Yinyang Gongji Pills have the effects of strengthening the body resistance to eliminate pathogenic factors, removing stasis, and reducing swelling, which is a commonly used traditional Chinese medicine(TCM) formula for treating intestinal accumulation. A real-world, registered, and single-arm clinical trial was conducted to observe the clinical efficacy and safety of Yinyang Gongji Pills combined with capecitabine in the treatment of advanced colorectal cancer and analyze the clinical characteristics of the patients. A total of 60 patients with advanced colorectal cancer who refused or could not tolerate standard treatment of western medicine were included in the study. They were treated with Yinyang Gongji Pills combined with capecitabine until disease progression or intolerable adverse events occurred. The main observation indicators were progression-free survival(PFS) and safety. The treatment effects of the patients under different baseline characteristics were analyzed. The clinical trial has found that the median PFS of all enrolled patients was 7.3 months, with 30.1% of patients having a PFS exceeding 12.0 months. Layered analysis showed that the median PFS of patients with the onset site being the colon and rectum were respectively 8.4 and 4.7 months. The median PFS of patients with high, medium, and low tumor burden were respectively 7.0, 4.7, and 10.8 months. The median PFS of patients with wild-type and mutant-type RAS/BRAF were respectively 7.9 and 6.9 months. The median PFS of patients with KPS scores ≥80 and ≤70 were respectively 7.9 and 6.5 months. The median PFS of patients treated with Yinyang Gongji Pills for ≥6, 3-6, and ≤3 months were respectively 8.0, 5.2, and 4.2 months. The median PFS of patients with spleen, kidney, liver, and lung syndrome differentiation in TCM were respectively 8.3, 6.7, 7.3, and 5.6 months. The median PFS of patients with TCM pathological factors including phlegm, dampness, and blood stasis were respectively 7.0, 7.3, and 6.5 months. Common adverse reactions include anemia, decreased white blood cells, decreased appetite, fatigue, and hand foot syndrome, with incidence rates being respectively 44.2%, 34.6%, 42.3%, 32.7%, and 17.3%. The results showed that the combination of Yinyang Gongji Pills and capecitabine demonstrated potential clinical efficacy and good safety in this study. The patients have clinical characteristics such as low tumor burden, onset site at the colon, KPS scores ≥ 80, long duration of oral TCM, and TCM syndrome differentiation including spleen or liver.
Humans ; Capecitabine/adverse effects* ; Colorectal Neoplasms/mortality* ; Drugs, Chinese Herbal/adverse effects* ; Male ; Middle Aged ; Female ; Aged ; Adult ; Treatment Outcome

The traditional Chinese medicine(TCM) industry is a crucial part of China's pharmaceutical sector and plays a strategic role in ensuring public health and promoting economic and social development. In response to the practical demand for high-quality development of the TCM industry, this paper focused on the bottlenecks encountered during the digital and intelligent transformation of TCM production systems. Specifically, it explored technical strategies and methodologies for constructing the best TCM production mode. An innovative artificial intelligence(AI)-centered technical architecture for TCM production was proposed, focusing on key aspects of production management including process modeling, state evaluation, and decision optimization. Furthermore, a series of critical technologies were developed to realize the best TCM production mode. Finally, a novel AI-driven TCM production mode characterized by a closed-loop system of "measurement-modeling-decision-execution" was presented through engineering case studies. This study is expected to provide a technological pathway for developing new quality productive forces within the TCM industry.
Artificial Intelligence ; Drugs, Chinese Herbal ; Medicine, Chinese Traditional/methods* ; Humans

Decoction is the most commonly used dosage form in the clinical treatment of traditional Chinese medicine (TCM). During boiling, the violent movement of various active ingredients in TCM creates molecular forces such as hydrogen bonding, π-π stacking, hydrophobic interactions and electrostatic interactions, which results in the formation of self-assembled aggregates in decoction (SADs), including particles, gels, fibers, etc. It was found that SADs widely existed in decoction with biological activities superior to both effective monomers and their physical mixtures, providing a new idea to reveal the pharmacodynamic material basis of Chinese herbal medicine from the perspective of component interactions-phase structure. Recently, SADs have become a novel focus of research in TCM. This paper reviewed their relevant studies in recent years and found some issues to be concerned in the research, such as the polydispersity of decoction system, instability of active ingredient interactions during boiling, uncertainty of the aggregates self-assembly rules, and stability, purity, yield of the products. In this regard, some solutions and new ideas were presented for the integrated development and clinical application of SADs.

The working principle and development of flexible semiconductor devices based on organic field effect transistor(OFET)technology were introduced.The current research status of OFET-based wearable flexible monitoring devices were reviewed,including biomechanical monitoring devices,tattoo biomonitoring devices and cellular detection devices and etc.The deficiencies of OFET-based wearable flexible monitoring devices were analyzed,and it's pointed out that miniaturization,personalization and diversification were the directions for the development of the future OFET-based wearable flexible moni-toring devices.[Chinese Medical Equipment Journal,2024,45(1):93-100]

Objective:To assess the diagnostic performance of serum anti-toxocara immunoglobulin G (anti-T-IgG) in ocular toxocariasis (OT) patients.Methods:A diagnostic tests. A total of 109 patients (109 eyes) with clinically-suspected OT who treated in Department of Ophthalmology of Xuzhou First People’s Hospital from June 2015 to December 2022 were included. Patients were divided into two groups, 76 with OT and 33 with non-OT, according to the clinical manifestations and Goldmann-Witmer coefficient. Paired serum and intraocular fluid samples from each patient were collected and analyzed for specific anti-T-IgG using enzyme linked immunosorbent assay. Mann-Whitney test was performed for comparison between groups. The area under the receiver operating characteristic curve (ROC) was used to assess the diagnostic performance of serum anti-T-IgG. Kappa analysis was performed to examine the consistency of serum or intraocular fluid anti-T-IgG positive rate with OT diagnostic result. Spearman’s rank correlation test was performed to assess the association.Results:Compared with the non-OT group, the proportions of children and history of exposure to cats and dogs ( χ2=9.785, 12.026) were significantly higher in OT group, and the differences were statistically significant ( P<0.01). The positive rate ( χ2=24.551) and U value ( Z=-4.379) of serum anti-T-IgG in OT group were higher than those in non-OT group, and the differences were statistically significant ( P<0.000 1). The recommended serum anti-T-IgG cut-off value of 11 U had 0.72 sensitivity, 0.79 specificity, 0.89 positive predictive value, 0.55 negative predictive value, and 0.77 area under the ROC with 95% confidence interval ( CI) 0.669-0.860. Correlation analysis showed that serum anti-T-IgG was positively correlated with intraocular fluid anti-T-IgG ( r s=0.520, 95% CI 0.363-0.648, P<0.000 1). The Kappa values of serum and intraocular fluid anti-T-IgG positive rate with OT diagnosis were 0.457 (95% CI 0.292-0.622) and 0.711 (95% CI 0.582-0.840), respectively. The Kappa value of serum anti-T-IgG positive rate with OT diagnosis was lower than that of intraocular fluid. Conclusion:The sensitivity and specificity of serum anti-T-IgG and the consistency between serum anti-T-IgG positive rate and OT diagnosis are low, suggesting that serum anti-T-IgG level cannot be used as a basis for OT diagnosis.

Objective To investigate the changing distribution and antibiotic resistance profiles of clinical isolates of Staphylococcus in hospitals across China from 2015 to 2021.Methods Antimicrobial susceptibility testing was conducted for the clinical isolates of Staphylococcus according to the unified protocol of CHINET(China Antimicrobial Surveillance Network)using disk diffusion method and commercial automated systems.The CHINET antimicrobial resistance surveillance data from 2015 to 2021 were interpreted according to the 2021 CLSI breakpoints and analyzed using WHONET 5.6.Results During the period from 2015 to 2021,a total of 204,771 nonduplicate strains of Staphylococcus were isolated,including 136,731(66.8％)strains of Staphylococcus aureus and 68,040(33.2％)strains of coagulase-negative Staphylococcus(CNS).The proportions of S.aureus isolates and CNS isolates did not show significant change.S.aureus strains were mainly isolated from respiratory specimens(38.9±5.1)％,wound,pus and secretions(33.6±4.2)％,and blood(11.9±1.5)％.The CNS strains were predominantly isolated from blood(73.6±4.2)％,cerebrospinal fluid(12.1±2.5)％,and pleural effusion and ascites(8.4±2.1)％.S.aureus strains were mainly isolated from the patients in ICU(17.0±7.3)％,outpatient and emergency(11.6±1.7)％,and department of surgery(11.2±0.9)％,whereas CNS strains were primarily isolated from the patients in ICU(32.2±9.7)％,outpatient and emergency(12.8±4.7)％,and department of internal medicine(11.2±1.9)％.The prevalence of methicillin-resistant strains was 32.9％in S.aureus(MRSA)and 74.1％in CNS(MRCNS).Over the 7-year period,the prevalence of MRSA decreased from 42.1％to 29.2％,and the prevalence of MRCNS decreased from 82.1％to 68.2％.MRSA showed higher resistance rates to all the antimicrobial agents tested except trimethoprim-sulfamethoxazole than methicillin-susceptible S.aureus(MSSA).Over the 7-year period,MRSA strains showed decreasing resistance rates to gentamicin,rifampicin,and levofloxacin,MRCNS showed decreasing resistance rates to gentamicin,erythromycin,rifampicin,and trimethoprim-sulfamethoxazole,but increasing resistance rate to levofloxacin.No vancomycin-resistant strains were detected.The prevalence of linezolid-resistant MRCNS increased from 0.2％to 2.3％over the 7-year period.Conclusions Staphylococcus remains the major pathogen among gram-positive bacteria.MRSA and MRCNS were still the principal antibiotic-resistant gram-positive bacteria.No S.aureus isolates were found resistant to vancomycin or linezolid,but linezolid-resistant strains have been detected in MRCNS isolates,which is an issue of concern.

Sanghuang, a famous ethnomedicine widely used in China, Japan, Korea and other countries for a long history, is produced from the dried fruiting bodies of the medical fungi belonging to Sanghuangporus. With abundant bioactive natural chemicals including polysaccharides, flavonoids, triterpenoids, and polyphenols, Sanghuang exhibits anticancer, antioxidant, blood glucose-and lipid-lowering, liver protecting, anti-inflammatory, antimicrobial, and gout symptom-relieving effects, thus demonstrating broad application and development prospects in the pharmaceutical and food fields. However, the sustainable development of Sanghuang resources is limited by the scarce stock of wild resources, the diverse original fungi of cultivated Sanghuang, the inconsistency of local standards of Sanghuang materials or products, and the lagging application of Sanghuangporus mycelia. In view of the shortages mentioned above, this article reviews the research progress in the current situation of Sanghuang resources, the chemical composition, bioactivities, and fermentation process regulation of Sanghuangporus strains, and the related biosynthesis regulating strategies for enhancing the production of bioactive metabolites. This review is expected to provide comprehensive information for the sustainable development and utilization of Sanghuang resources.
Fermentation ; Medicine, East Asian Traditional ; Basidiomycota

OBJECTIVE: To investigate whether the combination of chemotherapy with staged Chinese herbal medicine (CHM) therapy could enhance health-related quality of life (QoL) in non-small-cell lung cancer (NSCLC) patients and prolong the time before deterioration of lung cancer symptoms, in comparison to chemotherapy alone. METHODS: A prospective, double-blind, randomized, controlled trial was conducted from December 14, 2017 to August 28, 2020. A total of 180 patients with stage I B-IIIA NSCLC from 5 hospitals in Shanghai were randomly divided into chemotherapy combined with CHM (chemo+CHM) group (120 cases) or chemotherapy combined with placebo (chemo+placebo) group (60 cases) using stratified blocking randomization. The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life-Core 30 Scale (QLQ-C30) was used to evaluate the patient-reported outcomes (PROs) during postoperative adjuvant chemotherapy in patients with early-stage NSCLC. Adverse events (AEs) were assessed in the safety analysis. RESULTS: Out of the total 180 patients, 173 patients (116 in the chemo+CHM group and 57 in the chemo+placebo group) were included in the PRO analyses. The initial mean QLQ-C30 Global Health Status (GHS)/QoL scores at baseline were 57.16 ± 1.64 and 57.67 ± 2.25 for the two respective groups (P>0.05). Compared with baseline, the chemo+CHM group had an improvement in EORTC QLQ-C30 GHS/QoL score at week 18 [least squares mean (LSM) change 17.83, 95% confidence interval (CI) 14.29 to 21.38]. Conversely, the chemo+placebo group had a decrease in the score (LSM change -13.67, 95% CI -22.70 to -4.63). A significant between-group difference in the LSM GHS/QoL score was observed, amounting to 31.63 points (95% CI 25.61 to 37.64, P<0.001). The similar trends were observed in physical functioning, fatigue and appetite loss. At week 18, patients in the chemo+CHM group had a higher proportion of improvement or stabilization in GHS/QoL functional and symptom scores compared to chemo+placebo group (P<0.001). The median time to deterioration was longer in the chemo+CHM group for GHS/QoL score [hazard ratio (HR)=0.33, 95% CI 0.23 to 0.48, P<0.0010], physical functioning (HR=0.43, 95% CI 0.25 to 0.75, P=0.0005), fatigue (HR=0.47, 95% CI 0.30 to 0.72, P<0.0001) and appetite loss (HR=0.65, 95% CI 0.42 to 1.00, P=0.0215). The incidence of AEs was lower in the chemo+CHM group than in the chemo+placebo group (9.83% vs. 15.79%, P=0.52). CONCLUSION The staged CHM therapy could help improve the PROs of postoperative patients with early-stage NSCLC during adjuvant chemotherapy, which is worthy of further clinical research. (Registry No. NCT03372694).
Humans ; Carcinoma, Non-Small-Cell Lung/surgery* ; Male ; Middle Aged ; Female ; Lung Neoplasms/pathology* ; Double-Blind Method ; Drugs, Chinese Herbal/therapeutic use* ; Chemotherapy, Adjuvant ; Patient Reported Outcome Measures ; Quality of Life ; Aged ; Postoperative Period ; Prospective Studies

Management and treatment of terminal metastatic castration-resistant prostate cancer (mCRPC) remains heavily debated. We sought to investigate the efficacy of programmed cell death 1 (PD-1) inhibitor plus anlotinib as a potential solution for terminal mCRPC and further evaluate the association of genomic characteristics with efficacy outcomes. We conducted a retrospective real-world study of 25 mCRPC patients who received PD-1 inhibitor plus anlotinib after the progression to standard treatments. The clinical information was extracted from the electronic medical records and 22 patients had targeted circulating tumor DNA (ctDNA) next-generation sequencing. Statistical analysis showed that 6 (24.0%) patients experienced prostate-specific antigen (PSA) response and 11 (44.0%) patients experienced PSA reduction. The relationship between ctDNA findings and outcomes was also analyzed. DNA-damage repair (DDR) pathways and homologous recombination repair (HRR) pathway defects indicated a comparatively longer PSA-progression-free survival (PSA-PFS; 2.5 months vs 1.2 months, P = 0.027; 3.3 months vs 1.2 months, P = 0.017; respectively). This study introduces the PD-1 inhibitor plus anlotinib as a late-line therapeutic strategy for terminal mCRPC. PD-1 inhibitor plus anlotinib may be a new treatment choice for terminal mCRPC patients with DDR or HRR pathway defects and requires further investigation.
Male ; Humans ; Prostate-Specific Antigen ; Treatment Outcome ; Prostatic Neoplasms, Castration-Resistant/drug therapy* ; Immune Checkpoint Inhibitors/therapeutic use* ; Retrospective Studies

Objective To investigate the clinical effect of remimazolam combined with remifentanil in patients undergoing laryngoscope vocal cord surgery under general anesthesia.Methods A total of 180 patients undergoing laryngoscope vocal cord surgery under general anesthesia from January to August 2022,77 males and 103 females,aged 18-64 years,BMI 18-30 kg/m2,ASA physical status Ⅰ-Ⅲ were select-ed.The patients were divided into four groups using a random number table method:propofol group(group C),remimazolam 1.0 mg·kg-1·h-1 group(group R1),remimazolam 1.5 mg·kg-1·h-1 group(group R2),and remimazolam 2.0 mg·kg-1·h-1 group(group R3),45 patients in each group.Group C main-tained by intravenous infusion of propofol 5 mg·kg-1·h-1,groups R1,R2,and R3 were maintained by intravenous infusion of remimazolam 1.0,1.5,and 2.0 mg·kg-1·h-1,respectively.All patients were combined with remifentanil 0.2 μg·kg-1·min-1.HR,MAP,and BIS were recorded before anesthesia in-duction(T1),immediately after laryngoscope insertion(T2),immediately at the end of anesthesia mainte-nance(T3),and at tracheal extubation(T4).The onset time of sedation,awakening time,sedation-agita-tion score at extubation and Ramsay score 5 minutes after extubation were recorded.The intraoperative use of ephedrine and nitroglycerin were recorded.The number of injection pain and remedy sedations were recor-ded,the occurrence of adverse reactions such as nausea and vomiting,respiratory depression within 1 hour after extubation,and intraoperative awareness were recorded.Results Compared with group C,MAP at T3,BIS at T2 and T3 were significantly increased,MAP at T4 was significantly decreased,the onset time of sedation was significantly prolonged,the use of ephedrine and the incidence of injection pain were signifi-cantly decreased in group R1(P＜0.05),HR and MAP were significantly decreased at T2 and T4,MAP was significantly increased at T3,the onset time of sedation,awakening time,extubation time were signifi-cantly prolonged,the use of ephedrine and the incidence of injection pain were significantly reduced in group R2(P＜0.05),HR and MAP were significantly decreased at T2 and T4,the onset time of sedation,awakening time,extubation time were significantly prolonged,Ramsay score was significantly increased in group R3(P＜0.05).Compared with group R1,HR and MAP were significantly decreased at T2 and T4,BIS was significantly decreased at T2 and T3,the awakening time and extubation time were significantly pro-longed in group R2(P＜0.05),HR at T2 and T4,MAP at T2-T4,BIS at T2 and T3 were significantly de-creased,the awakening time and extubation time were significantly prolonged,Ramsay score was significant-ly increased in group R3(P＜0.05).Compared with group R2,MAP at T3 was significantly decreased and Ramsay score was significantly increased in group R3(P＜0.05).There were no significantly differences between the rates of nitroglycerin usage,rescue sedation,nausea and vomiting,and respiratory depression in the four groups.Conclusion Remimazolam can be safely used for anesthesia induction and maintenance in laryngoscope vocal cord surgery.The maintenance of remimazolam 1.5 mg·kg-1·h-1 combined with remifentanil can better maintain the hemodynamics stability during the surgery than remimazolam 1.0 and 2.0 mg·kg-1·h-1.