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中华肺部疾病杂志(电子版)

中华肺部疾病杂志(电子版) ›› 2019, Vol. 12 ›› Issue (05) : 550 -554. doi: 10.3877/cma.j.issn.1674-6902.2019.05.003

论著

替加环素治疗重症肺炎不良反应分析
邵敏建1, 高蕾1, 钱倩2, 谈绮1, 黄茂1, 施毅3, 孙文逵1,†(), 戴山林1,†()   
  1. 1. 210029　南京，南京医科大学第一附属医院呼吸与危重症医学科
    2. 210029　南京，南京市胸科医院
    3. 210002　南京，东部战区总医院呼吸与危重症医学科
  • 收稿日期:2019-03-18 出版日期:2019-10-20
  • 通信作者: 孙文逵, 戴山林
  • 基金资助:
    国家自然科学基金资助项目(81770009，81500073，81800011); "六大人才高峰"资助项目(2015-WSN-086)

Adverse reactions of tigecycline in treatment of severe pneumonia

Minjian Shao1, Lei Gao1, Qian Qian2, Qi Tan1, Mao Huang1, Yi Shi3, Wenkui Sun1,†(), Shanlin Dai1,†()   

  1. 1. Department of Respiratory and Critical Care Medicine, First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China
    2. Nanjing Chest Hospital, Nanjing 210029, China
    3. Department of Respiratory and Critical Care Medicine, Eastern Theater General Hospital, Nanjing 210029, China
  • Received:2019-03-18 Published:2019-10-20
  • Corresponding author: Wenkui Sun, Shanlin Dai
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引用本文：

邵敏建, 高蕾, 钱倩, 谈绮, 黄茂, 施毅, 孙文逵, 戴山林. 替加环素治疗重症肺炎不良反应分析[J]. 中华肺部疾病杂志(电子版), 2019, 12(05): 550-554.

Minjian Shao, Lei Gao, Qian Qian, Qi Tan, Mao Huang, Yi Shi, Wenkui Sun, Shanlin Dai. Adverse reactions of tigecycline in treatment of severe pneumonia[J]. Chinese Journal of Lung Diseases(Electronic Edition), 2019, 12(05): 550-554.

目的

探讨替加环素治疗重症肺炎患者的不良反应和超说明书剂量用药对不良反应的影响。

方法

选择南京医科大学第一附属医院呼吸重症监护病房(RICU)2016年7月至2018年6月使用替加环素治疗的患者，根据替加环素用量分为推荐剂量组和超剂量组，收集两组患者的一般资料、临床特征以及实验室检查，进行分析统计。

结果

纳入患者100例，整体观察发现31(31.00%)例出现不良反应，其中皮疹1例，消化系统不适9例，肝功能损伤10例，药物性血小板减少10例，肝功能损伤合并血小板减少1例。推荐剂量组和超剂量组比较，FIB血浆浓度差异有统计学意义(P<0.05)，其余不良反应分析差异无统计学意义。在替加环素联合1种或2种抗菌药物共用时，不良反应发生率别为30.77%(24/78例次)和40.00%(8/20例次)，组间比较差异无统计学意义(P>0.05)。替加环素用药前后比较发现，凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)和凝血酶时间(TT)延长，纤维蛋白原(FIB)降低，尿素氮(BUN)升高，用药前后组间比较差异有统计学意义(P<0.05)。

结论

替加环素超剂量使用未明显增加不良反应。应用替加环素应关注肝肾功能损伤、血小板降低等不良反应，警惕药物对凝血系统的影响。

关键词: 替加环素, 不良反应, 重症肺炎, 超说明书用药
Objective

To investigate the adverse reactions of tigecycline in the treatment of severe pneumonia and the relationship between overdoses and adverse reaction rates.

Methods

The data of 100 patients with severe pneumonia receiving tigecycline in the Respiratory Intensive Care Unit (RICU) of the First Affiliated Hospital of Nanjing Medical University from July 2016 to June 2018 were analyzed retrospectively. The patients were divided into a recommended dose group (n=50) and an overdose group (n=50) according to the administration of tigecycline. The general information, clinical information and laboratory examination information were collected and statistically analyzed.

Results

Adverse reactions were observed in 31 cases (31.00%), including skin rash in 1 case, alimentary system reaction in 9, liver function damage in 10, thrombopenia in 10 and liver function damage complicated with thrombopenia in 1. Significant difference of fibrinogen (FIB) was found between the recommended dose group and the overdose group (P<0.05), however, no statistical significant difference was found between the two groups in the other adverse reactions. The incidences of adverse reactions were 30.77% (24/78 case-times) and 40.00% (8/20 case times), respectively, of all the tigecycline takers who were given one or two antibacterials at the same time, but there was no statistical significant difference between the two groups (P>0.05). Before and after use of tigecycline, significant differences were found in the prothrombin time (PT), the activated partial thromboplastin time (APTT), the thrombin time (TT), FIB and the blood urea nitrogen (BUN).

Conclusion

The incidence of adverse reactions was not significantly increased when taking overdose tigecycline. Special attention should be paid to the blood coagulation system, the liver and the renal function and the level of platelets when using tigecycline.

Key words: Tigecycline, Adverse drug reaction, Severe pneumonia, Off-label drug use
表1 替加环素与抗菌药物联用的不良反应[n(%)]
联合用药 例数 消化系统 肝功能损伤 血小板减少 皮疹
TGC+1种抗菌药物 78 7(8.97) 9(11.54) 8(10.26)  
TGC+2种抗菌药物 20 2(10.00) 2(10.00) 3(15.00) 1(5.00)
表2 两组患者不良反应[n(%)]
组　别 例数 胃肠道反应 血小板减少 肝功能损伤
推荐剂量组 21 0 3(14.29) 2(9.52)
超剂量组 79 9(11.39) 8(10.13) 9(11.39)
χ2值   1.42 0.22 0.00
P值   0.23 0.88 1.00
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