利奈唑胺联合常规化疗治疗广泛耐药肺结核的疗效观察

Clinical observation of linezolid combined with conventional chemotherapy in treatment of extensively drug-resistant tuberculosis

目的探讨利奈唑胺联合常规化疗治疗广泛耐药肺结核的临床效果及安全性。方法选取2010年1月—2014年1月唐山市第四医院收治的广泛耐药结核病患者94例,按治疗方案不同分为对照组（40例）和治疗组（54例）。对照组口服丙硫异烟胺肠溶片,0.25 g/次,2-3次/d;口服盐酸左氧氟沙星胶囊,0.2 g/次,2次/d;口服盐酸乙胺丁醇片,0.75 g/次,1次/d;口服吡嗪酰胺片,0.75 g/次,2次/d;静脉静滴硫酸阿米卡星注射液,0.2 g/次,2次/d。治疗组在对照组基础上,初始静脉滴注利奈唑胺注射液,600 mg/次,2次/d;治疗1-2个月后,根据患者耐受度和不良反应情况改为600 mg,1次/d,或者口服利奈唑胺片,600 mg/次,1次/d。两组患者均治疗4-10个月,平均时间（8.5±0.6）个月。观察两组的临床疗效,比较两组的症状改善时间、SF-36量表评分、复发和转归的情况。结果治疗后,对照组和治疗组的总有效率分别为45.00%、85.19%,两组比较差异有统计学意义（P〈0.05）。治疗后,治疗组空洞缩小时间、空洞闭合时间、痰涂片转阴时间、痰培养转阴时间和痰定量PCR阴转时间均短于对照组,两组比较差异有统计学意义（P〈0.05）。随访6、12、18个月后,两组SF-36量表评分均上升,同组治疗前后比较差异有统计学意义（P〈0.05）;且治疗组SF-36量表评分的升高程度明显优于对照组,两组比较差异具有统计学意义（P〈0.05）。对照组和治疗组的复发率分别为35.00%、7.41%,转归率分别为30.00%、59.26%,两组比较差异有统计学意义（P〈0.05）。结论利奈唑胺联合常规化疗治疗广泛耐药结核病具有较好的临床疗效,可改善临床症状,缩短痰菌阴转时间,改善生活质量,具有一定的临床推广应用价值。

Objective To explore clinical effect and safety of linezolid combined with conventional chemotherapy in treatment of extensively drug-resistant tuberculosis. Methods Patients（84 cases） with extensively drug-resistant tuberculosis in Tangshan Fourth Hospital from January 2010 to January 2014 were enrolled in this study. According to the difference treatment plan, patients were divided into control group（40 cases） and treatment group（54 cases）. Patients in the control group were po administered with Protionamide Enteric-coated Tablets, 0.25 g/time, 2 — 3 times daily. And patients in the control group were po administered with Levoloxacin Hydrochloride Capsules, 0.2 g/time, twice daily. And patients in the control group were po administered with Ethambutol Hydrochloride Tablets, 0.75 g/time, once daily. And patients in the control group were po administered with Pyrazinamide Tablets, 0.75 g/time, twice daily. And patients in the control group were iv administered with Amikacin Sulfate Injection, 0.2 g/time, twice daily. Patients in the treatment group were iv administered with Amikacin Sulfate Injection on the basis of the control group, starting dosage was 600 mg/time, once daily. After treatment for 1 — 2 months, according to the patient＇s tolerance and adverse reactions, the dose was changed to iv administered with Amikacin Sulfate Injection, or po administered with Amikacin Sulfate Injection, 600 mg/time, once daily. Patients in two groups were treated for 4 — 10 months, average time（8.5 ± 0.6） months. After treatment, the clinical efficacies were evaluated, and symptoms improvement time, SF-36 scale score, recurrence, and prognosis in two groups were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 45.00% and 85.19%, respectively, and there was difference between two groups（P〈0.05）. After treatment, cavity shrinking time, cavity closure time, sputum smear negative conversion time, sputum culture negative conversion time, and sputum quantitative PCR negative conversion time in the treatment group were shorter than those in the control group, and there was difference between two groups（P〈0.05）. After treatment for 6, 12 and 18 months, SF-36 scores in two groups were increased, and the difference was statistically significant in the same group（P〈0.05）. And SF-36 scores in the treatment group were significantly higher than those in the control group, with significant difference between two groups（P〈0.05）. The recurrence rates in the control and treatment groups were 35.00% and 7.41%, respectively, and the recovery rates in the control and treatment groups were 30.00% and 59.26%, respectively, and there was difference between two groups（P〈0.05）. Conclusion Linezolid combined with conventional chemotherapy has clinical curative effect in treatment of extensively drug-resistant tuberculosis, and can improve clinical symptoms, shorten sputum bacteria negative conversion time, improve quality of life, which has a certain clinical application value.