内外同治治疗支气管哮喘发作期的随机对照试验研究
Randomized Controlled Trial of Combination of Internal and External Therapy for the Attack Stage of Bronchial Asthma
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摘要: 目的 评价清肺平喘颗粒联合固本清肺贴膏治疗支气管哮喘发作期(热哮证)的疗效与安全性。方法 将120例支气管哮喘发作期(热哮证)患者随机分为试验组和对照组，分别接受清肺平喘颗粒联合固本清肺贴膏与茶碱缓释片联合布地奈德粉吸入剂治疗，观察治疗前后中医症状积分、病情严重程度分级、哮喘控制测试表（ACT）及外周血嗜酸性粒细胞（EOS）计数等指标。结果 ①疾病疗效：清肺平喘颗粒联合固本清肺贴膏组(简称试验组)显效率为78.18%，总有效率为92.73%，茶碱缓释片联合布地奈德粉吸入剂(简称对照组)显效率为80.39%，总有效率为90.20%，2组间比较差异无统计学意义(P>0.05)。②中医证候疗效:试验组显效率为63.63%，总有效率为92.73%，对照组显效率为52.94%，总有效率为88.24%，2组间比较差异无统计学意义(P>0.05)。③病情严重程度分级及控制情况2组无明显差异(P>0.05)。④对外周血嗜酸性粒细胞（EOS）计数的影响2组无明显差异(P>0.05)。结论 清肺平喘颗粒联合固本清肺贴膏与茶碱缓释片联合布地奈德粉吸入剂疗效基本相当，未发现明显不良反应，为临床用药提供了新的选择。Abstract: OBJECTIVE To evaluate the curative effect and safety of the combination therapy of Qingfei Pingchuan Granule and Guben Qingfei Plaster in treating the attack stage of bronchial asthma (the heat syndrome). METHODS 120 cases of bronchial asthma in the attack stage (the heat syndrome) were randomly divided into experimental group and control group which received the combination therapy of Qingfei Pingchuan Granule and Guben Qingfei Plaster and the combination therapy of Theophylline Sustained-release Tablet and Budesonide Powder Inhalation respectively. Then the changes of indexes， such as TCM symptoms integral， disease severity classification， asthma control test (ACT) and eosinophils (EOS) count in peripheral blood， before and after treatment were observed. RESULTS Curative effects on the disease: the group with the combination therapy of Qingfei Pingchuan Granule and Guben Qingfei Plaster (experimental group) showed a markedly effective rate of 78.18% and a total effective rate of 92.73%， while the group with the combination therapy of Theophylline Sustained-release Tablet and Budesonide Powder Inhalation (control group) had a 80.39% markedly effective rate and a 90.20% total effective rate. The difference between two groups had no statistical significance (P>0.05)， meaning the two therapies had equivalent curative effects. Curative effects on the TCM syndrome: the markedly effective rate of experimental group was 63.63%， and the total effective rate was 92.73%， while those of control group were 52.94% and 88.24% respectively. The difference between two groups had no statistical significance (P>0.05)， which meant that the two therapies had equivalent curative effects on the TCM syndrome. There was no difference between two groups in the aspects of disease severity classification， asthma control situation and the influence on EOS count (P>0.05). CONCLUSION The curative effect of Qingfei Pingchuan Granule combined with Guben Qingfei Plaster is equal to that of Theophylline Sustained-release Tablet combined with Budesonide Powder Inhalation， and no obvious adverse reaction is found， which makes a new option for clinical medication possible.
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