不同剂型利福平血药浓度与疗效和安全性的相关性研究

Study on the correlation of therapeutic effect and safety of different dosage forms of rifampicin in blood concentration

目的前瞻性观察不同剂型利福平治疗过程中血药浓度与疗效和不良反应的相关性。方法将2022年7月-2022年12月于昆明市第三人民医院住院的活动性结核病患者,随机分为口服利福平组59例,注射利福平组64例,观察第7d 2组利福平血药浓度的差异;同时依据血药浓度分为<8mg/L、8~24mg/L、>24mg/L,观察利福平不同血药浓度与治疗效果、发生药物不良反应的相关性。结果注射组利福平血药浓度明显高于口服组,差异有统计学意义(P<0.05);利福平血药浓度>24mg/L时,注射组病灶吸收人数25例(52.1%)多于口服组14例(25.0%),注射组发生肝脏损害人数12例(21.4%)多于口服组4例(17.4%),差异有统计学意义(P<0.05)。结论注射利福平时血药浓度升高较快,血药浓度越高其病灶吸收效果越好,但肝脏损害的发生率也较高,应加强血药浓度的监测。

Objective To prospectively observe the correlation of blood concentration,therapeutic effect and adverse reactions in the therapeutic process of different dosage forms of rifampicin.Methods Active TB patients hospitalized in Kunming Third People s Hospital from July 2022 to December 2022 were randomly divided into oral rifampicin group(59 cases)and injection rifampicin group(64 cases).The difference blood concentration of rifampicin between the two groups was observed for seven days.At the same time,rifampicin was divided into<8mg/L,8-24mg/L and>24mg/L according to blood concentration,and the correlation of different blood concentrations of rifampicin,the therapeutic effect and the occurrence of adverse drug reactions was observed.Results The blood concentration of rifampicin in injection group was significantly higher than that in oral group,the difference was statistically significant(P<0.05).When the blood concentration of rifampicin was>24mg/L,the number of lesions absorbed in the injection group was 25 cases(52.1%)more than that in the oral group(14 cases,25.0%).12 cases(21.4%)occurred liver damage in the injection group and 4 cases(17.4%)more than that in the oral group,with statistical significance(P<0.05).Conclusions The higher the blood concentration of rifampicin,the better the lesion absorption effect is.However,the incidence of liver damage is also higher.Therefore,the monitoring of blood concentration of rifampicin should be strengthened.