OBJECTIVE To analyze the factors affecting the inclusion of Chinese patent medicines in China’s National reimbursement drug list （NRDL）， and assist these medicines in fully reflecting their actual value in the reimbursement admission process. METHODS From the official website of the China’s National Healthcare Security Administration， the application materials of Chinese patent medicines outside the list that passed the formal review from 2021 to 2023 were obtained， including basic information on the medicines， safety， efficacy， innovation and heritage information， and supplemented with references from the pharmacopeia and the Yaozhi Database. Economic information and enterprise information were obtained through websites such as the Yaozhi Database. Univariate analysis， multivariate Logistic regression analysis and stepwise regression analysis were conducted on the initial application information and admission outcomes of the medicines. Sensitivity analysis was also performed on medicines that applied multiple times in different years as independent samples. RESULTS & CONCLUSIONS There were 27 Chinese patent medicines that passed the formal review from 2021 to 2023， involving 37 applications. The univariate analysis results showed that medicines with descriptions of traditional Chinese medicine （TCM） syndrome types， clear adjustment information for medication plans for specific population groups， short time to market in the indications of the package insert， registered as Class 1 to 6 following or class Ⅰ innovative TCM/class Ⅲ ancient classic prescription compound TCM registered， and those produced by enterprises listed in the “Top 100 Chinese Pharmaceutical Industry Enterprises” list for the current year were more likely to be included in the NRDL （P＜0.05）. The results of the multivariate Logistic regression analysis were not statistically significant， but the stepwise regression results indicated good consistency with the univariate analysis. The results of the sensitivity analysis were consistent with the trend of basic analysis. It is recommended that Chinese patent medicine enterprises further clarify the description of product instructions， expand innovation capabilities， inherit and develop ancient classic prescriptions， and promptly complete clinical trial evidence.

Objective To investigate the diagnostic value Tamm-Horsfall protein(THP)and osteopontin(OPN)in serum and 24-hour urine for urolithiasis.Methods A total of 101 patients with urolithiasis who underwent flexible ureteroscopy lithotripsy at the Urology Department of Civil Aviation General Hospital from April 2020 to March 2023 were included as the stone group,and 50 healthy individuals were enrolled as the control group.The samples of serum and 24-hour urine samples were collected from both the groups,and the levels of THP and OPN were measured using enzyme-linked immunosorbent assay(ELISA).Logistic regression analysis was performed to evaluate the association between each biomarker and urolithiasis,and receiver operating characteristic(ROC)curves were plotted to assess their diagnostic value.Results The stone group showed significantly lower THP levels(20.13[13.12,26.03]mg/d)and OPN levels(51.24[36.72,101.37]μg/d)in 24-hour urine,and THP levels(182.01[160.91,209.20]ng/mL)and OPN lev-els(18.76[15.72,22.48]ng/mL)in serum compared to the control group(all the P＜0.001).Binary Logistic regression analysis re-vealed that THP(OR=0.736,95％CI:0.606-0.895),OPN(OR=0.975,95％CI:0.958-0.993)and citrate(OR=0.067,95％CI:0.012-0.376)in 24-hour urine,and THP(OR=0.946,95％CI:0.908-0.986)and OPN(OR=0.896,95％CI:0.803-0.999)in ser-um were the protective factors for urolithiasis,while calcium level(OR=2.125,95％CI:1.243-3.633)24-hour urine was a risk factor(all the P＜0.05).ROC curve analysis showed that the areas under the curve(AUCROC)for the individual diagnosis of urolithiasis were 0.846,0.809,0.786,0.823,0.748,and 0.755 for the above six biomarkers,respectively.The AUCROC for the combined diagnosis u-sing THP+OPN in serum,THP+OPN in 24-hour urine and all the six biomarkers were 0.882,0.920 and 0.984,respectively,indica-ting better diagnostic performance.Conclusion The combined detection of the THP and OPN levels in serum and 24-hour urine may have good diagnostic value for urolithiasis and serve as potential diagnostic biomarkers.

Objective:To evaluate the effect of different doses of cisatracurium on the monitoring of motor-evoked potentials (MEPs) in the patients undergoing intracranial aneurysm clipping.Methods:Eighty patients of both sexes, aged 18-64 yr, with body mass index <30 kg/m 2, of American Society of Anesthesiologists physical statusⅠor Ⅱ, with Hunt-Hess grade 0-Ⅱ, undergoing intracranial aneurysm clipping under general anesthesia, were divided into 4 groups ( n=20 each) using a random number table method: conventional group (group R) and different doses of cis-atracurium groups (Cis 1-3 groups). After anesthesia induction, muscle relaxation was monitored, and train-of-four (TOF) stimulation (frequency 2 Hz, wave width 0.2 ms, interval 15 s) was applied to the ulnar nerve of forearm, and the TOF ratio was recorded as the baseline value (T 1). MEPs were assessed with a nerve electrophysiology monitor after induction of anesthesia.In Cis 1-3 groups, cis-atracurium 0.625, 0.833 and 1.000 μg·kg -1·min -1 were intravenously infused, while the equal volume of normal saline was given instead in group R when TOF ratio returned to the baseline value and MEPs could be effectively elicited.At T 1, immediately after dural incision (T 2), immediately after aneurysm occlusion (T 3) and immediately after dural closure (T 4), the TOF ratio, effective elicitation of intraoperative MEPs, and occurrence of intraoperative cardiovascular events, recovery of spontaneous breathing and body movement were recorded. Results:Compared with group R, no significant change was found in TOF ratio at each time point in group Cis 1 ( P>0.05), and TOF ratio was significantly decreased at T 2-4 in group Cis 2 and at T 2-4 in group Cis 3 ( P<0.05). Compared with group Cis 1, TOF ratio was significantly decreased at T 3, 4 in group Cis 2 and at T 2-4 in group Cis 3 ( P<0.05). The effective elicitation rate of MEPs was 100% in the four groups.There was no significant difference in the incidence of intraoperative cardiovascular events, recovery of spontaneous breathing and body movement among the four groups ( P>0.05). Conclusion:Continuous intravenous infusion of cis-atracurium 0.833-1.000 μg·kg -1·min -1 can maintain a certain degree of muscle relaxation without affecting MEP monitoring in the patients undergoing intracranial aneurysm clipping.

Objective: To determine the level of Soluble Suppression of Tumorigenicity-2 (sST2) in patients with heart failure(HF) and atrial fibrillation (AF), and to explore its diagnostic and prognostic value in patients with HF and AF. Methods: A prospective cohort study was carried out to investigate the data of 185 HF patients who were hospitalized between January 2018 and June 2018 in department of cardiology or department of cardiac care unit in TEDA International Cardiovascular Hospital. And according to whether they had atrial fibrillation before admission, we categorized patients into: HF with sinus rhythm (HF-SR, n=90) and HF with AF(HF-AF, n=95). Meanwhile, 40 healthy controls were collected. Baseline data of HF-SR and HF-AF groups and plasma sST2 levels in different ejection fraction groups were compared. Plasma sST2 level was determined by enzyme-linked immunosorbent assay(ELISA). Statistical methods such as nonparametric test and Spearman correlation analysis were used. The receiver operating characteristic curve was applied to evaluate the diagnostic value of sST2 in HF-SR and HF-AF groups. And by using the COX risk model, Multi-factor COX analysis was used to analyze the prognosis of patients. Results: Compared with healthy controls, the median (P₂₅, P₇₅) of Plasma sST2 levels in HF patients increased remarkably [32.93 (20.31-51.39) ng/mL vs 15.99(7.97-22.69) ng/mL, Z=-4.373, P<0.001]. Patients with HF-AF group had significantly higher test results [39.86 (27.20-59.21)] ng/mL than HF-SR group [24.74 (14.83-44.11)] ng/mL, Z=-6.783, P<0.001].In the HFmrEF and HFpEF subgroups, the plasma sST2 level of patients in the HF-AF group was higher than that in the HF-SR group (Z=-2.381, P=0.017; Z=-3.701, P<0.001).Spearman correlation analysis showed that, in HF-AF patients, plasma sST2 level was positively correlated with diastolic blood pressure, Hypertension, New York Association (NYHA) cardiac function classification Ⅲ to Ⅳ, white blood count(WBC), and the level of Alanine Aminotransferase (ALT), Υ-glutamine transaminase (Υ-GT), B-type natriuretic peptide (BNP) (r>0, P<0.05).Also, there is a negative correlation between sST2, left ventricular ejection fraction (LVEF) and estimated Glomerular Filtration Rate (eGFR) (r<0, P<0.05). At ROC analysis, sST2 showed predictive value in both HF-AF and HF-SR group, with an optimal cut-off value of 25.33 ng/mL(AUC 0.872, 95%CI: 0.805-0.935, P<0.001, sensitivity 81.1%, specificity 87.5%) and 23.34 ng/mL(AUC 0.665, 95%CI: 0.570-0.761, P<0.001, sensitivity 55.6%, specificity 77.5%).The AUC of BNP and sST2 in differential diagnosis of HF-SR and HF-AF was 0.604 and 0.699, respectively, and the AUC of sST2 was higher than that of BNP. Multi-factor COX analysis indicated that plasma sST2 level, BNP, NYHA cardiac function grading could be risk factors for cardiac events in HF patients. Plasma sST2, left atrial diameter (LA-D), and associated cardiomyopathy are risk factors for cardiac events in patients with HF-AF. The incidence of cardiac events in HF patients with sST2≥20.31 ng/mL was significantly higher than that of patients with sST2<20.31 ng/mL (χ²=7.625, P=0.006). The incidence of cardiac events in HF-AF patients with plasma sST2≥39.86 ng/mL was significantly higher than that in patients with sST2<39.86 ng/mL (χ²=4.287, P=0.038). Conclusions The plasma sST2 level in patients with HF-AF is significantly higher than that both in HF-SR and healthy controls. The diagnostic value of plasma sST2 in patients with HF-AF is higher than that in patients with HF-SR. It is suggested that sST2 are more valuable for the differential diagnosis of HF-SR, HF-AF than BNP. HF-AF Patients with plasma sST2 ≥ 39.86 ng/mL are prone to cardiovascular events.

Objective To investigate the diagnosis and prognosis value of plasma microRNA-30d (miR-30d)in acute coronary syndrome(ACS)patients.Methods It retrospectively recruited 170 cases of ACS patients from TEDA International Cardiovascular Hospital between September 2011 to February 2012, including 70 STEMI(male 54,female 16), 52 NSTEMI(male 34,female 18),48 UAP(male 29,female 19).At the same time,41 healthy controls(male 24,female 17)were enrolled into the study.Plasma miR-30d levels were determined by real-time quantitative PCR.In order to evaluate the dynamic change of miR-30d and other cardiac biomarkers,20 plasma samples of AMI patients were collected at 0-3 h,4-6 h,7-9 h, 10-12 h after pectoralgia.ROC curves and Kaplan-Meier survival curve were used to investigate clinical value of miR-30d in ACS.Results At 0-3 h after pectoralgia, miR-30d were significant higher in STEMI 7.208(0.170-11 070.735)and NSTEMI 7.989(0.836-151.391)than the controls 1.561(0.044-17.520)（Z1＝-5.792,Z2 ＝-6.113,P＜0.001）, but there were no statistic differences between UAP 1.073 （0.051-11.095）patients and the controls（Z＝-0.325,P＝0.745）.In 20 AMI patients,miR-30d levels peaked at 4-6 h and then dropped following 7-9 h, both earlier than cTnI, and the variation tendency was positive correlated with cTnI（r＝0.402,P＜0.01）.At 0-3 h after pectoralgia, the AUC, sensitivity and specificity of miR-30d for differentiating AMI and UAP were 0.882（95％ CI:0.830-0.935）,0.795（95％CI:0.711-0.861）and 0.854（95％ CI:0.716-0.935）respectively.When combined miR-30d and cTnI, the diagnostic AUC and specificity were 0.937（95％ CI: 0.902-0.972）and 0.937（95％ CI:0.818-0.984）,both enhanced when compared with miR-30d or cTnI alone.Kaplan-Meier survival curves revealed that there were no significant correlations between the miR-30d levels and MACE in both 30 days and 12 months（χ$lt@span sup=1$gt@2$lt@/span$gt@＝0.506,P＝0.477 and χ$lt@span sup=1$gt@2$lt@/span$gt@＝0.002, P＝0.963 respectively）.Conclusion Plasma miR-30d may be used as a potential biomarker for early diagnosis, but not prognosis in ACS patients.

Objective To study the correlated factors of long-term survival after hepatectomy.Methods The preoperative and postoperative conditions of 94 patients with liver cancer survived over 10 years after hepatectomy were enrolled for reviewing analysis.Results The important correlated factors of postoperative long-term survival are the following:(1) Diameter of tumor≤ 5 cm(73.4 ％);peripheral liver cancer(70.2 ％).(2) Effective treatment for recurrence.(3) Long-term and regular treatment of antiliver fibrosis and anti-cancer after hepatectomy(mainly Chinese Medicine).(4)Enforcing follow-up survey.Conclusion Diameter of tumor≤5 cm,peripheral liver cancer patients,enforcing follow-up survey and Chinese Medicine treatment are important factors of achieve long-term survival after hepatectomy.

Objective To investigate the effect of endoscopic transnasal surgery for malignant sinus tumors involving the orbit,and to analyse the factors affecting the prognosis.Methods Thirty-four cases of malignant sinus tumors involving the orbit,who underwent surgical treatment in Chinese people's liberation army general hospital between January 2009 and April 2015,were reviewed retrospectively.The 5-year survival rate,the recurrence rate and the complications was analysed,the factors affecting prognosis were discussed.Results Among 34 patients,2 patients were lost to follow-up.Follow-up time of 32 patients ranged 7 to 75 months.The 5-year overall survival(OS) in this group was 53％.Twelve cases recurred,the recurrence rate was 35％.Eye function improved in 26 cases,the improvement rate was 76.5％.Four cases developed diplopia and peri-orbital swelling after surgery,and simple peri-orbit swelling in 25 cases.The 5-year survive rate of stage 1,stage 2 and stage 3 were 80％,36％ and 25％,respectively,with significant difference(x2 =6.643,P =0.036).Conclusions Endoscopic transnasal surgery for malignant sinus tumors is effective,minimally invasive and accurate.The prognosis is closely related to the clinical stages and the pathological type.

Objective To evaluate the performances of high-sensitivity cardiac troponin I ( cTnI ) on VITRO ECIQ with enhanced chemiluminescence method .Methods This verification study validated the limited of detection,function sensitivity,imprecision,linearity of the high-sensitivity cardic troponin used VITROS ECIQ according to the document EP-17A, EP-6A,EP-15A published by Clinical and Laboratory Standards Institute (CLSI) and determined 99th percentiles.All 652 patients with chest pain on immediate admission in TEDA International Cardiovascular Hospital during January to November 2013 were enrolled in this study.Including 323 cases of acute ST segment elevation myocardial infarction and non ST segment elevation myocardial infarction patients as the case group , exclude 329 cases of other diagnosis ,303 cases of apparent normal people as control group .The receiver operating characteristic curve was used to evaluated the sensitivity and the specificity of cTnI . Non-normal distribution of quantitative data were used nonparametric test Mann-Whitney U, With P<0.05 for the difference was statistically significant .Results The LoB was 0.006 5 ng/ml and the LoD was 0.015 5 ng/ml;the FS was 0.016 76 ng/ml;repeatability CV
was 1.73 % -2.33 %, reproducibility CV was 4.93% -9.96%.The imprecision were lower than that declared by assay producer.The linearity was 0.015 5-78.4 ng/ml(R2 =0.999 9); the 99th percentile reference value was 0.017 ng/ml.The area under the curve ( AUC) of cTnI was 0.986,95%CI 0.973 -0.994,with the cut-off value as 0.017 ng/ml, the diagnostic sensitivity and specificity in CIN were 90.09%and 99.34%.Compared between STEMI and NSTEMI groups after admission , the levels of cTnI had no significantly difference , Z were -0.485, P >0.05;compared between STEMI and control groups after admission, the levels of cTnI had significantly difference , Z were -19.567,P<0.001;compared between NSTEMI and control groups after admission , the levels of cTnI had significantly difference , Z were-14.598,P<0.001.Conclusions High-sensitivity cardiac troponin I detection by VITROS ECIQ with enhanced chemiluminescence method has good performances of sensitivity , linearity, specificity, which meet the clinical needs.

With the development of bio-technological drugs, drug immunogenicity evaluation has become key factor of clarifying safety and efficacy of these drugs. It has become the focus to establish a stable and reliable evaluation system. Due to the advantages such as continuous real-time monitoring, surface plasmon resonance (SPR) technology has been widely used in bio-technological drugs immunogenicity assessments. Our study applied this technology to detect anti-drug antibody (ADA) of a recombinant human anti-rabies monoclonal antibody NM57 in the sera of 48 volunteers admitted in phase I clinical trials. This method could satisfy the basic requirements of detection of ADA.

ObjectiveTo acquire the basic information of trainees and analyze the training results and it' s influence factors in the training of rural health appropriate technology in Jiangsu.MethodsWe used the questionnaire to collect data of the trainees' personal information and training results after training.Results A total of 2284 valid questionnaires were collected. There were 73.6％ trainees came from township hospitals,95.1 ％ of them under 45 years old,62.9％ for females,79.2％ have been working for 8 years,3％ with senior professional titles,only 0.4％ had acquire the master's degree or above.Multiple regression analysis showed that the different level of hospitals,the training needs, suitable degree,knowledge familiarity before the training,expert instruction and learning were the main influence factors for the master of the technology; The influence factors for the wish to be re-training were working age,education,the demand for training technology,ease of learning,expert instruction,grasp of this time,appliance of the technology.Conclusionlong-term mechanism for trainning and continue education should be established,and medical workers in rural areas should be strengthen to take the technical training to further improve the rural medical services.