肺泰胶囊辅助治疗初治肺结核的临床研究

Combined use of Feitai capsule and antituberculosis agents in initial treatment of pulmonary tuberculosis

目的:评价肺泰胶囊联合抗结核西药治疗初治肺结核的临床疗效和安全性。方法:53例初治肺结核患行,随机分为试验组和对照组,38例试验组病例服用肺泰胶囊+2HL2Z／4HL2治疗6月,15例对照组病例服用安慰剂+2HL2Z／4HL2治疗6月,观察治疗2月末和6月末痰结核菌阴转X线胸片上病灶和空洞变化情况。结果:治疗2月未痰结核菌阴转率试验组为93．8％,对照组为42．9％,病灶显吸率试验组为50％,对照组为13．3％;治疗6月末两组痰菌阴转率均为100％,病灶全吸率试验组为42．1％,对照组为13．3％,空洞闭合率试验组为78．6％,对照组为28．6％。试验组均优于对照组,差异有显著性意义(P<0．05)。肺泰胶囊未见不良反应。结论:肺泰胶囊与抗结核西药联合治疗初治肺结核患者,能加速痰结核菌阴转和病灶吸收,提高空洞闭合率,是一种有效而安全的抗结核中药制剂。

To evaluate the clinical efficacy and safety of Feitai capsule and antituberculosis agents in initially treatment of pulmonary tuberculosis patients. Methods ：38 patients were administrated with Feitai capsule and antituberculosis agents for 6 months. 15 patients were treated with placebo and antituberculosis angents for 6 months. The changes were observed at 2 and 6 months after treatment, which were changes of sputum smear from positive to negative, lesions and cavities on radiography. Adverse drug reactions were observed during the whole treatment course. Results ： The duration of change in sputum tuberculosis smear from positive to negative was short and the absorption rates of lesions and cavities on radiography were greater in the group of Feitai capsule than those of the control group. No evident adverse drug reaction was found. Conclusion ： Feitai capsule is a kind of traditional Chinese medicine that accelerates the improvement of pulmonary tuberculosis patients at initial treatment stage as antituberculosis agent. It is effective and safe.