A multicenter randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of rhubarb in treating acute exacerbation of chronic obstructive pulmonary disease of the syndrome type phlegm-heat obstructing the lungs

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 difference
1.67,95%CI:e2.66 to
0.69,P Z 0.001;PPS:mean difference
1.55,95%CI:
2.56 to
0.54,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.

Application Value of Lung-Fire-Clearing,Phlegm-Resolving,and Bowels-Relaxing Decoction in Treating Lung Cancer of Phlegm-Heat Pattern

Objective:This article explores the clinical effects of lung-fire-clearing,phlegm-resolving and bowels-relaxing decoction in the treatment of lung cancer of phlegm-heat pattern.Methods:A total of 6 cases of lung cancer patients with phlegm-heat pattern were randomly selected from Inner Mongolia Baicaotang Qin's Zhong Meng Medical Hospital from March 2018 to December 2020 to conduct the study.They were divided into the reference group and the study group by using the digital table method.The patients in the reference group were treated with conventional Western medicine whereas the patients in the study group were treated with lung-fire-clearing,phlegm-resolving,and bowels-relaxing decoction to observe the curative effect.Results:There were no significant differences in the levels of the tumor markers between the two groups before treatment(P>0.05).However,after treatment,the levels of cytokeratin 19 soluble fragments(CYFRA21-1),carbohydrate antigen 125(CA125),and carcinoembryonic antigen(CEA)in the study group were lower than those in the control group(P<0.05).The effective rate and the quality of life score of the study group were higher than those of the reference group while the incidence of adverse reactions was lower than that of the reference group,P<0.05.Conclusion:Lung-fire-clearnig,phlegm-resolving,and bowels-relaxing decoction can effectively improve the symptoms of patients with lung cancer and improve their quality of life.

Effects of acetylcysteine on micro-inflammation and pulmonary ventilation in chronic obstructive pulmonary disease exacerbation

BACKGROUND Acute exacerbation of chronic obstructive pulmonary disease(AECOPD)is a serious complication of chronic obstructive pulmonary disease,often characterized by increased morbidity and mortality.In traditional Chinese medicine,AECOPD is linked to phlegm-heat and blood-stasis,presenting symptoms like thick sputum,fever,and chest pain.It has been shown that acetylcysteine inhalation in conjunction with conventional therapy significantly reduced inflammatory markers and improved lung function parameters in patients with AECOPD,suggesting that acetylcysteine may be an important adjunctive therapy for patients with phlegm-heat-blood stasis type AECOPD.AIM To investigate the effect of acetylcysteine on microinflammation and lung ventilation in patients with phlegm-heat and blood-stasis-type AECOPD.METHODS One hundred patients with phlegm-heat and blood-stasis-type AECOPD were randomly assigned to two groups.The treatment group received acetylcysteine inhalation(10%solution,5 mL,twice daily)along with conventional therapy,whereas the control group received only conventional therapy.The treatment duration was 14 d.Inflammatory markers(C-reactive protein,interleukin-6,and tumor necrosis factor-alpha)in the serum and sputum as well as lung function parameters(forced expiratory volume in one second,forced vital capacity,and peak expiratory flow)were assessed pre-and post-treatment.Acetylcysteine inhalation led to significant reductions in inflammatory markers and improvements in lung function parameters compared to those in the control group(P<0.05).This suggests that acetylcysteine could serve as an effective adjunct therapy for patients with phlegm-heat and blood-stasis-type AECOPD.RESULTS Acetylcysteine inhalation significantly reduced inflammatory markers in the serum and sputum and improved lung ventilation function parameters in patients with phlegm-heat and blood-stasis type AECOPD compared with the control group.These differences were statistically significant(P<0.05).The study concluded that acetylcysteine inhalation had a positive effect on microinflammation and lung ventilation function in patients with this type of AECOPD,suggesting its potential as an adjuvant therapy for such cases.CONCLUSION Acetylcysteine inhalation demonstrated significant improvements in reducing inflammatory markers in the serum and sputum,as well as enhancing lung ventilation function parameters in patients with phlegm-heat and bloodstasis type AECOPD.These findings suggest that acetylcysteine could serve as a valuable adjuvant therapy for individuals with this specific type of AECOPD,offering benefits for managing microinflammation and optimizing lung function.

阻塞性肺病呼气末肺残气量的CT评价

目的 :探讨呼气末高分辨率CT(HRCT)对阻塞性肺病 (OLD)患者的肺残气量的评估价值。方法 :对有肺功能检测结果的 13名健康志愿者与 14例OLD患者行吸气与呼气末HRCT扫描 ,测量吸气与呼气状态下肺CT值 ,并目测呼气末HRCT扫描时肺残气量的范围。结果 :所有的OLD与 8名健康志愿者都有肺内空气残余 ,但OLD的范围明显增大。OLD患者在吸气与呼气时肺CT值变化及残气量分数与健康者明显不同 ,且与肺功能密切相关 (P <0 .0 1)。结论 :呼气末HRCT可用于评估OLD患者肺残气量并可诊断这类疾病。

慢性阻塞性肺疾病患者C反应蛋白与WBC、肺功能变化的临床研究

目的探讨慢性阻塞性肺疾病(Chronic Obstructive Pulmonary Disease,COPD)患者急性加重期与稳定期血清C反应蛋白(C-reactive protein,CRP)含量的变化及C反应蛋白与WBC、肺功能变化的临床意义。方法选择COPD患者68例,比较其治疗前后血清CRP水平及患者WBC总数和相应肺功能FEV1%、FEV1/FVC。结果 COPD急性加重期CRP为(48.8±13.2)mg/L,缓解期为(13.6±7.1)mg/L,差异有统计学意义。CRP与肺功能FEV1%、FEV1/FVC呈负相关。结论 C反应蛋白可作为COPD急性期感染的敏感指标,也可反映COPD感染治疗效果评价指标,亦可对COPD严重程度分级有一定指导意义。

麻杏石甘汤加减辨证分型治疗幼儿支气管肺炎64例临床观察

[目的]观察麻杏石甘汤加减辨证分型治疗幼儿支气管肺炎疗效。[方法]使用前瞻性设计方法,64例（住院/门诊）患者麻杏石甘汤（炙麻黄、炒杏仁各3g,生石膏9g,前胡4g,川贝3g,黄芩4g,桔梗3g,生姜2g,炙甘草3g）,风热闭肺（炙麻黄4.5g,麻黄：石膏之比1：3,加二花、连翘各5g）,痰热闭肺（炙麻黄4g,石膏20g,麻黄：石膏之比1：5,加瓜蒌、葶苈子各5g,半夏2g）,阴虚肺热（养阴清肺。加麦冬3g,沙参、梨皮各4g）,肺脾气虚（加炒白术4g,云苓3g,太子参4g）,1剂/d,水煎200m L,分2-4次口服;连续治疗3d为1疗程。观测临床症状、不良反应。治疗1疗程,判定疗效。[结果]痊愈34例,好转26例,无效4例,总有效率93.75%。急性发作期,痊愈22例,好转18例,无效2例,总有效率95.23%。迁延期,痊愈12例,好转8例,无效2例,总有效率88.90%。[结论]麻杏石甘汤加减辨证分型治疗幼儿支气管肺炎,疗效满意,无严重不良反应,值得推广。

Efficacy and safety of Qingfei Huatan formula in the treatment of acute exacerbation of chronic obstructive pulmonary disease:A multi-centre,randomised,double-blind,placebo-controlled trial

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.