【摘要】 目的评价化疗加免疫长疗程方案治疗耐多药肺结核的疗效和安全性。方法对203例耐多药肺结核患者,采用1∶1随机、平行对照的方法,分为治疗组和对照组,2组患者除采用对氨基水杨酸异烟肼、利福喷汀、左旋氧氟沙星、丙硫异烟胺(Pt)、克拉霉素和阿米卡星治疗外,治疗组患者加用免疫调节剂母牛分枝杆菌菌苗(M.vaccae,微卡),对照组患者不加用母牛分枝杆菌菌苗,疗程共18个月。结果治疗结束时(18个月)治疗组和对照组痰抗酸菌涂片阴性同时痰结核分枝杆菌培养阴性(涂阴培阴)分别为74.5%(73/98)和72.5%(66/91),(χ2=0.09,P=0.7599)。2组比较差异无统计学意义。X线影像结果表明,2组的病灶显效率分别为72.4%(71/98)和47.3%(43/91),差异有统计学意义(χ2=12.52,P=0.0004,P>0.05);有效率分别为90.8%(89/98)和82.4%(75/91),差异无统计学意义(χ2=2.90,P=0.088 6,P>0.05);空洞闭合率分别为33.3%(27/81)和22.1%(17/77),差异无统计学意义(秩和检验F=1.52,P=0.1294,P>0.05)。免疫学指标CD8阳性原细胞在治疗6个月时治疗组高于对照组,CD3阳性原细胞治疗后与治疗前免疫指标差值在3和9个月差异有统计学意义外,其余CD4,CD4/CD8,NK细胞,IL-2R等免疫学指标在各治疗阶段,治疗组与对照组近似,差异无统计学意义。临床症状咳嗽、咳痰、胸痛,呼吸困难,乏力等症状有改善;治疗组改善程度均大于对照组。结论本研究所设计的方案对耐多药肺结核病均有明确的疗效,具有有效的杀菌、抑菌作用,加用免疫调节剂在促进病灶吸收,症状改善方面有一定的作用。更多还原

【Abstract】 Objective To evaluate the efficacy and safety of long course chemotherapy regimens combined with immunopotentiator in the treatment of multi-drug resistant pulmonary tuberculosis.Methods During 18 months treatment,203 patients with multi-drug resistant pulmonary tuberculosis were randomized 1∶1 to a treatment group(rifapentine,pasiniazide,levofloxacin,ethambutol,ethionamide,amikacin,clarithromycin and M.vaccae for 3 months,followed by rifapentine,pasiniazide,levofloxacin,ethambutol,ethionamide,clarithromycin and M.vaccae for 6 months,and rifapentine,pasiniazide,levofloxacin,ethambutol,clarithromycin for 9 months),and a control group(the same chemotherapy regimen alone,without M.vaccae).Results At the end of the treatment,the sputum negative conversion rate(smear negative,culture negative) was 74.5%(73/98) in the treatment group,and was 72.5%(66/91) in the control group.There was no statistically significant difference between groups(χ2=0.09,P=0.759 9).The marked effective rates of chest X-ray in the treatment group and the control group were 72.4%(71/98) and 47.3%(43/91) with statistically significant difference(χ2=12.52,P=0.000 4),and the effective rates were 90.8%(89/98) and 82.4%(75/91) without statistically significant difference(χ2=2.90,P=0.088 6,P>0.05) between two groups.The cavity closure rates were 33.3%(27/81) and 22.1%(17/77) without statistically significant difference(F=1.52,P=0.129 4,P>0.05).CD3 count was improved statistically significant difference after 3 months and 6 months treatment in the treatment group,and the difference of CD8 in treatment group was also higher than that of control group after 6 months treatment.CD4,CD8,CD4/CD8,NK,IL-2R were similar in two groups at any stage of treatment without statistically significant difference.The symptom of cough,expectoration,chest pain,hypodynamia were improved in the treatment group better than those in control group.Conclusions Our study showed regimens combined with immunopotentiator were very effective in bactericidal activity and bacteriostatic activity for the treatment of multi-drug resistant pulmonary tuberculosis.It had also an activity to lesion Absorption and the improvement in symptoms.更多还原