伏立康唑注射剂治疗小儿真菌性肺炎的临床研究
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  • 英文篇名:Clinical trial of voriconazole injection in the treatment of fungal pneumonia in children
  • 作者:常会娟
  • 英文作者:CHANG Hui-juan;Department of Respiratory Medicine,Children's Hospital Affiliated to Zhengzhou University,Children's Hospital of Henan Province,Zhengzhou Children's Hospital;
  • 关键词:伏立康唑注射剂 ; 小儿 ; 真菌性肺炎 ; 安全性评价
  • 英文关键词:voriconazole injection;;pediatric;;fungal pneumonia;;safety evaluation
  • 中文刊名:GLYZ
  • 英文刊名:The Chinese Journal of Clinical Pharmacology
  • 机构:郑州大学附属儿童医院/河南省儿童医院/郑州儿童医院呼吸内科;
  • 出版日期:2019-07-28
  • 出版单位:中国临床药理学杂志
  • 年:2019
  • 期:v.35;No.292
  • 语种:中文;
  • 页:GLYZ201914001
  • 页数:3
  • CN:14
  • ISSN:11-2220/R
  • 分类号:5-7
摘要
目的观察伏立康唑注射剂治疗小儿真菌性肺炎的临床疗效和安全性,及其对患儿体内(1,3)-β-D葡聚糖水平的影响。方法将82例真菌性肺炎患儿随机分为对照组和试验组,每组41例。对照组予以降温和维持电解质平衡等常规治疗。试验组在对照组治疗的基础上,予以伏立康唑初始剂量6mg·kg~(-1),每12 h注射1次,24 h后根据患儿病情适当减量至4 mg·kg~(-1),每12h注射1次。2组患儿均治疗2周。比较2组患儿的临床疗效,(1,3)-β-D葡聚糖水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为90. 24%(37例/41例)和73. 17%(30例/41例),差异有统计学意义(P <0. 05)。治疗后,试验组和对照组的血浆(1,3)-β-D葡聚糖分别为(7. 65±2. 52)和(13. 23±5. 32) pg·mL~(-1),差异有统计学意义(P <0. 05)。2组患儿的药物不良反应均以精神萎靡、头痛、发热和胃肠道反应为主。试验组和对照组的总药物不良反应发生率分别为19. 51%和21. 95%,差异无统计学意义(P> 0. 05)。结论伏立康唑注射剂治疗小儿真菌性肺炎的临床疗效确切,其能显著地降低血浆(1,3)-β-D葡聚糖水平,且不增加药物不良反应的发生率。
        Objective To observe the clinical efficacy and safety of voriconazole injection in the treatment of fungal pneumonia in children,and its effect on the level of ( 1,3)-β-D glucan in children. Methods Eighty-two children with fungal pneumonia were randomly divided into control and treatment groups with 41 cases per group. Control group was treated with conventional treatment such as cooling and maintaining electrolyte balance. Treatment group was treated with voriconazole on the basis of control group. The initial dose of voriconazole was 6 mg·kg~(-1),and it was injected once every 12 h. After 24 h,it was appropriately reduced to 4 mg·kg~(-1) according to the condition of the child,and injected once every 12 h. Two groups were treated for 2 weeks. The clinical efficacy,( 1,3)-β-D glucan levels and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 90. 24%( 37 cases/41 cases) and 73. 17%( 30 cases/41 cases) with significant difference( P < 0. 05). After treatment,the plasma( 1,3)-β-D glucan of treatment and control groups were( 7. 65 ± 2. 52) and( 13. 23 ± 5. 32)pg·mL~(-1) with significant difference( P < 0. 05). The adverse drug reactions of two groups were mental malaise,headache,fever and gastrointestinal reactions. The total incidences of adverse drug reaction in the treatment and control groups were 19. 51% and 21. 95% without significant difference( P > 0. 05). Conclusion Voriconazole injection has a definitive clinical efficacy in the treatment of fungal pneumonia in children,which can effectively reduce plasma levels of( 1,3)-β-D glucan,without increasing the incidence of adverse drug reactions.
引文
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