四逆汤加味联合异甘草酸镁对药物性肝损伤患者的疗效观察

目的:探究四逆汤加味联合异甘草酸镁治疗药物性肝损伤患者临床疗效,及对患者肝功能、Nrf2抗氧化、炎性反应指标的影响,为药物性肝损伤患者治疗方案制定提供新思路。方法:选取2016年1月至2018年10月西安市临潼区中医院收治确诊为药物性肝损伤的患者116例作为研究对象,按照确诊时间编号,采用数字随机表法分为对照组和观察组,每组58例。2组患者均予以停用可疑药物、予以基础保肝药物治疗及异甘草酸镁治疗,观察组在对照组处理措施基础上再予以四逆汤加味联合异甘草酸镁治疗。2组患者均连续治疗观察4周。对2组患者治疗前后的临床症状积分(肝区胀痛、乏力、食欲减退、厌油、上腹不适、皮肤黄染)、肝功能指标(ALT、AST、TBIL和AKP)、Nrf2抗氧化指标(Nrf2、NQO1、HO1、GSH-Px、CAT)、炎性反应指标(TNF-α、NO、IL-10、)进行评定检测,并行治疗前后及组间比较。完成治疗周期后对患者进行临床疗效评价并行组间比较。收集比较2组患者治疗过程中的药物不良反应率并比较。结果:1)完成治疗后,2组患者肝区胀痛、乏力、食欲减退、厌油、上腹不适、皮肤黄染临床症状积分均较治疗前下降,且观察组患者肝区胀痛、乏力、食欲减退、上腹不适症状积分均低于对照组患者,差异有统计学意义(P<0.05);2)治疗后2组患者ALT、AST、TBIL和AKP均治疗前有明显下降,且观察组低于对照组,差异有统计学意义(P<0.05);3)治疗后2组患者Nrf2、NQO1、HO1、GSH-Px、CAT均较治疗前下降,且观察组低于对照组,差异有统计学意义(P<0.05);4)治疗3 d、7 d、15 d后2组患WBC、NEUT%值均较治疗前下降,且观察组治疗后均低于对照组,差异有统计学意义(P<0.05);5)治疗后2组患者TNF-α、NO均较治疗前下降,且观察组低于对照组,IL-10较治疗前上升,且观察组高于对照组,差异有统计学意义(P<0.05);6)治疗后观察组患者临床总有效率高于对照组患者,差异有统计学意义(P<0.05);7)2组患者药物不良反应率比较,差异无统计学意义(P>0.05)。结论:四逆汤联合异甘草酸镁可有效降低药物性肝损伤患者Nrf2抗氧化指标及炎性反应状态,提升患者肝功能,减轻患者临床症状,提升患者临床治疗总有效率,且不增加患者药物不良反应率。

Efficacy Observation on Modified Sini Decoction Combined with Magnesium Isoglycyrrhizinate in Patients with Drug-induced Liver Injury

Objective:To explore clinical efficacy of modified Sini Decoction combined with magnesium isoglycyrrhizinate in the treatment of patients with drug-induced liver injury,and its effects on liver function,Nrf2 antioxidant and inflammatory reaction indexes of the patients,so as to provide new ideas for the formulation of treatment plan for patients with drug-induced liver injury.Methods:A total of 116 patients with drug-induced liver injury admitted to Xi′an Lintong District Hospital of Traditional Chinese Medicine from January 2016 to October 2018 were selected as the study subjects.According to the number of diagnosis time,they were divided into control group and observation group by random number table method,with 58 cases in each group.Both groups stopped taking suspect drugs,and they were treated with basic hepatoprotective drugs and magnesium isoglycyrrhizinate.The observation group was treated with modified Sini Decoction combined with magnesium isoglycyrrhizinate on the basis of the treatment measures in the control group.The 2 groups of patients were observed for 4 weeks.Scores of clinical symptoms(distending pain in hepatic region,fatigue,loss of appetite,aversion to greasy food,epigastric discomfort and skin yellowing),liver function indexes(ALT,AST,TBIL and AKP),Nrf2 antioxidant indexes(Nrf2,NQO1,HO1,GSH-Px and CAT),inflammatory reaction indexes(TNF-α,NO and IL-10)were evaluated and compared before and after the treatment,and compared between the 2 groups.After the completion of the treatment cycle,the patients were evaluated for clinical efficacy and compared between the 2 groups.Rates of adverse drug reactions(ADRs)in the course of treatment were collected and compared between the 2 groups.Results:1)After the treatment,the scores of clinical symptoms of distending pain in hepatic region,fatigue,loss of appetite,aversion to greasy food,epigastric discomfort and skin yellowing in both groups were lower than those before the treatment,and the scores of distending pain in hepatic region,fatigue,loss of appetite and epigastric discomfort in the observation group were lower than those in the control group(P<0.05).2)After the treatment,the ALT,AST,TBIL and AKP in both groups were all significantly decreased compared to those before the treatment,and those in the the observation group were lower than those in the control group(P<0.05).3)After the treatment,the Nrf2,NQO1,HO1,GSH-Px and CAT in the 2 groups were all lower than those before the treatment,and those in the observation group were lower than those in the control group(P<0.05).4)WBC and NEUT%in the 2 groups were lower than those before the treatment after 3 d,7 d and 15 d of treatment,and those in the observation group were lower than those in the control group after the treatment(P<0.05).5)After the treatment,the TNF-αand NO of the patients in the 2 groups were lower than those before the treatment,and those in the observation group were lower than those in the control group.While IL-10 was higher than that before the treatment,and that in the observation group was higher than that in the control group(P<0.05).6)After the treatment,the total clinical effective rate in the observation group was higher than that in the control group(P<0.05).7)There was no significant difference in the rates of ADRs between the 2 groups(P>0.05).Conclusion:Sini Decoction combined with magnesium isoglycyrrhizinate can effectively reduce Nrf2 antioxidant indexes and inflammatory status in patients with drug-induced liver injury,improve their liver function,alleviate clinical symptoms,and improve the total effective rate of clinical treatment,without increasing the ADR rate in the patients.