注射用促肝细胞生长素治疗急慢性肝炎疗效及用药安全性  

Clinical observation of efficacy and safety of hepatocyte growth-promoting factor (pHGF) for injection in the treatment of acute and chronic hepatitis

作　　者：谢莹[1] 徐文胜[1] 高月求[2] 商斌仪[2] 倪鎏达[3] 张绍英 滕飞 王博 XIE Ying;XU Wen-sheng;GAO Yue-qiu;SHANG Bin-yi;NI Liu-da;ZHANG Shao-ying;TENG Fei;WANG Bo(Department of Infectious Diseases,Shanghai Chartgzheng Hospital,Shanghai 200003,China;Shanghai Shuguang Hospital Affilated to Shanghai University of Traditional Chinese Medicine,Shanghai 200021,China;3905 th Hospital of PLA Navy,Shanghai 200052,China;Yipinhong Pharmacy Co.,Ltd.,Guangzhou 510765,China)

机构地区：[1]上海长征医院,上海200003 [2]上海中医药大学附属曙光医院,上海200021 [3]中国人民解放军第905医院,上海200052 [4]广州一品红制药有限公司,广州510765

出　　处：《中国新药杂志》2019年第22期2729-2734,共6页Chinese Journal of New Drugs

摘　　要：目的:观察注射用促肝细胞生长素联合用药治疗急慢性肝炎的临床疗效和用药安全性。方法:选取2016年9月-2017年8月间在上海地区3家医院收治的120例急慢性肝炎患者,随机分为试验组(59例)和对照组(61例),两组根据需要可使用抗病毒药物和抗炎保肝类药物进行基础治疗。试验组加用注射用促肝细胞生长素240 mg溶于250 mL生理盐水中,静脉滴注(iv),qd。两组用药时间均为2周,比较两组疗效及用药安全性。结果:试验组患者治疗后(d 7和d 14)的血清总胆红素(TBIL),直接胆红素(DBIL),间接胆红素(IBIL),谷草转氨酶(AST),谷丙转氨酶(ALT)和γ-谷氨酰转氨酶(γ-GGT)均较治疗前显著下降(P<0.05),血清前白蛋白(PA)较治疗前显著上升(P<0.05),且试验组改善程度均显著优于对照组(P<0.05)。亚组分析显示:对于ALT≥200 U·L-1的患者,试验组患者治疗后的AST较治疗前下降极显著(P<0.01),PA较治疗前上升极显著(P<0.01),且试验组改善程度均极显著优于对照组(P<0.01);对于ALT≥400 U·L-1的患者,试验组患者治疗后的TBIL,DBIL和AST较治疗前下降极显著(P<0.01),PA较治疗前上升极显著(P<0.01),且试验组改善程度均极显著优于对照组(P<0.01)。试验组患者的住院时间(22.00±18.00)d,略短于对照组(25.00±17.00)d。两组间不良事件发生率、生命体征、血液生化学检查、血常规、尿常规、大便常规检查等安全性评价指标比较,均无显著性差异(P>0.05)。结论:各类急慢性肝炎在抗病毒药物和常规抗炎保肝药物治疗基础上加用较高剂量的注射用促肝细胞生长素,可显著改善肝功能疗效指标,缩短治疗时间,临床治疗确切,用药安全性高。Objective:To evaluate the efficacy and safety of combined use of hepatocyte growth-promoting factor(pHGF)for injection in the treatment of acute and chronic hepatitis.Methods:120 patients with acute and chronic hepatitis hospitalized in three hospitals in Shanghai from September 2016 to August 2017,were randomly divided into two groups,the control group(n=61)and the treatment group(n=59).Both groups were treated with antiviral therapy and liver protection therapy for two weeks,while the treatment group was combined with pHGF(240 mg dissolved in 250 mL saline,by intravenous dripping,once daily).The clinical efficacy and safety were observed.Results:The serum bilirubin(TBIL,DBIL,IBIL),alanine aminotransferase(ALT),aspartate transaminase(AST)andγ-glutamyltranspeptidase(γ-GGT)levels were significantly decreased(P<0.05)and the serum prealbumin(PA)level was significantly increased(P<0.05)in the treatment group at the 5 th day and14 th day after treatment.There was obvious difference between the treatment group and control group(P<0.05).In the subgroup of patients with ALT≥200 IU,the serum AST level was significantly decreased(P<0.01)and the PA level was significantly increased(P<0.01)in the treatment group after treatment,and there was more obvious improvement in the treatment group than the control group(P<0.01).In the subgroup of patients with ALT≥400 IU,the serum TBIL,DBIL and AST levels were significantly decreased(P<0.01)and the PA level was significantly increased(P<0.01)in the treatment group after treatment,and there was more obvious improvement in the treatment group than the control group(P<0.01).The length of hospital stay was(22.00±18.00)d in the treatment group,which was shorter than that of the control group,(25.00±17.00)d.There was no significant difference between the two groups in the rate of adverse events,vital signs,blood chemistries,routine blood tests,routine urinalysis and stool analysis(P>0.05).Conclusion:In the treatment of acute and chronic hepatitis,application of hepatocyte growth-pr

关 键 词：急慢性肝炎 注射用促肝细胞生长素 临床疗效 安全性 

分 类 号：R969.4[医药卫生—药理学] R975[医药卫生—药学]