【摘要】 目的 分析肺结核患者服用抗结核固定剂量复合制剂(FDC)致肝损伤的发生情况,为抗结核FDC在全国推广使用提供政策依据。方法 2011—2012年,选择甘肃、河北、吉林、四川、山东五省,每省选1个地市作为研究现场。各研究现场2011年7月1日至2011年12月31日新登记的初治活动性肺结核患者接受抗结核FDC治疗。共纳入患者5981例,用医学数据管理软件EpiData3.1录入患者个案信息,用SPSS 16.0软件进行数据统计学分析。分析患者肝损伤不良反应发生时间及程度、肝损伤不良反应临床症状与实验室检查异常一致性、肝损伤患者治疗方案调整方法等,以P<0.05为差异有统计学意义。结果 肝功能异常者占14.4%(862/5981),其中丙氨酸转氨酶异常者占2.4%(145/5981),总胆红素异常者占4.0%(241/5981),直接胆红素异常者占11.9%(714/5981)。中、重度肝损伤者占56.1%(484/862)。中、重度肝损伤发生在服药1个月内者占57.2%(277/484)。有消化系统不良反应临床症状者占10.3%(619/5981),将有消化系统不良反应临床症状者与肝功能异常者的率进行比较,消化系统不良反应率(10.3%)与直接胆红素异常发生率(11.9%)两者差异无统计学意义(X~2=1.1382,P>O.05),但与总胆红素异常(X~2=14.3116,P<0.05)和丙氨酸转氨酶异常(X~2=19.4849,P<0.0001)问差异有统计学意义。中、重度肝损伤患者中23.1%(112/484例)改用散装抗结核药品替换FDC治疗。结论 应用抗结核FDC治疗肺结核患者致肝损伤情况不可忽视,中、重度肝损伤患者应该改用散装抗结核药物进行治疗。更多还原

【Abstract】 Objective In order to provide evidence for developing policy on expansion of fixed-dose combination(FDC)anti-TB drugs in China,FDC-associated liver injuries were evaluated.Methods In 2011 and 2012,five provinces,including Gansu,Hebei,Jilin,Sichuan and Shandong,were involved in the evaluation.In each province,one prefecture was selected as the study site.All new pulmonary tuberculosis(PTB)patients notified from 1 July to 31 December 2011 were recruited in the study and FDC was used for treatment.EpiData 3.1 software was used for data entry and validation,and SPSS 16.0 was used for statistical analysis.The following data or information were collected and analyzed:time of getting liver damage and extent of liver damage,correlations between clinical symptoms and laboratory abnormalities,methods for dealing with liver damage(such as adjustment of treatment regimen and its influence to treatment outcomes).The value of P <0.05 was regarded as statistically significant difference.Results A total of 5981 PTB patients were enrolled in this study and 14.4%(862/5981)of them got abnormal liver function during treatment with FDC,including 2.4%(145/5981)of enrolled patients had abnormal alanine aminotransferase,4.0%(241/5981)of enrolled patients had abnormal total bilirubin and 11.9%(714/5981)of enrolled patients had abnormal direct bilirubin-Among the patients who got abnormal liver function,56.1%(484/862)of them had moderate or severe liver damage and it occurred within 1 month of treatment in57.2%(277/484)of patients.Ten point three percent(619/5981)of enrolled patients showed clinical symptoms of adverse reaction in digestive system,Data from the patients who had digestive reactions and abnormal liver function were compared and the results showed that:there was no significant difference between digestive reactions and abnormal DBIL(X~2=1.1382,P>0.05);however,there were significant difference between digestive reactions and TBIL(X~2=14.3116,P<0.05),digestive reactions and ALT(X~2=19.4849,P<0.0001).The treatment was adjusted in 23.1%(112/484)of patients who had moderate or severe liver damage,namely FDC.was replaced by loose drugs.Conclusion During treatment with FDC,the attention should be paid to liver injury.Patients who got moderate or severe liver injury,FDC should be replaced by loose drugs.更多还原