关键词: 氨基糖苷类, 卷曲霉素, 结核, 抗多种药物性, 药物毒性, 药物评价

Abstract:

Objective To observe and compare the adverse drug reactions (ADR) of amikacin and capreomycin in treating multidrug resistant tuberculosis (MDR-TB) patients and their impact on therapeutic regimen, and to provide references for the selection of second-line injectable anti-tuberculosis agents in MDR-TB patients.Methods This study retrospectively analyzed the data of 112 MDR-TB patients who were diagnosed and received individualized treatment over 1 year in Xi’an Chest Hospital from January 2015 to December 2016. According to the used second-line injectable anti-tuberculosis agents, the patients were divided into two groups, Group amikacin (n=43) and Group capreomycin (n=69). The negative conversion rate of Mycobacterium tuberculosis sputum cultivation and lesions absorption rate at the end of 6 and 12 months after treatment, the incidence and severity of hearing loss, tinnitus, nephrotoxicity and hypokalemia, and the impact of these ADR on treatment were observed in the two groups.Results The negative conversion rate at the end of 6 months after treatment in the Group amikacin and Group capreomycin was 65.1% (28/43) and 82.6% (57/69), respectively; the difference was statistically significant (χ ²=4.43, P<0.05). The negative conversion rate in the two groups at the end of 12 months after treatment was 69.8% (30/43) and 82.6% (57/69), and the lesions absorption rate were 53.5% (23/43) and 60.9% (42/69) at the end of 6 months and 65.1% (28/43) and 71.0% (49/69) at the end of 12 months, respectively; however, the differences were not statistically significant (χ ² values were 2.52, 0.59 and 0.43, P values were >0.05). In the Group amikacin and Group capreomycin, the incidence of hearing loss was 20.9% (9/43) and 5.8% (4/69), and the incidence of hypokalemia was 4.7% (2/43) and 30.4% (21/69); the differences were statistically significant (χ ² values were 4.53 and 10.79, P values were <0.05). The incidence of tinnitus in the two groups was 46.5% (20/43) and 30.4% (21/69), and the incidence of nephrotoxicity was 4.7% (2/43) and 10.1% (7/69), respectively; the differences were not statistically significant (χ ² values were 2.95 and 1.08, P values were >0.05). The overall incidence of ADR in the two groups was 60.5% (26/43) and 53.6% (37/69), respectively, and the difference was not statistically significant (χ ²=0.50, P>0.05). There were no serious ADR in the two groups. The mild ADR in the patients with ADR accounted for 65.4% (17/26) and 81.1% (30/37), respectively, and the difference was not statistically significant (χ ²=1.99, P>0.05). The occurrence rate of drug discontinuation caused by ADR within 4 months was 20.9% (9/43) and 5.8% (4/69) in the Group amikacin and Group capreomycin, respectively, and the difference was statistically significant (χ ²=4.53, P<0.05).Conclusion The incidence of ADR of second-line injectable anti-tuberculosis agents is high. Considering the occurrence of ADR and the therapeutic efficacy, capreomycin is recommended in MDR-TB patients as a second-line injectable agent.

Key words: Aminoglycosides, Capreomycin, Tuberculosis, multidrug-resistant, Drug toxicity, Drug evaluation