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.Play-based Intervention Models for Improving Verbal and Nonverbal Social Communication Skills in Children with Autism Spectrum Disorder
Wen WEN ; Shufeng WANG ; Qingqing XIE ; Liqun GAO
Journal of Audiology and Speech Pathology 2024;32(1):75-79
The social communication impairment is one of the core impairments of children with autism spec-trum disorder(ASD).This paper introduced five play-based intervention models that can improve social communica-tion skills of children with ASD.Guided by the concept of precision rehabilitation,practitioners who master these methods may effectively tailor interventions to different cases,by integrating personalized therapy for prescriptive treatment,may ensure healthy mind and body development of children with ASD while solving social communication problems,thus provide practice reference for parents of children with ASD,researchers and clinical educators in China.
3.TCM Guidelines for Diagnosis and Treatment of Chronic Cough in Children
Xi MING ; Liqun WU ; Ziwei WANG ; Bo WANG ; Jialin ZHENG ; Jingwei HUO ; Mei HAN ; Xiaochun FENG ; Baoqing ZHANG ; Xia ZHAO ; Mengqing WANG ; Zheng XUE ; Ke CHANG ; Youpeng WANG ; Yanhong QIN ; Bin YUAN ; Hua CHEN ; Lining WANG ; Xianqing REN ; Hua XU ; Liping SUN ; Zhenqi WU ; Yun ZHAO ; Xinmin LI ; Min LI ; Jian CHEN ; Junhong WANG ; Yonghong JIANG ; Yongbin YAN ; Hengmiao GAO ; Hongmin FU ; Yongkun HUANG ; Jinghui YANG ; Zhu CHEN ; Lei XIONG
Journal of Nanjing University of Traditional Chinese Medicine 2024;40(7):722-732
Following the principles of evidence-based medicine,in accordance with the structure and drafting rules of standardized documents,based on literature research,according to the characteristics of chronic cough in children and issues that need to form a consensus,the TCM Guidelines for Diagnosis and Treatment of Chronic Cough in Children was formulated based on the Delphi method,expert discussion meetings,and public solicitation of opinions.The guideline includes scope of application,terms and definitions,eti-ology and diagnosis,auxiliary examination,treatment,prevention and care.The aim is to clarify the optimal treatment plan of Chinese medicine in the diagnosis and treatment of this disease,and to provide guidance for improving the clinical diagnosis and treatment of chronic cough in children with Chinese medicine.
4.Analysis of risk factors for bladder neck funnel formation in spontaneous delivery primipara by pelvic floor three-dimensional ultrasound
Liqun WU ; Huiyan ZHAO ; Meixia WANG ; Jie GAO ; Rui YAO ; Qun XU
China Modern Doctor 2024;62(27):26-30
Objective To investigate value and risk factors of pelvic floor three-dimensional ultrasound parameters in single spontaneous delivery primipara with bladder neck funnel formation at 6-8weeks after delivery.Methods A total of 108 cases of single spontaneous delivery primipara were selected as research objects according to three-dimensional ultrasound indexes of pelvic floor,they were assigned into two groups:Observation group(40 cases)with bladder neck funnel formation and control group(68 cases)without bladder neck funnel formation.Three-dimensional ultrasound indexes of pelvic floor and clinical symptoms were compared between two groups.Results The incidence of stress urinary incontinence(SUI),anterior vaginal wall prolapse,bladder neck distance(BND),posterior urethrovesical angle(PUA)in Valsalva state,levator hiatus area(LHA)in resting and Valsalva states,levator hiatus length(LHL),and changes in LHL(△ LHL)in observation group were all higher than those in control group(P<0.05).Logistic regression analysis revealed that SUI and anterior vaginal wall prolapse are independent risk factors for bladder neck funnel formation,adjusted OR were 11.255 and 3.643;Resting state and Valsalva state LHA,LHL,and △ LHL were also independent risk factors for bladder neck funnel formation(P<0.05).Receiver operating characteristic(ROC)curve analysis revealed that area under the curve(AUC)for diagnosing bladder neck funnel formation in SUI and anterior vaginal wall prolapse were 0.744 and 0.615,respectively;In ultrasound indicators,when the LHL of Valsalva state is>63.5mm,the AUC is 0.706;The diagnostic sensitivity of the combination factor 1(resting state LHA+Valsalva state LHA)is 95.0%;The diagnostic specificity of the combination factor 2(Valsalva state LHL+△LHL)is 80.9%.Conclusion In patients of single spontaneous delivery primipara with bladder neck funnel formation,occurrence of SUI and vaginal anterior wall prolapse,increased LHA and LHL under two states and △LHL were independent risk factors.The diagnostic sensitivity of the combination factor 1 was higher than single index,the diagnostic specificity of the combination factor 2 was higher.
5.Efficacy and safety of hybrid surgery for the recanalization of carotid artery occlusion after stenting
Zhengyu WANG ; Guangdong LU ; Tao WANG ; Wenlong XU ; Xia LU ; Fei CHEN ; Bin YANG ; Peng GAO ; Yabing WANG ; Yanfei CHEN ; Yan MA ; Liqun JIAO
Chinese Journal of Cerebrovascular Diseases 2024;21(8):505-513
Objective To investigate the efficacy and safety of hybrid surgery for the recanalization of carotid artery occlusion after stenting.Methods Clinical data and results of 17 patients with occlusion after carotid artery stenting and treated with hybrid surgery from June 2016 to April 2023 at the Department of Neurosurgery Cerebral Blood Flow Reconstruction Center of Xuanwu Hospital,Capital Medical University were retrospectively analyzed.According to whether the recanalization was successful,17 patients were divided into the the successful recanalization group and the failed recanalization group.Successful recanalization was defined as achieving modified thrombolysis in cerebral infarction(mTICI)grade ≥2b and residual stenosis<50%.Baseline data(age,sex,body mass index,smoking history,alcohol consumption history,hypertension history,diabetes history,hyperlipidemia history,coronary heart disease history),clinical data(National Institutes of Health Stroke Scale[NIHSS]score at admission,fasting blood glucose,low density lipoprotein,high density lipoprotein,total cholesterol,triglyceride,occlusion side and segment,combination with severe stenosis or occlusion of the contralateral carotid artery,opening of the anterior communicating artery,opening of the posterior communicating artery,compensation of the external and internal carotid artery,compensation of the pia artery,stump morphology,and time from imaging diagnosis of occlusion to recanalization)were documented and compared between groups.The recanalization of occlusive vessels and perioperative complications were recorded.Imaging and clinical follow-up were performed 3,6 months and≥1 year after surgery.Results Among the 17 patients,the ratio of successful recanalization was 13/17.One patient had re-occlusion after operation,which was re-opened after thrombolysis,but neck hematoma with dyspnea occurred,and recovered after emergency operation.There was no postoperative stroke or death.The incidence of perioperative complications was 1/17.Compared with the successful recanalization group,the levels of high density lipoprotein and total cholesterol in the failed recanalization group were higher,and the differences between the groups were statistically significant(high density lipoprotein[1.3±0.3]mmol/L vs.[0.9±0.3]mmol/L,t=-2.139;total cholesterol:[4.2±0.8]mmol/L vs.[3.1±0.7]mmol/L,t=-2.649;both P<0.05);There were no significant differences in other baseline data and clinical data(all P>0.05).Imaging follow-up was completed in 9 of the 13 patients in the successful recanalization group,and the follow-up time was 3.8-36.9 months,with a median follow-up time of 22.8(12.8,34.7)months.Among them,1 patient(1/9)developed restenosis of recanalization vessels at 33.0 months after surgery and underwent stent implantation again.Conclusions The preliminary analysis showed that the occlusion after carotid artery stenting had better recanalization success and lower perioperative complications.In patients with chronic occlusion after carotid stenting,the application of a hybrid surgery for opening may be attempted under multimodal imaging assessment.
6.Efficacy and safety of mitoxantrone hydrochloride liposome injection in treatment of peripheral T-cell lymphomas: a multicenter, non-interventional, ambispective cohort, real-world study (MOMENT)
Huiqiang HUANG ; Zhiming LI ; Lihong LIU ; Liang HUANG ; Jie JIN ; Hongyan TONG ; Hui ZHOU ; Zengjun LI ; Zhenqian HUANG ; Wenbin QIAN ; Kaiyang DING ; Quande LIN ; Ming HOU ; Yunhong HUANG ; Jingbo WANG ; Pengcheng HE ; Xiuhua SUN ; Xiaobo WANG ; Zunmin ZHU ; Yao LIU ; Jinhai REN ; Huijing WU ; Liling ZHANG ; Hao ZHANG ; Liangquan GENG ; Jian GE ; Ou BAI ; Liping SU ; Guangxun GAO ; Xin LI ; Yanli YANG ; Yijian CHEN ; Aichun LIU ; Xin WANG ; Yi WANG ; Liqun ZOU ; Xiaobing HUANG ; Dongping HUANG ; Shujuan WEN ; Donglu ZHAO ; Jun MA
Journal of Leukemia & Lymphoma 2023;32(8):457-464
Objective:To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in the treatment of peripheral T-cell lymphoma (PTCL) in a real-world setting.Methods:This was a real-world ambispective cohort study (MOMENT study) (Chinese clinical trial registry number: ChiCTR2200062067). Clinical data were collected from 198 patients who received mitoxantrone hydrochloride liposome injection as monotherapy or combination therapy at 37 hospitals from January 2022 to January 2023, including 166 patients in the retrospective cohort and 32 patients in the prospective cohort; 10 patients in the treatment-na?ve group and 188 patients in the relapsed/refractory group. Clinical characteristics, efficacy and adverse events were summarized, and the overall survival (OS) and progression-free survival (PFS) were analyzed.Results:All 198 patients were treated with mitoxantrone hydrochloride liposome injection for a median of 3 cycles (range 1-7 cycles); 28 cases were treated with mitoxantrone hydrochloride liposome injection as monotherapy, and 170 cases were treated with the combination regimen. Among 188 relapsed/refractory patients, 45 cases (23.9%) were in complete remission (CR), 82 cases (43.6%) were in partial remission (PR), and 28 cases (14.9%) were in disease stabilization (SD), and 33 cases (17.6%) were in disease progression (PD), with an objective remission rate (ORR) of 67.6% (127/188). Among 10 treatment-na?ve patients, 4 cases (40.0%) were in CR, 5 cases (50.0%) were in PR, and 1 case (10.0%) was in PD, with an ORR of 90.0% (9/10). The median follow-up time was 2.9 months (95% CI 2.4-3.7 months), and the median PFS and OS of patients in relapsed/refractory and treatment-na?ve groups were not reached. In relapsed/refractory patients, the difference in ORR between patients with different number of treatment lines of mitoxantrone hydrochloride liposome injection [ORR of the second-line, the third-line and ≥the forth-line treatment was 74.4% (67/90), 73.9% (34/46) and 50.0% (26/52)] was statistically significant ( P = 0.008). Of the 198 PTCL patients, 182 cases (91.9%) experienced at least 1 time of treatment-related adverse events, and the incidence rate of ≥grade 3 adverse events was 66.7% (132/198), which was mainly characterized by hematologic adverse events. The ≥ grade 3 hematologic adverse events mainly included decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and anemia; non-hematologic adverse events were mostly grade 1-2, mainly including pigmentation disorders and upper respiratory tract infection. Conclusions:The use of mitoxantrone hydrochloride liposome injection-containing regimen in the treatment of PTCL has definite efficacy and is well tolerated, and it is a new therapeutic option for PTCL patients.
7.Research progress on minimally invasive and non-invasive blood glucose detection methods.
Xinyu GAO ; Zekai XU ; Liqun CHEN
Journal of Biomedical Engineering 2023;40(2):365-372
Blood glucose monitoring has become the weakest point in the overall management of diabetes in China. Long-term monitoring of blood glucose levels in diabetic patients has become an important means of controlling the development of diabetes and its complications, so that technological innovations in blood glucose testing methods have far-reaching implications for accurate blood glucose testing. This article discusses the basic principles of minimally invasive and non-invasive blood glucose testing assays, including urine glucose assays, tear assays, methods of extravasation of tissue fluid, and optical detection methods, etc., focuses on the advantages of minimally invasive and non-invasive blood glucose testing methods and the latest relevant results, and summarizes the current problems of various testing methods and prospects for future development trends.
Humans
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Blood Glucose
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Blood Glucose Self-Monitoring/methods*
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Diabetes Mellitus/diagnosis*
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Monitoring, Physiologic/methods*
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Tears
8.Analysis of risk factors of major adverse kidney events within 30 days in patients with acute pancreatitis
Liying GAO ; Yaling XU ; Weizhu FEI ; Liqun ZHANG ; Chunfang XU
Chinese Critical Care Medicine 2022;34(7):727-731
Objective:To analyze the risk factors of major adverse kidney events within 30 days (MAKE30) in patients with acute pancreatitis (AP).Methods:A retrospective cohort study was conducted. A total of 162 patients who were first diagnosed with AP in the First Affiliated Hospital of Soochow University from June 2019 to June 2021 and the onset time was less than 72 hours were enrolled. Patients were divided into MAKE30 group and non-MAKE30 group according to the occurrence of MAKE30 after hospitalization. MAKE30 was defined as death from any cause, new renal replacement therapy (RRT), and persistent renal insufficiency (PRD). The clinical data of the two groups at admission were compared. The independent risk factors of MAKE30 were analyzed by multivariate Logistic regression method, and a regression equation was established as a quantitative prediction model of MAKE30. Receiver operator characteristic curve (ROC curve) was drawn to analyze the prediction of the quantitative prediction model value.Results:All 162 patients were included in the final analysis, including 32 in the MAKE30 group and 130 in the non-MAKE30 group. Univariate analysis showed that compared with the non-MAKE30 group, the body mass index (BMI), the proportion of severe AP, and the acute physiology and chronic health evaluation Ⅱ (APACHEⅡ) score, the sequential organ failure assessment (SOFA) score, blood urea nitrogen (BUN), serum creatinine (SCr), C-reactive protein (CRP), HCO 3-, Cl - levels and the proportion of hyperchloremia at admission in the MAKE30 group were significantly increased. Multivariate Logistic regression analysis showed that APACHE Ⅱ score at admission [odds ratio ( OR) = 1.659, 95% confidence interval (95% CI) was 1.426-1.956, P = 0.009], SOFA score ( OR = 1.501, 95% CI was 1.236-1.840, P = 0.014) and hyperchloremia ( OR = 1.858, 95% CI was 1.564-2.231, P = 0.004) were independent risk factors for MAKE30 in AP patients. The MAKE30 regression equation was established by the above risk factors [Logit( P) = 0.063+0.525×APACHEⅡ score+0.328×SOFA score+0.895×hyperchloremia], which was used as the MAKE30 quantitative prediction model. ROC curve analysis showed that the area under the ROC curve (AUC) of the model for predicting MAKE30 was 0.846 (95% CI was 0.774-0.923, P = 0.001). The patients were divided into two subgroups with hyperchloremia (Cl -≥110 mmol/L, n = 19) and non-hyperchloremia (Cl - < 110 mmol/L, n = 143) according to the blood Cl - level at admission. The incidence of MAKE30 and acute kidney injury (AKI) in the hyperchloremia group was significantly increased (MAKE30: 68.4% vs. 13.3%, AKI: 89.5% vs. 43.4%), and the levels of BUN and SCr at admission were significantly increased [BUN (mmol/L): 9.3±2.5 vs. 5.9±1.1, SCr (μmol/L): 162.3±26.4 vs. 78.6±9.2], the total length of hospital stay and length of intensive care unit (ICU) stay were significantly longer [total length of hospital stay (days): 10.2±1.6 vs. 5.6±1.2, length of ICU stay (days): 6.2±1.0 vs. 3.1±0.6], the cumulative intravenous infusion volume increased significantly at 48 hours and 72 hours (mL: 7 235.9±1 025.3 vs. 5 659.6±956.7 at 48 hours, 11 052.6±1 659.8 vs. 7 156.9±1 052.4 at 72 hours), differences were statistically significant (all P < 0.01). Conclusions:MAKE30 can be used as an important indicator to evaluate the short-term clinical prognosis of AP patients. APACHEⅡ score, SOFA score and hyperchloremia at admission are the main risk factors. The risk model of MAKE30 based on these three indicators has good predictive performance. AP patients with hyperchloremia are at high risk of developing MAKE30, which should be highly regarded in clinical practice.
9.Compliance and associated factors of smartphone application usage in child dietary and exercise intervention
Chinese Journal of School Health 2021;42(9):1336-1339
Objective:
To study the compliance and associated factors of smartphone application (APP) usage in childhood dietary and exercise intervention.
Methods:
Based on one childhood intervention of diet and exercise in Beijing, Changzhi of Shanxi Province and Urumqi of Xinjiang Province, 694 children (and their primary caregivers) in the intervention group were investigated regarding usage of APP during the intervention. Compliance of APP usage was evaluated by the click times of APP, and Logistic regression models were used to analyze influencing factors of the compliance.
Results:
The median (inter quartile range) click times of APP in the four modules (information dissemination, behavior monitoring, homework uploading and feedback) were 10 (5,21), 20 (14,26), 7(4,10), 26 (15,53), respectively. Multivariable logistic regression analysis found that compliance of APP usage was higher among subjects in Changzhi region ( OR =1.67,95% CI =1.12-2.48), whose primary caregiver was mother ( OR =1.55,95% CI =1.09-2.22), or whose mother did not work ( OR =0.47, 95% CI =0.31-0.74).
Conclusion
Compliance of APP usage was generally high in the childhood intervention of diet and exercise. Some factors are associated with compliance of APP usage. Findings of the study provide a scientific basis for better implementation of APP based childhood interventions of diet and exercise in the future.
10.Radiotherapy of all metastatic lesions in metachronous oligometastatic prostate cancer
Xin QI ; Xianshu GAO ; Mingzhu LIU ; Peilin LIU ; Hongzhen LI ; Shangbin QIN ; Mingwei MA ; Yun BAI ; Min ZHANG ; Xiaomei LI ; Xiaoying LI ; Jiayan CHEN ; Xueying REN ; Liqun ZHOU
Chinese Journal of Urology 2021;42(9):656-661
Objective:To investigate the efficacy and safety of radiotherapy for all metastases in patients with metachronous oligo-metastatic prostate cancer after radical treatment.Methods:From October 2011 to February 2021, 41 patients with prostate cancer with less than 5 metastases after radical treatment were retrospectively analyzed in a single center. The median age at radiotherapy was 68 (57-81) years. Forty patients (98%) received androgen deprivation therapy (ADT). There were 28 patients in the hormone sensitive (HSPC) group and 13 patients in the hormone resistant (CRPC) group. The median initial PSA was 24.4 (7.4-399.0) ng/ml. Tumor stage: T 2 stage 11 patients, T 3 stage 27 patients, T 4 stage 3 patients.30 patients were in N 0 stage and 11 patients in N 1 stage. Gleason score was 7 in 12 patients, 8 in 9 patients, 9 in 18 patients, and 10 in 2 patients.33 patients were treated with surgery, and 8 patients were treated with radiotherapy. The time span from diagnosis to metastasis was 3.1 (0.2-1.8) years. Conventional imaging examination (CT/ MRI/bone scan) before radiotherapy was used in 7 patients, and PSMA PET/CT examination was used in 34 patients.The median PSA before radiotherapy was 1.3(0.1-33.8) ng/ml. There were 62 metastases in 41 patients, including 1 lesion in 28 patients, 2 lesions in 9 patients, 3 lesions in 2 patients, and 5 lesions in 2 patients. Fifty-four patients had bone metastases and eight had retroperitoneal lymph node metastases. Twenty-two bone metastases were located in the pelvis, 18 in the vertebral body, 12 in the ribs, one in the femur and one in the sternum.The median metastatic volume was 5.8(0.2-81.7) cm 3.Daily image-guided rotational intensity modulated radiotherapy was used to cover all metastases.Dose segmentation modes include 37.5Gy/7.5Gy/5F, 60Gy/3Gy/20F, 65-70Gy/2.6-2.8Gy/25F.The median biological effective dose (BED 3) was 120 (67-147) Gy. The primary endpoint was biochemical progression-free survival (BPFS), the secondary endpoints were acute and late toxic side effects, local relapse-free survival (LPFS), and overall survival (OS). Results:The median follow-up time was 21 months (range 5-72 months). All patients completed radiotherapy, and 16 patients had grade 1 to 2 acute toxicity and side effects, and no grade 3 or above acute and late stage side effects. 1-year LPFS was 97.1%.The 1-year and 2-year BPFS were 77.5% and 59.2%, respectively. The median BPFS time was 29 months (range 13.9-44.2 months). Univariate analysis showed that the HSPC group ( P<0.001) and the group with total metastatic volume ≤ 5.8cm 3 ( P=0.010) had higher BPFS. The median BPFS time was 37 months in the retroperitoneal lymph node metastases subgroup and 17 months in the bone metastases subgroup ( P=0.141). In the HSPC group, the median BPFS was 30(22-38) months. After radiotherapy, PSA decreased in all 28 patients, and increased in 6 patients. The median BPFS was 12(4-18) months. In the CRPC group, the median BPFS was 4(0-8) months. PSA decreased in 10 patients (76.9%) after radiotherapy, and PSA decreased in 6 patients. The median BPFS was 5(3-28) months. Three patients’PSA did not decrease after radiotherapy, and they were treated with new endocrine therapy drugs, chemotherapy, immunotherapy and other systemic therapy. Conclusions:For patients with metachronous metastases after radical treatment, full coverage radiotherapy has good safety and high local control rate. HSPC patients and patients with low tumor load could be recommended to receive radiotherapy for all metastatic lesions preferentially, and patients with only retroperitoneal lymph node metastases may have better prognosis after radiotherapy than patients with bone metastases.


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