1.Development of a Core Outcome Set for Clinical Evaluation of Chronic Pulmonary Heart Disease Treated with Traditional Chinese Medicine Therapy
Baihan NIU ; Mingyan ZHANG ; Zhaochen JI ; Bo PANG ; Haiyin HU ; Junhua ZHANG
Journal of Traditional Chinese Medicine 2025;66(12):1227-1232
ObjectiveTo construct an outcome set for clinical evaluation of traditional Chinese medicine (TCM) for chronic pulmonary heart disease, and to provide consensus outcomes for the evaluation of the clinical effectiveness of TCM for chronic pulmonary heart disease. MethodsWe searched randomised controlled trials of TCM for chronic pulmonary heart disease on China National Knowledge Infrastructure (CNKI), Wanfang Data Knowledge Service Platform (WF), VIP Chinese Science Journals Database (VIP), Chinese Biomedical Literature Service Database (SinoMed), PubMed, Cochrane Library, and Embase. We also searched Chinese Clinical Trial Registry Platform and the U.S. Clinical Trial Registry database to obtain the outcome indicators reported in the clinical research protocols of TCM for chronic pulmonary heart disease. The outcome indicators were also collected through semi-structured interviews of clinicians and patients. Then integrated the outcome indicators collected by the above methods to construct the indicator pool. Through two rounds of Delphi surveys and a consensus conference, the core outcome set for clinical evaluation of TCM for chronic pulmonary heart disease was determined. ResultsAfter screening, there were 1313 literature meeting the criteria, and 595 outcome indicators were extracted, then combined with the outcomes from semi-structured interviews which clinicians and patients concerned, finally an indicator item pool containing 369 outcome indicators were formed. After the initial screening of indicators in the pool by the steering committee, 58 indicators were established into the initial list of indicator entries. In the first round of Delphi survey, the expert coordination coefficient for the results was 0.401, and the Cronbach coefficient was 0.989. A total of 35 indicators that did not meet the criteria [<70% of the participants rated the outcome as 7~9 (critical) and the mean of the expert ratings <7] were deleted, and 23 were retained, with 7 new indicators added that were open to supplementation by the experts, resulting in a total of 30 indicators that were included in the second round of Delphi survey. In the second round of Delphi survey, the expert coordination coefficient was 0.303, and the Cronbach coefficient was 0.974, with a total of 7 indicators that did not meet the criteria being deleted, and 21 indicators being retained for the consensus conference. After the consensus meeting, the core outcome set for clinical evaluation of chronic pulmonary heart disease in two major categories, acute exacerbation stage and stable stage, was finally determined, in which there were four indicators in acute exacerbation stage: N-terminal B-type natriuretic peptide precursor (NT-proBNP), blood qi analysis, all-cause mortality rate, and complication rate; and there were eight indicators in the stable stage: pulmonary function index, six-minute walk test distance, New York cardiac function classification, all-cause mortality rate, re-hospitalisation rate, Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score, Short Form 36 Health Survey (SF-36), and TCM syndrome score. ConclusionThe core outcome sets of TCM clinical evaluation in the acute exacerbation stage and stable stage are constructed, which is helpful to improve the practicability, comparability and transparency of TCM clinical research results in pulmonary heart disease.
2.Construction and verification of a prediction nomogram for in-hospital death in elderly CHF patients based on noninvasive hemodynamic parameters
Mingyan YANG ; Wei CHEN ; Yang GAO ; Yanan HU ; Yuan LIU ; Yufei MA ; Yan YU ; Riuhan LIU ; Jiang YU ; Jian CAO
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2024;26(2):124-127
Objective To construct a nomogram model for predicting the risk of in-hospital death in CHF patients by using noninvasive hemodynamic monitoring combined with age,DBP,CRP and renal insufficiency(serum creatinine≥ 442 μmol/L).Methods A total of 223 elderly patients with acute onset of CHF admitted in First,Second Medical Centre of Chinese PLA General Hos-pital from September 2022 to March 2023 were recruited in this study.According to their clinical outcomes,they were divided into survival group(196 cases)and death group(27 cases).Based on the in-hospital death and other related indicators,a nomogram model was constructed to predict the risk factors of in-hospital death in CHF.Results Noninvasive hemodynamic mornitoring indi-cated that the death group had significantly higher LVEF and LCWI values but lower LVEDV value than the survival group(P<0.05,P<0.01).Multivariate logistic regression analysis showed that age(OR=1.131,95%CI:1.052-1.213,P=0.001),DBP(OR=0.932,95%CI:0.882-0.982,P=0.011),CRP(OR=1.171,95%CI:1.021-1.352,P=0.024),LVEDV(OR=0.984,95%CI:0.962-0.992,P=0.011)and renal insufficiency(OR=5.863,95%CI:1.351-1.731,P=0.004)were independent risk factors for the short-term prognosis of the elderly CHF patients.The AUC value of the nomogram model was 0.902(95%CI:0.819-0.948,P<0.05),and calibration curve analysis showed the C-index was 0.902,indicating accurate predictive perform-ance.Conclusion Age,DBP,LVEDV,CRP and renal insufficiency are independent risk factors for the short-term prognosis of the elderly CHF patients.
4.Expert consensus on recombinant B subunit/inactivated whole-cell cholera vaccine in preventing infectious diarrhea of enterotoxigenic Escherichia coli
Chai JI ; Yu HU ; Mingyan LI ; Yan LIU ; Yuyang XU ; Hua YU ; Jianyong SHEN ; Jingan LOU ; Wei ZHOU ; Jie HU ; Zhiying YIN ; Jingjiao WEI ; Junfen LIN ; Zhenyu SHEN ; Ziping MIAO ; Baodong LI ; Jiabing WU ; Xiaoyuan LI ; Hongmei XU ; Jianming OU ; Qi LI ; Jun XIANG ; Chen DONG ; Haihua YI ; Changjun BAO ; Shicheng GUO ; Shaohong YAN ; Lili LIU ; Zengqiang KOU ; Shaoying CHANG ; Shaobai ZHANG ; Xiang GUO ; Xiaoping ZHU ; Ying ZHANG ; Bangmao WANG ; Shuguang CAO ; Peisheng WANG ; Zhixian ZHAO ; Da WANG ; Enfu CHEN
Chinese Journal of Clinical Infectious Diseases 2023;16(6):420-426
Enterotoxigenic Escherichia coli(ETEC)infection can induce watery diarrhea,leading to dehydration,electrolyte disturbance,and even death in severe cases. Recombinant B subunit/inactivated whole-cell cholera(rBS/WC)vaccine is effective in preventing ETEC infectious diarrhea. On the basis of the latest evidence on etiology and epidemiology of ETEC,as well as the effectiveness,safety,and health economics of rBS/WC vaccine,National Clinical Research Center for Child Health(The Children’s Hospital,Zhejiang University School of Medicine)and Zhejiang Provincial Center for Disease Control and Prevention invited experts to develop expert consensus on rBS/WC vaccine in prevention of ETEC infectious diarrhea. It aims to provide the clinicians and vaccination professionals with guidelines on using rBS/WC vaccine to reduce the incidence of ETEC infectious diarrhea.
5.Efficacy of endoscopic ultrasound-guided fine needle aspiration in the diagnosis of metastases to the pancreas: an analysis of 11 cases
Zhen ZHANG ; Tianyin CHEN ; Pinghong ZHOU ; Weifeng CHEN ; Quanlin LI ; Jianwei HU ; Mingyan CAI ; Xiaoyue XU ; Yanbo LIU ; Yiqun ZHANG
Chinese Journal of Digestive Endoscopy 2021;38(9):743-746
To evaluate the efficacy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for patients with metastases to the pancreas.Data on patients with pancreatic lesions who underwent EUS-FNA and confirmed as having metastases to the pancreas at the Endoscopy Center of Zhongshan Hospital, Fudan University from January 2015 to November 2020 were retrospectively analyzed.Characteristics of patients, EUS performance, pathological results, and follow-up were reviewed and analyzed. A total of 11 patients were diagnosed of metastasis to pancreas by EUS-FNA.The primary tumor mainly came from kidney (4/11) and lung (4/11), and the rest from colon (1/11), breast (1/11) and bladder (1/11), respectively. EUS performance of metastases to the pancreas mostly presented homogeneous hypoecho (10/11)with unclear margin (6/11). Enlarged lymphnodes were noticed in nearly half of the patients (5/11). The time span from detection of primary tumor to metastases ranged from 6 days to 27 years. EUS-FNA is effective in the diagnosis of metastases to the pancreas.
6.Study on HPLC Characteristic Chromatogram and Chemical Pattern Recognition of Different Medicinal Parts of Cirsium japonicum
Mingyan XIE ; Zheng ZHANG ; Yao HUANG ; Zhipeng ZHANG ; Yao HU ; Xueren CHENG
China Pharmacy 2020;31(7):820-825
OBJECTIVE:To establish HP LC ch aracteristic ch romatogram of different medicinal parts of Cirsium japonicum , and to compare the difference of chemical components in different medicinal parts of C. japonicum according to chemical identification method ,and to provide reference for quality control and evaluation of C. japonicum . METHODS :Medicinal material (overground part ),leaves,flower,main stem and lateral stem of C. japonicum were determined by HPLC. According to the TCM Chromatographic Fingerprint Similarity Evaluation System (2012A edition ),the chromatograms were matched to generate the HPLC characteristic chromatogram of each medicinal part. The differences of common characteristic peak area were analyzed according to variance analysis of single factor. The chromatographic peaks were identified by comparison of reference substance. Meanwhile,the chemical pattern recognition was performed to research the different medicinal parts of C. japonicum according to principal component analysis (PCA)and cluster analysis. RESULTS :HPLC characteristic chromatograms of medicinal material , leaves,flower,main stem and lateral stem from C. japonicum were established respectively ,and 15 common peaks were confirmed for medicinal material ,leaves and flower of C. japonicum ;11 common peaks were confirmed in chromatograms of main stem and lateral stem from C. japonicum (absence of No. 7,9,12,13 peak). The contents of chemical components were different greatly among different medicinal parts. No. 1,2,3,10,11 peaks were identified as neochlorogenic acid ,chlorogenic acid , cryptochlorogenic acid ,linarin and pectolinarin. Results of PCA and cluster analysis showed that chemical pattern recognition and clustering of the flower and stem of C. japonicum were distinct and can be clustered into one category respectively. However ,the leaves distribution of C. japonicum was relatively scattered ,so it was difficult to cluster . CONCLUSIONS :Established HPLC characteristic chromatogram-chemical pattern recognition can reflect the differences of different medicinal parts of C. japonicum integrally, comprehensively and truly , which has vital significance for origin indentification , quality control and overall evaluation of C. japonicum .
7.Stratified outcomes of "Kidney Disease: Improving Global Outcomes" serum creatinine criteria in critical ill patients: a secondary analysis of a multicenter prospective study
Guiying DONG ; Junping QIN ; Youzhong AN ; Yan KANG ; Xiangyou YU ; Mingyan ZHAO ; Xiaochun MA ; Yuhang AI ; Yuan XU ; Yushan WANG ; Chuanyun QIAN ; Dawei WU ; Renhua SUN ; Shusheng LI ; Zhenjie HU ; Xiangyuan CAO ; Fachun ZHOU ; Li JIANG ; Jiandong LIN ; Erzhen CHEN ; Tiehe QIN ; Zhenyang HE ; Lihua ZHOU ; Bin DU
Chinese Critical Care Medicine 2020;32(3):313-318
Objective:To investigate the different outcomes of two types of acute kidney injury (AKI) according to standard of Kidney Disease: Improving Global Outcomes-AKI (KDIGO-AKI), and to analyze the risk factors that affect the prognosis of intensive care unit (ICU) patients in China.Methods:A secondary analysis was performed on the database of a previous study conducted by China Critical Care Clinical Trial Group (CCCCTG), which was a multicenter prospective study involving 3 063 patients in 22 tertiary ICUs in 19 provinces and autonomous regions of China. The demographic data, scores reflecting severity of illness, laboratory findings, intervention during ICU stay were extracted. All patients were divided into pure AKI (PAKI) and acute on chronic kidney disease (AoCKD). PAKI was defined as meeting the serum creatinine (SCr) standard of KDIGO-AKI (KDIGO-AKI SCr) and the estimated glomerular filtration rate (eGFR) at baseline was ≥ 60 mL·min -1·1.73 m -2, and AoCKD was defined as meeting the KDIGO-AKI SCr standard and baseline eGFR was 15-59 mL·min -1·1.73 m -2. All-cause mortality in ICU within 28 days was the primary outcome, while the length of ICU stay and renal replacement therapy (RRT) were the secondary outcome. The differences in baseline data and outcomes between the two groups were compared. The cumulative survival rate of ICU within 28 days was analyzed by Kaplan-Meier survival curve, and the risk factors of ICU death within 28 days were screened by Cox multivariate analysis. Results:Of the 3 063 patients, 1 042 were enrolled, 345 with AKI, 697 without AKI. The AKI incidence was 33.11%, while ICU mortality within 28 days of AKI patients was 13.91% (48/345). Compared with PAKI patients ( n = 322), AoCKD patients ( n = 23) were older [years old: 74 (59, 77) vs. 58 (41, 72)] and more critical when entering ICU [acute physiology and chronic health evaluation Ⅱ (APACHEⅡ) score: 23 (19, 27) vs. 15 (11, 22)], had worse basic renal function [eGFR (mL·min -1·1.73 m -2): 49 (38, 54) vs. 115 (94, 136)], more basic complications [Charlson comorbidity index (CCI): 3 (2, 4) vs. 0 (0, 1)] and higher SCr during ICU stay [peak SCr for diagnosis of AKI (μmol/L): 412 (280, 515) vs. 176 (124, 340), all P < 0.01]. The mortality and RRT incidence within 28 days in ICU of AoCKD patients were significantly higher than those of PAKI patients [39.13% (9/23) vs. 12.11% (39/322), 26.09% (6/23) vs. 4.04% (13/322), both P < 0.01], while no significant difference was found in the length of ICU stay. Kaplan-Meier survival curve analysis showed that the 28-day cumulative survival rate in ICU in AoCKD patients was significantly lower than PAKI patients (Log-Rank: χ2 = 5.939, P = 0.015). Multivariate Cox regression analysis showed that admission to ICU due to respiratory failure [hazard ratio ( HR) = 4.458, 95% confidence interval (95% CI) was 1.141-17.413, P = 0.032], vasoactive agents treatment in ICU ( HR = 5.181, 95% CI was 2.033-13.199, P = 0.001), and AoCKD ( HR = 5.377, 95% CI was 1.303-22.186, P = 0.020) were independent risk factors for ICU death within 28 days. Conclusion:Further detailed classification (PAKI, AoCKD) based on KDIGO-AKI SCr standard combined with eGFR is related to ICU mortality in critical patients within 28 days.
8.The effects of hypoxia on the expression of inflammatory factor high mobility group box-1 in the pulmonary arteriolae of neonatal SD rats
Zhen TANG ; Min JIANG ; Zhicui OUYANG ; Na HU ; Xing ZHU ; Mingyan HEI
Chinese Journal of Neonatology 2019;34(3):210-215
Objective To study the effects of hypoxia on the expression of inflammatory factor high mobility group box-l(HMGB1) in the pulmonary arteriolae of neonatal SD rats.Method A total of 80 neonatal SD rats were randomly assigned into control group and hypoxia-induced persistent pulmonary hypertension of the newborn model (PPHN) group.The PPHN group was subdivided into 2 h,8 h,24 h,and 3 d post-PPHN subgroups according to the time of sacrifice.PPHN model was established on postnatal day 4 when rat pups in PPHN group were kept in low-oxygen box (10% O2 and 90% N2) for consecutively 7 days.Multi-channel physiological transducer RM-6280 was used recording the mean pulmonary artery pressure (mPAP) at the root to pulmonary artery of rat pups.ELISA method was used examining the serum level of HMGB1 of rat pups in each group.The pathology of the lung tissue was studied using optical microscope after HE staining,and MIAS-2000 medical image analysis software was used to calculate the ratio of the middle membrane thickness to the outer diameter of the pulmonary arteriolae wall (MT%).Protein level of HMGB1 in the lung was examined using Western Blot.Result The lung pathology in PPHN rats showed thickening of the middle membrane of the pulmonary arteriolae wall and stenosis of the pulmonary arteriolae.MT% of control group and PPHN group were 5.3% (3.7%,7.6%) and 7.1% (4.6%,9.2%),respectively,without significant differences (P>0.05).At 2 h,8 h,24 h,3 d post-PPHN timepoints,the serum levels of HMGB1 in PPHN group were (13.2±3.1),(15.4±3.6),(17.1±3.5),and (15.8±3.6) ng/ml,respectively,without intra-subgroup differences (F=2.134,P>0.05),but significant differences existed when compared with control group at each timepoint (P<0.01).Western Blot showed that HMGB1 protein expression in the lungs were significantly elevated soon after PPHN,peaked at 8~24 h,and reduced but still significantly elevated at 3 d after PPHN comparing with normal control.Significant differences existed at 2 h,8 h,and 24 h timepoints (P<0.01,respectively).The HMGB1 protein of PPHN group declined significantly at 3 d timepoint without significant differences comparing with the control group (P>0.05).Conclusion HMGB1 is closely related with the pathogenesis of PPHN,indicating the inflammatory response plays an important role in the mechanisms of PPHN.HMGB1 may be an indicator for the assessment of hypoxia-induced PPHN.
9.The amplitude integrated electroencephalogram feature of term newborns with different blood glucose level
Zhen TANG ; Zhicui OUYANG ; Na HU ; Yanyan SUN ; Xing ZHU ; Li HE ; Qiong XI ; Mingyan HEI
Chinese Journal of Neonatology 2018;33(6):427-431
Objective To study the characteristics of amplitude integrated electroencephalogram (aEEG) in full-term newborns with different blood glucose levels,so as to provide clinical evidence for assessing brain function after hypoglycemia.Method Full-term neonates admitted to the neonatal ward of the Third Xiangya Hospital of Central South University from June 2014 to May 2016 with the initial diagnosis of hypoglycemia were enrolled to hypoglycemia group.According to the lowest level of blood glucose,infants were assigned to three subgroups,severe hypoglycemia group (< 1.1 mmol/L),moderate hypoglycemia group (1.1 ~ <2.2 mmol/L),and mild hypoglycemia group (2.2 ~ <2.8 mmol/L).Time matched asymptomatic term infants,who were admitted to the neonatal ward due to maternal high risks and with normal blood glucose after birth,were enrolled to control group.A 4 h continuous aEEG monitoring was completed for each infant in hypoglycemia group within 12 h after the blood glucose level stabilized.The newborns in control group were given aEEG examination 72 ~ 120 h after birth,the duration of monitoring was also 4 h.The aEEG scoring was completed and compared by rank sum test.Result A total of 83 neonates were enrolled in hypoglycemia group,including 11 with severe hypoglycemia,32 with moderate hypoglycemia,and 40 with mild hypoglycemia.Another 26 neonates with normal blood glucose level were enrolled in control group.The incidence of pregnancy-induced maternal blood glucose elevation was statistically significant among each group (P < 0.05).The duration of neonatal hypoglycemia in severe hypoglycemia group was longer than that in moderate hypoglycemia group and mild hypoglycemia group [38.3 (20.7,50.4) h vs.20.4(15.3,22.6) h,13.7 (7.8,19.4) h] (P< 0.05).The range of glucose level in severe hypoglycemia group was larger than that in mild and moderate hypoglycemia group [5.0 (4.0,5.5) mmol/Lvs.3.5 (3.0,3.9) mmol/L,3.3 (2.8,3.8) mmol/L] (P < 0.05),but there was no significant difference in the onset of first hypoglycemia between groups (P > 0.05).The aEEG score showed that there was significant difference in total score and sleep-wake cycle score between groups (P < 0.05).The score of sleep-wake cycle in severe hypoglycemia group was significantly lower than that in moderate hypoglycemia group or in mild hypoglycemia group or in the control group (P < 0.05),while there was no significant difference between moderate and mild hypoglycemia groups,and between moderate hypoglycemia and control group (P > 0.05).Conclusion Severe hypoglycemia can lead to neonatal aEEG changes,mainly in the sleep-wake cycle changes.
10.Clinical value of endoscopic ultrasonography in diagnosis and treatment of common bile duct dilatation
Han DING ; Pinghong ZHOU ; Meidong XU ; Tao CHEN ; Weifeng CHEN ; Quanlin LI ; Jianwei HU ; Mingyan CAI ; Jingjing LIAN ; Yuan HUANG ; Yiqun ZHANG
Chinese Journal of Digestive Endoscopy 2017;34(12):882-886
Objective To investigate the value of endoscopic ultrasonography(EUS)in the diagnosis and treatment of undetermined etiology of common bile duct (CBD) dilatation. Methods Patients, who were referred for dilated CBD but unable to identify the cause by imaging, underwent EUS for the diagnosis of etiology in Endoscopy Center of Zhongshan Hospital Affiliated to Fudan University from December 2015 to December 2016. The therapy was on the basis of diagnosis of EUS. Final diagnoses were determined by surgical pathology or follow-up for at least 3 months. Results A total of 76 patients were included in the study. The sensitivity, specificity and accuracy of EUS for patients with choledocholithiasis,patients with ampullary tumor, and patients with inflammatory stenosis were 100.0%(7/7), 100.0%(69/69), 100.0%(76/76), and 88.0%(22/25), 92.2%(47/51), 90.8%(69/76),and 90.9%(40/44), 93.8%(29/32), 90.8%(69/76), respectively. Accuracy of EUS for etiological diagnosis of CBD dilatation was 90.8%(69/76). The sensitivity,specificity and accuracy of EUS combined with tumor markers for patients with malignant CBD dilatation were 96.0%(24/25), 96.1%(49/51),and 96.1%(73/76), respectively. Conclusion EUS is an effective method for the etiological diagnosis of CBD dilatation and has guiding significance for the treatment. EUS combined with tumor markers may benefit differential diagnosis of benign and malignant CBD dilatation.

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