水飞蓟宾胶囊治疗肝炎有效性的系统评价  

Systematic Review on Efficacy of Silybin Capsules in the Treatment of Hepatitis

作　　者：郑子恢[1] 高峰 赵紫楠[1] 潘慧杰[3] 郭思瑞 张亚同[1] 金鹏飞[1] ZHENG Zihui;GAO Feng;ZHAO Zinan;PAN Huijie;GUO Sirui;ZHANG Yatong;JIN Pengfei(Dept.of Pharmacy,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine of Chinese Academy of Medical Sciences,Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application(Beijing Hospital),Beijing 100730,China;Dept.of Health Care,Security Bureau of the Central Military Commission Joint Staff,Beijing 100017,China;Dept.of Clinical Laboratory,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine of Chinese Academy of Medical Sciences,Beijing 100730,China)

机构地区：[1]北京医院药学部,国家老年医学中心,中国医学科学院老年医学研究院,北京市药物临床风险与个体化应用评价重点实验室(北京医院),北京100730 [2]中央军委联合参谋部警卫局卫生保健处,北京100017 [3]北京医院检验科,国家老年医学中心,中国医学科学院老年医学研究院,北京100730

出　　处：《中国医院用药评价与分析》2022年第8期980-983,989,共5页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家重点研发计划项目(No.2020YFC2009001);国家卫健委药政司委托课题(No.NHC-YZS-202103)。

摘　　要：目的:系统评价水飞蓟宾胶囊治疗肝炎的有效性。方法:计算机检索Embase、中国知网等国内外数据库,纳入水飞蓟宾胶囊治疗肝炎的随机对照试验(研究组患者的治疗方案为单独使用水飞蓟宾胶囊,对照组患者的治疗方案为除水飞蓟宾胶囊外的其他方案),检索时间为建库至2022年2月。选取文献、评估纳入文献的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果:共纳入6项随机对照试验研究,包括450例患者,研究组、对照组患者分别为250、200例。分析结果表明,采用水飞蓟宾胶囊治疗的研究组患者,其总有效率(OR=3.20,95%CI=1.82~5.62,P<0.0001)、纳差缓解率(OR=5.25,95%CI=2.77~9.94,P<0.00001)、乏力缓解率(OR=2.73,95%CI=1.65~4.52,P<0.0001)、肝区不适缓解率(OR=5.62,95%CI=2.90~10.90,P<0.00001)、丙氨酸转氨酶水平(MD=-13.46,95%CI=-24.02~-2.90,P=0.01)和天冬氨酸转氨酶水平(MD=-9.77,95%CI=-14.68~-4.86,P<0.0001)均显著优于采用其他方案的对照组,差异均有统计学意义。结论:现有证据表明,单独使用水飞蓟宾胶囊治疗肝炎在有效性方面较对照方案有显著优势。受所选取研究的数量和质量所限,上述结论有待更多高质量的随机对照试验予以验证。OBJECTIVE:To systematically review the efficacy of Silybin capsules in the treatment of hepatitis.METHODS:Randomized controlled trials on Silybin capsules in the treatment of hepatitis(the research group was given Silybin capsules alone,while the control group was treated with a regimen other than Silybin capsules)were retrieved from Embase,CNKI and other domestic and overseas database from the establishment of the database to Feb.2022.After screening literature and assessing the risk of bias,Meta-analysis was performed by using RevMan 5.3 software.RESULTS:A total of 6 randomized controlled trials including 450 patients were enrolled,with 250 cases in the research group and 200 cases in the control groups,respectively.Results of analysis showed that patients in the research group treated with Silybin capsules had significantly better overall effective rate(OR=3.20,95%CI=1.82-5.62,P<0.0001),remission rate of poor appetite(OR=5.25,95%CI=2.77-9.94,P<0.00001),remission rate of fatigue(OR=2.73,95%CI=1.65-4.52,P<0.0001),remission rate of liver discomfort(OR=5.62,95%CI=2.90-10.90,P<0.00001),alanine aminotransferase level(MD=-13.46,95%CI=-24.02--2.90,P=0.01)and aspartate aminotransferase level(MD=-9.77,95%CI=-14.68--4.86,P<0.0001)than those of the control group with other therapeutic regimens,with statistically significant differences.CONCLUSIONS:The available evidence indicated that the application of silymarin capsules alone in the treatment of hepatitis has a significant advantage over the control regimens in terms of efficacy.Due to the number and quality of the selected studies,the above findings need to be validated in more high-quality randomized controlled trials.

关 键 词：水飞蓟宾胶囊 肝炎 META分析 随机对照试验 

分 类 号：R975.5[医药卫生—药品]