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目的研究国产4联固定剂量复合剂(FDC)治疗肺结核不良反应发生情况,为FDC在结核病治疗中的应用提供依据。方法在湛江市6个县区选择540例初治涂阳肺结核病人,采用简单随机分组方法分为研究组和对照组,分别采用FDC与抗结核板式组合药进行治疗,观察2组病人临床不良反应的发生情况。结果研究组与对照组的不良反应发生率分别为21.5%(58/270)和20.0%(54/270),差异无统计学意义(P>0.05);2组的老年组不良反应发生率均高于青壮年组(均P<0.05);低体重组(30～37kg)中对照组的不良反应发生率高于研究组(P<0.05);研究组不同体重组之间不良反应发生率比较差异无统计学意义(P>0.05),而对照组的不良反应发生率随体重增加而降低(P<0.01)。在治疗观察过程中研究组和对照组分别有8、1例因药物严重不良反应停药。结论国产4联FDC与板式组合药不良反应发生率相接近,且4联FDC具有按体重服药的优势,但在应用中应注意对严重不良反应的观察。
Objective To study the incidence of tuberculosis adverse reactions induced by domestic 4-dose fixed-dose combination (FDC) in order to provide basis for the application of FDC in the treatment of tuberculosis. Methods 540 cases of newly diagnosed smear positive pulmonary tuberculosis patients were selected from 6 counties in Zhanjiang City. The patients were divided into study group and control group by simple randomized method. FDC and anti-TB plate combination drugs were used respectively for treatment. Clinical adverse reactions The occurrence of. Results The incidences of adverse reactions in study group and control group were 21.5% (58/270) and 20.0% (54/270) respectively, with no significant difference (P> 0.05). The incidence of adverse reactions in the two groups was (P <0.05). The adverse reaction rate of the control group in the low body weight group (30 ~ 37kg) was higher than that in the study group (P <0.05). The incidence of adverse reactions in the different body weight groups in the study group The difference was not statistically significant (P> 0.05), while the incidence of adverse reactions in the control group decreased with weight gain (P <0.01). In the course of treatment observation, there were 8 and 1 cases in study group and control group, respectively, because of serious adverse drug reactions. Conclusion The incidence of adverse reactions of domestic 4-FDC and plate-based combination is similar, and 4-FDC has the advantage of taking medicine according to body weight. However, serious adverse reactions should be observed in the application.