水飞蓟宾胶囊预防抗结核药物所致肝损伤的疗效分析

Efficacy of Silibinin capsules in the prevention of liver injury induced by anti-tuberculosis drugs

目的 探讨水飞蓟宾胶囊预防抗结核药物所致肝损伤的临床疗效.方法 按照纳入及排除标准,收集山西省长治市人民医院2014年1月至2016年10月经门诊免费抗结核组合药物（FDC）治疗的232例初治肺结核患者.根据研究目的采用前瞻性队列研究的方法将患者按照随机数字表法分为观察组（118例,采用FDC＋水飞蓟宾胶囊）和对照组（114例,单用FDC,中途脱落4例）,观察两组患者治疗8周内肝损伤发生的例数、严重程度、发生时间,以及不同年龄段的发生情况.采用SPSS 17.0统计软件分析数据,计量资料采用t检验,计数资料采用卡方检验,以P＜0.05为差异有统计学意义.结果 观察组患者治疗8周内的肝损伤发生率[2.54％（3/118）]低于对照组[14.04％（16/114）]（χ^2 =10.05,P=0.002）.老年患者多发生肝损伤,观察组＜60岁和≥60岁的患者肝损伤发生率[0.85％（1/118）,1.70％（2/118）]明显低于对照组[5.26％（6/114）,8.77％（10/114）]（χ^2=3.86,P=0.050;χ^2=6.00,P=0.014）;观察组＜60岁和≥60岁的患者间肝损伤发生率差异无统计学意义（χ^2=1.78,P=0.182）,而对照组两者间的差异有统计学意义（χ^2=19.23,P=0.000）.两组患者在8周内发生肝损伤19例,其中4周内发生18例（94.7％）,观察组在2～4周内的肝损伤发生率[（0.00％（0/118）]明显低于对照组[7.02％（8/114）]（χ^2=9.13,P=0.003）.结论 对结核病患者采用水飞蓟宾胶囊预防抗结核药物所致的肝损伤有一定疗效,尤其对于老年肺结核患者有减少肝损伤发生的可能.

Objective To investigate the effects of Silibinin on preventing liver injury induced by anti-tuberculosis drugs.Methods Two hundred and thirty two outpatients with primary pulmonary tuberculosis treated with fixed-dose combination （FDC） free antituberculosis drugs were enrolled according to inclusion and exclusion criteria in Changzhi People＆#39;s Hospital of Shanxi province during Jan.2014 to Oct.2016.According to the purpose of the study,a prospective cohort study was used to divide the patients into an observation group （118 cases,FDC＋ Silibinin capsules） and control group （114 cases,FDC only） according to the random number table method.The data including numbers of cases,the severity,occurrence time,and the incidence of different ages on liver injury in 8 weeks were recorded in two groups.Data were analyze with SPSS software 17.0 version,measurement data using t test and enumeration data suing Chi-square test,P〈0.05 was considered significant difference statistically.Results The incidence rate of liver injury in 8 weeks in observation group （2.54% （3/118）） was lower than that （14.04% （16/114）） in the control group （χ^2 =10.05,P=0.002）.Liver injury was common in the elderly.The incidence rates of liver injury among patients less than 60 years old and equal to or more than 60 years old （0.85% （1/118）,1.70% （2/118）） in the observation group were lower than those （5.26% （6/114）,8.77% （10/114）） in the control group （χ^2 =3.86,P =0.050;χ^2 =6.00,P=0.014）.The incidence rates of liver injury among the patients less than 60 years old and equal to or more than 60 years old were no difference statistically in the observation group （χ^2 =1.78,P=0.182）,but were difference statistically in the control group （χ^2 =19.23,P=0.000）.There were 19 cases with liver injury in 8 weeks and 18 cases in 4 weeks in two groups.The incidence rate of liver injury （（0.00% （0/118）） in 2-4 weeks in the observation group was lower than that （7.02% （8/114）） in the control group （χ^2 =9.13,P=0.003）.Conclusion It is effective to use Silibinin capsules to prevent liver injury caused by antituberculosis drugs in the patients with tuberculosis,especially for elderly patients with pulmonary tuberculosis.