摘要
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 assess the advantages and disadvantages of FDC in chemotherapy and management in anti-tuberculosis therapy. Methods Six districts in Shenzhen city were allocated into two groups： FDC treatment group and controlled group according to the distribution of patients and economic - culture level. From Aug. 1, 2003 to Dec. 31, 2003, 373 new smear positive pulmonary tuberculosis patients were enrolled and allocated to two groups according to their treatment convenience. Results （1） Compared with controlled group, less patients in treatment group complained about the manner of taking medicine, the size and quantity of pills （ P〈0.05）. （2）The rates of complement treatment were nearly similar in two groups, but the cure rate in treatment group was higher than that of controlled group. （3）There was no significant difference of adverse reactions between two groups . Stopping treatment rates because of liver damage in two groups were similar （8.9% and 5.4% respectively, P 〉 0.05） ; （4） More supervision doctors in treatment group felt inconvenience in pills distribution, quantity management of pills and patients supervision. In their viewpoint, there was almost no advantage in increasing patients＇ adherence （ P 〈 0.05）. （5） The cost-effective of the controlled group showed a remarkable advantage over FDC. Conclusions FDC can improve the patients＇ compliance and cure rate of chemotherapy, but acceptability of doctors and cost - effective analysis are inferior to controlled group due to manufacture technique, market and some other factors.
出处
《中国防痨杂志》
CAS
2005年第4期209-214,共6页
Chinese Journal of Antituberculosis
