苦参素对良性瘢痕增生性气管狭窄影响的临床初步研究

Preliminary clinical study of effect of Marine injection on benign hypertrophic scar tracheostenosis

目的探讨苦参素在良性瘢痕增生性气管狭窄中的作用及其安全性。方法将30例良性瘢痕增生性气管狭窄患者随机分为对照组（15例）和苦参素组（15例）。对照组单纯给予气管镜下介入治疗,苦参素组在介入治疗后,采用一次性内镜喷洒管在病变部位局部喷洒苦参素注射液,根据狭窄长度或截面积确定给药浓度：狭窄长度≥2cm或截面积≤正常截面积50%,选择高浓度（1200 mg/ml）,否则选择低浓度（600 mg/ml）。术后一周复查支气管镜,根据病情,每周给药一次,累计2-4次,在气管狭窄起始端上方1 cm处拍照截图,使用Digimizer软件测量治疗前后狭窄管腔的横截面积。随访3个月,对比两组的气管横截面积、第1秒用力呼气容积（FEV1）占预计值百分比,观察药物不良反应。结果两组治疗后患者气管管腔的横截面积、FEV1占预计值百分比均明显改善,苦参素组治疗效果优于对照组,差异有统计学意义（P〈0.05或0.01）。术后一周复查气管镜,病变部位愈合良好,未见水肿、出血、溃疡、气管痉挛等不良反应发生。结论气管镜介入治疗后,气管内局部喷洒苦参素注射液对于抑制良性瘢痕增生导致的气管再狭窄有一定的预防及治疗作用,疗效确切,安全性好。

Objective To investigate efficacy and safety of Marine injection for benign hypertrophic scar tracheostenosis.Methods 30 cases of benign hypertrophic scar tracheostenosis were randomly divided into control group（ n = 15） and Marine group（ n = 15）. The control group were treated with only interventional therapy under bronchoscope,based on which the Marine group were given Marine injection sprayed by one-off endoscopic spray tube in local diseased region. Concentrations of drugs were given to the two groups according to the length or sectional area of the stenosis,Marine injection with high concentration（ 1200 mg / ml） was given to patients with length of the stenosis ≥2 cm or sectional area of the stenosis ≤50% of normal sectional area,while Marine injection with low concentration（ 600 mg / ml） was given to the rest patients. The effects were assessed by bronchoscope after a week. Depending on the patients＇ condition,Marine injection was given to the patients once a week,adding up to 2- 4 times. Digimizer was used to measure the cross sectional area of tracheostenosis before and after treatment which was captured at 1 cm above initiating terminal of luminal stenosis. The patients were followed up for 3months. Cross sectional area,percentage of forced expiratory volume in one second（ FEV1） and predicated value were compared between groups,and adverse drug reactions were observed. Results After treatment,cross sectional area,percentage of FEV1 and predicated value of both group significantly improved. Therapeutic effect of the Marine group was superior to that of the control group,so difference was statistically significant（ P〈0. 05 or 0. 01）. One week after treatment,all patients were rechecked by bronchoscope,which showed that diseased region healed perfectly,no adverse drug reactions like edema,hemorrhage,ulcers and tracheal spasm,etc. were found. Conclusion After interventional therapy under bronchoscope,Marine injection sprayed in local diseased region has certain prophylactic and therapeutic effects in recurrent tracheal stenosis caused by benign hypertrophic scar with definite therapeutic effect and high safety.