左氧氟沙星和卷曲霉素联合化疗方案用于耐多药肺结核的临床观察

Clinical Observation of Levofloxacin and Capreomycin Combined with Chemotherapy Regimen in the Treatment of Multi-drug Resistant Tuberculosis

目的:观察左氧氟沙星和卷曲霉素联合化疗方案用于耐多药肺结核的疗效和安全性。方法:84例耐多药肺结核患者随机分为观察组(42例)和对照组(42例)。观察组患者给予注射用硫酸卷曲霉素0.75 g,加入0.9%氯化钠注射液100 ml中,静脉滴注,每日1次+盐酸左氧氟沙星片0.4 g,口服,每日1次+丙硫异烟胺片0.2 g,口服,每日3次+帕司烟肼片0.3 g,口服,每日3次+吡嗪酰胺片0.5 g,口服,每日4次。对照组患者给予硫酸阿米卡星注射液0.4 g,加入0.9%氯化钠注射液100 ml中,静脉滴注,每日1次+氧氟沙星片0.3 g,口服,每日2次+丙硫异烟胺片(用法用量同观察组)+帕司烟肼片(用法用量同观察组)+吡嗪酰胺片(用法用量同观察组)。两组患者均给予葡醛内酯片0.1 g,口服,每日3次。两组疗程均为12个月。观察两组患者的痰阴转率、痰菌转阴时间、症状改善时间、病灶吸收率、肺部空洞闭合情况,治疗前后免疫指标(CD4^+CD25^+/CD4^+、CD4^+CD25^+CD127^(low)/CD4^+)、白细胞介素(IL)-17水平及不良反应发生情况。结果:观察组患者治疗3、6、9、12、18个月后的痰阴转率、病灶吸收率、肺部空洞闭合及缩小占比率均显著高于对照组,痰菌转阴时间、症状改善时间均显著短于对照组,差异均有统计学意义(P<0.05)。治疗前,两组患者CD4^+CD25^+/CD4^+、CD4^+CD25^+CD127^(low)/CD4^+、IL-17水平比较,差异均无统计学意义(P>0.05)。治疗后,两组患者CD4^+CD25^+/CD4^+、CD4^+CD25^+CD127^(low)/CD4^+均显著低于同组治疗前,且观察组低于对照组,IL-17水平显著高于同组治疗前,且观察组高于对照组,差异均有统计学意义(P<0.05)。两组患者不良反应发生率比较差异无统计学意义(P>0.05)。结论:左氧氟沙星和卷曲霉素联合化疗方案用于耐多药肺结核可显著提高疗效,有效降低患者调节性T淋巴细胞水平,升高IL-17水平,且不增加不良反应的发生。

OBJECTIVE： To observe the efficacy and safety of levofloxacin and capreomycin combined with chemotherapy regi- men in the treatment of multi-drug resistant tuberculosis （MDR-TB）. METHODS： 84 MDR-TB patients were randomly divided in- to observation group （42 cases） and control group （42 cases）. Observation group received 0.75 g Capreomycin sulfate for injec- tion, addint into 100 ml 0.9% Sodium chloride injection, intravenous infusion, once a day＋0.4 g Levofioxacin hydrochloride tab- let, orally, once a day＋0.2 g Protionamide tablet, orally, 3 times a day＋0.3 g Pasiniazid tablet, orally, 3 times a day＋0.5 g Pyra- zinamide tablet, orally, 4 times a day. Control group received 0.4 g Amikacin sulfate injection, adding into 100 ml 0.9% Sodium chloride injection, once a day, intravenous infusion＋0.3 g Ofloxacin tablet, orally, twice a day＋Protionamide tablet （the same dose with observation group）＋Pasiniazid tablet （the same dose with observation group）＋Pyrazinamide tablet （the same dose with observation group）. All patient were given 0.1 g Glucuronolactone tablet, orally, 3 times a day. The treatment course for both group was 12 months. Sputum negative conversion rate, negative conversion time, symptom improvement time, lesion absorption and lung cavity closing, and cell immune indexes （CD4＋CD25＋/CD4＋, CD4＋CD25＋CD127low/CD4＋）,IL-17 level before and after treatment, and the incidence of adverse reactions in 2 groups were observed. RESULTS： The sputum negative conversion rate, ab- sorption rate, lung cavity closing and narrowing cases in research group after 3, 6, 9, 12, 18 months treatment were significantly higher than control group, sputum negative conversion time, symptom improvement time in observation group were significantly lower than control group, the differences were statistically significant （P〈0.05）. Before treatment, there were no significant differ- ences in CD4＋CD25＋/CD4＋, CD4＋CD25＋CD127low/CD4＋, IL-17 level in 2 groups （P〉0.05）. After treatment, CD4＋CD25VCD4＋, CD4＋ CD25＋CD127low/CD4＋ in 2 groups were significantly lower than before, and observation group was lower than control group, IL-17 level was significantly higher than before, and observation group was higher than control group, the differences were statistically significant （P〈0.05）. And there was no significant difference in the incidence of adverse reactions in 2 groups （P〉0.05）. CONCLUSIONS ： Levofloxacin and capreomycin combined with chemotherapy in the treatment of MDR-TB, it can reduce T regulatory cells, increase IL-17 level, do not increase the incidence of adverse reactions.