结核病与肺部健康杂志 ›› 2015, Vol. 4 ›› Issue (4): 233-238.doi: 10.3969/j.issn.2095-3755.2015.04.006

• 论著 • 上一篇    下一篇

1200例儿童进行结核病化学预防的不良反应观察

魏晓慧,靳晓伟,段海霞,靳鸿建   

  1. 452370 郑州,河南省新密市结核病防治所
  • 收稿日期:2015-10-08 出版日期:2015-12-30 发布日期:2015-12-30
  • 通信作者: 靳晓伟,Email:xmjfs18@126.com

Study on adverse reactions of 1200 children on tuberculosis preventive treatment

WEI Xiao-hui, JIN Xiao-wei, DUAN Hai-xia, JIN Hong-jian   

  1. Tuberculosis Control Institute of Xinmi City, Henan Province, Xinmi 452370, China
  • Received:2015-10-08 Online:2015-12-30 Published:2015-12-30
  • Contact: JIN Xiao-wei, Email:xmjfs18@126.com

摘要: 目的观察儿童应用利福喷丁(L)和异烟肼(H)方案进行预防性结核病化疗中的不良反应。方法对新密市2012—2014年1200例结核菌素试验强阳性的6~15岁儿童应用L和H进行预防性结核病化学治疗,治疗前和治疗后1、2、3个月末分别进行血常规和肝功能检查,观察其不良反应发生情况。结果(1)预防性治疗1个月不良反应发生率为7.0%(84/120),男女分别为7.2%(44/614)和6.8%(40/586),不同性别间差异无统计学意义(χ2=0.05, P>0.05)。其中,胃肠道反应1.2%(14/1200),肝功能异常2.8%(33/1200),白细胞下降3.1%(37/1200)。(2)预防性治疗2个月不良反应发生率为7.1%(34/482),男女分别为7.5%(19/254)和6.6%(15/228),不同性别间差异无统计学意义(χ2=0.15, P>0.05)。其中胃肠道反应0.6%(3/482),肝功能异常2.5%(12/482),白细胞下降3.9%(19/482)。(3)预防性治疗3个月不良反应发生率为6.2%(27/439),男女分别为7.0%(16/228)和5.2%(11/211),不同性别组差异无统计学意义(χ2=0.62, P>0.05)。其中肝功能异常1.4%(6/439),白细胞下降4.8%(21/439)。(4)预防性治疗月均不良反应发生率为6.8%(145/2121),男女分别为7.2%(79/1096)和6.4%(66/1025),不同性别组差异无统计学意义(χ2=0.49, P>0.05)。(5)6~15岁儿童不良反应发生率依次是11.6%(13/112)、9.1%(17/187)、7.2%(11/152)、5.4%(7/129)、6.7%(8/119)、3.3%(3/92)、7.1%(10/141)、7.1%(8/112)、5.7%(3/53)和3.9%(4/103),各年龄组之间不良反应发生率对比差异无统计学意义(χ2=7.86, P>0.05)。结论6~15岁儿童应用L和H方案进行预防性结核病化疗的不良反应发生率属正常反应水平,但在预防治疗期间须定期进行肝功能和血常规检查,以免发生过重反应。

Abstract: Objective To study the adverse reactions of 1200 children aged between 6-15 years old on rifapentine (L) and isoniazid (H) for TB preventive treatment.Methods A total of 1200 cases of children aged 6-15 at Xinmi from 2012—2014, whose tuberculin test were strongly positive, were selected. To observe the adverse reaction through the blood and liver function tests before and 1, 2 and 3 months after the treatment onset.Results (1) The adverse reaction incidence rate was 7.0% (84/120) in the first month, for boys and girls respectively 7.2% (44/614) and 6.8% (40/586), no significant difference (χ2=0.05, P>0.05). Among them 1.2% (14/1200) of gastrointestinal reactions, 2.8% (33/1200) of hepatic dysfunction, 3.1% (37/1200) of decreased white blood cell. (2) The adverse reaction incidence rate was 7.1% (34/482) in the second month, for boys and girls respectively 7.5% (19/254) and 6.6% (15/228), no significant difference (χ2=0.15, P>0.05). Among them 0.6% (3/482) of gastrointestinal reactions, 2.5% (12/482) of hepatic dysfunction, 3.9% (19/482) of decreased white blood cell. (3) The adverse reaction incidence rate was 6.2% (27/439) in the third month, for boys and girls respectively 7.2% (16/228) and 5.2% (11/211), no significant difference (χ2=0.62, P>0.05). Among them 1.4% (6/439) of hepatic dysfunction, 4.8% (21/439) of decreased white blood cell. (4) The average monthly incidence of adverse reactions was 6.8% (145/2121), 7.2% (79/1096) and 6.4% (66/1025) respectively for boys and girls, no significant difference (χ2=0.49, P>0.05). (5) Adverse reaction incidence in children aged 6-15 years old in turn was 11.6% (13/112), 9.1% (17/187), 7.2% (11/152), 5.4% (7/129), 6.7% (8/119), 3.3% (3/92), 7.1% (10/141), 7.1% (8/112), 5.7% (3/53) and 3.9% (4/103) respectively, there was no statistically significant difference in the incidence of adverse reactions by age (χ2=7.86, P>0.05).Conclusion The adverse reaction incidence rate of L+H regimen for preventive treatment for children aged between 6-15 years old are in normal level, but we need to perform periodic liver function and blood test during treatment so as to avoid severe reaction.