喘可治注射液治疗哮喘的疗效及其作用机制研究

目的: 评价喘可治注射液治疗哮喘的有效性、安全性及作用机制。方法: 62例哮喘病人分 2组,喘可治组使用喘可治注射液 (4mL·次 -1,qd),对照组使用相同剂量的安慰剂;疗程共 4wk。2组病人治疗前后行肝、肾功能,血、尿常规,心电图及细胞因子检测。结果:治疗后 2组日间症状评分(1. 30±s0. 20)分vs(0. 50±0. 10)分、夜间憋醒次数(1. 10±0. 20)次vs(0. 40±0. 20 )次及沙丁胺醇减少喷数(1. 40±0. 20)次vs(0. 60±0. 10 )次比较,差异有非常显著意义(P<0. 01); 2组肺功能较治疗前均有非常显著改善 (P<0. 01); 2组组间比较,差异亦有非常显著意义(P<0. 01)。治疗后 2组病人血常规,肝、肾功能及心电图无明显异常。喘可治组使Th1 /Th2细胞因子比值提高 15. 3±1. 3,对照组仅提高 9. 2±1. 0, 2组比较差异有非常显著意义 (P<0.01)。结论 :喘可治注射液是治疗哮喘有效、安全的中药制剂,它可能是通过调整Th1 /Th2平衡发挥疗效的。

Evaluation of efficacy, safety and mechanism of Chuankezhi injection in treating asthma

AIM: To evaluate the efficacy ,safety and mechanism of Chuankezhi injection to treat asthma. METHODS: Sixty-two patients were divided in to two groups, with group A injected by Chuankezhi injection (4 mL/once, qd) and group B injected by comfort of same dosage. The period of the treatment was 4 wk. Hepatic and renal function, blood serum routine , urinary routine, EKG and cytokins were examined before and after the treatment. RESULTS:After treatment,the difference in daytime symptom scores (1.30± s 0.20 vs 0.50±0.10), awaken times in the night(1.10±0.20 vs 0.40±0.20)and decrease puffs of using salbutional(1.40±0.20 vs 0.60± 0.10)between the two groups were significant(P< 0.01). Lung functions of both groups were better than those before the treatment (P<0.01); the difference between the two groups was also significant(P< 0.01). There were no significant abnormalities in both groups on blood routine, hepatic and renal functions, EKG .In addition, the ratio of the Th1/Th2 cytokines of the patients in group A was elevated by 15.3±1.3 and group B of 9.2±1.0. The difference was significat too(P<0.01). CONCLUSION: Chuankezhi injection is an effective and safe Chinese traditional medicine,perhaps it plays a role by adjusting the imbalance of Th1/Th2.