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目的研究抗结核板式组合药治疗肺结核不良反应发生情况,为抗结核板式组合药在结核病临床应用提供资料。方法随机按2:1配比将487例初治涂阳肺结核患者分成板式药组332例和传统药组155例,观察两组患者治疗期间不良反应并进行比较。结果 487例肺结核患者不良反应发生率33.47%,板式药组、传统药组药物不良反应发生率分别为36.54%、27.10%,板式药组药物不良反应发生率、胃肠道不适发生率高于传统药组(P<0.05);强化期板式药组不良反应发生率为25.90%,老年患者中板式药组不良反应发生率53.62%,均高于传统药组,且差异有统计学意义(P<0.05);板式药物与传统抗结核药对肝损伤差异无统计学意义(P>0.05)。结论板式抗结核药物不良反应发生率要高于传统散装抗结核药,尤其是胃肠道副反应发生率,临床使用板式抗结核药物时应加强不良反应监测,特别是强化期老年服药患者。
Objective To study the incidence of tuberculosis (TB) adverse reactions in combination with anti-tuberculosis drugs and provide information for the clinical application of anti-tuberculosis drugs in tuberculosis. Methods A total of 487 newly diagnosed smear-positive pulmonary tuberculosis patients were divided into two groups according to the ratio of 2: 1: 332 cases of plate-shaped medicine group and 155 cases of traditional medicine group. The adverse reactions during the treatment period were observed and compared. Results The incidence of adverse reactions in 487 patients with pulmonary tuberculosis was 33.47%. The incidences of adverse drug reactions in plate-type drug group and traditional drug group were 36.54% and 27.10% respectively. The incidence of adverse drug reactions and gastrointestinal upset in plate-type drug group were higher than those in traditional (P <0.05). The incidence of adverse reactions in intensive phase plate therapy group was 25.90%, and the incidence of adverse reactions in middle-aged plate therapy group was 53.62%, which were significantly higher than those in traditional medicine group (P < 0.05). There was no significant difference between the plate-type drug and traditional anti-TB drug on liver injury (P> 0.05). Conclusions The incidence of adverse reactions of plate-type anti-tuberculosis drugs is higher than that of traditional bulk anti-TB drugs, especially gastrointestinal side effects. Adverse reaction monitoring should be strengthened when using plate-type anti-tuberculosis drugs clinically, especially in elderly patients in intensive phase.