A New Mixture Model With Cure Rate Applied to Breast Cancer Data.

We introduce a new modelling for long-term survival models, assuming that the number of competing causes follows a mixture of Poisson and the Birnbaum-Saunders distribution. In this context, we present some statistical properties of our model and demonstrate that the promotion time model emerges as a limiting case. We delve into detailed discussions of specific models within this class. Notably, we examine the expected number of competing causes, which depends on covariates. This allows for direct modeling of the cure rate as a function of covariates. We present an Expectation-Maximization (EM) algorithm for parameter estimation, to discuss the estimation via maximum likelihood (ML) and provide insights into parameter inference for this model. Additionally, we outline sufficient conditions for ensuring the consistency and asymptotic normal distribution of ML estimators. To evaluate the performance of our estimation method, we conduct a Monte Carlo simulation to provide asymptotic properties and a power study of LR test by contrasting our methodology against the promotion time model. To demonstrate the practical applicability of our model, we apply it to a real medical dataset from a population-based study of incidence of breast cancer in São Paulo, Brazil. Our results illustrate that the proposed model can outperform traditional approaches in terms of model fitting, highlighting its potential utility in real-world scenarios.

A New Approach to Modeling the Cure Rate in the Presence of Interval Censored Data.

We consider interval censored data with a cured subgroup that arises from longitudinal followup studies with a heterogeneous population where a certain proportion of subjects is not susceptible to the event of interest. We propose a two component mixture cure model, where the first component describing the probability of cure is modeled by a support vector machine-based approach and the second component describing the survival distribution of the uncured group is modeled by a proportional hazard structure. Our proposed model provides flexibility in capturing complex effects of covariates on the probability of cure unlike the traditional models that rely on modeling the cure probability using a generalized linear model with a known link function. For the estimation of model parameters, we develop an expectation maximization-based estimation algorithm. We conduct simulation studies and show that our proposed model performs better in capturing complex effects of covariates on the cure probability when compared to the traditional logit link-based two component mixture cure model. This results in more accurate (smaller bias) and precise (smaller mean square error) estimates of the cure probabilities, which in-turn improves the predictive accuracy of the latent cured status. We further show that our model's ability to capture complex covariate effects also improves the estimation results corresponding to the survival distribution of the uncured. Finally, we apply the proposed model and estimation procedure to an interval censored data on smoking cessation.

Clinical Efficacy and Safety Meta-Analysis of Different Surgical Approaches for Female Stress Urinary Incontinence.

OBJECTIVE: Meta-analysis was conducted to compare and evaluate the efficacy and safety of tension-free vaginal tape (TVT), outside-in trans-obturator tape (TOT), inside-out tension-free vaginal tape-obturator (TVT-O) and transvaginal tension-free urethral sling surgery (TVT-S) in the treatment of female stress urinary incontinence (SUI). METHODS: A computer-based systematic search of the PubMed, The Cochrane Library, Medline, Embase, Web of Science and ScienceDirect databases for randomised controlled trials (RCTs) comparing TVT, TOT, TVT-O and TVT-S for the treatment of SUI was performed from the time of library construction to November 2023. Two investigators performed data extraction and quality evaluation of the included RCTs, extracting information including the follows: First author, time of publication, intervention, sample size, age, duration of follow-up and objective cure rate, subjective cure rate, dyspareunia, vaginal mucosal perforation, urinary tract infection, sling exposure and postoperative thigh pain/groin pain. Review Manager (RevMan) 5.4 was used for data processing. RESULTS: A total of 14 RCTs with 2665 patients were included. Meta-analysis showed no statistically significant differences in objective cure rate, urinary tract infection, sling exposure and postoperative thigh pain/groin pain. The subjective cure rate of TVT was higher than that of TOT (odds ratio (OR), 95% confidence interval (CI) = 1.37 (1.02, 1.84), p = 0.03); The incidence of TVT-O voiding difficulty was lower than that of TVT (OR, 95% CI = 2.94 (1.20, 7.20), p = 0.02); And the incidence of vaginal mucosal perforation of TOT was lower than that of TVT (OR, 95% CI = 0.11 (0.02, 0.61), p = 0.01). CONCLUSIONS: The four surgical procedures, TVT, TOT, TVT-O and TVT-S, were relatively similar in terms of SUI outcomes. TVT had a higher subjective cure rate than TOT and a higher incidence of postoperative dyspareunia and vaginal mucosal perforation.

Analysis of Clinical Characteristics of Tuberculosis Patients with Dementia in Gyeongsangbuk-do, Republic of Korea.

(1) Background: Among Korean research papers there have been studies on the correlation between tuberculosis-hypertension and diabetes and the correlation between dementia-hypertension and diabetes, but there were no analysis data specifically on tuberculosis and dementia. (2) Methods: A total of 2992 tuberculosis patients in the Gyeongbuk region were analyzed through a final analysis of integrated disease and health management system data collected from 2021 to 2022. In this selection, patients with tuberculosis under 50 years of age and 368 people diagnosed with tuberculosis were excluded. (3) Results: From 2021 to 2022, among the 2992 tuberculosis patients in Gyeongsangbuk-do aged 50 or older, 2722 (91.0%) belonged to the general tuberculosis patient group, while 270 (9.0%) belonged to the dementia-tuberculosis patient group. The average age in the dementia-tuberculosis group was 81.4 years, significantly higher than the general group's average of 75.7 years. Within the dementia-tuberculosis patient group, 235 patients (87.0%) had underlying medical conditions in addition to dementia and tuberculosis. The tuberculosis treatment cure rate was 56.3% (1477 patients) in the general group and 38.9% (105 patients) in the dementia-tuberculosis patient group. (4) Conclusions: The cure rate was notably higher in the general group. Similarly, the mortality rate (deaths due to tuberculosis) was significantly higher in the dementia-tuberculosis patient group (7.0%, 19 patients) compared to the normal group (3.0%, 81 patients). The mortality rate in the dementia group was more than twice that of the general group.

Efficacy of 400 mg albendazole against soil-transmitted helminthes among Salgy Primary School Children, Dembia district, Northwest Ethiopia, 2020. "Uncontrolled experimental study".

Background and Aims: Soil-transmitted helminths are one of the most prevalent causes of both intellectual and physical disability in the world. Albendazole (ALB) is a drug recommended for mass treatment of the high burden of soil-transmitted helminths in schoolchildren, particularly in developing countries. However, some researchers have reported that the efficacy of albedazole against soil-transmitted helminths is inconsistent. Monitoring the programs is crucial to evaluating the effectiveness of 400 mg of ALB against soil-transmitted helminths, as well as any changes in its therapeutic efficacy. Thus, the purpose of this study was to evaluate ALB effectiveness in treating soil-transmitted helminthes in Salgy Primary School Children. Methods: An uncontrolled experimental study was conducted at Salgy Primary School Children, Northwest Ethiopia, from March to May 2020. A total of 439 schoolchildren were enrolled and screened for soil-transmitted helminths by stratified proportionate systematic random sampling to get 228 positive schoolchildren. Students in grades one through eight were grouped based on their educational attainment. Using the Kato-Katz thick smear technique, the selected stool sample collected from school children was examined using the Kato-Katz thick smear technique to determine the cure and egg reduction rates. The statistical package for social science software, version 20, was used to analyze the data. To determine the relationship between CR (cure rate) and ERR (egg reduction rate) by age, a chi-square test (X 2) was employed and significance was considered at A 95% confidence interval and p Value (p < 0.05). Results: A 400 mg single dosage of ALB showed a 99.35% CR and a 97.30% egg reduction rate against Ascaris lumibricoides. Additionally, a 400 mg dose of ALB showed a 95.75% CR and an 82.07% egg reduction rate, suggesting questionable effectiveness against hookworm infections. Trichuris trichiura showed a decreased efficacy, with a 43.53% CR and a 23.12% egg reduction rate. Conclusion: A single dose of 400 mg ALB is effective (satisfactory), doubtful, and unsatisfactory against Ascaris lumbricoides, hookworm, and T. trichiura infections, respectively. Further studies using different brands, doses, and routes will be needed to treat hookworm and T. trichiura infections successfully by using a larger sample size.

Two-phase designs with failure time processes subject to nonsusceptibility.

Epidemiological studies based on 2-phase designs help ensure efficient use of limited resources in situations where certain covariates are prohibitively expensive to measure for a full cohort. Typically, these designs involve 2 steps: In phase I, data on an outcome and inexpensive covariates are acquired, and in phase II, a subsample is chosen in which the costly variable of interest is measured. For right-censored data, 2-phase designs have been primarily based on the Cox model. We develop efficient 2-phase design strategies for settings involving a fraction of long-term survivors due to nonsusceptibility. Using mixture models accommodating a nonsusceptible fraction, we consider 3 regression frameworks, including (a) a logistic "cure" model, (b) a proportional hazards model for those who are susceptible, and (c) regression models for susceptibility and failure time in those susceptible. Importantly, we introduce a novel class of bivariate residual-dependent designs to address the unique challenges presented in scenario (c), which involves 2 parameters of interest. Extensive simulation studies demonstrate the superiority of our approach over various phase II subsampling schemes. We illustrate the method through applications to the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.

Evaluation of the benefit of the addition of 1% topical luliconazole versus topical bland emollient to the systemic itraconazole therapy for the management of disseminated dermatophytosis: A randomised control trial.

BACKGROUND: The present epidemic of dermatophytosis in India is marked by an increase in chronic, recurrent and disseminated cases. A combination of oral itraconazole and topical luliconazole is being increasingly utilised by dermatologists in India. The superiority of this combination is not supported by robust clinical trial data. OBJECTIVE: We conducted this randomised, open-label, two arms, parallel assignment intervention trial between November 2022 and May 2023 to determine the superiority of topical 1% Luliconazole over bland emollient as adjuvant to systemic Itraconazole therapy in the management of dermatophytosis. METHOD: In this study, 135 patients of either sex were randomised to two study cohorts. Major exclusions being concomitant medical illness, use of concomitant medication and substance abuse. Participants were randomly assigned to receive topical bland emollient, (Cohort I, n = 67) or topical luliconazole, (Cohort II, n = 68). Both cohorts received oral itraconazole 200 mg/day (100 mg BID) and levocetirizine 5 mg twice a day as a systemic regime. Clinical and mycological cure at the end of 6 weeks and clinical relapse among cure patients during 10-week follow-up were observed. RESULTS: The cure rates for Cohorts I and II at 6 weeks were 50 (74.62%) and 56 (82.35%), (p = .46), respectively. During the 4-week follow-up period, clinical relapses were observed in 16 (32%) of the 50 patients in Cohort I and 12 (21.43%) of the 56 patients in Cohort II (p = .18). Luliconazole cohort shows a significantly higher medical cost (p < .05). CONCLUSION: Our study shows a similar cure rate and relapse rate for patients receiving topical Luliconazole versus topical bland emollient as an adjuvant to the systemic itraconazole regime.

Sustain-release lipid-liquid crystal formulations of pexiganan against Helicobacter pylori infection: in vitro evaluation in C57BL/6 mice.

INTRODUCTION: The Gram-negative bacterium Helicobacter pylori, H. pylori, is associated with significant digestive disorders. However, the effectiveness of bacterial eradication is declining due to drug resistance. A potent anti-H. pylori activity is shown by the natural antimicrobial peptide pexiganan. OBJECTIVE: The current study aimed to evaluate the effectiveness of pexiganan and its lipid-liquid crystals (LLCs) in inducing Helicobacter pylori in mice. METHODS: In this experimental study, H. pylori infection was first induced in C57BL/6 mice. Secondly, the antibacterial efficacy of pexiganan and its LLCs formulations was investigated to eliminate H. pylori infection. RESULTS: The H. pylori infection could not be completely eradicated by pexiganan peptide alone. However, incorporating pexiganan within the LLC formulation resulted in an increased elimination of H. pylori. Under the H&E strain, the pexiganan-LLCs formulation revealed minimal mucosal alterations and a lower amount of inflammatory cell infiltration in the stomach compared to the placebo. CONCLUSION: Clarithromycin was more effective than pexiganan at all tested concentrations. Furthermore, the pexiganan-loaded LLCs exhibited superior efficacy in curing H. pylori infection in a mouse model compared to pexiganan alone. This formulation can enhance H. pylori clearance while mitigating the adverse effects, typically associated with conventional drugs, leading to a viable alternative to current treatment options.

Efficacy and safety of praziquantel treatment against Schistosoma mansoni infection among pre-school age children in southern Ethiopia.

BACKGROUND: Preventive chemotherapy with a single dose of praziquantel given to an all-at-risk population through mass drug administration is the cornerstone intervention to control and eliminate schistosomiasis as a public health problem. This intervention mainly targets school age children, and pre-school age children (pre-SAC) are excluded from receiving preventive chemotherapy, partly due to scarcity of data on praziquantel treatment outcomes. METHODS: We conducted active efficacy and safety surveillance of praziquantel treatment among 240 Schistosoma mansoni-infected pre-SAC who received a single dose of praziquantel (40 mg/kg) in southern Ethiopia. The study outcomes were egg reduction rates (ERR) and cure rates (CRs) four weeks after treatment using the Kato-Katz technique and treatment-associated adverse events (AEs) that occurred within 8 days post-treatment. RESULTS: The overall ERR was 93.3% (WHO reference threshold ≥ 90%), while the CR was 85.2% (95% CI = 80.0-89.5%). Baseline S. mansoni infection intensity was significantly associated with CRs, 100% among light infected than moderate (83.4%) or heavy (29.4%) infected children. An increase of 100 in baseline S. mansoni egg count per gram of stool resulted in a 26% (95% CI: 17%, 34%) reduction in the odds of cure. The incidence of experiencing at least one type of AE was 23.1% (95% CI: 18.0%, 29.0%). Stomachache, diarrhea, and nausea were the most common AEs. AEs were mild-to-moderate grade and transient. Pre-treatment moderate (ARR = 3.2, 95% CI: 1.69, 6.14) or heavy infection intensity (ARR = 6.5, 95% CI: 3.62, 11.52) was a significant predictor of AEs (p < 0.001). Sex, age, or soil-transmitted helminth coinfections were not significant predictors of CR or AEs. CONCLUSIONS: Single-dose praziquantel is tolerable and effective against S. mansoni infection among pre-SAC, and associated AEs are mostly mild-to-moderate and transient. However, the reduced CR in heavily infected and AEs in one-fourth of S. mansoni-infected pre-SAC underscores the need for safety and efficacy monitoring, especially in moderate-to-high infection settings. Integrating pre-SACs in the national deworming programs is recommended to accelerate the elimination of schistosomiasis as a public health problem.

A support vector machine-based cure rate model for interval censored data.

The mixture cure rate model is the most commonly used cure rate model in the literature. In the context of mixture cure rate model, the standard approach to model the effect of covariates on the cured or uncured probability is to use a logistic function. This readily implies that the boundary classifying the cured and uncured subjects is linear. In this article, we propose a new mixture cure rate model based on interval censored data that uses the support vector machine to model the effect of covariates on the uncured or the cured probability (i.e. on the incidence part of the model). Our proposed model inherits the features of the support vector machine and provides flexibility to capture classification boundaries that are nonlinear and more complex. The latency part is modeled by a proportional hazards structure with an unspecified baseline hazard function. We develop an estimation procedure based on the expectation maximization algorithm to estimate the cured/uncured probability and the latency model parameters. Our simulation study results show that the proposed model performs better in capturing complex classification boundaries when compared to both logistic regression-based and spline regression-based mixture cure rate models. We also show that our model's ability to capture complex classification boundaries improve the estimation results corresponding to the latency part of the model. For illustrative purpose, we present our analysis by applying the proposed methodology to the NASA's Hypobaric Decompression Sickness Database.

Effect of restrictive fluid resuscitation on the coagulation function and hemodynamic parameters in patients with hemorrhagic traumatic shock.

OBJECTIVES: To investigate the changes in the coagulation function and hemodynamic parameters in patients with Hemorrhagic Traumatic Shock (HTS) after restrictive fluid resuscitation. METHODS: A total of 139 patients with HTS admitted to our hospital were enrolled, among which 69 HTS patients were divided into the control group and the remaining 70 HTS patients as the observation group. Patients in the control group underwent regular fluid resuscitation, while those in the observation group underwent restrictive fluid resuscitation. RESULTS: During treatment, 70 patients in the observation group had a lower bleeding amount, infusion amount, and blood transfusion volume than those in the control group (p < 0.05). After treatment, patients in the observation group had better hemodynamic parameters and blood coagulation than those in the control group (p < 0.05), and the incidence rate in the observation group was only 12.9%, which was significantly lower than 60.87% in the control group, while the cure rate in the observation group was 100%, which was significantly higher than that in the control group (p < 0.05). CONCLUSIONS: Restrictive fluid resuscitation could remarkably increase the cure rate and reduce the bleeding amount during HTS treatment, thereby benefiting the recovery of the patient's blood coagulation.

Outcomes of Pharmacist-Led Treatment of Hepatitis C in the Virginia Department of Corrections.

A higher proportion of people in correctional settings have, or are at risk for, hepatitis C virus (HCV) due to socioeconomic factors, mental health concerns, substance use disorders, history of high-risk experiences, and more. Compared with the general population, the prevalence of HCV is 10 times higher among people who are incarcerated. The objective of this retrospective cohort study was to describe the HCV treatment cascade in a pharmacist-led clinic model, from referral through treatment completion and documentation of cure. Pharmacists in the Virginia Department of Corrections, in collaboration with Virginia Commonwealth University, established and led a telemedicine HCV clinic. A total of 1,040 incarcerated individuals with chronic HCV infection were treated between January 2020 and January 2022. In this study, the clinical endpoint was the number of patients achieving a 12-week sustained virological response (SVR12), which is considered cure of an HCV infection. The economic endpoint was total dollars spent per patient to achieve the SVR12. Participants were HCV treatment naïve, positive for HCV genotypes 1-6, not concurrently infected with HIV, and without decompensated liver disease. The overall cure rate was 97% with no discontinuation due to adverse effects. The cost-to-cure ratio was $23,223/person achieving SVR12.

Antibiotics therapy combined with probiotics administered intravaginally for the treatment of bacterial vaginosis: A systematic review and meta-analysis.

The objective was to examine the pooled effects of antibiotic-probiotic combinations by examining the cure rate and recurrence rate for bacterial vaginosis (BV). A systematic literature search was conducted from electronic databases. All parallel randomized controlled trials (RCTs) that focused on the effects of antibiotics combined with intravaginal probiotics were included. Cure rate and recurrence rate were the primary and secondary outcomes to be analyzed. Meta-analysis was conducted following the Cochrane handbook for Systematic Reviews of Interventions. As a result, of 923 studies identified, 11 articles involving 1,493 BV patients met the inclusion criteria and nine were available for meta-analysis. A meta-analysis of two studies evaluated the recurrence rate 12-16 weeks after treatment. Results showed a statistically significant difference favoring the antibiotics plus probiotics group vs the antibiotics plus placebo group (relative risk 0.62, 95% confidence interval [CI]: 0.45-0.85). The narrative review in one study indicated that the cure rate was higher in the antibiotics plus probiotics group, giving a significant HR ratio of 0.73 (95% CI 0.54-0.98) (p = 0.042). In conclusion, vaginal application of Lactobacillus in combination with antibiotics for the treatment of BV could be a promising method for both reducing the recurrence rate and relieving symptoms of BV.

Long-term control of acromegaly after pituitary surgery in South-Eastern Norway.

PURPOSE: Sustained cure of acromegaly can only be achieved by surgery. Most growth hormone (GH) secreting pituitary adenomas are macroadenomas (≥ 10 mm) at diagnosis, with reported surgical cure rates of approximately 50%. Long-term data on disease control rates after surgery are limited. Our aim was to estimate short- and long-term rates of biochemical control after pituitary surgery in acromegaly and identify predictive factors. METHODS: Patients operated for GH-secreting pituitary adenomas between 2005-2020 were included from the local pituitary registry (n = 178). Disease activity and treatment data were recorded at one-year (short-term) and five-year (long-term) postoperative follow-up. Biochemical control was defined as insulin-like growth factor 1 (IGF-1) ≤ 1.2 × upper limit of normal value. Multivariate regression models were used to identify factors potentially predicting biochemical control. RESULTS: A total of 178 patients with acromegaly (median age at diagnosis 49 (IQR: 38-59) years, 46% women) were operated for a pituitary adenoma. Biochemical control was achieved by surgery in 53% at short-term and 41% at long-term follow-up, without additional treatment for acromegaly. Biochemical control rates by surgery were of same magnitude in paired samples (45% vs. 41%, p = 0.213) for short- and long-term follow-up, respectively. At short-term, 62% of patients with microadenomas and 51% with macroadenomas, achieved biochemical control. At long-term, the biochemical control rate was 58% for microadenomas and 37% for macroadenomas (p = 0.058). With adjunctive treatment, 82% achieved biochemical control at long-term. Baseline IGF-1 levels significantly predicted biochemical control by surgery at short-term (OR: 0.98 (95% CI: 0.96-0.99), p = 0.011), but not at long-term (OR: 0.76 (95% CI: 0.57-1.00), p = 0.053). CONCLUSION: In unselected patients with acromegaly, the long-term biochemical control rate remains modest. Our findings indicate a need to identify patients at an earlier stage and improve therapeutic methods and surgical outcomes.

The efficacy of ureteroscopic triage in increasing the cure rate of the first-line treatment for a ureterovaginal fistula resulting from radical hysterectomy.

Study objective: To explore the effect of pretreatment with ureteroscopic triage for iatrogenic ureterovaginal fistula (UVF) resulting from radical hysterectomy. Design: A retrospective cohort study. Setting: Department of gynecology at a tertiary medical center. Patients: Women diagnosed with UVF secondary to radical hysterectomy at our center between April 2008 to June 2018. Interventions: The patients were divided into two groups according to whether pretreatment with ureteroscopic triage was performed. Those in the non-triage group underwent retrograde placement of a double-J stent immediately following diagnosis as the first-line therapy. Patients in the triage group were first evaluated under ureteroscopy, their ureteral injuries were then classified into different grades and then underwent different treatments as the first-line therapy, including stent placement or reconstruction surgeries. The cure rate of the first-line therapy and the timeliness of the implementation of adjuvant radiotherapy were subsequently analyzed. Measurements and main results: Ninety-eight UVF patients were included. The demographics, ECOG status, stage of cervical cancer (FIGO 2009), types and onset time of symptoms were not different between the two groups. There were 54 patients in the nontriage group, with an overall first-line cure rate of 70.4% and a timely implementation rate of adjuvant radiotherapy of 38.5%. There were 44 patients in the evaluation group, with an overall first-line cure rate of 93.2% and a timely implementation rate of adjuvant radiotherapy of 90.0%. The differences were statistically significant (p < 0.001). Conclusion: Ureteroscopic triage of ureteral injuries can guide the selection of the optimal first-line therapy for patients with UVF secondary to radical hysterectomy, increase the cure rate and ensure the timely implementation of adjuvant radiotherapy.

The Neural Response Process of Cognitive Decision Making: An ERP Study.

Cognitive decision has the basic characteristics of risk avoidance and benefit seeking. To explore the neural response process of cognitive decision making, we asked 32 undergraduates to make a decision on whether to accept a specific treatment option with a certain cure rate and a certain risk rate while recording their electrical brain responses. The results showed that more participants chose the treatment option with a high cure rate and moderate or low risk. Compared with low and high risk, medium risk produced greater N1 and smaller P300. Low risk produced larger LPP than the moderate risk in the left hemisphere. The right prefrontal region appeared to have a smaller LPP for low risk than for high risk. The results suggest that individuals prioritize risk when making cognitive decisions. In addition, in medium-risk conditions, solution integration is more difficult. The effect of benefit size appears at the late stage of cognitive decision making and adjusts the effect of risk. These results support the satisfaction principle of decision making.

Efficacy and Safety of Vonoprazan and Amoxicillin Dual Therapy for Helicobacter pylori Eradication: A Systematic Review and Meta-Analysis.

INTRODUCTION: Vonoprazan, a novel potassium-competitive acid blocker, has a strong acid suppression effect and potent efficacy in acid-associated diseases, including Helicobacter pylori eradication. We performed a systematic review and meta-analysis to investigate the efficacy and safety of vonoprazan/amoxicillin dual therapy for H. pylori eradication. METHODS: We conducted a systematic literature search through PubMed, Web of Science, EMBASE, and the Cochrane Library up to June 2022, to identify randomized controlled trials and cohort studies comparing vonoprazan/amoxicillin dual therapy and triple therapies for H. pylori eradication. Primary outcomes were cure rates and relative efficacy. Secondary outcomes included adverse events, dropout rate, and subgroup analysis. RESULTS: Five studies with 1,852 patients were included in the analysis. The cure rates of vonoprazan/amoxicillin dual therapy were 85.6% with 95% confidence interval (CI) of 79.7-91.5% and 88.5% (95% CI: 83.2-93.8%) in the intention-to-treat and per-protocol analyses. The efficacy of vonoprazan/amoxicillin dual therapy was not inferior to that of triple therapy with pooled risk ratio (RR) of 1.03 (95% CI: 0.97-1.10) and 1.02 (95% CI: 0.98-1.08) in intention-to-treat and per-protocol analyses; while it was significantly superior to the omeprazole or lansoprazole-based triple therapy (RR = 1.15, 95% CI: 1.05-1.25, p = 0.001). For clarithromycin-resistant strains, vonoprazan/amoxicillin dual therapy showed superiority to vonoprazan-based triple therapy (86.7% vs. 71.4%, RR = 1.20, 95% CI: 1.03-1.39, p = 0.02); however, vonoprazan/amoxicillin dual therapy was significant inferior to vonoprazan-based triple therapy for clarithromycin-sensitive strains (83.0% vs. 92.8%, RR = 0.90, 95% CI: 0.85-0.95, p = 0.0002). The adverse effects of vonoprazan/amoxicillin dual therapy were lower than those of triple therapy (21.2% vs. 26.5%, RR = 0.86, 95% CI: 0.73-1.01, p = 0.06), especially the incidence of diarrhea (p = 0.01). CONCLUSIONS: The efficacy of vonoprazan/amoxicillin dual therapy is noninferior to vonoprazan-based triple therapy but superior to the omeprazole or lansoprazole-based triple therapy and has less side effects. Patients with clarithromycin-resistant strains are particularly expected to benefit from vonoprazan/amoxicillin dual therapy.

Platelet-rich plasma in the treatment of anal fistula: a systematic review and meta-analysis.

OBJECTIVE: To analyse the safety and effectiveness of platelet-rich plasma (PRP) in anal fistula patients. METHODS: Online databases including PubMed, Embase, Cochrane Library, and Web of Science were searched from inception to December 5, 2022, for eligible studies about evaluating the efficacy of platelet-rich plasma (PRP) in treating anal fistula. Literature search, screening, data extraction, and quality assessment were carried out by two independent investigators. The overall cure rate, the complete cure rate, the recurrence rate, and the adverse event rate with their 95% confidence intervals (95% CI) were the primary calculation indexes. Subgroup analyses were conducted primarily according to whether PRP was combined with other treatments. Softwares of MedCalc 18.2 and Review Manager 5.3 were used for meta-analysis. RESULTS: A total of 14 studies with 514 patients were included in the meta-analysis. The overall cure rate of 14 studies was 72.11% (95% CI 0.64-0.79). The cure rate of PRP alone was 62.39% (95% CI 0.55-0.69). The combined cure rate of PRP with other treatments was 83.12% (95% CI 0.77-0.88). The cure rate of interventions involving PRP were superior to the cure rate of surgery methods without using PRP significantly in the 4 randomized controlled studies (RR = 1.30, 95% CI 1.10-1.54, p = 0.002). The complete cure rate of the 8 studies was 66.37% (95% CI 0.52-0.79). The recurrence rate of the 12 studies was 14.84% (95% CI 0.08-0.24). The adverse event rate of the 12 studies was 6.31% (95% CI 0.02-0.12). CONCLUSION: PRP showed favorable safety and effectiveness in the treatment of anal fistula, especially combined with other treatment procedures.

Efficacy and safety of praziquantel preventive chemotherapy in Schistosoma mansoni infected school children in Southern Ethiopia: A prospective cohort study.

Background: The World Health Organization recommends efficacy and safety surveillance of anti-helminths used in mass drug administration campaigns. We evaluated the effectiveness of single-dose praziquantel against Schistosoma mansoni infection, and the safety of praziquantel plus albendazole preventive chemotherapy (PC) in Schistosoma mansoni infected school children (n = 512) in Southern Ethiopia. Method: Stool examinations were done using thick smear Kato-Katz at baseline, week-4, and week-8 of post-Mass drug administration (MDA) to assess praziquantel efficacy. Participants were followed for MDA-associated adverse events up to day 7 of post-MDA. The primary and secondary study outcomes were praziquantel efficacy (parasitological cure and egg reduction rates) and MDA-associated adverse events (AEs), respectively. Result: The overall cure rates at week-4 and week-8 were 89.1% (95%CI = 86.1-91.7) and 87.5% (95%CI = 83.6-90.8), respectively. Cure rates among moderate-to-heavily infected children were significantly lower (p = 0.001) compared to those with light infection at week-4 (84.4% vs. 91.1%, p = 0.03) and week-8 (78.6% vs. 91.9%, respectively). Older children had a higher cure rate than younger ones at week-8 (90.1% vs. 79.5%, p = 0.01). Among those who were Schistosoma egg-free (cured) at week 4, 7.8% became egg-positive at week 8. The overall egg reduction rate (ERR) at week-4 and week-8 were 93.5% and 91.3%, respectively, being lower among the 5-9 years old age groups (p = 0.01) at week-8. The proportion of children who remained schistosoma egg-positive throughout the study follow-up period was 4.6%, and their ERR at week-4 and week-8 was 50% and 51%, respectively, which is below the 90% World Health Organization threshold for efficacy. The incidence of experiencing at least one type of MDA-associated AEs were 17.0% (95%CI = 13.8%-20.5%); abdominal pain, headache, and vomiting were the most common. The proportion of mild, moderate, and severe AEs was 63.2%, 26.3%, and 10.5%, respectively. Females experienced more AEs than males (p = 0.03). Conclusion: Single-dose praziquantel is still effective for the treatment of intestinal schistosomiasis. Praziquantel and albendazole preventive chemotherapy is safe and tolerable, and associated AEs are mostly mild-to-moderate and transient. However, the reduced PZQ effectiveness in moderate-to-heavy infection and observed AEs in about one-fifth of infected children underscores the need for better treatment strategies and surveillance for early detection of parasite resistance and management of AEs.

Efficacy and safety of Ginkgo biloba extract as an adjuvant in the treatment of Chinese patients with sudden hearing loss: a meta-analysis.

CONTEXT: Ginkgo biloba Linn (Ginkgoaceae) [leaves extract (GBE)] is authorized for the treatment of sudden hearing loss (SHL); however, its clinical feasibility in SHL has not been thoroughly investigated. OBJECTIVE: To evaluate the efficacy and safety of adjuvant GBE in the treatment of SHL. MATERIALS AND METHODS: We used PubMed, EMBASE, Web of Science, Cochrane Library, China National Knowledge Infrastructure, Wanfang, Chinese Scientific Journal Database, China Biomedical Database for literature research, starting from inception to 30 June 2022. The key terms: Ginkgo biloba extract, Sudden Sensorineural Deafness. This meta-analysis contained randomized controlled trials that compared the safety and efficacy of the combination of GBE and general treatments (GT) with GT alone for SHL. The extracted data were analyzed using Revman5.4 software with risk ratio (RR), 95% confidence intervals (CI) and mean difference (MD). RESULTS: Our meta-analysis included 27 articles with a total of 2623 patients. The results revealed that the effects of GBE adjuvant therapy was superior than GT (total effective rate: RR = 1.22, 95% CI: 1.18-1.26, p < 0.00001), the pure tone hearing threshold (MD = 12.29, 95% CI: 11.74-12.85, p < 0.00001) and hemorheology indexes (whole blood high shear viscosity: MD = 1.46, 95% CI: 0.47-2.44, p = 0.004) after treatment were significantly improved compared to non-treatment, while there was no significant difference as for hematocrit (red blood cells) (MD = 4.15, 95% CI: -7.15-15.45, p = 0.47). CONCLUSION: The efficacy of GBE + GT for the treatment of SHL may be more promising than GT alone.