Objective:To analyze and summarize the key points of design and implementation of new drug clinical trials for ankylosing spondylitis.Methods:The platform for drug clinical trial registration and information published on the official website of center for drug review and evaluation of national medical products administration (CDE) was searched to obtain data and classified statistics was conducted then. The Mean±SD and M ( Q1, Q3) were used for quantitative data for statistical description, and the rate, composition or relative ratio of qualitative data were used for statistical description. Results:A total of 23 clinical trials meeting the requirements were screened, among which 19 were biological products included in nine phase Ⅲ clinical trials. Among the four chemical drugs, two were phase Ⅱ clinical trials. One of the clinical trials on AS adopted the 1966 New York classification criteria, accounting for 4%. Nineteen of the trials adopted the1984 New York classification criteria, accounting for 83%. Three other trials adopted unspecified classification criteria, accounting for 13%. In one of these clinical trials, the age of patients included was older than 16 years old, 9 trials were 18 to 65 years old, 6 were 18 years old but without upper limit. In the definition of active AS, 19 trials took BASDAI≥4 as the cut-off value for active disease, and BASDAI, total back pain, spinal pain and morning stiffness were regarded as active disease in 4.Conclusion:The number of dosestic AS clinical trial projects continnes to rise. The 1984 classification criteria is adopted as the classification criteria in clinical trials. The minimum age in the inclusion criteria is 18 years old, there is no upper limit in age for inclusion. Disease activity can be evaluated by BASDAI score, combined with comprehensive indicators such as night-time back pain, global spinal pain and morning stiffness.

Objective To investigate the efficacy and safety of interventional therapy for bronchopleural fistula(BPF).Methods A total of 172 patients with confirmed BPF were treated with continuous negative pressure drainage(CNPD)and/or airway stent occlusion therapy.The clinical data were collected,and its effectiveness and safety were analyzed.Results In 5-7 days after interventional treatment,the pneumonia severity index(PSI)decreased significantly,and successful drainage was achieved in 166 patients(96.5％).One month after interventional therapy,the lung volume was remarkably increased.The median clinical healing time of interventional therapy was 9.0 months(95％CI=6.18-1 1.83).Multivariate analysis of the Cox proportional hazards model showed that the diagnosis time(HR=0.53,95％CI=0.38-0.74,P＜0.01)and fistula size(HR=0.74,95％CI=0.55-0.99,P=0.04)were significantly correlated with the clinical healing time.Conclusion For the treatment of BPF,CNPD and/or airway stent occlusion has several advantages such as accurate operation,minimally invasive,safe and effective.It can quickly improve the symptoms and quality of life,and prolong survival,therefore,it is worthy of clinical promotion and application.(J Intervent Radiol,2024,33:641-645)

Objective:To compare the efficacy and safety of different dosages of new drugs in the treatment of PsA by using network meta-analysis.Methods:Three medical databases (PubMed, Web of Science, Cochrane Library) were searched for the studies that compared the efficacy and safety of 4 new drugs (secukinumab, ixekizumab, apremilast, tofacitinib) with different dosages in the treatment of PsA. Data from included studies were analyzed by Stata 15.0.Results:A total of 16 RCTs were included. The results of the network meta-analysis showed that: (1) Among the overall patients, in terms of ACR20 response rate, the larger the surface under the cumulative ranking (SUCRA), the more effective it is. Secukinumab 300 mg Q4W(96.1%) had the best efficacy, followed by ixekizumab 80 mg Q4W(79.0%), ixekizumab 80 mg Q2W(75.1%), secukinumab 150 mg Q4W(73.2%), apremilast 30 mg BID(50.6%), apremilast 20 mg BID(38.6%), tofacitinib 5 mg BID(18.1%), tofacitinib 10 mg BID(17.7%) and placebo(2.0%). (2) In terms of PASI75 response rate, the larger the area under the SUCRA curve, the more effective it is. Ixekizumab 80 mg Q4W(96.1%) had the best efficacy, followed by ixekizumab 80 mg Q2W(88.7%), secukinumab 300 mg Q4W(75.6%), secukinumab 150 mg Q4W(63.3%), apremilast 30 mg BID(44.5%), apremilast 20 mg BID(38.4%), tofacitinib 10 mg BID(30.0%), tofacitinib 5 mg BID(12.5%) and placebo(1.0%). (3) Among the overall patients, in terms of safety, the smaller the area under the SUCRA curve, the higher the safety it is. Secukinumab 300 mg Q4W (17.3%) has the best safety. (4) The results of subgroup analysis showed that in terms of ACR20 response rate, ixekizumab 80 mg Q2W(85.3%) had the best efficacy in bDMARDs-na?ve patients, while in bDMARDs-IR patients, secukinumab 300 mg Q4W(83.9%) had the best efficacy.Conclusion:Among all patients, secukinumab 300 mg Q4W is the best in terms of ACR20 response rate and safety, but ixekizumab 80 mg Q4W is more effective in improving PsA lesions comparing yo other drugs.

Objective: The consistency of 24-hour oropharyngeal Dx-pH monitoring and proton pump inhibitor(PPI) test in the diagnosis of laryngopharyngeal reflux disease (LPRD) was investigated. Methods: Sixty patients with laryngopharyngeal reflux (LPR) related symptoms who had never received PPI treatment were assessed by reflux symptom index (RSI) and reflux finding score (RFS) between October 2017 and October 2018, including 28 males and 38 females, aged from 16 to 72 years, with a medium age of 38 years. Prior to treatment, all patients were evaluated with 24 hours oropharyngeal Dx-pH monitoring(Restech). After empiric therapy with PPI twice-daily for 8 weeks, the efficacy was evaluated according to posttreatment RSI score.The data was analysed with Kruskal-Wallis test, Student Newman Keuls test and consistency check. Results: (1)Among all 60 patients,13 patients (21.7%) had pathologic Ryan score and all resulted responsive to PPI;27 patients (45.0%) with a negative Ryan score were unresponsive to PPI; 20 patients (33.3%) despite a negative Ryan score resulted responsive to PPI therapy. Considering responsiveness to PPI therapy as the gold standard for the diagnosis of LPRD, the sensitivity, specificity, positive predictive value and negative predictive value of Ryan score were 39.4%, 100%, 100% and 57.4% respectively. The Kappa value was 0.369 (P<0.01). (2)Among 34 patients (56.7%) with positive Dx-pH results (24-hour oropharyngeal acid reflux events≥ 3 times), 29 patients were positive and 5 patients were negative in PPI test. Among 26 patients with negative Dx-pH results (24-hour oropharyngeal acid reflux events<3 times), 4 patients were positive and 22 patients were negative in PPI test. Considering responsiveness to PPI therapy as the gold standard for the diagnosis of LPRD, the sensitivity, specificity, positive predictive value and negative predictive value of 24-hour oropharyngeal acid reflux events were 87.9%, 81.5%, 85.3% and 84.6% respectively. The Kappa value was 0.696(P<0.01). Conclusions There is a positive correlation between 24-hour oropharyngeal Dx-pH monitoring positive results (24-hour oropharyngeal acid reflux events≥3 times) and PPI test in the diagnosis of LPRD. The 24-hour oropharyngeal Dx-pH monitoring can be a promising tool for the diagnosis of suspected LPRD patients, and more sensitive and accurate Dx-pH diagnostic index will be required in the clinic.

Objective To provide references for future government science and technology plan on providing projects for the research and development of new vaccine products.Methods Through analyzing various vaccines that have gained projects from government science and technology plan,this paper summarizes types of science and technology projects,funding proportion and characteristics of science and technology projects at national,provincial and municipal level for vaccine at different research and development stages.Results In general,the supporting categories and levels of projects at different levels are clear.Each research and development stage of new vaccine products has corresponding science and technology planning projects,which are closely linked with each other.Conclusions The government's science and technology funding plays an important role in guiding and promoting the research and development of new vaccine products.

Objective To explore the correlation between lipoprotein-associated phospholipase A2 (Lp-PLA2) and perioperative myocardial injury (PMI),and to discuss the predictive value of Lp-PLA2 in patients with stable angina after percutaneous coronary intervention (PCI).Methods A total of 222 consecutive patients with stable angina,who were admitted to Yixing Municipal People's Hospital,Jiangsu Province,China to receive PCI during the period from June 2015 to March 2017,were enrolled in this study.The patients' baseline data as well as the distribution pattern of coronary lesions,were recorded.According to the paclitaxel-PCI and the surgical cooperative study (SYNTAX) score,the severity of target vascular lesions was assessed,which was classified into low score group (0 to 22 points),middle score group (23 to 32 points) and high score group (≥33 points).The preoperative blood lipid level and renal function,both preoperative and postoperative Troponin T (cTnT),high sensitive C reactive protein(hs-CRP),as well as the postoperative Lp-PLA2 were tested.Results After the procedure,the Lp-PLA2 levels in patients with normal cTnT value (n=155) and in patients with elevated cTnT value (n=67) were(122.21±43.80) ng/ml and (224.53±65.00) ng/ml respectively (P＜0.05).SYNTAX score analysis showed that low score group had 120 patients,middle score group had 78 patients and high score group had 24 patients,the Lp-PLA2 levels of the above three groups were (119.51±51.96) ng/ml,(178.67±61.49) ng/ml and (233.16±61.32) ng/ml respectively,the differences were statistically significant between each other among the three groups (P＜0.05).Pearson correlation analysis indicated that a parallel correlation existed between Lp-PLA2 levels and postoperative cTnT values (R=0.492,P＜0.05).Logistic regression analysis revealed that Lp-PLA2 was the independent risk factor for elevated cTnT value during the perioperative period of PCI (OR=7.377,95％CI=3.368-16.156,P＜0.05).The area under ROC curve of Lp-PLA2 was 0.896 (95％CI=0.874-0.945,P＜0.001),the best cut-off point was 179 ng/ml,and the sensitivity and specificity for the diagnosis of PMI were 92.2％ and 66.7％,respectively.Conclusion Lp-PLA2 levels are closely correlated with the increased cTnT values after PCI,and the preoperative high level of Lp-PLA2 is the independent risk factor for PMI after PCI.

Objective:To investigate the effects of Liuweidihuang pill on the insulin levels in sera and pancreatic islets from spontaneous mouse models of human type 2 diabetes administrated with different doses .Methods:The 6-8 week-old KK-Ay mice were randomly divided into three groups including no drug control group ,low-dose group and high-dose group,in addition C57BL/6J mice were used as a genetic control group .All the animals were given with different dose Liuweidihuang pill solutions or sterile distilled water by intragastrical administration for fifteen weeks .The fasting blood glucose ,body mass and food consumption were measured weekly .The serum insulin levels were surveyed by ELISA .And the insulin levels in the pancreas islets were detected by immunofluorescence and immunohistochemistry .Results:Decreased fasting blood glucose ,controlled body mass and food consumption ,and lower levels of insulin in the sera and pancreas islets were confirmed from the KK-Ay mice administered with Liuweidihuang pill .Furthermore,the low dose program exhibits a stronger effect .Conclusion:Liuweidihuang pill has exhibited relatively therapeutic effects in the spontaneous type 2 diabetes mice including controls of hyperglycemia and body mass and relieving insulin resistance .In addition , the low-dose regimen showed even better treatment in controlling insulin levels in the sera and pancreas islets .

Objective To learn current status and influentcing factors of post competency among preventive medicine graduates from a medical university,in order to provide evidence for the improvement of post competency preventive medicine graduates.Methods We adopted stratified sampling strategy,chose 1 provincial,1 municipal and 2 county level CDCs,used self-developed questionnaires to survey preventive medicine graduates from a specific medical university.Clustering analysis,correlation analysis,Logistic regression and rank-sum test were applied to analyze data.Results Among all respondents,26 (40.63％) reported that they were totally competent on their posts,the rest 38 (59.37％) reported ordinary post competency.We found 7 factors that were significantly associated with post competency:fondness of the job,whether proactive on the job,whether responsible to the job,et al.Conclusion Post competency of preventive medicine graduates from this particular medical university exceeded preventive medicine graduates from Xinjiang Medical University.However,there still exists some problems for improvement.We recommend that universities and working units should improve post competency of preventive medicine students based on those influential factors we identified.

Objective To evaluate the comprehensive medical goal appraisal system on hand hygiene compliance rate of health care workers(HCWs).Methods Comprehensive medical goal appraisal system was adopted to inter-vene hand hygiene compliance rate of HCWs in a comprehensive hospital ,hand hygiene compliance rates of HCWs and consumption of instant hand sanitizer per bed-day before (December 2012)and after intervention (January 2013-June 2014)were compared.Results Hand hygiene compliance rate after intervention was higher than before interven-tion (85.17% [18 208/21 379]vs 39.92%[853/2 137]),hand hygiene compliance rate enhanced by 113.35%(χ2 =2 590. 81,P <0.001).Hand hygiene compliance rates of HCWs of different departments,different occupations and different hand hygiene moments were all higher than before intervention (all P <0.001);after intervention ,hand hygiene compliance rate revealed a increased tendency,and has maintained high since October 2013 (>90%),consumption of instant hand sanitizer before and after intervention was 7.24 mL/bed-day(4 200 L/579 841 bed-day)and 10.54 mL/bed-day(9 323.5L/884 489 bed-day)respectively,the consumption after intervention increased by 45.58% compared with that before intervention. Conclusion Comprehensive medical goal appraisal can effectively enhance hand hygiene compliance rate ,and maintains at a high level;the measure can affect hand hygiene behavior of HCWs by hawthorne effect,and is an effective and long-term measure to improve hand hygiene compliance of HCWs.

Background and purpose:Suppression of apoptotic signaling pathways is an important factor in tumor cell resistance. Research on cell apoptosis will open up a new way of reversing drug resistance and tumor treatment. This study examined the effects of a novel naphthalimide derivative 8c on multidrug resistant colon cancer HCT116/L-OHP cells and explored the molecular mechanisms underlying the apoptosis induction. Methods: The anti-proliferative effects of 8c were detected by CCK-8 assays and the effects on apoptosis induction were examined by lfow cytometry. The mRNA expression levels of p53, Bax and Bcl-2 were measured by real-time PCR;The protein expressions of p-p53, Bax, Bcl-2 and Cyt-c were detected by Western blot. Results:8c (IC50=8.16 μmol/L) seemed to be more potent than amonaifde (IC50=28.37 μmol/L) against HCT116/L-OHP cells. 8c induced apoptosis on HCT116/L-OHP cell lines through intrinsic or mitochondria dependent pathway. The protein expression of phosphorylation of p53 at Ser-15 was increased, but the mRNA level of p53 did not increase in HCT116/L-OHP cells. Bax protein and mRNA levels were signiifcantly increased, and Bcl-2 protein and mRNA levels were decreased, suggesting an increase of Bax/Bcl-2 ratios. Meanwhile, 8c induced a substantial release of cytochrome c from the mitochondria into the cytosol in HCT116/L-OHP cells. Conclusion: 8c induced cell death signal by inducing the activation p53 phosphorylation which subsequently activated related protein expressions of apoptotic pathway, which may be an important mechanism of 8c on inhibiting proliferation of HCT116/L-OHP resistant cells. All the results suggested that 8c was a potent compound to be developed as an anti-tumor and anti-resistance agent for clinic application in the future.