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目的评价红鹤胶囊对耐药性肺结核(MDR-TB)阴虚肺热络伤型的临床疗效。方法选取MDR-TB阴虚肺热络伤型患者128例,随机分为治疗组和对照组各64例。对照组选用西医3DL1OZA/18DL1OZ化疗方案,疗程为12个月。治疗组在对照组基础上加服红鹤胶囊(处方的免煎颗粒),每日1剂,服用6个月。比较两组中医证候疗效、X线疗效、痰菌转阴率、免疫学指标及不良反应。结果两组中医证候疗效比较,治疗组优于对照组(P<0.05)。两组患者X线疗效比较,两组患者随治疗时间的增加,病灶吸收率增加,组内相邻时间点比较差异有统计学意义(P<0.05或P<0.01);两组治疗6、9个月比较,治疗组均优于对照组(P<0.05)。随治疗时间的增加,两组患者痰菌转阴率升高,组内相邻时间点比较差异均有统计学意义(P<0.05);治疗3、6、9、12个月比较,治疗组高于对照组(P<0.05)。两组患者CD3+、CD4+、白细胞介素17治疗后较治疗前均明显升高(P<0.05或P<0.01),治疗后治疗组各指标均高于对照组(P<0.05)。两组患者治疗前后血、尿、便常规,肾功能及心电图未见明显异常。两组患者丙氨酸氨基转移酶者及胃肠道反应者比较,差异无统计学意义(P>0.05)。结论红鹤胶囊治疗MDR-TB阴虚肺热络伤型可提高临床疗效,安全性高。
Objective To evaluate the clinical efficacy of Honghe Capsule in treating lung injury caused by drug-resistant pulmonary tuberculosis (MDR-TB). Methods 128 cases of MDR-TB yin-deficiency type of heat-induced lung injury were randomly divided into treatment group and control group of 64 cases. The control group selected Western medicine 3DL1OZA / 18DL1OZ chemotherapy, treatment for 12 months. On the basis of the control group, the treatment group was given the red-crowned capsule (prescription-free decoction) one day and taking for 6 months. The curative effects of traditional Chinese medicine (TCM), X-ray efficacy, sputum negative conversion rate, immunological indexes and adverse reactions were compared between the two groups. Results The curative effect of TCM syndrome in the two groups was better than that in the control group (P <0.05). The two groups of patients with X-ray efficacy comparison, two groups of patients with the increase of treatment time, the lesion absorption rate, the adjacent time points within the group was statistically significant (P <0.05 or P <0.01); two groups of treatment 6,9 Compared with the control group, the treatment group was better than the control group (P <0.05). With the increase of treatment time, the rate of sputum negative conversion rate increased in both groups, and there was significant difference between adjacent time points in the two groups (P <0.05). Compared with the control group at 3, 6, 9 and 12 months, Higher than the control group (P <0.05). The levels of CD3 +, CD4 +, and interleukin 17 in both groups were significantly higher than those before treatment (P <0.05 or P <0.01). After treatment, the indexes in the treatment group were all higher than those in the control group (P <0.05). Two groups of patients before and after treatment of blood, urine, they routine, renal function and ECG showed no abnormalities. Two groups of patients with alanine aminotransferase and gastrointestinal tract were compared, the difference was not statistically significant (P> 0.05). ConclusionHonghe capsule treatment of MDR-TB yin-lung-heat injury can improve clinical efficacy, high safety.