益气滋阴、行瘀抗痨法联合化疗长疗程治疗耐多药肺结核的随机对照临床研究

Combination of replenishing qi to nourish yin method,eliminating blood stasis method with chemotherapy in the treatment of multi-drug resistant pulmonary tuberculosis: A randomized controlled trial

目的评价益气滋阴、行瘀抗痨法联合化疗长疗程方案治疗耐多药肺结核的疗效。方法将72例耐多药肺结核患者用1∶1随机、平行对照的方法分为治疗组和对照组,两组均用化疗(对氨基水杨酸异烟肼、左氧氟沙星、阿米卡星、丙硫异酰胺、吡嗪酰胺),治疗组同时服用益气滋阴、行瘀抗痨中药颗粒剂,疗程均为18个月;观察痰抗酸杆菌涂片及培养阴转率、胸部X线病灶吸收情况、空洞闭合率及中医证候积分、生活质量评分变化情况。结果①治疗结束时,经Wilcoxon秩和检验,治疗组、对照组痰菌涂片阳性分级计数较治疗前差异均有统计学意义(P<0.05,P<0.01);治疗组、对照组痰结核菌痰菌阴转率分别为73.5%、56.3%,组间差异有统计学意义(P<0.05)。②治疗组、对照组胸部X线病灶吸收显效率分别为73.5%和53.1%,空洞闭合率分别为80.6%和53.5%,组间差异均有统计学意义(P<0.05)。③治疗组、对照组中医证候总有效率分别为100.0%、65.6%;组间中医证候疗效比较,差异有统计学意义(P<0.05)。④治疗结束时,治疗组生活质量量表的躯体功能、心理健康、社会功能、躯体疼痛、总体健康评分和生存总积分较治疗前差异有统计学意义(P<0.01),对照组躯体功能、总体健康评分和生存总积分较治疗前差异有统计学意义(P<0.01)。组间治疗后比较,躯体疼痛、心理健康、总体健康评分和生存总积分差异有统计学意义(P<0.05,P<0.01)。结论益气滋阴、行瘀抗痨中药联合化疗较单用西药抗痨化疗能提高痰菌阴转率,有助于胸部病灶吸收及空洞闭合,提高生活质量。

Objective To evaluate the clinical efficacy and satfety of combined replenishing qi to nourish yin methods, eliminating blood stasis methods with chemo- therapy in the treatment of nmlti-drug resistant pulmonary tuberculosis. Methods Seventy-two cases were randomized into treatment group and control group by 1 ： 1 randomized parallel controlled trial. All cases in both of the groups were treated by chemotherapy, and the cases in treatment group were added Chinese granular furnmlation for pulmonary tuberculosis, with the course of 18 months. The sputmn smear, culture negative conversion rate, focus absorption of chest X-ray, cavity closure rate, symptom score, and quality of life were obsmwed. Results （1）At the end of the treatment, there were statistical differences in grade count of sputun specimens between before and after treatment in both of the groups （ P 〈 0.05, P 〈 0.01 ） ; the the sputum smear and culture negative conversion rate of acidfast bacilli were 73.5 % and 56.2% in treatment group and control group respectively, with a significant difference between the two groups （ P 〈 0.05 ）. （2）The effective rate of chest X-ray was 73.5% in treatment group and 53.1% in control group, and the cavity closure rate was 80.6% in treatment group and 53.5% in control group, with a significant difference between the two groups （P 〈0.05 ）. （3）The overall effective rate of Chinese medicine was 100.0% in treatment group and 65.6% in control group, with a difference between the two groups （ P 〈 0.05 ）. （4）In treatment group, there were significant differences in body function, psychological health, society function, body pain, total health and total living accumulated points between before and after treatment （P 〈 0.01 ） ; in control group, there were significant differences in body tuncfion, total health and total living accumulated points between before and after treatment （ P 〈 0.01 ）. After treatment, there were significant differences in body pain, psychological health, total health and total living accumulated points between the two groups （ P 〈 0.05, P 〈 0.01 ）. Conclusion Combined replenishing qi to nourish yin method, eliminating blood stasis method with chemotherapy can improve the negative conversion rate of sputum, promote focus absorption and cavity closing, and improve the quality of life in patients with pulmonary tuberculosis.