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.

Objective:To explore the early clinical effect of arthroplasty with rotating hinge knee prosthesis in the treatment of severe knee deformity.Methods:A retrospective study was conducted on 55 patients who underwent primary rotating hinge knee arthroplasty at Shanghai Sixth People's Hospital from January 2017 to October 2023, including 19 male patients and 36 female patients, with an average age of 60.9±9.0 years (ranging from 31 to 74 years). The four main indications were end-stage deformity of osteoarthritis (valgus/varus>20°, 16 cases), post-traumatic joint deformity (15 cases), severe joint ligament instability (12 cases), and neuromuscular or immune diseases (12 cases). The patients were divided into two age groups: ≥60 years old group (32 cases) and <60 years old group (23 cases). Various pre-operative and post-operative data, including knee society score (KSS), range of motion (ROM), forgotten joint score (FJS), degree of force line offset and post-operative complications, were collected and compared.Results:All the 55 cases successfully underwent the operation. The operation time was 102.3±15.8 min. The intraoperative blood loss was 63±23.7 ml. The follow-up time was 37.2±7.9 months. KSS clinical score increased from 27.5(12, 45) before surgery to 90.5(85, 95) after surgery ( P<0.001) and the mean score of KSS function increased from 50.4(45, 60) before surgery to 84.3(85, 95) after surgery ( P<0.001), both with significant difference ( P<0.05). Similarly, the average postoperative ROM improved from 97.2°±34.4° to 120.1°±10.9°with significant difference ( P<0.05). The postoperative FJS was 81.0±6.6. Up to the last follow-up, the implant survival rate was 98%[95% CI(90.4%, 99.6%)]. For the all four groups of end-stage deformity of osteoarthritis, post-traumatic joint deformity, severe joint ligament instability and neuromuscular or immune diseases, both the KSS score and the ROM of the knee joint were significantly improved. There was no significant difference in neither the KSS score or the ROM of the knee joint between the ≥60 years old group and the <60 years old group ( P>0.05). The incidence of complications was 24% (13/55). The complication rates for patients with end-stage deformity of osteoarthritis, post-traumatic joint deformity, severe joint ligament instability and neuromuscular or immune diseases were 12.5% (2/16), 20% (3/15), 25% (3/12), and 41.7% (5/12) respectively, without significant difference. The incidence of complications in elderly patients (85%, 11/13) was much higher than that in younger patients (5%, 2/42),with significant difference ( P<0.05). Conclusions:For end-stage deformity of osteoarthritis (valgus or varus >20°), post-traumatic joint deformity, severe joint ligament instability and neuromuscular or immune diseases, the rotating hinge knee can provide good clinical improvement effects. For neuromuscular or immune diseases, the incidence of complications was relatively high. The therapeutic effect of patients over 60 years old showed no significant difference in the early postoperative efficacy compared with younger patients, but the complications of elderly patients were much higher than those of younger patients.

As people's attention to health continues to increase,the market demand for traditional Chinese medi-cine(TCM)is growing steadily.The quality and safety of Chinese medicinal materials have attracted unprecedent-ed 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 detec-tion 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.Moreo-ver,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.

Objective:To explore the early clinical effect of arthroplasty with rotating hinge knee prosthesis in the treatment of severe knee deformity.Methods:A retrospective study was conducted on 55 patients who underwent primary rotating hinge knee arthroplasty at Shanghai Sixth People's Hospital from January 2017 to October 2023, including 19 male patients and 36 female patients, with an average age of 60.9±9.0 years (ranging from 31 to 74 years). The four main indications were end-stage deformity of osteoarthritis (valgus/varus>20°, 16 cases), post-traumatic joint deformity (15 cases), severe joint ligament instability (12 cases), and neuromuscular or immune diseases (12 cases). The patients were divided into two age groups: ≥60 years old group (32 cases) and <60 years old group (23 cases). Various pre-operative and post-operative data, including knee society score (KSS), range of motion (ROM), forgotten joint score (FJS), degree of force line offset and post-operative complications, were collected and compared.Results:All the 55 cases successfully underwent the operation. The operation time was 102.3±15.8 min. The intraoperative blood loss was 63±23.7 ml. The follow-up time was 37.2±7.9 months. KSS clinical score increased from 27.5(12, 45) before surgery to 90.5(85, 95) after surgery ( P<0.001) and the mean score of KSS function increased from 50.4(45, 60) before surgery to 84.3(85, 95) after surgery ( P<0.001), both with significant difference ( P<0.05). Similarly, the average postoperative ROM improved from 97.2°±34.4° to 120.1°±10.9°with significant difference ( P<0.05). The postoperative FJS was 81.0±6.6. Up to the last follow-up, the implant survival rate was 98%[95% CI(90.4%, 99.6%)]. For the all four groups of end-stage deformity of osteoarthritis, post-traumatic joint deformity, severe joint ligament instability and neuromuscular or immune diseases, both the KSS score and the ROM of the knee joint were significantly improved. There was no significant difference in neither the KSS score or the ROM of the knee joint between the ≥60 years old group and the <60 years old group ( P>0.05). The incidence of complications was 24% (13/55). The complication rates for patients with end-stage deformity of osteoarthritis, post-traumatic joint deformity, severe joint ligament instability and neuromuscular or immune diseases were 12.5% (2/16), 20% (3/15), 25% (3/12), and 41.7% (5/12) respectively, without significant difference. The incidence of complications in elderly patients (85%, 11/13) was much higher than that in younger patients (5%, 2/42),with significant difference ( P<0.05). Conclusions:For end-stage deformity of osteoarthritis (valgus or varus >20°), post-traumatic joint deformity, severe joint ligament instability and neuromuscular or immune diseases, the rotating hinge knee can provide good clinical improvement effects. For neuromuscular or immune diseases, the incidence of complications was relatively high. The therapeutic effect of patients over 60 years old showed no significant difference in the early postoperative efficacy compared with younger patients, but the complications of elderly patients were much higher than those of younger patients.

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.

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.

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.

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.

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.

Metallothionein (MT) plays a significant role in heavy metal removal, antioxidant defense, and immune regulation. The current predominant approach for obtaining natural MT is extraction from tissue, which often entails complex procedures resulting in limited yields. In recent years, researchers have adopted the strategy of fusing labels such as GST or His for the heterologous expression of MT. However, a challenge in industrial production arises from the subsequent removal of these labels, which often leads to a significant reduction in the yield. The fusion with elastin-like polypeptides (ELPs) offers a promising solution for achieving soluble expression of the target protein, while providing a simple and fast purification process. In this study, ELP was fused with MT, which significantly up-regulated the soluble expression of MT. The fusion protein ELP-MT with the purity above 97% was obtained efficiently and simply by inverse transition cycling (ITC). ELP-MT exhibited a remarkable 2,2'-azinobis(3-ethylbenzothiazoline-6- sulfonic acid) ammonium salt (ABTS) scavenging activity, with the half maximal inhibitory concentration (IC₅₀) of 0.77 μmol/L, which was 53.7 times that of the vitamin E derivative Trolox. In addition, the fusion protein demonstrated strong 1,1-diphenyl-2-trinitrohydrazine (DPPH) scavenging ability. Furthermore, ELP-MT had no toxicity to the proliferation and promoted the adhesion and migration of NIH/3T3 cells. All these results indicated that ELP-MT had good biocompatibility. We constructed the fusion protein ELP-MT combining the unique properties of MT and elastin, laying a technical foundation for the large-scale production of recombinant MT and facilitating the applications in food, health supplement, and cosmetic industries.
Metallothionein/metabolism* ; Elastin/chemistry* ; Recombinant Fusion Proteins/pharmacology* ; Mice ; Animals ; Peptides/metabolism* ; Escherichia coli/metabolism* ; NIH 3T3 Cells