百合固金汤加减辅助抗结核药治疗老年初治肺结核肺肾阴虚证临床研究

Clinical trial on the modified Baihe-Gujin Decoction combined with routine chemotherapy for the elderly patients with primary treated pulmonary tuberculosis and lung-kidney yin deficiency

目的评价百合固金汤加减辅助抗结核药物治疗老年初治肺结核肺肾阴虚证患者的疗效。方法将符合入选标准的2016年1月-2018年1月本院94例老年初治肺结核肺肾阴虚证患者,按随机数字表法分为2组,每组47例。对照组采用2HRZE/4HR化疗方案,观察组在对照组基础上联用百合固金汤。2组均连续治疗6个月。分别于治疗前后进行中医证候评分,于治疗后2、5、6个月观察痰转阴率,采用胸部CT观察空洞性阴影的闭合情况,采用双抗体夹心ELISA法检测血清IL-6、IFN-γ诱导蛋白-10,采用流式细胞术检测免疫T细胞亚群,评价临床疗效。结果观察组总有效率为87.2%(41/47)、对照组为61.7%(29/47),2组比较差异有统计学意义(χ^2=8.050,P=0.004)。观察组治疗后中医证候评分低于对照组(t=5.698,P<0.01);治疗后6个月痰转阴率高于对照组(χ^2=5.317,P=0.021),空洞阴影闭合总有效率[95.7%(45/47)比83.0%(39/47),χ^2=4.029,P=0.044]高于对照组。治疗后,观察组CD3+、CD4+、CD4+/CD8+水平高于对照组(t值分别为2.107、3.571、2.351,P值均<0.05),CD8+水平低于对照组(t=2.711,P=0.005);IL-6、IFN-γ诱导蛋白-10水平低于对照组(t值分别为2.517、2.890,P值均<0.05)。结论百合固金汤加减辅助抗结核药物可提高老年初治肺结核肺肾阴虚证患者机体免疫力及临床疗效。

Objective To evaluate the clinical efficacy of modified Baihe-Gujin Decoction combined with routine chemotherapy for the elderly patients with primary treated pulmonary tuberculosis and lung-kidney yin deficiency.Methods A total of 94 patients who met the inclusion criteria in our hospital from January 2016 to January 2018 were selected and divided into 2 groups according to the random number table method,with 47 patients in each group.The control group was treated with the routine chemotherapy regimen of 2HRZE/4HR(H:isoniazid,R:rifampicin,Z:pyrazinamide,E:ethambutanol),the observation group was treated with Baihe-Gujin Decoction on the basis of the routine chemotherapy.Both groups were treated continuously for 6 months.The sputum negative rate was observed 2,5 and 6 months after treatment,The closure of cavity shadows was observed by chest CT.The content of IL-6 and IFN-γ-inducible protein-10 were detected by double antibody sandwich ELISA.T cell subsets was detected by flow cytometry.And the clinical efficacy was evaluated.Results The total effective rate was 87.2%(41/47)in the observation group and 61.7%(29/47)in the control group,and the difference between the two groups was statistically significant(χ^2=8.050,P=0.004).After treatment,the TCM syndrome score of the observation group was significantly lower than that of the control group(t=5.698,P<0.01).At the end of 6 months after treatment,the sputum negative rate in the observation group was significantly higher than that of the control group(t=5.317,P=0.021),the effective rate of cavity shadow closure(95.7%with 45/47 vs.83.0%with 39/47)in the observation group was significantly higher than that of the control group(χ^2=4.029,P=0.044).After treatment,the levels of CD3+,CD4+and CD4+/CD8+in the observation group were all significantly higher than those in the control group(t values were 2.107,3.571 and 2.351,respectively,all Ps<0.05),and the levels of CD8+in the observation group were all significantly lower than those in the control group(t=2.711,P=0.005).The levels of IL-6 and IFN-γ-induced protein-10 in the observation group were significantly lower than those in the control group(t values were 2.517 and 2.890,respectively,all Ps<0.05).Conclusions The modified Baihe-Gujin Decoction combined with routine chemotherapy can improve the immunity of the elderly patients with primary treated pulmonary tuberculosis with lung-kidney yin deficiency,and improve the clinical efficacy.