异烟肼片治疗结核性胸膜炎的临床研究  

Clinical trial of isoniazid tablets in the treatment of tuberculous pleurisy

作　　者：张力[1] 邵伟杰[1] 方晴[1] 朱育银[1] ZHANG Li;SHAO Wei-jie;FANG Qing;ZHU Yu-yin(Department of Lung,Ningbo No.2 Hospital,Ningbo 315000,Zhejiang Province,China)

机构地区：[1]宁波市第二医院肺科,浙江宁波315000

出　　处：《中国临床药理学杂志》2018年第15期1776-1778,共3页The Chinese Journal of Clinical Pharmacology

基　　金：国家科技重大专项资助项目(2013ZX10003009)

摘　　要：目的观察不同剂量异烟肼结核治疗方案用于复治结核性胸膜炎的临床疗效及安全性。方法将74例结核性胸膜炎患者随机分为对照组和试验组,每组37例。对照组的2个月强化期予以利福平每次0.45 g(体重<50 kg)或每次0.6 g(体重≥50 kg),qd,口服+吡嗪酰胺每次0.5 g,tid,口服+乙胺丁醇每次0.75 g,qd,口服+6 mg·kg^(-1)异烟肼,qd,口服;10个月巩固期予以利福平每次0.45 g(体重<50 kg)或每次0.6 g(体重≥50 kg),qd,口服+乙胺丁醇每次0.75g,qd,口服+6 mg·kg^(-1)异烟肼,qd,口服。试验组强化期予以异烟肼的剂量为16~20 mg·kg^(-1),qd,其余治疗方法与对照组相同。比较2组患者的临床疗效,干扰素-γ(INF-γ)、白细胞介素-2(IL-2)和IL-5的水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组治疗的总有效率分别为89.19%(33例/37例)和62.16%(23例/37例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的INF-γ分别为(212.52±81.71)和(402.75±109.45)pg·m L^(-1),IL-2分别为(23.17±12.95)和(58.18±14.87)pg·m L^(-1),IL-5分别为(314.63±101.06)和(474.63±112.12)pg·m L^(-1),差异均有统计学意义(均P<0.05)。2组患者发生的药物不良反应均以胃肠道反应和皮肤瘙痒为主。试验组和对照组的总药物不良反应发生率分别为8.11%和5.41%,差异无统计学意义(P>0.05)。结论高剂量异烟肼结核治疗方案用于结核性胸膜炎的临床疗效确切,且不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of different doses of isoniazid tablets in the treatment of tuberculous pleurisy.Methods A total of 74 patients with tuberculous pleurisy were randomly divided into control and treatment groups with 37 cases per group. In the control group,during the 2-month intensive period： rifampicin 0. 45 g per time（ body weight 50 kg） or 0. 6 g per time（ weight ≥ 50 kg）,qd,orally ＋ pyrazinamide 0. 5 g · d^（-1）,tid,orally ＋ ethambutanol0. 75 g·d,qd,orally ＋ 6 mg·kg^（-1） isoniazid,qd,orally,and during the 10-month consolidation period： rifampicin 0. 45 g per time（ body weight 50 kg） or 0. 6 g per time（ weight ≥ 50 kg）,qd,orally ＋ethambutanol 0. 75 g per time,qd,orally ＋ 6 mg·kg^（-1） isoniazid,qd,orally. The dosage of isoniazid in treatment group was 16-20 mg·kg^（-1）·d^（-1） during the intensive period,and the other dosage was the same as that of control group. The clinical efficacy,levels of interferon-γ（ INF-γ）,interleukin-2（ IL-2） and IL-5,and adverse drug reactions were compared between two groups. Results After treatment, the totaleffective rates of treatment and control groups were 89. 19%（ 33 cases/37 cases） and 62. 16%（ 23 cases/37 cases）with significant difference（ P 0. 05）. After treatment,the main indexes of treatment and control groups were compared： INF-γ were（ 212. 52 ± 81. 71） and（ 402. 75 ± 109. 45） pg · m L^（-1）,IL-2 were（ 23. 17 ± 12. 95） and（ 58. 18 ± 14. 87） pg·m L^（-1）,IL-5 were（ 314. 63 ± 101. 06） and（ 474. 63 ± 112. 12） pg·m L^（-1）,the differences were statistically significant（ all P 0. 05）. The adverse drug reactions of two groups were gastrointestinal reaction and pruritus. The total incidences of adverse drug reactions in treatment and control groups were 8. 11% and 5. 41%without significant difference（ P 0. 05）. Conclusion High-dose isoniazid tuberculosis therapy has a definitive clinical efficacy in the treatmen

关 键 词：异烟肼片 利福平片 吡嗪酰胺片 乙胺丁醇片 结核性胸膜炎 安全性 

分 类 号：R97[医药卫生—药品]