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目的研究肺泰胶囊辅助治疗初治涂阳肺结核的疗效及安全性。方法采用前瞻性对照研究对2006年6月—2007年6月期间符合入选标准的初治涂阳肺结核120例,治疗组标化方案联合肺泰胶囊,对照组单用标化方案。记录治疗前、疗程2个月末、6个月末的疗效指数、X线胸片、痰菌、空洞的变化及不良反应。结果 (1)治疗组及对照组分别有57例、55例完成该试验;(2)治疗组在疗程2个月末、6个月末的疗效指数高于对照组,t值分别为2.13、2.32,P<0.05;治疗组的X线胸片病灶吸收率、痰菌阴转率、6个月末的空洞闭合率均高于对照组,P值均<0.05;(3)口服肺泰胶囊的不良反应发生率仅5.3%(3/57)。结论肺泰胶囊可有效缓解肺结核病人的临床症状,可辅助标化方案提高病灶的吸收率、空洞的闭合率及痰菌的阴转率,且长期口服安全性较高。
Objective To study the efficacy and safety of Fei Tai Capsule in adjuvant treatment of smear-positive pulmonary tuberculosis. Methods A prospective controlled study was conducted on 120 newly diagnosed smear-positive pulmonary tuberculosis patients who met the inclusion criteria between June 2006 and June 2007. The standardization regimen of the treatment group was combined with the lung-Tai capsule and the control group was given a single standardization regimen. Record before treatment, the end of 2 months of treatment, the end of 6 months index of efficacy, X-ray, sputum, empty changes and adverse reactions. Results (1) There were 57 cases in the treatment group and 55 cases in the control group respectively. (2) The curative effect index of the treatment group at the end of 2 months and the end of 6 months was higher than that of the control group (t = 2.13, 2.32, (P <0.05). The absorption rate of the X-ray, the negative conversion rate of sputum and the void closure rate at the end of 6 months in the treatment group were all higher than those in the control group (P <0.05). (3) Adverse reactions The incidence was only 5.3% (3/57). Conclusion Fei Tai Capsule can effectively relieve the clinical symptoms of patients with pulmonary tuberculosis, and can assist the standardization program to improve the absorption rate of the lesion, empty closed rate and negative conversion rate of sputum bacteria, and long-term oral safety is high.