芪甲利肺胶囊辅助治疗初治肺结核的回顾性分析研究

目的 回顾性分析芪甲利肺胶囊辅助治疗初治肺结核患者的临床疗效。 方法 选取2012年7月至2013年7月在上海市肺科医院接受抗结核化学治疗2S（E）HRZ/4HR并辅以芪甲利肺胶囊抗结核治疗的初治肺结核患者128例，作为治疗组；并以同期112例仅使用抗结核化学治疗2S（E）HRZ/4HR的初治肺结核患者作为对照组。收集整理两组患者抗结核治疗疗程结束前后痰菌涂片和培养结果、影像学资料，对中医证候轻重进行分级评分。使用SAS 9.2软件采用χ^2验和秩和检验对比分析两组患者治疗前后痰涂片及培养阳性结果变化情况、影像学疗效、病灶吸收程度、空洞变化情况、停止抗结核西药后患者病灶继续吸收的情况、中医证候疗效情况，P〈0.05为差异有统计学意义。 结果 疗程结束时治疗组47例涂阳患者中痰菌阴转41例（87.2%），56例培养阳性患者中痰菌阴转47例（83.9%）；对照组41例涂阳患者中痰菌阴转36例（87.8%），49例培养阳性患者中痰菌阴转42例（85.7%），两组比较差异均无统计学意义（χ^20.007，P=0.936；χ^20.065，P=0.800）。治疗组128例患者病灶吸收程度［显著吸收10例（7.8%），吸收64例（50.0%），不变27例（21.1%），恶化27例（21.1%）］与对照组［显著吸收8例（7.1%），吸收35例（31.3%），不变40例（35.7%），恶化29例（25.9%）］相比差异有统计学意义（Z=―2.290，P=0.022），其中治疗组病灶吸收率57.8%（74/128）高于对照组38.4%（43/112）（χ^28.979，P=0.003）。治疗组（33例）和对照组（25例）患者中空洞闭合、缩小、不变和增大分别为16（48.5%）、9（27.3%）、5（15.1%）、3（9.1%）例和12（48.0%）、8（32.0%）、3（12.0%）、2（8.0%）例，两组比较差异无统计学意义（Z=―0.110，P=0.912）。在停止抗结核西药治疗后3个月时，治疗组患者病灶继续吸收率（41.9%，31/74）高于对照组（23.3%，10/43）（χ^24.150，P=0.042）；停药后6个月时治疗组患者病灶吸收者11例（14.9%，11/74），高于对照组的3例（7.0%，3/43），但两组比较差异无统计学意义（χ^21.606，P=0.205）。治疗组与对照组中医证候疗效差异有统计学意义（Z=-2.723，P=0.006），治疗组中医症候疗效总有效率（90.6%，116/128；其中治愈59例、显效38例、有效19例）高于对照组（81.3%，91/112；其中治愈38例，显效27例，有效26例）（χ^24.427，P=0.035）。 结论 芪甲利肺胶囊辅助治疗肺结核尤其是在中医证候改善及肺部病灶吸收上有一定的疗效。

A retrospective analysis of QIJIALIFEIJIAONANG in treatment of new pulmonary tuberculosis as adjuvant therapy

Objective To analyze the clinical effect of Chinese medicine QIJIALIFEIJIAONANG in treatment of new pulmonary tuberculosis （PTB） as adjuvant therapy retrospectively. Methods One hundred and twenty-eight new PTB patients who received standard treatment regimen of 2S（E）HRZ/4HR and QIJIALIFEIJIAONANG as adjuvant therapy in Shanghai Pulmonary Hospital from July 2012 to July 2013 were enrolled as the treatment group, and 112 cases of new PTB patients only treated by the standard regimen were enrolled as controls. Their sputum smear and culture outcome, imaging data, the grading score of traditional Chinese medicine （TCM） syndromes before and after treatment were recorded and analyzed statistically. The change of positive smear and culture outcome, effect on imaging, foci absorption, the change of cavity before and after treatment, and foci absorption and effect on TCM syndromes after anti-TB drugs were compared between the two groups, P〈0.05 was considered statistically significant. Results At the end of treatment, the sputum smear negative conversion rate and sputum culture negative conversion rate of treatment group were 87.2% （41/47） and 83.9% （47/56）, and those of control group were 87.8% （36/41） and 85.7%（42/49）. The both differences of the two groups were not statistically significant （χ^20.007, P=0.936; χ^20.065, P=0.800）. The foci absorption degrees of 128 cases in the treatment group were as follows： 10 cases （7.8%） showed significant absorption, 64 cases （50.0%） absorption, 27 cases （21.1%） no change, 27 cases aggravation （21.1%）, those for control group were 8 cases （7.1%） significant absorption, 35 cases （31.3%） absorption, 40 cases （35.7%） no change and 29 cases （25.9%） aggravation. The differences between the two groups were statistically significant （Z=―2.290, P=0.022）.The foci absorption rate was significantly higher in treatment group （57.8%, 74/128） than the control group （38.4%, 43/112） （χ^28.979, P=0.003）. The numbers of case with cavity closure, narrowing, no change and widening in treatment group were 16 （48.5%）, 9（27.3%）, 5 （15.1%） and 3（9.1%）, and those for control group were 12 （48.0%）, 8（32.0%）, 3（12.0%） and 2（8.0%）. There was no significant difference of cavity changing in imaging between the two groups （Z=-0.110, P=0.912）. There were more cases with continual foci absorption in the treatment group （31/74, 41.9%） than control group （10/43, 23.3%） 3 months after the end of the treatment （χ^24.150,P=0.042）. There were 11 cases （14.9%） with foci absorption in treatment group, and 3 cases （7.0%） in control group 6 months after the end of the treatment, there was no significant difference between the two groups （χ^21.606, P=0.205）. There was significantly better effect in improving TCM syndromes in the treatment group than control group（Z=-2.723, P=0.006）. The overall effective rate for TCM syndromes in treatment group was 90.6% （116/128）, which was significantly higher than that in control group （81.3%,91/112） （χ^24.427, P=0.035）. Conclusion The QIJIALIFEIJIAONANG is effective in treating tuberculosis as adjuvant therapy, especially in improving TCM syndromes and the foci absorption in lungs.