Objective Pharmacovigilance,as an essential component of post-marketing drug regulation,plays a crucial role in ensuring the safety of public medication use.In recent years,Artificial intelligence(AI)technology,with its powerful data processing and analysis capabilities,has shown tremendous potential in the field of Pharmacovigilance.This article introduced and analyzed the application background of AI technology in Pharmacovigilance,its exploration and current status both internationally and within China,highlighted its application in the country,as well as the associated problems and challenges from the perspective of post-marketing regulation.It aims to provide reference for post-marketing regulation in China.Currently,China's exploration and application of AI in pharmacovigilance have just begun,and efforts should be intensified and the pace accelerated.Regulatory agencies should actively develop and implement regulatory standards or relevant guidelines for AI technologies throughout the product lifecycle,strengthen personnel training,talent cultivation,and introduction,actively promote close cooperation among regulatory agencies,pharmaceutical companies,research institutes,and universities,and jointly promote the innovative application of AI technology in the field of drug regulation.

Objective Pharmacovigilance,as an essential component of post-marketing drug regulation,plays a crucial role in ensuring the safety of public medication use.In recent years,Artificial intelligence(AI)technology,with its powerful data processing and analysis capabilities,has shown tremendous potential in the field of Pharmacovigilance.This article introduced and analyzed the application background of AI technology in Pharmacovigilance,its exploration and current status both internationally and within China,highlighted its application in the country,as well as the associated problems and challenges from the perspective of post-marketing regulation.It aims to provide reference for post-marketing regulation in China.Currently,China's exploration and application of AI in pharmacovigilance have just begun,and efforts should be intensified and the pace accelerated.Regulatory agencies should actively develop and implement regulatory standards or relevant guidelines for AI technologies throughout the product lifecycle,strengthen personnel training,talent cultivation,and introduction,actively promote close cooperation among regulatory agencies,pharmaceutical companies,research institutes,and universities,and jointly promote the innovative application of AI technology in the field of drug regulation.

Objective To discuss the cause of relapse after the first surgery of varicose veins of lower limb,and corresponding prevention and treatment methods.Methods The data of 81 cases of recurrence varicose veins of lower limb in Department of Vascular Surgery,Yanzhou First People's Hospital from September 2010 to October 2016 were analyzed retrospectively,all patients receded ascending phlebography for deep veins Postoperative follow-up of 6 to 48 months was followed by the combination of outpatient and telephone follow-up,with the symptoms,signs and blood vessels of the lower extremities as the follow-up.Results Remnant of the main trunk or tributaries of great saphenous vein in 19 cases,31 limbs of deep venous incompetent,incompetent perforator veins 25 limbs,the residual of small saphenous vein were 3 cases,crockett's syndrome 10 cases,sequelae of deep venous thrombosis belongs to the residual 5 limbs,Klippel-Trenaunay syndrome 1 limbs.There were some patients who suffered from 2 reasons or more than two reasons simultaneously.After surgery again,the cure vate was 100％ and no serious complications such as deep vein throm-bosis.During the follow-up,12 patients showed different degrees of subcutaneous stasis,oral drug observation,and later regression.Local subcutaneous hematoma was 5 cases,2 cases of pure syringe were treated with pressure after suction,3 routine local incision was removed to remove stitches,drainage change and delayed healing.Six patients showed the sensory impairment of skin numbness in the leg boot area,and oral related neurotrophic drugs improved within 1 to 6 months after surgery.The remaining patients recovered well after operation.Conclusions Various causes can lead to the varicose vein of lower limb,a varicose vein of lower limb is a common clinical symptoms of many different diseases.Preoperative comprehensive examination to clarify the cause,this will help to reduce the probability of recurrence of lower extremity varicose veins.

Objective To evaluate the feasibility and efficacy of subfascial endoscopic perforator surgery in treating varicose ulcer after great saphenous vein stripping.Methods Between July 2008 and July 2013,152 limbs of venous ulceration after great saphenous vein stripping were divided into two groups (conservative therapy and subfascial endoscopic perforator surgery therapy) and followed up at least for 2 years,respectively compared symptoms and signs improvement,ulcer healing time,ulcer healing and ulcer recurrence rate after healing for 6,12,24 months.Results No patient underwent the surgery occured pulmonary embolism or death,2 limbs appeared hematoma.Conservative and subfascial endoscopic perforator surgery group's symptoms and signs improvement rates were 81.9％ (59/72) and 86.3％ (69/80) (not significant,P =0.528),while the ulcer healing time,ulcer healing and ulcer recurrence rate respectively were 65.3％ (47/72) and 78.8％ (63/80),(73 ±15.7) d and (41 ± 12.6) d,34.0％ (16/47) and 14.3 ％ (9/63) (significantly different,P ＜ 0.05).According to the three time-points' (6,12,24 months) follow-up,the non-recurrence rate were 89.4％ (42/47) and 96.8％ (61/63),P=0.135;72.3％ (34/47) and 92.1％ (58/63),P=0.006;66.0％ (31/47) and 85.7％ (54/63),P =0.014.Conclusions Subfascial endoscopic perforator surgery is a reliable,safe and minimally invasive surgery,and has a long-term effect in treating varicose ulcer after great saphenous vein stripping.

Purpose To investigate relationship between PD-L1 molecule expression and Treg infiltration in non-small cell lung cancer ( NSCLC) tissue and to explore their clinical significance. Methods Immunohistochemistry was used to detect the PD-L1 molecules expression and Treg infiltration of 78 NSCLC tissues. The relationship among PD-L1 expression, Treg infiltration and clinic-pathological parameters was analyzed in the patients. Results PD-L1 molecule was highly expressed in lung cancer tissues than adjacent tissues (52. 5% vs 6. 4%), and same to Foxp3 +Treg (18. 63 ± 16. 67)/HPF vs (2. 96 ± 2. 97)/HPF. There was close relationship between PD-L1 expression and Treg infiltration with lymph node metastasis and clinical stage of patients, but was no statistical correlation with patient’ s age, gender, histological type and degree of differentiation of the tumor cells. PD-L1 expression was significantly higher in advanced stage than that in early stage (70. 0% vs 41. 7%) and same to Treg infiltration (73. 3% vs 35. 4%). There were also signif-icantly higher infiltration with lymph node metastasis than that without metastasis. In addition, PD-L1 molecule expression and Foxp3 +Treg infiltration were positively correlated (rs =0. 611, F=78. 82, P=0. 023). Conclusion There was strong relationship among PD-L1 expression, Treg infiltration and disease progress in lung cancer patients, and they possibly participate in the progression and immune escape of lung cancer.

Objective To investigate the role of pancreatic β cell on pancreatic regeneration following experimental acute pancreatitis.Methods Eighty-seven SD male rats were randomly divided into four groups:control group ( n =15 ),STZ group ( n =24),L-Arg group ( n =24 ),STZ + Arg group ( n =24).60 mg/kg of STZ was administrated by intraperitoneal injection to induce the diabetes model.2.5 g/kg body weight of LArg was administrated by intraperitoneal injection to induce the acute pancreatitis model.The rats were sacrificed 1,3,5,7 d later and the serum levels of amylase and glucose were measured.Relative pancreatic weight (pancreatic weight/body weight) were measured.Pancreatic tissue underwent routine pathologic examination,and the percentage of area of necrosis and tissue transformation was calculated.The expression of Reg4 and insulin was performed by immunofluorescence.Results Serum level of glucose significantly increased after STZ injection.After L-Arg injection,serum level of amylase significantly increased,and there was pancreatic tissue edema,necrosis,infiltration of inflammatory cells,which suggested the successful model induction.The percentage of area of necrosis in STZ + L-Arg group was (71.6 ± 6.0) ％ at the 3rd day,which were significantly higher than (42.3 ± 4.0 ) ％ in L-Arg group; the percentage of area of transformation was (45.6 ± 5.4) ％,which were significantly lower than (78.5 ± 6.4) ％ in L-Arg group.Expression of Reg4 in pancreatic islets of STZ + L-Arg group was significantly lower than those in L-Arg group.Conclusions STZ impairs pancreatic β cells,aggravates pancreatic damage following L-arginine induced pancreatitis and inhibits pancreatic regeneration.

This study designed one index of HRV from Poincaré plot named 5SSD1 by the present authors, which can describe the characteristics of the heart rate dynamics with 5-second data. We also investigated the feasibility of its clinical application in real-time monitoring of the activity of autonomic nervous system. We studied 20 patients scheduled for oral maxillofacial surgery. ECG recording was obtained when kept awake and anesthetic states, respectively. We calculated the correlation coefficients between the 5SSD1 and the other quantitative indicators, such as 5-minute HRV in the time domain, the frequency domain, and the Poincaré plot families. The correlation between 5SSD1 and indicators, such as rMSSD, HF and SD1 of 5-minute HRV was significantly high, with r=0.995, 0.895, 0.996, respectively, at P<0.01 for all. However, the correlation between 5SSD1 and the other indicators of 5-minute HRV was relatively poor. It was proved that 5SSD1 could be used to assess the activities of the autonomic nervous system in real-time, and the stable and reliable results might play more roles in the clinical applications.
Adolescent ; Adult ; Algorithms ; Autonomic Nervous System ; physiology ; Electrocardiography ; methods ; Female ; Heart Rate ; physiology ; Humans ; Male ; Middle Aged ; Signal Processing, Computer-Assisted ; Young Adult

Objective To investigate the effect of cytokines on pancreatic function in patients after acute pancreatitis(AP) and its mechanisms. Methods Fifty-nine patients (mild in 25 and severe in 34) after AP and 20 healthy controls were enrolled in the study. Serum levels of cytokines including hepatocyte growth factor (HGF), epidermal growth factor(EGF), basic fibroblast growth factor (bFGF), regeneration protein(Reg)-1 and Reg-4 were determined using enzyme-linked immunosorbent assay (ELISA). Fasting blood-glucose, insulin, C-peptide and fecal elastase 1 (FE1) were detected for evluation of endocrine and exocrine pancreatic function. The association of pancreatic function with clinical parameters and serum cytokines was analyzed. Results The expression of FE1 was lower in patients [(205.9±18.3) μg/g] after AP in comparison with the controls [(333.9±19.7) μg/g, P<0. 01], but levels of fasting blood-glucose, C-peptide and insulin were higher in patients group (P<0.01). Serum level of HGF was higher in patients with insufficient pancreatic exoerine [(983.76±372.65) pg/ml] than those with normal exocrine function [(263.44±110. 35) pg/ml]. Meanwhile,EGF level was higher in patients with DM after AP [(704.41±190. 37) pg/ml] than those without DM [(360. 03±48.39) pg/mh P<0.05]. There was a negatively correlation between FE1 and HGF (P ＜0. 01). The abnormal fasting blood glucose was correlated with CT grading (P<0. 05).Conclusions The patients after AP develope insufficient exocrine and endocrine function. Serum EGF and HGF may be associated with restoration of pancreatic endocrine and exocrine function.