抗结核固定剂量复合制剂治疗初治肺结核患者的不良反应监测结果分析  

Analysis of adverse drug reactions monitoring of fixed-dose combination in initial treatment TB patients

作　　者：李运葵[1] 何金戈[1] 李婷[1] 吴建林[1] 

机构地区：[1]四川省疾病预防控制中心,成都610041

出　　处：《中国防痨杂志》2016年第6期465-470,共6页Chinese Journal of Antituberculosis

基　　金：“重大新药创制”科技重大专项结核病治疗新剂型研究课题（2010ZX09102-301）

摘　　要：目的了解接受免费抗结核固定剂量复合制剂（fixed-doseCombination，FIX；）治疗的初治肺结核患者出现抗结核药物不良反应（adversedrugreactions，ADR）的频率和主要表现，探索发生ADR的相关危险因素，为制订和完善抗结核药物ADR的防治措施提供科学依据。方法采用连续单纯随机抽样的方法以抽签的形式抽取四川省9个县（区）作为研究现场，对2014年5月1日至10月31日登记并接受国家免费FIX；治疗的初治肺结核患者开展抗结核药物ADR监测。共纳入1261例患者，年龄15～92岁，平均年龄（48．00±16．76）岁，其中15～19岁组49例，20~29岁组198例，30-39岁组129例，40-49岁组292例，50-59岁组232例，≥60岁组361例；纳入患者中体质量≥50kg有932例，％50kg有329例。采用Epidata3．1软件录入数据，用SPSS19．0软件进行分析，采用7。检验进行率的比较，以P％0．05为差异有统计学意义。结果1261例患者中，抗结核药物ADR总的发生率为55．75％（703／1261）。其中15～19岁组ADR的发生率为48．98％（24／49），20～29岁组为46．46％（92／198），30-39岁组为57．36％（74／129），40-49岁组为56．85％（166／292），50-59岁组为61．64％（143／232），≥60岁组为56．51％（204／361）；经趋势卡方检验，各年龄组ADR的发生率呈现随年龄的增加而升高的趋势（x2趋势=5．54，P：0．019）。体质量≥50b组ADR发生率为48．71％（454／932）；体质量〈50kg组达75．68％（249／329），差异有统计学意义（x2=71．70，P=0．000）。按发生ADR的系统或器官分类，发生率最高的是消化系统（35．05％，442／1261），其中肝损伤i00例，发生率为7．93％；其次是运动系统（12．45％，157／1261）；泌尿、呼吸循环系统ADR发生率最低，分别为0．63％（8／1261）和0．24％（3／1261）。ADR的发生率、临床表现在治疗的第1～2个月最高，以后逐渐下Objective To understand the frequency and the main clinical features of adverse drug reactions （ADR） of fixed-dose combination （FDC） among the initial treatment pulmonary tuberculosis （TB） patients, and ex- plore the risk factors causing ADR~ thus to provide a scientific basis for the development of policies on ADR preven- tion and control of anti-TB drugs. Methods Nine counties （districts） in Sichuan Province were randomly selected by sortition as the study sites. All initial treatment pulmonary TB patients who were registered in the selected 9 counties （districts） from May 1st to October 31st, 2014 and received FDC treatment free of charge were enrolled into this study and were monitored for the occurrence of ADR. A total of 1261 cases aged 15 to 92 （mean age （48.00± 16.76） years） were enrolled, of which 49 cases were in the age group 15-19, 198 cases were 20-29, 129 cases were 30-39, 292 cases were 40-49, 232 cases were 50--59 and 361 cases were 60 and above. The body weight of 932 cases were 50 kg and above while 329 cases weighted under 50 kg. Epidata 3.1 was used for data input and management. SPSS version 19.0 was used for analysis. Chi-square test in a significance level of 0.05 was used for comparisons of the ADR incidence between different groups of the patients. Results Among 1261 cases, 703 cases were reported to have ADR, so the overall ADR recidence was 55.75% （703/1261）. The incidences of ADR in the age group 15-19, 20-29, 30-39, 40-49, 50-59 and ≥60 years old were 48.98% （24/49）, 46.46% （92/198）, 57.36%0 （74/129）, 56.85G （166/292）, 61.64%0 （143/232） and 56.51%0 （204/361） respectively. The incidence of ADR increased with age （x2trend =5. 54, P=0. 019）. The ADR incidence was 48.71% （454/932） in the patients whose body weight was ≥50 kg while it was 75.68% （249/329） in those patients whose body weight was 〈50 kg, the difference was statistically significant （X2= 71.70, P= 0. 000）. According to the ICH MedDRA, 35.05% （442

关 键 词：结核 肺 抗生素类 抗结核 复方合剂 药物毒性 人群监测 

分 类 号：R978.3[医药卫生—药品]