关键词: 结核,肺/药物疗法, 对照研究

Abstract: Objective To assess the advantages and disadvantages of FDC in chemotherapy and management in anti-tuberculosis therapy. MethodsSix 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. ConclusionsFDC 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.

Key words: Pulmonary tuberculosis/drug therapy, controlled study