新加八味降酶汤联合异甘草酸镁治疗药物性肝损伤临床疗效观察

发布时间：2018-10-31 20:34

【摘要】：目的:本课题通过观察新加八味降酶汤联合异甘草酸镁(magnesium isoglycyrrhizinate,MgIG)治疗药物性肝损伤(drug-included liver injury,DILI)的中医证候积分、不适症状及血清生化学指标、B超积分等,对新加八味降酶汤联合异甘草酸镁治疗DILI进行疗效观察,探讨中医药联合异甘草酸镁的治疗效果及利弊,为临床治疗DILI提供新的治疗方案。方法:所有病例均选自2015年9月至2016年12月就诊于江苏省中医院感染科的门诊及住院DILI患者。将符合课题研究纳入标准的60例DILI患者按照随机原则分为2组,即治疗组和对照组,各30例。对照组给予异甘草酸镁常规治疗,治疗组则在对照组用药基础上联合新加八味降酶汤,均治疗6周。观察并记录患者治疗前后肝功能、不适症状及B超评分值等指标的变化,进行疗效分析;观察治疗前后患者的血、尿、粪常规及心电图、肾功能等指标的变化,进行安全性分析。结果:(1)经统计学分析,治疗第3周,治疗组临床有效30例,无效0例,有效率100%;对照组临床有效15例,无效15例,有效率50%。第6周,治疗组临床治愈1例,显效27例,有效2例,无效0例,总有效率100%;对照组临床显效5例,有效23例,无效2例,总有效率50%。两组患者总体疗效比较,差异有显著统计学意义(P0.01)。(2)两组患者间治疗3周与6周中医证候积分比较,差异有显著统计学意义(P0.01);治疗后,治疗组与对照组的症状积分均较治疗前明显下降,且差异有显著统计学意义(P0.01)。(3)血清学指标:组间比较:治疗3周时,AST、AKP、GGT三项具有统计学差异(P0.05),ALT、TB具有显著统计学差异(P0.01);6周时,组间比较,P值均0.05,无统计学差异。组内各项经分析:治疗组:3周、6周时各项指标与治疗前比较有显著统计学差异(P0.01);第6周与第3周比较,AST项无明显统计学差异(P=0.737),ALT、AKP、GGT、TB项有显著统计学差异(P0.01)。对照组:3周时AST、ALT两项指标与治疗前比较有明显统计学差异(P0.01),AKP、GGT、TB项则无显著统计学差异(P0.01);6周时各项项指标与治疗前比较有明显统计学差异(P0.01);第6周与第3周比较,各项指标有统计学差异(P0.05)。两组患者治疗0、3、6周时B超评分组间比较差异无统计学意义(P0.05);组内比较,3周与6周B超评分与治疗前相比明显下降,差异有统计学意义(P0.05)两组患者在本次研究期间接受治疗未出现明显的不良反应,血、尿、粪常规、心电图、肾功能等均为出现与本次用药相关的异常改变。结论:新加八味降酶汤联合异甘草酸镁治疗DILI,在改善患者症状体征及肝功能指标等方面效果优于单用异甘草酸镁,且具有良好的安全性。
[Abstract]:Objective: to observe the TCM syndromes scores, symptoms of discomfort and serum biochemical indexes, B-ultrasound scores, and so on, in the treatment of drug-induced liver injury (drug-included liver injury,DILI) by the combination of Xinjiawei Jiangxintang and magnesium isoglycyrrhizinate (magnesium isoglycyrrhizinate,MgIG). In order to provide a new therapeutic scheme for DILI, the therapeutic effect of traditional Chinese medicine combined with magnesium isoglycyrrhizinate was observed, and the therapeutic effect, advantages and disadvantages of the combination of traditional Chinese medicine and magnesium isoglycyrrhizinate were discussed in order to provide a new therapeutic scheme for clinical treatment of DILI. Methods: all the cases were selected from September 2015 to December 2016 in the Department of infection of Jiangsu Provincial Hospital of traditional Chinese Medicine (DILI). Sixty patients with DILI were randomly divided into two groups: treatment group (n = 30) and control group (n = 30). The control group was treated with magnesium isoglycyrrhizinate, and the treatment group was treated for 6 weeks. To observe and record the changes of liver function, symptoms of discomfort and B-ultrasound score before and after treatment, and to analyze the curative effect. The changes of blood, urine, fecal routine, electrocardiogram and renal function were observed before and after treatment. Results: (1) after 3 weeks of treatment, 30 cases were clinically effective, 0 cases were ineffective and 100 cases were effective in the treatment group, while 15 cases were effective, 15 cases were ineffective, and the effective rate was 50 cases in the control group. In the treatment group, 1 case was clinically cured, 27 cases were effective, 2 cases were effective, 0 cases were ineffective, and the total effective rate was 100 cases in the treatment group, while in the control group, 5 cases were clinically effective, 23 cases were effective, 2 cases were ineffective, and the total effective rate was 50%. There was significant difference in the total curative effect between the two groups (P0.01). (2). There was significant difference in TCM syndromes score between the two groups after 3 weeks and 6 weeks of treatment (P0. 01). After treatment, the symptom scores of the treatment group and the control group were significantly lower than those of the control group before treatment, and the difference was statistically significant (P0.01). (3) serological index: comparison between groups: at 3 weeks after treatment, AST,AKP, GGT had statistical difference (P0.05) and ALT,TB had significant difference (P0.01). At 6 weeks, there was no statistical difference between the two groups (P = 0.05). Analysis of each item in the group: treatment group: at 3 weeks, 6 weeks after treatment, the indexes were significantly different from those before treatment (P0.01); There was no significant difference in AST (P0. 737) and significant difference in ALT,AKP,GGT,TB (P0. 01) between week 6 and week 3. In the control group, the two indexes of AST,ALT were significantly different from those of before treatment at 3 weeks (P0.01), but AKP,GGT,TB had no significant difference (P0.01). At 6 weeks after treatment, there was significant statistical difference between the indexes before treatment (P0.01) and between the 6th week and 3rd week (P0.05). There was no significant difference in B-ultrasound score between the two groups at 6 weeks after treatment (P0.05). Compared with before treatment, the B-ultrasound score at 3 weeks and 6 weeks decreased significantly (P0.05). There were no significant adverse reactions in the two groups, blood, urine, fecal routine, electrocardiogram (ECG), blood, urine, stool routine, electrocardiogram (ECG), blood, urine, stool routine, electrocardiogram (ECG). The renal function were all abnormal changes related to this drug. Conclusion: the treatment of DILI, with new eight kinds of Jiangxin decoction combined with magnesium isoglycyrrhizinate is superior to that of magnesium isoglycyrrhizinate alone in improving the symptoms and signs and liver function of the patients, and has good safety.
【学位授予单位】：南京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R575

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