1.Current Situation and Suggestion of Comprehensive Clinical Evaluation of Medical Products in China in Recent Ten Years
Ning DAI ; Qingyun HE ; Fang LU
Journal of Traditional Chinese Medicine 2024;65(4):357-361
		                        		
		                        			
		                        			Through analyzing the current situation of clinical comprehensive evaluation researches of domestic medical products from 2013 to 2023, it is found that there is a phenomenon of “four more, four less”. Specifically, there is a greater emphasis on conducting research on drug clinical comprehensive evaluation, but fewer comprehensive evaluation opinions provided; more research data come from publicly available information, but fewer derived from real world; more options for similar reference drugs, but less pre-defined research on reference drugs; the research process involves more steps, yet there are fewer studies strictly implementing quality control. Based on this, suggestions are proposed in three aspects: improving the quality of clinical comprehensive evaluation of medical products, enhancing the transformation and dissemination of results, and improving the standardization of clinical comprehensive evaluation of medical products. Regarding the current state of clinical comprehensive evaluation research on Chinese patent medicine, reflections are presented on elevating original research evidence and highlighting the characteristics and advantages of Chinese patent medicine, so as to promote better transformation and application of the results of clinical comprehensive evaluation of medical products. 
		                        		
		                        		
		                        		
		                        	
2.Analysis of curative effect of interventional therapy for postoperative multiple metastases of breast cancer
Di LIU ; Jun ZHOU ; Xun DING ; Yang ZHU ; Fugang YANG ; Sicheng HE ; Qingyun LONG ; Wei LU
Journal of Practical Radiology 2024;40(10):1695-1698
		                        		
		                        			
		                        			Objective To investigate the curative effect of interventional therapy on postoperative multiple metastases of breast cancer.Methods A total of 15 patients with multiple metastases after breast cancer surgery were treated with interventional therapy.After comprehensive evaluation,all patients were treated with chemoembolization.The therapeutic regimen was docetaxel loaded on drug-eluting bead(DEB)combined with carboplatin,once in 1 d for 21 d,2 times in total,and then the regimen was changed to docetaxel and carboplatin combined with ordinary embolization microspheres,once in 1 d for 21 d,4 times in total.CT/MRI was performed on every 2 cycles and 1,3,and 6 months after interventional therapy to evaluate its efficacy and record adverse reactions.Results The overall remission rate(ORR)at 3 months after treatment was 75%,and the disease control rate(DCR)was 91.7%.The ORR and DCR at 6 months after treatment were 50%and 83.3%,respectively.Most of the common adverse reactions were below grade Ⅲ.Conclusion Interventional therapy for multiple metastases of breast cancer after operation has a definite short-term effect,with little adverse reactions.It is worthy of further promotion in the comprehensive treatment of postoperative metastases of breast cancer.
		                        		
		                        		
		                        		
		                        	
3.Retrospective study on the types and characteristics of shock in polytrauma patients at different stages after trauma
Jialiu LUO ; Liangsheng TANG ; Deng CHEN ; Hai DENG ; Jingzhi YANG ; Teding CHANG ; Jing CHENG ; Huaqiang XU ; Miaobo HE ; Dongli WAN ; Feiyu ZHANG ; Mengfan WU ; Qingyun LIU ; Shibo WEI ; Wenguo WANG ; Gang YIN ; Zhaohui TANG
Chinese Journal of Emergency Medicine 2023;32(1):70-75
		                        		
		                        			
		                        			Objective:To investigate the types, incidences, and clinical characteristics of shock in polytrauma patients at different stages after polytrauma.Methods:A retrospective study was conducted on polytrauma patients admitted to multiple trauma centers from June 2020 to December 2021. The inclusion criteria were patients >18 years old and treated due to polytrauma. Exclusion criteria included an admission time of more than 48 h after trauma, a history of malignancy, or metabolic, consumptive, and immunological diseases. The early stage was defined as the period of ≤48 h after polytrauma, and the middle stage was defined as the period between 48 h and 14 days. The patient’s medical history, clinical manifestations, laboratory tests, imaging examination, injury severity score (ISS), and Glasgow coma scale (GCS) were collected. The types, incidences, and clinical characteristics of shock in different stages after polytrauma were analyzed, according to the diagnostic criteria of each type of shock. The differences between the groups were compared by Student’s t test, χ2 test or Mann-Whitney U test. Results:The incidence of the early and middle stage shock after polytrauma were 73.1% and 36.4%, respectively, with statistically significant difference between stages ( P<0.01). There were significant differences in the incidence of hypovolemic shock (83.6% vs. 28.4%), distributed shock (13.7% vs. 80.9%) and cardiogenic shock (3.5% vs. 6.6%) between stages (all P<0.05). The incidence of obstructive shock (8.4% vs. 9.7%, P>0.05) was similar between stages. The incidence of undifferentiated shock was 1.6% and 1.2%, respectively. There were 9.5% patients with multifactorial shock in the early stage and 14.4% in the middle stage. Totally 7 combinations of multifactorial shock were found in different stages after polytrauma. In the early stage, the combination of HS and DS accounted the highest ratio (42.3%) and followed by HS and OS for 28.8%. In the middle stage, the combination of HS and DS was the most common (48.6%) and followed by DS and OS (24.3%). Conclusions:The incidence of shock in polytrauma patients is high. Different types of shock can occur simultaneously or sequentially. Therefore a comprehensive resuscitation strategy is significant to improve the success rate of treatment.
		                        		
		                        		
		                        		
		                        	
4.Clinical expert consensus on platelet-rich plasma treatment for lateral epicondylitis (2022 version)
Jian LI ; Guoqing CUI ; Chengqi HE ; Shiyi CHEN ; Boxu CHEN ; Hong CHEN ; Xuesong DAI ; Hongchen HE ; Hui KANG ; Tieshan LI ; Guoping LI ; Jiuzhou LU ; Chao MA ; Xin TANG ; Jun TAO ; Hong WANG ; Ming XIANG ; Dan XING ; Yiquan XIONG ; Qingyun XUE ; Rui YANG ; Tin YUAN ; Qiang ZHANG ; Jingbin ZHOU ; Weihong ZHU ; Yan XIONG ; Yan LIU
Chinese Journal of Trauma 2022;38(8):673-680
		                        		
		                        			
		                        			Lateral epicondylitis is a common clinical disease with characteristics of lateral elbow pain, insidious onset and easy recurrence, which can cause forearm pain and decreased wrist strength, seriously affecting patients′ daily life and work. Although there are various treatment methods for lateral epicondylitis with different effects, standard treatments are still lacking nowadays. Platelet-rich plasma (PRP) has good effects on bone and tendon repair, and is now widely used in the treatment of lateral epicondylitis. However, there is a lack of a unified understanding of the technology and specifications of PRP in the treatment of lateral epicondylitis. Therefore, the Sports Medicine Branch of the Chinese Medical Association and Physical Medicine and Rehabilitation Branch of the Chinese Medical Association organized experts in the fields of sports medicine and rehabilitation medicine in China to formulate the "clinical expert consensus on platelet-rich plasma treatment for lateral epicondylitis (2022 version)", and proposed suggestions based on evidence-based medicine mainly from the concept, epidemiology and pathophysiology of lateral epicondylitis, symptoms, signs and imaging manifestations of lateral epicondylitis, PRP concept and application component requirements, quality control of PRP preparation technology, indications and contraindications of PRP in the treatment of lateral epicondylitis, PRP injection in the treatment of lateral epicondylitis, application of PRP in the operation of lateral epicondylitis, related problems after PRP treatment of lateral epicondylitis, evaluation of the results after PRP treatment of lateral epicondylitis, and health and economic evaluation of PRP treatment of lateral epicondylitis, so as to provide guidance for clinical diagnosis and treatment.
		                        		
		                        		
		                        		
		                        	
5.Research advances in intraductal papillary mucinous neoplasm of the bile tract
Ying XU ; Jia TANG ; Qingyun HE ; Huichao WU
Journal of Clinical Hepatology 2021;37(12):2981-2985
		                        		
		                        			
		                        			 Intraductal papillary mucinous neoplasm of the bile duct (IPMN-B) is a special type of tumor occurring in the biliary system, with no specific clinical manifestations and imaging findings, and thus it is difficult to diagnose before surgery. It is often considered when a large amount of mucus is found in the bile duct during surgery and then it is forced to change the surgical plan. Clinicians lack an understanding of this disease due to its low incidence rate. This article reviews the recent research advances in the etiology and classification, clinical features, differential diagnosis, treatment, and prognosis of IPMN-B, so as to improve the clinical diagnosis and treatment of IPMN-B among clinicians. 
		                        		
		                        		
		                        		
		                        	
6.Correlation of baseline neutrophil-to-lymphocyte ratio with the curative effect and prognosis of breast cancer patients after neoadjuvant chemotherapy
Meirong FAN ; Yangtao OU ; Yingjian HE ; Zhexuan LI ; Xueshuo GAO ; Qingyun ZHANG ; Guobin XU
Chinese Journal of Clinical Laboratory Science 2017;35(2):114-117
		                        		
		                        			
		                        			Objective To investigate the predictive value of baseline neutrophil-to-lymphocyte ratio (NLR) in the curative effect and prognosis of breast cancer patients treated with neoadjuvant chemotherapy.Methods The clinical data of 304 breast cancer patients received neoadjuvant chemotherapy in Beijing Cancer Hospital during 2010 were retrospectively analyzed.The correlations of baseline NLR with clinicopathological parameters of breast cancer patients were analyzed by Wilcox or Kruskal-Wallis tests,and the correlation of NLR with pathologic complete response (pCR) after neoadjuvant chemotherapy was analyzed by the binary logistic regression.The effect of clinic pathological parameters on the disease-free survival(DFS) of the patients was evaluated by the univariable and muhivariable Cox regression models.Results The medians of NLR in pCR + patients (n =62) and pCR-patients (n =242) were 1.76 and 1.72,respectively,and there was no significant difference between themn (P > 0.05).Multivariate analysis indicated that the TNM stage (P < 0.05) and pCR (P < 0.05) were the independent risk factors influencing the prognosis of breast cancer patients.There was no significant correlation between NLR and 5-year DFS (HR=0.842,95%CI=0.566-1.255,P>0.05).Condusion NLR lacks the predictive value in the curative effect and prognosis of breast cancer patients treated with neoadjuvant chemotherapy,while TNM stage and pCR are the independent risk factors influencing the prognosis of breast cancer patients.
		                        		
		                        		
		                        		
		                        	
7.The quantitative measurement of pulmonary lobar volume using 3-dimensional volumetric diagnosis system and 64 row MDCT
Zhai LIU ; Li HE ; Lizhuo JIA ; Qingyun REN
Journal of Practical Radiology 2016;32(5):781-784
		                        		
		                        			
		                        			Objective To explore the value of 3‐dimensional volumetric diagnosis system in quantitative measurement of pulmona‐ry lobar volumetry using a 64 row MDCT .Methods Seventy‐seven adult volunteers were scanned twice on a 64 row MDCT at the end of the maximum inspiratory and maximum expiratory end respectively .On a volumetric computer‐aided diagnosis system ,the en‐tire lung was semiautomatically separated into 5 anatomy lobes including the right upper lobe ,right middle lobe ,right lower lobe ,left upper lobe ,and left lower lobe .Each lobar volume was measured .Results The lung volume of left upper lobe ,right lower lobe ,left lower lobe ,right upper lobe ,right middle lobe in male volunteers were 1 303 .90 mL and 938 .31 mL ,1 276 .90 mL and 737 .69 mL , 1 204 .47 mL and 678 .67 mL ,1 048 .49 mL and 754 .83 mL ,519 .53 mL and 407 .86 mL at the end of the inspiratory and expiratory respectively .The lung volume of left upper lobe ,right lower lobe ,left lower lobe ,right upper lobe ,right middle lobe in female volun‐teers were 915 .78 mL and 666 .23 mL ,913 .87 mL and 576 .62 mL ,822 .17 mL and 509 .30 mL ,734 .20 mL and 530 .23 mL ,389 .13 mL and 316 .70 mL at the end of the inspiratory and expiratory respectively .The values of each lobe volume between the full inspiration phase and expiration phase group showed significant difference the same sex group (P<0 .05) .The values of each lobe volume in the man group were significantly larger than those of female group in both respiratory phase (P<0 .05) .Of the D‐value in the each lobe volume in 5 anatomy lobe at full inspiration phase and expiration phase in both sex group ,both of the lower lobes were the largest , followed by the left upper lobe ,right upper lobe and right middle lobe .The D‐value in the each lobe volume at full inspiration phase and expiration phase in the man group were significantly larger than those of female group .Conclusion Three‐dimensional volumet‐ric diagnosis system and 64 row MDCT images can be used to assess the volume of each lung lobe .
		                        		
		                        		
		                        		
		                        	
8.Cognitive status investigation and its influence factors analysis of diabetic foot among caregiver of elderly with diabetic foot
Chinese Journal of Modern Nursing 2015;21(4):431-433,434
		                        		
		                        			
		                        			Objective To comprehend cognitive status and its influence factors of diabetic foot ( DF) among caregiver of elderly with DF, and provide reference for the health education. Methods From October 2011 to October 2013 in our department, a total of 223 care staffs were selected. Using self-made questionnaire to collecting data, statistical analysis was performed used SPSS and AMOS. Results The average score of cognitive DF was (70. 32 ± 10. 80) and the length of caregiver experience had positive correlation with cognitive scores (r=0. 479,P<0. 05). Different nationalities, education degree and occupation, whether patients had DF or not, and length of caregiver experience were main factors to influence caregiver′s recognition of DF. Conclusions We should strengthen cognition of caregiver especially for people with low education, minority, freelancers, caregivers who have not take care of DF before, and new caregivers.
		                        		
		                        		
		                        		
		                        	
9.The study of diffusion tensor imaging in patients with mild cognitive impairment
Li HE ; Zhai LIU ; Qingyun REN ; Licun LEI ; Yuxuan QI
Journal of Practical Radiology 2014;(8):1255-1258
		                        		
		                        			
		                        			Objective To evaluate the value of diffusion tensor imaging (DTI)in diagnosing MCI.Methods DTI and conventional MRI were performed in 26 patients with MCI and 26 age-matched normal control subjects (NC).FA were measured in the 10 select-ed white matter regions,included bilateral frontal lobe,temporal lobe,parietal lobe,parahippocampal gyrus and cingulate gyrus,in the patients with MCI (n=26)and NC (n=26).FA of each ROI (region of interest)between the patients and controls were com-pared by using independent sample t-test.The correlation between the FA values and the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA)scores was analyzed by using Spearman correlation analysis.Results Compared with NC,the FA values of the right frontal lobe,temporal lobe white matter and bilateral cingulate gyrus in the patients were significant-ly reduced (P <0.05).FA values of the left temporal lobe,right frontal lobe and bilateral parahippocampal gyrus were significant correlated with MoCA scores,and FA values of the bilateral parahippocampal gyrus were significant correlated with MMSE scores (P <0.05).Conclusion DTI can be used as a diagnosis index of MCI.It has important value in early intervention and improving the quality of life of patients to early diagnosing MCI.
		                        		
		                        		
		                        		
		                        	
10.Normal-appearing white matter in children with developmental delay:a diffusion tensor imaging study
Li HE ; Qingyun REN ; Zhai LIU ; Licun LEI ; Yaqiang DU
Journal of Practical Radiology 2014;(6):987-990,1068
		                        		
		                        			
		                        			Objective To explore the changes of white matter microstructure by using DTI in children with developmental delay (DD)with normal routine MRI results.Methods We performed routine MRI and DTI in 23 children with DD and 23 age-matched normal children,FA values of five deep white matters (limb of internal capsule,anterior limb,genu and knee of corpus callosum and optic radiation)and four shallow white matters (frontal lobe,temporal lobe,occipital cortex,centrum ovale)were measured.FA values of the white matter for two groups were assessed by paired t tests for each region of interest.Results FA values on the deep white matter for DD,and on the deep white matter and the shallow white matter for normal development group increased with age significantly (P <0.05).FA values on the shallow white matter for DD were lower than that for normal development group,which had no significant correlation with age (P >0.05).The FA values on the shallow white matter and deep white matter (corpus callo-sum knee,optic radiation)for children with DD were lower than that for the control group (P <0.05),and the FA values of the limb of deep white matter (genu of corpus callosum,internal capsule and anterior limb)were no difference with the contorl group (P >0.05).Conclusion DTI may detect the changes of white matter microstructure in children with developmental delay,and provides an objective basis for quantitative diagnosis.
		                        		
		                        		
		                        		
		                        	
            
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