中国临床药学杂志

目的 探讨低白蛋白血症对肺部感染患者替加环素血药浓度、临床疗效及不良反应的影响。方法 纳入60例肺部感染患者，根据入组时血清白蛋白水平分为低白蛋白血症组(n=29)和非低白蛋白血症组(n=31)。替加环素治疗达稳态后，通过LC-MS/MS法测定其总谷浓度(C_t,min)和游离谷浓度(C_f,min)。疗程结束时评估2组临床疗效和不良反应发生情况。比较2组C_t,min、C_f,min、临床有效率和不良反应发生率。结果 低白蛋白血症组的C_t,min、C_f,min分别为201.0(152.0,348.0)、171.0(123.0,303.0)ng·mL^-1，非低白蛋白血症组分别为241.0(155.0,297.0)、173.0(119.0,270.0)ng·mL^-1,2组间差异无统计学意义(P > 0.05)。然而低白蛋白血症组的临床有效率显著低于非低白蛋白血症组(55.2% vs 83.9%,P<0.05)。不良反应方面，低白蛋白血症组的碱性磷酸酶升高发生率(34.5% vs 12.9%)和纤维蛋白原降低发生率(48.3% vs 16.1%)均显著高于非低白蛋白血症组(P<0.05)，其他不良反应发生率的组间差异无统计学意义。结论 低白蛋白血症虽不影响替加环素的血药浓度，但会降低其临床疗效并增加不良反应风险。建议在低白蛋白血症患者中使用替加环素时，应加强血药浓度和血清白蛋白水平的监测，以提高治疗效果并减少不良反应。

AIM To investigate the impact of hypoalbuminemia on blood concentration, clinical efficacy, and adverse reactions of tigecycline(TGC) in patients with pulmonary infections. METHODS A total of 60 patients with pulmonary infections were enrolled and divided into a hypoalbuminemia group(n=29) and a non-hypoalbuminemia group(n=31) based on their serum albumin levels at enrollment. After tigecycline treatment reached a steady state, the total trough blood concentration(C_{t, min}) and free trough concentration(C_{f, min}) were measured by LC-MS/MS. The clinical efficacy and adverse drug reactions of patients in 2 groups were evaluated at the end of the course of treatment. The C_{t, min},C_{f, min} clinical efficacy rate and the incidence of adverse reactions were compared between 2 groups. RESULTS The C_{t, min} and C_{f, min} in the hypoalbuminemia group were 201.0(152.0, 348.0) ng·mL^-1, and 171.0(123.0, 303.0) ng·mL^-1, respectively, while in the non-hypoalbuminemia group, they were 241.0(155.0, 297.0) ng·mL^-1 and 173.0(119.0, 270.0) ng·mL^-1, respectively, with no statistically significant difference between 2 groups(P > 0.05). However, the clinical response rate in the hypoalbuminemia group(55.2%) was significantly lower than that in the non-hypoalbuminemia group(83.9%, P < 0.05). In terms of adverse reactions, the incidence of elevated alkaline phosphatase(34.5% vs 12.9%) and reduced fibrinogen(48.3% vs 16.1%) was significantly higher in the hypoalbuminemia group than in the nonhypoalbuminemia group(P < 0.05), with no significant differences in the incidence of other adverse reactions between 2 groups. CONCLUSION Although the blood concentration of tigecycline is not affected by hypoalbuminemia, it reduces clinical efficacy and increases the risk of adverse reactions. It is recommended to strengthen the monitoring of blood concentration and serum albumin levels in hypoalbuminemia patients using tigecycline to optimize treatment outcomes and reduce adverse reactions.