Evidence-based medicine (EBM) is a new technique for medical research. It is interesting to know how to publish a high quality paper after clinical trial by the criteria of EBM. This paper presents our experience on clinical trials as well as publishing EBM papers, including the aim of research, the design of study methods, the selection and application of statistical methods, the analysis of study results, feedback to the reviewer’s comments, and other technology related to the submitted manuscript, in order to improve the skill of publishing EBM study in our country.
Objective To assess the efficacy of acupuncture versus western medicine in the treatment of depression in China. Methods Randomized controlled trials (RCTs) involving acupuncture versus western medicine in the treatment of depression in China were identified from CNKI (1979 to 2007), VIP (1989 to 2007), WANFANG Database (1998 to 2007) and CBM (1978 to 2007). We also hand searched relevant journals and conference proceedings. Data were extracted and evaluated by two reviewers independently with a specially designed extraction form. The Cochrane Collaboration’s RevMan4.2.8 software was used for data analyses. Results A total of 8 trials involving 619 patients were included. Meta-analyses showed that the total effective rate in the acupuncture group was similar when compared with fluoxetine (RR 1.03, 95%CI 0.94 to 1.14), doxepin (RR 1.14, 95%CI 0.91 to 1.43), amitriptyline (RR 0.95, 95%CI 0.70 to 1.29) and venlafaxine (RR 1.02, 95%CI 0.90 to 1.16). As for the HAMD score at week 2, no significant difference was noted between acupuncture and fluoxetine (WMD 0.03, 95%CI -1.26 to 1.31) or amitriptyline (WMD –?0.33, 95%CI –?1.88 to 1.23); for the HAMD score at week 4, no significant difference was observed between acupuncture and fluoxetine (WMD –?0.24, 95%CI –?1.85 to 1.37) or amitriptyline (WMD –?0.57, 95%CI –?2.02 to 0.88); for the HAMD score at week 6, acupuncture also had similar effects to fluoxetine (WMD –?0.19, 95%CI –?1.51 to 1.13). In terms of the SDS scores at week 2, 4, 6 and 8, no significant differences were noted between acupuncture and fluoxetine. Two trials reported adverse events and these observed no adverse events in the acupuncture group, but 31 and 25 patients experienced adverse events in the western medicine groups of these two trials. Conclusion Acupuncture is not inferior to western medicine, and it is worth noting that acupuncture is associated with few adverse reactions. Further large-scale trials are required to define the role of acupuncture in the treatment of depression.
Respiratory oscillometry is a lung function test that measures the mechanical properties of respiratory system by the forced oscillation technique. Oscillometry can be used in those who cannot perform traditional lung function tests, including young children. It is also an important tool to assess small airways function in clinical and research fields. In 2020, the European Respiratory Society published a new technical standard for respiratory oscillometry, which offered updated technical recommendations on the hardware, software, testing protocols and quality control of oscillometry measurements. This paper interpreted the new technical standard, for providing technical suggestions regarding oscillometry measurements in clinical and research settings, and as a reference for developing technical statements and recommendations for oscillometry in China.
In 2005, interpretative strategies for pulmonary function tests were issued jointly by the American Thoracic Society (ATS) and the European Respiratory Society (ERS), and they have since been updated in 2021. In this article, we introduced the updated key points, including reference equations and normal limits, natural changes in lung function over time, bronchodilator responsiveness testing, the classification of physiological impairments, and the severity of lung function impairment. We also put forward some suggestions from the viewpoint of our national conditions. We expected it to provide useful references for those concerned with the application of pulmonary function tests in China.
In 1994, a statement on the performance of lung function testing was issued by the Association for Respiratory Technology & Physiology (ARTP), and it has been updated in 2020. In this paper, we introduced the updated content, including general procedures, normal value ranges and interpretations of obstructive ventilation dysfunction, precautions of lung function tests, and paediatric lung function testing. We also compared the differences between the ARTP statement and the lung function guidelines issued by the Chinese Thoracic Society (CTS) and put forward some appropriate suggestions from the viewpoint of our current situation. We expected it to provide valuable references for the normative update and application of pulmonary function tests in China.
Objective To evaluate the impacts of pulmonary rehabilitation at different levels of exercise intensity on health status of patients with moderate to severe COPD. Methods Thirty-two COPD patients treated with pulmonary rehabilitation by ergometry exercise were randomly assigned to exercise intensity level either by anaerobic threshold （AT group; n=15） or by maximum tolerate [high intensity group（HI group）; n=17]. Nine COPD patients without exercise training served as control. Bicycle exercise training was conducted in two separate days each week for 12 weeks. Spirometry，cardiopulmonary exercise testing，the St George’s Respiratory Questionnaire （SGRQ） were accessed before and after the rehabilitation program. Results Exercise intensity （%Wmax） was significantly higher in HI group than AT group （69%±14% vs 52%±7%，Plt;0.01）. Significant improvement of SGRQ scores after rehabilitation were found both in AT group （－11.91±15.48 U） and HI group （－8.39±9.49 U）. However，no significant difference was found between the two groups in the degree of improvement （Z=－0.540，P=0.589）. Symptoms and impacts subscale scores of SGRQ were decreased significantly in HI group，but only symptoms scores decreased significantly in AT group. The control group did not show any significant improvement in SGRQ scores. No statistically significant correlation was found between improvement of peak oxygen consumption per predicted (VO2peak%pre) and SGRQ scores. Conclusion Both pulmonary rehabilitation strategies by anaerobic threshold and by maximum tolerate can improve health status of COPD patients significantly with no significant difference between each other.
Objective To evaluate the clinical value and safety of adenosine monophosphate( AMP)bronchoprovocation test in patients with asthma. Methods Sixty asthmatics, including 19 cases with uncontrolled asthma, 22 with partially controlled asthma, and 19 with controlled asthma were enrolled. Twenty-four healthy volunteers were enrolled as control and 20 patients with upper respiratory tract infection ( URI) were also included. AMP bronchoprovocation test ( AMP-BPT) was performed. PD20 FEV1-AMP lt;40 mg was set as a cut-off value of positive response to AMP. Positive rate, sensitivity, specificity, accuracy and adverse reactions of AMP-BPT were evaluated. Eleven cases with uncontrolled asthma and 12 cases with partially controlled asthma were followed up with AMP-BPT three months and six months after inhaledcorticosteroids treatment. Asthma symptom scores were recorded a week early before each challenge. The correlation between PD20FEV1 -AMP and asthma symptom score was analyzed. Values of PD20 FEV1 -AMP were represented as median and quartile range [ M( QR) ] . Results No positive responses to AMP were found in both healthy and URI subjects. On the other hand, positive responses to AMP were found in all the uncontrolled asthmatics ( 100% ) with PD20FEV1 -AMP as 0. 6 mg ( 0. 4 mg) , in 19 partially controlled asthmatics ( 86. 4% ) with PD20 FEV1 -AMP as 5. 38 mg ( 32. 67 mg ) , and in 5 controlled asthmatics( 26. 3% ) with PD20FEV1 -AMP as 40 mg ( 29. 3 mg) . There were negative correlations between the logarithms of PD20 FEV1 -AMP and logarithms of asthma symptom scores ( r = - 0. 598, P lt; 0. 01) . The sensitivity, specificity and accuracy was 72% , 100%, and 84% , respectively. Percentage of subjects who experienced wheezing, cough, dyspnea, swallows stimulation, chest tightness, expectoration and cyanosis during AMP-BPT were 37. 5%, 21. 2%, 15. 4%,7. 7%, 7. 7%, 4. 8%, and 1. 0%, respectively. No severe adverse reaction was found. Conclusions AMP-BPT is helpful to the diagnosis and differential diagnosis of bronchial asthma. It also can be used to evaluate the severity and control level, and to monitor the therapeutic efficacy in clinical practice. Moreover, AMP-BPT is well tolerated with little adverse reaction.
ObjectiveTo investigate CT image features of ground glass opacity (GGO)-like 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) pneumonia (COVID-19) and early-stage lung carcinoma for control and therapy of this acute severe respiratory disease.MethodsWe retrospectively analyzed the clinical data of 71 GGO-like COVID-19 patients who received therapy in Tongji Hospital of Huazhong University of Science and Technology between January 17th and February 13th, 2020. These 71 GGO-like COVID-19 patients were as a COVID-19 group. And 80 GGO-like early-stage lung carcinoma patients who underwent resection were as a lung carcinoma group. Clinical features such as sex, age, symptoms including fever, cough, fatigue, myalgia and dyspnea, detailed exposure history, confirmatory test (SARS-CoV-2 quantitative RT-PCR) and pathologic diagnosis were analyzed.ResultsSignificantly different symptoms and exposure history between the two groups were detected (P<0.001). More lesions (61 patients at percentage of 85.92%, P<0.001), relative peripheral locations (69 patients at percentage of 97.18%, P<0.001) and larger opacities (65 patients at percentage of 91.55%, P<0.001) were found in chest radiographs of GGO-like COVID-19 compared with GGO-like early-stage lung carcinoma. Similar features appeared in early-stage of COVID-19 and lung carcinoma, while pneumonia developed into more extensive and basal predominant lung consolidation. Coexistence of GGO-like COVID-19 and early-stage lung carcinoma might occur.ConclusionConsidering these similar and unique features of GGO-like COVID-19 and early-stage lung carcinoma, it is necessary to understand short time re-examination of chest radiographs and other diagnostic methods of these two diseases. We believe that the findings reported here are important for diagnosis and control of COVID-19 in China.
ObjectiveTo investigate the effectiveness of proximal femoral nail anti-rotation (PFNA) and cerclage fixation for complicated femoral subtrochanteric fractures.MethodsA clinical data of 74 patients with complicated femoral subtrochanteric fractures, who were admitted between March 2016 and March 2019 and met the criteria, was retrospectively analyzed. Among them, 39 patients were treated with limited open reduction and PFNA combined with cerclage fixation (observation group) and 35 patients were treated with closed reduction and PFNA fixation (control group). There was no significant difference in gender, age, cause of injury, side and type of fracture, and the time from injury to operation (P>0.05). The ratio of postoperative hemoglobin (1, 3, and 5 days) to the preoperative hemoglobin, the operation time, the first weight-bearing time after operation, and the hospital stay were recorded. X-ray films were taken to observe fracture healing in the two groups and bone resorption around the cerclage in the observation group, and the fracture healing time was recorded. Hip function was evaluated by Harris scoring. ResultsThe operation time of the observation group was significantly longer than that of the control group (P<0.05), but the first weight-bearing time and hospital stay were significantly shorter (P<0.05). All patients were followed up 12 months. There was no significant difference in the ratios of post- to pre-operative hemoglobin (1, 3, and 5 days) between the two groups (P>0.05). X-ray film reexamination showed that the fractures of the two groups healed smoothly, and the fracture healing time of the observation group was significantly shorter than that of the control group (t=−12.989, P=0.000). No bone resorption around the cerclage occurred in the observation group. The Harris scores of the observation group were better than those of the control group at 7 days and 1, 2, and 3 months after operation (P<0.05), and there was no significant difference between the two groups at 6 months after operation (t=1.329, P=0.180).ConclusionCompared with PFNA fixation, PFNA combined with cerclage fixation for the complicated femoral subtrochanteric fractures has a shorter operation time, and can obtain immediate stability after fixation, which can meet the needs of patients for early functional exercise.
ObjectiveTo determine the ability of cardiopulmonary exercise testing (CPET) to distinguish chronic thromboembolic pulmonary hypertension (CTEPH) from chronic thromboembolic disease (CTED). MethodsFifty patients diagnosed with CTED and fifty-eight patients with CTEPH in the the First Affiliated Hospital of Guangzhou Medical University from April 2019 to February 2022 were retrospectively included. The basic characteristics including age, gender, body mass index, symptom duration, and N-terminal prohormone of brain natriuretic peptide (NTpro-BNP), parameters of arterial blood gas analysis, right heart catheterization, echocardiography, pulmonary function, and CPET were all compared between patients with CTED and those with CTEPH. ResultsPatients with CTEPH displayed longer symptom duration, increased NTpro-BNP, decreased arterial partial pressure of oxygen, larger right atrial and ventricular diameters, and impaired worse resting pulmonary diffusing function compared with those with CTED (P<0.05). However, there was no statistically significant difference in the resting pulmonary ventilation function between the two groups (P>0.05). Among the CPET parameters of the CTEPH group, peak exercise oxygen uptake per kilogram, oxygen uptake at anaerobic threshold, oxygen pulse, oxygen uptake efficiency slope and oxygen saturation were all decreased, while the minute ventilation-carbon dioxide production at anaerobic threshold (VE/VCO2@AT) and VE/VCO2 slope were increased (P<0.05). However, there was no statistically significant difference in heart rate reserve and breathing reserve (P>0.05). Furthermore, VE/VCO2@AT showed high accuracy for distinguishing CTEPH from CTED (sensitivity, 0.825; specificity, 0.860; and the area under the receiver operating characteristic curve 0.897). ConclusionsPatients with CTEPH showed more significant decreased exercise endurance, diffusion dysfunction, and hypoxemia during exercise and insufficient increase in cardiac output compared with CTED patients. Therefore, it is feasible to apply CPET as a new objective examination to distinguish CTED from CTEPH.