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目的评价国产抗结核FDC制剂化疗及管理的可行性。方法自2003年6月1日至2003年12月31日在深圳市6个区就诊的肺结核病人,按往年的病人分布、各个区的经济文化程度等将深圳市6个区分别划分为观察区(FDC制剂组,包括罗湖区、南山区和宝安区)和对照区(组合药组,包括福田区、盐田区和龙岗区)。对2组病人治疗期间的耐受性、管理效果、治疗效果、不良反应进行比较。结果(1)更多的FDC制剂组病人认为服药方式可以接受,药片大小合适,药片数适中(P<0.05);(2)2组完成治疗率接近(P>0.05),但FDC制剂组治愈率高于对照组(P<0.05);(3)不良反应无显著性差异(P>0.05);2组病人因肝损害停药率接近,分别为8.9%与5.4%,2组之间均无显著性差异(P>0.05);(4)更多的FDC制剂组督导管理医生认为发放药物的难度大、药品的量化管理困难、目前药物管治病人不方便、同时说不清能增加病人的依从性(P<0.05);(5)对照组药物的成本效果分析优于FDC制剂。结论国产FDC制剂可以改善病人的接受性,提高治愈率;但是由于制作工艺、技术和市场等多方面原因,医务人员的接受性和成本效果方面比组合药差,有待进一步改进。
Objective To evaluate the feasibility of chemotherapy and management of domestic anti-tuberculosis FDC preparations. Methods From June 1, 2003 to December 31, 2003, six tuberculosis patients in six districts of Shenzhen were divided into six observation areas according to the distribution of patients in previous years and the economic and cultural level of each district. (FDC preparation group including Luohu District, Nanshan District and Bao’an District) and control group (combination drug group including Futian District, Yantian District and Longgang District). To 2 groups of patients during treatment tolerance, management, treatment, adverse reactions were compared. The results showed that: (1) More patients in the FDC group were considered to be able to accept the medication, the tablets were of the right size, and the number of tablets was moderate (P <0.05); (2) The completed treatment rates of the two groups were close (P <0.05). There was no significant difference in adverse reactions between the two groups (P> 0.05). The stopping rates of liver damage in the two groups were close (8.9% vs 5.4%, respectively) There was no significant difference (P> 0.05); (4) more FDC preparation group supervision and management doctors think the difficulty of dispensing drugs, the quantitative management of drugs is difficult, the current drug management of patients inconvenient at the same time can not say can increase the patient (P <0.05). (5) The cost-effectiveness analysis of the control group was better than that of FDC. Conclusion Domestic FDC preparations can improve patient acceptance and improve cure rate. However, the acceptability and cost-effectiveness of medical staff are worse than those of combination medicines due to many factors, such as the production process, technology and market, which needs to be further improved.