1.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
2.Clinical value of high frequency ultrasound in the diagnosis of hip joint involvement in patients with ankylosing spondylitis
Guo-Yan XUE ; Ying-Qi LI ; Rui WANG ; Wen-Xing WANG ; Zhuang DONG ; Jian-Feng DING
China Journal of Orthopaedics and Traumatology 2024;37(4):374-380
Objective To analyze the correlation between hip joint musculoskeletal ultrasound score and ankylosing spondylitis(AS)disease activity,as well as to investigate the value of high frequency ultrasound in the assessment of hip joint involvement in AS.Methods The clinical data of 244 patients with AS who were treated in the rheumatology department of from March 2019 to March 2022 were retrospectively analyzed.Among them,there 174 males and 70 females,aged from 19 to 58 years old with an average of(34.22±9.49)years old;the disease duration of AS patients ranged from 8 months to 26 years,with an average of(13.68±4.04)years.The 244 patients were divided into disease group(83 cases)and control group(161 cases)based in the presence of hip joint involuement.According to the the disease activity,patients in the disease group were further categorezed into active phase(45 cases)and stable phase(38 cases).The ultrasound scores of patients in the active and stable phases of the disease group and the control group were compared.Relevant factors of hip joint involvement in AS patients were analyzed,and analyze the correlation between ultrasound score and Bath ankylosing spondylitis disease activity score index(BASD AI),Bath ankylosing spondylitis functional index(BASFI),visual analogue score of pain(VAS),C-reactive protein(CRP),erythrocyte sedimentation rate(ESR),and the correlation between hip joint capsule score and tendon attach-ment end score and BASDAI,BASFI,VAS,CRP and ESR.Results The hip joint capsule score(3.06±1.12),femoral head score(1.45±0.43),tendon attachment end score(3.28±1.30)and total ultrasound score(6.65±2.31)of the disease group were higher than those of the control group(1.51±0.48)、(0.66±0.27)、(1.61±0.53)、(3.81±1.44)scores(P<0.05).Multifactor Logstic re-gression analysis showed that the course of disease,hip joint capsule score and total ultrasound score were independent risk factors for hip involvement in AS patients.The hip capsule score(3.65±1.22)and total ultrasound score(8.28±2.33)in the ac-tive phase of the disease group were higher than those in the stable phase(2.48±1.04)、(6.82±1.96)scores(P<0.05).The hip joint capsule score and total ultrasonic score of AS patients were positively correlated with BASDAI,BASFI,VAS,CRP,and ESR(P<0.05,P<0.01).The score of tendon attachment end was positively correlated with CRP(P<0.05).The score of joint capsule effusion in AS patients was positively correlated with BASDAI,BASFI and VAS(P<0.05,P<0.01).The synovial blood flow score was positively correlated with BASDAI,VAS,CRP and ESR(P<0.05,P<0.01).The synovial thickening score was positively correlated with BASDAI,BASFI,VAS,CRP and ESR(P<0.05,P<0.01).There was no correlation between the score of tendon attachment end and BASDAI,BASFI,VAS,CRP and ESR.Conclusion There is a correlation between hip joint ul-trasonic score of hip joint and clinical indexes in AS patients.Hip joint capsule score and total ultrasonic score were indepen-dent risk factors for hip involvement in AS patients.High frequency ultrasound exhibits clinical value in the diagnosis of hip joint involvement in AS patients.
3.AI-HIP system for prosthesis size,global femoral offset and osteotomy in total hip arthroplasty
Guo-Yuan SUN ; Yan-Kun JIANG ; Tong LI ; Xue-Feng CONG ; Cheng HUANG ; Ran DING ; Wei-Guo WANG ; Qi-Dong ZHANG
China Journal of Orthopaedics and Traumatology 2024;37(9):848-854
Objective To explore planning effect of AI-HIP assisted surgical planning system in primary unilateral total hip arthroplasty(THA)and its influence on clinical outcomes.Methods A retrospective analysis was conducted on clinical data of 36 patients who underwent their first unilateral THA from March 2022 to November 2022 and continuously used AI-HIP system(AI-HIP group),including 16 males and 20 females,aged from 43 to 81 years old with an average of(62.2±10.9)years old.According to the matching principle,36 patients who were planned by the traditional template method at the same period were selected as the control group,including 16 males and 20 females,aged from 40 to 80 years old with an average of(60.9±12.1)years old.The accuracy between two groups of prostheses were compared,as well as the combined eccentricity difference between preoperative planning and postoperative practice,lower limb length difference,osteotomy height from the upper edge of the lesser trochanter and top shoulder distance to evaluate planning effect.Harris score and visual analogue scale(VAS)were used to evaluate clinical efficacy.Results Both groups were followed up for 12 to 18 months with an average of(14.5±2.1)months.The complete accuracy and approximate accuracy of acetabular cup and femoral stalk prosthesis in AI-HIP group were 72.2%,100%,58.3%,88.9%,respectively,which were better than 44.4%,83.3%,33.3%,66.7%in control group(P<0.05).There was no statistical significance in planning of femoral head prosthesis size(P>0.05).The actual combined eccentricity difference and combined eccentricity difference(practical-planning)in Al-HIP group were 1.0(0.2,2.4)mm and 1.1(-2.1,3.2)mm,respectively;which were better than 3.0(1.4,4.9)mm and 3.5(-1.6,6.5)mm in control group(P<0.05).There was no significant difference between two groups in actual osteotomy height of the upper margin of the lesser trochanter(P>0.05).In AI-HIP group,the actual difference of lower extremity length after surgery,the difference of lower extremity length(practical-planning),osteotomy height from the upper margin of lesser trochanter(practical-planning),actual topshoulder distance after surgery,and topshoulder distance(practical-planning)were 1.5(0.2,2.8),1.1(-0.3,2.2),2.1(-2.3,4.1),(15.3±4.1),2.2(-4.8,0.3)mm,respectively;which were better than control group of 2.6(1.3,4.1),2.5(0.3,3.8),5.8(-2.4,7.7),(13.0±4.3),-5.7(-9.4,-2.2)mm(P<0.05).At final follow-up,there were no significant differences in Harris scores of pain,function,deformity,total scores and VAS between two groups(P>0.05).The range of motion score was 4.8±0.6 in AI-HIP group,which was higher than that in control group(4.4±0.8)(P<0.05).Conclusion Compared with traditional template planning,AI-HIP assisted surgical planning system has good accuracy in predicting the prosthetic size of the acetabular cup and femoral stalk,restor-ing joint eccentricity,planning lower limb length,osteotomy height and top shoulder distance on the first unilateral THA,and the clinical follow-up effect is satisfactory.
4.Comparison on efficacy of MRI-transrectal ultrasound software fusion-guided biopsy and cognitive fusion-guided biopsy for detecting prostate cancer
Jing YANG ; Hao FENG ; Han XIA ; Yanhui MA ; Xiao XIAO ; Zhiyuan WANG ; Wenjuan XU ; Zheng WANG ; Qibing FAN ; Yuyong SHEN ; Jing DING ; Tingyue QI
Chinese Journal of Interventional Imaging and Therapy 2024;21(7):403-407
Objective To compare the efficacy of MRI-transrectal ultrasound(TRUS)software fusion-guided biopsy and cognitive fusion-guided biopsy for detecting prostate cancer(PC).Methods Data of 120 patients with suspected PC(127 lesions)who underwent transperineal prostate biopsy with 2-3 times of target biopsy(TB)and 10 times of system biopsy were retrospectively analyzed.According to TB guidance methods,73 cases(78 lesions)received MRI-TRUS software fusion-guided biopsy were classified into group A,and 47 cases(49 lesions)received cognitive fusion-guided biopsy were classified into group B.The positive rate of PC,clinic significant PC(csPC)and PC in different sized lesions by TB were compared between groups,and the positive rate of PC between 2 or 3 times TB was also compared within each group.Results The positive rate of PC and csPC detected by TB was 55.13%(43/78)and 39.74%(31/78)in group A,53.06%(26/49)and 34.69%(17/49)in group B,respectively,no significant difference was found(all P>0.05).The positive rate of PC in lesions with the maximum diameter≤10 mm detected by TB in group A was higher than that in group B(P<0.05),but no significant difference of lesions with the maximum diameter>10 mm and<15 mm nor≥15 mm was found between groups(all P>0.05).No significant difference of positive rate of PC was found between 2 and 3 times TB in group A(P>0.05),while positive rate of PC of 3 times TB was significantly higher than that of 2 times TB in group B(P<0.05).Conclusion MRI-TRUS software fusion-guided biopsy had positive rate of PC and csPC similar to that of cognitive fusion-guided biopsy,but was helpful for reducing times of TB and increasing detecting rate for lesions with the maximum diameter≤10 mm.
5.Impact of autologous hematopoietic stem cell transplantation on the efficacy of CAR-T treatment of relapsed/refractory multiple myeloma
Meijing DING ; Xingxing JIE ; Hujun LI ; Zhiyi XU ; Li NIAN ; Kunming QI ; Zhiling YAN ; Feng ZHU ; Jiang CAO ; Huanxin ZHANG ; Kailin XU ; Hai CHENG ; Zhenyu LI
Chinese Journal of Internal Medicine 2024;63(6):587-592
Objective:To evaluate the effect of autologous hematopoietic stem cell transplantation (ASCT) on the treatment of relapsed/refractory multiple myeloma (RRMM) with chimeric antigen receptor T cell (CAR-T) therapy.Methods:A retrospective cohort study. The clinical data of 168 patients with RRMM who underwent CAR-T therapy at the Department of Hematology, Xuzhou Medical University Hospital from 3 January 2020 to 13 September 2022 were analyzed. Patients were classified into a transplantation group (TG; n=47) and non-transplantation group (NTG; n=121) based on whether or not they had undergone ASCT previously. The objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and the levels of CD3, CD4, CD8, CD19, CD56 and natural killer (NK) cells before CAR-T infusion were analyzed by χ2 test, Kaplan-Meier method and independent sample t-test. Results:Among 168 patients with RRMM, 98 (58.3%) were male. The median age of onset was 57 (range 30-70) years. After CAR-T therapy, the ORR of patients was 89.3% (92/103) in the NTG and 72.9% (27/73) in the TG. The ORR of the NTG was better than that of the TG ( χ2=5.71, P=0.017). After 1 year of CAR-T therapy, the ORR of the NTG was 78.1% (75/96), and that of the TG was 59.4% (19/32). The ORR of the NTG was better than that of the TG ( χ2=4.32, P=0.038). The median OS and PFS in the NTG were significantly longer than those in the TG (OS, 30 vs. 20 months; PFS, 26 vs. 12 months; both P<0.05). The CD4 level before CAR-T infusion in the TG was significantly lower than that in the NTG (25.65±13.56 vs. 32.64±17.21; t=-2.15, P=0.034), and there were no significant differences in the counts of CD3, CD8, CD19, CD56, and NK cells between the TG and NTG (all P>0.05). Conclusion:Among patients suffering from RRMM who received CAR-T therapy, patients who did not receive ASCT had significantly better outcomes than those who had received ASCT previously, which may have been related to the CD4 level before receiving CAR-T therapy.
6.Comparison of the effect of indocyanine green injection through peripheral vein and gallbladder in laparo-scopic cholecystectomy of difficult gallbladder
Qizhu FENG ; Zhe XU ; Jie SUN ; Jiaquan ZHANG ; Sheng DING ; Jian ZHANG ; Qi WANG ; Chao ZHANG
The Journal of Practical Medicine 2024;40(11):1537-1541,1548
Objective The aim of this study was to compare the effect of injection of indocyanine green(ICG)through peripheral vein and gallbladder in laparoscopic cholecystectomy(LC)of difficult gallbladder.Methods Patients with difficult gallbladder who underwent LC by the same surgical team from May to October 2023 in the Department of Hepatobiliary Surgery,the First Affiliated Hospital of Anhui University of Science and Technology were divided into three groups according to A random number table.Group A was injected ICG through peripheral vein before operation,group B was injected ICG through gallbladder during operation,and group C was the control group.The differences of operation time,intraoperative blood loss,hospitalization time,hospitalization cost and postoperative complications among the three groups were compared,and the effects of fluorescence mode cholangio-gram in group A and group B were compared.One-way analysis of variance was used to compare the normal distri-bution of the measurement data among groups,and LSD-t test was used to compare the two groups.The counting data was compared by chi-square test.The Boferroni test was appied to compare the two groups.Results There were no differences in length of stay,hospitalization cost and postoperative complications among the three groups(P>0.05).The operative time and intraoperative blood loss of group A and group B were lower than those of group C(P<0.05),but there was no difference between group A and group B(P>0.05).The total imaging rate of the first three tubes of free gallbladder triangle(early stage)in group A was 41.67%,which was significantly lower than that in group B(63.89%)(P<0.05).Conclusion ICG is beneficial for the identification of extrahepatic bile duct structures during LC of difficult gallbladder,and ICG injection through the gallbladder is helpful for the early identification of extrahepatic bile duct.
7.Novel markers of systemic inflammation in prediction of the early severity of acute pancreatitis
Qizhu FENG ; Manman LU ; Jie SUN ; Jiaquan ZHANG ; Sheng DING ; Jian ZHANG ; Qi WANG
The Journal of Practical Medicine 2024;40(14):1963-1968
Objective To investigate the values of systemic inflammatory response index(SIRI),systemic immunoinflammatory index(SII),neutrophil count/lymphocyte count(NLR),platelet count/lymphocyte count(PLR)and lymphocyte count/monocyte count(LMR)in prediction of the severity of acute pancreatitis(AP)at early stage.Methods The clinical data on 666 AP patients admitted to the department of hepatobiliary surgery,the First Affiliated Hospital of Anhui University of Science and Technology,from January 2020 to November 2023 were retrospectively analyzed.The patients were divided into a mild group(MAP group,mild acute pancreatitis)and a non-mild group(non-MAP group,including moderate to severe acute pancreatitis).Blood routine and biochemical indicators were collected at admission and 24 hours after admission.The differences in SIRI,SII,NLR,PLR and LMR between the two groups were compared,so were the values of these five indexes in prediction of non-MAP.Results Of the 666 AP patients,507 were in the MAP group and 159 in the non-MAP group.In the non-MAP group,C-reactive protein(CRP),SIRI,SII,and NLR were higher than those in the MAP group 24 hours after admission,while LMR was lower than that in the MAP group,and the differences were statistically significant(P<0.05).CRP(HR=1.008,95%CI:1.004~1.012,P<0.05)and SIRI(HR=1.216,95%CI:1.029~1.436,P<0.05)were identified as the risk factors for the severity of AP.The ROC curve showed that the AUC and sensitivity of SIRI for predicting non-MAP 24 hours after admission were 0.718 and 75.00%,respectively,higher than those of SII,CRP,NLR,and LMR.Both SIRI and CRP had AUC values greater than 0.7,and the combined AUC was 0.788(0.738~0.837),the sensitivity was 86.00%and the specificity was 81.44%.Conclusions SIRI can be used as a predictor of disease severity in early AP patients,and combined with CRP can improve the predictive value.
8.Risk factors for bronchopulmonary dysplasia in twin preterm infants:a multicenter study
Yu-Wei FAN ; Yi-Jia ZHANG ; He-Mei WEN ; Hong YAN ; Wei SHEN ; Yue-Qin DING ; Yun-Feng LONG ; Zhi-Gang ZHANG ; Gui-Fang LI ; Hong JIANG ; Hong-Ping RAO ; Jian-Wu QIU ; Xian WEI ; Ya-Yu ZHANG ; Ji-Bin ZENG ; Chang-Liang ZHAO ; Wei-Peng XU ; Fan WANG ; Li YUAN ; Xiu-Fang YANG ; Wei LI ; Ni-Yang LIN ; Qian CHEN ; Chang-Shun XIA ; Xin-Qi ZHONG ; Qi-Liang CUI
Chinese Journal of Contemporary Pediatrics 2024;26(6):611-618
Objective To investigate the risk factors for bronchopulmonary dysplasia(BPD)in twin preterm infants with a gestational age of<34 weeks,and to provide a basis for early identification of BPD in twin preterm infants in clinical practice.Methods A retrospective analysis was performed for the twin preterm infants with a gestational age of<34 weeks who were admitted to 22 hospitals nationwide from January 2018 to December 2020.According to their conditions,they were divided into group A(both twins had BPD),group B(only one twin had BPD),and group C(neither twin had BPD).The risk factors for BPD in twin preterm infants were analyzed.Further analysis was conducted on group B to investigate the postnatal risk factors for BPD within twins.Results A total of 904 pairs of twins with a gestational age of<34 weeks were included in this study.The multivariate logistic regression analysis showed that compared with group C,birth weight discordance of>25%between the twins was an independent risk factor for BPD in one of the twins(OR=3.370,95%CI:1.500-7.568,P<0.05),and high gestational age at birth was a protective factor against BPD(P<0.05).The conditional logistic regression analysis of group B showed that small-for-gestational-age(SGA)birth was an independent risk factor for BPD in individual twins(OR=5.017,95%CI:1.040-24.190,P<0.05).Conclusions The development of BPD in twin preterm infants is associated with gestational age,birth weight discordance between the twins,and SGA birth.
9.Effect of the setting of control point of Monaco radiotherapy planning system on dosimetry of dIMRT plan for esophageal cancer of middle and lower segment
Hao WANG ; Yunyi YANG ; Yi LI ; Qi DING ; Feng GUO ; Yantao GONG ; Genxiang CHEN ; Ya CHE ; Yinghong REN
China Medical Equipment 2024;21(9):1-6
Objective:To study the dosimetry effects of differently selected values of control point(CP)in Monaco radiotherapy planning system on dynamic intensity modulated radiation therapy(dIMRT)for esophageal cancer of middle and lower segment.Methods:Thirteen patients with esophageal cancer at middle and lower segment who received dIMRT in Shangluo Central Hospital from January to June 2023 were selected.In the Monaco radiotherapy planning system,nine groups of dIMRT plans were designed for each patient according to the 9 kinds of CP limit values(10,20,30,40,50,60,70,80 and 90).There were not changes in other optimized parameters except CP parameter.The differences of the dosimetry between target region and organs at risk(OAR)included lung,heart and spinal cord were analyzed.Results:With the increase of the CP limit value,the maximum dose of the target region which was radiation dose(D2%)of 2%volume of target region,the mean dose,which was radiation dose(D50%)of 50%volume of target region,and the homogeneity index(HI)appeared a trend of gradual stability after reduction,and the radiation dose(D98%)of 98%volume of target region which was the minimum dose of target region and the conformance index(CI)appeared a trend of gradual stability after increase.There was not significant in each dose indicator of OAR(P>0.05).The variation ranges of lung at 5,10,20,30 Gy dose(V5,V10,V20 and V30)were respectively 1.13%,0.75%,0.29%and 0.19%,and the maximum deviation of mean dose(Vmean)of lung was 18.7 cGy.The variation ranges of V10,V20,V30 and V40 in the heart were respectively 2.2%,1.23%,1.39%and 1.12%,and the maximum deviation of Vmean in the heart was 63.85 cGy,and the maximum deviation of Dmax in the spinal-cord was 70.78 cGy.There were statistically significant differences in the actual CP number(CPs),execution time(DT)of plan,and ratio value of machine unit(MU)of the complexity of plan to CPs(MU/CPs)among the plans of 9 groups(F=2.857,25.145,135.467,P<0.05),respectively.Conclusion:In the dIMRT plan of esophageal cancer of middle and lower segment,the maximum CP value is set at between 40-50,which can reduce the optimization time of the plan,the number of subfields and the treatment time of patients under the premise of meeting the dose of the target region and the OAR.
10.Analysis of risk factors for trauma-induced coagulopathy in elderly major trauma patients
Kang YANGBO ; Yang QI ; Ding HONGBO ; Hu YUFENG ; Shen JIASHENG ; Ruan FENG ; Chen BOJIN ; Feng YIPING ; Jin YUCHEN ; Xu SHANXIANG ; Jiang LIBING ; Wang GUIRONG ; Xu YONG'AN
World Journal of Emergency Medicine 2024;15(6):475-480
BACKGROUND:Trauma-induced coagulopathy(TIC)due to serious injuries significantly leads to increased mortality and morbidity among elderly patients.However,the risk factors of TIC are not well elucidated.This study aimed to explore the risk factors of TIC in elderly patients who have major trauma. METHODS:In this retrospective study,the risk factors for TIC in elderly trauma patients at a single trauma center were investigated between January 2015 and September 2020.The demographic information including gender,age,trauma parts,injury severity,use of blood products,use of vasopressors,need of emergency surgery,duration of mechanical ventilation,length of stay in the intensive care unit(ICU)and hospital,and clinical outcomes were extracted from electric medical records.Multivariate logistic regression analysis was performed to differentiate risk factors,and the performance of the model was evaluated using receiver operating characteristics(ROC)curves. RESULTS:Among the 371 elderly trauma patients,248(66.8%)were male,with the age of 72.5±6.8 years,median injury severity score(ISS)of 24(IQR:17-29),and Glasgow coma score(GCS)of 14(IQR:7-15).Of these patients,129(34.8%)were diagnosed with TIC,whereas 242(65.2%)were diagnosed with non-TIC.The severity scores such as ISS(25[20-34]vs.21[16-29],P<0.001)and shock index(SI),(0.90±0.66 vs.0.58±0.18,P<0.001)was significantly higher in the TIC group than in the non-TIC group.Serum calcium levels(1.97±0.19 mmol/L vs.2.15±0.16 mmol/L,P<0.001),fibrinogen levels(1.7±0.8 g/L vs.2.8±0.9 g/L,P<0.001),and base excess(BE,-4.9±4.6 mmol/L vs.-1.2±3.1 mmol/L,P<0.001)were significantly lower in the TIC group than in the non-TIC group.Multivariate logistic regression analysis revealed that ISS>16(OR:3.404,95%CI:1.471-7.880;P=0.004),SI>1(OR:5.641,95%CI:1.700-18.719;P=0.005),low BE(OR:0.868,95%CI:0.760-0.991;P=0.037),hypocalcemia(OR:0.060,95%CI:0.009-0.392;P=0.003),and hypofibrinogenemia(OR:0.266,95%CI:0.168-0.419;P<0.001)were independent risk factors for TIC in elderly trauma patients.The AUC of the prediction model included all these risk factors was 0.887(95%CI:0.851-0.923)with a sensitivity and specificity of 83.6%and 82.6%,respectively. CONCLUSION:Higher ISS(more than 16),higher SI(more than 1),acidosis,hypocalcemia,and hypofibrinogenemia emerged as independent risk factors for TIC in elderly trauma patients.


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