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 study of intracranial hypotension targeted body posture combined with pharmacotherapy in the treatment of chronic subdural hematoma
Jiayu CHEN ; Zhe WANG ; Di ZANG ; Ruizhe ZHENG ; Xiangru YE ; Zengxin QI ; Zeyu XU ; Zhiqiang LI ; Chengfeng SUN ; Liangjun SHEN ; Luoping SHENG ; Fulin XU ; Ruyong YE ; Kaiyu ZHOU ; Weijun TANG ; Yueqing HU ; Dapeng SHI ; Yuquan WANG ; Xizhen WU ; Ying WANG ; Qilin ZHANG ; Feili LIU ; Guo YU ; Yiping LU ; Yirui SUN ; Ning ZHANG ; Feng HUANG ; Xialong GU ; Han ZHANG ; Jian DING ; Yongyan BI ; Haolan DU ; Jing ZHANG ; Hailong JI ; Ding DING ; Wei ZHANG ; Xuehai WU
Chinese Journal of Surgery 2025;63(3):212-218
Objective:To compare the efficacy of body posture combined with pharmacotherapy and pharmacotherapy alone in the treatment of chronic subdural hematoma(CSDH).Methods:Firstly, retrospective case series study was conducted. Thirty cases of CSDH that had received body posture combined with pharmacotherapy at Department of Neurosurgery, Huashan Hospital Affiliated to Fudan University from December 2016 to October 2020 were studied retrospectively. Twenty-seven patients were male, and 3 patients were female. The age of patients ( M(IQR)) was 66(16) years (range:28 to 84). Nineteen patients had unilateral hematoma, and 11 patients had bilateral hematoma. All patients received pharmacotherapy and body posture therapy that was to raise their lower limbs 20 to 30 cm with leg lift pad and get abdominal compressed with customized abdominal belt in supine position. Patients were required to maintain the body posture as much as possible, with the maximum to 16 to 18 hours per day. Patients with unilateral hematoma should tilt the head to the affected side and avoid tilting it to the opposite side. For patients with bilateral hematoma, there was no need for head lateralization. Patient were treated with oral dexamethasone and atorvastatin simultaneously. The preliminary efficacy of body posture combined with pharmacotherapy was determined by hematoma improvement rate which was analyzed by Clopper-Pearson method. Then, the multi-center, prospective, randomized controlled trial had carried out in 9 medical centers from August 2020 to November 2021. The stratified block randomization method was adopted. Patients were randomized in a ratio of 1∶1 to either receive pharmacotherapy alone(the control group) or body posture combined with pharmacotherapy(the experiment group) for 3 months and followed up for 6 months. Effective treatment was defined as complete absorption of hematoma, or the hematoma volume decreased by more than 10 ml and Markwalder grading scale score had improved by more than 1 point compared to the baseline. The efficacy rate and surgery conversion rate at 3 months and recurrence at 6 months were observed. Comparison between groups was performed with paired sample t test, Mann-Whitney U test, χ2 test, corrected χ2 test, or Fisher exact probability method. Logistic regression was used to compare the effective rate and operation rate between the two groups. Results:In the respective study, 30 patients completed follow-up 13 to 353 days after treatment. At the last follow-up, the incidence of almost complete absorption or significantly absorption of hematoma (hematoma volume was significantly reduced accompanied by symptom improvement) was 93.3%. The 95% CI for the incidence that analyzed by the Clopper-Pearson method was 77.9% to 99.2%. One hundred and six patients were enrolled in the multicenter study. Fifty-five patients underwent body posture combined with pharmacotherapy. The age was 74(17) years (range:26 to 92). Thirty-nine patients were males and 16 were females. Fifty-one patients underwent pharmacotherapy alone. The age was 69(12) years (range:48 to 84). Thirty-seven patients were males and 14 were females. The length of body posture recorded in diary card was (15.7±2.3) hours(range:7.6 to 19.3 hours). The efficacy rate in the body posture combined with pharmacotherapy group and pharmacotherapy alone group were 83.6% (46/55) and 56.9% (29/51), respectively at 3 months. The result of the logistic regression analysis showed that the efficacy of body posture combined with pharmacotherapy group was better than that of pharmacotherapy alone group ( OR=3.88,95% CI:1.57 to 9.58, P=0.003). Surgery rate in the body posture combined with pharmacotherapy group and pharmacotherapy alone group were 5.5% (3/55) and 21.6% (11/51) respectively. The result of Logistic regression showed that the pharmacotherapy alone group was more likely to be converted to surgery ( OR=0.21,95% CI:0.05 to 0.80, P=0.023). At the 6 months, no recurrence of cases was found in the body posture combined with pharmacotherapy group. However, the recurrence rate of pharmacotherapy alone group was 6.3% (3/48), there was no significant difference between the two groups ( P>0.05). Conclusion:The effect of body posture combined with pharmacotherapy for chronic subdural hematoma is better than that of pharmacotherapy alone.
3.Clinical study of intracranial hypotension targeted body posture combined with pharmacotherapy in the treatment of chronic subdural hematoma
Jiayu CHEN ; Zhe WANG ; Di ZANG ; Ruizhe ZHENG ; Xiangru YE ; Zengxin QI ; Zeyu XU ; Zhiqiang LI ; Chengfeng SUN ; Liangjun SHEN ; Luoping SHENG ; Fulin XU ; Ruyong YE ; Kaiyu ZHOU ; Weijun TANG ; Yueqing HU ; Dapeng SHI ; Yuquan WANG ; Xizhen WU ; Ying WANG ; Qilin ZHANG ; Feili LIU ; Guo YU ; Yiping LU ; Yirui SUN ; Ning ZHANG ; Feng HUANG ; Xialong GU ; Han ZHANG ; Jian DING ; Yongyan BI ; Haolan DU ; Jing ZHANG ; Hailong JI ; Ding DING ; Wei ZHANG ; Xuehai WU
Chinese Journal of Surgery 2025;63(3):212-218
Objective:To compare the efficacy of body posture combined with pharmacotherapy and pharmacotherapy alone in the treatment of chronic subdural hematoma(CSDH).Methods:Firstly, retrospective case series study was conducted. Thirty cases of CSDH that had received body posture combined with pharmacotherapy at Department of Neurosurgery, Huashan Hospital Affiliated to Fudan University from December 2016 to October 2020 were studied retrospectively. Twenty-seven patients were male, and 3 patients were female. The age of patients ( M(IQR)) was 66(16) years (range:28 to 84). Nineteen patients had unilateral hematoma, and 11 patients had bilateral hematoma. All patients received pharmacotherapy and body posture therapy that was to raise their lower limbs 20 to 30 cm with leg lift pad and get abdominal compressed with customized abdominal belt in supine position. Patients were required to maintain the body posture as much as possible, with the maximum to 16 to 18 hours per day. Patients with unilateral hematoma should tilt the head to the affected side and avoid tilting it to the opposite side. For patients with bilateral hematoma, there was no need for head lateralization. Patient were treated with oral dexamethasone and atorvastatin simultaneously. The preliminary efficacy of body posture combined with pharmacotherapy was determined by hematoma improvement rate which was analyzed by Clopper-Pearson method. Then, the multi-center, prospective, randomized controlled trial had carried out in 9 medical centers from August 2020 to November 2021. The stratified block randomization method was adopted. Patients were randomized in a ratio of 1∶1 to either receive pharmacotherapy alone(the control group) or body posture combined with pharmacotherapy(the experiment group) for 3 months and followed up for 6 months. Effective treatment was defined as complete absorption of hematoma, or the hematoma volume decreased by more than 10 ml and Markwalder grading scale score had improved by more than 1 point compared to the baseline. The efficacy rate and surgery conversion rate at 3 months and recurrence at 6 months were observed. Comparison between groups was performed with paired sample t test, Mann-Whitney U test, χ2 test, corrected χ2 test, or Fisher exact probability method. Logistic regression was used to compare the effective rate and operation rate between the two groups. Results:In the respective study, 30 patients completed follow-up 13 to 353 days after treatment. At the last follow-up, the incidence of almost complete absorption or significantly absorption of hematoma (hematoma volume was significantly reduced accompanied by symptom improvement) was 93.3%. The 95% CI for the incidence that analyzed by the Clopper-Pearson method was 77.9% to 99.2%. One hundred and six patients were enrolled in the multicenter study. Fifty-five patients underwent body posture combined with pharmacotherapy. The age was 74(17) years (range:26 to 92). Thirty-nine patients were males and 16 were females. Fifty-one patients underwent pharmacotherapy alone. The age was 69(12) years (range:48 to 84). Thirty-seven patients were males and 14 were females. The length of body posture recorded in diary card was (15.7±2.3) hours(range:7.6 to 19.3 hours). The efficacy rate in the body posture combined with pharmacotherapy group and pharmacotherapy alone group were 83.6% (46/55) and 56.9% (29/51), respectively at 3 months. The result of the logistic regression analysis showed that the efficacy of body posture combined with pharmacotherapy group was better than that of pharmacotherapy alone group ( OR=3.88,95% CI:1.57 to 9.58, P=0.003). Surgery rate in the body posture combined with pharmacotherapy group and pharmacotherapy alone group were 5.5% (3/55) and 21.6% (11/51) respectively. The result of Logistic regression showed that the pharmacotherapy alone group was more likely to be converted to surgery ( OR=0.21,95% CI:0.05 to 0.80, P=0.023). At the 6 months, no recurrence of cases was found in the body posture combined with pharmacotherapy group. However, the recurrence rate of pharmacotherapy alone group was 6.3% (3/48), there was no significant difference between the two groups ( P>0.05). Conclusion:The effect of body posture combined with pharmacotherapy for chronic subdural hematoma is better than that of pharmacotherapy alone.
4.Effects of transdermal meridian-targeted drug delivery of Pelvic Inflammation No.1 formula on IL-10,IL-6,MMP-9 and immune function in patients with chronic pelvic inflammatory disease
Qiang FENG ; Hongmei CHEN ; Ruilian TANG ; Yuqing WU ; Yongyan YU ; Jiping YE
Chinese Journal of Immunology 2024;40(8):1735-1739
Objective:To investigate the application value of Pelvic Inflammation No.1 formula of transdermal meridian point-targeted drug delivery therapy in the treatment of patients with chronic pelvic inflammatory disease(damp-heat stasis type).Methods:All patients with chronic pelvic inflammatory disease(damp-heat stasis type)visited Danzhou Hospital of Traditional Chinese Medi-cine from August 2017 to March 2021 and were randomly grouped,57 patients in the control group were treated with simple Western medicine,and 57 patients in the observation group were combined with Pelvic Inflammation No.1 formula transdermal meridian target-ed transdermal medication,and the therapeutic efficacies were compared after 3 months of treatment.Results:After treatment,serum matrix metalloproteinase-9(MMP-9),D dimer(D-D),IL-6 and other indexes in the observation group were lower than those in the control group,and IL-10 was higher than that in the control group,the difference was statistically significant(P<0.05).After treat-ment,the carbohydrate antigen CA125 in the observation group was lower than that in the control group,and the CD4+/CD8+and CD4+cells in the observation group were higher than those in the control group(P<0.05).After treatment,the score of summary of health status surveys(SF-36)in the observation group was higher than that in the control group,and the total score of TCM symptoms was lower than that in the control group(P<0.05).The total effective rate in the observation group was 96.49%(55/57),which was higher than 82.46%(46/57)in the control group(P<0.05).Conclusion:For patients with chronic pelvic inflammatory disease(damp-heat stagnation type),combined with Pelvic Inflammation No.1 formula transdermal via acupoints targeted drug therapy can help to regu-late inflammatory factors,regulate immune function,and improve clinical efficacy.
5.Impact of overweight/obesity on postoperative complications in breast reduction surgery
Dandan LIU ; Jian HAO ; Xiangwen XU ; Lin LUO ; Mengfan WU ; Jun FENG ; Yongyan CUI ; Tianshi LI
Chinese Journal of Medical Aesthetics and Cosmetology 2023;29(6):460-463
Objective:To investigate the impact of overweight/obesity on postoperative complications in breast reduction surgery.Methods:A retrospective study was conducted on patients who underwent breast reduction surgery in our hospital from 2016 to 2022. Basic patient information and postoperative complications, such as poor wound healing, infection, hematoma, nipple necrosis, etc., were collected. Patients were categorized into normal/low weight group and overweight/obese group according to their body mass index (BMI). The differences in postoperative complications between the two groups were compared and statistically analyzed.Results:The study included 82 patients, 48 in the normal/low weight group and 34 in the overweight/obese group. The gender, age, and surgical methods of the two groups of patients were relatively balanced, and there was no statistical difference. However, the incidence of postoperative complications was 50.0% (17/34) in overweight/obeseitg group, higher than 18.8% (9/48) in normal/low weight group. Common complications included delayed healing such as infection or dehiscence in 8 cases (9.8%), skin necrosis in 5 cases (6.1%), and hypertrophic scars in 5 cases (6.1%). The incidence of skin necrosis and delayed healing in the overweight/obese group was higher than that in the normal/low weight group, but the difference was not statistically significant ( P>0.05). Postoperative hematoma and hypertrophic scars occurred in both groups, while fat liquefaction and thrombosis only occurred in the overweight/obese group. Conclusions:Overweight/obesity is an important risk factor for postoperative complications in breast reduction surgery. Patients should be evaluated before surgery, and necessary measures should be taken to reduce the risk of complications.
6.Research on the contamination, drug resistance and molecular typing of Vibrio parahaemolyticus isolated from aquatic products in Nanchang City market
LONG Yongyan ; LONG Hui ; FAN Guoyin ; XUE Lin ; SHUAI Shufen ; WANG Wei ; WU Kai
China Tropical Medicine 2023;23(9):936-
Abstract: Objective To understand the contamination status, drug resistance, virulence gene carrying status, and molecular typing characteristics of Vibrio parahaemolyticus (VP) in aquatic products sold in Nanchang City. Methods A total of 170 commercial crayfishes, freshwater fish frogs and related smears samples were collected from various farmers' markets in Nanchang from March to September 2021. The strains of V. parahaemolyticus were detected and isolated from the samples. Antibiotic resistance test, virulence gene test, and pulsed-field gel electrophoresis (PFGE) molecular typing analysis were carried out. Results Among the collected samples, V.parahaemolyticus was only isolated from crayfish and crayfish smear samples, with a total of 35 strains of VP isolated. No V.parahaemolyticus strain was isolated from other freshwater fish, frogs, and their smear samples. Among the 17 common antibiotics tested, only two trains showed resistance to ampicillin, and one strain to streptomycin, , and all were sensitive to other antibiotics; all 35 strains of V. parahaemolyticus carried the gene, but only one strain carried the heat-resistant related hemolysin gene trh, and no direct heat-resistant hemolysin gene tdh positive strain was found; PFGE pattern clustering showed that there was no strain with the same PFGE pattern, and there was no obvious dominant cluster among these strains, and their genetic relationship was relatively distant. Conclusions The contamination of V. parahaemolyticus in small and medium-sized crayfish sold in the market in Nanchang City is relatively serious. The V. parahaemolyticus isolates in these polluted crayfish generally do not carry key virulence genes such as tdh, are sensitive to common antibiotics, and only have low-level resistance to ampicillin and streptomycin. PFGE pattern clustering showed that V. parahaemolyticus does not have no obvious dominant cluster, and these strains have rich genetic diversity, indicating that they may have different sources.
7.Progress on abdominal sonography in neonatal necrotizing enterocolitis
International Journal of Pediatrics 2022;49(11):739-743
As a critical bowel disease in neonates and preterm births, neonatal necrotizing enterocolitis(NEC)is hard to diagnose and treat in time, leaving bad outcomes.With the development of perinatal medicine, the survival rate of premature infants has gradually increased.NEC has become a major digestive system disease that seriously affects the morbidity and compromised life quality of premature infants.Abdominal ultrasound examination has been widely used in the early diagnosis, treatment guidance and outcome assessment of NEC.It is non-invasive and in real time, with high sensitivity and specificity.This review summarizes recent progress on the application of abdominal sonography in the prediction, diagnosis, assessment and treatment guidance of NEC.
8.Effect of cognitive training intervention on attention deficit of methamphetamine-dependent female youth
Yongyan JIANG ; Lushi JING ; Binbin WU ; Tao JU ; Jia HUANG ; Li ZHOU
Chinese Journal of Behavioral Medicine and Brain Science 2022;31(5):407-413
Objective:To explore the effect of methamphetamine (MA) dependence on the attention of female youth, and to analyze the intervention effect of computer-based cognitive training on the attention of MA-dependent female youth.Method:From May to August 2021, a total of 64 MA-dependent female youths in abstinence period from a women's compulsory isolated drug rehabilitation center in Sichuan Province were selected as the MA group, and 53 ordinary female youths matched with their age and education level were selected as the normal control group.According to the matching principle of age, education level, and attention pre-test scores, the subjects in MA-dependent group were divided into MA-dependent intervention group( n=30)and MA-dependent waiting group( n=34). CogniPlus cognitive training system was used to train the attention of subjects in MA-dependent intervention group( n=30), while the subjects in MA-dependent waiting group( n=34) and normal control group did not receive training.The Vienna Test System was used to collect the attention scores of all subjects.SPSS 20.0 analysis software was used for data processing.Statistical analysis was performed using independent samples t test and paired samples t test. Results:The MA-dependent group had significantly longer endogenous alertness, temporary alertness, and concentration response time ((275.61±47.79)ms, (268.63±51.41)ms, (444.08±134.40)ms) compared with the normal control group ((247.02±34.09)ms, (237.60±46.04)ms, (355.15±44.37)ms) ( t=3.767, 3.405, 4.976; all P<0.05). After attention training, the post-test reaction time of endogenous alertness, temporary alertness, and concentration ((264.10±38.98)ms, (251.67±38.06)ms, (352.03±65.70)ms) in the MA-dependent intervention group were significantly shorter than those in the MA-dependent waiting group ((323.18±83.28)ms, (302.74±82.75)ms, (402.76±74.34)ms) ( t=-3.702, -3.232, -2.876; all P<0.05). The post-test reaction time of temporary alertness and concentration in the MA-dependent intervention group ((251.67±38.06)ms, (352.03±65.70)ms)were shorter than those of the pre-test ((265.70±37.84)ms, (428.67±120.11)ms) ( t=2.179, 3.588; both P<0.05). The MA-dependent waiting group had a longer post-test reaction time of endogenous alertness and temporary alertness(323.18±83.28)ms, (302.74±82.75)ms) compared with the pre-test ((285.35±51.43)ms, (271.21±61.42)ms) ( t=-2.752, -2.664; both P<0.05) and the post-test reaction time of concentration ((402.76±74.34)ms) was shorter than that of the pre-test ((457.68±146.29)ms)( t=2.431, P<0.05). The MA-dependent intervention group had longer endogenous alertness, temporary alertness, and pre-test reaction time of concentration ((264.57±41.41)ms, (265.70±37.84)ms, (428.67±120.11)ms)compared with the normal control group( t=2.083, 2.841, 3.230; all P<0.05). The post-test of endogenous alertness ((264.10±38.98)ms) was longer than that of the normal control group ( t=2.082, P<0.05). Conclusion:The cognitive training based on the CogniPlus system has a certain effect on the attention maintenance or recovery of MA-dependent female youth.It can be used as an intervention measure for cognitive impairment of drug addicts and help them healthy return to society.
9.Engineered polymer nanoparticles incorporating L-amino acid groups as affinity reagents for fibrinogen
Zhu YONGYAN ; Liu RUIXUAN ; Wu DENGYU ; Yu QIANQIAN ; J.Shea KENNETH ; Zhu QUANHONG
Journal of Pharmaceutical Analysis 2021;11(5):596-602
Synthetic polymer hydrogel nanoparticles(NPs)were developed to function as abiotic affinity reagents for fibrinogen.These NPs were made using both temperature-sensitive N-isopropyl acrylamide(NIPAm)and L-amino acid monomers.Five kinds of L-amino acids were acryloylated to obtain functional mono-mers:L-phenylalanine(Phe)and L-leucine(Leu)with hydrophobic side chains,L-glutamic acid(Glu)with negative charges,and L-lysine(Lys)and L-arginine(Arg)with positive charges.After incubating the NPs with fibrinogen,y-globulin,and human serum albumin(HSA)respectively,the NPs that incorporated N-acryloyl-Arg monomers(AArg@NPs)showed the strongest and most specific binding affinity to fibrin-ogen,when compared with y-globulin and HSA.Additionally,the fibrinogen-AArg binding model had the best docking scores,and this may be due to the interaction of positively charged AArg@NPs and the negatively charged fibrinogen D domain and the hydrophobic interaction between them.The specific adsorption of AArg@NPs to fibrinogen was also confirmed by the immunoprecipitation assay,as the AArg@NPs selectively trapped the fibrinogen from a human plasma protein mixture.AArg@NPs had a strong selectivity for,and specificity to,fibrinogen and may be developed as a potential human fibrinogen-specific affinity reagent.
10. Concept and clinical application of surgical margin principle on head and neck cancers
Shuxin WEN ; Binquan WANG ; Wei GAO ; Chunming ZHANG ; Yongyan WU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2019;54(9):704-707
Surgical margin principle is one of the central surgical principles for head and neck cancers. Negative surgical margin is the primary purpose of surgery for head and neck cancers. This paper is based on the current clinical application of surgical margins of head and neck cancers, and it is proposed that surgical margins of head and neck cancers may be classified into three types: surface margin, deep margin, and tissue interface margin in consideration of surgical exposure of tumors. The classification of surgical margins can make the clinical application and the research of surgical margins of head and neck cancers more systematic and clear.


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