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@#Objective To summarize the progress and trend on clinical drug trials of esophageal squamous cell carcinoma in China. Methods Based on the clinical drug trial registration and information disclosure platform and the drug data query system of the National Medical Products Administration, the characteristics of clinical trials, investigational drugs and listed drugs of esophageal squamous cell carcinoma in China from 2012 to 2021 were analyzed. Results From 2012 to 2021, a total of 49 clinical drug trials of esophageal squamous cell carcinoma were registered in China, accounting for 1.6% of all clinical trials of anticancer drugs. Among them, there were 39 (79.6%) trials initiated by domestic pharmaceutical enterprises, 6 (12.2%) for adjuvant and neoadjuvant treatment, and 9 (18.4%) for local treatment. There were differences in the treatment line distribution between global and domestic enterprise-initiated trials (P=0.032). The above trials covered 29 investigational drugs, including 23 (79.3%) targeted drugs, most of which targeted programmed death-1, programmed death-ligand 1 and epidermal growth factor receptor. From 2012 to 2021, there were 2 drugs for esophageal squamous cell carcinoma listed in China, both of which were approved for the first-line and second-line treatment. Conclusion Great achievements have been made in the clinical development of esophageal squamous cell carcinoma drugs in China. It is suggested that domestic enterprises increase the investment of esophageal squamous cell carcinoma, pay attention to adjuvant and local treatment, explore novel targets and drug categories, and focus on the details of pivotal trials.
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Objective:To study the feasibility of non-fasting blood lipid detection in patients with type 2 diabetes mellitus (T2DM) .Methods:A total of 426 diabetic patients hospitalized in the Second Hospital of Tianjin Medical University from Oct. 2018 to Apr. 2019 were selected to collect blood samples from the fasting and non-fasting state of the patients respectively. The levels of plasma three acylglycerol (TG) , total cholesterol (TC) , high density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C) were measured at the same time, and self-control method was used. The results of two tests were compared with the wilcoxon signed-rank test.Results:Compared with the fasting results, non-fasting TG increased by 0.25 mmol/L (11.2%) , with statistical significance ( P<0.05) ; TC increased by 0.17 mmol/L (4.5%) , HDL-C increased by 0.08 mmol/L (5.7%) , and LDL-C decreased by 0.05 mmol/L (5.9%) , without significant differenc ( P>0.05) . Conclusion:Except for TG, non-fasting TC, HDL-C, LDL-C has little change compared with those in fasting state, which can replace fasting blood lipid detection as a method for detecting blood lipid profile in patients with T2DM.
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Objective:To explore the epidemiological characteristics and clinical outcomes of patients diagnosed with novel coronavirus (COVID-19) pneumonia (NCP), and to provide clinical reference for subsequent epidemic prevention and control.Methods:The pathogenesis, clinical characteristics and clinical outcomes of 62 patients with imported novel coronavirus COVID-19 pneumonia in Qingdao area from January 21, 2020 to April 6, 2020 were analyzed.Results:There were 24 males and 38 females, aged from 5 to 91 (52.5±15.7)years. Among them, 31 cases (31/62, 50%) were family cluster disease, 11 cases (17.74%) were nosocomial cross infection, 14 cases (22.58%) came back from Wuhan to Qingdao and community contact infection, and 6 cases (9.68%) were imported from abroad. The longest time from fever to diagnosis was 26 days. Clinical classification: 40 cases were mild, 13 were general, 7 were severe, 2 were critically ill. 61 cases were discharged from hospital, and 1 was dead. The clinical cure rate was 98.39%. The average stay was (18.5±4.8)days. All patients were treated combined with Chinese medicine on the basis of symptomatic treatment.Conclusions:The clinical symptoms of imported NCP are relatively mild, and mild cases were more, the recovery rate was higher. The intervention strategy of traditional Chinese medicine is conducive to rehabilitation. The external input cases and symptomless infected patients are important for epidemic situation in the future.
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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.
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Objective@#To deliver macro understanding of the latest research progress on clinical trials and approved products of cancer drugs in China in 2019.@*Methods@#The number of clinical trials and related investigational products by domestic and foreign enterprises in 2019 were acquired in the China Food and Drug Administration Registration and Information Disclosure Platform for Drug Clinical Studies, while listed drugs were obtained in the China Food and Drug Administration Query System for Domestic and Imported Drug. Characteristics on stage, scope, indication of those trials, classification and mechanism of involved products, as well as listed anticancer drugs were summarized and depicted.@*Results@#There were 474 cancer drug trials registered in China in 2019, accounting for 21.8% of the total, and 397 (83.8%) were initiated by domestic pharmaceutical enterprises. Overall, international multicenter trials accounted for 13.1%, and phase I trials accounted for 47.3%. Compared with global enterprises, the proportion of international multi-center trials initiated by domestic companies is lower (4.8% vs. 55.8%, P<0.001), and the proportion of phase I clinical trials and bioequivalence trials is higher (51.9% vs. 23.4%, 19.4% vs. 1.3%, P<0.001). An accumulative of 27 cancer types were involved for all the cancer drug trials, and lung cancer, solid tumor, and breast cancer were the most common cancer types, with 103, 95 and 49 trials, respectively. For the three cancer types unique to Chinese population, gastric, liver and esophageal cancer, the total number of initiated trials was 47. For all those trials, there were 335 cancer drug varieties, with 86.0% developed by domestic pharmaceutical enterprises, including 300 therapeutic drugs, 30 adjunctive drugs and 5 preventive drugs. In terms of mechanism, targeted drugs and immune drugs were the most popular, accounting for 74.6% and 20.3%, respectively. In addition, 17 anticancer drugs targeting on 11 cancer types were approved in China in 2019.@*Conclusions@#Clinical trials on cancer drugs in China have ushered a booming era, with large number of innovative agents represented by targeted drugs and immune drugs under clinical development or putting into clinical practice. Those local enterprises are playing more and more critical roles. Strengthening clinical research and development on Chinese unique cancer types is the key direction of future work.
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Immune checkpoint inhibitors have been approved for clinical application in China. However, the increased immune-related adverse event (irAE) needs more attention. This review summarized the incidence, characteristic clinical manifestation and treatment of irAEs associated with programmed cell death protein-1(PD-1) and programmed cell death ligand-1(PD-L1) inhibitors. To have a deep insight into irAE, the potential mechanisms, the different incidences of cancer types, influencing factors and the direction of future research were also discussed here to provide guidance for clinical oncologist to identify and monitor irAE.
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BACKGROUND@#Early investigation suggested patients' level of awareness regarding clinical trials was related with willingness to participation. This study was intended to evaluate the level of awareness of cancer patients regarding clinical trials and related influencing factors, and to compare the differences of awareness between patients who attended clinical trials before and not.@*METHODS@#From Jun, 2018 to April, 2019, standardized question-naires were gathered from cancer patients (attended clinical trials vs not attended clinical trials) in our hospital regarding basic information and 10 other questions about awareness. The level of awareness was evaluated and patients were classified into "low cognition" and "high cognition" groups. Logistic regression analysis was performed to determine whether certain characteristics would predict for awareness.@*RESULTS@#Of the 617 participants, 38.6% have attended clinical trials before. 338 (54.6%) patients had a correct overall understanding of clinical trials, while 44 (7.1%) patients still thought participants were the victim of scientific research. Except for the compensation of medical expenses (51.5% vs 48.7%) and related laws of clinical trials (52.3% vs 45.5%), other parts of understanding were elevated in patients attended clinical trials before comparing with patients who didn't, including significance (86.2% vs 77.6%), risk disclosure (91.2% vs 71.6%), confidentiality (73.2% vs 59.7%), voluntariness (95.8% vs 76.3%), withdrawal (86.6% vs 68.2%) and expenses (62.8% vs 39.2%). The proportion of participants who understand these components did not increase even in 239 patients who had attended clinical trials before. Participants who attended clinical trials before (OR=1.83, 95%CI: 1.11-3.00), unmarried/divorced (OR=5.04, 95%CI: 1.73-14.66), retired (OR=2.53, 95%CI: 1.16-5.50) had a higher level of awareness, while patients who had bad impression with doctors (OR=0.43, 95%CI: 0.26-0.72) had lower awareness.@*CONCLUSIONS@#The current level of awareness for clinical trials of cancer patients in our hospital was relatively low, even in patients who had attended clinical trials before. It's necessary to improve patients' awareness of clinical trial by promoting harmony relationship between patients and doctors, as well as by enhancing related propagation. Strengthening the adequacy and efficacy of informed consent in clinical trials also needs to be achieved in the future.
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BACKGROUND@#The clinical trials of new anti-tumor drugs are prospering in China. The acceptance of clinical trials in patients is an important factor affecting the speed and quality of clinical trials. Previous studies have investigated the acceptance of clinical trials in those cancer patients, who have never participated in a trial. This study is designed to investigate and compare the acceptance and related causes of clinical trials in cancer patients who have once participated in a clinical trial or not.@*METHODS@#From June 2018 to April 2019, a standardized questionnaire-based survey was conducted among two groups of cancer patients classified by history of clinical trial participation in Cancer hospital, Chinese Academy of Medical Science, mainly focusing on their overall acceptance of clinical trials and related considerations, including the role of attending doctors, as well as group differences between the two participants.@*RESULTS@#A total of 538 patients were enrolled with an average age of 53.5 years old, 51.1% of whom were males, and 43.3% of whom have never participated in a clinical trial. Overall, 502 patients (93.3%) were willing to or recommend their relatives or friends to participate in clinical trials, and patients with history of clinical trial participation had higher willingness (96.6% vs 90.8%, P=0.008). Patients were most likely to be motivated by expectation of optimal treatment (100.0% vs 99.3%) for both those who had once participated in a clinical trial or those not, respectively followed by financial burden reduction (56.0%) and recommendation by attending doctor (43.7%). The main reasons for unwillingness-to-participate for those who had once participated in a clinical trial were abandoning other treatment options, divided into control group or additional visits, while for those who had never participated in a clinical trial, ineffective treatment or serious adverse reactions were their main concerns. In the decision-making of clinical trial participation, 88% patients highly valued the role of recommendation by attending doctors. Among patients without trial participation history, 60.9% of those had no unwillingness-to-participate expressed that recommendation by attending doctors would change their decisions. The study also reported patients' preferences for information and access to clinical trials.@*CONCLUSIONS@#The acceptance of clinical trials in cancer patients in our hospital is generally high, especially in patients who had a history of trial participation. It's of substantial significance to give full play to the role of doctors in improving the acceptance of clinical trials of cancer patients in China.
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Objective@#To investigate the adrenocortical function changes of patients with advanced solid tumors who received the anti- programmed cell death protein-1 (PD-1) antibody, SHR-1210 therapy.@*Methods@#The clinical data of 98 patients with advanced solid tumors who were enrolled in a prospective phase I trial of SHR-1210 therapy at our institution between April 27, 2016 and June 8, 2017 were collected. The levels of plasma adrenocorticotropic hormone (ACTH) and cortisol were evaluated in 96 patients. The clinical manifestations, laboratory tests and radiologic data were collected to define the immune-related adrenal insufficiency.@*Results@#Until December 14th, 2018, no SHR-1210 related primary adrenal insufficiency occurred, and the incidence of immune-related secondary adrenal insufficiency was 1.0% among the 96 patients, which was identified as grade 2. No patient developed grade 3-4 adrenal insufficiency. The main clinical manifestations of the patient who was diagnosed as secondary adrenal insufficiency were grade 2 fatigue, anorexia and headache.The patient developed fatigue and anorexia at the 267th day after receiving the first dose of SHR-1210, the hypocortisolism occurred on the 279th day, and the headache emerged on the 291th day. The anorexia of patient who treated by physiological replacement doses of glucocorticoid since the 457th day was attenuated.The patient whose cortisol level was still below the normal limit continued to accept the hormone replacement therapy up to 776 days after the initial administration of SHR-1210.@*Conclusions@#The incidence of SHR-1210 related adrenal insufficiency of patients with advanced solid tumors is low, and the symptoms can be effectively ameliorated by hormone replacement therapy. The potential adverse outcome of adrenal insufficiency following immunotherapy should be noticed by clinicians to avoid the occurrence of adrenal crisis.
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To explore the mechanism for changes in brain microstructure in long-term abstinent from methamphetamine-dependence by using the diffusion tensor imaging (DTI). Methods: A total of 26 patients with long-term abstinent methamphetamine-dependence, whose abstinence time more than 14 months, and 26 normal controls all underwent cognitive executive function tests and DTI scans. We used voxel-based analysis to compare the fractional anisotropy (FA) and mean diffusivity (MD) to obtain the abnormal brain regions of DTI parameters between the two groups. Spearman correlation analysis was used to explore the correlation between FA, MD of the brain regions with abnormal parameters and cognitive executive function tests. Results: There were no statistical differences in the cognitive executive function tests between the two groups (P>0.05). Compared with the normal control group, the long-term abstinent from methamphetamine-dependence group showed the decreased FA in the right precuneus, right superior frontal gyrus, right calcarine, left inferior temporal gyrus and the increased MD in the right triangular part of inferior frontal gyrus, right precuneus, right posterior cingulate, right middle temporal gyrus, bilateral middle occipital gyrus, left superior parietal lobule, and lobule VIII of cerebellar hemisphere. The MD values of the right middle temporal gyrus in the long-term abstinent group were negatively correlated with the number of completions within 60 seconds (r=-0.504) and within 120 seconds (r=-0.464) . Conclusion: The DTI parameters in multiple brain regions from the methamphetamine-dependence patients are still abnormal after a long-term abstinence. DTI can provide imaging evidence for brain microstructural abnormalities in long-term abstinent from methamphetamine-dependence.
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Humans , Amphetamine-Related Disorders , Anisotropy , Brain , Diffusion Tensor Imaging , MethamphetamineABSTRACT
Objective@#To assess the incidence and characteristics of thyroid dysfunction during anti-Programmed cell death 1 receptor (PD-1) antibody SHR-1210 therapy in patients with advanced solid tumor.@*Methods@#The medical records of 98 patients who initiated SHR-1210 treatment between April 27, 2016 and June 8, 2017 in the phase 1 trial to evaluate the safety, efficacy, and pharmacokinetics of SHR-1210 in patients with advanced solid tumors were retrospectively reviewed. Serological tests of thyroid stimulating hormone (TSH) and free thyroxine (fT4) were measured at baseline and prior to each SHR-1210 administration.@*Results@#A total of 86 patients had normal thyroid function before the first dose of SHR-1210 treatment. Nine out of 86 (10.5%) patients developed new onset hypothyroidism from euthyroid state. 12 patients presented thyroid dysfunction at baseline, 10 of whom were subclinical hypothyroid and 2 were hypothyroidism. Four out of 10 patients developed hypothyroidism from subclinical hypothyroid. Most patients with hypothyroidism were asymptomatic. Thyroid dysfunction occurred early (median, 55days) after the initiation of SHR-1210. The severity of hypothyroidism were all grade 1-2. No grade 3-4 hypothyroidism occurred. No patients discontinue the treatment of SHR-1210 due to clinical impact of the thyroid dysfunctions.@*Conclusions@#Thyroid-related adverse events were common during anti-PD-1 antibody SHR-1210 treatment . The incidence of hypothyroidism is lower in patients with euthyroid state than in patients with thyroid dysfunction at baseline during SHR-1210 treatment . Thyroid function can be improved after thyroid hormone replacement. During SHR-1210 treatment, it is necessary to pay attention to monitor the thyroid function, especially in the patients with thyroid dysfunction at baseline.@*Trial registration@#Chinese Clinical Trial Registry, 2016L01455
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Objective DSA and/or surgery was used as a control to evaluate the image quality, radiation dose and diagnostic efficacy of 70 kV combined with low contrast agent dose and 80 kV dual-source CT scanning of coronary artery. Methods Between Apr, 2012 and Apr, 2017, a total of 150 consecutive pediatrics with suspected or confirmed coronary arterial diseases underwent DSCTCA, and the patients were randomly divided into 3 groups by different scanning protocols. Group A (n=50): 80 kV with 1.5 ml/kg contrast agent;Group B (n=50): 70 kV with 1.5 ml/kg contrast agent;Group C (n=50): 70 kV with 1.0 ml/kg contrast agent. ANOVA was used to compare the differences of subjective coronary arteries image quality between the three groups; The t-test was used to compare the difference in effective radiation dose between the 70 kV group and the 80 kV group; The surgery and/or angiography results were used as gold standard to evaluate the diagnostic efficacy of the three groups. Results All patients underwent DSCTCA successfully and satisfactory diagnostic images were gained . The mean scores of subjective image quality of coronary artery were 3.5±0.7, 3.4±0.6, 3.7±0.8, respectively. There was no significant difference between the 3 groups (F=2.042, P=0.133). The diagnostic accuracy of the three groups for coronary artery disease was 100%, as the surgical and/or angiographic results were used as gold standard. The effective radiation doses in 80 kV group (A group) and the 70 kV group (B+C group) were (0.49 ± 0.04) and (0.30 ± 0.03) mSv, respectively, with a statistically significant difference (t=4.037, P=0.001). Conclusions DSCTCA can better display and diagnose pediatric coronary artery lesions with 70 kV tube voltage combined with low contrast agent, and has a high diagnostic accuracy. It is a reliable method for diagnosing pediatric coronary artery disease.
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Objective To compare the difference between fasting blood lipids and non－fasting blood lipids in children in Tianjin,and to explore the feasibility of non－fasting blood lipids detection in children.Methods A total of 223 child patients were enrolled in Department of Pediatrics,the Second Hospital of Tianjin Medical University from January 2017 to February 2018,fasting and 1－6 h post－dining blood samples were collected from each patient.Total cholesterol (TC),triglyceride (TG),high－density lipoprotein cholesterol (HDL－C)and low－density lipoprotein cholesterol (LDL－C)were measured.Self－control methods were used.Wilcoxon signed rank test was used for statisti-cal analysis.Results Compared with fasting lipids,non－fasting TC increased with 0.02 mmol/L,TG increased with 0.01 mmol/L,HDL－C increased with 0.03 mmol/L,while LDL－C decreased with 0.01 mmol/L,but non－high－density lipoprotein cholesterol did not change.Among them,only the difference in HDL －C between the fasting and non－fasting was statistically significant (Z＝ －2.870,P＜0.05).The difference in the change rate of all indicators was ＜3%.According to the dyslipidemia group comparison,the differences in hypercholesterolemia (0.72 mmol/L, Z＝ －2.551,P＝0.011),hypertriglyceridemia (0.73 mmol/L,Z＝ －3. 846,P＜0.001),low high－density lipopro-tein cholesterolemia (－0.04 mmol/L,Z ＝ －8.625,P ＜0.001)and normal level HDL －C (0.1 mmol/L,Z ＝－5.040,P＜0.001)between non －fasting lipids and fasting blood lipids were statistically significant.Conclusions The change of children's blood lipid profile in fasting and non－fasting conditions is little.Lipid testing in children does not require fasting.Blood tests can be performed at any appropriate time point in the normal diet.
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Objective To observe the effect of peripheral blood microRNA-182 (miR-182) combined with interleukin-17 (IL-17) in the early diagnosis of cerebral infarction (CI) in patients with eclampsia. Methods A prospective non-randomized controlled study was conducted. The patients with eclampsia admitted to intensive care unit (ICU) of Liaocheng People's Hospital from January 1st, 2013 to September 30th 2016 were enrolled. Cerebral imaging was conducted in 7 days after admission to make a definite diagnosis of the occurrence of CI, excluding patients with cerebral hemorrhage. Patients were divided into CI group and non-CI group. Twenty healthy women of childbearing age were selected as control group. Peripheral venous blood of all patients with eclampsia at 1 day after admission, the expression of miR-182 was detected by real-time fluorescence quantitative polymerase chain reaction (PCR), regulatory T cells (Treg) and T helper 17 cells (Th17) ratio was detected by flow cytometry, and the level of plasma IL-17 was detected by enzyme linked immunosorbent assay (ELISA). Pearson method was used to analyze the correlation between the indexes. The receiver operating characteristic curve (ROC) was used to analyze the diagnostic value of each index for CI in patients with eclampsia. Results In the 30 patients with eclampsia, there were 13 cases of CI, including 10 case of cerebral venous thrombosis (CVT) and 3 cases of arterial thrombus; 17 cases of non-CI, including 15 cases of reversible posterior leukoencephalopathy syndrome (RPLS) and 2 cases without obvious abnormalities. Compared with control group, the levels of miR-182, Th17% and IL-17 in non-CI group and CI group were significantly higher, and the Treg% was significantly lower. The levels of parameters mentioned above were further increased in CI group than those in non-CI group [miR-182 (2-ΔΔCt): 2.35±0.79 vs. 1.75±0.56, Th17%: (5.16±1.89)% vs. (3.93±1.92)%, IL-17 (ng/L):37.45±6.20 vs. 26.65±5.13, all P < 0.05]. Pearson correlation analysis showed that miR-182 was positively correlated with Th17% and IL-17 (r1 = 0.761, r2 = 0.842, both P < 0.01). ROC curves showed that when the cut-off value of miR-182 was 2.88, the diagnosis sensitivity of preeclampsia CI was 84.6%, the specificity was 82.4%, and area under the ROC curve (AUC) was 0.816 [95%CI confidence interval (95%CI) = 0.641-0.992]; when cut-off value of IL-17 was 34.44 ng/L, diagnosis of preeclampsia CI the sensitivity was 71.5%, the specificity was 85.3%, and AUC was 0.773 (95%CI = 0.602-0.945); when miR-182 was combined with IL-17, the diagnosis sensitivity was 92.3%, specificity was 83.6%, and AUC was 0.896 (95%CI = 0.759-1.032). Conclusions To some extent the expression of miR-182 and IL-17 in peripheral blood can predict the occurrence of CI in early stage. When the two are used together, the predictive value is better.
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BACKGROUND:No studies currently focus on the measurement of daily water loss under certain physical activity level continuously and precisely. OBJECTIVE:To provide evidence for daily water requirement in Chinese young men based on the measurement of the daily water loss in Chinese young men under moderate physical activity. METHODS:Twenty male subjects were enroled, and 23-hour whole-body sweat loss and urine output were measured using high-precision body weighting scale in whole-room indirect calorimeter. The results were converted to daily (24-hour) water requirement to determine the daily water requirement. Daily whole-body sweat loss per unit body weight, daily whole-body sweat loss per unit fat free mass and daily whole-body sweat loss per unit surface area were calculated. RESULTS AND CONCLUSION:In Chinese young men, daily water loss was (3 339.7±509.9) g, daily urine output was (1 982.9±449.5) g and daily whole-body sweat loss was (1 356.7±215.6) g. There was a linear correlation between water intake and water loss (r=0.616,P < 0.05). Daily whole-body sweat loss per unit body weight was (21.0±3.6) g/kg, daily whole-body sweat loss per unit fat free mass was (25.8±3.9) g/kg and daily whole-body sweat loss per unit surface area was (799.4±129.4) g/m2. Daily water requirement of Chinese young men under moderate physical activity is approximately 3 340g, and moreover, water loss increases with the increase of water intake.
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OBJECTIVE To compare the clinical characteristics between eosinophilic and noneosinophilic CRSwNP and identify the predictors of eosinophilic CRSwNP. The impact of comorbidity (allergic rhinitis-AR, bronchial asthma-BA) on the predictors was also studied. METHODS Histologic characteristics of surgical samples were analyzed in 182 CRSwNP patients, who were classified into eosinophilic CRSwNP (ECRSwNP) group and noneosinophilic CRSwNP (non-ECRSwNP) group. Factors associated with ECRSwNP were selected by correlation analyses. The optimal cutoff points of the predictors were determined by a receiver operating characteristic curve. Based upon the different comorbidity, four groups were divided to study the impact of comorbidity on the optimal cutoff points of the predictors. RESULTS Patients with ECRSwNP had significant higher rate of revision FESS, significant higher concurrent rate of allergic rhinitis and bronchial asthma than non-ECRSwNP patients (all P<0.05). There were significant differences in Ratio of Lund-Mackay scores, peripheral blood eosinophil percentage and serum total IgE between ECRSwNP group and non-ECRSwNP group except the peripheral blood neutrophilic percentage (U value were 1028.00, 1143.50, 800.00 respectively, all P<0.05). Peripheral blood eosinophilic percentage had the highest significant correlation with degree of infiltration of eosinophils in nasal polyps (r =0.538, 0.568, both P<0.05) and there also existed significant correlation between degree of infiltration of eosinophils in nasal polyps and Lun-Mackay score (r =0.419, P<0.05). Comorbidity of AR and BA could impact the peripheral blood eosinophil percentage. According to the different combination of comorbidity, the range of the optimal cutoff points of peripheral blood eosinophil percentage was 3.05%-4.8%. CONCLUSION ECRSwNP and non-ECRSwNP displayed significant differences in certain clinical features. Comorbidity of AR and BA could increase the peripheral blood eosinophil percentage, that may impact the diagnosis of the subtype of ECRSwNP.
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Objective To investigate the predictive value of serum albumin level in patients with severe sepsis .Methods One hundred and twenty cases of patients with severe sepsis admitted to Qilu Hospital ,Shandong University from April 2014 to October 2014 were prospectively enrolled .The serum albumin levels were measured and the laboratory and clinical data were collected at the onset of severe sepsis .Acute Physiology and Chronic Health Evaluation (APACHE ) Ⅱ score and Sequential Organ Failure Assessment (SOFA) score were calculated .Patients were grouped according to the prognosis by day 28 or stratified by albumin level . Prognostic factors were analyzed by multivariable Logistic regression .Results A total of 120 patients were enrolled with mean age of (57 .6 ± 18 .3) years ,among which 75 were male .The mean duration of hospitalization was (20 .1 ± 17 .8) days .The 28‐day mortality was 25 .8% (31/120) .The most common infection sources were respiratory tract (56 .7% ) ,abdominal/pelvis (19 .2% ) and bloodstream (9 .2% ) .Serum albumin level in survival group was significantly higher than that in death group ([32 .1 ± 6 .4] g/L vs [27 .5 ± 5 .5] g/L ,t=3 .562 ,P=0 .001) .Compared with survival group ,the patients in death group had higher APACHE Ⅱ and SOFA scores (22 .0 ± 9 .1 vs 13 .4 ± 7 .2;7 .1 ± 3 .7 vs 4 .3 ± 3 .5 ;t= —5 .372 and —3 .690 ,both P<0 .05) .Along with the decrease of serum albumin level ,the incidence of bloodstream infection ,solid tumor ,septic shock ,acute kidney injury and liver injury significantly increased .Patients with lower albumin level had significantly higher SOFA scores and 28‐day mortality (all P<0 .05) .Multivariable regression analysis showed that albumin level lower than 28 g/L and higher APACHE Ⅱ score were independent risk factors for mortality (OR=4 .156 ,95% CI:1 .198—14 .415 ;OR=1 .121 ,95% CI:1 .039—1 .210;both P<0 .05) .Conclusions A significantly lowered serum albumin level would increase the risk of mortality in patients with severe sepsis .The combination of albumin level and APAHCE Ⅱ score might be beneficial to evaluate the prognosis .
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Chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma is a common clinical refractory airway disease. Comprehensive treatment of nasal endoscopic surgery including nasal endoscopic surgery and medication, which can significantly improve nose-pulmonary symptoms and make sinusitis and asthma easier to be controlled by medication, has certain superiority. But the existence of disease heterogeneity of CRSwNP with asthma causes different reactions to the current treatment, which manifests as parts of polyps and asthma easy to recur and difficult to control. According to the research recently, the study of the heterogeneity of airway diseases, for example endotype, is a hot area of research. Endotype is a subtype of a condition, which is defined by a distinct functional or pathobiological mechanism. This is distinct from a phenotype, which is any observable characteristic or trait of a disease. Different Inflammatory subtypes often represent different pathophysiology and even different pathogenesis. The concept of inflammatory subtypes of airway diseases provides a new perspective for studies of airway diseases of endotype and the mechanism of combined airway diseases. This review summarizes recent advances in the clinical characterization and treatment of the CRSwNP with asthma. On this basis, we analyze and summarize the heterogeneity of CRSwNP and asthma separately from the perspective of inflammatory subtypes. Then according to the concept of the combined airway diseases and the common pathogenesis, we put forward the definition of inflammatory subtypes of the CRSwNP with asthma and preliminarily discuss the method of the definition.
Subject(s)
Humans , Asthma , Chronic Disease , Endoscopy , Nasal Polyps , Rhinitis , Diagnosis , Sinusitis , DiagnosisABSTRACT
Chronic rhinosinusitis (CRS) can be controlled by a combination of conservative treatment and surgical procedures. However, there is one group of CRS endotypes, refractory CRS, such as eosinophilic chronic rhinosinusitis with nasal polyp (ECRSwNP), for which the current treatment strategies of anti-inflammatory and/or antibiotic therapy or surgical removal of the lesion to improve sinus drainage are less effective. This lack of treatment efficacy highlights the need for further fundamental and clinical research to improve or restore nasal mucosal function of CRS. The role of the immune response in the pathogenesis of mucosal remodeling, which is a key problem in refractory CRS, is of particular current interest. ECRSwNP characterized by Th17/Treg imbalance in- duced by IL-6 has a different mucosal remodeling pattern. This review intends to illustrate the role of the imbalance between Th17 (T helper 17) and Treg (regulatory T) cells in the mucosal remodeling of ECRSwNP and to suggest a novel therapeutic target on treating ECRSwNP.
Subject(s)
Humans , Chronic Disease , Nasal Mucosa , Nasal Polyps , Metabolism , Rhinitis , Metabolism , Sinusitis , Metabolism , T-Lymphocytes, Regulatory , Th17 CellsABSTRACT
Objective To study the effects of compound factors of simulated weightlessness and noise in spaceship on auditory function ,and the expression of apoptotic marker Caspase -3 in inner ear in guinea pigs ,and study the influence of compound factor above on its hearing loss and apoptosis of inner ear .Methods Thirty -six guinea pigs were randomly divided into four groups ,6 in control group ,10 in simulated weightlessness with noise group (Group A) ,treatment estrogen group (Group B) and prevention estrogen (Group C) ,respectively .All the experiment groups were suspended posterior limb ,with the exposure of the simulated noise circumstance in space-ship .Estrogen prevention group received intramuscular injection of estradiol benzoate for 3 days before the experiment ,while estrogen treatment group was treated in the same way for 8 days from the beginning of experiment to 3 days after the experiment .Bilateral auditory brainstem response thresholds (ABR) were tested in pre- exposure ,post-exposure and 3 -day recovery respectively .Cochleae were obtoined for immunohistochemistry staining to observe the expression of the apoptotic marker Caspase -3 in inner ear .Results At the time point of post -exposure ,ABR threshold in Group B was lower than those in Group A by 14 .5 dB and Group C by 9 dB .For the ABR change of pre ,and post-exposure ,Group B was lower 12 .75 dB than those of in Group A and 7 .75 dB than in Group C .For the ABR change between pre ,and post-recovery ,ABR threshold of Group C was higher than those of in Group A by 14 .5 dB and in Group B by 7 dB .These differences were significant (P<0 .05) .The expression of Caspase-3 was positive in the hair cell ,spiral ganglion cells and stria vascularis of three groups in both post exposure and 3-day recovery .The expression of Caspase-3 in hair cell and stria vascularis was strongly positive in spiral ganglion cells in Group C in post -exposure ,while it was slightly positive in Group B .After 3 -day recovery ,Group A turned to negative ,while Group B and Group C were still in positive expression with an increase of that in post -ex-posure .Conclusion Estrogen treatment could effectively reduce the hearing loss and the apoptosis of inner ear in-duced by the compound factor of weightlessness and noise .Preventive use of estrogen could not produce an instant protection on the hearing loss induced by exposure ,and the apoptosis was enhanced .However ,it speeded up the procedure of recovery and reduced the apoptosis of inner ear .