On-site supervision is a risk-based regulatory system that requires the scientific development of supervision plans for quality risks and hidden dangers in pharmaceutical enterprises， the rational allocation of supervision resources based on their risk levels， and the implementation of classified supervision measures. In this study， the quality risk monitoring business support system is set up for pharmaceutical enterprises by establishing the quality risk expert database and quality risk monitoring index system for pharmaceutical enterprises based on the difficulty analysis of on-site drug supervision. Based on this support system， the quality risk classification method， the differentiated spot check strategy and business auxiliary visualization system are established. This support system is used to learn the risk level of pharmaceutical enterprises， so as to innovate supervision methods and optimize monitoring strategies. Taking Jiangxi Province as an example， it is verified that the support system can guide the risk assessment of sample enterprises， can improve the targeting of on-site drug supervision in the process of technical review， scheme editing， on-site implementation and comprehensive evaluation， and can effectively improve the quality and efficiency of supervision.

Objective:The evidence-based and Delphi methods were used to construct the exercise program for hospitalized patients with diabetes foot to provide guidance for clinical practice.Methods:Evidence on exercise management of diabetic foot patients was systematically searched from BMJ Best Practice, UpToDate, Registered Nurses′ Association of Ontario and other domestic and foreign databases and professional association websites. The retrieval period was from the establishment of the database to April 2021. The quality of the included literature was independently evaluated, and the evidence of the literature meeting the quality standards was extracted and summarized to form the first draft of exercise program for inpatients with diabetic foot. After two rounds of Delphi expert letter consultation, the program items were revised, and the final draft of the exercise program for inpatients with diabetic foot suitable for clinical practice was formed.Results:The effective recovery rate of the two rounds of expert correspondence questionnaire both were15/15. The expert authority coefficient was 0.865 and 0.895 respectively. And the Kendall coordination coefficient was 0.232 and 0.291 (both P<0.01). An exercise program for inpatients with diabetic foot had been formed, including 5 modules(exercise evaluation, exercise prescription, exercise monitoring, post-exercise evaluation and exercise management), 12 items and 40 operational items. Conclusions:The exercise program for inpatients with diabetic foot constructed in this study is scientific and clinically applicable, which provide scientific guidance for clinical medical staff to carry out exercise practice.

Objective:The aim of this study was to explore the perception and cognition of patients with laryngeal cancer post total laryngectomy accepted expressive writing intervention, analyze the intervention effect from the perspective of patients, and provide a basis for psychological intervention of these patients.Methods:From July to August 2021, the descriptive research method was applied to 13 patients with laryngeal cancer post total laryngectomy who had participated in the expressive writing intervention hosted in the General Hospital of Ningxia Medical University, in order to understand the patients′ perception and cognition of the intervention, and the data were analyzed by using content analysis method.Results:A total of 2 themes and 9 sub themes were extracted. Theme 1: the positive feedback of expressive writing intervention: relieve related physical symptoms and improve sleep; reduce anxiety and regulate emotions effectively; reduce psychological stress and promote positive coping; reduce stigma and improve social withdrawal; make up for lost pronunciation and clear mind. Theme 2: Difficulties and challenges in the application of expressive writing intervention: physical discomfort affects the compliance of patients, poor economic status affects the enthusiasm of patients to participate, poor social and family support affects the willingness of patients to participate, and literacy and writing habits affect the completion of participation.Conclusions:The application of expressive writing intervention promotes the psychological and social functional rehabilitation of patients with laryngeal cancer post total laryngectomy and has satisfactory effects and certain feasibility. The researchers should fully consider the influencing factors of intervention and optimize the plan in the future.

Objective To understand the HPV vaccination situation in the vaccination clinic of Shaanxi Provincial Center for Disease Control and Prevention, and to guide the rational use of the vaccine. Methods The vaccination information and the information on HPV vaccine inoculated subjects in the clinic of Shaanxi Provincial Center for Disease Control and Prevention from 2018 to 2019 were analyzed. Results A total of 5 714 HPV vaccination subjects were analyzed, among which the largest proportion (48.97%) was in the 20-26.5 years old group, and the smallest proportion (1.12%) was in the 9-15 years old group. The 9-valent HPV vaccination accounted for 98.72% of the 20-26.5-year-old group. There were statistically significant differences in the distribution of vaccination populations between the bivalent and quadrivalent HPV vaccines (P＜0.01，χ²=252.85), and between the bivalent and 9-valent HPV vaccines (P＜0.01，χ²=258.15). The vaccination rate of the bivalent HPV vaccine was 88.25% (894/1 013), and the vaccination rate of the quadrivalent HPV vaccine was 94.43% (1 915/2 028). The difference was statistically significant (Z=-2.02, P=0.043). Conclusion Vaccination subjects tend to choose high-valent HPV vaccines, and the proportion of HPV vaccination in the younger age group is seriously insufficient. Both bivalent and quadrivalent HPV vaccines have relatively high overall vaccination rates. The next step should be to strengthen the vaccination publicity for younger age groups.

OBJECTIVE To establish a method for simultaneous determination of zeaxanthin ，β-carotene，β-cryptoxanthin palmitate and zeaxanthin dipalmitate in Lycium barbarum . METHODS L. barbarum was extracted with n-hexane-anhydrous ethanol-acetone-toluene（10∶6∶7∶7，V/V/V/V）by ultrasonic method. High performance liquid chromatography （HPLC）method was adopted. The determination was performed on YMC C 30 column with mobile phase A consisted of methanol-acetonitrile-water （81∶ 14 ∶ 5，V/V/V）and mobile phase B consisted of dichloromethane （gradient elution ）at the flow rate of 1.0 mL/min. The column temperature was set at 20 ℃. The detection wavelength was set at 450 nm，and sample size was 20 μL. Using zeaxanthin as control，the relative correction factors （RCFs）of β-carotene，β-cryptoxanthin palmitate and zeaxanthin dipalmitate were calculated ， and then the content of each component was calculated according to RCFs and compared with the results of external standard method（ESM）. RESULTS The linear range of zeaxanthin ，β-carotene，β-cryptoxanthin palmitate and zeaxanthin dipalmitate were 0.119 4-2.983 8，0.121 7-1.521 6，0.285 9-5.718 8，8.460 5-211.513 3 μg/mL（all R2＞0.999）. RSDs of precision ，repeatability and stability（16 h）tests were all less than 4％. The average recoveries were 103.34％，107.37％，105.64％，96.16％（RSD＜5％，n＝ 9）. The average RCFs of β-carotene，β-cryptoxanthin palmitate and zeaxanthin dipalmitate were 1.109，1.390，1.158. The relative errors of the content determination results by quantitative analysis of multi-components by singer marker （QAMS）and ESM were within ±1％. CONCLUSIONS The established HPLC-QAMS method is accurate and stable ，which can be used for the content determination and quality control of 4 carotenoids in L. barbarum .

【Objective】 To explore the precautions of pre-transfusion examination in patients with antibodies to erythrocyte protective solution, discrepant ABO blood typing results, and positive unexpected antibodies, so as to ensure the safety of blood transfusion. 【Methods】 The screen cells were divided into two groups according to the presence or absence of washing reagent red blood cells in normal saline. One group had untreated forward typing cells, antibody screening cells and identification panel, and the other group had saline-washed reverse typing cells, antibody screening cells and identification panel. The experiments were carried out by microcolumn gel method, saline medium method and polyamine method to analyze the effect of red blood cell preservation solution on serum agglutination reaction of specific patients. 【Results】 Among the 8 patients, forward typing was AB (+ ) in 1 patient, B (+ ) in 4, and A(+ ) in 3, and the reverse typing were interfered. The plasma of 8 patients agglutinated with unwashed reverse typing cells (saline tube method), screen cells and identification panels (saline tube method plus cassette method), while not agglutinated with the polybrene method. The interference was eliminated as using washed reverse typing cells (salinetube method), screen cells and identification panels (saline tube method plus cassette method). 【Conclusion】 The erythrocyte preservation solution affected patients’ blood group typing, but not affected the outcome of blood transfusion as no adverse reactions occurred.

BACKGROUND: Acquired immune deficiency syndrome (AIDS)-related non-Hodgkin lymphoma (AR-NHL) is a high-risk factor for morbidity and mortality in patients with AIDS. This study aimed to determine the prognostic factors associated with overall survival (OS) and to develop a prognostic nomogram incorporating computed tomography imaging features in patients with acquired immune deficiency syndrome-related non-Hodgkin lymphoma (AR-NHL). METHODS: A total of 121 AR-NHL patients between July 2012 and November 2019 were retrospectively reviewed. Clinical and radiological independent predictors of OS were confirmed using multivariable Cox analysis. A prognostic nomogram was constructed based on the above clinical and radiological factors and then provided optimum accuracy in predicting OS. The predictive accuracy of the nomogram was determined by Harrell C-statistic. Kaplan-Meier survival analysis was used to determine median OS. The prognostic value of adjuvant therapy was evaluated in different subgroups. RESULTS: In the multivariate Cox regression analysis, involvement of mediastinal or hilar lymph nodes, liver, necrosis in the lesions, the treatment with chemotherapy, and the CD4 ≤100 cells/μL were independent risk factors for poor OS (all P < 0.050). The predictive nomogram based on Cox regression has good discrimination (Harrell C-index = 0.716) and good calibration (Hosmer-Lemeshow test, P = 0.620) in high- and low-risk groups. Only patients in the high-risk group who received adjuvant chemotherapy had a significantly better survival outcome. CONCLUSION A survival-predicting nomogram was developed in this study, which was effective in assessing the survival outcomes of patients with AR-NHL. Notably, decision-making of chemotherapy regimens and more frequent follow-up should be considered in the high-risk group determined by this model.
Acquired Immunodeficiency Syndrome ; Humans ; Lymphoma, Non-Hodgkin ; Neoplasm Staging ; Nomograms ; Prognosis ; Retrospective Studies

Objective To study the effects of schisandrin B (Sch B) on the apoptosis of human breast cancer MDA-MB-231 cells and its mechanism. Methods Cell counting reagent (CCK-8) was used to detect the effect of Sch B on the survival rate of MDA-MB-231 cells. MDA-MB-231 cells were treated with Sch B (10, 20, 40 μmol/L) for 24 hours. The cell death was detected by Annexin V-FITC/PI. The levels of intracellular reactive oxygen species (ROS) were detected by DCFA-DA fluorescent probe. Apoptosis and the expression of endoplasmic reticulum stress related proteins (Bcl-2、Bax、CHOP、GPR78、PERK、p-PERK、p-eIF2α、eIF2) were detected by Western blot. Results Compared with the blank group, the cell survival rate decreased significantly (P<0.01) with the increase of Sch B concentration, and its IC₅₀ was 19.16 μmol/L. Compared with the control group, Sch B groups (10, 20, 40 μmol/L) inhibited cell clone formation in a dose-dependent manner (P<0.05). Sch B groups (10, 20, 40 μmol/L) induced apoptosis (P<0.05), significantly reduced the expression of anti-apoptotic protein Bcl-2 and significantly increased the expression of pro-apoptotic protein Bax (P<0.05). Sch B groups (10, 20, 40 μmol/L) significantly increased the level of intracellular ROS in a dose-dependent manner (P<0.05). Sch B groups (10, 20, 40 μmol/L) stimulated endoplasmic reticulum stress and increased the expressions of endoplasmic reticulum stress-related proteins CHOP, GPR78 and p-eIF2α in a dose-dependent manner (P<0.05). Conclusion Sch B induces apoptosis of MDA-MB-231 cells through ROS mediated endoplasmic reticulum stress.

Objective To analyze the epidemiological features,spectrum and case fatality of malignant tumor patients in Shenzhen city,to provide evidence for the development of prevention and treatment strategies on malignant tumor in Shenzhen.Methods All the hospitalized malignant tumor patients including deaths,were monitored from 1995 to 2014 in Shenzhen,and data was analyzed by SPSS 20.0 software.Results There were 160 988 inpatients of malignant tumors between 1995 and 2014 in Shenzhen.The top three hospitalized tumors were lung (13.64％),liver (11.13％) and breast (7.86％) cancers.Numbers of the malignant tumor inpatients had been rapidly increasing during the past 20 years,12.3 times in 2014 higher than in 1995.The total number of deaths due to malignant tumors was 19 460.Deaths of the top three malignant tumors were lung (24.40％),liver (19.84％) and colorectal (8.63％) cancers and the number of deaths was increasing,12.5 times higher in 2014 than in 1995.The overall case fatality rate was 12.09％.The annual percent change (APC) of malignant tumors case fatality rate was 9.7％(95％CI:2.0％-18.0％),during 1995-2003,with an increasing trend (t=2.72,P＜0.05).The APC of case fatality rate during 2003-2014 was-3.4％(95％CI:-7.6％-1.1％),but the decreasing trend (t=-1.63,P＞0.05) was not statistically significant.The top three major malignant tumors related to case fatality rate were lung cancer (21.62％),liver cancer (21.39％),and esophageal cancer (16.50％).The case fatality rates of leukemia and liver cancer had decreased during the past 20 years.The case fatality rates of cancers in lung,esophagus,stomach,breast,colorectal and nasopharyngeal,had all increased.The number of male patients was significantly exceeding the females (x2=41.691,P＜0.01),with sex ratio as 1.65:1.From age 35 and on,the number of deaths due to malignant tumors increased significantly,with the peak after 60 years of age.Conclusions The number of malignant tumor inpatients had an annual increase as well as the case fatality rate.Cancers in lung,liver appeared the leading causes of death among the malignant tumor patients,with elderly in particular.Strategies related to the prevention and treatment of cancers in lung,liver should be strengthened.

Objective ThrouGh the detection of heat shock protein 90(HSP90)Gene expression in the peripheral blood in in patients with hypertensive disorders complicatinG preGnancy( HDCP ),to understand its role in the pathophysioloGy of HDCP. Methods The expression of HSP90 was observed in Groups of normal preGnant women,Gestational hypertension patients,mild preeclampsia patients,severe preeclampsia patients by ELISA. Results The expression of HSP90 in peripheral blood of Gestational hypertension Group,mild preeclampsia Group,severe preeclampsia Group were siGnificantly hiGher than normal preGnant Group( P<0. 0l ) . Conclusion HSP90 may have close relationship with the onset and development of HDCP. It can predict HDCP by detectinG the level of HSP90 in peripheral blood.