Efficacy and Safety Profile of Novel Oral Anticoagulants in the Treatment of Left Atrial Thrombosis: A Systematic Review and Meta-Analysis.

Background: The presence of left atrial/left atrial appendage thrombosis is associated with a higher risk of thromboembolic events in patients with atrial fibrillation. The optimal antithrombotic strategy is not established to date. Objective: Our aim was to compare the efficacy and safety profile of novel oral anticoagulants with warfarin in the treatment of left atrial/left atrial appendage thrombosis. Methods: We conducted a systematic search in PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and 3 Chinese databases for all randomized controlled trials and cohort studies (PROSPERO, CRD42021238952) from inception to 7 May 2021. Two authors independently performed the articles selection, data extraction, and quality assessment. The efficacy outcome was the resolution of left atrial/left atrial appendage thrombosis, and the safety outcomes were bleeding and stroke/transient ischemic attack. Results: One randomized controlled trial and 5 cohort studies were included, with a total of 353 patients. Compared with warfarin, novel oral anticoagulants were associated with increased probability of left atrial/left atrial appendage thrombosis resolution (OR = 2.20; 95% CI, 1.35-3.60; I 2 = 0%). Compared with warfarin, novel oral anticoagulants had a similar risk of bleeding (OR = 0.91; 95% CI, 0.39-2.13; I 2 = 0%). There was no evidence of increased risk of stroke/transient ischemic attack (OR = 0.42; 95% CI, 0.12-1.45; I 2 = 0%). Conclusions: Novel oral anticoagulants were more effective than warfarin in promoting the resolution of left atrial/left atrial appendage thrombosis, without increased risks of bleeding and stroke/transient ischemic attack. Our study provides valuable insight into clinical practice. Further well-designed randomized controlled trials are needed to fully evaluate the benefits and risks in these patients. PROSPERO Registration No.: CRD42021238952.

Pharmacokinetics of benapenem for injection in subjects with mild to moderate renal impairment.

OBJECTIVE: This study evaluated the pharmacokinetic (PK) characteristics of benapenem in subjects with mild to moderate renal impairment to provide a reference for benapenem dosing regimens in this patient population. METHODS: Eighteen subjects were enrolled in this study. Each subject received a single dose of benapenem intravenously (1.0 g in 100 ml of 0.9% saline) followed by blood and urine collection to measure the concentrations of benapenem and its major metabolite. PK analysis was performed to evaluate the effect of varying degrees of renal impairment on the PK characteristics of benapenem. The safety of benapenem was also evaluated. RESULTS: In subjects with normal renal function, mild renal impairment, and moderate renal impairment, the maximum plasma benapenem concentrations were 163 ± 6.58 mg/L, 138 ± 17.4 mg/L, and 134 ± 0.11 mg/L, respectively (15.3% and 17.8% lower in subjects with mild and moderate renal impairment, respectively, than in subjects with normal renal function). The areas under the plasma concentration-time curve (AUC0-inf) were 1153.67 ± 143.2 mg·h/L, 1129.17 ± 241.41 mg·h/L, and 1316.46 ± 229.83 mg·h/L, respectively (P > 0.05); the cumulative urinary excretion rates at 72 h after dosing were 52.61 ± 8.58%, 39.42 ± 8.35%, and 29.84 ± 9.15%, respectively; and the metabolic ratio (AUC0-inf_KBP-3331/AUC0-inf_benapenem) were 3.96 ± 0.35%, 5.56 ± 0.82%, and 8.24 ± 0.85%, respectively. No drug-related adverse events (AEs), serious AEs, or AEs leading to withdrawal occurred in this study. CONCLUSION: No adjustment to benapenem dosing is needed in patients with mild to moderate renal impairment. CLINICAL TRIAL REGISTRATION: Drug clinical trial registration and information publicity platform: http://www.chinadrugtrials.org.cn/index.html . REGISTRATION NUMBER: CTR20190760.

Clinical value of minimally invasive percutaneous nephrolithotomy in the supine position under the guidance of real-time ultrasound: report of 92 cases.

To determine the clinical value of the real-time-ultrasound-guided minimally invasive percutaneous nephrolithotomy (m-PCNL) technique in the supine position, 92 patients suffering from renal or upper ureteral stones were treated by m-PCNL with a nephroscope/ureteroscope in the supine position. The ipsilateral flanks of the patients with different body sizes were elevated with a 1,000 or 3,000-ml water bag. Under cystoscopy, a ureteral catheter was inserted into the kidney. Normal saline was infused into the kidney via the ureteral catheter to dilate the entire urinary system. Under the guidance of real-time ultrasound, the needle was inserted into the urinary system to dilate the tract and establish the 16F mini-tract for percutaneous nephrolithotomy. All 92 (100%) m-PCNL procedures were successfully performed in the supine position. Primary stone clearance was achieved in 64 cases (69.6%). Residual stones occurred in 28 cases (30.4%). M-PCNL was performed for a second time in 16 cases to clear the residual stones. In 4 cases, stones remained after the second m-PCNL. Two of them were treated further by extracorporeal shockwave lithotripsy (ESWL). The total stone clearance rate of m-PCNL was 82.6%. Only one case required blood transfusion. No other serious complications occurred. The supine position is a favorable position for the patients, the surgeons and the anesthesiologists during the m-PCNL procedure. Real-time ultrasound is a valuable technique for guiding of the m-PCNL.

One-step percutaneous nephrostomy in patients with a history of open nephrolithotomy: comparison with the fascial dilator system.

BACKGROUND AND PURPOSE: A percutaneous nephrostomy (PCN) done on the same side as a previous open nephrolithotomy is always technically challenging. A novel one-step PCN tube that allows the puncture and placement of a drainage tube to be done in a single step has been developed. The hydrophilic coating on the tube's surface significantly reduces friction and allows easier insertion. We evaluated the tube's efficiency and safety compared with the traditional fascial dilator system. PATIENTS AND METHODS: Sixty-five patients with a history of open nephrolithotomy were randomly allocated (with the aid of a computer-derived assignment number) into two groups to have PCN performed in one step or multiple steps. In the one-step group, a new type of PCN tube was used. In the multistep group, fascial dilators were used serially prior to tube insertion. The two groups were similar in terms of mean age, width of target calix, and baseline serum creatinine and hemoglobin concentrations. The operating times, intubation rates, and complications in the two groups were compared. RESULTS: The mean number of attempts required to access the collecting system was 1.1 +/- 0.6 in the one-step group v 2.3 +/- 1.2 in the multistep group (P = 0.002), the successful intubation rate was 96.9% v 78.8% (P = 0.012), the mean operating time was 10.2 +/- 2.4 minutes v 25.6 +/- 2.8 minutes (P = 0.029), and the rate of intraoperative and postoperative complications was 3.1% v 15.2%, respectively (P = 0.019). No major complications occurred in the one-step group. CONCLUSIONS: The one-step PCN tube is a convenient and efficacious method for accessing an anatomic region where open nephrolithotomy was done previously and is a simple method for nephrostomy tube placement.