Randomized controlled trial(RCT) is considered to represent the gold standard for evaluating the efficacy of interventions and has been widely used to evaluate the clinical efficacy of traditional Chinese medicine(TCM). However, there are unique challenges in implementing RCT in TCM. Patients seeking TCM treatment often have preferences for TCM due to the unsatisfactory therapeutic effect of western medicine, their personal intolerance, and their rejection of certain drugs, medical devices, or surgery. Patients are generally reluctant to be randomly assigned to a group, making it challenging to enroll patients in the control group of western medicine during the implementation of RCT in TCM. This has become a prominent problem restricting the implementation of RCT in TCM and needs to be solved urgently. Therefore, this paper introduced commonly used research designs used in solving the problem of enrolling patients in control group during the implementation of RCT in TCM, including Zelen design, partially randomized patient preference trial(PRPP), single-arm objective performance criteria(OPC), cohort studies, single-arm clinical trials using real world data(RWD) alone as the external control group, and the design method based on RWD-augmented control group samples in RCT. The paper outlined the definitions and principles of these methods, evaluated their advantages, disadvantages, and applicable scenarios, and explored their applications in the TCM field, so as to offer insights for solving the difficulty in enrolling patients in the control group during the implementation of RCT in TCM.
Humans ; Medicine, Chinese Traditional/methods* ; Randomized Controlled Trials as Topic/methods* ; Research Design ; Patient Selection ; Drugs, Chinese Herbal/therapeutic use* ; Control Groups

Objective: To understand the moderating effect of cohabitation with parents on the association between peer dating behavior and sexual behaviors among secondary vocational school students, so as to provide a scientific basis for preventing sexual behaviors among secondary vocational school students. Methods: From March to April 2021, an electronic questionnaire survey was conducted among 3 180 students from 6 vocational schools in Shanghai (urban, suburban, exurban) and Shaanxi (Shangluo, Ankang, Baoji) using cluster sampling. Spearman correlation analysis was used to investigate the relationship of cohabitation with parents, peer dating behavior and sexual behaviors among secondary vocational school students. Binary Logistic regression analysis was performed to investigate the role of cohabitation with parents on peer dating behavior and sexual behaviors among secondary vocational students. Results: There was a significant negative between cohabitation with parents and sexual ( r =-0.04); and there was a positive correlation between peer dating behavior and sexual behaviors ( r =0.24), as well as cohabitation with parents and peer dating behavior ( r =0.04)( P <0.05). Multivariable Logistic regression analysis showed an association between peer dating behavior and the occurrence of sexual behaviors ( OR=2.79-12.95, P <0.05). Cohabitation with parents played a moderating role in the association between peer dating behavior and sexual behaviors, and a signification interaction was found between cohabitation with parents and reporting that a small part or about half of their peers had dating behavior ( OR =0.48, P <0.05). Conclusions The more peers dating behavior are associated with a higher risk of sexual behaviors among secondary vocational school students, and cohabitation with parents can partly reduce this risk. School and family sexuality education for secondary vocational students should be strengthened to improve their interpersonal skills and decision-making, and ability to resist peer pressure, so as to reduce their risk of sexual behaviors.

Objective:To evaluate the clinical utility of an intelligent endoscope transportation system in the digestive endoscopy center.Methods:A parallel-group controlled trial was conducted at Digestive Endoscopy Center of Qilu Hospital of Shandong University from June 1st to December 31st 2024, comparing robotic intelligent endoscope transport (experimental group) versus manual transport (control group). Performance metrics, including response time, transportation speed, labor efficiency, contamination prevention, closed-loop traceability, and nursing staff satisfaction, were statistically analyzed. Full-time equivalent (FTE) was introduced to quantify the operational efficiency of the experimental group.Results:The study included a total of 60 206 instances of intelligent endoscope transportation and 60 485 instances of manual transportation data. The robotic group demonstrated significantly shorter response times versus manual group for initial dispatch (51.08±14.97 seconds VS 54.44±13.61 seconds, t=35.8, P<0.001) and recovery response time (32.52±11.26 seconds VS 40.20±11.40 seconds, t=103.93, P<0.001). During the 148 days operational period, the success rate was 99.83% (60 104/60 206) and the failure rate was 0.17% (102/60 206) for robotic transports. Primary failure causes were wireless disconnection, pathfinding errors, and mechanical faults, averaging 1.05 malfunctions/month with no adverse events. The success and failure rate was 99.26% (60 043/60 485) and 0.74% (442/60 485) respectively for manual transports. Staff satisfaction was significantly higher for robotic transport in endoscopic transportation (4.65±0.55 scores VS 3.97±0.98 scores, t=96.5, P<0.001) and delivery process (4.71±0.59 scores VS 3.90±1.04 scores, t=210.3, P<0.001). and workload intensity was significantly lower (4.06±0.77 scores VS 4.48±0.63 scores, t=59.9, P=0.025). The system reduced labor requirements by 3.68 FTE, yielding annual savings of ￥657 000. Conclusion:The robotic intelligent endoscope transport system improves work efficiency, reduces nursing labor costs and physical workload, enhances job experience and satisfaction, and enables full-process smart traceability, providing a validated solution for endoscopy center logistics.

Objective:To evaluate the clinical utility of an intelligent endoscope transportation system in the digestive endoscopy center.Methods:A parallel-group controlled trial was conducted at Digestive Endoscopy Center of Qilu Hospital of Shandong University from June 1st to December 31st 2024, comparing robotic intelligent endoscope transport (experimental group) versus manual transport (control group). Performance metrics, including response time, transportation speed, labor efficiency, contamination prevention, closed-loop traceability, and nursing staff satisfaction, were statistically analyzed. Full-time equivalent (FTE) was introduced to quantify the operational efficiency of the experimental group.Results:The study included a total of 60 206 instances of intelligent endoscope transportation and 60 485 instances of manual transportation data. The robotic group demonstrated significantly shorter response times versus manual group for initial dispatch (51.08±14.97 seconds VS 54.44±13.61 seconds, t=35.8, P<0.001) and recovery response time (32.52±11.26 seconds VS 40.20±11.40 seconds, t=103.93, P<0.001). During the 148 days operational period, the success rate was 99.83% (60 104/60 206) and the failure rate was 0.17% (102/60 206) for robotic transports. Primary failure causes were wireless disconnection, pathfinding errors, and mechanical faults, averaging 1.05 malfunctions/month with no adverse events. The success and failure rate was 99.26% (60 043/60 485) and 0.74% (442/60 485) respectively for manual transports. Staff satisfaction was significantly higher for robotic transport in endoscopic transportation (4.65±0.55 scores VS 3.97±0.98 scores, t=96.5, P<0.001) and delivery process (4.71±0.59 scores VS 3.90±1.04 scores, t=210.3, P<0.001). and workload intensity was significantly lower (4.06±0.77 scores VS 4.48±0.63 scores, t=59.9, P=0.025). The system reduced labor requirements by 3.68 FTE, yielding annual savings of ￥657 000. Conclusion:The robotic intelligent endoscope transport system improves work efficiency, reduces nursing labor costs and physical workload, enhances job experience and satisfaction, and enables full-process smart traceability, providing a validated solution for endoscopy center logistics.

Objective: To understand sexual and reproductive health knowledge, access to sexuality education and associated factors among secondary vocational school students in Shanghai Municipality and Shaanxi Province, so as to provide a scientific basis for conducting sexuality educaiton in vocational schools. Methods: A crosssectional survey was conducted among 3 180 students in grades 1-3 selected by cluster sampling during April to June 2021 in six secondary vocational schools from three cities of Shanghai and Shaanxi (Shangluo, Ankang, Baoji). Participants were investigated through online questionnaire survey, inlcuding demographic characteristics, household information, sexual health at home and school, knowledge on sexual and reproductive health. Both t test and Chisquare test were used for group comparisons, and multivariate ordial Logistic regression was used to explore possible risk factors for sexual and reproductive health score in quartiles. Results: Respondents average score was (51.36±21.61), with the highest score on sexual harassment/sexual abuse (66.45±42.27) and the lowest score on reproduction and physiology (47.67±31.94) and contraception (43.85±26.81). Although significant differences were observed between two study sites, the primary source of knowledge in both sites was schools/teachers, followed by the Internet or friends; the main theme of school sexuality education was puberty development and health care (more than 80%); the most frequently reported topic between respondents and their parents in both sites was interpersonal relationships (more than 55%), and there were significant differences in the reporting rates of secondary vocational school students between the two regions(χ2=28.56，32.02，P<0.05). The results of multivariable Logistic regression analysis showed that residential area, gender, grade, registered residence, number of sexual related topics communicated with parents, number of subjects received from school sexuality education, and reported information sources from classmates/friends, books/magazines/newspapers, internet and communities were related to knowledge level of respondents (OR=1.62, 0.72, 1.20, 1.58, 2.09, 1.17, 1.18, 1.66, 1.62, 1.69, 1.22, P<0.05). Conclusions Vocational students of Shanghai and Shaanxi have poor sexual and reproductive health knowledge and limited access to school and family sexuality education. It is necessary to strengthen sexuality education for secondary vocational school students.

Objective To investigate the effects of Fuzheng Quxie Prescription(mainly with the actions of supporting healthy qi and dispelling pathogens)combined with neoadjuvant chemotherapy on tumor recurrence,serum thymidine kinase 1(TK1)level and immune function in patients with triple-negative breast cancer(TNBC).Methods Eighty patients with TNBC of qi and yin deficiency type were randomly divided into a combination group and a control group,with 40 patients in each group.The control group was treated with AC-T sequential chemotherapy(Doxorubicin combined with Cyclophosphamide plus sequential Docetaxel),and the combination group was treated with Fuzheng Quxie Prescription on the basis of treatment for the control group.One course of treatment covered 21 days,and the two groups were treated for 4 consecutive courses.The changes of traditional Chinese medicine(TCM)syndrome scores,Karnofsky Performance Status(KPS)score,levels of tumor markers of carbohydrate antigen 125(CA125),carbohydrate antigen 153(CA153)and TK1,and T lymphocyte subset levels in the two groups were observed before and after the treatment.Moreover,the clinical efficacy and tumor metastasis and recurrence in the two groups were compared.Results(1)After 4 courses of treatment,the total effective rate of the combination group was 87.50%(35/40),and that of the control group was 67.50%(27/40),and the intergroup comparison(tested by chi-square test)showed that the efficacy of the combination group was significantly superior to that of the control group(P＜0.05).(2)After treatment,the TCM syndrome scores in the two groups were significantly decreased compared with those before treatment(P＜0.05),and the KPS scores were significantly increased compared with those before treatment(P＜0.05),and the decrease of TCM syndrome scores and the increase of KPS scores in the combination group were significantly superior to that in the control group(P＜0.05 or P＜0.01).(3)After treatment,the serum CA125,CA153 and TK1 levels of patients in the two groups were significantly decreased compared with those before treatment(P＜0.05),and the decrease of serum CA125,CA153 and TK1 levels in the combination group was significantly superior to that in the control group(P＜0.01).(4)After treatment,the T lymphocyte subset CD3+,CD4+ levels and CD4+/CD8+ ratio in the two groups were significantly increased compared with those before treatment(P＜0.05),and the CD8+ level was significantly decreased compared with that before treatment(P＜0.05).The post-treatment intergroup comparison showed that the increase of the T lymphocyte subset CD3+,CD4+ levels and CD4+/CD8+ ratio as well as the decrease of the CD8+ level in the combination group was all significantly superior to that in the control group(P＜0.05 or P＜0.01).(5)The one-year follow-up showed that the tumor recurrence rate and tumor metastasis rate in the combination group were 7.50%(3/40)and 12.50%(5/40)respectively,significantly lower than 25.00%(10/40)and 35.00%(14/40)in the control group,and the differences were statistically significant when comparing between the two groups(P＜0.05).Conclusion The combination of neoadjuvant chemotherapy with Fuzheng Quxie Prescription has a better therapeutic effect on TNBC patients with qi and yin deficiency syndrome,which can effectively improve the immune function of the patients,decrease the level of serum tumor markers,improve the quality of life of the patients,and reduce the incidence of tumor recurrence and metastasis.

Objective To establish a high performance liquid chromatographic(HPLC)method for the determination of chidamide in human plasma.Methods The plasma sample was taken as 500 μL,and triamcinolone was used as the internal standard.After liquid-liquid extraction using methyl tert-butyl ether,the supernatant was centrifuged and blown dry under N2,then re-dissolved in 50 μL of water,and then centrifuged again,and then 10 μL of the supernatant was injected into the system.The separation was performed on a Shim-pack CLC-ODS(150 mm×60 mm,5 μm)at 35 ℃ using water-acetonitrile=(74∶26,v/v,adjusted to pH=3 by acetic acid)as mobile phase.The flow rate was 1.0 mL·min-1 and the wavelength was 260 nm.The specificity,standard curve,lower limit of quantitation,precision,recovery and stability of the method were investigated.In addition,the high performance liquid chromatography method described above was applied to determine the plasma drug concentration after oral administration of chidamide in one patient.Results The retention time of chidamide and internal standard was 8.00 and 9.40 min,respectively.The standard curve equation was y=10.28x-0.06(r=0.998).The intra-day and inter-day precision(RSD)of low,medium and high concentration quality control samples(0.02,0.15,0.75 μg·mL-)were 1.00％-4.87％(n=6),and the accuracy was-10.29％-3.37％.The average extraction recovery was 61.74％-69.85％.Conclusion The method was simple,sensitive and accurate,suitable for monitoring the concentrations of chidamide in human plasma.

Objective:The study aimed to quantify the contents of peimine and peiminine in huangshi xiangsheng pills using a nano quantity analyte detector(NQAD)and compare the results with the evaporative light scattering detector(ELSD).Methods:Analytical separation was conducted utilizing a CAPCELL PAK MG Ⅲ C18 column(4.6 mm ×250 mm,5 μmi)as the stationary phase.The mobile phase consisted of a mixture of acetonitrile-water-diethylamine(65∶35∶0.03),with a flow rate set at 1.0 mL·min-1 and the column maintained at a temperature of 25℃.Results:NQAD analysis revealed a robust linear correlation between the concentration and the peak area for peimine within a concentration range of 2.450 to 1.470 μg·mL-1,achieving a correlation coefficient of 0.999 3.The limit of detection(LOD)and recovery rate for peimine were determined to be 14.70 ng and 99.50％(n=9),respectively.Similarly,a linear relationship was observed for peiminine between the concentration and the peak area,spanning a range of 3.657 to 1.170 μg·mL-1,with a correlation coefficient of 0.999 1.The LOD and recovery rate for peiminine were 21.94 ng and 100.5％(n=9),respectively.In contrast,ELSD yielded LOD of 24.50 ng for peimine and 36.57 ng for peiminine,with linear range of double logarithmic fitting was 4.900 to 490.0 μg·mL-1 and 7.314 to 585.1 μg·mL-1,respectively.Conclusion:NQAD outperforms ELSD in the quantification of peimine and peiminine,offering superior accuracy,precision,and sensitivity,along with an extended dynamic linear range.By enabling direct content calculation via linear regression,it streamlines the process,bypassing the complex double logarithmic calculations.This approach not only boosts the efficiency of data handling but also substantially simplifies the computational steps,addressing the detection and analysis needs for peimine and peiminine in huangshi xiangsheng pills.

Objective To establish a high performance liquid chromatographic(HPLC)method for the determination of chidamide in human plasma.Methods The plasma sample was taken as 500 μL,and triamcinolone was used as the internal standard.After liquid-liquid extraction using methyl tert-butyl ether,the supernatant was centrifuged and blown dry under N2,then re-dissolved in 50 μL of water,and then centrifuged again,and then 10 μL of the supernatant was injected into the system.The separation was performed on a Shim-pack CLC-ODS(150 mm×60 mm,5 μm)at 35 ℃ using water-acetonitrile=(74∶26,v/v,adjusted to pH=3 by acetic acid)as mobile phase.The flow rate was 1.0 mL·min-1 and the wavelength was 260 nm.The specificity,standard curve,lower limit of quantitation,precision,recovery and stability of the method were investigated.In addition,the high performance liquid chromatography method described above was applied to determine the plasma drug concentration after oral administration of chidamide in one patient.Results The retention time of chidamide and internal standard was 8.00 and 9.40 min,respectively.The standard curve equation was y=10.28x-0.06(r=0.998).The intra-day and inter-day precision(RSD)of low,medium and high concentration quality control samples(0.02,0.15,0.75 μg·mL-)were 1.00％-4.87％(n=6),and the accuracy was-10.29％-3.37％.The average extraction recovery was 61.74％-69.85％.Conclusion The method was simple,sensitive and accurate,suitable for monitoring the concentrations of chidamide in human plasma.

Objective:The study aimed to quantify the contents of peimine and peiminine in huangshi xiangsheng pills using a nano quantity analyte detector(NQAD)and compare the results with the evaporative light scattering detector(ELSD).Methods:Analytical separation was conducted utilizing a CAPCELL PAK MG Ⅲ C18 column(4.6 mm ×250 mm,5 μmi)as the stationary phase.The mobile phase consisted of a mixture of acetonitrile-water-diethylamine(65∶35∶0.03),with a flow rate set at 1.0 mL·min-1 and the column maintained at a temperature of 25℃.Results:NQAD analysis revealed a robust linear correlation between the concentration and the peak area for peimine within a concentration range of 2.450 to 1.470 μg·mL-1,achieving a correlation coefficient of 0.999 3.The limit of detection(LOD)and recovery rate for peimine were determined to be 14.70 ng and 99.50％(n=9),respectively.Similarly,a linear relationship was observed for peiminine between the concentration and the peak area,spanning a range of 3.657 to 1.170 μg·mL-1,with a correlation coefficient of 0.999 1.The LOD and recovery rate for peiminine were 21.94 ng and 100.5％(n=9),respectively.In contrast,ELSD yielded LOD of 24.50 ng for peimine and 36.57 ng for peiminine,with linear range of double logarithmic fitting was 4.900 to 490.0 μg·mL-1 and 7.314 to 585.1 μg·mL-1,respectively.Conclusion:NQAD outperforms ELSD in the quantification of peimine and peiminine,offering superior accuracy,precision,and sensitivity,along with an extended dynamic linear range.By enabling direct content calculation via linear regression,it streamlines the process,bypassing the complex double logarithmic calculations.This approach not only boosts the efficiency of data handling but also substantially simplifies the computational steps,addressing the detection and analysis needs for peimine and peiminine in huangshi xiangsheng pills.