Artificial intelligence-assisted system for the assessment of Forrest classification of peptic ulcer bleeding: a multicenter diagnostic study.

BACKGROUND: Inaccurate Forrest classification may significantly affect clinical outcomes, especially in high risk patients. Therefore, this study aimed to develop a real-time deep convolutional neural network (DCNN) system to assess the Forrest classification of peptic ulcer bleeding (PUB). METHODS: A training dataset (3868 endoscopic images) and an internal validation dataset (834 images) were retrospectively collected from the 900th Hospital, Fuzhou, China. In addition, 521 images collected from four other hospitals were used for external validation. Finally, 46 endoscopic videos were prospectively collected to assess the real-time diagnostic performance of the DCNN system, whose diagnostic performance was also prospectively compared with that of three senior and three junior endoscopists. RESULTS: The DCNN system had a satisfactory diagnostic performance in the assessment of Forrest classification, with an accuracy of 91.2% (95%CI 89.5%-92.6%) and a macro-average area under the receiver operating characteristic curve of 0.80 in the validation dataset. Moreover, the DCNN system could judge suspicious regions automatically using Forrest classification in real-time videos, with an accuracy of 92.0% (95%CI 80.8%-97.8%). The DCNN system showed more accurate and stable diagnostic performance than endoscopists in the prospective clinical comparison test. This system helped to slightly improve the diagnostic performance of senior endoscopists and considerably enhance that of junior endoscopists. CONCLUSION: The DCNN system for the assessment of the Forrest classification of PUB showed satisfactory diagnostic performance, which was slightly superior to that of senior endoscopists. It could therefore effectively assist junior endoscopists in making such diagnoses during gastroscopy.

Lutein Loaded in ß-Cyclodextrin Metal-Organic Frameworks for Stability and Solubility Enhancements.

Lutein (Lut) is a recognized nutritional supplement known for its antioxidative and anti-inflammatory properties, crucial in mitigating ocular disease. However, enhancements to Lut stability and solubility remain challenges to be addressed in the healthcare industry. Herein, we fabricated and evaluated a food-grade highly porous ß-cyclodextrin metal-organic framework (ß-CD-MOF) for its ability to encapsulate Lut. Lut stability considerably improved when loaded into ß-CD-MOF to form a Lut@ß-CD-MOF complex, which exhibited better stability than Lut loaded into the γ-cyclodextrin metal-organic framework (Lut@γ-CD-MOF), Lut@ß-CD, and commercial product (Blackmores™) at 40°C, 60°C, and 70°C, respectively. The solubility of Lut@ß-CD-MOF in water increased by 26.8-fold compared to raw Lut at 37°C. Lut@ß-CD-MOF exhibited greater hydrophilicity, as determined by measuring the water contact angle. Molecular docking and other characterizations of Fourier transform infrared spectroscopy and powder X-ray diffraction confirmed that Lut was successfully encapsulated in the chamber formed by the three cyclodextrins in ß-CD-MOF. Thermogravimetric analysis and Raman spectroscopy demonstrated that Lut distributed in the ß-CD-MOF cavity deeply improved Lut stability and solubility. In conclusion, our findings underscored the function of ß-CD-MOF in enhancing Lut stability and solubility for formulation applications.

Advanced ovarian clear cell carcinoma with RAD50 mutation treated by PARP inhibitor pamiparib combined with anti-angiogenesis therapy: a case report.

Ovarian clear cell carcinoma (OCCC) is a relatively uncommon epithelial ovarian malignancy with unique clinical, histopathologic and genetic characteristics. Patients with advanced OCCC have poor outcomes and are resistant to standard chemotherapy. Targeted therapy offers a novel approach for treating OCCC. We report the case of a 45-year-old female patient with advanced OCCC who experienced relapse after standard treatment. Further, a frameshift mutation in the homologous recombination repair-related gene RAD50 (RAD50-p.I371Ffs*8) was identified by genetic testing. Next, the patient had received targeted combination therapy with poly (ADP-ribose) polymerase (PARP) inhibitor pamiparib and bevacizumab, achieving partial remission. Patient's symptoms improved significantly compared to before. To date, the patient has been followed up for more than half a year with favorable survival and high quality of life. The case report suggested that parmiparib-targeted therapy is a viable treatment option for advanced OCCC patients with RAD50 mutation.

A prospective, open-labeled, and randomized trial for assessing safety and clinical utility of gastric biopsies during emergency gastroscopy for patients with bleeding gastric ulcers.

OBJECTIVE: There is no consensus on whether a gastroscopic biopsy is necessary during the emergency treatment of gastrointestinal (GI) diseases such as gastric ulcer bleeding. In this study, we examined the clinical utility and safety of an emergency gastroscopic biopsy for the assessment of gastric ulcer bleeding. METHODS: We enrolled 150 patients with a single bleeding gastric ulcer after emergency gastroscopy (EG) from April 2020 to April 2022. The patients were randomly divided into the biopsy and no biopsy groups, and they were followed-up until June 2022 to examine whether recurrent gastric ulcer bleeding had occurred. RESULTS: Re-bleeding occurred in 15 out of 150 (10%) patients. We diagnosed malignancies in 17 (11.3%) patients and validated 14 (9.3%) of them during the initial gastroscopy procedure. Factors that could predict the occurrence of gastric ulcer re-bleeding with biopsy during EG included an absence of ischemic heart disease (odds ratio [OR] = 0.395, confidence interval [CI]: 0.24-0.65, p ≤ .005), renal disease (OR = 1.74, CI: 0.77-1.59, p ≤ .005), and using warfarin or oral anticoagulants (OR = 11.953, CI: 3.494-39.460, p ≤ .005). No significant differences were observed in 60-day bleeding (p = .077) and the duration of hospitalization (p = .700) between the two groups. CONCLUSIONS: Patients undergoing biopsy during EG did not exhibit an increased risk of re-bleeding compared with those who did not undergo a biopsy. An early biopsy facilitates an early pathologic diagnosis, early clinical intervention, safe discharge of low-risk patients, and improved outcomes in high-risk patients.

Novel beagle model of gastric local fibrotic target lesions for the evaluation and training of endoscopic techniques.

BACKGROUND: Novel endoscopic techniques used in the treatment of gastric lesions with local submucosal fibrosis need preclinical evaluation and training due to safety limitations. Therefore, the purpose of our study was to establish an animal model of gastric local fibrotic target lesions and assess its feasibility in the evaluation and training of endoscopic techniques. METHODS: In six experimental beagles, a 50% glucose solution was injected into three submucosal areas of the fundus, body, and antrum of the stomach to create gastric local fibrotic target lesions (experimental group). On post-injection day (PID) 7, the injection sites were assessed endoscopically to confirm the presence of submucosal fibrosis formation, and the dental floss clip traction assisted endoscopic submucosal dissection (DFC-ESD) procedure was performed on the gastric local fibrotic target lesions to confirm its feasibility after endoscopic observation. The normal gastric mucosa of six control beagles underwent the same procedure (control group). All the resected specimens were evaluated by histological examination. RESULTS: All 12 beagles survived without postoperative adverse events. On PID 7, 16 ulcer changes were observed at the injection sites (16/18) under the endoscope, and endoscopic ultrasonography confirmed the local submucosal fibrosis formation in all ulcer lesions. The subsequent DFC-ESD was successfully performed on the 32 gastric target lesions, and the mean submucosal dissection time in the ulcer lesions was greater than that in the normal gastric mucosa (15.3 ± 5.6 vs. 6.8 ± 0.8 min; P < 0.001). There was no difference in rates of en bloc resection, severe hemorrhage, or perforation between the two groups. Histological analysis of the ulcer lesions showed the absence of epithelial or muscularis mucosae and extensive submucosal fibrous tissue proliferations compared with normal gastric mucosa. Overall, endoscopists had high satisfaction with the realism and feasibility of the animal model. CONCLUSION: We developed a novel animal model of gastric local fibrotic target lesions to simulate difficult clinical situations, which strongly appeared to be suitable for the preclinical evaluation and learning of advanced endoscopic techniques.

Fecal Microbiota Transplantation Alleviates Severe PD-1 Inhibitor-Associated Colitis Caused by Neoadjuvant Therapy for Esophageal Cancer: A Case Report.

Surgical resection is the preferred treatment for early-stage esophageal cancer. But most patients with esophageal cancer are diagnosed at advanced stages, making them ineligible for surgery. Therefore, preoperative neoadjuvant therapy has been introduced to help them meet surgical requirements. However, this therapy has been associated with serious complications, such as diarrhea, preventing patients from surgery. During neoadjuvant therapy combined with chemoradiotherapy, a 58-year-old male patient with esophageal cancer was diagnosed with severe immune-related colitis, which seriously affected both cancer treatment and the patient's quality of life. Despite conventional antidiarrheal therapy, the patient remained refractory to treatment. However, after undergoing fecal microbiota transplantation, the frequency of diarrhea was significantly reduced. During e-colonoscopy, no significant ulcers were found in the sigmoid colon. Additionally, successful radical resection of esophageal cancer was performed, resulting in a favorable outcome for the patient. Regular follow-up appointments were scheduled to monitor the patient's progress. Fecal microbiota transplantation effectively relieved severe immune-related diarrhea in a patient undergoing neoadjuvant immunotherapy and chemoradiotherapy for esophageal cancer. This successful treatment ultimately enabled the patient to meet the surgical requirements for radical esophagectomy.

Gallbladder-preserving polypectomy for gallbladder polyp by embryonic-natural orifice transumbilical endoscopic surgery with a gastric endoscopy.

BACKGROUND AND AIMS: Cholecystectomy is performed for most gallbladder polyps (GPs). However, cholecystectomy results concerning complications in some patients. For benign GPs, adoption of gallbladder-preserving surgery is worth to recommend. We describe our experiences performing gallbladder-preserving polypectomy for GPs by embryonic-natural orifice transumbilical endoscopic surgery (E-NOTES) with a gastric endoscopy. METHODS: This is a retrospective study of patients with GPs who underwent gallbladder-preserving polypectomy by E-NOTES with a gastric endoscopy from April 2018 to September 2019 in our hospital. The operative time, intraoperative hemorrhage, intraoperative and postoperative complications, gallbladder emptying function were obtained and analyzed. RESULTS: The procedure was performed successfully in all 12 patients with 5 cases of single polyp and 7 cases of multiple polyps. The range of GPs size was 2 mm to 15 mm. The mean operation time was (95.33 ± 23.08) minutes (55-135 min). There were no adverse events including heavy bleeding, mortality and conversion to open surgery during operation. All patients were discharged in 4-5 days after surgery without postoperative complications such as delayed bleeding, fever, peritonitis, intra-abdominal abscess and abdominal wall incisional hernia. All patients were followed up at 1, 3, 6, and 12 months postoperation who had almost no visible incision on the umbilical region, no recurrent GPs. The gallbladder emptying function decreased one month after surgery, and gradually improved 3, 6 and 12 months after surgery. CONCLUSION: E-NOTES gallbladder-preserving polypectomy is a safe and effective option for patients with GPs and is close to scar-free surgery which can be performed in routine clinical practice.

Efficacy and Safety of Antofloxacin-Based Triple Therapy for Helicobacter pylori Eradication Failure in China.

AIMS: Quinolone-containing triple therapy has been considered as the second-line therapy for eradication of Helicobacter pylori (H. pylori). At present, there are no data to show the efficacy and safety of antofloxacin-based rescue therapy for the eradication of H. pylori, and this pilot clinical trial was designed. METHODS: A total of 196 patients who failed H. pylori eradication using the clarithromycin-based or metronidazole-based triple or bismuth quadruple therapy were randomly allocated to one of the following rescue eradication therapy groups: AEA group (antofloxacin 200 mg once daily, esomeprazole 20 mg + amoxicillin 1000 mg twice daily) for 14 days, or LEA group (levofloxacin 500 mg once daily, esomeprazole 20 mg + amoxicillin 1000 mg twice daily) for 14 days. The minimal inhibitory concentrations were tested by the E-test method. The gyrA mutation was analyzed by sequencing. Follow-up 13/14C-urea breath test was examined at 1 month after discontinuation. RESULTS: A total of 178 eligible patients were included in this study. The eradication rate was significantly higher in AEA group than in LEA group according to both ITT (87.6% vs. 68.5%; P = 0.002) and PP analyses (90.7% vs. 70.1%; P = 0.001). ITT analyses indicated that the eradication rate was significantly higher in AEA group than in LEA group with Asn87 mutation (78.9% vs. 31.3%; P = 0.005) and levofloxacin-resistant strains (76.9% vs. 44.2%; P = 0.003). Two groups exhibited similar adverse event rates (AEA 14.6% vs. LEA 20.2%, P = 0.323). CONCLUSIONS: The findings showed that antofloxacin may be a promising candidate in rescue therapy for H. pylori eradication failure in China.

Protective effect of Corynoline on the CFA induced Rheumatoid arthritis via attenuation of oxidative and inflammatory mediators.

Rheumatoid arthritis (RA) is a long-standing and growing autoimmune disease. Therefore, the present study was intended to investigate the effect of Corynoline (COR) on CFA induced rheumatoid arthritis in a rat model. Results suggested that COR causes significant reduction in paw swelling, edema, arthritis score, thymus and spleen indexes and neutrophil infiltration (p < 0.01). Moreover, the levels of inflammatory cytokines (interleukin- 1ß, -6, and -17, and TNF-α) and anti-collagen II-specific immunoglobulins (IgG1 and IgG2a) were decreased significantly (p < 0.01) together with increase in antioxidant enzymes (SOD, CAT, and GSH) (p < 0.01) in COR-treated group in dose-dependent manner. In western blot analysis, COR-treated group showed concentration-dependent reduction of expression of COX-2, 5-LOX and NF-p65 as compared to CFA rats. Moreover, COR-treated group showed mild inflammation of cartilage with fewer cartilage erosion and synovititis with most significant reversal of arthritic features in the rats treated with 30 mg/kg. It has been concluded that, COR alleviates oxidative stress and inflammation in arthritic rats, thus verifying its anti-rheumatoid arthritis property.

Efficacy and safety of three different endoscopic methods in treatment of 6-20 mm colorectal polyps.

Objective: Endoscopic resection of colorectal polyps is widely established as the optimal method to manage precancerous lesions. But the optimal technique for removal of the polyps is uncertain. The aim of this study was to compare the efficacy and safety of three methods for the management of 6-20mm colorectal polyps.Methods: A prospective, randomised controlled trial was conducted at the 900TH Hospital of Joint Logistics Support Force in Fujian, China. Endoscopically diagnosed colorectal polyps, 6-20 mm in size, were randomly assigned to the cold snare polypectomy (CSP), cold snare endoscopic mucosal resection (CS-EMR) or endoscopic mucosal resection (EMR) group. After polypectomy, additional 3-5 forceps biopsies by leading narrow-band imaging (NBI) were performed at the base and margins of polypectomy sites to assess the presence of residual polyp tissue and all samples were sent for histopathological analysis to assess completeness of resection. Polypectomy timing, tissue retrieval and complications were recorded at the time of the procedure.Results: A total of 781 polyps in 404 patients were assessed and randomly assigned to each group. Of these, 763 polyps were finally analyzed based on the pathology results. The complete resection rates with CSP, CS-EMR and EMR were 81.6%, 94.1% and 95.5%, respectively (p < .001). The intraprocedural bleeding rate, immediately after polypectomy, was significantly higher in the CSP group than in the CS-EMR and EMR group (9.4% vs. 4.4% vs. 1.9%; p < .001). However,delayed bleeding was higher in the EMR group than in the CSP and CS-EMR group (2.6% vs. 1.2% vs. 0.8%, respectively; p = .215). In the multivariate analysis showed that the operation method, lesion size, morphology and the number of resection were independent risk factors for complete resection rate (CRR) (p < .05), but the location and pathological classification of polyps had no significant influence on CRR.Conclusions: CS-EMR is safe and effective in the treatment of 6-20 mm colorectal polyps. Especially for 6-15 mm non-pedunculated polyps, CS-EMR has a high histological complete resection rate comparable to EMR, and retains the low risk of delayed complications after polypectomy with cold snare. CS-EMR is expected to become a more valuable new cold-cutting technique after cold snare polypectomy.

Relative position of the central hole after EVO-ICL implantation for moderate to high myopia.

BACKGROUND: This study aimed to evaluate the relative position of the central hole (CH) of EVO Implantable Collamer Lens (EVO-ICL), the pupil center (CP), and the corneal center (CC) after implantation of EVO-ICLs for moderate to high myopia. METHODS: Eighty-nine eyes of forty-seven patients with moderate to high myopia were evaluated. The mean preoperative spherical equivalent (SE) was - 12.58 ± 4.13D. A routine postoperative follow-up was performed within 1 ~ 12 months. Positions of the CH of EVO-ICLs, the CP and the CC were recorded using a slit lamp anterior segment photography system, and their relative distances were calculated with the Visio image analysis software. RESULTS: All surgeries were performed safely, and no complications were observed in follow-ups 4.3 ± 4.82 months after surgery. At the last follow-up, the safety index (postoperative CDVA/preoperative CDVA) was 1.23 ± 0.48, and the efficacy index (postoperative UDVA/preoperative CDVA) was 1.08 ± 0.31. The CH in 85 eyes (95.51%) was superior to the CC, with 47.19% (42/89) on the temporal side and 48.31% (43/89) on the nasal side. The CH in 84 eyes (94.38%) was located on the temporal side of the CP, with 56.18% (50/89) superior and 38.2% (34/89) inferior to the CP. The CP of 85 eyes (95.51%) was superior on the nasal side of the CC. On the defined x-axis, the average distance from the CH to CC was significantly shorter than the average distance from the CP to CC (p < 0.001). CONCLUSIONS: An imperfect match between the central hole of EVO-ICLs and the pupil center does not necessarily indicate ICL dislocation. Compared to the pupil center, the position of the central hole of EVO-ICL is closer to the corneal center.

Clinical and radiological outcome of Gustilo type III open distal tibial and tibial shaft fractures after staged treatment with posterolateral minimally invasive plate osteosynthesis (MIPO) technique.

OBJECTIVES: To evaluate the methods and the outcomes of Gustilo type III open distal tibial and tibial shaft fractures with severe anterior and medial soft-tissue injuries, treated with posterolateral minimally invasive plate osteosynthesis (MIPO) technique. METHODS: From May 2015 to May 2016, 10 patients with Gustilo type III open distal tibial and tibial shaft fractures with severe anterior and medial soft-tissue injuries (Gustilo-Anderson classification IIIA, 6; IIIB, 4) were treated with staged protocol using posterolateral minimally invasive plate osteosynthesis (MIPO) technique. The initial wound lavage, debridement, and application of a spanning external fixator were performed within 24 h and the mean interval from injury to definitive surgical treatment was 12.8 (range 4-21) days. An additional bone graft was performed in two patients when definitive internal fixation was performed. All patients were followed to union. Postoperative radiographs, postoperative complications, bone union, ankle joint motion, and limb functional outcome information of AOFAS ankle-hindfoot score were recorded. RESULTS: The mean follow-up period was 17.8 (range 12-26) months. The mean interval to bony union was 25.8 (range 20-40) weeks. Bone union was achieved in all cases. There were no complications, such as incision breakdown, deep infection, or impingement of the flexor hallucis longus tendon. The average AOFAS score was 90 (range 83-96). In ten patients, two patients had a superficial wound infection and another one patient showed a 6° varus deformity. CONCLUSIONS: Staged treatment using MIPO technique through a posterolateral approach is a reasonable and safe treatment option for open distal tibial and tibial shaft fractures, especially Gustilo type III with severe anterior and medial soft-tissue injuries. However, it should have a higher level of research evidence in more patients to confirm the safety of the clinical application of this technique.

Global Teleophthalmology With the Smartphone for Microscopic Ocular Surgery.

PURPOSE: This study aimed to determine the feasibility and quality of real-time video transferring in global teleophthalmology using two smartphones during microscopic ocular surgery. METHODS: An iPhone 4S (Apple) was adapted into a surgical microscope in Hangzhou, Zhejiang, China to capture video during microscopic ocular surgery. An iPhone 5 (Apple), an iPad2 (Apple), and a desktop computer were used as the receptor on the other side of the globe (Miami, FL). A standard resolution test card and the three surgeries of human eyes were captured. During the global video teleconferencing, the real-time video was transferred through Skype from Hangzhou to Miami. A standard resolution test card and the surgery of human eyes were captured. The real-time image resolutions captured and displayed on both phones at different places were measured. Real-time vocal communications concurrent between two parties took place during video conferencing when the ocular surgery was performed in Hangzhou. RESULTS: The video sequences were transferred in real time between the two cities while two parties conversed smoothly without any difficulty. The viewer in Miami clearly visualized the surgical procedure performed in Hangzhou without lagging and distortion. The spatial resolution observed on the video in real time was similar for both phones. CONCLUSIONS: The study demonstrated that global video teleophthalmology for microscopic ocular surgery is feasible using two smartphones. The simple, portable, and affordable add-on attachment to the surgical microscope transfers high-quality video for real-time global teleophthalmology.

Global teleophthalmology with iPhones for real-time slitlamp eye examination.

PURPOSE: To evaluate the image resolutions in global teleophthalmology using 2 smartphones. METHODS: A standard resolution test card and two human eyes (one eye wearing a contact lens) were imaged with an iPhone 4S adapted for slitlamp biomicroscopy in Hangzhou, Zhejiang, China. An iPhone 5 was used as a receptor on the other side of the world (Miami, FL). The real-time images and still images were transferred through Skype from Hangzhou to Miami during slitlamp eye examination. The real-time resolutions captured and displayed on the both phones at different places were measured. There was vocal communication concurrent between two parties during image transference and the examination by the slitlamp biomicroscopy performed in Hangzhou. RESULTS: The real-time and still images were transferred between two cities while two operators talked with each other smoothly and without difficulty. The viewer in Miami was able to instruct the operator in Hangzhou to thoroughly examine the eye using the slitlamp microscopy with different magnification settings and illumination settings. The resolution of the still images recorded in the iPhone in Hangzhou was higher than that of the real-time images on the screen. The main features of the eye were recognizable in real-time. CONCLUSIONS: The study demonstrated that global teleophthalmology is feasible using two smartphones. The system is simple, portable, and affordable, and the image quality in still and real-time images is acceptable for real-time teleophthalmology.

Efficacy of different endoscopic treatments for gastroesophageal reflux disease: a systematic review and network meta-analysis.

BACKGROUND: There are no direct comparisons across different endoscopic therapies for gastroesophageal reflux disease (GERD). This study aimed to evaluate the relative effects of different endoscopic therapies in GERD. METHODS: Five databases were searched until August 2023 for randomized controlled trials (RCTs) that compared the efficacy of endoscopic band ligation (EBL), Stretta, endoscopic fundoplication (transoral incisionless fundoplication [TIF], endoscopic full-thickness plication [EFTP], and EndoCinch plication procedure [EndoCinch, CR BARD, Billerica, Mass., USA]), or proton pump inhibitors (PPIs)/sham procedure for GERD. Bayesian network meta-analysis was performed. RESULTS: A total of 19 trials comprising 1181 patients were included. EBL (mean difference [MD], -7.75; 95% credible interval [CrI], -13.90 to -1.44), Stretta (MD, -9.86; 95% CrI, -19.05 to -0.58), and TIF (MD, -12.58; 95% CrI, -20.23 to -4.91) all significantly improved patients' health-related quality of life score with equivalent efficacy compared with PPIs. TIF and EBL achieved equivalent efficacy in reducing PPIs utility (risk ratio [RR], 0.66; 95% CrI, 0.40-1.05) and both were significantly superior to other endoscopic interventions (Stretta, EFTP, and EndoCinch). Besides, EBL and TIF also could significantly decrease the esophagitis incidence compared with PPIs (EBL [RR, 0.34; 95% CrI, 0.22-0.48] and TIF [RR, 0.38; 95% CrI, 0.15-0.88]). In terms of lower esophageal sphincter (LES) pressure, only TIF could significantly increase the LES pressure (MD, 6.53; 95% CrI, 3.65-9.40) to PPIs. In contrast, TIF was inferior to PPIs in decreasing esophageal acid exposure (MD, 2.57; 95% CrI, 0.77-4.36). CONCLUSION: Combining the evidence, EBL and TIF may have comparable efficacy and both might be superior to Stretta, EFTP, or EndoCinch in GERD treatment.

Supramolecular Structure of the ß-Cyclodextrin Metal-Organic Framework Optimizes Iodine Stability and Its Co-delivery with l-Menthol for Antibacterial Applications.

The spread of upper respiratory tract (URT) infections harms people's health and causes social burdens. Developing targeted treatment strategies for URT infections that exhibit good biocompatibility, stability, and strong antimicrobial effects remains challenging. The dual antimicrobial and antiviral effects of iodine (I2) in combination with the cooling sensation of l-menthol in the respiratory tract can simultaneously alleviate URT inflammation symptoms. However, as both I2 and l-menthol are volatile, addressing stability issues is crucial. In this study, a potassium iodide ß-cyclodextrin metal-organic framework [ß-CD-POF(I)] with appropriate particle size was used to coload and deliver I2 and l-menthol. Primarily, ß-CD-POF(I) was employed as the most efficient carrier to significantly enhance the stability of I2, surpassing any other known protection strategies in the pharmaceutical field (CD complexations, PVP conjugations, and cadexomer iodine). The mechanism underlying the improvement in stability of I2 by ß-CD-POF(I) was investigated through scanning electron microscopy with energy-dispersive X-ray spectroscopy, X-ray photoelectron spectroscopy, Raman spectroscopy, and molecular docking. The results revealed that the key processes involved in improving stability were the inclusion of I2 by ß-CD cavities in ß-CD-POF(I) and the formation of polyiodide anion between iodine ions and I2. Furthermore, the potential of ß-CD-POF(I) to load and deliver drugs was validated, and coloading of l-menthol and I2 demonstrated reliable stability. ß-CD-POF(I) achieved a rate of URT deposition ≥95% in vitro, and the combined antibacterial effects of coloaded I2 and l-menthol was better than I2 or PVP-I alone, with no irritation noted following URT administration in rabbits. Therefore, the stable coloading of drugs by ß-CD-POF(I), leading to enhanced antimicrobial effects, provides a new strategy for treating URT infections.

Purification of gamma-cyclodextrin via selective coordination with potassium ions to form metal-organic frameworks.

Efficient purification of gamma-cyclodextrin (γ-CD) is always challenging due to its structural similarity to other CDs and low crystallinity in water. In addressing this issue, an approach was proposed based on the formation mechanism of cyclodextrin metal-organic frameworks (CD-MOFs). This method involved the selective coordination of CDs mixture with potassium ions in water, facilitated by ethanol-induced crystallization, leading to the purification of γ-CD. The results showed that potassium ions enhanced γ-CD crystallization, and ethanol was crucial to selectively coordinating potassium ions with γ-CD. The characterizations revealed that the resulting CD-MOFs exhibited a small particle size, high surface area, and high thermal stability, and was identical to γ-CD-MOF, further indicating the final γ-CD with high purity. The separation factors of γ-CD/α-CD and γ-CD/ß-CD were 309 and 260, respectively. Moreover, this method was validated through its application to the industrial enzymatic CDs mixture. The purification of γ-CD could achieve 99.99 ± 0.01 % after four crystallization cycles. Therefore, selectively coordinating with potassium ions to form MOFs provided a valuable reference for the purification of γ-CD and even the direct synthesis of γ-CD-MOF from CDs mixture. This advancement will also benefit the future production and application of γ-CD.

Comparison of 10 and 14 days of antofloxacin-based versus 14 days of clarithromycin-based bismuth quadruple therapy for Helicobacter pylori eradication: A randomized trial.

OBJECTIVE: Our team previously reported the use of antofloxacin-based bismuth quadruple therapy for the eradication of Helicobacter pylori (H. pylori). This study aimed to compare the efficacy and safety of 10 and 14 days of antofloxacin-based versus 14 days of clarithromycin-based bismuth quadruple therapy in the first-line treatment for H. pylori infection. METHODS: 1174 patients with H. pylori infection were randomized into three groups: 10-days and 14-days antofloxacin (ANT10 and ANT14) groups who received 10 and 14 days of antofloxacin-based bismuth quadruple therapy (colloidal bismuth pectin 200 mg t.i.d., esomeprazole 20 mg b.i.d., amoxicillin 1 g b.i.d., and antofloxacin 200 mg q.d.), 14-days clarithromycin (CLA14) group who received 14 days of clarithromycin-based bismuth quadruple therapy (colloidal bismuth pectin 200 mg t.i.d., esomeprazole 20 mg b.i.d., amoxicillin 1 g b.i.d., and clarithromycin 500 mg b.i.d.). Eradication rate, antibiotic resistance and adverse events were analyzed. RESULTS: The intention-to-treat (ITT) and per-protocol (PP) analyses have showed statistically different eradication rates between ANT14 group and ANT10 group (ITT p = 0.001; PP p < 0.001), but no statistical difference between ANT10 group and CLA14 group (ITT p = 0.340; PP p = 0.092). Treatment regimen, drug resistance and therapy duration were important clinical factors related to H. pylori eradication rates in multivariate logistic analysis. Longer durations had significantly higher eradication rates in patients with antibiotic-resistant strains or antibiotic-susceptible strains. The incidences of nausea and bitter taste were significantly higher in CLA group compared with ANT group (p = 0.002 for nausea; p = 0.002 for bitter taste). The ANT10 and ANT14 group had similar adverse event rates of gastrointestinal reactions. CONCLUSION: The study showed that the H. pylori eradication rate with ANT14 therapy was higher than that with ANT10 and CLA14 therapy without significantly increasing the rates of adverse event. 14 days of antofloxacin-based bismuth quadruple therapy may be a more effective way as the first-line treatment for H. pylori infection.

The efficacy and safety of Saccharomyces boulardii in addition to antofloxacin-based bismuth quadruple therapy for Helicobacter pylori eradication: a single-center, prospective randomized-control study.

Background: We previously reported that antofloxacin-based bismuth quadruple therapy was safe and effective for Helicobacter pylori (H. pylori) eradication. It is not clear whether the addition of Saccharomyces boulardii (S. boulardii) to antofloxacin-based quadruple therapy can improve the eradication rate of H. pylori and reduce adverse events. Objective: To investigate the effect of adding S. boulardii to antofloxacin-based quadruple therapy on the eradication rate of H. pylori and the adverse events. Design: Single-center, prospective randomized controlled study. Methods: A total of 172 patients with H. pylori infection were randomly assigned to the test and control groups. Patients in the control group (n = 86) received antofloxacin-based bismuth quadruple therapy for 14 days. On this basis, cases in the test group (n = 86) received S. boulardii 500 mg b.i.d. The eradication rate of H. pylori and adverse events were observed 4 weeks after the treatment. Results: There were no statistically significant differences in the eradication rates of H. pylori and frequency of diarrhea between the test group and control group (p > 0.05). The duration of diarrhea in the test group was significantly shorter than in the control group (p < 0.001). In addition, the two groups exhibited similar adverse event rates for epigastric pain, abdominal distention, dizzy, vomiting, and rash (p > 0.05). The severity of adverse reactions was similar between the two groups (p > 0.05), and most of them had mild adverse events. Conclusion: Although the addition of S. boulardii to antofloxacin-based quadruple therapy could not improve the eradication rate of H. pylori, it could shorten the time of antibiotic-associated diarrhea and reduce the incidence of diarrhea. Trial registration number: ChiCTR2200056931.