Capsule In Patients Research Articles

Investigating the Additive Effects of Loxacon® Food Supplement Capsules in Patients with Knee Osteoarthritis. A Multicenter, Randomized, Double-Blind, Controlled, Crossover, Follow-Up, Three-Arm Study.

Osteoarthritis is one of the most common locomotor diseases, with a steadily increasing prevalence and incidence. Loxacon® is a food supplement capsule containing vitamins, minerals, and herbal extracts with Boswellia serrata extract and Harpagophytum procumbens extract as its two main active components. The study involved 88 patients at 4 sites. The 88 patients were divided into 3 groups. The first group received physical therapy and Loxacon® capsules for 5 weeks, while the second group (30 patients) received physical therapy only for 5 weeks, and the third group (30 patients) received physical therapy and placebo capsules for 5 weeks. After 5 weeks, physical therapy was discontinued in all three groups and all groups continued Loxacon® capsules exclusively for an additional 60 days. Physical therapy had been carried out by a standard protocol over 5 weeks. Investigated parameters included Western Ontario and McMaster Universities Arthritis Index (WOMAC) testing, European Quality of Life (EQ-5D-5L) quality of life test and the Range of Motion (ROM). Among the 4 visual analogue scale (VAS) values investigated from WOMAC, significant change was seen for functionality in all three groups; however, the extent of change was twice as large in the physical therapy + Loxacon® group at Visit 2 in comparison with the other two groups. In the physical therapy + placebo group, improvement was seen only at the 3rd visit when they were also receiving Loxacon® capsules. The most pronounced difference was seen in the minimum clinically important difference index, calculated from the quality of life-VAS, where those taking Loxacon® capsules had a chance 3 times as high to obtain clinical improvement versus the other two groups. Our study confirmed that a combination of boswellic acid and harpagosides is beneficial as an additional therapy in knee OA.

The Utility of Patency Capsule in Patients With Crohn’s Disease

Background: Video capsule retention is a complication that can have serious consequences in patients with Crohn’s disease (CD). The patency capsule was developed to detect small bowel strictures. The usefulness of patency capsules in patients who do not have evidence of small bowel disease on imaging is uncertain. Study: This is a multicenter retrospective study of patients with suspected or confirmed CD who underwent a patency capsule study between January 2017 and February 2023. We excluded patients who were lost to follow-up or did not have computerized tomography or magnetic resonance imaging of the abdomen within 180 days before or after the patency capsule study. Results: A total of 105 patients met the inclusion criteria with 69% having a confirmed CD diagnosis. The majority of patients (95/105; 90.5%) passed their patency capsule. A total of 91 patients had their subsequent video capsule endoscopy (VCE), with 96.7% (88/91) successfully passing the capsule. Out of those who passed the VCE, 2 patients had patency capsule retention. Both had normal small bowel imaging. Meanwhile, the 3 patients who had VCE retention had evidence of small bowel disease in their imaging scans. The presence of abnormal small bowel wall thickening or stricture on imaging had a statistically significant association with VCE retention (P=0.02). Conclusion: Our study demonstrated a statistically significant association between small bowel disease on imaging and retention of both patency capsules and VCE. Small bowel imaging in patients with suspected or documented CD had a negative predictive value of 100% for VCE retention.

Method for elimination of residual cavity with rigid fibrous capsule in patients with hepatic echinococcosis and comorbidity

Aim. To improve the results of organ-preserving surgeries for hepatic echinococcal cysts with rigid fibrous capsule.Materials and methods. The study analyzed the results of surgical treatment of 221 patients with hepatic echinococcosis that was performed from 2016 to 2023. The main group included 94 patients (2020–2023), who underwent laparotomic or laparoscopic echinococcectomy followed by additional treatment of the residual cavity by the suggested method (113 cysts in total). The comparison group included 88 patients (2016–2019) who underwent standard interventions (108 cysts in total).Results. A treatment method for the residual cavity is selected with regard to the condition of the fibrous capsule. In case of elastic fibrous capsule, resections were performed in 1.7% of patients in the comparison group and 1.9% in the main group. Laparoscopic echinococcectomy was performed in 29.1% and 38.5% of cases, open echinococcectomy – in 69.2% and 59.6%, respectively. In case of rigid fibrous capsule, resections were made in 4.3% of patients in the comparison group and in 8% in the main group. Laparoscopic echinococcectomy was performed in 8.5% and 23.9% of cases, open echinococcectomy – in 87.2% and 68.2%, respectively.Conclusion. The suggested method of additional treatment for the residual cavity in cases of open and laparoscopic interventions enables the risk of early complications to be reduced from 19.1% to 4.5%, and from 16% to 3.4% within 3 months after surgery.

Clinical trial: Effects of treatment with a vibrating capsule in patients with severe chronic constipation.

There is little information on the effectiveness of therapies for severe chronic constipation. In a phase 3 trial, we previously demonstrated that a vibrating capsule was significantly more efficacious than a placebo in chronic constipation. To examine the effects of a vibrating capsule and placebo on symptoms and health-related quality of life (HRQoL) in patients with severe chronic constipation. We performed a post hoc analysis of phase 3, multicentre, randomised, double-blind, and placebo-controlled 8-week clinical trial of a vibrating capsule to specifically assess outcomes among subjects who reported 0 complete spontaneous bowel movements (CSBMs) during the 2-week baseline period. We assessed effects of treatment on bowel symptoms, patient satisfaction, and HRQoL. CSBM responders were defined as subjects with increases of ≥1 or ≥2 or ≥3 weekly CSBMs (CSBM1 or CSBM2, CSBM3, respectively) over baseline for ≥6 out of 8 weeks of treatment. The severe chronic constipation subgroup comprised 175 (56%) of the 312 subjects. Significantly more subjects with severe chronic constipation who received the vibrating capsule than those who received the placebo were CSBM1 (44.9% vs. 20.9%, p = 0.007), CSBM2 (29.2% vs. 11.6%, p = 0.004), and CSBM3 (19.10% vs 6.98%, p = 0.017) responders. Straining effort, stool consistency, patient satisfaction, and HRQoL significantly improved in the severe chronic constipation subgroup. A mild vibrating sensation was reported in 10%. The vibrating capsule significantly improved constipation-related symptoms and HRQoL in patients with severe constipation, affirming its efficacy and safety across the spectrum of chronic constipation.

Efficacy and Safety of Sanjie Analgesic Capsule in Patients with Endometriosis-Associated Pain: A Multicenter, 3:1 Randomized, Double-Blind, Placebo-Controlled Trial.

To assess the efficacy and safety of Sanjie Analgesic Capsule (SAC) in Chinese patients with endometriosis-associated pain. This was a multicenter, randomized, double-blind, placebo-controlled trial conducted at 15 centers between November 2013 and July 2017 in China. Eligible 323 patients with endometriosis were randomized at a 3:1 ratio to the SAC group (241 cases) and placebo group (82 cases) by stratified block randomization. Patients in the SAC or placebo groups were given SAC or placebo 1.6 g 3 times per day, orally, respectively since the first day of menstruation for 3 consecutive menstrual cycles. The primary endpoint was clinical response to dysmenorrhea evaluated using a 10-point Visual Analogue Scale at 3 and 6 months. The secondary endpoint was the pain score evaluated by VAS (chronic pelvic pain, defecation pain, and dyspareunia) at 3 and 6 months, and the pain recurrence rate at 6 months. Adverse events (AEs) were recorded during the study. A total of 241 women were included in the SAC group, and 82 were in the placebo group. Among these women, 217 (90.0%) and 71 (86.6%) completed the intervention, respectively. At 3 months, overall response rate (ORR) was significantly higher in women administered SAC (80.1%) compared with those who received a placebo (30.5%, P<0.01). Six months after treatment, the ORR for dysmenorrhea was 62.7% in the SAC group and 31.7% in the placebo group (P<0.01). Chronic pelvic pain and defecation pain were significantly improved by SAC compared with placebo (both P<0.05). The incidence rates of total AEs events in the SAC and placebo groups were 6.6% and 9.8%, respectively, and no significant difference was shown between the two groups (P=0.339). SAC is well-tolerated and may improve dysmenorrhea in women with endometriosis-associated pain. (Trial registration: ClinicalTrials.gov, No. NCT02031523).

Effectiveness of Compound Dilong Capsules in Patients with Asymptomatic Cerebral Carotid Artery Stenosis: A Retrospective Case-Control Study.

Asymptomatic cerebral carotid artery stenosis (ACCAS) benefits from secondary prevention via statins and antiplatelets; nonetheless, the impact of medication alone is often limited. Evidence has suggested enhanced therapeutic outcomes when Chinese patent medicine-specifically, compound dilong capsules (CDC)-is integrated with conventional secondary prevention measures. We retrospectively analyzed 319 ACCAS patients from January 2018 to December 2022 at Xuanwu Hospital, Capital Medical University. Depending on the clinical outcomes-improvement or stabilization versus progression-patients were classified into effective or ineffective treatment groups. Patient medical records and questionnaire responses were the primary data sources. The study accounted for demographic variables, clinical history, and medication details, with the primary focus on CDC use and its duration. Treatment outcomes were gauged alongside Transcranial color-coded sonography and Carotid Doppler ultrasonography findings. We employed both univariate and multivariate statistical methods to assess the data. CDC administration (aOR=2.51, 95% CI 1.39-4.54, P=0.002) and extended usage beyond six months (aOR=3.54, 95% CI 1.71-7.32, P=0.001) demonstrate a statistically significant correlation with treatment efficacy. Gender (aOR=2.54, 95% CI 1.30-5.00, P=0.007), hypertension management (aOR=0.56, 95% CI 0.33-0.95, P=0.031), and antiplatelet therapy with aspirin (aOR=9.53, 95% CI 1.15-78.89, P=0.037) or clopidogrel (aOR=9.97, 95% CI 1.10-90.12, P=0.041) also influenced the therapeutic outcome significantly. Incorporating CDC as part of a secondary prevention strategy for over six months can beneficially modulate and limit the progression of vascular stenosis in ACCAS. These findings underscore the value of combining traditional Chinese medicine with modern pharmacological interventions in ACCAS management.

Microelectrode recording characterization of the nucleus accumbens and the anterior limb of internal capsule in patients with addiction

The nucleus accumbens (NAc) and the anterior limb of internal capsule (ALIC) are effective targets for treating addiction using deep brain stimulation (DBS). However, there have been no reports on the electrophysiological characteristics of addiction nuclei at the single-cell level in humans. This study aimed to investigate the electrical activity characteristics of neurons in the NAc and ALIC using microelectrode recording (MER) during DBS surgery in patients with addiction, and six patients with addiction were included (five with heroin addiction and one with alcohol addiction). The microelectrode recording trajectories were reconstructed and recording sites at different depths were determined by merging the pre- and post-operative images in the FrameLink system. The results showed that among the 256 neurons, 204 (80 %) were burst neurons. NAc neurons accounted for the majority (57 %), and the mean firing rate (MFR) was the highest (1.94 Hz). ALIC neurons accounted for the least (14 %), and MFR was the lowest (0.44 Hz). MFR increased after entering the NAc and decreased after entering the ALIC. In the patients with addiction treated using DBS, the single-cell level electrophysiological characteristics of the different nuclei were found to be distinct along the surgical trajectory.

Benefits of adjuvant treatment with the Pingxiao capsule in patients with early breast cancer: A single‑center retrospective cohort study.

Early breast cancer (EBC) is cancer that has not spread beyond the breast or the axillary lymph nodes. The present retrospective cohort study investigated the efficacy and safety of the Pingxiao capsule (PXC), which contains a formula of traditional Chinese herbs, as adjuvant therapy in patients with EBC in a single Chinese academic medical center. Patients with EBC who had received surgery and chemotherapy were analyzed and divided into the PXC and non-PXC groups. Disease-free survival (DFS) time, overall survival (OS) time, demographic characteristics and adverse events were examined. Kaplan-Meier survival curves were used to compare the differences in DFS and OS. A total of 371 participants with a median age of 54 years were included in this study. The median DFS time of all patients was 101 months. The overall DFS rate was 72.1% in the PXC group compared with 63.6% in the non-PXC group. For women with hormone receptor-negative tumors, the DFS rate in the PXC group was significantly higher than that in the non-PXC group, irrespective of node status. Adjuvant treatment with PXC for ≥3 months was associated with significantly longer median DFS time compared with that in the non-PXC group. In addition, the incidence of neutropenia rated to be grade 2 or higher was significantly lower in the PXC group compared with that in the control group, and a markedly, but non-significantly, lower prevalence of nausea was observed in PXC group (0 vs. 4.1%). In conclusion, PXC as an adjuvant therapy along with chemotherapy is associated with prolonged DFS times in patients with EBC when compared with chemotherapy alone. The therapeutic value of combined PXC and systemic chemotherapy should be further elucidated by rigorous prospective clinical trials.

Efficacy and safety of omega-3-acid ethyl acetate 90 capsules in severe hypertriglyceridemia: A randomized, controlled, multicenter study.

Omega-3-acid ethyl acetate 90 capsules (containing 465 mg of eicosapentaenoic acid and 375 mg docosahexaenoic acid) is composed of highly purified omega-3 polyunsaturated fatty acid (PUFA) ethyl esters, whose lipid-lowering effect for severe hypertriglyceridemia (HTG) treatment is unclear. This study aimed to evaluate the efficacy and safety of omega-3-acid ethyl acetate 90 capsules in patients with severe HTG. In this randomized, double-blind, placebo-controlled, multicenter study, 239 patients with severe HTG were enrolled and randomized (1:1) into omega-3 group (N = 122) and placebo group (N = 117) to receive 12-week corresponding treatments. Lipid-related indexes were obtained at treatment initiation (W0), 4 weeks (W4), W8, and W12 after treatment. Adverse events and adverse drug reactions were recorded. Triacylglycerols (TAG), total cholesterol (TC), non-high-density lipoprotein cholesterol (non-HDL-C), very-low-density lipoprotein cholesterol (VLDL-C), and apolipoprotein C-III (Apo C-III) at W4, W8, and W12 were decreased in the omega-3 group versus the placebo group (all p < 0.05). Moreover, the percentage changes of TAG, TC, non-HDL-C, and VLDL-C from W0 to W4, W8, and W12, and the percentage change of Apo C-III from W0 to W4 and W8, were more obvious in the omega-3 group compared with the placebo group (all p < 0.05). However, no difference was observed in the percentage changes of HDL-C, low-density lipoprotein cholesterol (LDL-C), and LDL-C/HDL-C ratio during follow-up between groups (all p > 0.05). Additionally, there was no discrepancy in adverse events and adverse drug reactions between groups (all p > 0.05). Omega-3-acid ethyl acetate 90 capsules exhibit satisfied lipid-lowering effect with tolerable safety profile in patients with severe HTG.

A phase IIA clinical trial to evaluate a reversible Bruton’s tyrosine kinase inhibitor (BTKi) HBW-3220 capsules in patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL).

e19042 Background: This clinical study is to evaluate HBW-3220, a novel BTKi with an improved in vitro profile than the existing non-covalent drugs pirtobrutinib (approved) and nemtabrutinib (Phase III). HBW-3220 shows superior inhibition against BTK wild-type and several common mutants, such as C481S, C481R, T474I, T316A, and L528W (enriched in pirtobrutinib resistance), and hematopoietic cell kinase (HCK, a key contributor to BTKi resistance due to kinase-defective BTK). Methods: This phase IIA clinical study is conducted in R/R B-NHL patients who had received two or more prior lines of treatment. The dose escalation study adopts accelerated titration and a "3+3" design, with a daily single dose of 15, 30, 60, 90, 120, or 150 mg. During the dose escalation phase, the sponsor and investigators determine whether to expand the cohort of the previous dose based on the existing data. Adverse events (AEs) are assigned according to NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Response assessment is based on iwCLL 2018 guidelines for chronic lymphocytic leukemia (CLL), IWWM-7 consensus for Waldenstrom macroglobulinemia (WM), and Lugano 2014 guidelines for all other lymphomas, including small lymphocytic lymphoma (SLL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and follicular lymphoma (FL). Results: 29 patients have been enrolled, and the dose escalation study has been completed. No dose-limiting toxicity (DLT) occurred in any patient, implicating good tolerability. Adverse events (AEs), similar to other BTKis, were mostly Grade 1 or 2, including fever (36%), diarrhea (32%), headache (18%), anemia (39%), infectious pneumonia (18%), decreased neutrophils count (39%), decreased platelet count (29%), increased alanine aminotransferase (21%), etc. Drug-related Grade 3 AEs included decreased neutrophil count (n=3, 11%), increased lymphocyte count (n=2, 7%), and infectious pneumonia (n=2, 7%). 23 patients underwent at least 1 response assessment. The overall response rate (ORR) in CLL/SLL (all with prior irreversible BTKi treatment, and 4 of them with additional BCL2 inhibitor treatment), MZL, MCL, and DLBCL patients were 83% (5/6), 50% (2/4), 40% (2/5) and 33% (1/3), respectively. Among the ORR, 90% (9/10) were in the 90 mg and above dose group, regardless of previous BTKi treatment history or mutation status of p53 and BTK. After oral administration, the drug exposures showed dose-dependent increases. The time to maximum plasma concentration (Tmax) was 2 hours, and the elimination half-life (T1/2) was 19 hours. Conclusions: The current data show that HBW-3220 is well tolerated with no DLT occurred at daily doses up to 150 mg, displaying most promising efficacy in patients with CLL/SLL, MZL, and MCL. Clinical trial information: ChiCTR2200062537.

Abstract CT147: Phase I clinical study of Bruton’s tyrosine kinase inhibitor (BTKi) HBW-3220 capsules in patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL)

Abstract Purpose: This clinical study is to evaluate HBW-3220, a novel reversible BTK inhibitor (BTKi) with an improved in vitro profile than the existing non-covalent drugs pirtobrutinib (LOXO-305, approved) and MK-1026 (Phase III). HBW-3220 shows superior inhibition against BTK wild-type and several common mutants, such as C481S, C481R, T474I, T316A, and L528W (the one predominantly enriched in patients resistant to the newer-generation BTKis), and hematopoietic cell kinase (HCK), a key contributor to the development of ibrutinib resistance associated with kinase-defective BTK. Methods: This phase I clinical study was conducted in R/R B-NHL patients who had received two or more prior lines of treatments. The dose escalation study adopts accelerated titration and a "3+3" design, with a daily single dose of 15, 30, 60, 90, 120, or 150 mg. During the dose escalation phase, the sponsor and investigators determined whether to expand the cohort of the previous dose based on the existing data. Adverse events (AEs) were assigned according to NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Response assessment was based on the iwCLL 2018 guidelines, the IWWM-7 consensus, or the Lugano 2014 guidelines, according to the respective disease type. Results: 28 patients have been enrolled so far, and the dose escalation study has been completed. No dose-limiting toxicity (DLT) occurred in any patient, implicating good tolerability. Adverse events (AEs), similar to other BTKis, were mostly Grade 1 or 2, including fever (38%), diarrhea (35%), headache (19%), anemia (42%), infectious pneumonia (23%), decreased neutrophils (42%), decreased platelet count (27%), increased alanine aminotransferase (23%), etc. Drug-related Grade 3 AEs included neutrophil count decreased (n=3, 11%), increased lymphocyte count (n=2, 7%), and infectious pneumonia (n=2, 7%). 21 patients underwent at least 1 response assessment (4 chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); 4 marginal zone lymphoma (MZL); 5 mantle cell lymphoma (MCL); 3 diffuse large B-cell lymphoma (DLBCL); 5 other B-NHL), and the results are 1 complete response (CR), 6 partial response (PR), and 1 partial response with lymphocytosis (PR-L). The overall response rate (ORR) in CLL/SLL (all with prior irreversible BTKi treatment, and 2 of them with additional BCL2 inhibitor treatment), MZL, MCL, and DLBCL patients were 75% (3/4, including 1 PR-L), 50% (2/4), 40% (2/5) and 33% (1/3), respectively. Among the ORR (including CR, PR, and PR-L), 88% (7/8) were in the 90 mg and above dose group, regardless of previous BTKi treatment history or mutation status of p53 and BTK C481S. In the 90 mg and above dose group, the ORR is 47%. After oral administration, the drug exposures showed dose-dependent increases. The time to maximum plasma concentration (Tmax) was 2 hours, and the elimination half-life (T1/2) was 19 hours. Conclusions: The current data show that HBW-3220 is well tolerated, showing no DLT occurred at daily doses up to 150 mg, and has good efficacy in patients with CLL/SLL, MZL, and MCL. Citation Format: Ning Lee, Yingfu Li, Yong Mao, Guanfeng Liu, Jiang Li, Qingchun Liu. Phase I clinical study of Bruton’s tyrosine kinase inhibitor (BTKi) HBW-3220 capsules in patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr CT147.

Efficacy and safety of Pien Tze Huang capsules in patients with herpes zoster: A multicenter, randomized, double-blinded, and placebo-controlled trial

BackgroundHerpes zoster (HZ) is a common medical condition accompanied by several distressing symptoms, including acute pain. Pien Tze Huang (PZH) is a well-known traditional Chinese medicine (TCM) with numerous pharmacological effects, including antiviral properties, neuroprotection, and immunity regulation. PurposeTo investigate the efficacy and safety of PZH capsules in patients with HZ. Study designA multicenter, double-blinded, randomized, and placebo-controlled trial from 8 hospitals in 5 cities of China. MethodsEligible participants were randomly assigned to the PZH capsule and placebo group at a 1:1 ratio. Treatment was conducted for 14 days with a window period of no more than 2 days. For the first 7 days, participants received antiviral drugs combined with PZH capsules (0.6 g/time, 3 times a day) or placebos. For the remaining 7 days, they were only treated with PZH capsules (0.6 g/time, 3 times a day) or placebos. ResultsWe included 222 patients in the full analysis set (FAS), and 187 patients in the per protocol set (PPS). The change of numeric rating scale pain scores from baseline to the seventh day (±1 day) after treatment in the PZH capsule group was statistically superior to the placebo group (FAS: 2.33 vs. 1.71, 97.5%CI: 0.03 ∼ 1.19; PPS: 2.29 vs. 1.51, 97.5%CI: 0.18 ∼ 1.38). In the PPS, there was a significant difference in the time (days) of pain relief between the placebo group and the PZH capsule group (Mean (SD): 5.71 (3.76) vs. 4.69 (3.57), p = 0.046). On the seventh day (±1 day) after treatment, the level of CD8+ cells in the PZH capsule group were higher than those of the placebo group (FAS: Mean (SD): 24.08 (6.81) vs. 21.93 (8.19), p = 0.007; PPS: Mean (SD): 24.26 (6.93) vs. 22.15 (8.51), p = 0.012). The level of cytotoxic lymphocyte cells found similar results on the seventh day (±1 day) (FAS: Mean (SD): 12.17 (4.65) vs. 10.55 (4.15), p = 0.018; PPS: Mean (SD): 12.25 (4.65) vs. 10.11 (3.93), p = 0.002). No serious adverse events were noted and PZH capsules were well tolerated. ConclusionPZH capsules confer therapeutic effects on HZ with the TCM symptom of stagnated heat of liver channel by substantially reducing the pain intensity, shortening the time of pain relief as well as regulating the immune function. On the basis of the efficacy and safety profiles, PZH capsules may be a promising complementary therapy for the treatment of HZ.

Efficacy of tacrolimus capsules in patients undergoing high-risk keratoplasty

Purpose: To evaluate the efficacy of tacrolimus capsules in patients undergoing high-risk keratoplasty.&#x0D; Methods: 40 high-risk patients who underwent penetrating keratoplasty at The Third Hospital of Hebei Medical University, China between January 2016 and December 2021 were included in this study. These patients were divided into two groups based on the specific immunosuppressant administered post-surgery. Twenty patients were administered oral tacrolimus capsules in conjunction with 0.1 % tacrolimus eye drops, constituting the combination with systemic treatment group (group 1), while another twenty patients were solely administered 0.1 % tacrolimus eye drops, forming the topical treatment group (group 2). The occurrence of rejection, corneal neovascularization, corneal graft edema and visual acuity were documented in both groups.&#x0D; Results: In comparison to patients in group 2, patients in group 1 exhibited a significant reduction in rejection rate (p &lt; 0.05). Additionally, the average time of neovascularization in group 1 was delayed and the number of cases was lower (p &lt; 0.05). Furthermore, a smaller proportion of patients in group 1 experienced corneal graft edema (25 vs 60 %, p &lt; 0.05), while a higher percentage of patients in group 1 demonstrated improved visual acuity (90 vs 60 %, p &lt; 0.05).&#x0D; Conclusion: Concurrent administration of tacrolimus eye drops and capsules orally effectively mitigates anti-rejection reactions, regulation of neovascularization, management of graft edema and enhancement of visual acuity in high-risk keratoplasty patients when compared to the use of tacrolimus eye drops as a standalone treatment. These results have the potential to stimulate novel avenues of investigation in future clinical research.

An integrated model incorporating deep learning, hand-crafted radiomics and clinical and US features to diagnose central lymph node metastasis in patients with papillary thyroid cancer

ObjectiveTo evaluate the value of an integrated model incorporating deep learning (DL), hand-crafted radiomics and clinical and US imaging features for diagnosing central lymph node metastasis (CLNM) in patients with papillary thyroid cancer (PTC).MethodsThis retrospective study reviewed 613 patients with clinicopathologically confirmed PTC from two institutions. The DL model and hand-crafted radiomics model were developed using primary lesion images and then integrated with clinical and US features selected by multivariate analysis to generate an integrated model. The performance was compared with junior and senior radiologists on the independent test set. SHapley Additive exPlanations (SHAP) plot and Gradient-weighted Class Activation Mapping (Grad-CAM) were used for the visualized explanation of the model.ResultsThe integrated model yielded the best performance with an AUC of 0.841. surpassing that of the hand-crafted radiomics model (0.706, p < 0.001) and the DL model (0.819, p = 0.26). Compared to junior and senior radiologists, the integrated model reduced the missed CLNM rate from 57.89% and 44.74–27.63%, and decreased the rate of unnecessary central lymph node dissection (CLND) from 29.87% and 27.27–18.18%, respectively. SHAP analysis revealed that the DL features played a primary role in the diagnosis of CLNM, while clinical and US features (such as extrathyroidal extension, tumour size, age, gender, and multifocality) provided additional support. Grad-CAM indicated that the model exhibited a stronger focus on thyroid capsule in patients with CLNM.ConclusionIntegrated model can effectively decrease the incidence of missed CLNM and unnecessary CLND. The application of the integrated model can help improve the acceptance of AI-assisted US diagnosis among radiologists.

Factors predicting indistinct plane of surgical capsule in patients underwent HoLEP procedures.

To evaluate factors that effectively predict indistinct plane (IP) in patients who underwent holmium laser enucleation of the prostate (HoLEP). Data of 208 consecutive patients from our HoLEP database were reviewed and analyzed. IP was defined in 107 cases, as the plane could be identified only depending on endoscopic beak dissection rather than laser dissection in the initial stage of HoLEP, whereas the control group consisted of 101 cases. Variables including age, body mass index, prostatic volume (PV), intravesical prostatic protrusion, prostate-specific antigen, prostate-specific antigen density, bladder stones, urinary tract infection, microscopic hematuria, prior biopsy (PB), diabetes, hypertension, history of acute urinary retention, 5-alpha reductase inhibitor treatment, catheter dependency, residual urine, region, smoking, and alcohol consumption were compared between the two groups. The risk factors for predicting the presence of IP were determined using a multivariable binary logistic regression model using a forward selection approach with a focus on improvement in the area under the receiver operating characteristic curve (AUC). The incidence of IP was 51.4% (107/208). PV (OR = 0.977, p < 0.001) and PB (OR = 0.297, p = 0.028) were identified as the independent predictors of capsule plane status. PV with a cutoff of 54ml had the best predictive effectiveness for IP based on AUC (0.727; 95% CI 0.659-0.795). The specificity and sensitivity of this cutoff were 82.2% and 53.3%, respectively. PV is the most reliable factor to predict IP during HoLEP procedures. There is a high possibility of IP in patients with a PV less than 54ml.

Application of optical coherence tomography in the assessment of the posterior lens capsule during anti-angiogenic therapy

This study uses optical coherence tomography method to analyze the risks of developing changes in the posterior lens capsule in patients after IVI of an anti-angiogenic drug. The study involved 100 people (14 men and 86 women) with a natural lens and neovascular age-related macular degeneration (nAMD). The average age was 70.57±7.98 years. During the study (12 months), all patients underwent IVI of an anti-angiogenic drug aflibercept in the treat-and-extend (T&E) mode. All subjects were divided into 2 groups: with a total number of IVI less than 10 - group 1 (50 patients), and more than 10 IVI - group 2 (50 patients, of which 49 were included in the study). All patients underwent OCT using the Optopol REVO NX device (Poland) with the Anterior B-scan Wide protocol before inclusion in the study, as well as after 3, 6 and 12 months. It was found that the risk of developing a posterior lens capsule rupture, visualized using OCT, depends on the total number of IVI (correlation coefficient 0.473 p=0.001): the more IVI, the higher the probability that damage to the posterior capsule will occur after the next IVI, and after the 15th injection the risk of developing damage to the posterior capsule increases sharply. The astudy analyzed the risk factors for the development of posterior lens capsule damage that can be detected using OCT, and presented three risk groups for the development of rupture (or damage) of the posterior lens capsule depending on the number of intravitreal injections performed.

THU057 Predictors Of Response To Oral Octreotide Capsules In Patients With Acromegaly In A Large Prospective International Trial

Abstract Disclosure: M. Fleseriu: Consulting Fee; Self; Amryt (fka Chiasma), Ipsen, Ionis Pharmaceuticals Inc., Recordati, Pfizer, Inc. Research Investigator; Self; Amryt(fka Chiasma), Crinetics, Ionis Pharmaceuticals Inc., Recordati. Other; Self; Deputy Editor at EJE. A. Dreval: Research Investigator; Self; Research Investigator: Amryt(fka Chiasma). Y. Pokramovich: Research Investigator; Self; Research Investigator: Amryt(fka Chiasma). I. Bondar: Research Investigator; Self; Amryt(fka Chiasma). E. Isaeva: Research Investigator; Self; Chiasma. D.P. Macut: Research Investigator; Self; Principle Investigator: Amryt(fka Chiasma). Speaker; Self; Novartis Pharmaceuticals, Novo Nordisk, Sanofi, Pfizer, Inc., (spouse) Novo Nordisk. Other; Self; member of the Executive Committee of the European Society of Endocrinology (ESE). M.E. Molitch: Consulting Fee; Self; Corcept, Janssen Research &amp; Development Company, Merck, Novo Nordisk, Pfizer, Inc., Novartis Pharmaceuticals. Grant Recipient; Self; Amryt(fka Chiasma), Crinetics, Ionis Pharmaceuticals Inc. Research Investigator; Self; Bayer, Inc. N.V. Leonova: Research Investigator; Self; Chiasma. G. Raverot: Consulting Fee; Self; Pfizer, Inc., Recordati Rare Diseases, Ipsen. Research Investigator; Self; Chiasma, Pfizer, Inc., Novartis Pharmaceuticals. Speaker; Self; Ipsen, Pfizer, Inc., Recordati Rare Diseases. A. Haviv: Employee; Self; Amryt(fka Chiasma). N. Biermasz: Advisory Board Member; Self; Recordati, Pfizer, Inc., Macro Registry. Grant Recipient; Self; Amryt(fka Chiasma). C.J. Strasburger: Advisory Board Member; Self; Sandoz, Ipsen, Recordati. Consulting Fee; Self; Ascendis, Amryt(fka Chiasma), Novo Nordisk, Merck, Sandoz, Recordati. Speaker; Self; Ipsen, Novo Nordisk, HRA Pharmaceuticals. S. Melmed: Advisory Board Member; Self; Ionis Pharmaceuticals Inc., Crinetics. Consulting Fee; Self; Ipsen. Grant Recipient; Self; Pfizer, Inc. Background: Oral octreotide capsules (OOC) are a treatment option for patients with acromegaly in several countries. Global MPOWERED trial (NCT02685709; Fleseriu et al, Lancet Diabetes Endocrinol. 2022; 10: 102-111)1 showed that OOC were noninferior to injectable somatostatin receptor ligands (iSRLs; octreotide or lanreotide) in maintenance of biochemical response in those previously responding to both OOC and iSRLs. Clinical characteristics predictive of response are useful to devise and implement personalized acromegaly treatment. Objective To identify patient and disease characteristics to predict the likelihood of OOC responsiveness. Methods Eligibility criteria included adults aged 18-75 years, acromegaly diagnosis at screening, and ≥6 months iSRL treatment (≥4 months responding to stable dose). All patients received OOC during the 26-week run-in phase. Responders at week 24 (IGF-I &amp;lt;1.3 × ULN and mean integrated GH &amp;lt;2.5 ng/mL) were randomized to receive OOC or iSRLs during the subsequent randomized controlled treatment (RCT) phase.1 Multivariate logistic regression analyses were performed to assess the relationship of baseline characteristics with OOC response during the run-in phase by comparing the group randomized to the RCT phase (those responding at end of run-in who opted to continue, n=92) to the group not randomized (n=54). Results One hundred forty-six patients enrolled in the run-in phase; 116 patients completed, 94 OOC responders, 92 randomized to RCT phase. IGF-I level prior to initiating OOC was the only predictor of response in the run-in phase for randomization into the RCT phase; randomized mean (SD) 0.8 × ULN (0.25), not randomized 1.0 × ULN (0.25), adjusted P&amp;lt;.0001. Other acromegaly characteristics, including duration of acromegaly, history of surgery and/or radiation, baseline pituitary adenoma size, residual postoperative pituitary adenoma size, GH level (randomized mean [SD] 0.78 ng/mL [0.644]; not randomized 1.06 ng/mL [1.010]), and signs/symptoms of GH excess (eg, joint pain, fatigue, sweating, swelling of extremities, snoring, sleep apnea, carpal tunnel syndrome, headache, and others) were not associated with subsequent OOC response (adjusted P=.11-P=1.0). Prior iSRL dose received was not a predictor of OOC response (adjusted P=1.0); randomized n (%): low dose 19 (20.7), middle 33 (35.9), high 40 (43.5); not randomized: low 11 (20.4), middle 22 (40.7), high 21 (38.9). Conclusions Baseline IGF-I level on iSRLs, but not other acromegaly baseline characteristics, were the sole predictor of subsequent OOC response. This IGF-I-value association may be expected, as response at end of run-in was determined by a strictly defined IGF-I cutoff. These results may guide clinicians considering transitioning patients with acromegaly from iSRLs to OOC. Presentation: Thursday, June 15, 2023

S691 Efficacy of Different Activation Modes of the Vibrating Capsule in Patients With Chronic Idiopathic Constipation

S691 Efficacy of Different Activation Modes of the Vibrating Capsule in Patients With Chronic Idiopathic Constipation

Fuzheng Huayu capsules reducing development of hepatocellular carcinoma in cirrhotic patients with chronic hepatitis B based on the ratio of neutrophils/lymphocytes

Objective: To explore the advantage of Fuzheng Huayu capsule in patients with hepatitis B cirrhosis based on neutrophil/lymphocyte ratio (NLR) risk stratification in reducing the incidence of hepatocellular carcinoma (HCC). Methods: 916 cases diagnosed with hepatitis B cirrhosis and followed up for five years from January 2011 to January 2016 at Beijing Ditan Hospital Affiliated with Capital Medical University were included, and clinical data were collected. Patients were divided into a combination group and an antiviral group according to whether they were treated with anti-fibrosis for≥6 months. The antiviral group was treated with entecavir or tenofovir disoproxil, while the combination group was treated with Fuzheng Huayu capsules based on the antiviral therapy. The incidence of HCC was compared between the two groups of patients within five years. The advantaged groups treated with Fuzheng Huayu capsule were explored based on NLR risk stratification. The independent sample t-test and Mann-Whitney U test were used to compare measurement data between two groups. Categorical variable data were compared using either the χ(2) test or Fisher's exact probability method. The incidence of HCC in the two groups of patients was analyzed through the Kalplan-Merier curve and compared using the log-rank method. Results: There were 299 (32.6%) and 617 (67.4%) cases in the combined group and the antiviral group, respectively. A total of 154 (16.8%) patients developed HCC during the follow-up period. The five-year cumulative incidence of HCC in the combination group was lower than that in the antiviral group (10.7% vs. 19.8%, χ(2) = 11.848, P = 0.000 4). Patients with baseline NLR>3 had an increased risk of HCC. According to NLR risk stratification, there were 191 cases in the low-risk group (NLR<1.4), 462 cases in the medium-risk group (NLR1.4 ~ 3.0), and 263 cases in the high-risk group (NLR>3). Among medium to high-risk patients, the incidence of HCC was significantly reduced in the combination group (11.5% vs. 19.4%, χ(2) = 4.519, P = 0.029; 13.2% vs. 26.2%, χ(2) = 5.258, P = 0.019), while there was no statistically significant difference in the incidence of HCC among the low-risk group (P = 0.38). Conclusion: Compared with antiviral treatment alone, Fuzheng Huayu capsules combined with antiviral treatment can better reduce the five-year HCC incidence rate in patients with hepatitis B cirrhosis. Medium-and high-risk patients with NLR stratification are the most advantageous population to be treated with Fuzheng Huayu capsules.

Efficacy and safety of Lianhuaqingwen capsules in high-risk common type COVID-19 pneumonia: A multicenter retrospective study

Objective: To evaluate the clinical safety and efficacy of Lianhuaqingwen (LHQW) capsules in patients with high-risk common type COVID-19 pneumonia. Methods: A retrospective multicenter study on 383 high-risk common type COVID-19 pneumonia cases was conducted. Patients were categorized as the standard treatment (SDT) group (n=168) and the LHQW+SDT group (n=215). The primary endpoint was the rate of symptom (fever, fatigue, coughing) recovery and the secondary endpoints included the time to symptom recovery, the proportion of patients with improvement in chest CT images, the proportion of patients with clinical cure, the timing and rate of negative conversion of SARS-CoV-2 RNA assay. Results: The recovery rate was significantly higher in the LHQW+SDT group as compared with the SDT group (89.7% vs. 72.0%, P&lt;0.01). The combined use of LHQW+SDT also showed shorter time for symptom recovery, as well as shorter time for individual symptom of fever, fatigue and coughing recovery than use of SDT alone. A higher proportion of patients in the LHQW+SDT group with improvements in chest CT images and clinical cure (77.7% vs. 57.1%, P&lt;0.01) but the proportion of patients deteriorating to severe cases (1% vs. 25%, P&lt;0.01) in this group was significant lower than those in the SDT group. No significant difference in negative conversion rate of viral assay results was observed (76.8% vs. 75.0%, P&gt;0.05). No serious adverse events were reported. Conclusions: LHQW capsules could be recommended to ameliorate clinical symptoms and reduce the rate of deteriorating to severe cases for high-risk common type COVID-19 pneumonia.