镁防治药物性肝损伤的药理及临床研究进展[J].药学进展,2013,37(4):161-166.