1.Development of Patient Self-Reported Core Outcome Set in Community Studies on Heat-Sensitive Moxibustion for Primary Hypertension
Jianyu YOU ; Shuqing LI ; Guihua DENG ; Xu ZHOU
Journal of Traditional Chinese Medicine 2025;66(1):34-41
ObjectiveTo establish the self-reported core outcome set (COS) for patients with an example of a community study on heat-sensitive moxibustion for primary hypertension (PH), to provide a reference for the selection of effectiveness evaluation indicators in community study on heat-sensitive moxibustion. MethodsA systematic literature search was conducted to collect outcomes used in randomized controlled trials and systematic review of heat-sensitive moxibustion for PH (Jan 2021), and additional outcomes were added through patient and expert questionnaires (Feb 2021) to create a pool of outcome entries. A multidisciplinary expert Delphi survey was conducted to screen outcomes applicable to patient self-reporting (Apr 2021), and the importance of outcome indicators was rated on a 5-Point Likert Scale. Finally, patient self-reported COS was determined through a consensus conference (June 2021). ResultsA pool of patient self-reported indicators in the community study of heat-sensitive moxibustion treatment for PH was generated by standardizing and combining the outcome indicators based on the results of the literature search and the questionnaire survey, which consisted of totally 100 measurement tools or contents, excluding 51 indicators or measurement tools required measurement by specialized physicians or hospital equipment, and 49 items were retained to enter the initial list of indicator entries. For the first round of Delphi survey, the mean score for expert familiarity was 0.819, the mean score for basis of judgment was 0.710, and the expert authority coefficient was 0.765, with a total of 21 indicator measurement tools or contents deleted (significance score ≤ 75 or coefficient of variation > 0.25), 28 retained, and 3 new expert-added indicator entries added. In the second round of Delphi survey, the average score for expert familiarity was 0.859, the average score for basis for judgment was 0.763, and the expert authority coefficient was 0.811, with a total of 11 indicator measurement tools or contents deleted and 20 retained involving 5 domains. Following an expert consensus meeting, 8 outcome indicators were finalized for inclusion in the patient self-reported COS, including 6 indicators of effectiveness evaluation such as quality-of-life scores, blood pressure, traditional Chinese medicine symptom scores, cost-benefit, cardiovascular and cerebrovascular events, and adverse reactions/events, and 2 indicators of factors influencing effectiveness such as sensation of heat-sensitive moxibustion, and adherence. ConclusionIn this study, we initially established a criteria for evaluating the effectiveness in the community study on heat-sensitive moxibustion by constructing patient self-reported COS in the community study on heat-sensitive moxibustion for PH, which can provide a scientific research paradigm for the subsequent development of the community study on heat-sensitive moxibustion.
2.Analysis of distortion product otoacoustic emissions results of noise-exposed workers at a metal shipbuilding enterprise
Jieting ZHOU ; Jianyu GUO ; Hairu YANG ; Linyan SHU ; Zhixing FAN ; Jia TANG ; Xinqiang NIE ; Guoyong XU ; Hansheng LIN ; Bin XIAO
China Occupational Medicine 2025;52(1):99-105
Objective To evaluate the role of distortion product otoacoustic emissions (DPOAE) testing in evaluating early hearing loss among noise-exposed workers. Methods A total of 174 noise-exposed workers in a metal shipbuilding enterprise were selected as the research subjects by the convenience sampling method. Pure tone audiometry (PTA), DPOAE and the level of noise exposure were conducted on the workers. The rank correlation analysis was used to analyze the correlation between DPOAE amplitude and PTA threshold. The multilevel model was used to analyze the effects of gender, age, noise exposure intensity, cumulative noise exposure (CNE), hearing loss classification and PTA threshold on DPOAE results. Results At the frequencies of 0.50, 1.00, 2.00, 3.00, 4.00, 6.00 and 8.00 kHz, the DPOAE amplitude was negatively correlated with the PTA threshold (rank correlation coefficients were -0.12, -0.48, -0.47, -0.18, -0.23, -0.44, -0.19, respectively, all P<0.01). At the most frequencies, DPOAE amplitude was negatively correlated with age and CNE (all P<0.05). The results of multilevel model analysis showed that there were significant differences in DPOAE amplitudes at certain frequencies across gender, age, noise intensity, CNE, and hearing loss classification (all P<0.05). Significant differences in DPOAE responses were found among different CNE and hearing loss groups (all P<0.01). Conclusion DPOAE testing can objectively reflect the hearing status of noise-exposed workers and could be considered for inclusion in routine hearing monitoring to facilitate early detection of noise-induced hearing loss.
3.Integrated evidence chain-based effectiveness evaluation of traditional Chinese medicines (Eff-iEC): A demonstration study.
Ye LUO ; Xu ZHAO ; Ruilin WANG ; Xiaoyan ZHAN ; Tianyi ZHANG ; Tingting HE ; Jing JING ; Jianyu LI ; Fengyi LI ; Ping ZHANG ; Junling CAO ; Jinfa TANG ; Zhijie MA ; Tingming SHEN ; Shuanglin QIN ; Ming YANG ; Jun ZHAO ; Zhaofang BAI ; Jiabo WANG ; Aiguo DAI ; Xiangmei CHEN ; Xiaohe XIAO
Acta Pharmaceutica Sinica B 2025;15(2):909-918
Addressing the enduring challenge of evaluating traditional Chinese medicines (TCMs), the integrated evidence chain-based effectiveness evaluation of TCMs (Eff-iEC) has emerged. This paper explored its capacity through a demonstration study that evaluated the effectiveness evidence of six commonly used anti-hepatic fibrosis Chinese patent medicines (CPMs), including Biejiajian Pill (BP), Dahuang Zhechong Pill (DZP), Biejia Ruangan Compound (BRC), Fuzheng Huayu Capsule (FHC), Anluo Huaxian Pill (AHP), and Heluo Shugan Capsule (HSC), using both Eff-iEC and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system. The recognition of these CPMs within the TCM academic community was also assessed through their inclusion in relevant medical documents. Results showed that the evidence of BRC and FHC received higher assessments in both Eff-iEC and GRADE system, while the assessments for others varied. Analysis of community recognition revealed that Eff-iEC more accurately reflects the clinical value of these CPMs, exhibiting superior evaluative capabilities. By breaking through the conventional pattern of TCMs effectiveness evaluation, Eff-iEC offers a novel epistemology that better aligns with the clinical realities and reasoning of TCMs, providing a coherent methodology for clinical decision-making, new drug evaluations, and health policy formulation.
4.Chemical knockdown of Keap1 and homoPROTAC-ing allergic rhinitis.
Jianyu YAN ; Tianyu WANG ; Ruizhi YU ; Lijuan XU ; Hongming SHAO ; Tengfei LI ; Zhe WANG ; Xudong CHA ; Zhenyuan MIAO ; Chengguo XING ; Ke XU ; Huanhai LIU ; Chunlin ZHUANG
Acta Pharmaceutica Sinica B 2025;15(8):4137-4155
Allergic rhinitis (AR), a globally prevalent immune-mediated inflammatory condition, is still an incurable disease. In the present study, we have validated the impact of the Kelch-like ECH associated protein 1 (Keap1)-related oxidative stress and inflammatory response in clinical AR patient peripheral blood and nasal swab samples, emphasizing the biological relevance of Keap1 and AR. Targeting Keap1 -nuclear factor erythroid 2-related factor 2 (Nrf2) related anti-oxidative stress may be effective for AR intervention. Drawing inspiration from the Keap1 homodimerization and the E3 ligase characteristics, we herein present a design of novel bivalent molecules for chemical knockdown of Keap1. For the first time, we characterized ternary complexes of Keap1 dimer and one molecule of bivalent compounds. The best bivalent molecule 8 encompasses robust capacity to degrade Keap1 as a homoPROTACKEAP1. It efficaciously suppresses inflammatory cytokines in extensively different cells, including human nasal epithelial cells. Moreover, in an AR mouse model, we confirmed that the chemical degradation induced by homoPROTACKEAP1 led to therapeutic benefits in managing AR symptoms, oxidative stress and inflammation. In summary, our findings underscore the efficacy of targeting the Keap1 system through the homoPROTAC-ing technology as an innovative and promising treatment strategy for the incurable allergic disorders.
5.Assessment and management of analgesic and sedation in critically ill patients from ICU in Guizhou Province.
Ya WEI ; Qianfu ZHANG ; Hongying BI ; Dehua HE ; Jianyu FU ; Yan TANG ; Xu LIU
Chinese Critical Care Medicine 2025;37(9):861-865
OBJECTIVE:
To investigate the current status of early pain and agitation management in critically ill patients in Guizhou Province.
METHODS:
A retrospective study was performed using data collected from a quality control activity conducted between April and June 2021 in non-provincial public hospitals with general intensive care unit (ICU) in Guizhou Province. Hospital-level data included hospital name and grade, ICU staffing, and number of ICU beds. Patient-level data included characteristics of patients treated in the general ICU on the day of the survey (e.g., age, sex, primary diagnosis), as well as pain and agitation assessments and the types of analgesic and sedative medications administered within 24 hours of ICU admission.
RESULTS:
A total of 947 critically ill ICU patients from 145 hospitals were included, among which 104 were secondary-level hospitals and 41 were tertiary-level hospitals. Within 24 hours of ICU admission, 312 (32.9%) critically ill patients received pain assessments, and 277 (29.3%) received agitation assessments. Among the pain assessment tools, the critical care pain observation tool (CPOT) was used in 44.2% (138/312) of critically ill ICU patients, with a significantly higher usage rate in tertiary hospitals compared to secondary hospitals [52.3% (69/132) vs. 38.3% (69/180), P < 0.05]. The Richmond agitation-sedation scale (RASS) was used in 93.8% (260/277) of critically ill ICU patients for agitation assessment, with no significant difference between hospital levels. Among the 947 critically ill patients, 592 (62.5%) received intravenous analgesics within 24 hours, with remifentanil being the most commonly used [42.9% (254/592)]; 510 (53.9%) received intravenous sedatives, with midazolam being the most frequently used [60.8% (310/510)]. Mechanical ventilation data were available for 932 critically ill patients, of whom 579 (62.1%) received mechanical ventilation and 353 (37.9%) did not. Compared with non-ventilated patients, ventilated patients had significantly higher rates of analgesic and sedative use [analgesics: 77.9% (451/579) vs. 38.8% (137/353); sedatives: 71.8% (416/579) vs. 25.8% (91/353); both P < 0.05]. In terms of analgesic selection, ventilated patients were more likely to receive strong opioids than non-ventilated patients [85.8% (95/137) vs. 69.3% (387/451), P < 0.05]. For sedatives, ventilated patients preferred midazolam [66.6% (277/416)], whereas non-ventilated patients more often received dexmedetomidine [45.1 (41/91)]. Blood pressure within 24 hours of ICU admission were available for 822 critically ill patients, of whom 245 (29.8%) had hypotension and 577 (70.2%) did not. Compared with non-hypotensive patients, hypotensive patients had significantly higher rates of analgesic and sedative use [analgesics: 74.7% (183/245) vs. 59.8% (345/577); sedatives: 65.7% (161/245) vs. 51.3% (296/577); both P < 0.05], but there was no significant difference in the choice of analgesic or sedative agents between the two groups.
CONCLUSIONS
The proportion of critically ill ICU patients in Guizhou Province who received standardized pain and agitation assessments was relatively low. The most commonly used assessment tools were CPOT and RASS, while remifentanil and midazolam were the most frequently used analgesic and sedative agents, respectively. Secondary-level hospitals had a lower rate of using standardized pain assessment tools compared to tertiary-level hospitals. Mechanical ventilation and hypotension were associated with the use of analgesic and sedative medications.
Humans
;
Critical Illness
;
Intensive Care Units
;
Analgesics/therapeutic use*
;
Hypnotics and Sedatives/therapeutic use*
;
Retrospective Studies
;
China
;
Pain Measurement
;
Pain Management
;
Female
;
Male
;
Critical Care
;
Middle Aged
6.Analysis on spectrum characteristics of high-intensity noise in key industries in Guangdong Province
Jianyu GUO ; Guoyong XU ; Zhipeng HE ; Maosheng YAN ; Yongjian JIANG ; Hua YAN ; Bin XIAO
China Occupational Medicine 2024;51(2):156-162
ObjectiveTo analyze the spectrum distribution characteristics of high-intensity productive noise in key industries in Guangdong Province. Methods A total of 2 806 enterprises in 21 prefecture-level cities in Guangdong Province were selected as the study subjects using the stratified sampling method. On-site investigations were conducted in workplaces. Noise in workplaces and work-sites, and the noise spectrum of the workplaces with sound pressure level ≥85.0 dB(A) were detected. Results The noise of a total of 23 076 workplaces and 20 969 work sites from 30 key industries were monitored. The median (M) and 25th and 75th percentiles (P25, P75) of workplace sound pressure level were 82.3 (78.6, 86.5) dB(A). The rate of the noise exceeded national standard was 30.4%. The sound pressure level M (P25, P75) of work-site was 78.6 (70.0, 83.5) dB(A). The rate of the noise exceeded national standard was 18.0%. Workplace noise and work site noise were positively correlated (Spearman correlation coefficient=0.86, P<0.01). The rate of the noise exceeded national standard was 46.5% in key work sites where the rate of noise exceeded the national standard was ≥25.0%, and corresponding rate of the workplace noise exceeded national standard was 58.1%. The noise spectrum result of 5 636 workplaces sound pressure level>85.0 dB(A) showed that most of the noise source was from grinding machines (441 cases), and the highest average sound pressure level of noise source was from screening machines [93.0 dB(A)]. Cluster analysis results showed that the main noise sources could be divided into three categories, including wideband noise with levels >80.0 dB in all frequency bands except 8 000.0 Hz, medium-high-frequency noise with the highest sound pressure level at 1 000.0, 2 000.0, and 4 000.0 Hz and low frequencies <75.0 dB, and medium-low-frequency noise below 500.0 Hz with sound pressure level >85.0 dB. Conclusion The rate of the noise exceeded national standard in workplace of key industries in Guangdong Province is high, involving a wide range of industries, with high sound pressure levels and obvious spectrum characteristics of corresponding noise sources. Corresponding noise control strategies can be formulated based on different spectrum characteristics and magnitudes.
7.Analysis of the risk factors of white matter damage in preterm infants
Hang ZHAO ; Yong JI ; Shuming XU ; Jianyu ZHAO
International Journal of Pediatrics 2024;51(4):277-282
Objective:To investigate the risk factors of white matter damage(WMD)in premature infants,especially intraventricular hemorrhage(IVH).Methods:This retrospective study included 639 premature infants admitted to the neonatal intensive care unit of Shanxi Children's Hospital from June 2022 to June 2023.The premature infants were divided into WMD group(145 cases)and control group(494 cases)according to the results of head MRI.Univariate analysis and multivariate logistic regression analysis were used to explore the risk factors for WMD in premature infants.Results:There were no significant differences in gender,gestational age,fetal distress,cesarean section,asphyxia,Apgar 1min,umbilical artery pH,maternal age,number of pregnancy,infants of assisted reproductive technology,gestational hypertension,gestational diabetes mellitus,acute chorioamnionitis and prelabor rupture of membranes between the two groups(all P>0.05).Compared the WMD group with the control group,birth weight[(1 571±611)g vs(1 438±489)g, t=-2.393],umbilical artery base excess[-5.9(-8.2,-3.9)mmol/L vs -5.3(-7.2,-3.5)mmol/L, Z=-2.538],umbilical artery lactate[3.7(2.4,5.3)mmol/L vs 2.8(2.0,4.1)mmol/L, Z=-4.607],sepsis(28.5% vs 15.6%, χ 2=12.280),patent ductus arteriosus(82.6% vs 74.7%, χ 2=3.911),hypocarbia(57.2% vs 45.0%, χ 2=6.696),invasive ventilation(75.9% vs 53.0%, χ 2= 24.010),multifetal pregnancy(19.3% vs 30.6%, χ 2=7.111),antenatal corticosteroids(51.0% vs 61.9%, χ 2=5.451),lowest PaCO 2 value[(28.4±6.7)mmHg vs(31.4±8.0)mmHg, t=4.471]were different significantly(all P<0.05).There was significant difference in the distribution of IVH between the two groups( χ 2 =40.015, P<0.01)and multiple comparisons showed that the proportion of grade Ⅲ-Ⅳ IVH in the WMD group was higher than that in the control group( P<0.05).Multiple logistic regression analysis showed that umbilical artery lactate,grade Ⅲ-Ⅳ IVH,sepsis and invasive ventilation were high risk factors of WMD,and multifetal pregnancy was protective factor of WMD,with OR( 95%CI)1.121(1.023,1.228),11.435(3.925,33.314),1.758(1.064,2.904),1.640(1.004,2.680),and 0.587(0.358,0.962),respectively. Conclusions:Umbilical artery lactate,grade Ⅲ-Ⅳ IVH,sepsis,and invasive ventilation are independent risk factors for WMD.
8.The value of clinical-radiomics nomogram in preoperative predicting N1-N2 lymph node metastasis in patients with stage Ⅰ to Ⅲ A primary lung adenocarcinoma
He XU ; Zongyu XIE ; Peng XU ; Lei LI ; Jianyu ZHAO ; Lijun WANG ; Hui ZHOU
Journal of Practical Radiology 2024;40(8):1253-1258
Objective To investigate the preoperative predictive value of clinical-radiomics nomogram on N1-N2 lymph node metastasis in patients with stage Ⅰ to Ⅲ A primary lung adenocarcinoma(PL A).Methods A total of 164 PLA patients were divided into a training set(n=114)and an validation set(n=50).Three logistic regression models were created separately and the predictive efficacy of the model was evaluated using the receiver operating characteristic(ROC)curve and area under the curve(AUC)respectively.The AUC difference between models was tested by the DeLong test.The calibration degree was evaluated by the calibration curve.Decision curve analysis was performed to evaluate the benefits of clinical application.Results The radiomics model consisted of 8 imaging features[Radiomics score(Radscore)].The clinical model was composed of tumor type(central or peripheral)and tumor size.The tumor type,tumor size and Radscore formed the nomogram model.In the training set,the prediction of the nomogram model was more effective(AUC=0.909)than the clinical model(AUC=0.748)and the radiomics model(AUC=0.814),while the differences in AUC were statistically significant(P<0.05).In the validation set,the prediction of the nomogram model was more effective(AUC=0.875)than the clinical model(AUC=0.682),and the difference in AUC was statistically significant(P<0.05).The prediction of the nomogram model was also more effective than the radiomics model(AUC=0.799),but the difference in AUC was not statistically significant(P>0.05).The calibration curve showed that the clinical-radiomics nomogram had a high level of calibration and the decision curve analysis showed good benefits from clinical application.Conclusion The clinical-radiomics nomogram is proven to be more effective than radiomics or clinical factors alone in the preoperative prediction of stage Ⅰ to Ⅲ A PLA N1-N2 lymph node metastasis.
9.Different methods in predicting mortality of pediatric intensive care units sepsis in Southwest China
Rong LIU ; Zhicai YU ; Changxue XIAO ; Shufang XIAO ; Juan HE ; Yan SHI ; Yuanyuan HUA ; Jimin ZHOU ; Guoying ZHANG ; Tao WANG ; Jianyu JIANG ; Daoxue XIONG ; Yan CHEN ; Hongbo XU ; Hong YUN ; Hui SUN ; Tingting PAN ; Rui WANG ; Shuangmei ZHU ; Dong HUANG ; Yujiang LIU ; Yuhang HU ; Xinrui REN ; Mingfang SHI ; Sizun SONG ; Jumei LUO ; Juan LIU ; Juan ZHANG ; Feng XU
Chinese Journal of Pediatrics 2024;62(3):204-210
Objective:To investigate the value of systemic inflammatory response syndrome (SIRS), pediatric sequential organ failure assessment (pSOFA) and pediatric critical illness score (PCIS) in predicting mortality of pediatric sepsis in pediatric intensive care units (PICU) from Southwest China.Methods:This was a prospective multicenter observational study. A total of 447 children with sepsis admitted to 12 PICU in Southwest China from April 2022 to March 2023 were enrolled. Based on the prognosis, the patients were divided into survival group and non-survival group. The physiological parameters of SIRS, pSOFA and PCIS were recorded and scored within 24 h after PICU admission. The general clinical data and some laboratory results were recorded. The area under the curve (AUC) of the receiver operating characteristic curve was used to compare the predictive value of SIRS, pSOFA and PCIS in mortality of pediatric sepsis.Results:Amongst 447 children with sepsis, 260 patients were male and 187 patients were female, aged 2.5 (0.8, 7.0) years, 405 patients were in the survival group and 42 patients were in the non-survival group. 418 patients (93.5%) met the criteria of SIRS, and 440 patients (98.4%) met the criteria of pSOFA≥2. There was no significant difference in the number of items meeting the SIRS criteria between the survival group and the non-survival group (3(2, 4) vs. 3(3, 4) points, Z=1.30, P=0.192). The pSOFA score of the non-survival group was significantly higher than that of the survival group (9(6, 12) vs. 4(3, 7) points, Z=6.56, P<0.001), and the PCIS score was significantly lower than that of the survival group (72(68, 81) vs. 82(76, 88) points, Z=5.90, P<0.001). The predictive value of pSOFA (AUC=0.82) and PCIS (AUC=0.78) for sepsis mortality was significantly higher than that of SIRS (AUC=0.56) ( Z=6.59, 4.23, both P<0.001). There was no significant difference between pSOFA and PCIS ( Z=1.35, P=0.176). Platelet count, procalcitonin, lactic acid, albumin, creatinine, total bilirubin, activated partial thromboplastin time, prothrombin time and international normalized ratio were all able to predict mortality of sepsis to a certain degree (AUC=0.64, 0.68, 0.80, 0.64, 0.68, 0.60, 0.77, 0.75, 0.76, all P<0.05). Conclusion:Compared with SIRS, both pSOFA and PCIS had better predictive value in the mortality of pediatric sepsis in PICU.
10.Application of phantom for dose measurement in interventional therapy for pediatric vascular anomalies
Jianyu XU ; Yingmin CHEN ; Rui CHEN ; Ya MA ; Xiaoshan WANG ; Junnan LU
Chinese Journal of Radiological Health 2023;32(2):131-136
Objective To apply a phantom for dose measurement in interventional therapy for pediatric vascular diseases, and calculate the effective dose (E) and conversion coefficient of dose area product (DAP) to E, and to provide a dose reference for studying radiation dose and radiation protection in children. Methods Thermoluminescent dosimeters were placed in the organs of the phantom. Low-, medium-, and high-dose groups were set for three types of vascular anomalies based on the duration of fluoroscopy. Digital subtraction angiography was used to simulate exposure conditions at different dose levels. The organ dose was measured, and the effective dose was calculated. Results For the three groups of vascular anomalies in the head and face, the red bone marrow doses were 8.15, 30.34, and 43.53 mGy, respectively, the effective doses were 12.88, 47.84, and 73.12 mSv, respectively; and the average conversion coefficient of DAP to E was 2.16. For the three groups of vascular anomalies in the trunk, the red bone marrow doses were 2.11, 15.62, and 31.21 mGy, respectively; the effective doses were 12.39, 70.56, and 134.60 mSv, respectively, and the average conversion coefficient of DAP to E was 3.03. For the three groups of vascular anomalies in the lower extremities, the red bone marrow doses were 3.58, 6.50, and 12.28 mGy, respectively, the effective doses were 3.64, 7.04, and 14.85 mSv, respectively, and the average conversion coefficient of DAP to E was 0.73. Conclusion Patient dose and DAP-to-E conversion coefficient are in the following order: vascular anomalies in the trunk > vascular anomalies in the head and face > vascular anomalies in the lower extremities. The dose data obtained can be used to estimate children’s radiation exposure.


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