1.Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
Qiu-Han CAI ; Cheng-Liang ZHONG ; Si-Yuan HU ; Xin-Min LI ; Zhi-Chun XU ; Hui CHEN ; Ying HUA ; Jun-Hong WANG ; Ji-Hong TANG ; Bing-Xiang MA ; Xiu-Xia WANG ; Ai-Zhen WANG ; Meng-Qing WANG ; Wei ZHANG ; Chun WANG ; Yi-Qun TENG ; Yi-Hui SHAN ; Sheng-Xuan GUO
China Journal of Chinese Materia Medica 2025;50(6):1699-1705
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent
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Child
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Child, Preschool
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Female
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Humans
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Male
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Double-Blind Method
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Drugs, Chinese Herbal/therapeutic use*
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Tic Disorders/drug therapy*
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Treatment Outcome
2.Quality evaluation of Bidentis Herba based on HPLC fingerprint, multi-component content determination, and chemometrics.
Guo-Li SHI ; Xin-Feng WANG ; Wei-Qun LI ; Jian-Wei FAN ; Yong-Xia GUAN
China Journal of Chinese Materia Medica 2025;50(14):3944-3950
This study established the HPLC fingerprints and a multi-component content determination method for Bidens pilosa var. radiata and B. pilosa and conducted comprehensive evaluation by integrating fingerprint similarity comparison, cluster analysis(CA), and principal component analysis(PCA), aiming to provide a reference for the establishment of quality standards for Bidentis Herba. HPLC was launched on an Agilent Poroshell 120 EC-C_(18) chromatographic column(4.6 mm×250 mm, 4 μm) by gradient elution with a mobile phase of 0.1% aqueous phosphoric acid-acetonitrile at a flow rate of 0.7 mL·min~(-1), detection wavelength of 270 nm, column temperature of 25 ℃, and an injection volume of 5 μL. The fingerprint similarity of 20 batches of Bidentis Herba ranged from 0.775 to 0.979. A total of 20 common peaks were identified, and seven components were confirmed through comparison with reference substances: neochlorogenic acid, chlorogenic acid, isochlorogenic acid A, isochlorogenic acid B, isochlorogenic acid C, rutin, and hyperoside. These seven components exhibited good linearity within the ranges of 3.4-67.4, 33.0-660.3, 26.6-531.2, 3.5-70.5, 6.2-124.9, 2.4-48.3, and 4.6-91.5 μg·mL~(-1), respectively, with correlation coefficients(r) greater than 0.999. The average recovery rates ranged from 96.47% to 104.6%. CA and PCA classified the 20 batches of Bidentis Herba into two categories. PCA yielded two principal components, with a cumulative variance contribution rate of 80.557%. The established HPLC fingerprints and multi-component content determination method are simple and accurate, providing a scientific basis for the quality control and quality standard formulation of Bidentis Herba.
Chromatography, High Pressure Liquid/methods*
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Drugs, Chinese Herbal/chemistry*
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Quality Control
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Chemometrics/methods*
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Bidens/chemistry*
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Principal Component Analysis
3.CFAP300 loss-of-function variant causes primary ciliary dyskinesia and male infertility via disrupting sperm flagellar assembly and acrosome formation.
Hua-Yan YIN ; Yu-Qi ZHOU ; Qun-Shan SHEN ; Zi-Wen CHEN ; Jie-Ru LI ; Huan WU ; Yun-Xia CAO ; Rui GUO ; Bing SONG
Asian Journal of Andrology 2025;27(6):743-750
Primary ciliary dyskinesia (PCD) is a genetically heterogeneous disorder characterized by impaired motility of cilia and flagella. Mutations in cilia- and flagella-associated protein 300 ( CFAP300 ) are associated with human PCD and male infertility; however, the underlying pathogenic mechanisms remain poorly understood. In a consanguineous Chinese family, we identified a homozygous CFAP300 loss-of-function variant (c.304delC) in a proband presenting with classical PCD symptoms and severe sperm abnormalities, including dynein arm deficiency and acrosomal malformation, as confirmed by transmission electron microscopy (TEM). Histological analysis revealed multiple morphological abnormalities of the sperm flagella in CFAP300 -mutant individual, whereas immunofluorescence demonstrated markedly reduced CFAP300 expression in the spermatozoa of the proband. Furthermore, tandem mass tag (TMT)-based quantitative proteomics showed that the CFAP300 mutation reduced key spermatogenesis proteins (e.g., sperm flagellar 2 [SPEF2], solute carrier family 25 member 31 [SLC25A31], and A-kinase anchoring protein 3 [AKAP3]) and mitochondrial ATP synthesis factors (e.g., SLC25A31, cation channel sperm-associated 3 [CATSPER3]). It also triggered abnormal increases in autophagy-related proteins and signaling mediator phosphorylation. These molecular alterations are likely to contribute to progressive deterioration of sperm ultrastructure and function. Notably, successful pregnancy was achieved via intracytoplasmic sperm injection (ICSI) using the proband's sperm. Overall, this study expands the known CFAP300 mutational spectrum and offers novel mechanistic insights into its role in spermatogenesis.
Humans
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Male
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Infertility, Male/pathology*
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Acrosome/pathology*
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Sperm Tail/pathology*
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Pedigree
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Spermatozoa
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Adult
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Loss of Function Mutation
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Ciliary Motility Disorders/genetics*
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Spermatogenesis/genetics*
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Female
5.Clinical trial of dexmedetomidine combined with esketamine in elderly patients undergoing spinal surgery
Ya-Qun WANG ; Xi-Shang XIA ; Dong-Xue WANG ; Hui WANG ; Ling WANG
The Chinese Journal of Clinical Pharmacology 2024;40(14):2013-2017
Objective To observe the effects of dexmedetomidine combined with esketamine on early postoperative pain and cognitive function in elderly patients undergoing spinal surgery.Methods The aged spinal surgery patients were divided into control group and treatment group by random number table method.Both groups were anesthetically induced by intramuscular injection of esketamine 3 mg·kg-1,while the control group was anesthetically induced by intravenous injection of propofol 4 mg·kg-1 with constant velocity pump.The treatment group was given 1 μg·kg-1 dexmedetomidine by intravenous pump for 10 min,and then continued pumping at 0.5 μg·kg-1 rate.The changes of vital signs 5 min before surgery(T1),5 min after surgery(T2),at the end of surgery(T3),at the time of recovery(T4),early postoperative pain,cognitive function,the time of the first patient control analgesia(PC A),the cumulative dosage of sufentanil in different time periods within 48 h and the occurrence of adverse drug reactions were observed in the 2 groups.Results 44 patients were included in the control group and 45 patients in the treatment group,respectively.At T2,T3 and T4,the heart rate of treatment group were(82.51±3.05),(80.15±3.21)and(81.51±3.04)beat·min-1,and that of control group were(92.54±3.10),(93.52±3.05)and(88.45±3.51)beat·min-1,respectively.The mean arterial pressure(MAP)of the treatment group were(54.51±3.58),(55.25±3.21)and(60.25±3.24)mmHg;and that of the control group were(73.25±3.54),(70.52±3.20)and(68.51±3.05)mmHg,respectively.The blood oxygen saturation(SPO2)of treatment groups were(98.56±0.38)%,(98.25±0.35)%and(99.02±0.14)%;and the SPO2 of control group were(94.52±0.35)%,(95.25±0.25)%and(96.25±0.32)%,respectively.Visual analogue pain(VAS)scores were(5.69±1.12),(5.02±0.89),(4.52±0.65)and(4.01±0.45)scores at 2,4,6 and 8 h after operation,respectively;the control group were(6.25±1.35),(5.46±1.12),(4.98±0.84)and(4.25±0.52)scores,respectively.24,36 and 72 h after operation,the scores of MMSE in treatment group were 24.25±1.15,26.25±1.14,27.25±0.89 and 28.86±0.62,respectively;the control group were 22.52±1.02,24.25±1.12,26.58±0.87 and 28.78±0.52,respectively.Compared with the control group,there were statistically significant differences in the above indexes of treatment groups(all P<0.05).The adverse drug reactions in the control group were mainly lethargy,respiratory depression,nausea and vomiting,and the adverse drug reactions in the treatment group were mainly lethargy,nausea and vomiting,and the incidence of total adverse drug reactions in the treatment group and the control group was 6.67%and 22.73%,respectively,with statistical significance(P<0.05).Conclusion Dexmedetomidine combined with esketamine is safe and effective in elderly patients undergoing spinal surgery.It can effectively reduce early postoperative pain and quickly restore cognitive function.
6.Study of The Y-STR Multiplex Microfluidic Chip Rapid Amplification System
Dao-Yu WANG ; Qun WAN ; Bin ZHUANG ; Li-Jian ZHAO ; Jun-Ping HAN ; Cai-Xia LI
Progress in Biochemistry and Biophysics 2024;51(3):696-705
ObjectiveAt present, the matching reagents of commercially available rapid DNA instruments based on microfluidics chip technology are autosome short tandem repeat (STR) individual identification reagents. The non-recombining part of the human Y chromosome is widely used in forensic DNA analysis, particularly in cases where standard autosomal DNA profile is uninformative. Y-STR loci are useful markers to identify males and male lineages in forensic practice. In order to achieve rapid and fully integrated detection ofY-STR loci, this study constructed the RTyper Y27 microfluidic chip rapid detection system and validated the performance of this system. MethodsThe system was verified and evaluated by sensitivity, success rate, typing accuracy, peak height balance, sizing precision and accuracy, mock case sample tests, mixture detection ability, and inhibition tolerance. ResultsComplete Y-STR profiles can be obtained when the template amount of DNA standard 9948 was ≥8 ng, the number of blood cards was ≥3 pieces, and the number of oral swab scrapings was≥7 times. The success rate of fully integrated detection was 91.52%, and the concordance rates was 99.74% for 165 testing samples. The success rate of 115 blood spots in these samples was 90.43%, with a typing accuracy of 99.65%, the success rate of 50 buccal swabs was 94%, with a typing accuracy of 99.92%. There was no significant difference in typing accuracy between blood spots and buccal swab samples. The peak height ratio between different fluorescence channels was 89.81%. The standard deviation of allelic ladder for 10 runs was within 0.5 bp. The size differences between allele and corresponding allele in allelic ladder was within 0.5 bp. The maximum precision CV values within and between batches were 0.48% and 0.68%, respectively, which were lower than 15%. These data indicate that the system has good accuracy and precision. The system was capable of accurately typing oral swabs, blood cards, saliva cards, cigarette butts, blood swabs and seminal stains. Complete Y-STR profiles can be obtained and distinguish at the 1∶3 ratio of minor and major contributors in artificial male DNA mixtures. Complete Y-STR genotyping can be obtained under the interference of inhibitors, such as different concentrations of humic acid (50-400 mg/L), indigotin (20-100 nmol/L) and hemoglobin (100-500 μmol/L). ConclusionIn this study, the RTyper Y27 microfluidic chip rapid amplification system is combined with the Quick TargSeq 1.0 integrated system, and the Y-STR profile can be obtained in approximately 2 h. Through a series of verification experiments, the results show that the system has good repeatability, accuracy and stability, can meet the on-site Y-STR detection requirements, and can be used in forensic practice.
7.Construction of a model based on multipoint full-layer puncture biopsy for predicting pathological complete response after neoadjuvant therapy for locally advanced rectal cancer
Ying JIN ; Zhiwei ZHAI ; Liting SUN ; Pingdian XIA ; Hang HU ; Chongqiang JIANG ; Baocheng ZHAO ; Hao QU ; Qun QIAN ; Yong DAI ; Hongwei YAO ; Zhenjun WANG ; Jiagang HAN
Chinese Journal of Gastrointestinal Surgery 2024;27(4):403-411
Objective:To investigate the value of transanal multipoint full-layer puncture biopsy (TMFP) in predicting pathological complete response (pCR) after neoadjuvant radiotherapy and chemotherapy (nCRT) in patients with locally advanced rectal cancer (LARC) and to establish a predictive model for providing clinical guidance regarding the treatment of LARC.Methods:In this multicenter, prospective, cohort study, we collected data on 110 LARC patients from four hospitals between April 2020 and March 2023: Beijing Chaoyang Hospital of Capital Medical University (50 patients), Beijing Friendship Hospital of Capital Medical University (41 patients), Qilu Hospital of Shandong University (16 patients), and Zhongnan Hospital of Wuhan University (three patients). The patients had all received TMFP after completing standard nCRT. The variables studied included (1) clinicopathological characteristics; (2) clinical complete remission (cCR) and efficacy of TMFP in determining pCR after NCRT in LARC patients; and (3) hospital attended, sex, age, clinical T- and N-stages, distance between the lower margin of the tumor and the anal verge, baseline and post-radiotherapy serum carcinoembryonic antigen (CEA) and carbohydrate antigen (CA)19-9 concentrations, chemotherapy regimen, use of immunosuppressants with or without radiotherapy, radiation therapy dosage, interval between surgery and radiotherapy, surgical procedure, clinical T/N stage after radiotherapy, cCR, pathological results of TMFP, puncture method (endoscopic or percutaneous), and number and timing of punctures. Single-factor and multifactorial logistic regression analysis were used to determine the factors affecting pCR after NCRT in LARC patients. A prediction model was constructed based on the results of multivariat analysis and the performance of this model evaluated by analyzing subject work characteristics (ROC), calibration, and clinical decision-making (DCA) curves. pCR was defined as complete absence of tumor cells on microscopic examination of the surgical specimens of rectal cancer (including lymph node dissection) after NCRT, that is, ypT0+N0. cCR was defined according to the Chinese Neoadjuvant Rectal Cancer Waiting Watch Database Study Collaborative Group criteria after treatment, which specify an absence of ulceration and nodules on endoscopy; negative rectal palpation; no tumor signals on rectal MRI T2 and DWI sequences; normal serum CEA concentrations, and no evidence of recurrence on pelvic computed tomography/magnetic resonance imaging.Results:Of the 110 patients, 45 (40.9%) achieved pCR after nCRT, which was combined with immune checkpoint inhibitors in 34 (30.9%). cCR was diagnosed before puncture in 38 (34.5%) patients, 43 (39.1%) of the punctures being endoscopic. There were no complications of puncture such as enterocutaneous fistulae, vaginal injury, prostatic injury, or presacral bleeding . Only one (2.3%) patient had a small amount of blood in the stools, which was relieved by anal pressure. cCR had a sensitivity of 57.8% (26/45) for determining pCR, specificity of 81.5% (53/65), accuracy of 71.8% (79/110), positive predictive value 68.4% (26/38), and negative predictive value of 73.6% (53/72). In contrast, the sensitivity of TMFP pathology in determining pCR was 100% (45/45), specificity 66.2% (43/65), accuracy 80.0% (88/110), positive predictive value 67.2% (45/67), and negative predictive value 100.0% (43/43). In this study, the sensitivity of TMFP for pCR (100.0% vs. 57.8%, χ 2=24.09, P<0.001) was significantly higher than that for cCR. However, the accuracy of pCR did not differ significantly (80.0% vs. 71.8%, χ 2=2.01, P=0.156). Univariate and multivariate logistic regression analyses showed that a ≥4 cm distance between the lower edge of the tumor and the anal verge (OR=7.84, 95%CI: 1.48-41.45, P=0.015), non-cCR (OR=4.81, 95%CI: 1.39-16.69, P=0.013), and pathological diagnosis by TMFP (OR=114.29, the 95%CI: 11.07-1180.28, P<0.001) were risk factors for pCR after NCRT in LARC patients. Additionally, endoscopic puncture (OR=0.02, 95%CI: 0.05-0.77, P=0.020) was a protective factor for pCR after NCRT in LARC patients. The area under the ROC curve of the established prediction model was 0.934 (95%CI: 0.892-0.977), suggesting that the model has good discrimination. The calibration curve was relatively close to the ideal 45° reference line, indicating that the predicted values of the model were in good agreement with the actual values. A decision-making curve showed that the model had a good net clinical benefit. Conclusion:Our predictive model, which incorporates TMFP, has considerable accuracy in predicting pCR after nCRT in patients with locally advanced rectal cancer. This may provide a basis for more precisely selecting individualized therapy.
8.Construction of a model based on multipoint full-layer puncture biopsy for predicting pathological complete response after neoadjuvant therapy for locally advanced rectal cancer
Ying JIN ; Zhiwei ZHAI ; Liting SUN ; Pingdian XIA ; Hang HU ; Chongqiang JIANG ; Baocheng ZHAO ; Hao QU ; Qun QIAN ; Yong DAI ; Hongwei YAO ; Zhenjun WANG ; Jiagang HAN
Chinese Journal of Gastrointestinal Surgery 2024;27(4):403-411
Objective:To investigate the value of transanal multipoint full-layer puncture biopsy (TMFP) in predicting pathological complete response (pCR) after neoadjuvant radiotherapy and chemotherapy (nCRT) in patients with locally advanced rectal cancer (LARC) and to establish a predictive model for providing clinical guidance regarding the treatment of LARC.Methods:In this multicenter, prospective, cohort study, we collected data on 110 LARC patients from four hospitals between April 2020 and March 2023: Beijing Chaoyang Hospital of Capital Medical University (50 patients), Beijing Friendship Hospital of Capital Medical University (41 patients), Qilu Hospital of Shandong University (16 patients), and Zhongnan Hospital of Wuhan University (three patients). The patients had all received TMFP after completing standard nCRT. The variables studied included (1) clinicopathological characteristics; (2) clinical complete remission (cCR) and efficacy of TMFP in determining pCR after NCRT in LARC patients; and (3) hospital attended, sex, age, clinical T- and N-stages, distance between the lower margin of the tumor and the anal verge, baseline and post-radiotherapy serum carcinoembryonic antigen (CEA) and carbohydrate antigen (CA)19-9 concentrations, chemotherapy regimen, use of immunosuppressants with or without radiotherapy, radiation therapy dosage, interval between surgery and radiotherapy, surgical procedure, clinical T/N stage after radiotherapy, cCR, pathological results of TMFP, puncture method (endoscopic or percutaneous), and number and timing of punctures. Single-factor and multifactorial logistic regression analysis were used to determine the factors affecting pCR after NCRT in LARC patients. A prediction model was constructed based on the results of multivariat analysis and the performance of this model evaluated by analyzing subject work characteristics (ROC), calibration, and clinical decision-making (DCA) curves. pCR was defined as complete absence of tumor cells on microscopic examination of the surgical specimens of rectal cancer (including lymph node dissection) after NCRT, that is, ypT0+N0. cCR was defined according to the Chinese Neoadjuvant Rectal Cancer Waiting Watch Database Study Collaborative Group criteria after treatment, which specify an absence of ulceration and nodules on endoscopy; negative rectal palpation; no tumor signals on rectal MRI T2 and DWI sequences; normal serum CEA concentrations, and no evidence of recurrence on pelvic computed tomography/magnetic resonance imaging.Results:Of the 110 patients, 45 (40.9%) achieved pCR after nCRT, which was combined with immune checkpoint inhibitors in 34 (30.9%). cCR was diagnosed before puncture in 38 (34.5%) patients, 43 (39.1%) of the punctures being endoscopic. There were no complications of puncture such as enterocutaneous fistulae, vaginal injury, prostatic injury, or presacral bleeding . Only one (2.3%) patient had a small amount of blood in the stools, which was relieved by anal pressure. cCR had a sensitivity of 57.8% (26/45) for determining pCR, specificity of 81.5% (53/65), accuracy of 71.8% (79/110), positive predictive value 68.4% (26/38), and negative predictive value of 73.6% (53/72). In contrast, the sensitivity of TMFP pathology in determining pCR was 100% (45/45), specificity 66.2% (43/65), accuracy 80.0% (88/110), positive predictive value 67.2% (45/67), and negative predictive value 100.0% (43/43). In this study, the sensitivity of TMFP for pCR (100.0% vs. 57.8%, χ 2=24.09, P<0.001) was significantly higher than that for cCR. However, the accuracy of pCR did not differ significantly (80.0% vs. 71.8%, χ 2=2.01, P=0.156). Univariate and multivariate logistic regression analyses showed that a ≥4 cm distance between the lower edge of the tumor and the anal verge (OR=7.84, 95%CI: 1.48-41.45, P=0.015), non-cCR (OR=4.81, 95%CI: 1.39-16.69, P=0.013), and pathological diagnosis by TMFP (OR=114.29, the 95%CI: 11.07-1180.28, P<0.001) were risk factors for pCR after NCRT in LARC patients. Additionally, endoscopic puncture (OR=0.02, 95%CI: 0.05-0.77, P=0.020) was a protective factor for pCR after NCRT in LARC patients. The area under the ROC curve of the established prediction model was 0.934 (95%CI: 0.892-0.977), suggesting that the model has good discrimination. The calibration curve was relatively close to the ideal 45° reference line, indicating that the predicted values of the model were in good agreement with the actual values. A decision-making curve showed that the model had a good net clinical benefit. Conclusion:Our predictive model, which incorporates TMFP, has considerable accuracy in predicting pCR after nCRT in patients with locally advanced rectal cancer. This may provide a basis for more precisely selecting individualized therapy.
9.Analysis of the characteristics of infectious pathogens in burn patients with sepsis based on metagenomic next-generation sequencing technology
Jijing SHI ; Liang ZHAO ; Xiaoliang LI ; Qun ZHANG ; Chengde XIA ; Chao MA
Chinese Journal of Burns 2024;40(10):940-947
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.
10.Application of task-driven approach combined with "7E" learning cycle in nurse refresher training on endoscopic retrograde cholangiopancreatography
Li LIU ; Xiujuan LIU ; Qun LUO ; Xia OU ; Lei LIU ; Li WANG
Chinese Journal of Medical Education Research 2024;23(4):512-516
Objective:To explore the application of the task-driven method combined with the "7E" learning cycle mode in nurse refresher training on endoscopic retrograde cholangiopancreatography (ERCP).Methods:We assigned 54 nurses who received refresher training on ERCP in the Department of Hepatobiliary Surgery of The First Affiliated Hospital of Army Medical University from January 2019 to December 2022 into control group (28 nurses from January 2019 to December 2020) to shadow and practice ERCP in a traditional way or experimental group (26 nurses from January 2021 to December 2022) to be taught using the task-driven method combined with the "7E" learning cycle method. At the end of training, the two groups undertook a theoretical and practical examination and a questionnaire survey. SPSS 25.0 was used to perform the t test, Wilcoxon test, chi-square test, and Fisher's exact test. Results:After training, compared with the control group, the experimental group had significantly higher scores of theory [87.50 (85, 90) vs. 90.51 (89, 92), P<0.05], and practice [84.11 (82.75, 85) vs. 90.52 (89, 92), P<0.05]. The proportions of trainees rating teaching methods excellent in the experimental group and control group were 76.92% ( n=20) and 42.86% ( n=12), respectively, and the proportions of teachers rating teaching effects excellent in the experimental group and control group were 84.62% ( n=22) and 42.86% ( n=12), respectively, both showing significant between-group differences (both P<0.05). Conclusions:The combination of the task-driven method and the "7E" learning cycle mode can mobilize learning initiative and enthusiasm, improve collaboration ability, promote learning interest and comprehensive practical ability for ERCP in nurses, which is suitable for ERCP training and teaching.

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