摘要：
Objective To investigate the efficacy and safety of the two atomization inhalation therapies in the patients with bacteriologically positive tracheobronchial tuberculosis (TBTB).Methods Sixty patients who had bacteriologically positive TBTB and were susceptible to the first-line anti-TB drugs were enrolled in this study from Fuzhou Pulmonary Hospital between Oct 2014 and Sep 2015.They were randomly put into two groups by using the random number table method:namely isoniazid-rifampicin (H-R) treatment group (was called Group A) and isoniazid-amikacin (H-Am) control group (was called Group B).There were 30 cases in each group and all cases received the standard chemotherapy regimens:3H-R-Z-E/9 H-R-E (Z:pyrazinamide;E:ethambutol).The treat ment duration was 3 months intensive phase plus 9 months continuous phase.In addition,the patients in the two groups received the different adjuvant therapies respectively in the intensive phase:the cases in Group A was treated with H and R atomization inhalation,twice per day;the cases in Group B was treated with H and Am atomization inhalation,twice per day.The effectiveness and safety of the atomization inhalation treatment in the two groups were evaluated by comparing the duration and rate of each indication,and P＜0.05 was considered to be statistically significant difference.Results There were no statistically significant differences between Group A and Group B on the following indicators:the number of days of bacteriological conversion (24.00 (14.25,32.00) vs.27.50 (15.50,38.25)) (Z=0.70,P=0.48),the duration of clinical symptoms improvement ((7.00 (3.75,9.00) vs.7.00 (5.00,10.25)) (Z=1.40,P=0.16),the absorption rates of lesions at the third month,the sixth month and the ninth month of treatment (46.67％ (14/30)vs.40.00％ (12/30),86.67％ (26/30)vs.86.67％ (26/30),96.67％ (29/30) vs.93.33％ (28/30)) (x23m=1.99,P=0.37;x26m=1.14,P=0.57;x29m=0.35,P=0.55),the closure rate of cavities (47.62％ (10/21) vs.45.0％ (9/20),71.43％ (15/21) vs.65.00％ (13/20),90.48％ (19/21) vs.75.00％ (15/20) (x23m=1.25,P=0.54;x26m=2.12,P=0.35;x29m=1.78,P=0.41),the incidence rate of ADR (70.0％ (21/30) vs.80.0％ (24/30)) (x2 =0.80,P=0.37).At the end of 3 months of treatment,the lesions had been absorbed mainly in all patients of two groups and under the bronchoscopy,which were visible to submucosal invasion under the mucosa,mucosal erosion,ulcer,granulation tissue and the bronchial lumens had unobstructed.On the 65 days of treatment,all patients' sputum smear were negative and the resistant strains were not detected.Conclusion Auxiliary treatment of TBTB with atomization inhalation of H-R,H-Am were quite effective and it has a certain security that the drug resistant strains will not appear in the near future.%目的 探讨两种雾化吸入治疗方案对菌阳气管支气管结核(TBTB)患者的有效性和安全性.方法 纳入2014年10月至2015年9月入住福州肺科医院的对一线抗结核药物敏感的初治菌阳TBTB患者60例,以随机数字表法将患者分别纳入异烟肼-利福平(H-R)治疗组(简称“A组”)与异烟肼-阿米卡星对照治疗组(简称“B组”),两组各30例,均采用标准化疗方案:3H-R-Z-E/9H-R-E(H:异烟肼;R:利福平;Z:吡嗪酰胺;E:乙胺丁醇;强化期3个月,巩固期9个月);另外辅助治疗为:治疗组于强化期2次/d雾化吸入H和R,对照组2次/d雾化吸入H和Am(阿米卡星),以各项指标时长和率的比较评估两组雾化吸入治疗方案的有效性与安全性,以P＜0.05为差异有统计学意义.结果 A、B两组患者治疗后在痰菌阴转天数[24.00(14.25,32.00),27.50(15.50,38.25)](Z=0.70,P=0.48)、临床症状改善时长[(7.00(3.75,9.00),7.00(5.00,10.25)] (Z=1.40,P=0.16)组间差异无统计学意义;以及在治疗后3个月、6个月、9个月的病灶吸收率[46.67％ (14/30)和40.00％ (12/30),86.67％(26/30)和86.67％(26/30),96.67％(29/30)和93.33％(28/30)](x23个月 =1.99,P=0.37;x26个月 =1.14,P=0.57;x29个月=0.35,P=0.55)、空洞闭合率[47.62％ (10/21)和45.00％ (9/20),71.43％ (15/21)和65.00％(13/20),90.48％(19/21)和75.00％ (15/20)](x23个月=1.25,P=0.54;x26个月=2.12,P=0.35;x29个月=1.78,P=0.41),以及药物不良反应(ADR)发生率[70.0％ (21/30)和80.0％ (24/30)]组间差异无统计学意义(x2=0.80,P=0.37).在治疗的第3个月末,A、B两组患者支气管镜检查均可见黏膜下浸润病灶和黏膜糜烂、溃疡及肉芽组织等病灶基本吸收和愈合,管腔通畅.在治疗的第65天,所有患者痰涂片检查均阴性,且均未检测到耐药菌株.结论 雾化吸入H-R、H-Am作为TBTB的辅助治疗方案,二者疗效相当,并且在近期不会出现耐药菌株,具有一定的安全性.
