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目的对抗结核固定剂量复合剂不同服药方式治疗新发肺结核的不良反应进行对比观察,为抗结核固定剂量复合剂的合理应用提供科学依据。方法对新发肺结核患者采取每日服药方式(每日组)和隔日服药方式(隔日组)进行治疗,每日组治疗方案为2HRZE/4HR,隔日组治疗方案为2H3R3Z3E3/4H3R3。对两组不良反应发生情况进行比较分析。结果抗结核固定剂量复合剂总体不良反应发生率每日组与隔日组比较,差异无统计学意义(χ~2=2.11,P>0.05)。不同年龄段不良反应发生率在青壮年两组间差异无统计学意义(χ~2=0.32,P>0.05),在老年隔日组大于每日组,差异有统计学意义(χ~2=4.53,P<0.05);不同性别不良反应发生率男性与女性两组间各自比较,差异均无统计学意义(χ~2=2.16、0.23,P>0.05);不同体质量不良反应发生率<50 kg两组间比较,隔日组大于每日组,差异有统计学意义(χ~2=4.29,P<0.05),而≥50 kg两组间比较,差异无统计学意义(χ~2=0.84,P>0.05)。实验室检测结果血常规异常、肝功能异常及肾功能异常发生率,两组间差异均无统计学意义(χ~2=0.56、0.06、0.60,P>0.05)。结论抗结核固定剂量复合剂隔日服药方式在老年和低体质量者不良反应发生率相对较高,因此对于老年患者和低体质量患者,推荐采取每日服药方式进行治疗。
OBJECTIVE To compare the adverse reactions of tuberculosis fixed dose combination with different medication methods in the treatment of newly diagnosed pulmonary tuberculosis and provide a scientific basis for rational use of fixed dose combination of tuberculosis. Methods The patients with newly diagnosed pulmonary tuberculosis were treated with daily medication (daily) and every other day (every other day). The daily treatment regimen was 2HRZE / 4HR, and the second day treatment was 2H3R3Z3E3 / 4H3R3. The two groups of adverse reactions were compared. Results There was no significant difference in the overall incidence of adverse reactions between the fixed-dose combination anti-TB and daily group (χ ~ 2 = 2.11, P> 0.05). The incidence of adverse reactions in different age groups was no significant difference between the two groups (χ ~ 2 = 0.32, P> 0.05), and the difference was statistically significant (χ ~ 2 = 4.53 , P <0.05). There was no significant difference between male and female in the incidence of ADR (χ ~ 2 = 2.16,0.23, P> 0.05). The incidence of ADR was <50 kg, the difference was statistically significant (χ ~ 2 = 4.29, P <0.05), while there was no significant difference between two groups (χ ~ 2 = 0.84 , P> 0.05). There was no significant difference between the two groups in laboratory test results (χ ~ 2 = 0.56,0.06,0.60, P> 0.05). Conclusion The incidence of adverse reactions of anti-tuberculosis fixed-dose combination in the elderly and low-body-weight medication every other day is relatively high, so it is recommended to take daily medication for elderly patients and patients with low body weight.