芪甲利肺胶囊治疗复治肺结核患者的疗效观察

Observation on the Clinical Efficacy of the QIJIALIFEIJIAONANG for the Retreatment Pulmonary Tuberculosis

目的评价芪甲利肺胶囊治疗复治肺结核的临床疗效。方法将2012年1月至2014年10月在首都医科大学附属北京胸科医院住院的复治肺结核患者109例，随机分为研究组（化疗加芪甲利肺胶囊组，53例）和对照组（单纯化疗组，56例）。观察治疗前及治疗后2个月、5个月和8个月的临床疗效、症状改善及免疫功能变化。结果研究组治疗2个月和5个月后痰涂片的转阴率分别为50．0％（28／56），53．6％（30／56），明显高于对照组的30．2％（16／53），34．0％（18／53），差异有统计学意义（X2=4．40，P=0．036；X2=4．21，P=0．040）；治疗8个月后痰涂片的转阴率研究组为76．8％（43／56），与对照组的71．7％（38／53）比较，差异无统计学意义（x2=0．37，P=0．545）；治疗3个月和8个月后研究组病灶显著吸收率分别为44．6％（25／56）、62．5％（35／56），明显高于对照组的26．4％（14／53）、43．4％（23、53），差异均有统计学意义（X2=3．94，P=0．047；X2=3．99，P=0．046）；治疗8个月后研究组空洞闭合率58．5％（24／41），与对照组的34．2％（13／38）比较，差异有统计学意义（x2=4．69，P=0．031）；研究组CD4＋T淋巴细胞、CD4’／CD8＋比值治疗后分别达（820．9±255．2）个／mm2、2．02±0．1，与对照组[分别为（707．8±254．6）个／mm2、1．69±0．4]比较，差异有统计学意义（X2=0．72，p=-0．036；X2=2．76，P=0．041）。结论芪甲利肺胶囊具有加速痰菌转阴及促进病灶吸收的作用，芪甲利肺胶囊可能有调节免疫功能，从而起到辅助抗结核作用。

Objective To evaluate the clinical efficacy of QIJIALIFEIJIAONANG （a kind of traditional Chinese medicine, QJLFYN） in patients with the retrcatment pulmonary tuberculosis （PTB）. Methods One hundred and nine cases with the retreatment PTB hospitalized in Beijing Chest Hospital, Capital Medical University from January 2012 to October 2014 were randomly divided into two groups. Fifty-six cases who received the standard treatment regiment of 2S-H-R-Z-E/6H-R-E or 2S-H-R-Z-E/H-R-E-Z/5H-R-E plus QJLFJN as adjuvant therapy were enrolled as the research group, and 53 cases who received only standard treatment regiment were enrolled as the control. The clinical efficacy, symptoms and immune function were observed before and after treatment in the 2nd, 5th and 8th month. Results In the 2nd and 5th month after treatment, the rate of sputum smear negative conversion for the research group （50. 0%, 28/56 ; 53.6%, 30/56） were significantly higher than those in the control （30.2% （16/53）, 34.0% （18/53））, the difference was significant statistically, respectively （X2=4.40, P =0.036 ;X2=4.21, P=0.040）. However, in the 8th month after treatment, the rate of sputum smear conversion between the group of the research group （76.8%, 43/56） and the control （71.7%, 38/53） were no significant statistically differences （X2=0.37, P= 0.545）. The rate of focus improvement in research group （44.6%, 25/56 ; 62.5%, 35/56） was significantly higher than those in the control （26.4%, 14/53; 43.4%, 23/53） in the 3rd and 8th month, respectively （X2= 3.94, P=0.047; X2 = 3.99,X2=-0.046）. Meanwhile, the rate of cavity closure in the research group （58.5%, 24/41） was significantly higher than that in the control （34.2%, 13/38） in the 8th month. （X2 = 4.69, P=0.031）. The CD4＋ T lymphocyte count and the CD4＋/CD8＋ ratio in the research group （（820.9 ± 255.2） cells/m3, 2.02 ± 0.1） were significantly higher than those in the control （（707.8 ± 254.6） cells/mm3, 1.69 ± 0.4） after treatment, respectively （X2 =0.72, P = 0.036; X2= 2.76, P=0.041）. Conclusion QJLFJN can accelerate the sputum smear conversion and promote the absorption of the lesions. QJLFJN may regulate immune function, so as to play an auxiliary role of treatment in patients with the first retreatment PTB.