The pre-market approval and clinical application of innovative medical devices should be based on high-quality evidence, proving their reliability, safety and effectiveness. In 2016, the IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up) collaboration modified the original IDEAL framework and recommendation to the IDEAL-D methodological framework for the entire life cycle evaluation of innovative medical devices. The framework included five stages, namely the preclinical development stage, idea stage, exploration stage, assessment stage and long-term follow-up stage. This paper aims to interpret the study purpose, content and design at each step of the IDEAL-D framework based on IDEAL framework and recommendation (2019) to provide practical methodological guidance for the design and conduct of clinical research on innovative medical devices.

Objective     To systematically evaluate the safety, efficacy, and economics of intracardiac echocardiography (ICE) versus transesophageal echocardiography (TEE) in left atrial appendage occlusion (LAAO). Methods     PubMed, EMbase, The Cochrane Library, CBM, CNKI, VIP and WanFang Database were systematically  searched to collect relevant studies on comparing ICE and TEE-guided LAAO from inception to June 15th, 2022. Two reviewers independently screened the literatures, extracted the data, and assessed the risk of bias of the included studies. Meta-analyses were performed using RevMan 5.3 and R 4.0.3. Retrospective cohort studies were excluded for sensitivity analysis. Subgroup analyses were performed based on the types of occluder and ICE catheter. Results     A total of 14 studies with 6 599 patients were included. Meta-analyses showed no statistical differences in technical success rate, overall complications, device embolization, peri-device leakage, device-related thrombus, stroke, vascular complications, bleeding, operation time, fluoroscopy time, or contrast agent volume between the ICE and TEE-guided LAAO. The total in-room time (MD=–33.47 min, 95%CI –41.20 to –25.73, P<0.000 01) and radiation dosage (MD=–170.20 mGy, 95%CI –309.79 to –30.62, P=0.02) were lower in the ICE group than those in the TEE group, whereas the incidence of pericardial effusion/tamponade was higher than the TEE group (RR=1.57, 95%CI 1.01 to 2.45, P=0.048). Except for pericardial effusion/tamponade, subgroup analyses and sensitivity analysis showed similar results. The analysis based on the cost data from the United States showed comparable or even lower total costs for ICE versus TEE, but comparative domestic cost studies were lacking. Conclusion     Current evidence suggests that ICE-guided LAAO can reduce radiation dosage and total in-room time, and there is no statistical difference in the overall complication rate between the two groups. Owing to the limitations of sample size and quality of the included studies, the conclusion still needs to be verified by large sample size and high-quality randomized controlled trials.

Humans ; Nephrectomy ; Hemostatics/therapeutic use* ; Laparoscopy ; Kidney Neoplasms/surgery* ; Minimally Invasive Surgical Procedures

BACKGROUND: Lung cancer is the leading cause of cancer-related death in China. The results from a randomized controlled trial using annual low-dose computed tomography (LDCT) in specific high-risk groups demonstrated a 20% reduction in lung cancer mortality. The aim of tihs study is to establish the China National lung cancer screening guidelines for clinical practice. METHODS: The China lung cancer early detection and treatment expert group (CLCEDTEG) established the China National Lung Cancer Screening Guideline with multidisciplinary representation including 4 thoracic surgeons, 4 thoracic radiologists, 2 medical oncologists, 2 pulmonologists, 2 pathologist, and 2 epidemiologist. Members have engaged in interdisciplinary collaborations regarding lung cancer screening and clinical care of patients with at risk for lung cancer. The expert group reviewed the literature, including screening trials in the United States and Europe and China, and discussed local best clinical practices in the China. A consensus-based guidelines, China National Lung Cancer Screening Guideline (CNLCSG), was recommended by CLCEDTEG appointed by the National Health and Family Planning Commission, based on results of the National Lung Screening Trial, systematic review of evidence related to LDCT screening, and protocol of lung cancer screening program conducted in rural China. RESULTS: Annual lung cancer screening with LDCT is recommended for high risk individuals aged 50-74 years who have at least a 20 pack-year smoking history and who currently smoke or have quit within the past five years. Individualized decision making should be conducted before LDCT screening. LDCT screening also represents an opportunity to educate patients as to the health risks of smoking; thus, education should be integrated into the screening process in order to assist smoking cessation. CONCLUSIONS A lung cancer screening guideline is recommended for the high-risk population in China. Additional research , including LDCT combined with biomarkers, is needed to optimize the approach to low-dose CT screening in the future.
Aged ; China ; epidemiology ; Early Detection of Cancer ; Female ; Humans ; Lung Neoplasms ; diagnostic imaging ; epidemiology ; Male ; Mass Screening ; Middle Aged ; Patient Selection ; Practice Guidelines as Topic ; Radiation Dosage ; Risk ; Rural Population ; statistics & numerical data ; Tomography, Spiral Computed

Objective To establish a specific HPLC method for simultaneous determination of three components ( baicalin, linarin and rhein) in Cuochuang Xiaoyan lotion. Methods The three components in Cuochuang Xiaoyan lotion were assayed by HPLC gradient elution method.The assay was performed with Waters Xterra MS C18(4.6 mm×250 mm,5 μm) column, with acetonitrile (A) and 0.2% phosphoric acid solution (B) as mobile phase in gradient elution.The flow rate was 1.0 mL·min-1.The detection wave length was 277 nm and column temperature was 30 ℃. Results Three components were completely separated from the adjacent peaks and a good linear relationship between each sample concentration and integral area was obtained.The linear equations were as follows:Ybaicalin=9.208X-0.0994(R2=0.9999, 83.97-839.70 μg·mL-1);Ylinarin=3.0628X-0.0038 ( R2 = 0. 9999, 34. 75-347. 49 μg · mL-1 );Yrhein = 1. 0225X-0. 0286 ( R2 = 0. 9998, 63. 20-632.00 μg·mL-1 ) . Conclusion The HPLC method is simple, accurate and reproducible, which is effective in controlling the quality of Cuochuang Xiaoyan lotion.

Objective To analyze the association of serum γ-glutamyl transpeptidase(γ-GT)level with carotid intima media thickness(IMT) in essential hypertension.Methods All the 300 essential hypertension patients and 70 healthy controls were from Ganzhou People′s Hospital.They were divided into healthy control group(70 cases),hypertension with out arteriosclerosis group(141 cases) and hypertension with arteriosclerosis group(159 cases) based on carotid IMT.Fasting blood glucose,serum lipid,routine laboratory tests,hepatic and renal function were detected by routine methods.The one-way analysis of variance and χ2-test were used to compared among the three groups,and the relationship of γ-GT with IMT was assessed by using the Spearman correlation coefficient,multiple linear regressions and Logistic regression analysis.Results The diastolic blood pressure,body mass index,fasting blood glucose,glomerular filtration rate and glycosylated hemoglobin had no differences among the three groups(P>0.05),but systolic pressure,triacylglycerol,total cholesterol,high density lipoprotein cholesterol,aspartate transaminase(AST),low density lipoprotein cholesterol alanine,transaminase(ALT) and γ-GT had significant differences among the three groups(P<0.05).Multiple linear regression analysis showed that the serum γ-GT(β=-0.345,95%CI was-0.005——0.511,P=0.036) was also negatively correlated with IMT,and Logistic regression analysis showed that γ-GT(OR=0.569,95%CI was 0.237-0.867,P=0.029)was a protective factor for atherosclerosis.Conclusion Our study demonstrated the level of γ-GT is negative with IMT among essential hypertension patients,and monitoring the changes of serum liver enzyme might has significant effect on the early detection of arteriosclerosis.

Objective To analyze the relationship and clinical meaning of serumglutamyl transpeptidase (GGT) level with left atrial diameter.Methods All the 320 essential hypertension patients from Ganzhou People′s Hospital were divided into normal left atrial group and enlarged left atrial group based on the size of left atrial diameter.Fasting blood glucose,serum lipid,routine laboratory tests,hepatic and renal function and blood pressure were measured by routine methods,and used for analyzing between groups.Results Among essential hypertension patients,the GGT level in enlarged left atrial group [(24.78±10.93)U/L] was lower than normal left atrial group[(35.23±12.46)U/L] (P=0.004).Multiple linear regression analysis showed that the serum GGT was negatively correlated with left atrial diameter (P=0.032),and logistic regression analysis showed that GGT was a protective factor for enlarged left atrial (OR=0.424,P=0.026).Conclusion Our study demonstrated the level of GGT was negatively with left atrial diameter among essential hypertension patients,and monitoring the changes of serum liver enzyme may has significant effect on the early detection of enlarged left atrial diameter.

Objective:To prepare Cuochuang Xiaoyan lotion and establish HPLC fingerprint chromatogram for the quality control . Methods:The separation was performed on a Waters XTerra MS C 18column(250 mm ×4.6 mm, 5μm).The mobile phase consisted of acetonitrile-0.2%phosphoric acid with gradient elution at a flow rate of 1.0 ml· min-1 , the eluent was monitored by a UV detector at 277 nm, and the column temperature was at 30℃.Results: There were sixteen common peaks for the sample , and among them, three ones were identified as baicalin , linarin and rhein , respectively .Conclusion:The repeatability and information of chromatogram peaks of the method are satisfied , which can provide credible quality control method for Cuochuang Xiaoyan lotion .

Objective To compare the effects of ticagrelor and clopidogrel on patients undergoing percutane-ous coronary intervention(PCI)with acute ST elevated myocardial infarction (STEMI).Methods 120 patients with STEMI received PCI within 12h of symptom onset in our hospital were randomly divided into clopidogrel treated group (n=60)and ticagrelor treated group (n=60).Serum was collected before surgery and 36 hours after PCI for ALT, Cr,CK-MB,and MA.Cardiac ultrasound was examined,too.All patients were followed 6 months post-PCI for main adverse cardiovascular and cerebrovascular events (MACCE)and medicine side effect.Results No significantly difference was noted in baseline between the two groups.The level of CK-MB and MA in the ticagrelor treated group [CK-MB(56.5 ±8.3)U/L,MA (45.9 ±6.4)mm[and clopidogrel treated group[CK-MB(74.3 ±9.6)U/L,MA (35.6 ±7.3)mm]were significant difference (CK-MB,P=0.043;MA,P=0.038).The MACCE of patients in ticagrelor treated group were significantly lower than patients in clopidogrel treated group during post-PCI 6 months follow-up(The ratio of angina in ticagrelor group was 1.7%,while in clopidogrel group was 6.7%,P=0.042). Conclusion Ticagrelor is more effective in suppress the function of platelet,decrease MACCE in patients with STE-MI undergoing PCI.