利福类联合多种药物长疗程方案治疗耐多药肺结核

A controlled clinical trial of long course chemotherapy regimens containing rifabutin in the treatment of multi-drag resistant pulmonary tuberculosis

目的评价国产利福布汀的治疗方案对耐多药肺结核患者的疗效和安全性。方法对130例耐多药肺结核患者,采用1:1随机、平行对照的方法,分为试验组和对照组,两组患者除采用帕司烟肼、左旋氧氟沙星、乙胺丁醇、丙硫异烟胺和阿米卡星治疗外,试验组患者加用利福布汀,对照组患者加用利福喷汀,疗程共18个月。结果强化期结束时,试验组和对照组的痰涂片和痰结核分枝杆菌培养阴转率分别为41．54％(27／65)和35．94％(23／65),差异无统计学意义(X2=2．42,P> 0．05)。X线影像学结果表明,两组的病灶显效率均为10．77％(7／65),差异无统计学意义(X2= 0．01,P>0．05);有效率分别为67．69％(44／65)和56．92％(37／65),差异无统计学意义(X2=1．44, P>0．05)。疗程结束时,试验组和对照组的痰涂片和痰结核分枝杆菌培养阴转率分别为75．00％(48／65)和65．08％(41／65),差异无统计学意义(X2=1．88,P>0．05)。X线影像学结果表明,两组的病灶显效率分别为46．15％(30／65)和44．62％(29／65),差异无统计学意义(X2=0．02,P>0．05);有效率分别为76．92％(50／65)和73．85％(48／65),差异无统计学意义(X2=0．19,P>0．05);空洞闭合率分别为23．64％(13／55)和33．33％(17／51)。结论含利福布汀或利福喷汀的多药联合长疗程方案治疗耐多药肺结核,具有促进痰细菌学阴转、病灶吸收和空洞关闭的作用,其安全性和耐受性良好。

Objective To evaluate the curative effect and safety of a long course regimen containing Chinese-made rifabutin as compared to the regimen containing rifapentine in the treatment of multi-drug resistant pulmonary tuberculosis. Method During 18 month treatment, 130 patients with multi-drug resistant pulmonary tuberculosis were divided into a treatment group （rifabutin, pasiniazide, levofloxacin, ethambutol, ethionamide, amikacin for 3 months, rifabutin, pasiniazide, levofloxacin, ethambutol, ethionamide for 6 months, rifabutin, pasiniazide, levofloxacin, ethambutol for 9 months）, and a control group （rifapentine , pasiniazide, levofloxacin, ethambutol, ethionamide, amikacin for 3 months, rifabutin, pasiniazide, levofloxacin, ethambutol, ethionamide for 6 months, rifabutin, pasiniazide, levofloxacin, ethambutol for 9 months） with proportion 1 ： 1 random, and parallel compared method. Results After intensive phase, the sputum negative conversion rates （smear negative, culture negative） of the treatment group and the control group were 41.54% （ 27/65 ） and 35.94% （ 23/65 ）, X^2 = 2. 42, P 〉 0. 05, respectively. The remarkable effective rates in chest X-ray of the two groups were all 10. 77% （7/65）, X^2 = 0. 01, P 〉 0. 05, and the effective rates were 67. 69% （44/65） and 56. 92% （37/65）, X^2 = 1.44, P 〉 0. 05, respectively. At the end of the treatment, the sputum negative conversion rate （ smear negative, culture negative） of the treatment group was 75.0% （48/65）, and of the control group was 65.08% （41/ 65）, X^2 = 1.88, P 〉0. 05. The remarkable effective rates in chest X-ray of the two groups were 46. 15% （30/65） and 44.62% （29/65） , X^2 =0.02, P〉0.05, and the effective rates were76.92% （50/65） and 73. 85% （48/65）, X^2 = 0. 19, P 〉 0. 05, respectively. The cavity closure rates were 23.64% （13/55） and 33.33% （ 17/51 ）, X^2 = 0. 00, P 〉 0. 05, respectively. Conclusion Regimens containing rifabutin or rifapentine, are very effective in sputum negative conversion rate, lesion absorption and cavity closing for the treatment of multi-drug resistant pulmonary tuberculosis, with good safety and tolerance.