| 阿米卡星和卷曲霉素在耐多药结核病治疗中不良反应的观察及对比分析 |
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| 引用本文： | 任斐,许优,党丽云,武延琴,马进宝,郑思思. 阿米卡星和卷曲霉素在耐多药结核病治疗中不良反应的观察及对比分析[J]. 中国防痨杂志, 2018, 40(8): 815-820. DOI: 10.3969/j.issn.1000-6621.2018.08.008 |
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| 作者姓名： | 任斐 许优 党丽云 武延琴 马进宝 郑思思 |
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| 作者单位： | 710100.西安市胸科医院 |
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| 基金项目： | 陕西省2016年度科学技术研究发展计划项目(2016sf-032) |
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| 摘 要： | 目的 对阿米卡星和卷曲霉素在耐多药结核病(MDR-TB)治疗过程的不良反应及对治疗的影响进行观察并进行对比分析,为注射类二线抗结核药物的选择提供参考依据。方法 回顾性分析2015年1月至2016年12月西安市胸科医院确诊并使用个体化治疗方案治疗满1年的MDR-TB患者112例,根据二线注射类抗结核药物的使用情况分为阿米卡星组(43例)和卷曲霉素组(69例),观察两组患者在治疗后6个月末及12个月末痰菌阴转率和病变吸收好转率,两组患者听力下降、耳鸣、肾损伤、低钾血症的发生率和严重程度,以及不良反应对治疗的影响。结果 阿米卡星和卷曲霉素两组患者治疗后的6个月末痰培养阴转率分别为65.1%(28/43)和82.6%(57/69),差异有统计学意义(χ 2=4.43,P<0.05);12个月末痰培养阴转率分别为69.8%(30/43)和82.6%(57/69),6个月末、12个月末病变吸收好转率分别为53.5%(23/43)和60.9%(42/69),65.1%(28/43)和71.0%(49/69),差异均无统计学意义(χ 2值分别为2.52、0.59、0.43,P值均>0.05)。阿米卡星和卷曲霉素两组患者听力下降的发生率分别为20.9%(9/43)和5.8%(4/69)、低钾血症发生率分别为4.7%(2/43)和30.4%(21/69),差异均有统计学意义(χ 2值分别为4.53、10.79,P值均<0.05);耳鸣发生率分别为46.5%(20/43)和30.4%(21/69),肾损伤发生率分别为4.7%(2/43)和 10.1%(7/69),差异均无统计学意义(χ 2值分别为2.95、1.08,P值均>0.05)。两组患者不良反应发生率分别为60.5%(26/43)和53.6%(37/69),差异无统计学意义(χ 2=0.50,P>0.05)。两组均无重度不良反应,出现不良反应的患者轻度不良反应分别占65.4%(17/26)和81.1%(30/37),差异无统计学意义(χ 2=1.99,P>0.05)。阿米卡星组和卷曲霉素组4个月内不良反应导致药物停用的发生率分别为20.9%(9/43)和5.8%(4/69),差异有统计学意义(χ 2=4.53,P<0.05)。结论 二线注射类抗结核药物的不良反应发生率较高,从不良反应及治疗效果方面考虑,MDR-TB的治疗中建议优先选择卷曲霉素。
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| 关 键 词： | 氨基糖苷类 卷曲霉素 结核 抗多种药物性 药物毒性 药物评价 |
| 收稿时间： | 2018-04-22 |
Observation and comparative analysis on the adverse drug reactions of amikacin and capreomycin in treating multidrug resistant tuberculosis patients |
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| Fei REN,You XU,Li-yun DANG,Yan-qin WU,Jin-bao MA,Si-si. ZHENG. Observation and comparative analysis on the adverse drug reactions of amikacin and capreomycin in treating multidrug resistant tuberculosis patients[J]. The Journal of The Chinese Antituberculosis Association, 2018, 40(8): 815-820. DOI: 10.3969/j.issn.1000-6621.2018.08.008 |
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| Authors: | Fei REN You XU Li-yun DANG Yan-qin WU Jin-bao MA Si-si. ZHENG |
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| Affiliation: | Xi’an Chest Hospital,Xi’an 710100, China |
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| Abstract: | Objective To observe and compare the adverse drug reactions (ADR) of amikacin and capreomycin in treating multidrug resistant tuberculosis (MDR-TB) patients and their impact on therapeutic regimen, and to provide references for the selection of second-line injectable anti-tuberculosis agents in MDR-TB patients.Methods This study retrospectively analyzed the data of 112 MDR-TB patients who were diagnosed and received individualized treatment over 1 year in Xi’an Chest Hospital from January 2015 to December 2016. According to the used second-line injectable anti-tuberculosis agents, the patients were divided into two groups, Group amikacin (n=43) and Group capreomycin (n=69). The negative conversion rate of Mycobacterium tuberculosis sputum cultivation and lesions absorption rate at the end of 6 and 12 months after treatment, the incidence and severity of hearing loss, tinnitus, nephrotoxicity and hypokalemia, and the impact of these ADR on treatment were observed in the two groups.Results The negative conversion rate at the end of 6 months after treatment in the Group amikacin and Group capreomycin was 65.1% (28/43) and 82.6% (57/69), respectively; the difference was statistically significant (χ 2=4.43, P<0.05). The negative conversion rate in the two groups at the end of 12 months after treatment was 69.8% (30/43) and 82.6% (57/69), and the lesions absorption rate were 53.5% (23/43) and 60.9% (42/69) at the end of 6 months and 65.1% (28/43) and 71.0% (49/69) at the end of 12 months, respectively; however, the differences were not statistically significant (χ 2 values were 2.52, 0.59 and 0.43, P values were >0.05). In the Group amikacin and Group capreomycin, the incidence of hearing loss was 20.9% (9/43) and 5.8% (4/69), and the incidence of hypokalemia was 4.7% (2/43) and 30.4% (21/69); the differences were statistically significant (χ 2 values were 4.53 and 10.79, P values were <0.05). The incidence of tinnitus in the two groups was 46.5% (20/43) and 30.4% (21/69), and the incidence of nephrotoxicity was 4.7% (2/43) and 10.1% (7/69), respectively; the differences were not statistically significant (χ 2 values were 2.95 and 1.08, P values were >0.05). The overall incidence of ADR in the two groups was 60.5% (26/43) and 53.6% (37/69), respectively, and the difference was not statistically significant (χ 2=0.50, P>0.05). There were no serious ADR in the two groups. The mild ADR in the patients with ADR accounted for 65.4% (17/26) and 81.1% (30/37), respectively, and the difference was not statistically significant (χ 2=1.99, P>0.05). The occurrence rate of drug discontinuation caused by ADR within 4 months was 20.9% (9/43) and 5.8% (4/69) in the Group amikacin and Group capreomycin, respectively, and the difference was statistically significant (χ 2=4.53, P<0.05).Conclusion The incidence of ADR of second-line injectable anti-tuberculosis agents is high. Considering the occurrence of ADR and the therapeutic efficacy, capreomycin is recommended in MDR-TB patients as a second-line injectable agent. |
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| Keywords: | Aminoglycosides Capreomycin Tuberculosis multidrug-resistant Drug toxicity Drug evaluation |
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