1.Clinical Study on Qishao Huoxue Prescription for the Treatment of Lumbar Disc Herniation in Qi Stagnation and Blood Stasis Syndrome
Yadi FENG ; Shimin ZHANG ; Guojun WANG ; Jiao JIN ; Hai LIN ; Fudong SHI ; Chun CHEN
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(7):142-147
Objective To observe the clinical efficacy of Qishao Huoxue Prescription in treating low back pain caused by lumbar disc herniation with qi stagnation and blood stasis syndrome.Methods Totally 80 patients of lumbar disc herniation with qi stagnation and blood stasis syndrome were divided into observation group and control group according to random number table method,with 40 cases in each group.The observation group received oral administration of Qishao Huoxue Prescription,while the control group received oral celecoxib capsules for 3 weeks.Follow-ups were conducted after 1 month and 3 month of treatment,and the clinical efficacy of two groups after 3 months of treatment was evaluated.The Visual Analog Scale(VAS)scores,Japanese Orthopaedic Association Assessment of Treatment Score(JOA),Oswestry Disability Index(ODI)and Quality of Life(SF-36)scores for pain before treatment,1 and 3 weeks after treatment,and 1 and 3 months after treatment in two groups were observed;the blood flow changes of two groups before and after 3 weeks of treatment were observed,including whole blood high shear,medium shear,and low shear viscosity,plasma viscosity,and fibrinogen(FIB);adverse reactions in both group were recorded.Results The total effective rate in the observation group was 97.5%(39/40),significantly higher than 87.5%(35/40)in the control group(P<0.05).At 1 and 3 weeks of treatment and 1 and 3 months after treatment,VAS scores and ODI scores significantly decreased compared to before treatment,while JOA scores and SF-36 scores significantly increased in both groups.The improvement in scores in the observation group was better than that in the control group(P<0.01).The observation group showed a significant decrease in blood high,medium,and low shear viscosity,PV and FIB levels after 3 weeks of treatment compared to before treatment(P<0.05),and all levels were lower than those in the control group(P<0.05).No significant adverse reactions were observed in both groups.Conclusion Qishao Huoxue Prescription can significantly improve the clinical symptoms,hemorheological indicators,and quality of life of low back pain caused by lumbar disc herniation with qi stagnation and blood stasis syndrome,with good safety.
2.Analysis of the Effect and Prognostic Factors of Deep Brain Electrical Stimulation Therapy on Parkinson's Disease Patients with Frozen Gait
Kang MENG ; Xin-qi HU ; Zhao-hai FENG ; Jia-ming WANG ; Lei JIANG
Progress in Modern Biomedicine 2025;25(12):1996-2002,2033
Objective:To analyze the effect of deep brain electrical stimulation therapy on Parkinson's disease patients with frozen gait and explore its prognostic factors.Methods:A retrospective study was conducted on 86 Parkinson's disease patients with frozen gait admitted to our hospital from January 2020 to December 2022.All patients received deep brain electrical stimulation therapy.Conduct a 2-year outpatient follow-up for all patients,and analyze the scores of the Parkinson's Disease Rating Scale Part 2(UPDRS Ⅱ),Parkinson's Disease Rating Scale Part 3(UPDRS Ⅲ),Fugl Meyer Lower Limb Motor Function Assessment Scale(FMA),and Schwab&England Daily Activity Scale(S&E)before and after medication opening and closing,6 months after surgery,1 year after surgery,and 2 years after surgery.And based on the 2-year follow-up results of the patients,the prognosis level of the patients was evaluated according to the S&E score during drug closure.60 patients with drug closure S&E score>70 were divided into a good prognosis group,and 26 patients with drug closure S&E score≤70 were divided into a poor prognosis group.Logistic regression model was used to analyze the influencing factors of deep brain electrical stimulation therapy in Parkinson's disease gait freezing patients.Results:At 6 months,1 year,and 2 years after surgery,the UPDRS Ⅱ and UPDRS Ⅲ scores of all patients were lower than those before surgery(P<0.05).The UPDRS Ⅱ and UPDRS Ⅲ scores of patients before surgery,6 months,1 year,and 2 years after surgery were lower than those of patients before surgery(P<0.05);At 6 months,1 year,and 2 years after surgery,the FMA and S&E scores of all patients were higher than those before surgery(P<0.05).There was no significant difference in the FMA and S&E scores between 6 months,1 year,and 2 years after surgery(P>0.05).However,the FMA and S&E scores at 6 months,1 year,and 2 years after surgery were lower than those at the end of surgery(P<0.05);There was no significant difference between the gender,BMI,combined underlying disease,levodopa equivalent dose,preoperative UPDRSⅢ score before the on and off periods,and FMA scores before the on and off periods(P>0.05),Age,Parkinson's disease stage,preoperative UPDRS Ⅱ score between open and off period,and preoperative S&E score between the good prognosis and off prognosis groups(P<0.05);The UPDRS Ⅱ score(95%CI:1.353~5.782,OR value:2.462),S&E score(95%CI:1.658~4.687,OR value:2.789),and S&E score(95%CI:1.265~6.879,OR value:3.645)before opening surgery are independent influencing factors on deep brain electrical stimulation therapy in Parkinson's disease gait freezing patients(P<0.05).Conclusion:Deep brain electrical stimulation therapy can improve the condition and motor function of Parkinson's disease patients with frozen gait,but some patients may have poor prognosis due to the influence of UPDRS Ⅱ score before surgery and S&E scores during the opening and closing phases.
3.Effect of different decompression methods on unilateral biportal endoscopy in the treatment of elderly patients with severe lumbar spinal stenosis
Zhi-long ZHANG ; Hai-ying WANG ; Feng-hua MA ; Yan-jie HOU
Journal of Regional Anatomy and Operative Surgery 2025;34(9):780-784
Objective To investigate the effect of different decompression methods on the efficacy of the unilateral biportal endoscopy(UBE)in the treatment of severe lumbar spinal stenosis(LSS).Methods A total of 203 elderly patients with LSS who underwent UBE treatment in our hospital from September 2021 to June 2024 were selected and divided into the unilateral group(102 cases)and the bilateral group(101 cases)according to different decompression methods.The unilateral group underwent unilateral decompression during operation,while the bilateral group underwent bilateral decompression(with bilateral decompression through the same incision and unilateral approach)during operation.The perioperative conditions,anatomical image parameters,visual analogue scale(VAS)scores,Oswestry disability index(ODI),and complications were compared between the two groups.The rehabilitation progress and complications of patients with different Charlson comorbidity index(CCI)values were compared.Results The operation time of patients in the bilateral group was longer than that in the unilateral group(P<0.05).The dural sac area and lumbar spinal canal area of patients in the bilateral group were larger than those in the unilateral group immediately after operation and 3 months after operation(P<0.05).The VAS scores and ODI 7 days and 3 months after operation of patients in the bilateral group were lower than those in the unilateral group(P<0.05).There was no statistically significant difference in the total incidence of complications between the two groups of patients(P>0.05).The first time of getting out of bed after operation and hospital stay in patients with CCI value>2 scores were longer than those in patients with CCI value≤2 scores(P<0.05).Conclusion Compared with unilateral decompression,bilateral decompression for elderly patients with severe LSS takes a longer surgical time,but it can better restore lumbar shape,alleviate pain,improve lumbar function,and has higher safety,and the milder the patient's condition,the faster the postoperative recovery.
4.Application of surgical adhesive membrane combined with modified towel placement method in orthopaedic unilateral biportal endoscopy operation
Hai-feng WANG ; Ting JIANG ; Shan-shan ZHANG
Journal of Regional Anatomy and Operative Surgery 2025;34(4):350-353
Objective To observe the application effect of surgical adhesive membrane combined with modified towel placement method in patients undergoing orthopedic unilateral biportal endoscopy(UBE)operation.Methods A total of 61 patients who underwent orthopedic UBE operation in our hospital from December 2022 to September 2023 were selected and divided into the control group(31 cases,conventional surgical adhesive membrane and towel placement)and the observation group(30 cases,surgical adhesive membrane combined with modified towel placement method)according to different placement methods of membrane and towel during operation.The degree of wetting in the surgical area,vital signs,intraoperative adverse events,postoperative incision infection rate and patients'satisfaction were compared between the two groups.Results The proportions of wet sterile sheets around the surgical area and moist skin of patients in the observation group were lower than those in the control group(P<0.05).The saturation of peripheral oxygen(SpO2),heart rate(HR),mean arterial pressure(MAP)at spinal canal decompression and the end of the operation of patients in the observation group were significantly better than those in the control group(P<0.05).No postoperative incision infection occurred in the two groups,and there was no statistically significant difference in the total incidence of adverse events between the two groups(P>0.05).The patients'satisfaction in the observation group was significantly higher than that in the control group(P<0.05).Conclusion Surgical adhesive membrane combined with modified towel placement method can reduce the degree of wetting in the surgical area during orthopedic UBE operation,stabilize the patients'vital signs,and improve patients'satisfaction.
5.Clinical Study on Qishao Huoxue Prescription for the Treatment of Lumbar Disc Herniation in Qi Stagnation and Blood Stasis Syndrome
Yadi FENG ; Shimin ZHANG ; Guojun WANG ; Jiao JIN ; Hai LIN ; Fudong SHI ; Chun CHEN
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(7):142-147
Objective To observe the clinical efficacy of Qishao Huoxue Prescription in treating low back pain caused by lumbar disc herniation with qi stagnation and blood stasis syndrome.Methods Totally 80 patients of lumbar disc herniation with qi stagnation and blood stasis syndrome were divided into observation group and control group according to random number table method,with 40 cases in each group.The observation group received oral administration of Qishao Huoxue Prescription,while the control group received oral celecoxib capsules for 3 weeks.Follow-ups were conducted after 1 month and 3 month of treatment,and the clinical efficacy of two groups after 3 months of treatment was evaluated.The Visual Analog Scale(VAS)scores,Japanese Orthopaedic Association Assessment of Treatment Score(JOA),Oswestry Disability Index(ODI)and Quality of Life(SF-36)scores for pain before treatment,1 and 3 weeks after treatment,and 1 and 3 months after treatment in two groups were observed;the blood flow changes of two groups before and after 3 weeks of treatment were observed,including whole blood high shear,medium shear,and low shear viscosity,plasma viscosity,and fibrinogen(FIB);adverse reactions in both group were recorded.Results The total effective rate in the observation group was 97.5%(39/40),significantly higher than 87.5%(35/40)in the control group(P<0.05).At 1 and 3 weeks of treatment and 1 and 3 months after treatment,VAS scores and ODI scores significantly decreased compared to before treatment,while JOA scores and SF-36 scores significantly increased in both groups.The improvement in scores in the observation group was better than that in the control group(P<0.01).The observation group showed a significant decrease in blood high,medium,and low shear viscosity,PV and FIB levels after 3 weeks of treatment compared to before treatment(P<0.05),and all levels were lower than those in the control group(P<0.05).No significant adverse reactions were observed in both groups.Conclusion Qishao Huoxue Prescription can significantly improve the clinical symptoms,hemorheological indicators,and quality of life of low back pain caused by lumbar disc herniation with qi stagnation and blood stasis syndrome,with good safety.
6.Construction of a combined disease-syndrome animal model of dilated cardiomyopathy with heart failure toxin syndrome and study on potential biomarkers
Feng JIANG ; Jiayang TANG ; Xiangyi QIAN ; Hai PAN ; Aolong HE ; Xiaoqi WEI ; Jinling XIAO ; Wei WANG ; Shuzhen GUO
Journal of Beijing University of Traditional Chinese Medicine 2025;48(5):613-624
Objective To construct an animal model of dilated cardiomyopathy(DCM)with heart failure toxin syndrome that conforms to the characteristics of traditional Chinese medicine(TCM)syndrome and identify potential biomarkers or intervention targets for DCM with heart failure toxin syndrome.Methods Fifteen male SD rats were divided into a blank control,doxorubicin,or DCM with heart failure toxin syndrome group using a random number table method,with five rats per group.The doxorubicin group received intraperitoneal injection of doxorubicin at a dose of 1.25 mg/kg,administered on the first and fourth days of each week,along with a standard diet.The DCM with heart failure toxin syndrome group,in addition to the doxorubicin treatment,was given 42%white liquor(10 mL/kg)via gavage every other day,along with a 45%high-fat feed and 10%fructose water.The blank control group received intraperitoneal injection of an equivalent volume of phosphate-buffered saline at the same time points as the doxorubicin group,along with a standard diet.The model was established for 10 weeks.At the fourth and tenth weeks of modeling,echocardiography was performed to measure left ventricular ejection fraction(LVEF),fractional shortening(FS),systolic left ventricular posterior wall thickness(LVPWs),diastolic left ventricular posterior wall thickness,systolic left ventricular internal diameter(LVIDs),and diastolic left ventricular internal diameter(LVIDd);macroscopic changes in fur color of the rats were assessed using the red-green-blue colorimetric method.After modeling,the open field test was conducted to evaluate the exercise tolerance of the rats,and the grip strength test was performed to assess changes in forelimb grip strength.Hematoxylin-eosin,Masson,and wheat germ agglutinin staining were used to evaluate pathological changes in cardiac tissue.Bulk RNA sequencing analysis was performed to identify differentially expressed genes(DEGs)in the hearts of rats between the blank control and the DCM with heart failure toxin syndrome groups.Using DCM,the Blue value of rat fur color,and forelimb grip strength as phenotypic traits,weighted gene co-expression network analysis(WGCNA)was performed to screen for characteristic module gene sets(MEs)associated with DCM with heart failure toxin syndrome.Overlapping analysis was performed on DEGs,immune-related gene sets,and MEs,and the intersecting genes were identified as potential biomarkers or intervention targets for DCM with heart failure toxin syndrome.The sensitivity and specificity of these targets were evaluated using receiver operating characteristic(ROC)curve analysis.Results Compared with the blank control group,at the tenth week of modeling,the LVEF,FS,and LVPWs of rats in the doxorubicin group and the DCM with heart failure toxin syndrome group decreased,whereas LVIDs and LVIDd increased,and the movement distance of the open field test and forelimb grip strength were reduced(P<0.05).At the 10th week of modeling,the Blue value of fur color in the DCM with heart failure toxin syndrome group was significantly lower than that of the blank control and doxorubicin groups(P<0.05).Compared with the blank control group,rats in the doxorubicin and DCM with heart failure toxin syndrome groups exhibited significant cardiac dilation and increased immune cell infiltration in cardiac tissue,accompanied by collagen deposition and cardiomyocyte hypertrophy.Bulk RNA sequencing identified 2,003 DEGs,including 1,082 downregulated genes and 921 upregulated genes.WGCNA results revealed that the MEturquoise module had the strongest positive correlation with DCM and the strongest negative correlation with the Blue value and forelimb grip strength.The overlapping analysis identified four intersecting genes:bone morphogenetic protein 6(Bmp6),serine-threonine-protein kinase 1(Pak1),proto-oncogene JunD(JunD),and S100 calcium-binding protein A3(S100A3).ROC curve analysis demonstrated that these four genes exhibited high sensitivity and specificity for DCM with heart failure toxin syndrome.Conclusion The rat model constructed by intraperitoneal injection of doxorubicin combined with a high-fat feed,fructose water,and white liquor gavage closely aligns with the characteristics of the DCM with heart failure toxin syndrome.Bmp6,JunD,Pak1,and S100A3 are potential biomarkers or therapeutic targets for DCM heart failure toxin syndrome.
7.Analysis of the Effect and Prognostic Factors of Deep Brain Electrical Stimulation Therapy on Parkinson's Disease Patients with Frozen Gait
Kang MENG ; Xin-qi HU ; Zhao-hai FENG ; Jia-ming WANG ; Lei JIANG
Progress in Modern Biomedicine 2025;25(12):1996-2002,2033
Objective:To analyze the effect of deep brain electrical stimulation therapy on Parkinson's disease patients with frozen gait and explore its prognostic factors.Methods:A retrospective study was conducted on 86 Parkinson's disease patients with frozen gait admitted to our hospital from January 2020 to December 2022.All patients received deep brain electrical stimulation therapy.Conduct a 2-year outpatient follow-up for all patients,and analyze the scores of the Parkinson's Disease Rating Scale Part 2(UPDRS Ⅱ),Parkinson's Disease Rating Scale Part 3(UPDRS Ⅲ),Fugl Meyer Lower Limb Motor Function Assessment Scale(FMA),and Schwab&England Daily Activity Scale(S&E)before and after medication opening and closing,6 months after surgery,1 year after surgery,and 2 years after surgery.And based on the 2-year follow-up results of the patients,the prognosis level of the patients was evaluated according to the S&E score during drug closure.60 patients with drug closure S&E score>70 were divided into a good prognosis group,and 26 patients with drug closure S&E score≤70 were divided into a poor prognosis group.Logistic regression model was used to analyze the influencing factors of deep brain electrical stimulation therapy in Parkinson's disease gait freezing patients.Results:At 6 months,1 year,and 2 years after surgery,the UPDRS Ⅱ and UPDRS Ⅲ scores of all patients were lower than those before surgery(P<0.05).The UPDRS Ⅱ and UPDRS Ⅲ scores of patients before surgery,6 months,1 year,and 2 years after surgery were lower than those of patients before surgery(P<0.05);At 6 months,1 year,and 2 years after surgery,the FMA and S&E scores of all patients were higher than those before surgery(P<0.05).There was no significant difference in the FMA and S&E scores between 6 months,1 year,and 2 years after surgery(P>0.05).However,the FMA and S&E scores at 6 months,1 year,and 2 years after surgery were lower than those at the end of surgery(P<0.05);There was no significant difference between the gender,BMI,combined underlying disease,levodopa equivalent dose,preoperative UPDRSⅢ score before the on and off periods,and FMA scores before the on and off periods(P>0.05),Age,Parkinson's disease stage,preoperative UPDRS Ⅱ score between open and off period,and preoperative S&E score between the good prognosis and off prognosis groups(P<0.05);The UPDRS Ⅱ score(95%CI:1.353~5.782,OR value:2.462),S&E score(95%CI:1.658~4.687,OR value:2.789),and S&E score(95%CI:1.265~6.879,OR value:3.645)before opening surgery are independent influencing factors on deep brain electrical stimulation therapy in Parkinson's disease gait freezing patients(P<0.05).Conclusion:Deep brain electrical stimulation therapy can improve the condition and motor function of Parkinson's disease patients with frozen gait,but some patients may have poor prognosis due to the influence of UPDRS Ⅱ score before surgery and S&E scores during the opening and closing phases.
8.Construction of a combined disease-syndrome animal model of dilated cardiomyopathy with heart failure toxin syndrome and study on potential biomarkers
Feng JIANG ; Jiayang TANG ; Xiangyi QIAN ; Hai PAN ; Aolong HE ; Xiaoqi WEI ; Jinling XIAO ; Wei WANG ; Shuzhen GUO
Journal of Beijing University of Traditional Chinese Medicine 2025;48(5):613-624
Objective To construct an animal model of dilated cardiomyopathy(DCM)with heart failure toxin syndrome that conforms to the characteristics of traditional Chinese medicine(TCM)syndrome and identify potential biomarkers or intervention targets for DCM with heart failure toxin syndrome.Methods Fifteen male SD rats were divided into a blank control,doxorubicin,or DCM with heart failure toxin syndrome group using a random number table method,with five rats per group.The doxorubicin group received intraperitoneal injection of doxorubicin at a dose of 1.25 mg/kg,administered on the first and fourth days of each week,along with a standard diet.The DCM with heart failure toxin syndrome group,in addition to the doxorubicin treatment,was given 42%white liquor(10 mL/kg)via gavage every other day,along with a 45%high-fat feed and 10%fructose water.The blank control group received intraperitoneal injection of an equivalent volume of phosphate-buffered saline at the same time points as the doxorubicin group,along with a standard diet.The model was established for 10 weeks.At the fourth and tenth weeks of modeling,echocardiography was performed to measure left ventricular ejection fraction(LVEF),fractional shortening(FS),systolic left ventricular posterior wall thickness(LVPWs),diastolic left ventricular posterior wall thickness,systolic left ventricular internal diameter(LVIDs),and diastolic left ventricular internal diameter(LVIDd);macroscopic changes in fur color of the rats were assessed using the red-green-blue colorimetric method.After modeling,the open field test was conducted to evaluate the exercise tolerance of the rats,and the grip strength test was performed to assess changes in forelimb grip strength.Hematoxylin-eosin,Masson,and wheat germ agglutinin staining were used to evaluate pathological changes in cardiac tissue.Bulk RNA sequencing analysis was performed to identify differentially expressed genes(DEGs)in the hearts of rats between the blank control and the DCM with heart failure toxin syndrome groups.Using DCM,the Blue value of rat fur color,and forelimb grip strength as phenotypic traits,weighted gene co-expression network analysis(WGCNA)was performed to screen for characteristic module gene sets(MEs)associated with DCM with heart failure toxin syndrome.Overlapping analysis was performed on DEGs,immune-related gene sets,and MEs,and the intersecting genes were identified as potential biomarkers or intervention targets for DCM with heart failure toxin syndrome.The sensitivity and specificity of these targets were evaluated using receiver operating characteristic(ROC)curve analysis.Results Compared with the blank control group,at the tenth week of modeling,the LVEF,FS,and LVPWs of rats in the doxorubicin group and the DCM with heart failure toxin syndrome group decreased,whereas LVIDs and LVIDd increased,and the movement distance of the open field test and forelimb grip strength were reduced(P<0.05).At the 10th week of modeling,the Blue value of fur color in the DCM with heart failure toxin syndrome group was significantly lower than that of the blank control and doxorubicin groups(P<0.05).Compared with the blank control group,rats in the doxorubicin and DCM with heart failure toxin syndrome groups exhibited significant cardiac dilation and increased immune cell infiltration in cardiac tissue,accompanied by collagen deposition and cardiomyocyte hypertrophy.Bulk RNA sequencing identified 2,003 DEGs,including 1,082 downregulated genes and 921 upregulated genes.WGCNA results revealed that the MEturquoise module had the strongest positive correlation with DCM and the strongest negative correlation with the Blue value and forelimb grip strength.The overlapping analysis identified four intersecting genes:bone morphogenetic protein 6(Bmp6),serine-threonine-protein kinase 1(Pak1),proto-oncogene JunD(JunD),and S100 calcium-binding protein A3(S100A3).ROC curve analysis demonstrated that these four genes exhibited high sensitivity and specificity for DCM with heart failure toxin syndrome.Conclusion The rat model constructed by intraperitoneal injection of doxorubicin combined with a high-fat feed,fructose water,and white liquor gavage closely aligns with the characteristics of the DCM with heart failure toxin syndrome.Bmp6,JunD,Pak1,and S100A3 are potential biomarkers or therapeutic targets for DCM heart failure toxin syndrome.
9.The RNA-binding protein KHSRP activates JAK1/STAT3 pathway to promote the growth and metastasis of gastric cardia adenocarcinoma
Xiao-long WANG ; Meng-yao WANG ; Hai-feng ZHANG ; Yang-yang LIU ; Li LI ; Hai-tao WEI
Chinese Pharmacological Bulletin 2025;41(1):71-80
Aim To investigate the effect of KHSRP on the malignant biological behavior of gastric cardia ade-nocarcinoma by targeting JAK1/STAT3 signaling axis.Methods The expression levels of KHSRP in adeno-carcinoma tissues of gastric cardia adenocarcinoma and adjacent tissues were collected and compared.qRT-PCR experiment to detect transfection efficiency in gas-tric cardia adenocarcinoma cell lines(OE-19,TE-7,BIC-1,FLO-1,SK-GT-4,BE-3)and normal gastric mucosal epithelial cell line(GES-1).The knockdown and overexpression of KHSRP were treated by packa-ging lentiviral Vector,and the cells were divided into sh-NC group,sh-KHSRP group,vector group,and KH-SRP group.Cell counting kit-8(CCK-8)and Tran-swell assay were used to determine the effects of KH-SRP on the proliferation,migration and invasion of ade-nocarcinoma cells of gastric cardia adenocarcinoma.Xenograft tumor models were used to detect the effects of knockdown and overexpression of KHSRP in live an-imals.WB experiments confirmed that KHSRP targeted the JAK/STAT signaling pathway.Results KHSRP was overexpressed in GCA tissues and cell lines(P<0.05).Cell function assay analysis showed that KH-SRP overexpression significantly promoted GCA cell proliferation,migration and invasion in vitro(P<0.05).After KHSRP knockdown,the phosphorylation levels of JAK1 and STAT3 in JAK/STAT signaling pathway were significantly decreased,and the situation was opposite after KHSRP overexpression(P<0.05).Conclusion KHSRP regulates the malignant progres-sion of metastasis of gastric cardia adenocarcinoma by activating JAK1/STAT3 signaling axis.
10.Innovation in the design and technique use of drug clinical trial
Hai-yan XIONG ; Jian-feng LUO ; Wei-bing WANG
Fudan University Journal of Medical Sciences 2025;52(1):153-158
Drug clinical trial is a method of experimental epidemiology to evaluate the effectiveness and safety of medicines.This article introduced the types and design thought of innovation in drug clinical trial design,and provided methodological reference for related researches.Adaptive design is a complex and innovative clinical trial design,which can be divided into group sequential design,sample size re-estimation,seamless trial,enrichment design and master protocol design(basket trial,umbrella trial,platform trial,etc.)according to the purpose of adaptability.The adaptive design has greater adjustment flexibility,which overcomes the shortcomings of conventional clinical trials to a certain extent,then improves the validity of the trial results and the strength of the evidence.The design innovation and remodeling of drug clinical trials will provide more powerful evidence-based evidence for the realization of precision medicine.

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