Objective To evaluate the therapeutic effect, safty and tolerance of Gankeshuangqing Capsule in the treatment of patients suffering from wind-heat syndrome (acute upper respiratory infection or acute bronchitis). Methods The clinical trials were designed multicentered, double blind, double dummy, randomized and parallel positive drug controlled. A total of 289 patients participated in the trials. Those who suffered from acute upper respiratory infection were given throat virus-detection to make a definite diagnosis of the origins of disease. Results Among the 40 patients who were diagnosed with virus infection, 81.82% in Gankeshuangqing group were healed, but only 50.00% in control group, and significant differences were observed between the two groups (Plt;0.05). At the end of the third day of treatment, the rates of cure and excellence in patients suffering from acute upper respiratory infection were 80.00% in Gankeshuangqing group, and 68.57% in control group, and both groups showed good therapeutic effect，but there was no significant difference between the two groups (Pgt;0.05). At the end of the seventh day of treatment, the rates of cure and excellence in patients suffering from acute bronchitis were 82.35% in Gankeshuangqing group, and 63.77% in control group, and both groups showed good therapeutic effect, and there were significant differences between the two groups (Plt;0.05)；only one patient in Gankeshuangqing group had constipation during the treatment, but there was no evidence showing that it is caused by Gankeshuangqing. Conclusion The results show that Gankeshuangqing Capsule has a definite effect on wind-heat syndrome (acute upper respiratory infection or acute bronchitis) with good safety.
Objective To investigate the effects of methylprednisolone on airway inflammation of chronic bronchitis in rats, and to explore its possible mechanism. Methods Forty SD rats were randomly divided into five groups, ie. a blank control group, amethylprednisolone control group, a model group, and two methylprednisolone intervention groups. Chronic bronchitis model was established by cigarette inhalation in the model group and two intervention groups. Methylprednisolone was injected intraperitoneally in the two intervention groups before exposing to cigarette smog ( at the dose of 1 mg/ kg and 10 mg/ kg, qd,respectively) . The protein expression of phosphodiesterase 4D ( PDE4D ) in trachea and lung samples was determined by immunohistochemical staining. The average optical density of positive staining of PDE4D was determined by image analysis technique and gray scale scanning. Bronchoalveolar lavage fluid ( BALF) was collected for total and differential cell counts, and the concentrations of TNF-αand interleukin-8 ( IL-8) in BALF were detected by ELISA. Results Cigarette smoking induced obvious airway inflammation in themodel group, and the inflammation was alleviated in the two methylprednisolone intervention groups.Compared with the two control groups, the expression of PDE4D was obviously elevated in tracheal and lungs in the model group( P lt; 0. 05) . Moreover, the increased expression of PDE4D was positively related with theincreased release of TNF-αand IL-8 in BALF. The expression of PDE4D and the release of TNF-αand IL-8 in BALF were decreased after the treatment with methylprednisolone in a dose-dependent manner ( P lt;0. 05) . Compare with the low dose intervention group, there was no markedly difference related to PMNnumber and TNF-α release in the high dose intervention group ( P gt; 0.05) . Conclusions Methylprednisolone may alleviate airway inflammation of chronic bronchitis by inhibiting the expression of PDE4D in rats. Inhibition of PDE4D may down-regulate TNF-αactivity, which may further reduce IL-8 release and alleviate airway inflammation.
Objective To determine the airway wall thickness at the segmental and subsegmental levels in patients with bronchial asthma and eosinophilic bronchitis ( EB) by high resolution CT scanning,and evaluate its relationship with airway hyperresponsiveness. Methods High resolution CT scanning was performed in 14 subjects with asthma,15 subjects with EB, 15 subjects with cough variant asthma ( CVA) ,and 14 healthy volunteers. Total airway and lumen diameter, total airway cross sectional area and lumen area which corrected by body surface area ( BSA) were measured. The percentage of airway wall area to total airway cross sectional area ( WA% ) and wall thickness to airway diameter ratio ( T/D) were calculated for the right upper lobe apical segmental bronchus ( RB1) and all airways clearly visualized with a transverse diameter of 1-6 mm. Results T/D/BSA and WA% in the asthma patients were all significantly higher than those in the subjects with EB, CVA and healthy volunteers. T/D/BSA and WA% in the EB patients were significantly higher than the healthy volunteers, and similar with the CVA patients. Al /BSA in the patientswith asthma and CVA was less than the subjects with EB and the healthy volunteers. However, Al /BSA in the EB patients was similar with the healthy volunteers. Conclusions The airway wall thickness and remodeling can be measured and assessed by high resolution CT. Airway wall thickness and remodeling inEB patients are milder than asthma patients, which may be associated with airway hyperresponsiveness that presents in asthma but not in EB.
Objective To evaluate and select essential medicine for acute bronchitis using evidence-based methods based on the burden of disease. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Eight guidelines were included (seven foreign guidelines, one domestic guideline; five based on evidence, three based on expert consensus). (2) A result of six RCTs (n=816, low quality) indicated that pentoxyverine had efficiencies of 53% to 82% for cough relief. Among the six RCTs, a result of three RCTs (n=283) indicated that pentoxyverine was slightly less efficient than procaterol (RR=0.86, 95%CI 0.78 to 0.94, P=0.001); a result of two RCTs (n=233) indicated that pentoxyverine was slightly less efficient than Chinese medicinals decoction (RR=0.82, 95%CI 0.74 to 0.91, Plt;0.001). Adverse reaction of pentoxyverine (incidence: 0% to 2.4%) mainly covered nausea, palpitation, etc. Pentoxyverine cost 0.20 yuan (for adult) or 0.08 yuan (for child) daily, which was orally taken and applicable to the target population. (3) A result of six RCTs (n=403, low quality) indicated that the efficiencies of dextromethorphan for cough relief was 47.0% to 95.3%. Among the six RCTs, a result of one RCT (n=283) indicated that dextromethorphan hydrobromide (nasal drop) was more efficient than blank intervention (RR=3.71, 95%CI 1.91 to 7.21); a result of one RCT (n=43) indicated that dextromethorphan (for oral use) was more efficient than placebo (RR=1.74, 95%CI 1.13 to 2.66); a result of one RCT (n=300, moderate quality) indicated that dextromethorphan was more efficient than pentoxyverine (RR=1.16, 95%CI 1.07 to 1.26); a result of one observational study (n=121, low quality) indicated that dextromethorphan given for 5 days had an efficiency of 66.5%. Adverse reaction of dextromethorphan (incidence: 2% to 30%) mainly covered mouth dryness, dizziness, nausea, etc. Conclusion (1) We offer a b recommendation for dextromethorphan used in relieving dry cough due to acute bronchitis. (2) We offer a weak recommendation for pentoxyverine as symptomatic treatment for cough relief. (3) We make a recommendation against antibiotics, β2-agonist bronchodilators and mucolytic agents as routine use. (4) More large-scale, multi-center, double-blinded RCTs are needed in clinical and pharmacoeconomic studies of acute bronchitis in hopes of producing high-quality local evidence.
Objective To evaluate and select essential medicine for acute exacerbation of chronic bronchitis (AECB) using evidence-based methods based on the burden of disease. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Five guidelines were included (four foreign guidelines, one domestic guideline; three based on evidence, two based on expert consensus). (2) Medicines recommended at least twice by the National Essential Medicine List (NEML, 2009 version) and Chinese National Formulary (CNF) contained: ipratropium bromide (four times), amoxicillin amp; clavulanate potassium (three times), and corticosteroid (three times), cefuroxime (twice), ciprofloxacin (twice), levofloxacin (twice), salbutamol (twice) and dextromethorphan (twice). (3) As for domestic study evidence, a result of one RCT indicated that amoxicillin amp; clavulanate potassium had efficiencies of 92.3% to 94.7% (n=77, low quality). A result of three RCTs (n=275, low quality) indicated that cefuroxime had efficiencies of 67.6% to 90% and an incidence of 5% as to adverse reaction that mainly included skin rashes, diarrhea, etc. A result of two RCTs (n=120, low quality) indicated that ciprofloxacin had efficiencies of 78.3% to 86.6%, bacterial clearance rates of 72.7% to 86.5% and the incidences of 8.7% to 16.2% as to adverse reaction that mainly included gastrointestinal reaction, skin rashes, etc. A result of seven RCTs (n=523, low quality) indicated that levofloxacin had efficiencies of 72.5% to 94.5%, bacterial clearance rates of 82.1% to 95.8% and the incidences of 5% to 7.5% as to adverse reaction. A result of two RCTs (n=239, low quality) indicated that salbutamol had efficiencies of 85.4% to 96.7%. A result of one RCT (n=95, low quality) indicated that ipratropium bromide had efficiencies of 98%. A result of five RCTs (n=466, low quality) indicated that the combined use of budesonide and bronchodilators had efficiencies of 93.4% to 97.8%. Conclusion (1) We offer a b recommendation for cefuroxime, amoxicillin amp; clavulanate potassium, ciprofloxacin and levofloxacin used in the treatment of AECB. (2) We offer a b recommendation for glucocorticoid (budesonide, aerosol) and anticholinergic bronchodilator (ipratropium bromide) and a weak recommendation for short-acting β2-agonist bronchodilator (salbutamol) and antitussive agent (dextromethorphan) for alleviating symptoms due to AECB. (3) We make a recommendation against mucolytic agents and theophylline as routine use. (4) More large-scale, multi-center, double-blinded RCTs are needed in clinical and pharmacoeconomic studies on AECB and outcome indicator should be improved in order to produce high-quality local evidence.
Objective To evaluate the effectiveness and safety of clarithromycin extended-release and immediate-release formulations in the treatment of patients with acute exacerbation of chronic bronchitis. Methods The randomized controlled trials (RCTs) of clarithromycin extended-release and immediate-release formulations in the treatment of patients with acute exacerbation of chronic bronchitis were searched in the following electronic databases: The Cochrane Library (Issue 1, 2010), PubMed (2000 to Jan. 2010), EMbase (1980 to Dec. 2009), CBM (2000 to Jan. 2010), and WanFang Data (2000 to Jan. 2010). Two reviewers independently screened the included studies, abstracted the data and assessed the quality. The RevMan 5.0 software was used to conduct meta-analyses. Results A total of four RCTs involving 2041 patients were included, and the Jadad scales of all studies were more than five. The results of meta-analyses showed that there was no significant difference between the extended-release formulation group and the immediate-release formulation group in aspects of the clinical cure rate (RR=0.93, 95%CI 0.96 to 1.03), the pathogen eradication rate (RR=0.99, 95%CI 0.94 to 1.04), and the adverse reaction incidence rate (RR=1.06, 95%CI 0.90 to 1.25). Conclusion As the present evidence shows, there is no significant difference in effectiveness and safety between the clarithromycin extended-release and immediate-release formulations in the treatment of patients with acute exacerbation of chronic bronchitis.
Objective To study the efect of montelukast for improving bronchial hyperresponsiveness (BHR) in treatment of bronchiolitis. Methods Four hundreds infants, 3 to 24 months old, hospitalized with acute bronchiolitis in three Hospitals (Urumqi Children’s Hospital, Pediatrics Department of First Ailiated Hospital of Xinjiang Medical University, and Pediatrics Department of Army General Hospital) from January, 2007 to January, 2008, were randomly assigned into four groups: placebo group (n=92), budesonide group (n=91), montelukast short-course group (7 days, n=88), and montelukast long-course group (28 days, n=90). Main outcome measure was BHR ater treatment, including recurrent bronchiolitis wheezing and asthma incidence rate. Secondary measures were changes in serum T-IgE level and eosinophilic cationic protein (ECP) level. Results All four groups were comparable at baseline. No signiicant diferences were observed between placebo group and budesonide group in changes of serum T-IgE (F=6.17, P=0.00), ECP (F=8.13, P=0.00), recurrent post-bronchiolitis-wheezing (χ2=49.46, P=0.00) and asthma incidence rate (χ2=27.21, P=0.00). Ater treatment with montelukast, there was statistical signiicance in T-IgE and ECP level, times of recurrent bronchiolitis wheezing and asthma incidence rate, as follows, montelukast short-course group versus placebo group (F=12.56, P=0.00), montelukast short-course group versus budesonide group (F=7.22, P=0.00), montelukast long-course group versus placebo group (F=20.48, P=0.00), montelukast long-course group versus budesonide group (F=13.56, P=0.00), montelukast short-course group versus montelukast long-course group (F=1.04, P=0.00). Conclusions Budesonide treatment for 7 days can not improve bronchial hyperresponsiveness induced by bronchiolitis, while montelukast does, that is, montelukast can decrease both the times of bronchiolitis wheezing and asthma incidence rate. Long-course treatment of montelukast is superior to that of short-course.
Objective To evaluate the anti-tussive effect of a total alkaloid agent extracted from Papaver Somniferum L. on simple chronic bronchitis of which the syndrome was counterflow ascent of lung qi according to traditional Chinese medicine (TCM). Methods Randomised, double blind method, placebo control and add on design were applied. Forty-five patients with counterflow ascent of lung qi of simple chronic bronchitis were randomly divided into two groups: treatment group (n=21) with alkaloid agent and control group (n=24) with placebo. Results The incidences of obvious coughing in treatment and control groups were 66.67% and 70.83% (P=0.763 3) respectively. The cough alleviation time of patients was 14.64±16.30 h and 15.12±15.28 h (P=0.795 6) respectively. The loss of cough rates on the third day was 28.57%, 16.67% (P=0.337 7) respectively. The average scores decreased were 4.29 and 2.88 (P=0.054 8) respectively. Conclusions The study indicates that total alkaloid agent extracted from Papaver somniferum L. has no significant anti-tussive effect on patients with counterflow ascent of lung qi of simple chronic bronchitis treated with cefaclor sustained release capsules simultaneously. The trial was interrupted by the advice from experts who disagreed with the selection of drug indication.
目的 评价酚妥拉明治疗小儿毛细支气管炎的疗效和安全性。 方法 计算机检索Cochrane图书馆，Medline（1950年－2013年），Embase（1980年－2013年），中国生物医学文献数据库（1978年－2013年）、中国知网（1979年－2013年）、万方（1986年－2013年）、维普（1989年－2013年），收集酚妥拉明联合常规方法对比仅用常规方法治疗小儿毛细支气管炎的随机对照试验（RCT），由两名研究者根据纳入与排除标准筛选文献、提取资料并评价质量后，采用RevMan 5.1软件进行Meta分析。 结果 共纳入13个RCT，1 186例患儿。Meta分析结果显示：在常规治疗基础上加用酚妥拉明，其总有效率[RR=1.30，95%CI（1.15，1.46），P＜0.000 1]、平均住院时间[MD=?2.15 d，95%CI（?2.78，?1.53） d，P＜0.000 01]、啰音消失的平均时间[MD=?1.62 d，95%CI（?2.02，?1.23） d，P＜0.000 01]，憋喘消失的平均时间[MD=?2.39 d，95%CI（?4.64，?0.13）d，P=0.04]差异有统计学意义，而气促消失的平均时间差异无统计学意义[MD=?0.62 d，95%CI（?1.31，0.07）d，P=0.08]。 结论 在常规治疗基础上加用酚妥拉明治疗小儿毛细支气管炎时，其疗效疗效优于仅采用常规治疗，在缓解啰音、憋喘等临床症状上起效更快。而在安全性方面证据不足，需要进一步的研究。