宣肺平喘胶囊治疗慢性阻塞性肺疾病急性加重期临床疗效观察

Effective observation on treating acute exacerbation of COPD with the Xuanfei Pingchuan capsule

目的:观察宣肺平喘胶囊治疗慢性阻塞性肺疾病急性加重期(AECOPD)患者的安全性及有效性。方法:收集2014年1月-2015年6月就诊于山西省中医院肺病科的AECOPD患者,采用随机数字表法将符合纳入标准的患者随机分为两组,每组各60例。对照组给予西医抗感染、解痉平喘、止咳化痰等常规治疗,试验组在常规治疗基础上加用宣肺平喘胶囊,两组疗程均为14d,观察两组患者治疗前后中医证候评分、肺功能、血气分析、血常规、C反应蛋白(CRP)、COPD评估测试评分(CAT)及安全性指标的变化。结果:临床研究过程中试验组脱落1例,即试验组59例,对照组60例。统计结果显示,试验组患者咳嗽、咳痰、气喘症状明显改善,总有效率高于对照组(P<0.05)。与对照组相比较,试验组患者第1秒用力肺活量占预计值的百分比(FEV1.0%)、第1秒用力呼气容积占肺活量的百分比(FEV1.0/FVC)及最大通气量占预计值的百分比(MVV%)明显升高(P<0.05),肺活量占预计值的百分比(VC%)升高不明显,差异无统计学意义(P>0.05);试验组患者动脉血氧分压(Pa O2)、血氧饱和度(Sa O2)明显升高(P<0.05),动脉血二氧化碳分压(Pa CO2)降低,但差异无统计学意义(P>0.05);试验组患者炎症相关指标明显改善(P<0.05)且CAT评分明显低于对照组(P<0.01);两组治疗前后各项安全性检查均未见异常改变。结论:宣肺平喘胶囊可明显改善AECOPD患者的临床症状,改善患者肺功能、血气分析及炎症相关指标,且对肝肾功能无明显损害,值得在临床应用和推广。

Objective： To observe the safety and efficacy of the Xuanfei Pingchuan capsule on acute exacerbation of chronic obstructive pulmonary disease- Methods： From January 2014 to June 2015, 120 patients with AECOPD were selected and randomly divided into the experimental group and control group, 60 cases in each- The control group received conventional western medicine treatment such as anti-infection, suppressing cough and calming panting and so on; and the experimental group received the Xuanfei Pingchuan capsule more- The treatment lasted for 14 days- The changes of relevant indicators were observed- Results： 1 case in the experimental group falled off, namely there were 59 cases in the experimental group and 60 cases in the control group- Compared with the control group, clinical symptoms such as cough, sputum, asthma and the total efficiency in the experimental group were improved significantly（P〈0.05）; patients＇ pulmonary function such as FEV1-0%, FEV1-0/FVC and MVV% in the experimental group were increased significantly（P〈0-05）; VC% was also higher but not obvious; the difference was not statistically significant（P〉0.05）- Partial pressure of oxygen and blood oxygen saturation in the experimental group increased significantly（P〈0.05）; and pressure of carbon dioxide was decreased, with no statistical difference（P〉0.05）- Inflammation indices in the experimental group were improved significantly（P〈0.05）; and CAT scores were lower（P〈0.01）- Before and after the treatment, the security indices did not appear abnormal change- Conclusion： The Xuanfei Pingchuan capsule can improve clinical symptoms of patients with AECOPD, and improve the pulmonary function, Qi and Xue analysis, inflammation indexes, with no obvious harmless, was worthy of application and promotion-