Objective To investigate the value of procalcitonin (PCT) on predicting the severity and prognosis in patients with early acute respiratory distress syndrome (ARDS).Methods A prospective observation study was conducted. A total of 113 patients with ARDS undergoing mechanical ventilation admitted to intensive care unit (ICU) of Affiliated People's Hospital ofJiangsu University from October 2012 to April 2016 were enrolled. Based on oxygenation index (PaO2/FiO2), the patients were classified into mild, moderate, and severe groups according to Berlin Definition. Twenty-five healthy volunteers were served as controls. Demographics, acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ) score, and Murray lung injury score were recorded. Within 24 hours after diagnosis of ARDS, the serum levels of PCT and C-reactive protein (CRP) were determined by enzyme-linked fluorescence analysis (ELFA) and immune turbidimetric method, respectively. The patients were also divided into survival and non-survival groups according to clinical outcome within 28-day follow-up, and the clinical data were compared between the two groups. Spearman rank correlationwas applied to determine the correlation between variables. The predictive value of the parameters on 28-day mortality was evaluated with receiver operating characteristic curve (ROC). Kaplan-Meier survival curve analysis was used to compare different PCT levels of patients with 28-day cumulative survival rate. Results After excluding patients who did not meet the inclusion criteria and loss to follow-up, the final 89 patients were enrolled in the analysis. Among 89 ARDS patients analyzed, 27 of them were mild, 34 moderate, and 28 severe ARDS. No significant differences were found in age and gender between ARDS and healthy control groups. Infection and trauma were the most common etiology of ARDS (55.1% and 34.8%, respectively). Compared with healthy control group, both CRP and PCT in serum of ARDS group were higher [CRP (mg/L): 146.32 (111.31, 168.49) vs. 6.08 (4.47, 7.89), PCT (μg/L): 3.46 (1.98, 5.56) vs. 0.02 (0.01, 0.04), bothP < 0.01], and the two showed sustained upward trends with the ARDS course of disease. Compared with mild group, severe group had significantly higher APACHE Ⅱ and Murray scores. Spearman rank correlation analysis showed that both serum PCT and CRP in patients with ARDS was correlated well with APACHE Ⅱ score (r values were 0.669 and 0.601, respectively, bothP < 0.001), while PCT was weakly but positively correlated with Murray score (r = 0.294,P = 0.005), but not the case of CRP (r = 0.203,P = 0.052). APACHE Ⅱ score and serum PCT in non-survival group (n = 38) were significantly higher than those of the survival group [n = 51; APACHE Ⅱ score: 26.00 (23.00, 28.50) vs. 21.00 (17.00, 25.00), PCT (μg/L): 6.38 (2.82, 9.49) vs. 3.09 (1.08, 3.57), both P < 0.01], but Murray score and CRP level were similar between survivors and non-survivors. The areas under ROC curve (AUC) of APACHE Ⅱ score and PCT for predicting 28-day mortality were 0.781 and 0.793, respectively, which were better than those of AUC of Murray score and CRP (0.606 and 0.561, respectively, allP < 0.05). The AUC of APACHE Ⅱ score combined with PCT was significantly higher than that of PCT (0.859 vs. 0.793,P = 0.048) or APACHE Ⅱ score alone (0.859 vs. 0.781,P = 0.038). Using a PCT cut-off value of > 4.35μg/L for predicting 28-day mortality, the sensitivity and specificity was 92.2% and 63.2%, respectively, and the positive and negative likelihood ratios were 2.50 and 0.12 respectively. Kaplan-Meier survival curve analysis indicated that the patients whose PCT more than 4.35μg/L, had lower 28-day cummulative survival rate as compared with those with PCT ≤ 4.35μg/L (log-rank test: χ2 = 5.013,P = 0.025).Conclusion The elevated serum PCT level in patients with ARDS seems to be correlated well with the severity of lung injury, and appears to be a useful prognostic marker of outcome in the early phases of ARDS.

Objective To evaluate the effects of real-time continuous glucose monitoring (RT-CGM) system on oxidative stress and mortality in critically ill patients and to explore the correlation between glucose index,oxidative stress and mortality.Methods Selected 123 cases of critically ill patients were enrolled in this prospective randomized controlled study.They were randomly divided into the RT-CGM group(n =61) and blood glucose meter group (GM group,n =62).The following parameters were compared between the two groups:mean amplitude of glucose excursions (MAGE),hypoglycemia incidence,low blood glucose index (LBGI),high blood glucose index (HBGI),28-day mortality and plasma level of 8-iso-PGF2α (8-iso) at 48 hours (R2),72 hours (R3) and 96 hours(R4) after admission to ICU.The correlation between glucose index and plasma level of 8-iso-PGF2α were analyzed.The correlation between glucose index,plasma 8-iso level and 28-day death were analyzed.Results The parameters of MAGE,hypoglycemia incidence,LBGI and HBG1 in the RT-CGM group and the GM group were (3.73 ±1.09) mmol/Land (4.19±1.11)mmol/L(P=0.02),3.28％ and 14.52％(P=0.03),0.0011 and 0.0119 (P ＜ 0.01) and 0.2258 and 0.3697 (P ＜ 0.01),respectively.The plasma levels of 8-iso at R2,R3,R4 in the RT-CGM group and the GM group were (111.44 ± 16.99) ng/L and (114.03 ± 14.64) ng/L(P=0.37),(94.53 ±14.92)ng/L and (110.31 ±13.42) ng/L(P＜0.01) and (57.84±12.22) ng/L and (84.41 ± 14.16)ng/L(P ＜0.01),respectively.The r values between MAGE,LBGI,HBGI and the plasma level of 8-iso were 0.69,0.71 and 0.67,respectively (all P values ＜ 0.01).Multivariate stepwise regression analysis showed MAGE,LBGI,HBGI entered final models (corrected R2 =0.61,P ＜ 0.01) with β values of 0.64,0.65 and 0.6 respectively(all P values ＜0.01).The 28-day mortality in the RT-CGM group and the GM group was 9.84％ and 30.65％ (P ＜0.01).The OR values of MAGE,hypoglycemia incidence,LBGI,HBGI and the plasma level of 8-iso for 28-day death were 2.14 (0.98-4.35),3.43 (1.12-5.82),2.67 (1.01-5.14),1.32 (0.24-2.96) and 1.89 (0.67-3.44),respectively.Conclusion RT-CGM can optimize the care in critically ill patients by improving hypoglycemia,hyperglycemia,glucose variability and oxidative stress and bring more detailed concern in the process,and to reduce the mortality.

Objective To determine the influence of continuous mild sedation versus usual sedation on the sedative effect and inflammatory factor level in ICU patients with multiple trauma.Methods In this prospective, randomized double-blind investigation, 58 multiple trauma patients hospitalized from October 2013 to April 2015 were randomized into continuous mild sedation group (continuous group, n =30) and conventional sedation group (conventional group, n =28) using the sealed envelopes.Between-group differences were made on the duration of mechanical ventilation, length of stay in the ICU, ratio of inception of continuous renal replacement therapy (CRRT), tracheotomy rate, accidental extubation rate, sepsis rate, multiple organ failure (MOF) rate and mortality.Serum inflammatory factor levels of the patients were recorded.Results There were 3 deaths (10％) in continuous group versus 4 deaths (14％) in conventional group (P ＞ 0.05).Patients in continuous group showed significantly less time spent on mechanical ventilation [(4.8 ±2.7) vs.(8.9 ±3.1)d] and in the ICU [(10.7 ± 5.4) vs.(16.9 ± 7.3) d] compared with conventional group (P ＜ 0.01).Between-group differences were insignificant regarding the ratio of CRRT inception, tracheotomy rate, accidental extubation rate, sepsis rate and MOF rate (P ＞ 0.05).Serum levels of interleukin (IL)-6, tumor necrosis factor (TNF)-α, Creactive protein (CRP) were lower in continuous group than those in conventional group at 24 h, 48 h and 72 h post-ICU, but significant differences were only observed at 48 h (P ＜ 0.05).At these time periods, serum IL-10 levels in continuous group were significantly higher than those in conventional group (P ＜0.05).In receiver operative characteristic curve (ROC) analysis, the area under the curve for IL-6, IL-10, TNF-α and CRP in continuous group was 0.726, 0.608, 0.729 and 0.757 respectively at 48 h post-ICU, indicating a predictive value of these markers for sepsis.Conclusion Continuous mild sedation results in shortened length of stay in the ICU and decreased inflammatory response in the treatment of patients with multiple trauma.

Objective To investigate the clinical therapeutic value of CRRT on severe sepsis coincidence with capillary leak syndrome in surgical patients. Methods 38 patients suffering from severe sepsis coincidence with capillary leak syndrome were random divided into routine group ( n = 18 ) and CRRT group ( n =20). Both groups were given routine treatment, while the patients of CRRT group were given CRRT in addition. Red blood cell count (RBC), haematoglobin level, blood platelets count, leukocyte count, hematocrit (HCT), plasma-albumin level, central venous pressure ( CVP), arterial blood pressure ( ABP), urinary production change of every hour, oxygenation index condition ( PO2\FiO2 ) were measured at 0, 12, 24, 48,72 hour following routine treatment or CRRT. Additionally, serum levels of tumor necrosis factor- a (TNF-α), interleukin-6 (IL-6) and interleukin-8(IL-8) were determined at the same time. Results Blood platelets count, HCT, plasma-albumin level in CRRT group were significantly higher than those of routine group [72 h: (211. 75 ± 45. 23 ) × 109 vs ( 135.67 ± 41.45 ) × 109 ;0. 43 ± 0. 05 vs 0. 35 ±0. 04; (48. 60 ±4. 76) g/L vs (41.17 ±4. 64) g/L, P <0. 01 ]. WBC were significantly lower than those of routine group[72 h:(7.58 ±2.31) ×109 vs (13.77 ±2.67) × 109, P <0.01]. Change of ABP, PO2\FiO2, urinary production for every hour was notably increased than those of routine group [72 h: (94. 25 ±8.60) mmHg vs ( 84. 22 ± 7. 37 ) mmHg; 345. 25 ± 35. 21 vs 304. 22 ± 38. 74; ( 80. 15 ± 14. 54 ) ml vs (62. 72 ± 12. 33) ml, P <0. 01 ]. The serum levels of TNF-α, IL-6 and IL-8 of CRRT group were markedly decreased compared with those of routine group(72 h:249. 55 ±99. 60 vs 368. 83 ±97. 11 ;600. 75 ±98. 31 vs 718. 94 ± 92. 00 ;665. 35 ±138. 44 vs 843. 22 ±123. 95 , P <0. 01,P <0.05). Conclusions CRRT can significantly improve patient's condition, which may be an effective nechanism to treat the surgical patients with severe sepsis coincidence with capillary leak syndrome.

Objective: Randomized controlled trials (RCTs) of Chinese patent medicines and classic traditional Chinese medicine prescriptions were systematically reviewed from both Chinese and English journals published in 2023. A preliminary summary and evaluation were conducted on the generation and translation of clinical evidence for these treatments. This analysis aims to inform future research on clinical efficacy evaluation and guide the rational application of evidence. Methods: RCTs of Chinese patent medicines and classic traditional Chinese prescriptions published in 2023 were comprehensively retrieved from the Artificial Intelligence Clinical Evidence Database for Chinese Patent Medicine (AICED-CPM), with supplementary searches conducted in China National Knowledge Infrastructure (CNKI), Wanfang Data, Chinese Science and Technology Journal Database (VIP), Chinese Biomedical Literature Database (SinoMed), Cochrane Library, PubMed, Embase, and Web of Science. The study characteristics and methodological quality of these RCTs were systematically analyzed and evaluated. Results: A total of 1 443 RCTs of Chinese patent medicines were included, comprising 1 399 Chinese articles and 44 English articles. Additionally, 334 RCTs of classic traditional Chinese medicine prescriptions were found, with 331 published in Chinese and 3 in English. 196 567 participants were included, covering 585 types of Chinese patent medicines (487 oral, 61 injectable, and 37 topical) and 179 classic traditional Chinese medicine prescriptions. The involved studies encompassed 22 types of diseases, with research primarily focusing on diseases of the circulatory system, the respiratory system, and the genitourinary system. The sample sizes ranged from 18 to 3 777 participants, and most studies were conducted at a single center. Methodologically, the implementation of allocation concealment and blinding remained insufficiently emphasized. Conclusion Overall, compared with 2022, both the number of RCT publications and their methodological quality have improved in 2023, with heightened attention to research on diseases of the genitourinary system. However, quality control and standardized management in the design and implementation processes still require enhancement to produce more high-quality clinical evidence and accelerate the translation and application of this evidence.

Objective This study aims to summarize and evaluate clinical evidence of randomized controlled trial(RCT)of Chinese patent medicine published in 2021 and providing reasonable suggestions.Methods The collection literatures of Evidence Database System of TCM(EVDS)was main source,and CNKI,Wan Fang Data,VIP,SinoMed,Cochrane Library,PubMed,and EMbase databases were supplement.Obtaining the RCT of Chinese patent medicine published in 2021,and to analyze and evaluate their characteristics and methodological quality.Results 2215 RCTs of Chinese patent medicine(2206 in Chinese/9 in English)were included,which involving 237,379 patients,26 types of diseases,and 750 types of proprietary Chinese medicines(619 types of oral Chinese patent medicine,91 types of Chinese injections,and 40 types of topical Chinese patent medicine).The circulatory system diseases,respiratory system diseases and neurological diseases was highlight research area.The most number of diseases were ischemic Stroke,coronary heart disease,and angina pectoris.The sample size between 30 and 8,000 cases,and the case sources were mainly single-center.Methodologically,the implementation of allocation concealment and blinding remained unappreciated.Conclusion The number of RCTs publication increased in 2021 compared with 2020,more studies pay attention to neurological disease research,and quality control and standardized management during study design and implementation still need to be improved.

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.