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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。
Objective To evaluate the efficacy and safety of chemotherapy plus long immunization regimen in the treatment of multidrug-resistant pulmonary tuberculosis. Methods Totally 203 patients with multidrug-resistant pulmonary tuberculosis were divided into treatment group and control group by 1: 1 randomized, parallel control. The patients in two groups were treated with isoniazid, rifapentine, In the treatment group, the immunomodulatory agent M. vaccae vaccine (M.vaccae, micro-card) was used in addition to the control group Patients do not add mycobacterium vaccine, a total of 18 months. Results At the end of treatment (18 months), sputum acid-fast bacillus smear-negative and sputum negative Mycobacterium smegmatis culture negative in the treatment group and control group were 74.5% (73/98) and 72.5% (66 / 91), (χ2 = 0.09, P = 0.7599). There was no significant difference between the two groups. The radiographic results showed that the effective rates of lesions in two groups were 72.4% (71/98) and 47.3% (43/91), respectively, with significant difference (χ2 = 12.52, P = 0.0004, P> 0.05) The effective rates were 90.8% (89/98) and 82.4% (75/91) respectively, with no significant difference (χ2 = 2.90, P = 0.0886, P> 0.05). The void closure rates were 33.3% (27/81) ) And 22.1% (17/77) respectively. The difference was not statistically significant (rank sum test F = 1.52, P = 0.1294, P> 0.05). Immunological indicators of CD8 positive cells in the treatment group 6 months after the treatment group was higher than the control group, CD3-positive cells after treatment and the difference between the immune parameters before and after treatment in 3 and 9 months, the difference was statistically significant, the remaining CD4, CD4 / CD8, NK cells, IL-2R and other immunological indicators in each treatment stage, the treatment group and the control group similar, the difference was not statistically significant. Clinical symptoms Cough, expectoration, chest pain, dyspnea, fatigue and other symptoms have improved; the treatment group improved more than the control group. Conclusion The design of this study has a clear effect on multidrug-resistant pulmonary tuberculosis and has effective bactericidal and bacteriostatic effects. The addition of immunomodulatory agents plays a role in promoting the absorption of the lesion and improving the symptoms.