关键词: 结核, 抗多种药物性, 药物毒性, 药物治疗依从性, 治疗结果, 方案评价

Abstract:

Objective This study aims to analyze the adverse drug reactions and treatment outcomes of multidrug-resistant tuberculosis (MDR-TB) patients who received different chemotherapy regimens.Methods A prospective study was conducted from October 2009 to May 2014 in Anhui Provincial Chest Hospital. A total of 102 MDR-TB cases (including outpatients and inpatients) who met the inclusion criteria and received treatment were enrolled in this study. The cases were continuously and randomly assigned to regimen One (54 patients) and regimen Two (48 patients) group, according to their time of enrollment. Regimen One: 3Clr-Z-Am-Mfx+XY/3Clr-Z-Am3-Mfx+XY/12Clr-Z-Mfx+X, Regimen Two: 3Z-Am-Lfx+XY/3Z-Am3-Lfx+XY/18Z-Lfx+XY. In the regimens, Clr represented clarithromycin, Z represented pyrazinamide, Am represented amikacin, Lfx represented levofloxacin, Mfx represented moxifloxacin, and XY represented selecting two sensitive drugs according to the drug sensitivity test and drug tolerance results (could choose from protionamide (Pto), P-aminosalicylicacid (PAS), and ethambutol (E)). Adverse drug reactions and treatment outcomes of MDR-TB cases in the two groups were analyzed.Results The treatment success rates of the two regimens were 59.3% (32/54) and 64.6% (31/48), and there was no significant difference (χ ²=0.31, P=0.581). The adverse drug reactions rates of two treatment regimens were 66.7% (36/54) and 62.5% (30/48), and there was no significant difference (χ ²=0. 41,P=0.815). The top three adverse drug reactions for Regimen One were gastrointestinal reactions (41.7%, 15/36), simple uric acid increase (41.7%, 15/36) and blood system influence (25.0%, 9/36). And for the Regimen Two, the top three adverse drug reactions were gastrointestinal reactions (36.7%, 11/30), simple uric acid increase (33.3%, 10/30) and liver dysfunction (20.0%, 6/30). There were 12 (22.2%) patients in Regimen One and 3 (6.3%) patients in Regimen Two appeared QT interval prolongation. The difference between the two regimens was statistically significant (χ ²=3.97, P=0.046). In Regimen One, the treatment compliance rates between patients with (83.3% (30/36)) and without adverse reactions (88.9% (16/18)) were not statistically significant (χ ²=0.02, P=0.892). For the patients treated with Regimen Two, the treatment compliance rates of with and without adverse reactions was 83.3% (25/30) and 88.9% (16/18), respectively, with no statistically significant difference (χ ²=0.01, P=0.916). In Regimen One, there was no significant difference in the treatment success rate between patients with (55.6% (20/36)) and without adverse reactions (66.7% (12/18)) (χ ²=0.61, P=0.433); in Regimen Two, the difference in treatment success rate between the patients with adverse drug reactions (60.0% (18/30)) and without adverse drug reactions (72.2% (13/18)) was not statistically significant (χ ²=0.74,P=0.391). Conclusion The two treatment regimens achieved good results. And the treatment outcomes and compliance rates were not affected by adverse drug reactions.

Key words: Tuberculosis, multidrug-resistant, Drug toxicity, Medication adherence, Treatment outcome, Program evaluation