Objective:To observe the clinical efficacy and safety of oral administration of the traditional Chinese herb rhubarb to treat acute exacerbation of chronic obstructive pulmonary disease(AECOPD).Method:This was a multi...Objective:To observe the clinical efficacy and safety of oral administration of the traditional Chinese herb rhubarb to treat acute exacerbation of chronic obstructive pulmonary disease(AECOPD).Method:This was a multicenter randomized double-blinded placebo controlled study that took place in 7 provinces of China that enrolled 244 patients(aged 18e80 years)who had acute exacerbation of COPD with the traditional Chinese syndrome pattern of phlegm-heat obstructing lung.Participants were divided into experimental and control groups.The experimental group received 4.5 g of rhubarb granules twice daily and the control group received placebo granules.Both groups also received conventional Western therapy consisting of oxygen therapy,an antibiotic,expectorant,and a bronchodilator.Treatment lasted 10 days.Symptom scores for cough,sputum volume and color,wheezing and chest tightness before treatment and on days 3,5,7,and 10 during the treatment were recorded.Lung function,arterial blood gas and levels of serum inflammatory factors,interleukin-4(IL-4),interleukin-8(IL-8),and interleukin-10(IL-10)and tumor necrosis factor-alpha(TNF-a),before and after treatment were measured.Results:The sample size of the full analysis set(FAS)was 244 participants,and the sample size of per protocol set(PPS)was 235.Following 10 days’treatment,symptom scores of the experimental group were markedly lower than those of the placebo group(FAS:mean difference1.67,95%CI:e2.66 to0.69,P Z 0.001;PPS:mean difference1.55,95%CI:2.56 to0.54,P Z 0.003).Lung function in the experimental group was significantly higher than in the placebo group(FEV1,FAS:mean difference 0.12,95%CI:0.06 to 0.18;P<0.001;PPS:mean difference 0.12,95%CI 0.05 to 0.18;P<0.001.FVC:FAS:mean difference 0.16,95%CI:0.06 to 0.26;P Z 0.002;PPS:mean difference 0.16,95%CI 0.05 to 0.26;P Z 0.003.FEV1%,FAS:mean difference 5.95,95%CI:3.36 to 8.53;P<0.001;PPS:mean difference 5.92,95%CI 3.28 to 8.56;P<0.001.).PaO2,PaCO2,as well as serum inflammatory factors were also improved when compared to the placebo group.There were no significant differences in the incidence rate of adverse reaction between the two groups.Conclusions:Compared with placebo,rhubarb granules significantly reduced symptom scores,improved blood oxygen level,controlled systemic inflammatory response,without significant adverse effects.Thus,rhubarb may be a beneficial adjuvant method for treating the phlegm-heat obstructing the lung syndrome pattern of AECOPD.展开更多
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
基金This study was funded by the China National Key Basic Research Project through The Ministry of Science and Technology(No.2009CB522704).
文摘Objective:To observe the clinical efficacy and safety of oral administration of the traditional Chinese herb rhubarb to treat acute exacerbation of chronic obstructive pulmonary disease(AECOPD).Method:This was a multicenter randomized double-blinded placebo controlled study that took place in 7 provinces of China that enrolled 244 patients(aged 18e80 years)who had acute exacerbation of COPD with the traditional Chinese syndrome pattern of phlegm-heat obstructing lung.Participants were divided into experimental and control groups.The experimental group received 4.5 g of rhubarb granules twice daily and the control group received placebo granules.Both groups also received conventional Western therapy consisting of oxygen therapy,an antibiotic,expectorant,and a bronchodilator.Treatment lasted 10 days.Symptom scores for cough,sputum volume and color,wheezing and chest tightness before treatment and on days 3,5,7,and 10 during the treatment were recorded.Lung function,arterial blood gas and levels of serum inflammatory factors,interleukin-4(IL-4),interleukin-8(IL-8),and interleukin-10(IL-10)and tumor necrosis factor-alpha(TNF-a),before and after treatment were measured.Results:The sample size of the full analysis set(FAS)was 244 participants,and the sample size of per protocol set(PPS)was 235.Following 10 days’treatment,symptom scores of the experimental group were markedly lower than those of the placebo group(FAS:mean difference1.67,95%CI:e2.66 to0.69,P Z 0.001;PPS:mean difference1.55,95%CI:2.56 to0.54,P Z 0.003).Lung function in the experimental group was significantly higher than in the placebo group(FEV1,FAS:mean difference 0.12,95%CI:0.06 to 0.18;P<0.001;PPS:mean difference 0.12,95%CI 0.05 to 0.18;P<0.001.FVC:FAS:mean difference 0.16,95%CI:0.06 to 0.26;P Z 0.002;PPS:mean difference 0.16,95%CI 0.05 to 0.26;P Z 0.003.FEV1%,FAS:mean difference 5.95,95%CI:3.36 to 8.53;P<0.001;PPS:mean difference 5.92,95%CI 3.28 to 8.56;P<0.001.).PaO2,PaCO2,as well as serum inflammatory factors were also improved when compared to the placebo group.There were no significant differences in the incidence rate of adverse reaction between the two groups.Conclusions:Compared with placebo,rhubarb granules significantly reduced symptom scores,improved blood oxygen level,controlled systemic inflammatory response,without significant adverse effects.Thus,rhubarb may be a beneficial adjuvant method for treating the phlegm-heat obstructing the lung syndrome pattern of AECOPD.
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.
