关键词: 冷冻疗法, 支气管疾病, 结核, 随机对照试验, 疗效比较研究

Abstract:

Objective To analyze the earlier clinical efficacy for inflammatory infiltrative type endobronchial tuberculosis with three interventional techniques which was intra-airway administration, cryotherapy and cryotherapy combined with intra-airway administration.Methods One hundred and eighty patients with inflammatory infiltrative type endobronchial tuberculosis admitted in Harbin Chest Hospital were randomly divided into three groups which were drug perfusion group, cryotherapy group and combined treatment group during November, 2015 to June, 2017. There were 60 patients in each group. All patients were received chemotherapy with 2H-R-Z-E/10H-R-E and interventional treatment under bronchoscopy once one week. Isoniazid with 0.3 gram was injected in local site of bronchial under bronchoscopy in drug perfusion group. The freezing alone was performed in the cryotherapy group, and the cryotherapy combination with injection of INH with 0.3 gram was conducted in the combined treatment group under bronchoscopy. The improvement of clinical symptoms (cough, expectoration), the absorption of lesions under bronchoscopy, the negative conversion of sputum bacteria, the absorption of obstructive pneumonia in the lungs and the occurrence of adverse reactions were observed and recorded after 1, 2 and 6 months of treatment, and the results were compared and analyzed.Results The median number of treatment times (M(Q₁,Q₃)) was 4 (3, 5) in the cryotherapy group and in the combined treatment group each other, which were significantly lower than those in the drug perfusion group 6 (4, 7) times) (χ ²=28.62, P<0.01). One month after treatment, in the cryotherapy group and combined treatment group, the sputum negative conversion rate (88.3% (53/60) and 90.0% (54/60)), the effective absorption rate under bronchoscopy (71.7% (43/60) and 73.3% (44/60)), the improvement rate of clinical symptoms (cough, expectoration) (95.0% (57/60) and 96.7% (58/60)) and showed that the absorption rate of obstructive pneumonia showed in pulmonary CT imaging (77.3% (17/22) and 78.9% (15/19)) were significantly higher than those (70.0% (42/60), 51.7% (31/60), 66.7% (40/60), and 40.0% (8/20)) of drug perfusion group with the significant differences statistically (χ ² values were 10.37, 7.73, 28.52, 8.63 in each, and P were 0.006, 0.021, <0.01, 0.013, respectively). At the end of 2 months after treatment, in the cryotherapy group and combined treatment group, the sputum negative conversion rate (100.0% (60/60) and 100.0% (60/60)) and the effective absorption rate under bronchoscopy (96.7% (58/60) and 96.7% (58/60)) were significantly higher than those (90.0% (54/60) and 85.0% (51/60)) in drug perfusion group with the significant differences statistically (χ ² were 12.41 and 8.12, respectively, and P were 0.002 and 0.017, respectively). The effective absorption of obstructive pneumonia in the drug perfusion group, cryotherapy group and combined treatment group was 80.0% (16/20), 90.9% (20/22) and 89.5% (17/19), respectively, with no significant difference (χ ²=1.26, P=0.534), and the clinical symptoms (cough, expectoration) disappeared. After 6 months of treatment, all sputum bacteria in the three groups were negative conversion, and the lesions, clinical symptoms (cough, expectoration) and obstructive pneumonia disappeared in the three groups. Conclusion Cryotherapy can promote quickly sputum negative conversion of inflammatory infiltrative type endobronchial tuberculosis, focus absorption, effective improvement of the clinical symptoms, recovering bronchial patency, and no obvious adverse reactions. It is a safe and effective treatment technique.

Key words: Cryotherapy, Bronchial diseases, Tuberculosis, Randomized controlled trial, Comparative effectiveness research