Background Chronic obstructive pulmonary disease(COPD),a common respiratory disease,can be effectively treated by traditional Chinese medicine(TCM).Qingfei Huatan,a TCM formula,has been reported to effectively allevia...Background Chronic obstructive pulmonary disease(COPD),a common respiratory disease,can be effectively treated by traditional Chinese medicine(TCM).Qingfei Huatan,a TCM formula,has been reported to effectively alleviate the clinical symptoms of COPD patients.However,there is a lack of multi-centre,randomised,double-blind,controlled clinical trials documenting the clinical efficacy and safety of this formula in the treatment of acute exacerbation of COPD(AECOPD).Objective This study evaluated the efficacy and safety of Qingfei Huatan formula in the treatment of AECOPD,thereby providing high-quality clinical evidence.Design,setting,participants and interventions A total of 276 patients with AECOPD were included in this multi-centre,randomised,double-blind,placebo-controlled trial and were randomised into treatment and control groups at a ratio of 1:1.Patients in the treatment and control groups took Qingfei Huatan granules or simulated Qingfei Huatan granules twice a day,for 14 days,in addition to Western medicine treatment.All patients were followed up for 3 months.Main outcome measures The primary outcome was time taken to symptom stabilisation.The secondary outcomes included duration of antibiotic use,clinical symptom and sign score,TCM syndrome score,dyspnoea score,and quality of life(QOL)score.Meanwhile,the safety of the formula was assessed through routine urine and stool tests,electrocardiograms,liver and kidney function tests,and the observation of adverse events throughout the trial.Results The time taken for effective stabilisation(P<0.05)and obvious stabilisation(P<0.01),and the duration of antibiotic use(P<0.05)were significantly shorter in the treatment group than in the control group.On days 6,9,12 and 14 of treatment,clinical symptom and sign score decreased in both groups,particularly in the treatment group(P<0.01).On days 9,12 and 14 of treatment,the TCM syndrome scores of both groups were reduced(P<0.01),with more significant reductions in the treatment group.At 3 months after the end of treatment,the treatment group continued to have lower clinical symptom and sign score and TCM syndrome score than the control group(P<0.01).On days 6,9,12 and 14 of treatment,dyspnoea and QOL scores were markedly reduced in the two groups(P<0.05 and P<0.01,respectively),especially in the treatment group.At 3 months after the end of treatment,dyspnoea and QOL scores were lower in the treatment group than those in the control group(P<0.01).No serious adverse events were observed in either group.Conclusion The Qingfei Huatan formula can effectively shorten the duration of AECOPD and antibiotic use,significantly relieve clinical symptoms,and increase QOL for AECOPD patients,with a favourable safety profile.These results suggest that this formula can be used as a complementary treatment for AECOPD patients.展开更多
目的 探讨益气化痰通络方联合八段锦对尘肺病患者治疗的效果。方法 选择2022年3月至2023年9月广西壮族自治区工人医院收治的痰湿蕴肺证尘肺病患者120例,随机分为研究组60例、对照组60例。在常规治疗的基础上,对照组采用八段锦干预训练,...目的 探讨益气化痰通络方联合八段锦对尘肺病患者治疗的效果。方法 选择2022年3月至2023年9月广西壮族自治区工人医院收治的痰湿蕴肺证尘肺病患者120例,随机分为研究组60例、对照组60例。在常规治疗的基础上,对照组采用八段锦干预训练,研究组采用八段锦联合益气化痰通络方治疗,两组均连续干预3个月。比较两组治疗后总有效率、视觉模拟评分(visual analogue scale,VAS)、血气分析指标、运动耐量、肺功能指标及生活质量情况。结果 治疗后研究组总有效率(93.33%)高于对照组(78.33%)(P<0.05);研究组咳嗽、咳痰、胸痛、呼吸困难VAS评分,二氧化碳分压(partial pressure of carbon dioxide,PaCO_(2)),圣乔治呼吸问卷(St George’s respiratory questionnaire,SGRQ)评分低于对照组(P<0.05);研究组动脉血氧分压(partial pressure of oxygen,PaO_(2))、血氧饱和度(oxygen saturation of blood,SaO_(2))、6分钟步行试验(6 min walk test,6MWT)、用力肺活量(forced vital capacity,FVC)、第1秒用力呼气量(forced expiratory volume in one second,FEV1)、FEV1/FVC高于对照组(P<0.05)。结论 益气化痰通络方联合八段锦治疗可有效改善尘肺病患者肺通气,增强运动耐力,效果较为理想,临床应用价值较高。展开更多
基金supported by Research on the Modernisation of Traditional Chinese Medicine in National Key R&D Programmes(No.2018YFC1704804 and 2018YFC1704800)the Sixth Special Support Program for Innovative Leading Talents in Anhui(No.T000614).
文摘Background Chronic obstructive pulmonary disease(COPD),a common respiratory disease,can be effectively treated by traditional Chinese medicine(TCM).Qingfei Huatan,a TCM formula,has been reported to effectively alleviate the clinical symptoms of COPD patients.However,there is a lack of multi-centre,randomised,double-blind,controlled clinical trials documenting the clinical efficacy and safety of this formula in the treatment of acute exacerbation of COPD(AECOPD).Objective This study evaluated the efficacy and safety of Qingfei Huatan formula in the treatment of AECOPD,thereby providing high-quality clinical evidence.Design,setting,participants and interventions A total of 276 patients with AECOPD were included in this multi-centre,randomised,double-blind,placebo-controlled trial and were randomised into treatment and control groups at a ratio of 1:1.Patients in the treatment and control groups took Qingfei Huatan granules or simulated Qingfei Huatan granules twice a day,for 14 days,in addition to Western medicine treatment.All patients were followed up for 3 months.Main outcome measures The primary outcome was time taken to symptom stabilisation.The secondary outcomes included duration of antibiotic use,clinical symptom and sign score,TCM syndrome score,dyspnoea score,and quality of life(QOL)score.Meanwhile,the safety of the formula was assessed through routine urine and stool tests,electrocardiograms,liver and kidney function tests,and the observation of adverse events throughout the trial.Results The time taken for effective stabilisation(P<0.05)and obvious stabilisation(P<0.01),and the duration of antibiotic use(P<0.05)were significantly shorter in the treatment group than in the control group.On days 6,9,12 and 14 of treatment,clinical symptom and sign score decreased in both groups,particularly in the treatment group(P<0.01).On days 9,12 and 14 of treatment,the TCM syndrome scores of both groups were reduced(P<0.01),with more significant reductions in the treatment group.At 3 months after the end of treatment,the treatment group continued to have lower clinical symptom and sign score and TCM syndrome score than the control group(P<0.01).On days 6,9,12 and 14 of treatment,dyspnoea and QOL scores were markedly reduced in the two groups(P<0.05 and P<0.01,respectively),especially in the treatment group.At 3 months after the end of treatment,dyspnoea and QOL scores were lower in the treatment group than those in the control group(P<0.01).No serious adverse events were observed in either group.Conclusion The Qingfei Huatan formula can effectively shorten the duration of AECOPD and antibiotic use,significantly relieve clinical symptoms,and increase QOL for AECOPD patients,with a favourable safety profile.These results suggest that this formula can be used as a complementary treatment for AECOPD patients.
文摘目的 探讨益气化痰通络方联合八段锦对尘肺病患者治疗的效果。方法 选择2022年3月至2023年9月广西壮族自治区工人医院收治的痰湿蕴肺证尘肺病患者120例,随机分为研究组60例、对照组60例。在常规治疗的基础上,对照组采用八段锦干预训练,研究组采用八段锦联合益气化痰通络方治疗,两组均连续干预3个月。比较两组治疗后总有效率、视觉模拟评分(visual analogue scale,VAS)、血气分析指标、运动耐量、肺功能指标及生活质量情况。结果 治疗后研究组总有效率(93.33%)高于对照组(78.33%)(P<0.05);研究组咳嗽、咳痰、胸痛、呼吸困难VAS评分,二氧化碳分压(partial pressure of carbon dioxide,PaCO_(2)),圣乔治呼吸问卷(St George’s respiratory questionnaire,SGRQ)评分低于对照组(P<0.05);研究组动脉血氧分压(partial pressure of oxygen,PaO_(2))、血氧饱和度(oxygen saturation of blood,SaO_(2))、6分钟步行试验(6 min walk test,6MWT)、用力肺活量(forced vital capacity,FVC)、第1秒用力呼气量(forced expiratory volume in one second,FEV1)、FEV1/FVC高于对照组(P<0.05)。结论 益气化痰通络方联合八段锦治疗可有效改善尘肺病患者肺通气,增强运动耐力,效果较为理想,临床应用价值较高。
