Objective:To analyze the characteristics of infectious pathogens in burn patients with sepsis based on metagenomic next-generation sequencing (mNGS) technology.Methods:This study was a retrospective observational study. From July 2021 to December 2023, 109 burn patients with sepsis who met the inclusion criteria were admitted to the Department of Burns of the First People's Hospital of Zhengzhou, including 68 males aged 57 to 92 years and 41 females aged 48 to 83 years. Blood, bronchoalveolar lavage fluid, cerebrospinal fluid, sputum, or other fluid specimens were collected from the patients during their hospital stay for microbiological culture (86 patients) and mNGS technology detection (109 patients). The types of specimens and pathogens detected by mNGS technology were counted. Patients were divided into intensive care unit (ICU) group (78 cases) who were admitted to the ICU and non-ICU group (31 cases) who were not admitted to the ICU, and the pathogens for infection in the two groups of patients were analyzed. In addition, the detection of pathogens in the specimens of 86 patients who underwent both mNGS technology detection and microbiological culture detection was analyzed.Results:Among the 109 specimens detected by mNGS technology, there were 42 blood specimens, 17 bronchoalveolar lavage fluid specimens, 4 sputum specimens, 6 cerebrospinal fluid specimens, 16 pus specimens, and 24 tissue fluid specimens; a total of 39 pathogens were detected, including 13 bacteria, 12 fungi, 10 viruses, 2 parasites, and 2 mycoplasmas. The overall positive rate of pathogen detection was 88.99% (97/109). Ranked by the detection rate, the top three Gram-negative bacteria were Klebsiella pneumoniae, Acinetobacter baumannii, and Pseudomonas spp, the top three Gram-positive bacteria were Streptococcus pneumoniae, Staphylococcus aureus, and Enterococcus faecalis; the top three viruses were human herpesvirus, cytomegalovirus, and circovirus; the top three fungi were Aspergillus fumigatus, Candida albicans, and Aspergillus flavus. Twenty-seven patients were infected with one pathogen, 45 patients with two pathogens, and 25 patients with three or more pathogens. Compared with those in non-ICU group, the proportions of Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas spp, Streptococcus pneumoniae, Aspergillus fumigatus, and cytomegalovirus detected in the patients in ICU group were significantly higher (with χ2 values of 8.62, 7.93, 3.93, 5.48, 4.28, and 5.58, respectively, P<0.05). In the pathogens detected by mNGS technology and microbiological culture method, the most common bacteria were Klebsiellapneumoniaeand Acinetobacter baumannii, and the most common fungi were strains of Aspergillus and Candida. There were 19 pathogens those could only be detected by mNGS technology, such as Lichtheimia ramosa, Pneumocystis jirovecii, Mycobacterium tuberculosis, viruses, etc.; there were no pathogens detected by microbiological culture method that couldn't be detected by mNGS technology. Compared with those detected by microbiological culture method, the overall positive rate, bacterial positive rate, and fungal positive rate detected by mNGS technology were significantly increased (with χ2 values of 45.52, 5.88, and 4.94, respectively, P<0.05). The 27.91% (24/86) of patients were detected positive by both methods, and 72.09% (62/86) of the patients were detected positive by mNGS technology but negative by microbiological culture method. The consistency test of the results obtained by the two detection methods showed that the difference was not statistically significant ( κ=0.02, P>0.05). Conclusions:The positive rate of pathogen detection in specimens using mNGS technology is higher than that detected by using conventional microbiological culture method, and it can detect pathogens those cannot be detected by the latter, such as Lichtheimia ramosa, Pneumocystis jirovidii, Mycobacterium tuberculosis, viruses, etc. Detection using mNGS technology can help clarify the types of infectious pathogens in burns patients with sepsis, and provide basis and guidance for clinical medication.

BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone

OBJECTIVE: To evaluate the efficacy and safety of Cidan Capsule combined with adjuvant transarterial chemoembolization (TACE) in patients with a high risk of early recurrence after curative resection of hepatocellular carcinoma (HCC). METHODS: A multicenter, randomized controlled trial was conducted in patients with high-risk recurrence factors after curative resection of HCC from 9 medical centers between July 2014 and July 2018. Totally 249 patients were randomly assigned to TACE with or without Cidan Capsule administration groups by stratified block in a 1:1 ratio. Postoperative adjuvant TACE was given 4-5 weeks after hepatic resection in both groups. Additionally, 125 patients in the TACE plus Cidan group were administrated Cidan Capsule (0.27 g/capsule, 5 capsules every time, 4 times a day) for 6 months with a 24-month follow-up. Primary endpoints included disease-free survival (DFS) and tumor recurrence rate (TRR). Secondary endpoint was overall survival (OS). Any drug-related adverse events (AEs) were observed and recorded. RESULTS: As the data cutoff in July 9th, 2018, the median DFS was not reached in the TACE plus Cidan group and 234.0 days in the TACE group (hazard ratio, 0.420, 95% confidence interval, 0.290-0.608; P<0.01). The 1- and 2-year TRR in the TACE plus Cidan and TACE groups were 31.5%, 37.1%, and 60.8%, 63.4%, respectively (P<0.01). Median OS was not reached in both groups. The 1- and 2-year OS rates in TACE plus Cidan and TACE groups were 98.4%, 98.4%, and 89.5%, 87.9%, respectively (P<0.05). The most common grade 3-4 AEs included fatigue, abdominal pain, lumbar pain, and nausea. One serious AE was reported in 1 patient in the TACE plus Cidan group, the death was due to retroperitoneal mass hemorrhage and hemorrhagic shock, and was not related to study drug. CONCLUSIONS Cidan Capsule in combination with TACE can reduce the incidence of early recurrence in HCC patients at high-risk of recurrence after radical hepatectomy and may be an appropriate option in postoperative anti-recurrence treatment. (Registration No. NCT02253511).

Objective: To investigate the efficacy and safety of a new cervical artificial disc prosthesis in the treatment of cervical degenerative diseases. Methods: The clinical data of 18 patients with single-level cervical degenerative diseases who underwent three dimensional printed anatomical bionic cervical disc replacement at Department of Spinal Surgery,Honghui Hospital,Xi'an Jiaotong University from May 2019 to July 2020 were analyzed retrospectively. There were 7 males and 11 females,aged (45±8) years old(range:28 to 58 years).The surgical segment was located at C_3－4 level in 2 cases, C_4－5 level in 5 cases, C_5－6 level in 9 cases, and C_6－7 level in 2 cases.The clinical and radiographic outcomes were recorded and compared at preoperative,postoperative times of one month and twelve months.The clinical assessments contained Japanese orthopedic association (JOA) score,neck disability index (NDI) and visual analogue scale (VAS).Imaging assessments included range of motion (ROM) of cervical spine, prosthesis subsidence and prosthesis anteroposterior migration.Repeated measurement variance analysis was used for comparison between groups,and paired t test was used for pairwise comparison. Results: All patients underwent the operation successfully and were followed up for more than 12 months.Compared with preoperative score,the JOA score,NDI and VAS were significantly improved after surgery (all P<0.01).There was no significant difference in postoperative ROM compared with 1-and 12-month preoperative ROM (t=1.570,P=0.135;t=1.744,P=0.099). The prosthesis subsidence was (0.29±0.13) mm (range: 0.18 to 0.50 mm) at 12-month postoperatively.The migration of prosthesis at 12-months postoperatively were (0.71±0.20) mm (range: 0.44 to 1.08 mm).There was no prosthesis subsidence or migration>2 mm at 12-month postoperatively. Conclusion: Three dimensional printed anatomical biomimetic cervical artificial disc replacement has a good early clinical effect in the treatment of cervical degenerative diseases, good mobility can be obtained while maintaining stability.
Adult ; Biomimetics ; Cervical Vertebrae/surgery* ; Female ; Follow-Up Studies ; Humans ; Intervertebral Disc/surgery* ; Intervertebral Disc Degeneration/surgery* ; Male ; Middle Aged ; Range of Motion, Articular ; Retrospective Studies ; Total Disc Replacement/methods* ; Treatment Outcome

ObjectiveIn order to establish a systematic quality evaluation system for Fritillariae Cirrhosae Bulbus adulteration， portable near-infrared （NIR） spectroscopy was used to identify Fritillariae Cirrhosae Bulbus and its adulterants and detect their adulteration quantity. MethodA total of 72 batches of Fritillariae Cirrhosae Bulbus samples were collected and 570 batches of adulterated products （dry bulbs of Fritillaria thunbergii， F. ussuriensis， F. pallidiflora and F. hupehensis， Bulbus Tulipae， flour） were prepared， NIR spectral data of samples were collected by the portable NIR spectrometer. Linear discriminant analysis （LDA） was used to establish the qualitative correction models of Fritillariae Cirrhosae Bulbus-adulterants and adulterants of different categories， partial least squares （PLS） was used to establish the quantitative correction models of adulteration quantity of different kinds of adulterants. ResultThe recognition rates of qualitative analysis model of Fritillariae Cirrhosae Bulbus and its adulterants were 99.49% （calibration set） and 100.00% （validation set）， respectively. In different adulterant models， the recognition rates of calibration set and validation set were 70.47% and 73.68%， respectively. Moreover， the correlation coefficients of validation set （R²_P） of the six quantitative models of adulteration ratio were 0.840 2 （Fritillariae Cirrhosae Bulbus adulterated with F. thunbergii dry bulbs）， 0.960 2 （Fritillariae Cirrhosae Bulbus adulterated with F. ussuriensis dry bulbs）， 0.765 7 （Fritillariae Cirrhosae Bulbus adulterated with F. pallidiflora dry bulbs）， 0.902 5 （Fritillariae Cirrhosae Bulbus adulterated with F. hupehensis dry bulbs）， 0.957 4 （Fritillariae Cirrhosae Bulbus adulterated with Bulbus Tulipae）， 0.976 1 （Fritillariae Cirrhosae Bulbus adulterated with flour）， the root mean square error of prediction （RMSEP） were 10.948 5， 5.463 9， 13.256 4， 8.549 2， 5.655 3， 4.235 6， respectively. The two qualitative models and six quantitative models showed good prediction performance. ConclusionThe portable NIR spectroscopy can be used to identify Fritillariae Cirrhosae Bulbus and its adulterants in real time， the method is rapid and accurate， which can meet the requirements of nondestructive identification of Fritillariae Cirrhosae Bulbus on site.

Objective: To explore the effect of perioperative chemotherapy on the prognosis of gastric cancer patients under real-world condition. Methods: A retrospective cohort study was carried out. Real world data of gastric cancer patients receiving perioperative chemotherapy and surgery + adjuvant chemotherapy in 33 domestic hospitals from January 1, 2014 to January 31, 2016 were collected. Inclusion criteria: (1) gastric adenocarcinoma was confirmed by histopathology, and clinical stage was cT2-4aN0-3M0 (AJCC 8th edition); (2) D2 radical gastric cancer surgery was performed; (3) at least one cycle of neoadjuvant chemotherapy (NAC) was completed; (4) at least 4 cycles of adjuvant chemotherapy (AC) [SOX (S-1+oxaliplatin) or CapeOX (capecitabine + oxaliplatin)] were completed. Exclusion criteria: (1) complicated with other malignant tumors; (2) radiotherapy received; (3) patients with incomplete data. The enrolled patients who received neoadjuvant chemotherapy and adjuvant chemotherapy were included in the perioperative chemotherapy group, and those who received only postoperative adjuvant chemotherapy were included in the surgery + adjuvant chemotherapy group. Propensity score matching (PSM) method was used to control selection bias. The primary outcome were overall survival (OS) and progression-free survival (PFS) after PSM. OS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the last effective follow-up or death. PFS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the first imaging diagnosis of tumor progression or death. The Kaplan-Meier method was used to estimate the survival rate, and the Cox proportional hazards model was used to evaluate the independent effect of perioperative chemo therapy on OS and PFS. Results: 2 045 cases were included, including 1 293 cases in the surgery+adjuvant chemotherapy group and 752 cases in the perioperative chemotherapy group. After PSM, 492 pairs were included in the analysis. There were no statistically significant differences in gender, age, body mass index, tumor stage before treatment, and tumor location between the two groups (all P>0.05). Compared with the surgery + adjuvant chemotherapy group, patients in the perioperative chemotherapy group had higher proportion of total gastrectomy (χ(2)=40.526, P<0.001), smaller maximum tumor diameter (t=3.969, P<0.001), less number of metastatic lymph nodes (t=1.343, P<0.001), lower ratio of vessel invasion (χ(2)=11.897, P=0.001) and nerve invasion (χ(2)=12.338, P<0.001). In the perioperative chemotherapy group and surgery + adjuvant chemotherapy group, 24 cases (4.9%) and 17 cases (3.4%) developed postoperative complications, respectively, and no significant difference was found between two groups (χ(2)=0.815, P=0.367). The median OS of the perioperative chemotherapy group was longer than that of the surgery + adjuvant chemotherapy group (65 months vs. 45 months, HR: 0.74, 95% CI: 0.62-0.89, P=0.001); the median PFS of the perioperative chemotherapy group was also longer than that of the surgery+adjuvant chemotherapy group (56 months vs. 36 months, HR=0.72, 95% CI:0.61-0.85, P<0.001). The forest plot results of subgroup analysis showed that both men and women could benefit from perioperative chemotherapy (all P<0.05); patients over 45 years of age (P<0.05) and with normal body mass (P<0.01) could benefit significantly; patients with cTNM stage II and III presented a trend of benefit or could benefit significantly (P<0.05); patients with signet ring cell carcinoma benefited little (P>0.05); tumors in the gastric body and gastric antrum benefited more significantly (P<0.05). Conclusion: Perioperative chemotherapy can improve the prognosis of gastric cancer patients.
Chemotherapy, Adjuvant ; Female ; Gastrectomy ; Humans ; Male ; Neoadjuvant Therapy ; Neoplasm Staging ; Prognosis ; Retrospective Studies ; Stomach Neoplasms/surgery*

Four cadinane-type sesquiterpenes were obtained from the petroleum ether of 95% ethanol extract of Eupatorium adenophorum Spreng by using an HP-20 macroporous resin column, silica gel, and semi-preparative HPLC. Their structures were determined by physical, chemical and spectroscopic methods and identified as eupatorinol (1), (+)-(5R,7S,9R,10S)-2-oxocadinan-3,6(11)-dien-12,7-olide (2), (1S,4R)-7-hydroxycalamenen-3-one(3) and (-)-(5R,6R,7S,9R,10S)-cadinan-3-ene-6,7-diol (4). Among them, compound 1 is a new cadinane-type sesquiterpene, and compound 3 was isolated from this genus for the first time. In bioassay, none of these compounds displayed obvious cytotoxicity.

Objective:To propose a new method for detecting and evaluating traditional Chinese medicine （TCM） by artificial intelligence and machine vision technology. Method:Taking Fritillariae Cirrhosae Bulbus， Crataegi Fructus and Pinelliae Rhizoma as the research objects， big data of pictures was collected by machine vision and the image database was established. Through the intelligent analysis of the external characteristics of TCM， the deep convolutional neural network model was established to realize the functions of location detection and variety identification by means of deep learning， so as to significantly improve the accuracy of rapid identification of TCM. Result:The classification accuracy of 11 kinds of Chinese herbal pieces （raw， fried， parched and charred products of Crataegi Fructus， Pinelliae Rhizoma， Pinelliae Rhizoma Praeparatum Cum Zingibere et Alumine， Pinelliae Rhizoma Praeparatum， Pinelliae Rhizoma Praeparatum Cum Alumine and three products of Fritillariae Cirrhosae Bulbus） could be more than 99%， and the average recognition accuracy of specific categories could reach more than 97%. Conclusion:The intelligent identification technology of TCM decoction pieces realized by deep learning algorithms has the advantages of simplicity， rapidity， high precision and quantifiable detection， which can provide technical support for the quality detection and evaluation of TCM， and enrich the research ideas of quality evaluation of TCM.