1.Analysis and suggestions on the registration path of Traditional Chinese Medicine products in Sweden
Haiming CAO ; Tong LIU ; Wenjing XU ; Weihui LYU ; Wei JIANG ; Xiaoqing LI ; Jiaqi WANG
International Journal of Traditional Chinese Medicine 2022;44(6):606-609
The existing regulations and systems of the Swedish Medical Products Agency (MPA) have clear provisions on the definition, classification and listed on the market procecure of pharmaceutical products, and the supervision strictly follows the EU standards. Traditional Chinese Medicine (TCM) products belong to the category of Swedish Herbal Medicine Products (HMP) or Traditional Herbal Medicine Products (THMP) and are under the supervision of Swedish Pharmaceutical Products Administration (MPA). This paper analyzes the classification, relevant regulations and registration procecures of TCM products in Sweden. It is suggests that TCM enterprises should fully understand the EU regulations and guidance regulations before listed on the market of TCM products. They should also clarify the product category, and provide sufficient and accurate evidence. In the application process, they should pay attention to strengthening communication with the drug administration units of Sweden.
2.Design and application of a new type of biliary-intestinal nutrient tube
Jianhua CAO ; Sheng WANG ; Jianjun YAO ; Jinlian MA ; Haiming LI ; Zhanhu MU ; Jie CHEN
Chinese Critical Care Medicine 2022;34(7):762-763
The establishment of a nutritional pathway is the premise and basis of nutritional therapy for patients with malignant tumor. The nasogastric tube, nasoenteric tube, and percutaneous endoscopic gastric/jejunostomy are commonly used clinical pathways for enteral nutrition (EN) therapy. However, these EN pathways are often difficult to establish in patients with malignant obstructive jaundice (MOJ) with pyloric or duodenum primary obstruction. For this reason, a new type biliary-intestinal nutrient tube placed through percutaneous transhepatic cholangiography drainage (PTCD) pathway was designed by the medical staff of hepatobiliary surgery department of Yinchuan First People's Hospital, and National Utility Model Patent of China were obtained (ZL 2020 2 0283951.5, ZL 2020 2 0288938.9). The new biliary-intestinal nutrient tube has two types: double-lumen tube and single-lumen tube, which consists of tube head, tube body, tail ring and developing ring. The double lumen tube realizes bile internal drainage and EN simultaneously through the double lumen structure of the tube body. The single-lumen tube is used for nutrient infusion after bile duct metal stent implantation, which is not limited by the type of nutrient solution. The tail ring of the two types of nutrient tube is placed in the upper jejunum to reduce retrograde infection and unexpected extubation. Compared with the prior art, the utility model has the advantages of simple structure, reasonable design, safe and effective placement through PTCD pathway, and opens up a new EN path for MOJ patients.
3.Study of quantitative flow ratio-guided surgical coronary artery revascularization strategy
Cong CHEN ; Yang ZHAO ; Kui ZHANG ; Pengyun YAN ; Haiming DANG ; Taoshuai LIU ; Yue SONG ; Jubing ZHENG ; Yang LI ; Lisong WU ; Jian CAO ; Ran DONG
Chinese Journal of Thoracic and Cardiovascular Surgery 2022;38(5):272-276
Objective:To explore the feasibility of applying quantitative flow ratio(QFR) to assess the degree of coronary artery functional stenosis before surgery, and to guide coronary artery bypass grafting(CABG) revascularization strategy.Methods:The study prospectively included a total of 154 patients who were electively treated with CABG in the 11th ward of the Department of Cardiac Surgery of Beijing Anzhen Hospital from January 2019 to September 2020, and their coronary angiography visually showed stenosis of the coronary artery to perform QFR analysis to know the diseased blood vessels. For functional stenosis, the surgeon was blinded to the results of QFR analysis before surgery. Collect its baseline data, perioperative data and recent clinical outcomes for summary analysis.Results:One year later, the coronary artery CTA showed that the occlusion rate of functionally significant disease(QFR<0.8) was 5.5%, and that of non-functionally significant disease(QFR≥0.8) was 15.6%. There was no difference in angina class or repeat interventions between patients with or without occluded bypass grafts.Conclusion:According to QFR analysis, coronary arteries with functional non-significant disease have a higher risk of grafts failure than those with functionally significant disease. For coronary arteries with negative QFR lesions, the risk of occlusion of arterial grafts is higher than that of venous. However, this finding is not significantly related to clinical prognosis, because patients with patency or occlusion of the grafts in non-significant lesions have not found excessive angina pectoris or repeated coronary interventions. QFR-guided selection of coronary surgery strategies is safe and feasible.
4.Coronary angiographic characteristics of 997 patients with symptomatic recurrence after coronary artery bypass grafting
Xiaolong MA ; Jiangang WANG ; Ran DONG ; Haiming DANG ; Lisong WU ; Jian CAO ; Qingyu KONG ; Lin LIANG ; Wei XIAO ; Jiaji LIU ; Liqun CHI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2022;29(09):1156-1160
Objective To explore coronary angiographic characteristics in patients with symptomatic recurrence after coronary artery bypass grafting (CABG). Methods We performed a retrospective study of 997 patients with symptomatic recurrence after CABG in Beijing Anzhen Hospital from 2010 to 2020. There were 762 males and 235 females, with an average age of 62.41±8.70 years. Results There was a high prevalence of risk factors like hypertension, diabetes and a history of smoking. Diseased arterial grafts accounted for 27.44% while saphenous vein graft 54.40%; 240 (24.07%) patients had all patent grafts. The main lesion characteristics of diseased grafts were chronic total occlusion lesions (79.57%). Most patients had more diseased native vessels after CABG than before. The type C coronary artery disease in native vessels relevant to ischemic area occurred in 674 (67.60%) patients; 525 (52.66%) patients with recurrent symptom after CABG had both diseased grafts and diseased native vessels. Conclusion Graft status in patients with symptomatic recurrence after CABG is worse than we expected. The majority have newly developed lesions both in grafts and native vessels. Native vascular lesions will continue to progress after CABG.
5.Association between hyperuricemia and hypertriglyceridemic waist phenotype in children and adolescents in Inner Mongolia
CAO Ning, LI Lehui, ZHANG Nan, NIU Liwei, LYU Haiming, ZHANG Xingguang
Chinese Journal of School Health 2022;43(7):1075-1078
Objective:
To investigate the prevalence and association of hyperuricemia (HUA) and hypertriglyceridemic Waist (HTW) phenotype in children and adolescents aged 6-17 years in Inner Mongolia, providing a basis for the prevention and treatment of hyperuricemia in adolescents in Inner Mongolia.
Methods:
A total of 2 175 students of primary, junior high, and senior high school students from eight counties (districts) in Inner Mongolia were chosen and received a questionnaire survey, physical examination, and laboratory test by used a multi stage stratified random sampling approach. The association between the HTW phenotype and HUA was analyzed using binary Logistic regression.
Results:
The prevalence of the HTW phenotype was 2.1%, with boys(2.5%) higher than that of girls(1.6%) ( χ 2=14.50, P<0.05). The average SUA level of the participants was 308.00 (259.00, 371.00) mmol/L, with a statistically significant sex difference(Z=-9.87, P<0.05). The prevalence of HUA was 21.1%. The frequency of HUA in the HTW phenotype(44.4%) was higher than in other phenotypes, followed by enlarged waist (EW) phenotype. After controlling for associated variables, the EW phenotypes (OR=1.76,95%CI=1.26-2.47) and HTW phenotypes (OR=2.25, 95%CI=1.12-4.52) were associated with higher risk for HUA(P<0.05).
Conclusion
In Inner Mongolia, the prevalence of HUA in children and adolescents aged 6-17 years is high, and there shows a positive association between the HTW phenotype and hyperuricemia. For the prevention of hyperuricemia, more attention should be paid to children and adolescents with HTW phenotype.
6.Assess grafts status in symptomatic patients with prior coronary artery bypass graft
Lisong WU ; Ran DONG ; Xiaolong MA ; Haiming DANG ; Yue SONG ; Jian CAO ; Dong LIU ; Qi HUANG
Chinese Journal of Thoracic and Cardiovascular Surgery 2020;36(8):498-501
Objective:To assess the clinical characteristics and grafts status by coronary angiography(CAG) in symptomatic patients with prior coronary artery bypass graft(CABG).Methods:A retrospective descriptive study of symptomatic patients with prior CABG who underwent CAG was performed, 1 136 patients were included and analyzed. The mean age was(62.5±8.7) years, 76.4% were male. There was a high prevalence of risk factors like hypertension(75.0%), dyslipidemia(48.2%), diabetes(46.1%) and smoking history(62.8%).Results:The mean duration after CABG was (4.65±3.39) years. 94.5% of patients had chest pain. 12.9% of patients had all diseased grafts and 28.7% had all patent grafts. The proportion of diseased SVG was higher than that of diseased arterial grafts. The proportion of diseased grafts anastomosed to RCA territory was higher than that of grafts anastomosed to LCX territory or LAD territory. 52.5% of patients received percutaneous coronary intervention(PCI) revascularization, and 88.3% of PCI was performed in native vessels.Conclusion:The most common symptom recurring to patients with prior CABG was chest pain. Graft status in symptomatic patients with prior CABG was worse than we expected. Patients received repeated revascularization mostly by PCI and PCI was mainly performed in native vessels.
7.Assessment of perioperative outcomes of surgery in patients with coronary heart disease and moderate ischemic mitral regurgitation
Yue SONG ; Ran DONG ; Haiming DANG ; Lisong WU ; Jian CAO ; Dong LIU ; Qi HUANG ; Xiaolong MA
Chinese Journal of Thoracic and Cardiovascular Surgery 2020;36(10):613-616
Objective:To explore the perioperative effect of coronary artery bypass grafting(CABG) or CABG+ mitral valve repair(MVP) in patients with coronary heart disease(CAD) and moderate ischemic mitral regurgitation(IMR).Methods:The clinical data and perioperative complications of 210 patients with CAD and moderate IMR, who underwent CABG from January 2018 to December 2019, were included into this study, with 155 males and mean age of(62.3±8.5) years old. According to the operation mode, patients were divided into CABG group(138 cases) and CABG+ MVP group(72 cases).Results:There were no significant differences in age, gender, comorbidities(diabetes, hypertension, hyperlipidemia, peripheral vascular disease, cerebrovascular events, previous history of myocardial infarction and PCI), LVEF and of coronary artery lesions between the two groups(all P>0.05). Sequential anastomosis was the main method, and most patients underwent internal mammary artery graft in both groups, there was no significant difference between the two groups( P>0.05). CABG group was higher than CABG+ MVP group in all-cause death, heart failure, cerebrovascular events, secondary thoracotomy, CRRT and IABP support events, but there were no significant differences between the two groups( P>0.05). Echocardiographic reexamination showed that the indexes of cardiac function in CABG+ MVP group were higher than those in CABG group, but there was no significant difference between the two groups( P>0.05). The mean area of mitral regurgitation in CABG + MVP group was 1.3 cm 2, significantly lower than that in CABG group(2.5 cm 2), P<0.05. Conclusion:CABG+ MVP has low perioperative risk in patients with CAD and moderate IMR, and the area of mitral regurgitation is lower.
8.Cardioprotection induced by combination of dexmedetomidine and limb ischemic preconditioning in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass
Ling YANG ; Shouyuan TIAN ; Dingrui CAO ; Chunyan YANG ; Kaikai XUE ; Haiming CHEN
Chinese Journal of Anesthesiology 2018;38(6):641-644
Objective To evaluate the cardioprotection induced by combination of dexmedetomidine and limb ischemic preconditioning in the patients undergoing coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB).Methods Eighty American Society of Anesthesiologists physical starus Ⅱ or Ⅲ patients of both sexes,aged 52-64 yr,weighing 51-78 kg,with New York Heart Association Ⅱ or Ⅲ,scheduled for elective CABG with CPB,were divided into 4 groups (n =20 each) using a random number table method:control group (group C),limb ischemic preconditioning group (group L),dexmedetomidine group (group D) and dexmedetomidine plus limb ischemic preconditioning group (group DL).Limb ischemic preconditioning was induced by 3 cycles of 5-min unilateral lower limb ischemia followed by 5-min reperfusion starting from 30 min before aortic clamping in L and DL groups.Dexmedetomidine was injected via the central vein in a loading dose of 1 μg/kg after induction of anesthesia,followed by an infusion of 0.4 μg · kg-1 · h-1 until the end of operation in D and DL groups.Venous blood samples were obtained immediately before aortic clamping,at the end of CPB and at the end of operation for determination of plasma concentrations of cardiac troponin Ⅰ (cTnI) by enzyme-linked immunosorbent assay.Myocardial tissues were obtained from the right auricle immediately before aortic clamping and at the end of CPB for determination of the expression of Bcl-2 and Bax (by immunohistochemistry) and apoptosis index (AI) (using TUNEL).The restoration of spontaneous heart beat was recorded.Bcl-2/Bax ratio was calculated.Results Compared with group C,the plasma cTnI concentrations were significantly decreased,the Bcl-2 expression was up-regulated,the Bcl-2/Bax ratio was increased,Bax expression was down-regulated,and AI was decreased in the other three groups (P<0.05).Compared with L and D groups,the plasma cT-nI concentrations were significantly decreased,the Bcl-2 expression was up-regulated,the Bcl-2/Bax ratio was increased,Bax expression was down-regulated,and AI was decreased in group DL (P<0.05).The rate of restoration of spontaneous heart beat was significantly increased in group DL as compared with the other three groups (P<0.05).Conclusion Combination of dexmedetomidine and limb ischemic preconditioning can mitigate myocardial injury,it provides better efficacy than either alone,and the mechanism is related to inhibiting cell apoptosis in the patients undergoing CABG with CPB.
9.Surgical progress of the treatment of obstructive azoospermia
Shuai FAN ; Wei CAO ; Haiming QU ; Maolin CHU ; Chunying ZHANG
Journal of Chinese Physician 2017;19(5):795-798
Nowadays,with the rapid development of science and technology of medicine,the detection rate of obstructivc azoospermia increased gradually,clinically not uncommon.Surgical treatment of obstructive azoospermia is also improved from traditional vasovasostomy and epididymovasostomy to microsurgical vasovasos-tomy and microsurgical va-soepididymostomy,and from 3-suture intussusception vasoepididymostomy to 2-suture intussusception vasoepididymostomy,then our modified reverse single needle anastomosis,and finally to the robot assisted anastomosis.Therefore,the anastomosis is more precise,the recanalization rate and the pregnancy rate have a revolutionary improvement.The robot era is coming.The article focuses on surgical treatment of obstructive azoospermia,comparison of the advantages and disadvantages of each operation,and prediction of the future direction of development.
10.Analysis of controllable risk factors of osteoporotic vertebral fractures
Xiufen ZHU ; Zhande HE ; Lin BRIAN ; Wei CAO ; Xin CHEN ; Haiming YANG ; Hua LIN
Chinese Journal of Health Management 2017;11(4):308-313
Objective To analyze the controlled risk factors of osteoporotic vertebral fractures, and determine the clinical value for the management of risk factors. Methods 626 cases of postmenopausal women were selected, age, height, weight and bone mineral density(BMD) of patients were collected.The Tetrax balance test system was used to assess the fall risks.Vertebral changes of patients were evaluated through X ray of thoracolumbar lateral. The clinical data were analyzed and compared between vertebral fracture group and non-vertebral fracture group. Spearman test was used to analyze the correlation between vertebral fracture and age, height, weight, body mass index(BMI), the risk of fall, body fat and BMD. Results 328 patients presented with osteoporotic vertebral fractures, while the other 298 cases did not suffer from osteoporotic vertebral fractures. There were 426 vertebral bodies involved. Comparing to non-vertebral fracture group, the vertebral fracture group showed higher age [(68.67±9.29)years vs.(63.04± 9.30)years], lower height[(151.10 ± 4.39)cm vs.(154.90 ± 5.86)cm], lower bone mineral density[lumbar spine BMD (0.85 ± 0.16)g/cm2 vs.(0.93 ± 0.17)g/cm2, hip spine BMD (0.72 ± 0.18)g/cm2 vs.(0.81 ± 0.13)g/cm2],higher body fat [(41.30 ± 5.20)%vs.(36.30 ± 5.90)%] and higher fall risk (41.38 ± 25.79 vs. 36.20 ± 26.22) ( P<0.001). While there were no statistical differences in weight and BMI between the two groups, age, height, BMI, body fat, fall risk, lumbar spine and hip BMD were significantly correlated with vertebral fracture (r=0.358,-0.323, 0.169, 0.186, 0.135,-0.398,-0.364, respectively, all P<0.001). Conclusions Decreased bone mineral density, increased age, abdomen fat content and increased fall risk, are the risk factors of osteoporotic vertebral fractures.


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