摘要
目的探究乙酰半胱氨酸辅助治疗初治肺结核的临床效果。方法前瞻性选取河南省胸科医院2022年1月至2024年6月予以针对性治疗的初治肺结核患者共215例为此次试验对象,经随机数字表法将其分成对照组和观察组,对照组107例采用抗结核HRZE治疗方案,观察组108例在对照组基础上联合乙酰半胱氨酸治疗,比较对照组和观察组患者的痰菌转阴率、病灶吸收和空洞情况、药物性肝损伤(DILI)发生情况、肝功能指标等。结果观察组治疗1、3、6个月后的痰菌转阴率[分别为60.19%(65/108)、82.41%(89/108)、95.37%(103/108)]均高于对照组[42.99%(46/107)、54.21%(58/107)、78.50%(84/107)],差异均有统计学意义(χ^(2)=6.363、19.769、13.498,均P<0.05)。末次随访时,观察组病灶总吸收率94.44%(102/108)高于对照组81.31%(87/107),观察组空洞缩小率95.37%(103/108)高于对照组85.05%(91/107),差异有统计学意义(χ^(2)=8.725、6.500,均P<0.05)。215例患者共有29例发生DILI(13.49%),观察组DILI发生率为8.33%(9/108),对照组DILI发生率为18.69%(20/107),观察组DILI的发生率低于对照组(Log-rank检验χ^(2)=5.282,P=0.022);对照组发生DILI的平均时长为67 d(95%CI:43.58~690.62),观察组发生DILI的平均时长为107 d(95%CI:75.17~139.06),对照组和观察组比较差异有统计学意义(t=-2.083,P=0.047)。治疗后,观察组的总胆红素、天冬氨酸氨基转移酶、γ谷氨酰转移酶、碱性磷酸酶、丙氨酸氨基转移酶[分别为(16.94±4.23)μmol/L、(36.92±8.60)U/L、(113.24±10.63)U/L、(165.23±7.33)U/L、(30.60±6.35)U/L]均低于对照组[(23.40±5.32)μmol/L、(58.71±11.16)U/L、(165.32±9.65)U/L、(170.31±7.64)U/L、(36.79±8.31)U/L],差异均有统计学意义(t=9.860、16.045、37.602、4.975、6.140,均P<0.001)。结论乙酰半胱氨酸辅助HRZE方案治疗初治肺结核具有良好的疗效,既能提升痰菌转阴率、病灶吸收及空洞缩小效果,又能通过保护肝细胞功能降低DILI风险,是一种安全且有效的联合治疗方案。
Objective To investigate the clinical efficacy of acetylcysteine as an adjunctive therapy in the treatment of newly diagnosed pulmonary tuberculosis.Methods A total of 215 patients with newly diagnosed pulmonary tuberculosis admitted to Henan Provincial Chest Hospital from January 2022 to June 2024 were prospectively selected as the study subjects and divided into two groups using a random number table method.The reference group(n=107)received the standard HRZE anti-tuberculosis treatment regimen(consisting of isoniazid,rifampin,pyrazinamide,and ethambutol),while the experimental group(n=108)received acetylcysteine in addition to the HRZE regimen.The sputum negative conversion rate,lesion absorption and cavity condition,incidence of drug-induced liver injury(DILI),and liver function indicators were compared between the two groups.Results The sputum negative conversion rates in the observation group at 1,3,and 6 months post-treatment(60.19%(65/108),82.41%(89/108),95.37%(103/108),respectively)were significantly higher than those in the control group(42.99%(46/107),54.21%(58/107),78.50%(84/107),respectively),with statistically significant differences(χ^(2)=6.363,19.769,13.498,all P<0.05).At the final follow-up,the total lesion absorption rate in the observation group was 94.44%(102/108),significantly higher than that in the control group(81.31%(87/107)),and the cavity reduction rate in the observation group was 95.37%(103/108),higher than that in the control group(85.05%(91/107)),with statistically significant differences(χ^(2)=8.725,6.500,both P<0.05).Among 215 patients,29 cases(13.49%)developed DILI.The incidence of DILI in the observation group was 8.33%(9/108),significantly lower than 18.69%(20/107)in the control group(Log-rank test:χ^(2)=5.282,P=0.022).The average time to DILI onset was 67 days(95%CI:43.58-690.62)in the control group and 107 days(95%CI:75.17-139.06)in the observation group,with a statistically significant difference between the two groups(t=-2.083,P=0.047).After treatment,the levels of total bilirubin,aspartate aminotransferase,γ-glutamyl transferase,alkaline phosphatase and alanine aminotransferase in the observation group((16.94±4.23)μmol/L,(36.92±8.60)U/L,(113.24±10.63)U/L,(165.23±7.33)U/L,(30.60±6.35)U/L,respectively)were lower than those in the control group((23.40±5.32)μmol/L,(58.71±11.16)U/L,(165.32±9.65)U/L,(170.31±7.64)U/L,and(36.79±8.31)U/L,respectively),with statistically significant differences(t=9.860,16.045,37.602,4.975,6.140,all P<0.001).Conclusion Acetylcysteine as an adjunctive therapy to the HRZE regimen for initial treatment of pulmonary tuberculosis demonstrates favorable efficacy.It not only improves the sputum negative conversion rate,promotes lesion absorption,and enhances cavity reduction,but also reduces the risk of DILI by protecting hepatocyte function.This combination represents a safe and effective treatment strategy.
作者
胡旭
段华鑫
王珂
王伟
曹莹
乔博
陈瑛
HU Xu;DUAN Huaxin;WANG Ke;WANG Wei;CAO Ying;QIAO Bo;CHEN Ying(Department of Tuberculosis Medicine,Henan Provincial Chest Hospital,Zhengzhou 450000,China;Department of InfectiousDiseases,Henan Provincial Chest Hospital,Zhengzhou 450000,China;Department of Clinical Laboratory,Henan ProvincialChest Hospital,Zhengzhou 450000,China)
出处
《中国药物应用与监测》
2025年第9期1507-1511,共5页
Chinese Journal of Drug Application and Monitoring
基金
2021年度河南省医学科技攻关计划联合共建项目(LHGJ20210232)。
关键词
乙酰半胱氨酸
肺结核
辅助治疗
肝细胞功能
临床对照研究
acetylcysteine
pulmonary tuberculosis
adjuvant therapy
hepatocyte function
clinical controlled study
