1.Interpretation and thoughts on the formulation and revision of the standards for exogenous harmful residues in traditional Chinese medicinal materials in the Chinese Pharmacopoeia 2025 Edition
WANG Ying ; SHEN Mingrui ; LIU Yuanxi ; ZUO Tiantian ; WANG Dandan ; HE Yi ; CHENG Xianlong ; JIN Hongyu ; LIU Yongli ; WEI Feng ; MA Shuangcheng
Drug Standards of China 2025;26(1):083-092
As people’s attention to health continues to increase, the market demand for traditional Chinese medicine (TCM) is growing steadily. The quality and safety of Chinese medicinal materials have attracted unprecedented social attention. In particular, the issue of exogenous harmful residue pollution in TCM has become a hot topic of concern for both regulatory authorities and society. The Chinese Pharmacopoeia 2025 Edition further refines the detection methods and limit standards for exogenous harmful residues in TCM. This not only reflects China’s high-level emphasis on the quality and safety of TCM but also demonstrates the continuous progress made by China in the field of TCM safety supervision. Basis on this study, by systematically reviewing the development history of the detection standards for exogenous harmful residues in TCM and analyzing the revisions and updates of these detection standards in the Chinese Pharmacopoeia 2025 Edition, deeply explores the key points of the changes in the monitoring standards for exogenous harmful residues in TCM in the Chinese Pharmacopoeia 2025 Edition. Moreover, it interprets the future development directions of the detection of exogenous residues in TCM, aiming to provide a reference for the formulation of TCM safety supervision policies.
2.Expression of STEAP1 in bladder transitional cell carcinoma and its potential diagnostic value
Macao WAN ; Jie BAI ; Xianlong ZHAO ; Bin CHANG ; Jianping WANG ; Lichang YANG
International Journal of Laboratory Medicine 2024;45(3):272-276
Objective To investigate the expression and potential diagnostic value of six-transmembrane epithelial antigen of prostate 1(STEAP1)in bladder transitional cell carcinoma.Methods 52 patients with transitional cell carcinoma of the bladder who underwent surgical treatment at the 940th Hospital of Joint Lo-gistics Support Force of the Chinese People's Liberation Army from June 2021 to December 2022 were select-ed as the observation group.In addition,52 patients with benign tumors of the bladder who matched basic clin-ical data such as age,gender,and disease incidence were selected as the control group.The relative expression levels of STEAP1 and STEAP1 mRNA in bladder tumor tissues of patients in the two groups were deter-mined by enzyme-linked immunosorbent assay and real-time fluorescence quantitative PCR,and the relative expression levels of STEAP1 and STEAP1 mRNA in bladder tumor tissues of patients with different patho-logical parameters were compared.Spearman correlation analysis and binary Logistic regression analysis were used to screen the risk factors for the occurrence and clinical stage of bladder transitional cell carcinoma.Re-ceiver operating characteristic(ROC)curve and area under the curve(AUC)were used to evaluate the diagnos-tic and predictive value of each indicator for bladder transitional cell carcinoma.Results The relative expres-sion levels of STEAP1 and STEAP1 mRNA in bladder tumor tissues in observation group were significantly higher than those in control group,with statistical significance(P<0.05).The relative expression levels of STEAP1 and STEAP1 mRNA in bladder tumor tissues of patients with middle and advanced bladder transi-tional cell carcinoma were significantly higher than those of patients with early bladder transitional cell carci-noma,with statistical significance(P<0.05).Binary Logistic regression analysis showed that the relative ex-pression level of STEAP1 and STEAP1 mRNA in bladder tumor tissues of patients were independent risk fac-tors for the development of bladder transitional cell carcinoma and middle and advanced bladder transitional cell carcinoma(P<0.05).ROC curve analysis showed that the AUC of STEAP1 and STEAP1 mRNA inde-pendently predicting the occurrence of bladder transitional cell carcinoma was 0.841(95%CI:0.760-0.922,P<0.001)and 0.936(95%CI:0.893-0.980,P<0.001),respectively,both of which had high predictive ef-ficacy.Conclusion The relative expression levels of STEAP1 and STEAP1 mRNA in bladder tumor tissues of patients are positively correlated with the occurrence of bladder transitional cell carcinoma and the middle and advanced bladder transitional cell carcinoma,suggesting that STEAP1 can be used as a potential marker for di-agnosis and prediction of the occurrence and development of bladder transitional cell carcinoma.
3.The impact of constrained prostheses on the outcomes of two-stage revision for periprosthetic joint infection after total knee arthroplasty
Mengqi CHENG ; Qiaojie WANG ; Hao SHEN ; Qi WANG ; Yunsu CHEN ; Xianlong ZHANG
Chinese Journal of Orthopaedics 2024;44(4):226-232
Objective:To assess the clinical efficacy and infection control outcomes of two-stage revision in managing periprosthetic joint infection (PJI) following primary total knee arthroplasty (TKA) utilizing either a low or high constrained prosthesis.Methods:A retrospective analysis was performed on 40 patients who underwent revision TKA in the Sixth People's Hospital Affiliated to Shanghai Jiao Tong University from February 2019 to February 2022. According to the type of prosthesis selected in primary TKA, they were divided into low constrained prosthesis group and high constrained prosthesis group. There were 28 patients (28 knees) in the low constrained group, including 12 males and 16 females, aged 69.0(63.0, 74.0) years, with a body mass index of 25.18±0.55 kg/m 2. And there were 12 patients (12 knees) in the high-constrained group, including 5 males and 7 females, aged 66.5(65.0, 71.5) years, with a body mass index of 23.94±0.51 kg/m 2. All patients underwent two-stage revision surgery, with RHK used in 1 case and LCCK in 27 cases in the low-constrained prosthesis group. In the high-constrained prosthesis group, 3 patients were treated with RHK, 1 patient with PFC Sigma MBT, and 8 patients with LCCK. The preoperative and postoperative range of motion (ROM), Knee Society score (KSS), and postoperative infection control rate were compared between the two groups. Results:All patients were followed up. The follow-up time was 22.79±8.02 months in the low-constrained prosthesis group and 23.92±7.04 months in the high-constrained prosthesis group, with no significant difference between the two groups ( t=0.426, P=0.680). At the last follow-up, the KSS and ROM in the low-constrained prosthesis group were 77.96±9.74 and 93.48°±7.45°, respectively, significantly higher than 38.93±8.01 and 68.89°±9.44° before the operation ( P<0.05). The KSS score and ROM in the high-constrained prosthesis group were 67.83±8.31 and 80.08°±5.89° at the last follow-up, which were also significantly higher than those before operation (34.25±6.31 and 66.50°±10.48°, P<0.05). There was no significant difference in KSS and ROM between the two groups before operation ( P>0.05), but the KSS score and ROM in the low-constrained prosthesis group were significantly higher than those in the high-constrained prosthesis group at the last follow-up ( P<0.05). Bacterial culture results revealed that the primary infectious agents were coagulase-negative Staphylococcus and Staphylococcus aureus, with an overall infection control rate of 80% (32/40). The infection control rate was 89% (25/28) in the low-constrained prosthesis group and 58% (7/12) in the high-constrained prosthesis group, but the difference between the two groups was not statistically significant (χ 2=3.283, P=0.070). Conclusion:Two-stage revision effectively controls PJI, and the clinical outcomes of two-stage revision for PJI after primary TKA with a high-constrained prosthesis are inferior to those with a low-constrained prosthesis. Further exploration is needed to enhance efficacy.
4.Analysis on the assessment value of DCE-MRI quantitative parameters and tumor markers for the curative effect of neoadjuvant chemotherapy for breast cancer
Rui MA ; Yanhui WANG ; Min DU ; Xianlong QI ; Lin ZHANG ; Weiwei WANG
China Medical Equipment 2024;21(1):73-77
Objective:To explore the assessment value of quantitative parameters of dynamic contrast-enhanced magnetic resonance imaging(DCE-MRI)and tumor markers in assessing the curative effect of neoadjuvant chemotherapy for breast cancer.Methods:A total of 75 patients with breast cancer who received neoadjuvant chemotherapy combined with surgical intervention in Jining No.1 People's Hospital from May 2019 to May 2022 were selected,and they were divided into effective group(54 cases)and ineffective group(21 cases)according to the Response Evaluation Criteria In Solid Tumour(RECIST).The Ve,Kep and Ktrans of DCE-MRI quantitative parameters and CEA,CA125 and CA15-3 levels of tumor markers between two groups were compared before and after chemotherapy,and the receiver operating characteristics(ROC)curve was adopted to analyze the predictive efficiency of each diagnostic method.Results:After chemotherapy,the differences of the Ve,Kep and Ktrans of quantitative parameters between the two groups were significant(t=7.237,51.695,16.879,P<0.05),respectively.The differences of the CEA,CA125 and CA15-3 of tumor markers between two groups were significant(t=44.201,6.736,6.885,P<0.05),respectively.The AUC value of combined prediction of 6 indicators included Ve,Kep,Ktrans,CEA,CA125 and CA15-3 was 0.979 in predicting the curative effect of neoadjuvant chemotherapy for breast cancer,which was significantly higher than the AUC value of each alone indicator,and the differences of them were statistically significant(Z=2.993,2.679,2.510,2.731,3.215,3.071,P<0.05),respectively.Conclusion:The combination of tumor markers and DCE-MRI quantitative parameters can better predict the curative effect of neoadjuvant chemotherapy for breast cancer,which can indirectly assess the prognosis.
5.Multi-omics analysis of adamantinomatous craniopharyngiomas reveals distinct molecular subgroups with prognostic and treatment response significance
Xianlong WANG ; Chuan ZHAO ; Jincheng LIN ; Hongxing LIU ; Qiuhong ZENG ; Huadong CHEN ; Ye WANG ; Dapeng XU ; Wen CHEN ; Moping XU ; En ZHANG ; Da LIN ; Zhixiong LIN
Chinese Medical Journal 2024;137(7):859-870
Background::Adamantinomatous craniopharyngioma (ACP) is the commonest pediatric sellar tumor. No effective drug is available and interpatient heterogeneity is prominent. This study aimed to identify distinct molecular subgroups of ACP based on the multi-omics profiles, imaging findings, and histological features, in order to predict the response to anti-inflammatory treatment and immunotherapies.Methods::Totally 142 Chinese cases diagnosed with craniopharyngiomas were profiled, including 119 ACPs and 23 papillary craniopharyngiomas. Whole-exome sequencing (151 tumors, including recurrent ones), RNA sequencing (84 tumors), and DNA methylome profiling (95 tumors) were performed. Consensus clustering and non-negative matrix factorization were used for subgrouping, and Cox regression were utilized for prognostic evaluation, respectively.Results::Three distinct molecular subgroups were identified: WNT, ImA, and ImB. The WNT subgroup showed higher Wnt/β-catenin pathway activity, with a greater number of epithelial cells and more predominantly solid tumors. The ImA and ImB subgroups had activated inflammatory and interferon response pathways, with enhanced immune cell infiltration and more predominantly cystic tumors. Mitogen-activated protein kinases (MEK/MAPK) signaling was activated only in ImA samples, while IL-6 and epithelial-mesenchymal transition biomarkers were highly expressed in the ImB group, mostly consisting of children. The degree of astrogliosis was significantly elevated in the ImA group, with severe finger-like protrusions at the invasive front of the tumor. The molecular subgrouping was an independent prognostic factor, with the WNT group having longer event-free survival than ImB (Cox, P = 0.04). ImA/ImB cases were more likely to respond to immune checkpoint blockade (ICB) therapy than the WNT group ( P <0.01). In the preliminary screening of subtyping markers, CD38 was significantly downregulated in WNT compared with ImA and ImB ( P = 0.01). Conclusions::ACP comprises three molecular subtypes with distinct imaging and histological features. The prognosis of the WNT type is better than that of the ImB group, which is more likely to benefit from the ICB treatment.
6.Research progress on processing technology,chemical constituents and pharmacological activities of Polygoni multiflori radix praeparata
Rui YAO ; Hong GUO ; Xiaoshu ZHANG ; Ying WANG ; Xiaohan GUO ; Jia CHEN ; Jinhao LI ; Ling XU ; Jianbo YANG ; Wenguang JING ; Xianlong CHENG ; Feng WEI
China Pharmacist 2024;28(11):523-535
Polygoni multiflori radix praeparata is a processed product of Polygoni multiflori radix(Polygonum multiflorum Thunb.),and its main components include stilbene glycosides,anthraquinones,flavonoids,alkaloids,phenolic acids,etc.It has antioxidant,antianemic,anti-tumor,hypoglycemic,anti-inflammatory effects,etc,and is widely used in clinical practice.The processing technology is mainly stewinging with black bean juice,steaming,processing for 9 times and braising and simmering.After processing,the color deepens and the content of composition changes.By consulting domestic and foreign literature,the research on Polygoni multiflori radix praeparata is not comprehensive enough compared with Polygoni multiflori radix.Therefore,this paper mainly summarizes the processing technology,chemical composition and pharmacological activity of Polygoni multiflori radix preparata reported in the past 20 years,and provides a reference for further development of Polygoni multiflori radix preparata.
7.Teaching design and practice of "medical mathematical modeling" based on OBE concept
Chunxiang LI ; Xianlong WANG ; Xuan YANG ; Zhongliang WANG
Chinese Journal of Medical Education Research 2023;22(11):1637-1641
Objective:Based on the concept of outcomes-based education (OBE), aiming to improve students' medical mathematical modeling ability, the teaching design and practice of mathematical modeling module for the course Medical Advanced Mathematics are carried out and the direction of improvement is defined. Methods:Taking infectious disease model as an example, teaching practice was carried out, and then questionnaires from 44 students were collected for feedback opinions. Statistical description, Mann-Whitney U test, one-way ANOVA and Scheffe method, as well as chi-square test and z-test were used to analyze data. Results:The results showed that 90.91% of the students were interested in the subject of the course, and 65.91% of the students thought that this mode significantly improved the learning effect. In this course, there was no significant difference in the learning initiative of students on the two levels of being or not being interested in the course topic, but it had a significant impact on their mastery of knowledge points and their willingness to continue to carry out flipped classroom.Conclusion:The teaching mode is generally effective, but it needs to be further improved in three aspects: emphasizing modeling and downplaying computation, enhancing students' participation and strengthening the classroom learning effect.
8.Analysis of factors affecting the change in relative patellar height after robotic-assisted primary total knee arthroplasty
Zixiao YAN ; Qiaojie WANG ; Qi WANG ; Xianlong ZHANG ; Yunsu CHEN
Chinese Journal of Orthopaedics 2023;43(1):41-47
Objective:To analyze the factors affecting the relative height change of the patella after primary robotic-assisted total knee arthroplasty (R-TKA).Methods:The data of 97 patients with osteoarthritis of the knee treated with R-TKA admitted from June 2021 to March 2022 were retrospectively analyzed, including 15 males and 82 females, aged 70.0±5.4 years (range, 58-80 years). The bone resection parameters of the robotic system were recorded intraoperatively, including the bone resection amount of the medial and lateral distal femur, medial and lateral posterior femoral condyle and medial and lateral tibial plateau. The Blackburne-Peel index (BPI) and Caton-Deschamps index (CDI) were used to measure the preoperative and postoperative relative patellar height on lateral radiographs, as well as the posterior tibial slope (PTS) and the change in patellar ligament length before and after surgery. The relationship between the change in relative patellar height and the variables of interest was analyzed using partial correlation and multiple linear regression.Results:The mean postoperative CDI was lower than preoperatively (0.79±0.15 vs. 0.91±0.13, t=9.69, P<0.001), and the percentage of patients with postoperative CDI<0.6 was higher than preoperatively (9.3% vs. 0; χ 2=12.92, P<0.001); the differences in mean postoperative BPI and percentage of patients with postoperative BPI<0.45 were not statistically significant compared to preoperatively (0.69±0.13 vs. 0.71±0.17, t=1.35, P=0.182; 11.3% vs. 17.5%, χ 2=1.50, P=0.220). The mean patellar ligament length on the first postoperative day was 2.29 mm shorter than preoperatively, there was a statistically significant difference ( t=5.90, P<0.001). Partial correlation analysis showed that the amount of patellar ligament length change was positively correlated with the amount of BPI and CDI change ( r=0.84, P<0.001; r=0.70, P<0.001), and the amount of PTS change and the mean distal femoral bone resection were negatively correlated with the amount of BPI ( r= -0.41, P<0.001; r=-0.32, P=0.002) and CDI ( r=-0.23, P=0.029; r=-0.25, P=0.017) change. In contrast, the amount of posterior femoral condyle bone resection and tibial plateau bone resection did not correlate with the change of BPI and CDI. Multiple linear regression analysis showed that the amount of patellar ligament length change, PTS change and the distal femoral bone resection were factors influencing the change of BPI ( β=0.03, P<0.001; β=-0.01, P<0.001; β=-0.02, P=0.021) and CDI ( β=0.02, P<0.001; β=-0.01, P=0.001; β=-0.02, P=0.008). Conclusion:Amount of patellar ligament length change, PTS change and the distal femoral bone resection are factors affecting the BPI. In order to obtain a better relative patellar height in the primary R-TKA, attention should be paid to the adjustment of the distal femoral bone resection and PTS, while taking the necessary measures to reduce the postoperative patellar ligament length changes.
9.Investigation on nutritional health knowledge among regular unpaid blood donors in Zhoushan City
WANG Heng ; LI Peng ; HE Xianlong ; BAO Junping ; SONG Jing ; LI Haoru ; WANG Haihong
Journal of Preventive Medicine 2023;35(5):440-443
Objective :
To investigate the awareness of nutritional health knowledge regular unpaid blood donors in Zhoushan City, Zhejiang Province, so as to provide insights into nutrition and health education among unpaid blood donors.
Methods:
The regular unpaid blood donors were sampled using a convenient sampling method from Zhoushan Central Blood Station from January 1, 2021 to June 30, 2022. The nutritional health knowledge was investigated using the Chinese Nutrition Health Knowledge Questionnaire for Adults compiled by Chinese Center for Disease Control and Prevention, and the awareness and source of nutritional health knowledge was descriptively analyzed.
Results:
Totally 526 questionnaires were allocated, and 502 valid questionnaires were recovered, with an effective recovery rate of 95.44%. The respondents included 240 men (47.81%) and 262 women (52.19%), and included 343 individuals at ages of 18 to 44 years (68.33%), and 159 individuals at ages of 45 years and older (31.67%). The overall awareness of nutritional health knowledge was 14.54% among regular unpaid blood donors in Zhoushan City, and a higher awareness was seen among female regular unpaid blood donors (17.56%) than among males (11.25%) (P<0.05), while the awareness of nutritional health knowledge was significantly higher among respondents at ages of 18 to 44 years than among those at ages of 45 years and older (16.91% vs. 9.43%, P<0.05). The awareness of nutritional health knowledge was significantly higher among respondents with an educational level of junior college and above than among those with an educational level of high school/technical secondary school/technical school (17.24% vs. 12.22%, P<0.05), and the awareness was significantly higher among respondents with healthcare-related occupations than among those with other occupations (16.44% vs. 14.22%, P<0.05). Wechat, Weibo, Tik Tok and Kuaishou were main routes to obtain nutritional health knowledge (83.86%).
Conclusions
The awareness of nutritional health knowledge is low among regular unpaid blood donors in Zhoushan City. Men, middle-aged and elderly residents and residents with a low educational level are targets that should be given a high priority for nutritional health education, and new media may be fully utilized for nutritional health education.
10.HIV infection rate, high-risk behavior and pre-exposure prophylaxis/post-exposure prophylaxis in men who have sex with men in Beijing
Dongyan XIA ; Xueli SU ; Guowu LIU ; Xianlong REN ; Juan WANG ; Guiying LI ; Jing CHEN ; Conghui XU ; Hongyan LU
Chinese Journal of Epidemiology 2023;44(9):1390-1396
Objective:To understand the incidence of HIV infection, high risk behaviors and pre-exposure prophylaxis/post-exposure prophylaxis (PrEP/PEP) utilization in men who have sex with men (MSM) in Beijing.Methods:Sample size was estimated to be 1 227 persons and 207 person year respectively in the survey and the cohort by using Epi Info 7.0 software. Using convenient sampling method, MSM were recruited by using Wechat app. Questionnaire was completed online to collect the information about demographic characteristics, high risk behavior, and utilization of PrEP/PEP of the MSM. MSM collected dry blood spot (DBS) samples by themselves, and mailed the DBS samples to laboratory for HIV nucleic acid testing. Open cohort was established and those with HIV negative nucleic acid testing results were followed up. Non-conditional binary logistic regression method was used to identify the associated factors for high risk anal sex in the last month and having multiple homosexual partners in the last month.Results:A total of 1 147 MSM were recruited, and follow up for 236 person years was conducted in 956 MSM with negative HIV nucleic acid testing results. The detection rate of new HIV infection was 1.3 per 100 person-years (3/236). During the last month, the proportions of consistent condom use in anal sex and oral sex were 50.7% (238/469) and 4.9% (23/469). In the MSM, 5.9% (43/723) had sex with HIV positive partners in the last month. 9.8% (103/1 049) used PrEP, and 8.7% (91/1 049) used PEP. The proportion of consistent condom use in PrEP and PEP were 34.3% (24/70) and 72.2% (39/54) respectively. Logistic regression analysis revealed that compared with those who used no PrEP/PEP, those who used PrEP/PEP were more likely to have unprotected anal sex in the last month (a OR=3.16, 95% CI:1.45-7.18), and more likely to have multiple homosexual partners in the last month (a OR=2.64, 95% CI:1.19-6.30), and compared with those who used no Rush Popper or drugs in the last month, those who used Rush Popper or drugs in the last month were more likely to have unprotected anal sex in the last month (a OR=2.34, 95% CI:1.67-3.30), and more likely to have multiple homosexual partners (a OR=2.42,95% CI:1.76-3.33). Conclusions:It is necessary to strengthen the health education to promote condom use and introduce the harm of drug use in MSM. In PrEP and PEP services, it is still necessary to suggest consistent condom use for MSM.


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