【摘要】 目的 观察首次复治肺结核患者采用短程化疗方案的疗效和安全性。方法 子2009年7月至2012年6月,采用多中心、随机、对照、开放、前瞻性队列研究方法,对全国17家结核病防治机构的首次复治涂阳肺结核患者共542例进行治疗研究。患者被数字表法随机分为4个组,分别为标准复治方案组(A组,123例;2S-H-R-EZ/6H-R-E)、氧氟沙星组(B组,142例;2Ofx-PaR-E-Z/6Ofx-Pa-R)、左氧氟沙星组(C组:137例;2Lfx-Pa-R-E-Z/6Lfx-Pa-R)和超短程组(D组:140例;5Pa-Rfb-E-Z-Mfx)。各组患者结束治疗后随访2年,比较新方案的疗效、依从性、不良反应发生率和复发率。结果 治疗后4个组的治疗成功率分别为68.3%(84/123)、72.5%(103/142)、71.5%(98/137)和81.4%(114/140),其中D组的治疗成功率明显高于A组,差异有统计学意义(χ~2=6.07,P=0.014)。各组患者的脱落率分别为20.3%(25/123)、14.8%(21/142)、20.4%(28/137)和11.4%(16/140),其中D组的脱落率明显低于A组,差异有统计学意义(χ~2=3.94,P=0.047)。共有289例患者报道了药物不良反应,发生率为52.0%(289/556);其中,患者发生3~4级药物不良反应者A组有14例(11.4%)、B组有7例(4.9%)、C组有12例(8.8%)、D组有7例(5.0%);4个组之间差异无统计学意义(χ~2=5.67,P=0.129)。4个组患者的复发率如下:A组21.4%%(12/56)、B组23.3%(17/73)、C组2.9%(2/70)和D组9.7%(7/72),差异有统计学意义(χ~2=10.87,P=0.001)。结论 5个月Pa-Rfb-E-Z-Mfx短程化疗方案治疗首次复治肺结核患者有较好的疗效和安全性,并可缩短疗程。更多还原

【Abstract】 Objective To evaluate the efficacy and safety of short course chemotherapy to treat first retreatment pulmonary tuberculosis.Methods A multi-center,randomized,controlled and open prospective clinical trial was coducted in 17 tuberculosis dispensaries from July,2009 to June 2012.A total of 542 first retreatment pulmonary tuberculosis patients with positive smear were assigned into 4 different groups:Group A(n = 123):WHO standardized regime;Group B(n=142):started with 2 months of pasiniazide(Pa),ofloxacin(Ofx),rifampin(R),ethanbutol(E) and pyrazinamide(Z),followed by 6 months of Ofx-Pa-R;Group C(n=137),started with2 months of Pa,levofloxacin(Lfx),R,E,and pyrazinamide(Z),followed by 6 months of Lfx-Pa-R;Group D(n=140):5 months of moxifloxacin(Mfx),Pa,Rifabutin(Rfb),E,Z.All the patients were followed up for2 years after treatment.The outcome,compliance,adverse effects and relapse rate were observed.Results Therapeutic success rates of the four groups were 68.3%(84/123),72.5%(103/142),71.5%(98/137) and 81.4%(114/140),respectively;the rate of Group D was significantly higher than that of Group A(χ~2 =6.07,P =0.014).The drop-off rates of four groups were 20.3%(25/123),14.8%(21/142),20.4%(28/137) and 11.4%(16/140),respectively;the rate of Group D was significantly lower than that of Group A(χ~2 = 3.94,P=0.047).There were totally 289 cases who had adverse events with the incidence of 52.0%(289/556).The incidence of grade 3 — 4 adverse effects were 11.4%in Group A(n= 14),4.9%in Group B(w=7) 8.8%in Group C(n=12)and 5.0%in Group D(n=7),differences were not statistically significant(χ~2=5.67,F=0.129).The relapse ratea of 4 groups were 21.4%(12/56),23.3%(17/73),2.9%(2/70) and 9.7%(7/72),respectively,differences were not statistically significant(χ~2 = 10.87,P=0.001).Conclusion The novel regimen of Pa-Rfb-E-Z-Mfx had better efficacy than standardized regimen and could shorten the treatment duration to 5 months.更多还原