耐多药结核病患者环丝氨酸相关性药物不良反应的发生情况及其临床特征分析

Analysis of Occurrence and Clinical Characteristics of Cycloserine-related Adverse Drug Reactions in Patients with Multidrug-resistant Tuberculosis

目的:探讨耐多药结核病(multidrug-resistant tuberculosis,MDR-TB)患者环丝氨酸相关性药物不良反应(adverse drug reactions,ADRs)的发生情况及其临床特点,为临床MDR-TB患者环丝氨酸的用药安全提供参考。方法:选取2018年1月1日—2021年12月31日苏州市第五人民医院收治的182例MDR-TB患者作为研究对象,采集患者的年龄、性别、职业、结核病类型、治疗结局、环丝氨酸的使用情况及其相关ADRs的发生情况等信息,着重分析MDR-TB患者环丝氨酸相关性ADRs的发生情况和临床特点。结果:182例MDR-TB患者排除失访、死亡和未使用环丝氨酸的患者后仅剩167例,其中治疗成功的有134例,治疗成功率为80.24%;167例患者中,发生ADRs的有10例,发生率为5.99%;诺氏评估量表显示,10例ADRs与环丝氨酸的关联性评分均为5~8分,即关联性为“很可能”;10例ADRs的发生时间为用药后的4~361 d(中位数值为67.5 d),而其临床表现均为中枢神经毒性症状(如自杀倾向、精神错乱、重度失眠、焦虑、抑郁、嗜睡等);通过停用环丝氨酸或加大维生素B6用药量,10例患者的中枢神经毒性症状均缓解或消失。结论:含环丝氨酸抗结核治疗方案对MDR-TB患者的疗效较好,同时环丝氨酸相关性中枢神经毒性症状的发生率相对较低,但其症状表现较为严重,因此临床在对患者开展用药宣教时应交代明确,以保障患者的用药安全。

Objective:To explore the occurrence and clinical characteristics of cycloserine-related adverse drug reactions(ADRs) in patients with multidrug-resistant tuberculosis(MDR-TB),and provide reference for the clinical medication safety of cycloserine in patients with MDR-TB.Methods:182 MDR-TB patients admitted to the Fifth People's Hospital of Suzhou from January 1,2018 to December 31,2021 were selected as the research subjects,and the information such as patient's age,gender,occupation,tuberculosis type,treatment outcome,use of cycloserine,and occurrence of related ADRs was collected,focusing on analyzing the occurrence and clinical characteristics of cycloserinerelated ADRs in MDR-TB patients.Results:After excluding those who were lost to follow-up,died,and did not use cycloserine from 182 MDR-TB patients,there were only 167 cases.Among them,134 cases were successfully treated,with a treatment success rate of 80.24%;among 167 patients,ADRs occurred in 10 cases,with the incidence of 5.99%.The Naranjo's Assessment Scale showed that the correlation scores between 10 cases of ADRs and cycloserine were 5-8 points,i.e.the correlation was "very likely";the occurrence time of 10 cases of ADRs was 4 to 361 days(median:67.5days) after medication,and their clinical manifestations were the toxicity symptoms of central nerves(such as suicidal tendency,insanity,severe insomnia,anxiety,depression,lethargy,etc.).After cycloserine was discontinued or the dosage of vitamin B6 was increased,the toxicity symptoms of central nerves of 10 patients were relieved or disappeared.Conclusion:The cycloserine-based anti-tuberculosis treatment regimen has a good curative effect on MDR-TB patients;meanwhile,the incidence of cycloserine-related toxicity symptoms of central nerves is relatively low,but the symptoms are more serious.Therefore,clear instructions should be given during medication propaganda and education to patients to ensure the medication safety of patients.