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
目的:探究“针-药-模”结合治疗粉刺病肺胃热蕴证的临床效果。方法:收集2020年10月—2022年9月上海市嘉定区中医医院皮肤科门诊收治的粉刺病肺胃热蕴证患者150例,根据随机数字表法将其分为针-药-模治疗组(桑枇消痤颗粒+毫火针+石膏倒模...目的:探究“针-药-模”结合治疗粉刺病肺胃热蕴证的临床效果。方法:收集2020年10月—2022年9月上海市嘉定区中医医院皮肤科门诊收治的粉刺病肺胃热蕴证患者150例,根据随机数字表法将其分为针-药-模治疗组(桑枇消痤颗粒+毫火针+石膏倒模)、针-药对照组(桑枇消痤颗粒+毫火针)、药-模对照组(桑枇消痤颗粒+石膏倒模),每组50例,均每周治疗1次,持续治疗4周。观察3组患者的临床疗效,比较3组治疗前后皮疹情况及生活质量[皮肤病生活质量指数量表(dermatology quality of life index,DLQI)],统计不良反应发生情况与复发率。结果:治疗4周后,针-药-模治疗组临床有效率高于针-药对照组、药-模对照组,差异有统计学意义;针-药对照组与药-模对照组比较,差异无统计学意义。3组患者皮疹情况评分、DLQI评分与治疗前比较均降低,且针-药-模治疗组低于针-药对照组及药-模对照组,差异有统计学意义;针-药对照组与药-模对照组比较,差异无统计学意义。治疗期间,3组患者不良反应发生情况比较,差异无统计学意义;结束治疗后2个月,针-药-模治疗组复发率低于针-药对照组、药-模对照组,差异有统计学意义;针-药对照组与药-模对照组比较,差异无统计学意义。结论:与“药-模”及“针-药”治疗相比,“针-药-模”相结合的综合治疗方法在粉刺病肺胃热蕴证的治疗中临床疗效更为显著,有效改善患者皮疹情况,提高生活质量,减少复发,安全性可靠。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.
文摘目的:探究“针-药-模”结合治疗粉刺病肺胃热蕴证的临床效果。方法:收集2020年10月—2022年9月上海市嘉定区中医医院皮肤科门诊收治的粉刺病肺胃热蕴证患者150例,根据随机数字表法将其分为针-药-模治疗组(桑枇消痤颗粒+毫火针+石膏倒模)、针-药对照组(桑枇消痤颗粒+毫火针)、药-模对照组(桑枇消痤颗粒+石膏倒模),每组50例,均每周治疗1次,持续治疗4周。观察3组患者的临床疗效,比较3组治疗前后皮疹情况及生活质量[皮肤病生活质量指数量表(dermatology quality of life index,DLQI)],统计不良反应发生情况与复发率。结果:治疗4周后,针-药-模治疗组临床有效率高于针-药对照组、药-模对照组,差异有统计学意义;针-药对照组与药-模对照组比较,差异无统计学意义。3组患者皮疹情况评分、DLQI评分与治疗前比较均降低,且针-药-模治疗组低于针-药对照组及药-模对照组,差异有统计学意义;针-药对照组与药-模对照组比较,差异无统计学意义。治疗期间,3组患者不良反应发生情况比较,差异无统计学意义;结束治疗后2个月,针-药-模治疗组复发率低于针-药对照组、药-模对照组,差异有统计学意义;针-药对照组与药-模对照组比较,差异无统计学意义。结论:与“药-模”及“针-药”治疗相比,“针-药-模”相结合的综合治疗方法在粉刺病肺胃热蕴证的治疗中临床疗效更为显著,有效改善患者皮疹情况,提高生活质量,减少复发,安全性可靠。