含氯法齐明联合方案治疗耐多药肺结核患者的临床疗效和安全性

摘要

目的：探讨含氯法齐明（ Clofazimine，Cfz）联合方案治疗耐多药肺结核（ multidrug-resistant tuberculosis ，MDR-TB）患者的临床疗效和安全性。方法选取2011年10月～2016年9月大同市第四人民医院收治的采用含氯法齐明联合方案治疗MDR-TB患者32例，根据患者用药史及药敏试验结果采用个体化化疗方案，氯法齐明治疗开始剂量0.1 g／天，口服，部分患者因不良反应及耐受性情况调整为0.05 g／天。在最后12个月连续3次痰结核杆菌培养且痰涂片抗酸杆菌阴性为治愈，观察其临床疗效和安全性。结果经联合方案治疗后，56.2％（18／32）患者治愈，43.8％（14／32）患者治疗失败；失败患者服用CFZ前耐药种数与治愈患者比较，差异无统计学意义；失败患者服用CFZ前治疗时间与治愈患者比较，差异无统计学意义；服用含CFZ联合方案抗痨后，治愈患者用药种数与失败患者比较，差异有统计学意义（ P＜0.05）。痰培养阴转时间平均数16 w。90.6％（29／32）患者出现不良反应，主要包括皮肤颜色改变，鱼鳞病及胃肠道等不良反应，通过剂量调整及对症治疗继续治疗。氯法齐明使用疗程平均约13个月。结论氯法齐明耐受性良好，含氯法齐明联合方案治疗耐多药肺结核有较好疗效。%Objective To evaluate the clinical efficacy and safety of combination treatment with clofazimine ( Cfz ) and other antituberculosis drugs for patients with multidrug-resistant tuberculosis(MDR-TB).Methods 32 cases of MDR-TB patients were treated with combination regimens that included clofaziminefrom October 2011 to September 2016 in our hospitol,according to the history of drug use and drug susceptibility test results using individualized chemotherapy,the starting dose of clofazimine was 0.1 g/day,oral,some patients with adverse reactions and tolerance adjusted to 0.05 g/day,treatment for the last 12 months for three consecutive sputum mycobacterium tuberculosis culture and sputum smear acid-fast bacilli were cured,observe the clinical efficacy and safety.Results After treatment with the combined regimen,56.2%(18/32) of patients were cured,43.8%(14/32) of patients failed treatment, there was no statistically significant difference in the number of drug-resistant patients before and after CFZ treatment,there was no statistically significant difference between the time of failure and the time of CFZ treatment,after taking CFZ combined with anti-tuberculosis program,the number of drug users was statistically significant of patients cured and failed (P<0.05).The average time of sputum culture inversion was 16w.90.6% (29/32) of patients with adverse reactions,mainly including skin color change,ichthyosis and gastrointestinal tract and other adverse reactions, through dose adjustment and symptomatic treatment to continue treatment.The average duration of treatment with clofazimine was about 13 months.ConclusionClofazimine was welltolerated,combination treatment with Clofazimine and others for patients with MDR-TBhave better efficacy .