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首次复治肺结核患者短程化疗新方案的临床研究 被引量:22

A clinical study of short course chemotherapy for first retreatment pulmonary tuberculosis patients
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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。方法于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—RE-Z/6H-R-E)、氧氟沙星组(B组,142例;20frPa-R-E-Z/60fx-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)、72.5Z(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(χ2=6.07,P=0.014)。各组患者的脱落率分别为20.3%(25/123)、14.8Z(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(χ2=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.oH(289/556);其中,患者发生34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(χ2=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(χ2=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。 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 stan- dardized 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 with 2 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 for 2 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 (χ2= 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 (χ2=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 (n=7) 8.8% in Group C (n=12) and 5.0% in Group D (n=7), differences were not statistically significant (χ2 =5.67, P=0. 129). The rdapse 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 (χ2=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.
作者 沙巍 张青 崔文玉 王琳 施军卫 高绪胜 阎建栋 严晓峰 岳冀 顾欣荣 谭守勇 雷建平 谢兰品 李丽 李凫坚 接力 阚晓宏 陈裕 曹子中 肖和平 SHA Wei ZHANG Qing CUI Wen- yu WANG Lin SHI Jun-wei GAO Xu-sheng YAN Jian-dong YAN Xiao- feng YUE Ji GU Xin-rong TAN Shou-yong LEIJian-ping XIE Lan-pin LI Li LI Fu-jian JIE Li KAN Xiao-hong CHEN Yu CAO Zi-zhong XIAO He-ping(Clinic and Research Centre of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai Key Lab of Tuberculosis, Shanghai 200433, Chin)
出处 《中国防痨杂志》 CAS 2017年第1期39-45,共7页 Chinese Journal of Antituberculosis
关键词 结核 病人再入院 药物疗法 联合 喹诺酮类 药物治疗依从性 方案评价 Tuberculosis, pulmonary Patient readmission Drug therapy, combination Quinolones Medieation adherence Program evaluation
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