摘要
目的:探索炙甘草汤颗粒剂对含贝达喹啉方案治疗耐多药肺结核所致的心电图QT间期延长的影响。方法:选取2018年9月至2020年10月浙江大学医学院附属杭州市胸科医院使用含贝达喹啉方案治疗且符合入组标准的耐多药肺结核患者45例作为研究对象,根据随机数字表法分为中药组23例与对照组22例,中药组患者在含贝达喹啉方案治疗的第1个月联合服用炙甘草汤颗粒剂,对照组不服用该颗粒剂。监测并记录患者治疗前及治疗后的第2、4、8、12、16、20、24周心电图,同时计算QTcF值(根据Fridericia公式计算矫正后的QT间期)。结果:服用贝达喹啉的24周期间不良事件:中药组8例(8/23,34.8%)患者出现QTcF>450 ms,16例(16/23,69.6%)患者出现QTcF值较基线延长(ΔQTcF)≥30 ms;对照组16例(16/22,72.7%)患者出现QTcF>450 ms,20例(20/22,90.9%)患者出现ΔQTcF≥30 ms。严重不良事件:中药组1例(1/23,4.3%)患者出现QTcF≥500 ms,发生在用药第8周,4例(4/23,17.4%)患者出现ΔQTcF≥60 ms;对照组4例(4/22,18.2%)患者出现QTcF≥500 ms,分别发生在用药第4周(1例)、8周(1例)和24周(2例),11例(11/22,50.0%)患者出现ΔQTcF≥60 ms。中药组与对照组在不良事件QTcF>450 ms与严重不良事件ΔQTcF≥60 ms比较差异均有统计学意义(χ^(2)值分别为6.505和5.380,P值分别为0.011和0.020)。结论:含贝达喹啉方案治疗耐多药结核病可致患者QT间期延长,联合服用炙甘草汤颗粒剂可减少患者QTcF>450 ms和ΔQTcF≥60 ms的发生率。
Objective:To explore the effect of Roast Radix Glycyrrhizae Decoction Granules(RRGDG)on the prolongation of QT interval caused by the regimen containing bedaquiline in the treatment of multidrug-resistant pulmonary tuberculosis.Methods:From September 2018 to October 2020,45 patients with pulmonary tuberculosis who were treated with bedaquiline-containing regimen and met the inclusion criteria in Hangzhou Chest Hospital Affiliated to School of Medicine of Zhejiang University were selected as the research objects.They were randomly allocated into Traditional Chinese Medicine(TCM)group(23 cases)and control group(22 cases)using random number table.Patients in the TCM group were treated with RRGDG during the first month of the bedaquiline-containing anti-tuberculosis therapy,while the control group did not take RRGDG.ECGs were performed and recorded before the treatment and at 2,4,8,12,16,20 and 24 weeks after the treatment started,and QTcF values were calculated(the corrected QT intervals were calculated according to Fridericia formula).Results:During 24 weeks of bedaquiline administration,the adverse events were as follows:QTcF>450 ms in 8 patients(8/23,34.8%)and QTcF prolongation>30 ms comparing with baseline(ΔQTcF)in 16 patients(16/23,69.6%)in TCM group;QTcF value>450 ms in 16 patients(16/22,72.7%)andΔQTcF value≥30 ms in 20 patients(20/22,90.9%)in the control group.The serious adverse events were as follows:QTcF value≥500 ms in 1 case(1/23,4.3%),which occurred at the 8th week of treatment,andΔQTcF≥60 ms in 4 cases(4/23,17.4%)in the TCM group;QTcF value≥500 ms in 4 cases(4/22,18.2%),occurred at 4th(1 case),8th(1 case),and 24th(2 cases)week of treatment,respectively,andΔQTcF≥60 ms in 11 cases(11/22,50.0%)in the control group.There were significant differences between the TCM group and the control group in adverse event(QTcF>450 ms)incidence and serious adverse event(ΔQTcF≥60 ms)incidence(χ^(2) values were 6.505 and 5.380,P values were 0.011 and 0.020,respectively).Conclusion:The regimen containing bedaquiline in the treatment of multidrug-resistant tuberculosis could induce prolongation of QT intervals of patients.Combined use of RRGDG could reduce the incidence of QTcF>450 ms andΔQTcF≥60 ms.
作者
齐齐
蔡青山
崔岩飞
陈园园
鲍志坚
邱美华
郭意男
马晓卿
QI Qi;CAI Qing-shan;CUI Yan-fei;CHEN Yuan-yuan;BAO Zhi-jian;QIU Mei-hua;GUO Yi-nan;MA Xiao-qing(Tuberculosis Treatment Center,Affiliated to Hangzhou Chest Hospital,Zhejiang University School of Medicine,Hangzhou 310003,China)
出处
《中国防痨杂志》
CAS
CSCD
2022年第3期246-251,共6页
Chinese Journal of Antituberculosis
基金
国家自然科学基金青年科学基金项目(82104236)
杭州市医药卫生科技项目(A20200475)。
关键词
结核
肺
结核
抗多种药物性
炙甘草汤颗粒剂
贝达喹啉
药物评价
观察性研究
Tuberculosis,pulmonary
Tuberculosis,multidrug resistance
Roast Radix Glycyrrhizae Decoction Granules
Bedaquiline
Drug evaluation
Observational study
