The pre-research of medical device standards is of great significance for the enactment and amendment of standards.This study discusses four aspects and explores how to promote more scientific and reasonable pre-research.Based on the pre-research practice of medical device standards project,this study puts forward relevant work ideas and suggestions.

Objective:To explore the mediating role of mentoring function between proactive personality and transition shock in new nurses, with the aim of providing reference and basis for managers to develop effective intervention measures for new nurses during their transformational period.Methods:Convenience sampling method was used to select 280 new nurses from the Second Affiliated Hospital of Zhejiang University School of Medicine, and a cross-sectional survey was conducted by applying the General Information Questionnaire, Transition Shock Scale, Proactive Personality Scale, and Mentoring Function Scale. The mediating role of mentoring function between new nurses′ proactive personality and transition shock was evaluated by constructing structural equation modelling.Results:265 valid questionnaires were ultimately collected. Among 265 nurses, there were 25 males and 240 females, with an age of (22.88 ± 2.12) years. The score of transition shock, proactive personality, and mentoring function of new nurses were (83.45 ± 18.95), (58.66 ± 9.96) and (81.72 ± 14.46) respectively; transition shock was negatively correlated with proactive personality and mentoring function ( r=-0.379, -0.340, both P<0.01), and proactive personality was positively correlated with mentoring function ( r=0.452, P<0.01); the mediating effect of mentoring function between proactive personality and transition shock was significant (95% CI -0.085 - -0.015, P<0.01), accounting for 29.14% of the total effect. Conclusions:New nurses' transition shock is at a moderately high level, and proactive personality can affect transition shock directly or indirectly through mentoring function. Managers can mitigate new nurses′ transition shock by improving the quality of mentoring.

Objective To explore the relationship between different obesity indicators and carotid intima-media thickness(CIMT)in patients with type 2 diabetes mellitus(T2DM).Methods A total of 1762 T2DM patients who visited the Endocrinology Department of Changzhou Second People's Hospital Affiliated with Nanjing Medical University and the Integrated Traditional Chinese and Western Medicine Hospital Affiliated with Nanjing University of Traditional Chinese Medicine from January 2019 to February 2022 were enrolled in this study.They were divided into youth group(18～44 years old,n=402),middle aged group(45～59 years old,n=1032),and elderly group(≥60 years old,n=328)according to WHO age classification criteria.The influencing factors for CIMT thickening in T2DM patients were analyzed using binary logistic regression,and the evaluation of the predictive effect of different obesity indicators on CIMT thickening was evaluated by receiver operating characteristic(ROC)curves.Results The subcuta-neous fat area,visceral fat area(VFA),neck circumference(NC),BMI,WC,cardiac metabolic index(CMI),Chinese visceral fat index(CAVI),visceral fat index,triglyceride glucose index,body roundness index,lipid aggregation index,HbA1c,DBP,TC,TG,HDL-C,LDL-C were lower in the middle aged and elderly groups than in youth group(P＜0.05).Binary logistic regression showed that VFA,NC,CMI in young T2DM patients,CAVI in middle aged T2DM patients,and NC in elderly T2DM patients were influ-encing factors for CIMT thickening.ROC curve analysis showed that VFA in young T2DM patients,CAVI in middle aged T2DM patients,and NC in elderly T2DM patients had a better predictive effect on CIMT thickening,with areas under the ROC curve of 0.567,0.574,and 0.573 respectively.Conclusion VFA,CAVI,and NC have a certain predictive effect on CIMT thickening in young,middle aged,and elderly T2DM patients.

ObjectiveTo establish the quality standard of Liangditang benchmark samples. MethodUltra performance liquid chromatography-quadrupole time-of-flight mass spectrometry （UPLC-QTOF-MS） was used to qualitatively analyze the chemical composition of Liangditang on the basis of molecular and fragment ion peak information with cracking law. The mobile phase was methanol （A）-0.05% phosphate aqueous solution （B） for gradient elution （0-10 min， 5%-23.5%A； 10-20 min， 23.5%A； 20-58 min， 23.5%-63%A； 58-60 min， 63%-90%A）， the flow rate was 0.8 mL·min^-1， and the detection wavelength was 254 nm. Electrospray ionization was employed under positive ion mode， the detection range was m/z 100-1 700. Key quality attributes and sources were determined by comparing with single medicine and reference substances. Through mass transfer analysis of multiple batches from decoction pieces to benchmark samples， high performance liquid chromatography （HPLC） for determining the contents of index components and HPLC detection of characteristic maps were established. Through the determination of 15 batches of benchmark samples， the content range of the index components and the common peaks of the characteristic map were determined. Thin layer chromatography （TLC） was applied to the identification of 5 medicines in the formula. Moisture and dry extract yield of the benchmark samples were determined by drying method. ResultA total of 27 compounds were inferred from the benchmark samples of Liangditang， among which 9 compounds were confirmed by comparison with the control， including catalpol， harpagide， gallic acid， albiflorin， paeoniflorin， verbascoside， angoroside C， cinnamic acid and harpagoside. A method for determining the characteristic maps of the benchmark samples were established and 13 peaks were assigned， and the characteristic peaks were mainly derived from wine-processed products of Rehmanniae Radix， Scrophulariae Radix and wine-processed products of Paeoniae Radix Alba. The similarity between the characteristic map of 15 batches of benchmark samples and the control characteristic map was >0.9. Methods for the determination of paeoniflorin， harpagoside， L-hydroxyproline and glycine were established， and the contents of these four components in 15 batches of benchmark samples were within ±30% of the corresponding mean value， and the transfer rate of decoction pieces to the benchmark samples was stable and controllable. TLC was established to identify 5 prescription drugs （except Ejiao） with two kinds of test solutions， and the results showed that the method had good specificity. The average dry extract yield was 48.06%， and the average moisture was 5.58%， which were within the range of ±10% and ±30% of their mean values， respectively. ConclusionThe quality standard of Liangditang benchmark samples was as follows：the similarity between the benchmark samples and the control characteristic map is >0.9， the contents of paeoniflorin， harpagoside， L-hydroxyproline and glycine are 217-403， 24-46， 634-1 178， 1 253-2 328 mg per dose， the dry extract yield is 43.0%-53.0%， the moisture is 4.0%-7.0%， under the set detection conditions， the benchmark samples have corresponding characteristic spots by comparing with the control herbs of 5 medicines. This quality standard is stable and reliable， which fills the gap in the quality control of Liangditang， and can provide a reference for the establishment of the quality standard of Liangditang granules.

Objective:To evaluate the prognosis and determine the failure patterns after radiotherapy for low-risk early-stage patients with extranodal NK/T-cell lymphoma, nasal-type (ENKTCL).Methods:A total of 557 patients from 2000—2015 with low-risk early-stage ENKTCL who received radiotherapy (RT) with or without chemotherapy (CT) from China Lymphoma Collaborative Group were retrospectively reviewed. Among them, 427 patients received combined modality therapy, whereas 130 patients received RT alone. Survivals were calculated by Kaplan-Meier method and compared with Log-rank test. Overall survival (OS) was compared with age and sex-matched general Chinese population using expected survival and standardized mortality ratio (SMR). Cox stepwise regression model was used for multivariate analysis.Results:The 5-year OS and progression-free survival (PFS) were 87.2% and 77.2%. The SMR was 3.59 ( P<0.001) at 1 year after treatment, whereas it was 1.50 at 4 years after treatment, without significant difference between ENKTCL group and country-matched general population ( P=0.146). Compared with RT alone, CMT did not result in significantly superior 5-year OS (87.0% vs 87.4%, P=0.961) or PFS (76.1% vs 80.7%, P=0.129). Local failure (11.5%, 64/557) and distant failure (10.8%, 60/557) were the main failure modes, while regional failure was rare (2.9%, 16/557). The 5-year locoregional control rate (LRC) was 87.2% for the whole group, with 89.5% for ≥50 Gy versus 73.7% for <50 Gy ( P<0.001). Radiotherapy dose was an independent factor affecting LRC( P<0.05). Conclusions:Radiotherapy achieves a favorable prognosis in patients with low-risk early-stage ENKTCL. The incidence of either locoregional or distant failure is low. Radiation dose still is an important prognostic factor for LRC.

Objective:To assess the effect of serum heat inactivation on the detection of 2019 novel coronavirus (2019-nCoV) specific IgM and IgG antibodies by colloidal gold method.Methods:The serum specimens were collected from a total of 106 Coronavirus Disease 2019 (COVID-19) patients and 52 control subjects. Both the fresh serum and the heat inactivated serum samples from the same patient were detected simultaneously with the 2019-nCoV IgM and IgG antibodies detection kit (colloidal gold method). According to the patient′s onset time, the positive rates of antibodies production profile were calculated. The influence of heat inactivation on the detection rates of antibodies at different stages of disease after onset was analyzed.Results:The test results of the specimens of the healthy control group before and after inactivation were all negative. For the 106 specimens of COVID-19 patients, the detection rates of 2019-nCoV specific IgM and IgG antibodies were reduced after heating at 56 ℃ for 30 min. The positive rates of IgM antibodies significantly decreased from 66.04% (70/106) to 43.40% (46/106) ( χ2=22.042, P=0.000), while the positive rates of IgG antibodies slightly decreased from 81.13% (86/106) to 76.42% (81/106) ( χ2=0.800, P=0.063). Further analysis revealed that there was a significant difference in the positive rates of IgM antibodies before and after heat inactivation in the 3rd, 5th and 6th week after onset. However, there was no statistically significant difference in the detection rates of IgG antibodies before and after serum heat inactivation in different periods of onset. Conclusions:Heat inactivation significantly decreased the detection rates of 2019-nCoV specific IgM antibodies, which may lead to serological false negative results.

Objective:To evaluate the prognosis and determine the failure patterns after radiotherapy for low-risk early-stage patients with extranodal NK/T-cell lymphoma, nasal-type (ENKTCL).Methods:A total of 557 patients from 2000—2015 with low-risk early-stage ENKTCL who received radiotherapy (RT) with or without chemotherapy (CT) from China Lymphoma Collaborative Group were retrospectively reviewed. Among them, 427 patients received combined modality therapy, whereas 130 patients received RT alone. Survivals were calculated by Kaplan-Meier method and compared with Log-rank test. Overall survival (OS) was compared with age and sex-matched general Chinese population using expected survival and standardized mortality ratio (SMR). Cox stepwise regression model was used for multivariate analysis.Results:The 5-year OS and progression-free survival (PFS) were 87.2% and 77.2%. The SMR was 3.59 ( P<0.001) at 1 year after treatment, whereas it was 1.50 at 4 years after treatment, without significant difference between ENKTCL group and country-matched general population ( P=0.146). Compared with RT alone, CMT did not result in significantly superior 5-year OS (87.0% vs 87.4%, P=0.961) or PFS (76.1% vs 80.7%, P=0.129). Local failure (11.5%, 64/557) and distant failure (10.8%, 60/557) were the main failure modes, while regional failure was rare (2.9%, 16/557). The 5-year locoregional control rate (LRC) was 87.2% for the whole group, with 89.5% for ≥50 Gy versus 73.7% for <50 Gy ( P<0.001). Radiotherapy dose was an independent factor affecting LRC( P<0.05). Conclusions:Radiotherapy achieves a favorable prognosis in patients with low-risk early-stage ENKTCL. The incidence of either locoregional or distant failure is low. Radiation dose still is an important prognostic factor for LRC.

Objective: To evaluate the accuracy of the new non-invasive liver disease model platelet-albumin-bilirubin index (PALBI) in the diagnosis of patients with acute upper gastrointestinal hemorrhage (AUGIB) due to cirrhosis. Methods: 277 patients with AUGIB due to cirrhosis were analyzed retrospectively. The data of platelet, total bilirubin, albumin, creatinine, international standardized ratio and etiology of cirrhosis were collected. Univariate and multivariate logistic regression analysis was used to identify independent risk factors for death in patients with cirrhosis complicated by AUGIB. Analysis of variance was used to compare the differences between the model for end-stage liver disease (MELD) and PALBI grades. Pearson correlation analysis was used to assess the association between MELD and PALBI. The operating characteristic curve (ROC) was used to compare the predictive power of both for short-term and long-term mortality in patients with cirrhosis complicated by AUGIB. Results: The short-term and long-term mortality rates of patients with cirrhosis complicated by AUGIB were 13.7% and 23.5%, respectively. The average hospital stay was (9.1±3.9)days. The high MELD score and high PALBI index were confirmed as independent risk factors of death by single factor and multiple factors [odds ratio (OR)=1.17, 4.43; P<0.05]; the Pearson correlation analysis showed there was a positive correlation between MELD score and PALBI index (r=0.735, P<0.05). The PALBI score was scored in MELD-a patients, further subdivided into PALBI-1a and PALBI-1b. There were statistical difference in the 1-year mortality rate between the two groups (7.0% vs 17.8%, χ²=4.033, P<0.05). The ROC curve was used to compare the predictive power of MELD and PALBI for short-term mortality. The area under curve (AUC) of PALBI was 0.767 (95% CI: 0.712-0.815), while the AUC of the MELD score was 0.651 (95% CI: 0.591-0.707), with statistically significant difference (Z=2.328, P<0.05). The predictive power of PALBI and MELD for long-term mortality were 0.731(95% CI: 0.674-0.782), 0.754 (95% CI: 0.699-0.804), but the difference was not statistically significant (Z=0.828, P>0.05). Conclusions PALBI has a better predictive effect on patients with cirrhosis complicated by AUGIB than MELD scores. PALBI can achieve a more precise prognosis classification for patients with MELD-a, and maintain a good prediction ability on the short-term (within 30 days of hospitalization and discharge) and long-term (within 1 year after discharge) mortality of patients. As a new liver disease model, PALBI can be used as an effective non-invasive means to judge the prognosis of patients with liver cirrhosis complicated by AUGIB .

Objective To have SD rats inhaled with different drugs,and observe their lung pathological change of lungs through light microscopy,in order to evaluate the safety of different drugs inhaled by natural rats. Methods A total of 40 rats were randomly divided into 8 groups,and every group had 5 rats,including blank control groups,9 g/L saline group,Salbutamol group,Dingchuantang group,Shuanghuanglian group,Centamicin group,Danshen group,Silicon dioxide group,twice a day,last 56 days totally. Then,blood and bronchoalveolar lavage fluid were collected and analyzed for cell count,percent of each type of cell,to measure the severity of the inflammation. Additionally,histopathology re-vealed the lungˊs pathological change and the number of dust cell;while immunohistochemistry revealed CD163 respon-ding. Results (1)White blood cell count:blank control group(3. 96 ± 0. 36)×109/L,9 g/L saline group(4. 66 ± 0. 58)×109/L,Salbutamol group(4. 06 ± 0. 86)×109/L,Dingchuantang group(8. 98 ± 1. 08)×109/L,Shuanghuang-lian group(7. 10 ± 0. 88)×109/L,Centamicin group(6. 14 ± 0. 89)×109/L,Danshen group(9. 84 ± 2. 33)×109/L, Silicon dioxide group(8. 99 ± 2. 48)×109/L,and comparative analysis of the 8 groups had significant difference(F＝14. 530,P<0. 05);the differences among blank control group,9 g/L saline group and Salbutamol group were not sig- nificant(all P>0. 05). White cell count in BALF:blank control group(2. 16 ± 1. 04)×109/L,9 g/L saline group (3. 94 ± 0. 67)×109/L,Salbutamol group(4. 36 ± 1. 15)×109/L,Dingchuantang group(14. 58 ± 2. 93)×109/L, Shuanghuanglian group(19. 68 ± 6. 29)×109/L,Gentamicin group(11. 74 ± 1. 03)×109/L,Danshen group(44. 75 ± 10. 8)×109/L,Silicon dioxide group(53. 54 ± 14. 25)×109/L,and comparative analysis of the 8 groups had signifi-cant difference(F＝40. 616,P<0. 05);the differences among blank control group,9 g/L saline group and Salbutamol group were not significant(all P>0. 05). Lymphocyte count in BALF:blank control group(18. 70 ± 9. 00)×108/L, 9 g/L saline group( 36. 01 ± 5. 99 )×108/L,Salbutamol group( 38. 95 ± 11. 69 )×108/L,Dingchuantang group (132. 70 ± 26. 94)×108/L,Shuanghuanglian group(173. 56 ± 57. 6)×108/L,Gentamicin group(106. 60 ± 16. 76)× 108/L,Danshen group(340. 63 ± 70. 97)×108/L,Silicon dioxide group(495. 63 ± 131. 95)×108/L,and comparative analysis of the 8 groups had significant difference(F＝41. 980,P<0. 05);the differences among blank control group, 9 g/L saline group and Salbutamol group were not significant(all P>0. 05).(2)Number of lung dust cell count in 10 sight of high light microscopy:blank control group 12/10 HP,9 g/L saline group 26/10 HP,Salbutamol group 17/10 HP,Dingchuantang group 262/10 HP,Shuanghuanglian group 133/10 HP,Gentamicin group 109/10 HP,Danshen group 96/10 HP,Silicon dioxide group 315/10 HP,and comparative analysis of the 8 groups had significant difference (F＝69. 915,P<0. 05);the differences among blank control group,9 g/L saline group and Salbutamol group were not significant(all P>0. 05).(3)Hematoxylin-eosin staining of lung:blank control group,9 g/L saline group and Sal-butamol group had no pathological change in the lung,but Salbutamol group,Dingchuantang group,Shuanghuanglian group,Gentamicin group,Danshen group and Silicon dioxide group had pathological changes in different degrees.(4) Immunohistochemistry of CD163 responding:blank control group,9 g/L saline group and Salbutamol group had negative expression,Salbutamol group,Dingchuantang group,Shuanghuanglian group,Gentamicin group,Danshen group and Sili-con dioxide group had positive expression in different degrees. Conclusions 9 g/L saline,salbutamol for atomized inhalation does not cause lung tissue damage;Long-term use of non-atomized drugs in atomization can cause lung tissue injury in SD rats,and the severity varies with specific drugs.

Objective: To explore the related factors of death from severe heat stroke in Shanghai from 2013 to 2017. Methods: The data of 1 152 patients with severe heat stroke who were divided into survival (n=1 037) and death (n=115) groups including gender, age and heat stroke type (heat cramp, heat exhaustion, heat apoplexy and the mixed type) were collected from meteorological bureau and case report system for high temperature heat stroke in Shanghai from 2013 to 2017. Meanwhile, the meteorological data of the onset date of severe heat stroke cases were collected, including maximum temperature, minimum temperature, daily temperature, relative humidity, air pressure, precipitation and wind speed. The differences of individual and meteorological factors between the two groups were compared, and multivariate logistic regression model was used to analyze the related factors of death from severe heat stroke. Results: Among 1 152 cases, the mean±SD of age was (56.29±18.95) years old, 843 (73.18%)were male, 962 (83.51%) were in the heat wave period; 322 cases (27.95%) were heat cramp, 170 cases (14.76%) were heat exhaustion, 533 cases (46.27%) were heat apoplexy and 114 cases (9.90%) were the mixed type. Daily average temperature ((32.81±1.99) ℃), daily maximum and minimum temperatures ((38.20±2.24) ℃ and (29.22±1.94) ℃) in survival group were lower than those in death group (all P values<0.001), which were (33.76±1.17) ℃, (39.19±1.31) ℃ and (29.72±1.66) ℃. Daily average relative humidity ((60.36±9.75)%) and daily minimum relative humidity ((41.26±9.71)%) in survival group were higher than those in death group(allP values <0.05), which were (54.59±6.89)% and (35.60±7.24)%. The results of logistic regression analysis suggested that compared with the cases with daily average humidity <60% and a mixed type heat stroke, the death OR (95%CI) values of cases with daily average humidity >60%, heat cramp, heat exhaustion and heat apoplexy were 0.31 (0.18,0.54), 0.13 (0.05,0.34), 0.68 (0.58,2.30) and 0.87 (0.48,1.58). Conclusion The temperature, relative humidity and the type of heat stroke were the main related factors affecting the prognosis of severe heat stroke.