补肺活血胶囊辅助治疗初治肺结核82例临床观察

Clinical Observation on 82 Cases of Initial Pulmonary Tuberculosis by Adjuvant Treatment of Bufei Huoxue Capsule( 补肺活血胶囊)

目的评价补肺活血胶囊联合西药化疗治疗初治肺结核的疗效和安全性。方法 180例初治肺结核患者随机分为治疗组和对照组各90例。对照组单用标准化疗方案,治疗组采用标准化疗方案(2HREZ/4HR)联合补肺活血胶囊,疗程均为6个月,计算两组治疗3个月及治疗6个月后的临床症状疗效指数,观察两组治疗6个月后的细菌阴转情况和X线疗效,观察不良反应。结果治疗组最终纳入统计学分析82例,对照组纳入85例。治疗组在治疗3个月和6个月的疗效指数均高于对照组(P<0.01)。治疗6个月后两组的细菌转阴率(痰涂片及痰培养)差异无统计学意义(P>0.05);治疗组病灶明显吸收7例,吸收43例,不变16例,恶化16例,总吸收率为61.0%;对照组病灶明显吸收6例,吸收28例,不变30例,恶化21例,总吸收率40.0%,治疗组优于对照组(P<0.05);两组X线空洞闭合变化、空洞闭合率方面差异无统计学意义(P>0.05)。两组治疗过程中均未见不良反应。结论补肺活血胶囊可以用于初治肺结核的辅助治疗,在改善临床症状、促进病灶吸收方面有明确疗效,且无副作用。

Objective To evaluate the efficacy and safety of Bufei Huoxue Capsule（ 补肺活血胶囊） combined with chemotherapy for new patients with initial pulmonary tuberculosis（ TB）. Methods A total of 180 new cases with pulmonary tuberculosis were randomized divided into treatment group（ 90 cases） and control group（ 90 cases）.Standard chemotherapy（ 2 HREZ/4 HR） combined with Bufei Huoxue Capsule was used in treatment group,and standard chemotherapy（ 2 HREZ/4 HR） only was used in control group,both for continuously 6 months. Index of efficacy for symptoms improvement of both groups were calculated in the end of 3 rd and 6 th month after the treatment. Rates of negative conversion of bacteria,efficacy of X-rays of both groups after 6 months treatment,and the adverse reaction were recorded. Results A total of 82 cases in treatment group and 85 cases in control group finally completed the treatment. The therapeutic index in the treatment group was higher than those of the control group after 3 and 6 months of the treatment（ P 〈 0. 01）. The difference of negative conversion rate of bacteria（ including sputum smear and sputum culture） between both groups after 6 months of treatment has no statistical significance（ P 〉 0. 05）.There were 7 cases of obvious absorption,43 cases of absorption,16 cases without obvious changes,16 cases of deterioration and 61. 0% of total absorptance in treatment group,corresponding as 6 cases,28 cases,30 cases,21 cases and 40. 0% in control group. The results in the treatment group were better than those of control group（ P 〈 0. 05）.However,differences of the changes of conversion-ray closure and closure rate between 2 groups were not statistically significant（ P 〉 0. 05）. There was no adverse reaction in both groups. Conclusion Bufei Huoxue Capsule can effectively and safely alleviate the symptoms of TB patients,and also can improve the rate of focus absorption.