The Chinese prescription lianhuaqingwen capsule exerts anti-influenza activity through the inhibition of viral propagation and impacts immune function.

BACKGROUND: Lianhuaqingwen Capsule (LH-C) is a traditional Chinese medicine (TCM) formula used to treat respiratory tract infectious diseases in Chinese. The aim of this study was to determine the antiviral activity of LH-C and its immunomodulatory effects on viral infection. METHOD: The in vitro cytotoxicity and antiviral activity of LH-C was determined by MTT and Plaque reduction assays. Time course study under single-cycle virus growth conditions were used to determine which stage of viral replication was blocked. The effect of LH-C on the nuclear export of the viral nucleoprotein was examined using an indirect immunofluorescence assay. The regulation to different signaling transduction events and cytokine/chemokine expression of LH-C was evaluated using Western blotting and real-time RT-PCR. After virus inoculation, BALB/c mice were administered with LH-C of different concentrations for 5 days. Body-weight, viral titers and lung pathology of the mice were measured, the level of inflammatory cytokines were also examined using real-time RT-PCR. RESULTS: LH-C inhibited the proliferation of influenza viruses of various strain in vitro, with the 50% inhibitory concentration (IC50) ranging from 0.35 to 2 mg/mL. LH-C blocked the early stages (0-2 h) of virus infection, it also suppressed virus-induced NF-kB activation and alleviated virus-induced gene expression of IL-6, IL-8, TNF-a, IP-10, and MCP-1 in a dose-dependent manner. LH-C treatment efficiently impaired the nuclear export of the viral RNP. A decrease of the viral titers in the lungs of mice were observed in groups administered with LH-C. The level of inflammatory cytokines were also decreased in the early stages of infection. CONCLUSIONS: LH-C, as a TCM prescription, exerts broad-spectrum effects on a series of influenza viruses, including the newly emerged H7N9, and particularly regulates the immune response of virus infection. Thus, LH-C might be a promising option for treating influenza virus infection.

Lung function and incidence of chronic obstructive pulmonary disease after improved cooking fuels and kitchen ventilation: a 9-year prospective cohort study.

BACKGROUND: Biomass smoke is associated with the risk of chronic obstructive pulmonary disease (COPD), but few studies have elaborated approaches to reduce the risk of COPD from biomass burning. The purpose of this study was to determine whether improved cooking fuels and ventilation have effects on pulmonary function and the incidence of COPD. METHODS AND FINDINGS: A 9-y prospective cohort study was conducted among 996 eligible participants aged at least 40 y from November 1, 2002, through November 30, 2011, in 12 villages in southern China. Interventions were implemented starting in 2002 to improve kitchen ventilation (by providing support and instruction for improving biomass stoves or installing exhaust fans) and to promote the use of clean fuels (i.e., biogas) instead of biomass for cooking (by providing support and instruction for installing household biogas digesters); questionnaire interviews and spirometry tests were performed in 2005, 2008, and 2011. That the interventions improved air quality was confirmed via measurements of indoor air pollutants (i.e., SO2, CO, CO2, NO2, and particulate matter with an aerodynamic diameter of 10 µm or less) in a randomly selected subset of the participants' homes. Annual declines in lung function and COPD incidence were compared between those who took up one, both, or neither of the interventions. Use of clean fuels and improved ventilation were associated with a reduced decline in forced expiratory volume in 1 s (FEV1): decline in FEV1 was reduced by 12 ml/y (95% CI, 4 to 20 ml/y) and 13 ml/y (95% CI, 4 to 23 ml/y) in those who used clean fuels and improved ventilation, respectively, compared to those who took up neither intervention, after adjustment for confounders. The combined improvements of use of clean fuels and improved ventilation had the greatest favorable effects on the decline in FEV1, with a slowing of 16 ml/y (95% CI, 9 to 23 ml/y). The longer the duration of improved fuel use and ventilation, the greater the benefits in slowing the decline of FEV1 (p<0.05). The reduction in the risk of COPD was unequivocal after the fuel and ventilation improvements, with an odds ratio of 0.28 (95% CI, 0.11 to 0.73) for both improvements. CONCLUSIONS: Replacing biomass with biogas for cooking and improving kitchen ventilation are associated with a reduced decline in FEV1 and risk of COPD. TRIAL REGISTRATION: Chinese Clinical Trial Register ChiCTR-OCH-12002398.

Leritrelvir for the treatment of mild or moderate COVID-19 without co-administered ritonavir: a multicentre randomised, double-blind, placebo-controlled phase 3 trial.

Background: Leritrelvir is a novel α-ketoamide based peptidomimetic inhibitor of SARS-CoV-2 main protease. A preclinical study has demonstrated leritrelvir poses similar antiviral activities towards different SARS-CoV-2 variants compared with nirmatrelvir. A phase 2 clinical trial has shown a comparable antiviral efficacy and safety between leritrelvir with and without ritonavir co-administration. This trial aims to test efficacy and safety of leritrelvir monotherapy in adults with mild-to-moderate COVID-19. Methods: This was a randomised, double-blind, placebo-controlled, multicentre phase 3 trial at 29 clinical sites in China. Enrolled patients were from 18 to 75 years old, diagnosed with mild or moderate COVID-19 and not requiring hospitalization. Patients had a positive SARS-CoV-2 nucleic acid test (NAT) and at least one of the COVID-19 symptoms within 48 h before randomization, and the interval between the first positive SARS-CoV-2 NAT and randomization was ≤120 h (5 days). Patients were randomly assigned in a 1:1 ratio to receive a 5-day course of either oral leritrelvir 400 mg TID or placebo. The primary efficacy endpoint was the time from the first dose to sustained clinical recovery of all 11 symptoms (stuffy or runny nose, sore throat, shortness of breath or dyspnea, cough, muscle or body aches, headache, chills, fever ≥37 °C, nausea, vomiting, and diarrhea). The safety endpoint was the incidence of adverse events (AE). Primary and safety analyses were performed in the intention-to-treat (ITT) population. This study is registered with ClinicalTrials.gov, NCT05620160. Findings: Between Nov 12 and Dec 30, 2022 when the zero COVID policy was abolished nationwide, a total of 1359 patients underwent randomization, 680 were assigned to leritrelvir group and 679 to placebo group. The median time to sustained clinical recovery in leritrelvir group was significantly shorter (251.02 h [IQR 188.95-428.68 h]) than that of Placebo (271.33 h [IQR 219.00-529.63 h], P = 0.0022, hazard ratio [HR] 1.20, 95% confidence interval [CI], 1.07-1.35). Further analysis of subgroups for the median time to sustained clinical recovery revealed that (1) subgroup with positive viral nucleic acid tested ≤72 h had a 33.9 h difference in leritrelvir group than that of placebo; (2) the subgroup with baseline viral load >8 log 10 Copies/mL in leritrelvir group had 51.3 h difference than that of placebo. Leritrelvir reduced viral load by 0.82 log10 on day 4 compared to placebo. No participants in either group progressed to severe COVID-19 by day 29. Adverse events were reported in two groups: leritrelvir 315 (46.46%) compared with placebo 292 (43.52%). Treatment-relevant AEs were similar 218 (32.15%) in the leritrelvir group and 186 (27.72%) in placebo. Two cases of COVID-19 pneumonia were reported in placebo group, and one case in leritrelvir group, none of them were considered by the investigators to be leritrelvir related. The most frequently reported AEs (occurring in ≥5% of participants in at least one group) were laboratory finding: hypertriglyceridemia (leritrelvir 79 [11.7%] vs. placebo 70 [10.4%]) and hyperlipidemia (60 [8.8%] vs. 52 [7.7%]); all of them were nonserious. Interpretation: Leritrelvir monotherapy has good efficacy for mild-to-moderate COVID-19 and without serious safety concerns. Funding: This study was funded by the National Multidisciplinary Innovation Team Project of Traditional Chinese Medicine, Guangdong Science and Technology Foundation, Guangzhou Science and Technology Planning Project and R&D Program of Guangzhou Laboratory.

The association between BMI and COPD: the results of two population-based studies in Guangzhou, China.

BACKGROUND AND OBJECTIVE: An association between chronic obstructive pulmonary disease (COPD) and low body mass index (BMI) has been well established in cross-sectional studies. However, there have been few cohort studies investigating this issue. We therefore aimed to address this gap. METHODS: Two population-based studies, a cross-sectional study including 1818 subjects and a subsequent 4-year cohort study consisting of 759 individuals without COPD, were conducted in Guangzhou, China. Every subject was 40 years old or older at the time of recruitment and completed questionnaire interviews, anthropometric measurements and spirometry testing. As a follow-up, each subject underwent annual pre-bronchodilator spirometry testing. Subjects with a pre-bronchodilator FEV1/FVC <0.7 were required to undergo post-bronchodilator spirometry testing. Subjects with a post-bronchodilator FEV1/FVC <0.7 were diagnosed with COPD. RESULTS: Compared to subjects with normal BMI (18.5 to 23.9 kg/m(2)), those with low BMI (<18.5 kg/m(2)) had a higher prevalence of COPD (21.1% vs. 7.5%), with an adjusted OR of 2.75 [95% confidence intervals (CI): 1.69 to 4.47]. Both low BMI and obese (≥ 28.0 kg/m(2)) subjects had lower FEV1 after adjustment. This association was further confirmed in the cohort study; non-COPD subjects with low BMI at baseline were more likely to develop COPD (RR = 2.88, 95% CI: 1.06 to 7.85), independent of smoking status and other confounders. CONCLUSIONS: Low BMI was not only a systemic consequence of COPD but also an important risk factor for the development of COPD, which raises the possibility that early intervention in subjects with low BMI may reduce the incidence of COPD.

Adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration adverse event reporting system.

Molnupiravir, an urgently approved drug during the Coronavirus Disease 2019 (COVID-19) pandemic, serves as the basis for our study, which relies on the Food and Drug Administration Adverse Event Reporting System (FAERS). The objective is to extract adverse event (AE) signals associated with molnupiravir from the FAERS database, thereby providing a reference for post-marketing monitoring of adverse events. Specifically, we extracted individual case safety reports (ICSRs) from the database, focusing on cases with COVID-19 indications and molnupiravir identified as the primary suspect drug. Descriptive analysis of the extracted data was performed, followed by four disproportionality analyses using the reporting odds ratio (ROR) method. These analyses were conducted across four levels, encompassing overall data, reports by health professionals, as well as age and gender differentiations, ensuring the robustness of the analysis results. In total, 116,576 ICSRs with COVID-19 indications and 2,285 ICSRs with molnupiravir as the primary suspect were extracted. Notably, after excluding cases with unknown age or gender, a higher proportion of molnupiravir-related ICSRs were observed among individuals aged 65 years and older (70.07%) and women (54.06%). The most frequently reported adverse events and AE signals were associated with gastrointestinal disorders, as well as skin and subcutaneous tissue disorders. Moreover, individuals aged 65 years and older exhibited a higher risk of cardiac disorders, hepatobiliary disorders, renal and urinary disorders, and vascular disorders. In conclusion, this study found molnupiravir demonstrated a lower risk of serious adverse events compared to other RNA antiviral drugs like remdesivir in patients under 65 years old. However, close monitoring of its safety is still necessary for elderly patients aged 65 years and above. Further studies are warranted to continuously assess the safety profile of molnupiravir as its usage increases, especially in high risk populations.

Pollen allergens sensitization characteristics and risk factors among allergy rhinitis of children in mainland China: A multicenter study.

Background: No comprehensive multicenter study of sensitization patterns among patients with allergic rhinitis (AR) to various common pollen allergens was available nationwide, and risks factors of pollen-induced allergic rhinitis (PiAR) in mainland China was unclear. This study aimed to fill this gap. Methods: A multicenter study was performed on 736 AR patients aged below 18 from four regions of mainland China. Patients completed a standardized questionnaire asking for the environmental risk factors and AR severity, and undertook skin prick tests (SPT) with 14 common pollen allergens. Findings: Among the 736 patients, 341 patients (46.33%) suffered at least one positive pollen allergen sensitization. The positive rate of pollen allergens was significantly higher in the high-age group (Damato et al., 2007; Wang et al., 2018; Luo et al., 2016; Demoly et al., 2011; Sampson and Albergo, 1984; Li et al., 2009; Luo et al., 2021; Ziska and Beggs, 2011; Melén et al., 2020; Jensen-Jarolim, 2017; Rönmark et al., 2017; Ge et al., 2017) [6-17] than the low-age group ( ≤ 5), while no significant difference was found between the sexes. The sensitizations to pollen allergens varied widely among four geographical areas. The positive rate was higher in north China and west China than in east China, and south China had the lowest positive rate. The region of residence, ages, ethnic minorities, history of pollen exposure, the material of living room floor and material of pillow were statistically significant risks of PiAR. Interpretation: This study provides new insights into the pollen allergens sensitization characteristics in AR and the factors affecting PiAR in mainland China.

Trends of pulmonary fungal infections from 2013 to 2019: an AI-based real-world observational study in Guangzhou, China.

Recently, the prevalence trend of pulmonary fungal infection (PFI) has rapidly increased. Changes in the risk factors for, distributions of underlying diseases associated with and clinical characteristics of some individual PFIs have been reported in the past decade. However, data regarding PFIs remain uncertain. This study reports the epidemiological characteristics and trends of PFIs over time in recent years. We applied an automated natural language processing (NLP) system to extract clinically relevant information from the electronic health records (EHRs) of PFI patients at the First Affiliated Hospital of Guangzhou Medical University. Then, a trend analysis was performed. From January 1, 2013, to December 31, 2019, 40,504 inpatients and 219,414 outpatients with respiratory diseases were screened, in which 1368 inpatients and 1313 outpatients with PFI were identified. These patients were from throughout the country, but most patients were from southern China. Upward trends in PFIs were observed in both hospitalized patients and outpatients (P<0.05). The stratification by age showed that the incidence of hospitalized patients aged 14-30 years exhibited the most obvious upward trend, increasing from 9.5 per 1000 patients in 2013 to 88.3 per 1000 patients in 2019. Aspergillosis (56.69%) was the most common PFI, but notably, the incidence rates of Talaromyces marneffei, which used to be considered uncommon, exhibited the most rapid increases. In younger PFI patients, the incidence and trend of PFIs have increased. Infection by previously uncommon pathogens has also gradually increased. Increased attention should be paid to young PFI patients and uncommon PFI pathogen infections.

[Attitudes and actions of chronic obstructive pulmonary disease patients on treatment:a national multi-center investigative study].

OBJECTIVE: To investigate the attitudes and actions of patients with chronic obstructive pulmonary disease (COPD) on treatment. METHODS: A nation-wide multi-center, questionnaire study was carried out to investigate the patient understanding and experience of COPD treatment between Sep. 2007 and Dec. 2008. The questionnaire included the patients' understanding of goal of COPD treatment, previous treatment, and expectation on drugs. The data were analyzed by descriptive statistical methods. RESULTS: 2072 patients with COPD in 11 centers were interviewed in the study. The final effective questionnaires were collected from 1698 cases. 653 patients had known of COPD. The attitudes and actions on treatment were analyzed based on these patients. The patients had different understanding of goals for COPD treatment, including 59.1% (384/650) for relieving symptoms. In recent 3 months, the most commonly used drugs were theophylline (53.7%, 351/653), iprotropium (39.8%, 260/653), tiotropium (27.1%, 177/653). 72.0% (465/646) patients used the drugs according to the prescriptions. There were more than 80% patients who did not understand the side effects of anti-cholinergics, ß-adrenergic agonists, inhaled steroids, inhaled steroid/long-acting ß-agonist combination therapy, or theophyllines. 37.4% (240/641) patients were afraid of side effects of inhaled steroids. 42.2% (274/650) patients often took antibiotics. There was no oxygen supply at home in 60.1% (391/651) patients. 70.5% (457/648) did not have pulmonary rehabilitation. Requirement of long-term regular treatment was considered in 77.4% (500/646) patients. The most important thing about patients' attitude on ideal drugs for COPD was drug efficacy (79.6%, 481/604). The most ideal drug used in the past was fluticasone/salmeterol or tiotropium (16.9%, 78/461). CONCLUSIONS: Patients had different attitudes and actions on COPD treatment. Patient education should be strengthened to realize treatment goals for COPD.

High-dose N-acetylcysteine for long-term, regular treatment of early-stage chronic obstructive pulmonary disease (GOLD I-II): study protocol for a multicenter, double-blinded, parallel-group, randomized controlled trial in China.

INTRODUCTION: The presence of increased oxidative stress and airway inflammation has been proven in subjects with chronic obstructive pulmonary disease (COPD). Several studies have demonstrated that drugs with antioxidant and anti-inflammatory properties such as N-acetylcysteine (NAC) can reduce the rate of exacerbations in patients with COPD. However, the beneficial effects of NAC in early-stage COPD are minimally discussed. We are investigating whether high-dose NAC has therapeutic effects in Chinese patients with early-stage COPD. METHOD AND ANALYSIS: A randomized, double-blinded, placebo-controlled, parallel-group, multicenter clinical trial is evaluating the efficacy and safety of NAC for the long-term treatment of patients with early-stage COPD at 24 centers in China. Subjects aged 40-80 years and recruited by physicians or researchers with special training will be randomized to either NAC 600 mg twice daily group or matching placebo group for 2 years. Measurements will include forced expiratory volume in 1 s (FEV1), the number of COPD exacerbations, health-related quality, and pharmacoeconomic analysis. DISCUSSION: Currently, there are no randomized controlled trials with high-dose N-acetylcysteine (600 mg twice daily) for patients with mild-to-moderate COPD (GOLD I-II). We designed this multicenter randomized controlled trial (RCT) to assess the effectiveness, safety, and cost-effectiveness of long-term treatment with high-dose N-acetylcysteine. The results of this trial may guide clinical practice and change the standard of early COPD management. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-IIR-17012604 . Registered on 07 September 2017.

Chronic bronchitis is associated with severe exacerbation and prolonged recovery period in Chinese patients with COPD: a multicenter cross-sectional study.

BACKGROUND: Chronic bronchitis (CB) is closely associated with the frequency and severity of chronic obstructive pulmonary disease (COPD) exacerbation. However, little is known about the impact of CB on COPD exacerbations, severe and non-severe, and on recovery from an exacerbation. METHODS: We conducted a nation-wide multicenter cross-sectional survey in China between September 2007 and December 2008. Eleven hospitals participated in this study. Patients' demographic information, presence of CB, overall numbers of COPD exacerbation and severe exacerbation leading to emergency visit, hospitalization and intensive care unit (ICU) stay in the past year, recovery period following the last exacerbation, and well- or poor-recovery were recorded. RESULTS: A total of 1,101 patients with COPD were enrolled and 890 (80.8%) had CB. Patients with CB reported more history of frequent exacerbations (≥2/patient/year) (59.6% vs. 50.7%, P=0.019) and severe exacerbation (% emergency visit ≥1: 28.0% vs. 16.6%, P=0.001; % hospitalization ≥1: 51.2% vs. 28.0%, P<0.001; %ICU stay ≥1: 6.5% vs. 1.9%, P=0.009). Recovery period following the last exacerbation was longer in patients with CB (19.0±16.2 vs. 15.2±14.7 days, P=0.003) and more patients with CB reported poor recovery (85.8% vs. 78.4%, P=0.003). Multivariate analyses showed that CB was independently associated with severe exacerbation requiring emergency visit (adjusted OR, 1.512, P=0.048) and hospitalization (adjusted OR, 2.031, P<0.001) and prolonged recovery period (adjusted regression coefficient 2.861, P=0.030). CONCLUSIONS: CB is associated with frequent exacerbations of COPD in Chinese population, especially severe exacerbations requiring emergency visit and hospitalization admission. Additionally, CB significantly prolongs recovery period following COPD exacerbation.

[The relationship between mouth pressure or tracheal pressure and esophagus pressure and diaphragmatic pressure].

OBJECTIVE: To investigate the relationship between mouth pressure (Pmo) or tracheal pressure (Ptr) and esophagus pressure (Pes) or transdiaphragmatic pressure. METHODS: Seventeen patients were involved in the study. Maximal inspiratory pressure (MIP), maximal transdiaphragmatic pressure (Pdi(max)), maximal esophagus pressure (Pes(max)), twitch mouth pressure (TwPmo), twitch transdiaphragmatic pressure (TwPdi) and twitch esophagus pressure (TwPes) were measured before narcotization as a normal procedure for the abdominal operation and twitch tracheal pressure (TwPtr(nar)), twitch esophagus pressure (TwPes(nar)) and twitch transdiaphragmatic pressure (TwPdi(nar)) were dynamically monitored during narcotization. RESULTS: (1) The correlation coefficient (r) values between Pdi(max) and MIP, TwPdi and TwPmo, TwPdi(nar) and TwPtr(nar), Pes(max) and MIP, TwPes and TwPmo, TwPes(nar) and TwPtr(nar) were 0.976 +/- 0.030, 0.816 +/- 0.155, 0.923 +/- 0.446, 0.981 +/- 0.185, 0.829 +/- 0.168 and 0.955 +/- 0.292, respectively. (2) The coefficient variation (CV) of MIP, Pes(max), Pdi(max), TwPmo, TwPes and TwPdi were (14.2 +/- 4.7)%, (15.2 +/- 4.3)%, (15.5 +/- 4.1)%, (30.4 +/- 15.9)%, (10.8 +/- 5.1)% and (9.9 +/- 4.0)%, respectively. The CV of TwPmo was the highest (compare with others, all P < 0.05) and that of TwPes and TwPdi was the lowest (compare with others, all P < 0.05). There was no significant difference among MIP, Pes(max) and Pdi(max) (P > 0.05). (3) The r value between the changing values of TwPtr(nar) and TwPdi(nar) or TwPes(nar) during narcotization were 0.839 or 0.894 (P = 0.000, respectively). CONCLUSION: The measurement of MIP and TwPmo should be repeated and the highest value should be chosen in order to reduce the possibility of underestimating the function of diaphragm, which could be dynamically monitored by TwPtr(nar).

[The development and safety of cough provocation test by capsaicin inhalation].

OBJECTIVE: To assess the application and the safety of capsaicin cough provocation test by dosimeter method. METHODS: Capsaicin inhalation cough challenge test by dosimeter method was performed on 60 healthy volunteers (group A), 11 subjects with upper respiratory infection (group B), 10 patients with gastroesophageal reflux cough (group C) and 10 patients with asthma (group D). Each subject inhaled doubling concentrations of capsaicin (1.95, 3.90, 7.80, 15.6, 31.2, 62.5, 125, 250, 500, 1,000 micromol/L) by a breath-activated dosimeter until the concentration inducing five or more coughs (C(5)) was reached. The lg C(5) was calculated as the cough reflex sensitivity. General lung ventilation and impedance with impulse oscillometry were measured before and after the cough provocation test. RESULTS: There was no serious side effect of the test in all subjects; two subjects complained of slight nausea; one of heartburn, and three of hoarseness. Before the provocation the values of FEV(1) in group A, B, C and D were (3.6 +/- 0.5) L, (3.7 +/- 0.7) L, (2.7 +/- 0.8) L and (2.1 +/- 0.8) L, compared with (3.6 +/- 0.5) L, (3.7 +/- 0.8) L, (2.6 +/- 0.7) L and (2.1 +/- 0.8) L after the test, the differences being not significant (all P > 0.05). Compared with the measurements after provocation, Zrs was (2.6 +/- 0.8) mm Hg.L(-1).s(-1) vs (2.7 +/- 0.8) mm Hg.L(-1).s(-1) in group A, (2.5 +/- 0.5) mm Hg.L(-1).s(-1) vs (2.6 +/- 0.3) mm Hg.L(-1).s(-1) in group B, (2.7 +/- 0.7) mm Hg.L(-1).s(-1) vs (2.7 +/- 0.7) mm Hg.L(-1).s(-1) in group C, (3.3 +/- 1.5) mm Hg.L(-1).s(-1) vs (3.7 +/- 2.0) mm Hg.L(-1).s(-1) in group D, the differences showed no significance (all P > 0.05 respectively). The lg C(5) value was 2.45 +/- 0.46 in group A, 2.51 +/- 0.20 in group B, 1.52 +/- 0.70 in group C, 2.34 +/- 0.56 in group D. Compared with group A, B and D, the lg C(5) value in group C was significantly different (all P < 0.01 respectively). The lg C(5) value showed no significant difference among group A, group B and group D (all P > 0.05). CONCLUSION: Capsaicin inhalation cough provocation test by dosimeter method is a safe and specific tool for measuring cough reflex sensitivity.

[The efficacy of half of the Global Initiative for Asthma recommended dose of inhaled corticosteroids in the management of Chinese asthmatics].

OBJECTIVE: To explore the optimal doses of inhaled corticosteroids (ICS) for the management of Chinese asthmatics in order to enhance cost-effectiveness. METHODS: A randomized, paralleled and controlled multi-center study was carried out in 11 provincial hospitals. After one week run-in period when only inhaled salbutamol as needed was given, the asthmatic patients (n = 86) were divided into two groups: patients in group G (n = 42) received inhaled ICS with the doses recommended by Global Initiative for Asthma (GINA), ie, fluticasone propionate (FP) 250 microg bid for moderate asthma and 375 microg bid for severe asthma. Patients in group H (n = 44) received half of the above doses of FP (125 microg bid for moderate asthma and 125 microg in the morning, 250 microg in the evening for severe asthma). RESULTS: There were no significant differences between group G and group H in the 32 measurements after management, including day symptom score (severe asthma in group G 0.7 +/- 0.8, group H 0.4 +/- 0.6 and moderate asthma in group G 0.4 +/- 0.5, group H 0.3 +/- 0.5), FEV(1) [severe asthma in group G (1.5 +/- 0.5) L, group H (1.8 +/- 0.6) L/min and moderate asthma in group G (2.3 +/- 0.6) L, group H (2.3 +/- 0.8) L/min, FEV(1)% of predicted [severe asthma in group G (54 +/- 17)%, group H (59 +/- 19)%, and moderate asthma in group G (79 +/- 14)%, group H (79 +/- 15)%], the increased morning PEF value (45, 67 L/min in moderate and severe asthma in group G and 56, 65 L/min in moderate and severe asthma in group H respectively), frequency of nights awakened (81, 69 in severe asthma in groups G and H respectively), numbers of well controlled cases (88 and 98 d in severe asthma in groups G and H respectively) and the use of extra bronchodilators (salbutamol, puff/day, 5.0 and 3.4 d in severe asthma in groups G and H respectively, P > 0.05). On the other hand, in the subgroups of moderate asthma, night symptom score (0.30 +/- 0.22 in group G, 0.13 +/- 0.33, t = -2.06, P < 0.05), number of exacerbations (3/22 in group G, 11/24 in group H, chi(2) = 4.74, P < 0.05), number of total controlled cases (18/22 cases in group G, 12/24 cases in group H, chi(2) = 4.97, P < 0.05) were significantly different between group G and group H. In the subgroups of severe asthma, the total days of exacerbations were different between group G and group H (11 days in group G, 6 days in group H, U = 31, P < 0.05). CONCLUSION: As a whole, similar therapeutic effect was achieved using half of the GINA recommended dose of ICS with/without salbutamol inhalation as needed compared with those receiving the GINA recommended full dose of ICS in most Chinese asthmatics.

[Evaluation of the clinical efficacy and the safety of salmeterol/fluticasone propionate accuhaler compared to budesonide turbuhalar in the control of adult asthma].

OBJECTIVE: To evaluate the efficacy and the safety of low dose salmeterol/fluticasone (SM/FP) combination therapy as compared to morate dose of budesonide (BUD) in the management of adult asthma. METHODS: A multicentre, randomised, open-label, parallel-group, 6-week treatment study was conducted. 398 patients (18 - 70 years) were given SM/FP (50/100 microg) twice daily via Accuhaler or BUD 400 microg twice daily via Turbuhaler. RESULTS: The morning and the evening peak expiratory flow (PEF) measurements both increased significantly (P < 0.01) in the SM/FP group, and the increase was greater than that in the BUD group. The significant benefit of SM/FP was evident from the first week. SM/FP led to a more significant reduction in the use of rescue medication and in the day- and night-time asthma symptom scores, as compared to budesonide. Both treatments were well tolerated, and the adverse reactions showed no significant difference between the two groups. CONCLUSIONS: Combination use of low doses of SM/FP is a better choice for the control of asthma. The addition of a low-dose long-acting beta(2) agonist is superior to the simple increase of the dosage of inhaled corticosteroids.

A discriminant function model as an alternative method to spirometry for COPD screening in primary care settings in China.

OBJECTIVE: COPD is often underdiagnosed in a primary care setting where the spirometry is unavailable. This study was aimed to develop a simple, economical and applicable model for COPD screening in those settings. METHODS: First we established a discriminant function model based on Bayes' Rule by stepwise discriminant analysis, using the data from 243 COPD patients and 112 non-COPD subjects from our COPD survey in urban and rural communities and local primary care settings in Guangdong Province, China. We then used this model to discriminate COPD in additional 150 subjects (50 non-COPD and 100 COPD ones) who had been recruited by the same methods as used to have established the model. All participants completed pre- and post-bronchodilator spirometry and questionnaires. COPD was diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease criteria. The sensitivity and specificity of the discriminant function model was assessed. RESULTS: THE ESTABLISHED DISCRIMINANT FUNCTION MODEL INCLUDED NINE VARIABLES: age, gender, smoking index, body mass index, occupational exposure, living environment, wheezing, cough and dyspnoea. The sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, accuracy and error rate of the function model to discriminate COPD were 89.00%, 82.00%, 4.94, 0.13, 86.66% and 13.34%, respectively. The accuracy and Kappa value of the function model to predict COPD stages were 70% and 0.61 (95% CI, 0.50 to 0.71). CONCLUSIONS: This discriminant function model may be used for COPD screening in primary care settings in China as an alternative option instead of spirometry.

Community based integrated intervention for prevention and management of chronic obstructive pulmonary disease (COPD) in Guangdong, China: cluster randomised controlled trial.

OBJECTIVE: To evaluate the effects of a community based integrated intervention for early prevention and management of chronic obstructive pulmonary disease (COPD) in China. DESIGN: Cluster randomised controlled trial. SETTING: Eight healthcare units in two communities. PARTICIPANTS: Of 1062 people aged 40-89, 872 (101 with COPD and 771 without COPD) who fulfilled the inclusion and exclusion criteria were allocated to the intervention or the usual care programmes. INTERVENTION: Participants randomly assigned to integrated intervention (systematic health education, intensive and individualised intervention, treatment, and rehabilitation) or usual care. MAIN OUTCOME MEASURES: Annual rate of decline in forced expiratory rate in one second (FEV(1)) before use of bronchodilator. RESULTS: Annual rate of decline in FEV(1) was significantly lower in the intervention community than the control community, with an adjusted difference of 19 ml/year (95% confidence interval 3 to 36) and 0.9% (0.1% to 1.8%) of predicted values (all P<0.05), as well as a lower annual rate of decline in FEV(1)/FVC (forced vital capacity) ratio (adjusted difference 0.6% (0.1% to 1.2%) P=0.029). There were also higher rates of smoking cessation (21% v 8%, P<0.004) and lower cumulative death rates from all causes (1% v 3%, P<0.009) in the intervention community than in the control community during the four year follow-up. Improvements in knowledge of COPD and smoking hazards, outdoor air quality, environmental tobacco smoke, and working conditions were also achieved (all P<0.05). The difference in cumulative incidence rate of COPD (both around 4%) and cumulative death rate from COPD (2% v 11%) did not reach significance between the two communities. CONCLUSIONS: A community based integrated intervention can have a significant impact on the prevention and management of COPD, mainly reflected in the annual rate of decline in FEV(1). TRIAL REGISTRATION: Chinese Clinical Trials Registration (ChiCTR-TRC-00000532).