Background and Objective Previous study showed tenecteplase and alteplaxe were equovalent for 30-day mortality in the treatment of acute myocardial infarction. The purpose of this open-label, randomized, multi-center, angiographic trial was to assess the efficacy and safety of tenecteplase compared with alteplase in Chinese patients with acute myocardial infarction. Methods We recruited patients with acute ST-elevation myocardial infarction presenting within 6 hours of symptom onset from October, 2002 to March,2004, in 5 hospitals in Beijing. After giving informed consent, patients were randomly assigned a single-bolus injection of tenecteplase (30-50 mg according to body weight) or front loaded alteplase (100 mg), and underwent coronary angiography at 90 min after starting the study drug. All patients received aspirin and heparin (target activated partial thromboplastin time 50-70 s). The primary efficacy end point was the rate of TIMI grade 3 flow at 90 minutes. Other efficacy end points included TIMI grade 2/3 flow at 90 minutes. Safety end points included all stroke, intracranial hemorrhage (ICH), moderate/severe hemorrhage (except for ICH), all-cause mortality at 30-days, and major non-fatal cardiac events at 30 days. Results Overall 110 patients were eligible for statistical analysis, with 58 patients assigned to receive tenecteplase and 52 patients to alteplase. Tenecteplase produced a rate of TIMI grade 3 flow at 90 minutes after the start of thrombolysis(68.4%) similar to that of alteplase (66.7%, P=1.0); the rates of TIMI grade 2 or 3 were similar for patients treated with tenecteplase versus alteplase (89.5% versus 80.4%, respectively, P=0.278). At 30 days, rates for all strokes were similar for the two groups (5.17% for tenecteplase and 1.92% for alteplase, P=0.62); rates of ICH were 3.45% and 1.92% (tenecteplase and rt-PA,P=1.00) respectively. The rate of moderate/severe hemorrhage was 8.62% with tenecteplase and 5.77% with alteplase (P=0.72); total mortality was almost identical in the two groups (13.8% versus 9.6%, respectively, P=0.565) while the rates of non-fatal cardiac complications were 10.35% and 11.54% (tenecteplase and alteplase, P=1.0). Conclusions The efficacy of a single-bolus, weightadjusted tenecteplase fibrinolytic regimen is equivalent to front-loaded alteplase in terms of the rates of TIMI grade 3 flow, and TIMI 2 or 3 flow, but the 30-day mortality and ICH in both groups was so high that the use of tenecteplase is not permitted in China. These negative safety results might be due to the high rate of percutaneous coronary intervention (PCI) and high dose of bolus heparin and suboptimal concomitant medical therapy during hospitalization, so further studies are needed to confirm the safety for tenecteplase in Chinese patients.

Objective:To investigate the efficacy and safety of a new China-made direct visualization system of peroral cholangiopancreatography in the diagnosis and treatment of biliopancreatic diseases.Methods:Clinical data of 37 patients who underwent endoscopic examination through the direct visualization system of peroral cholangiopancreatography at Digestive Endoscopy Center of Nanjing Drum Tower Hospital from April 2020 to June 2021 were retrospectively analyzed. Technical success rate and complications were analyzed.Results:The examination was completed in 37 patients through the system. The technical success rate was 100.0%. The nature of biliary stricture was confirmed in 24 cases, presenece or absence of bleeding or residual stones in the bile duct was confirmed in 6 cases, neoplasm or residual stones in the pancreatic duct was determined in 2 cases, biliary stricture was passed assisted with visualized guidewire in 2 cases, and lithotripsy was performed assisted with biliary laser in 3 cases. Nine patients were pathologically diagnosed as having malignant biliary stricture, and 8 of them were confirmed malignant by the system. Drainage was performed in 34 cases after the examination. There were 3 cases of cholangitis, 4 cases of bacteremia and 2 cases of postoperative pancreatitis after the operation, which were relieved in a short time after conservative treatment. Bleeding occurred in 1 case which was improved after two times of endoscopic hemostasis.Conclusion:The new direct visualization system of peroral cholangiopancreatography is safe and effective in the diagnosis and treatment of biliopancreatic diseases.

Objective:To explore the effectiveness and safety of endoscopic ultrasound-guided pancreatic duct drainage (EUS-PD).Methods:A retrospective analysis was conducted on data of 16 patients who underwent EUS-PD because of endoscopic retrograde pancreatography (ERP) failure, poor effectiveness or anatomical changes and couldn't undergo the routine ERP in Nanjing Drum Tower Hospital from June 2018 to July 2022. The technical success of EUS-PD, clinical efficacy and post-procedure adverse events were analyzed.Results:In the 16 patients, there were 14 males and 2 females, with age of 50.69±12.95 years. A total of 19 times of EUS-PD operations were included, 3 of them were rendezvous-assisted endoscopic retrograde pancreatography (RV-ERP), 15 transgastric or transenteric EUS-guided stent placement and 1 was EUS-guided nasopancreatic duct placement. Technical success was achieved in 84.21% (16/19) patients, and among whom 93.75% (15/16) achieved clinical success. The overall incidence of postoperative adverse events was 52.63% (10/19) including 47.37% (9/19) abdominal pain, 15.79% (3/19) fever and 15.79% (3/19) postoperative pancreatitis. All adverse effects were relieved after general conservative treatment and no primary disease or surgery-related death occurred. The mean follow-up was 17.6 (8.2,22.3) months and 93.75% (15/16) of the patients were followed up. By the time of follow-up, 76.92% (10/13) of the patients who had successfully received EUS-PD had no recurrence of abdominal pain or distension.Conclusion:EUS-PD is a safe and effective alternative therapy for those with pancreatic diseases with ERP failure, poor efficacy or anatomical changes.

AIM:To analyze the compliance rate and possible influencing factors for blood concen-tration of meropenem in patients with central ner-vous system(CNS)infections,and to provide basis for optimizing the administration of meropenem in the patients.METHODS:A retrospective analysis was performed in patients who were treated with meropenem and monitored the concentration(Cmin)from January 2021 to December 2022.The basic clinical data of the patients were recorded,and the achievement of meropenem blood concentration was counted.Univariate and binary logistic regres-sion analysis were used to analyze the influencing factors for the e substandard steady-state blood trough concentration of meropenem.The ROC curve was drawn to predict the clinical characteris-tics.RESULTS:Forty-five cases were included.The median Cmin of meropenem was 4.14(0.82,16.29)mg/L,and 51.11％reached the target range with 4 mg/L.Binary logistic regression analysis showed that serum creatinine value and using mannitol were risk factors for the substandard steady-state blood trough concentration of meropenem(P＜0.05).When serum creatinine value was less than 84 μmol/L,the area under the ROC curve was the largest(0.916),the sensitivity was 0.783,the speci-ficity was 0.955,and the Youden index was 0.738.CONCLUSION:The Cmin compliance rate of merope-nem blood concentration in patients with CNS in-fection is low,especially in patients with hyperfunc-tion of kidney and those who using mannitol.It is necessary to conduct drug concentration monitor-ing to optimize the administration of meropenem in patients with CNS infection.