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目的了解天津市试点推行FDC的治疗管理效果、不良反应发生情况。方法回顾分析使用FDC的培阳肺结核患者216例、使用散药的培阳肺结核患者249例,比较2组患者治疗管理转归及不良反应发生情况。结果散药组和FDC组在2月痰培养阴转率分别为85.1%和90.1%,在疗程末痰培养阴转率分别为89.1%和96.4%,差异均无统计学意义(P>0.05)。散药组的丢失或迁出率21.7%,高于FDC组的11.1%(P<0.05)。在完成治疗的病例中,散药组的治疗成功率为90.8%,FDC组为91.7%,差异无统计学意义(P>0.05)。导致方案更改的不良反应发生率在散药组为10.4%,FDC组为11.6%,差异无统计学意义(P>0.05)。FDC组尿酸异常发生率低于散药组(P<0.05),其余不良反应2组间差异无统计学意义。FDC组患者,其异福酰胺、异福片、RFP、INH、PZA、EMB的使用量(月*人)比为1︰1.2︰0.4︰0.4︰0.3︰1.6。结论抗结核FDC的治疗效果和不良反应与散药相比无差异,但在管理上优于散药;在推行FDC时,仍然还需注意散药的储备。
Objective To understand the effect of trial management of FDC in Tianjin and its adverse reactions. Methods Two hundred and sixty-six patients with positive pulmonary tuberculosis treated with FDC were retrospectively analyzed. Among them, 249 were positive control pulmonary tuberculosis patients treated with FDC. The outcome of treatment management and adverse reactions in two groups were compared. Results The negative conversion rates of sputum culture in both groups were 85.1% and 90.1% in February and 89.1% and 96.4% in sputum culture at the end of treatment, respectively, with no significant difference (P> 0.05) . The casualty group lost or migrated 21.7%, up from 11.1% in the FDC group (P <0.05). Among the completed cases, the success rate was 90.8% for the bulk drug group and 91.7% for the FDC group, with no significant difference (P> 0.05). The incidence of adverse reactions that led to the change of the protocol was 10.4% in the group of randomized injection and 11.6% in the FDC group, with no significant difference (P> 0.05). The incidence of uric acid abnormality in FDC group was lower than that in bulk drug group (P <0.05), and there was no significant difference in other adverse reactions between the two groups. FDC patients, the amount of isofosfamide, bifuofen, RFP, INH, PZA, EMB usage (month * person) ratio of 1: 1.2: 0.4: 0.4: 0.3: 1.6. Conclusion The anti-tuberculosis FDC has no difference in treatment and adverse reactions compared with bulk medicine, but it is superior to bulk medicine in management. In the implementation of FDC, the reserve of bulk medicine still needs attention.