Quadruple Group Research Articles

P110 INITIAL TREATMENT WITH A SINGLE CAPSULE CONTAINING HALF-DOSE QUADRUPLE THERAPY VS STANDARD-DOSE DUAL THERAPY IN HYPERTENSIVE PATIENTS (QUADUAL): A RANDOMIZED, BLINDED, CROSSOVER TRIAL

Background and Objective: Guidelines recognized the dual combination in initial antihypertensive therapy. Studies demonstrated low-dose quadruple combination antihypertensive was superior to monotherapy. However, whether low-dose quadruple therapy is better than dual combination is unknown. Methods: A randomized blinded crossover trial was conducted to compare the efficacy and safety of low-dose quadruple antihypertensives (irbesartan 75 mg + metoprolol 23·75 mg + amlodipine 2·5 mg + indapamide 1·25 mg) with standard-dose dual antihypertensives (irbesartan 150 mg + amlodipine 5 mg) in the initial treatment of patients with mild to moderate hypertension. Patients were randomly assigned in a 1:1 ratio to two crossover sequences. Each sequence received four-weeks of either half-dose quadruple antihypertensives or standard-dose dual antihypertensives, followed by a two-week washout and crossover for four-weeks. Participants and researchers were blinded, except for randomization and drug coding. The primary outcome was the reduction of mean 24-hour systolic blood pressure in ambulatory blood pressure monitoring. Safety outcomes were adverse events and changes in biochemistry after treatment. Analyses were per intention to treat. This trial was prospectively registered on www.clinicaltrials.gov (NCT05377203), and is now complete. Results: A total of 90 eligible participants were randomized between July 13, 2022, and April 20, 2023. The mean age of the population was 43.88 years, and 25.6% were women. The mean baseline 24-h blood pressure was 145.59/93.84 mm Hg. Half-dose quadruple treatment compared with standard-dose dual treatment further reduced mean 24-hour blood pressure by 4.72/4.17 mm Hg (P < 0.001 for both systolic and diastolic blood pressure). Except for fasting blood glucose (P = 0.029) and blood uric acid increased significantly (P < 0.001) in half-dose quadruple group, other adverse events and changes in laboratory values between the two treatments were not statistical different. Conclusions: Initiating treatment with half-dose quadruple combination therapy was more effective in lowering blood pressure than standard-dose dual therapy. The safety of half-dose quadruple therapy was comparable.

Abstract PO3-27-12: Dexamethasone is necessary for preventing acute emesis induced by anthracycline/cyclophosphamide chemotherapy (HELEN-009) : a multicenter, randomized, open-labeled phase 3 trial

Abstract Background Olanzapine, in combination with NK1 receptor antagonist (RA), 5-hydroxytryptamine-3 (5-HT3) RA, and dexamethasone, is now the standard approach to prevent chemotherapy-induced nausea and vomiting (CINV). In this study, we assessed the preventive effect of removing dexamethasone from the quadruple standard antiemetic regimen on CINV caused by anthracycline/cyclophosphamide chemotherapy. Methods The HELEN-009 was a multicenter, randomized, open-labeled phase 3 trial to evaluate the efficacy of NK1RA,5-HT3RA and Olanzapine triplet-combination antiemetic therapy done in 3 hospitals in China.Key inclusion criteria were patients with early breast cancer who were scheduled to be treated with epirubicin plus cyclophosphamide chemotherapy for the first time, age between 18 and 75 years, and with Eastern Cooperative Oncology Group performance status of 0–1. Eligible patients were randomly assigned (1:1) to receive either fosaprepitant, tropisetron, dexamethasone and olanzapine(quadruple group)or fosaprepitant, tropisetron and olanzapine without dexamethasone(triple group). Patients were randomly assigned to interventions by use of a web entry system and the minimization method with a random component, with age as factors of allocation adjustment. The primary endpoint was the proportion of patients who achieved a complete response, defined as absence of vomiting and no use of rescue medications in the overall phase (days 1–5) after starting chemotherapy. All randomly assigned patients who satisfied eligibility criteria received epirubicin plus cyclophosphamide chemotherapy were included in efficacy analysis. All patients who received any treatment in this study were assessed for safety. This study is registered at Clinical Trials Registry, number NCT05242874. Findings Between January 2022 and July 2023, 439 patients with breast cancer were enrolled in the study, with 218 participants randomly assigned to quadruple group and 221 participants assigned to triple group. All eligible patients were observed 120 h after epirubicin plus cyclophosphamide chemotherapy initiation. One patient in the quadruple group withdrew consent. One patient in the quadruple group and one in triple group discontinued treatment on day 1 and was excluded from the efficacy analysis. In the overall phase, the proportion of patients who achieved a complete response was 180 (83.3% [95% CI 78.3–88.3] of 216 patients in the quadruple group and 137 (62.4% [55.8–68.7] of 220 patients in the triple group (p< 0·0001). No grade 3 or higher treatment-related adverse events occurred in either of the groups. Interpretation Dexamethasone remains essential in preventing acute emesis in patients receiving epirubicin plus cyclophosphamide chemotherapy. Table. Proportion of patients in the efficacy analysis set achieving a complete response Table. Treatment-related adverse events with an incidence ≥ 2% Citation Format: Xiuchun Chen, Jiao Dechuang, Chongjian Zhang, Xianfu Sun, Zhenduo Lu, Lianfang Li, Jianghua Qiao, Chengzheng Wang, Min Yan, Yueqing Feng, Ya Wei, Zhenzhen Liu. Dexamethasone is necessary for preventing acute emesis induced by anthracycline/cyclophosphamide chemotherapy (HELEN-009) : a multicenter, randomized, open-labeled phase 3 trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-27-12.

Comparative Study on the Efficacy of Two Perioperative Chemotherapy Regimens for Lumbar Brucellosis.

The clinical efficacy of perioperative chemotherapy regimen (rifampicin, doxycycline, levofloxacin, ceftriaxone) was evaluated for lumbar brucellosis spondylitis patients with neurological injury. In Beijing Ditan Hospital affiliated with Capital Medical University, 32 patients with lumbar brucellosis spondylitis underwent surgery and triple perioperative chemotherapy (rifampicin, doxycycline, levofloxacin) between 2011 and 2021 due to neurological injury, and 34 patients matched up with the triple group underwent rifampicin, doxycycline, levofloxacin, and ceftriaxone. Both groups were compared in terms of changes in inflammation index, low back/leg pain, lumbar function, neurological function, and adverse drug reactions. There was no significant difference in erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), low back pain visualanalogue scale (VAS), leg pain VAS, lumbar Oswestry disability index (ODI) and nerve function injury rate between the two groups before chemotherapy (P>0.05). The ESR, CRP at 1 week and 2 weeks after chemotherapy and 1 week, 2 weeks, 1 month postoperatively in the quadruple group were significantly lower than those in the triple group, which is the same to ESR 3 months postoperatively (P<0.05). The low back pain VAS, leg pain VAS and lumbar ODI in the quadruple group were significantly lower than those in the triple group at 1 month and 3 months postoperatively (P<0.05). The recovery rate of neurological function in the quadruple group was significantly higher than that in the triple group at 3 and 6 months postoperatively (P<0.05). Both groups did not experience significantly different perioperative and postoperative adverse reactions (P>0.05). For lumbar brucellosis spondylitis with neurological injury, quadruple perioperative chemotherapy of rifampicin, doxycycline, levofloxacin and ceftriaxone can significantly reduce perioperative inflammation, and improve low back/leg pain, as well as promoting neurological function recovery in the short term.

Glucometabolic control of once-weekly dulaglutide switched from DPP4 inhibitor versus daily empagliflozin add-on in patients with type 2 diabetes inadequately controlled with metformin, sulfonylurea, and DPP4 inhibitor: A randomised trial

AimsTo compare the effectiveness and safety of empagliflozin and dulaglutide in patients with type 2 diabetes (T2D) inadequately controlled by oral triple therapy. MethodsIn this 24-week, multi-center, randomized trial, patients with T2D and HbA1c level ≥7.5% (58 mmol/mol) on metformin, sulfonylurea, and dipeptidyl peptidase 4 inhibitor (DPP4-i) were randomly assigned into two groups: daily empagliflozin add-on or once-weekly dulaglutide switched from DPP4-i. The primary endpoint was changes from baseline HbA1c at 24 weeks. ResultsIn total, 152 patients were recruited to the empagliflozin-added quadruple group (n = 76) or the switched-to-dulaglutide triple group (n = 76). At week 24, both groups showed significant reduction in HbA1c level from baseline with greater reduction with empagliflozin (the mean treatment difference: –0.27% [95% CI –0.50 to –0.04, p = 0.024]) (–2.88 mmol/mol [95% CI –5.37 to –0.39], p = 0.024). Empagliflozin significantly reduced body weight from baseline to week 24 (–1.72 kg [95% CI –1.98 to –0.59, p < 0.001]). No serious adverse events were reported with either empagliflozin or dulaglutide. ConclusionsEmpagliflozin, compared with once-weekly dulaglutide switched from DPP4-i, demonstrated greater HbA1c reduction and weight loss in patients with T2D inadequately controlled with metformin, sulfonylurea, and DPP4-i.Trial registration:cris.nih.go.kr (KCT0006157)

Comparing high-dose dual therapy with bismuth-containing quadruple therapy for the initial eradication of Helicobacter pylori infection on Hainan Island: A randomized, multicenter clinical trial

BackgroundTraditional bismuth-containing quadruple therapy, as a first-line eradication treatment for Helicobacter pylori (H. pylori), has several disadvantages, including drug side effects, low medication adherence, and high costs. Trials of high-dose dual treatment have demonstrated its advantages, which include good safety and adherence profiles. In this study, we investigated the efficacy, safety, and compliance of a high-dose dual therapy when compared with bismuth-based quadruple treatment for the initial eradication of H. pylori infection on Hainan Island, China. MethodsWe randomized 846 H. pylori-infected patients into two groups. A bismuth-containing quadruple therapy group was administered the following: esomeprazole 20 mg, amoxicillin 1000 mg, and clarithromycin 500 mg twice daily, and colloidal bismuth pectin in suspension 150 mg three times/day for 2 weeks. A high-dose dual therapy group was administered the following: esomeprazole 20 mg four times/day and amoxicillin 1000 mg three times/day for 2 weeks. Patients were given a 13C urea breath test at 4 weeks at treatment end. Adverse effects and compliance were evaluated at follow-up visits. ResultsEradication rates in the high-dose dual therapy group were: 90.3% (381/422, 95% confidence interval [CI]: 87.1%–92.9%) in intention-to-treat (ITT) and 93.6% (381/407, 95% CI: 90.8%–95.8%) in per-protocol (PP) analyses. Eradication rates were 87.3% in ITT (370/424, 95% CI: 83.7%–90.3%) and 91.8% in PP analyses (370/403, 95% CI: 88.7%–94.3%) for quadruple therapy, with no statistical differences (P = 0.164 in ITT and P = 0.324 in PP analyses). Adverse effects were 13.5% (55/407) in the dual group and 17.4% (70/403) in the quadruple group (P = 0.129). Compliance was 92.4% (376/407) in the dual group and 86.6% (349/403) in the quadruple group (P = 0.007). ConclusionsHigh-dose dual therapy had high eradication rates comparable with bismuth-based quadruple treatment, with no differences in adverse effects, however higher adherence rates were recorded.

A multi-center, randomized controlled study on the effect of Saccharomyces boulardii combined with triple therapy for the initial eradication of Helicobacter pylori infection

Objective: To assess the efficacy and safety of Saccharomyces boulardii (S. boulardii) in combination with triple therapy as a first-line regimen for the eradication of Helicobacter pylori (H. pylori) in non-ulcer dyspepsia (NUD) patients. Methods: A total of 497 Helicobacter pylori-positive patients who underwent gastroscopy and diagnosed with NUD were enrolled from June 2018 to January 2020 in 9 medical centers across China. Participants were segmentedly randomly divided into 3 groups. Patients in group A received S. boulardii for 14 days and triple therapy for 10 days, while patients in group B received bismuth quadruple group for 10 days, and patients in group C received triple therapy for 10 days. The H. pylori status was determined by the 13C-urea breath test on the 44th day of the treatment. Symptom improvement and adverse reactions were assessed on the 14th and 44th day. Results: There were 229 males and 268 females in all 497 patients enrolled. They were aged 18-69 (46.1±11.8) years and 472 of them (158 cases in group A, 159 cases in group B, and 155 cases in group C) completed the trial. The intention-to-treat (ITT) eradication rates in patients in patients A, B and C were 77.8% (126/162), 80.1% (137/171) and 65.2% (107/164) respectively, and per protocol-based (PP) eradication rates were 79.7% (126/158), 86.2% (137/159) and 69.0% (107/155) respectively. The differences were statistically significant in ITT and PP analysis among 3 groups (ITT: χ²=11.14, P<0.01; PP: χ²=13.86, P<0.01). There was no significant difference between eradication rates of two quadruple therapys(all P>0.05), but both of them were significantly higher than that of standard triple therapy (both P<0.05). Statistics revealed that both quadruple therapys led to significantly higher symptom improvement of belching compared with that of standard triple therapy in day 14 (P<0.05). The relief of abdominal distension and belching symptom scores of group A were significantly higher than those of group C in day 44(all P<0.05). There was no serious adverse event reported. The incidence of diarrhea in group A was significantly lower than those in the other two groups (both P<0.05). Conclusions: The combination of S. boulardii and triple therapy can achieve a better eradication effect on H. pylori infection with NUD, and has advantages in symptom relief and safety.

Adaptive and Optimal Overcurrent Protection of Wind Farms With Improved Reliability

This article presents a new adaptive and optimal overcurrent protection for large-scale wind farms using hybrid grey wolf optimizer and rule-based fuzzy logic controller (GWO-FLC) scheme. The proposed GWO-FLC based adaptive protection scheme overcomes the limitation of conventional protection scheme that suffers from maloperation of relays that damages the power components in the system during fault. Furthermore, due to the intermittent nature of wind, the generated current feeding the grid during extreme high and low wind speeds creates a significant difference in magnitudes of the generated current. Thus, the existence of only one group of settings for the overcurrent relays (OCRs) would cause drastic miscoordination and false tripping during fault. In order to test the performance of the proposed GWO-FLC scheme, several OCRs based on standard Schweitzer Engineering Laboratories industrial protection relay (SEL-751) are developed in MATLAB/Simulink. A large-scale wind farm model is also developed to perform fault analysis, relay setting, and coordination calculation. The GWO is implemented to attain optimal OCR coordination for the defined quadruple group settings for all relays, and the FLC is developed to provide adaptive feature for the relays so that the OCR group settings for each relay are intelligently updated according to the variation of wind speed. Finally, in a laboratory environment, the proposed protection scheme is implemented in real time using field-programmable gate array DE2-115 board equipped with Cyclone IV-E device (EP4CE115F29C7). It is found from both simulation and experimental results that the performance of the proposed hybrid GWO-FLC is robust, reliable, efficient and extremely satisfactory.

Olanzapine (5 mg) plus standard triple antiemetic therapy for the prevention of multiple-day cisplatin hemotherapy-induced nausea and vomiting: a prospective randomized controlled study

ObjectiveA prospective randomized controlled trial was conducted to compare 5 mg olanzapine plus standard triple antiemetic therapy for the prevention of nausea and vomiting induced by multiple-day cisplatin chemotherapy.MethodsPatients who received a 3-day cisplatin-based chemotherapy (25 mg/m2/d) were given either 5 mg olanzapine plus triple therapy with aprepitant, tropisetron, and dexamethasone (quadruple group) or 5 mg olanzapine plus tropisetron and dexamethasone, omitting aprepitant (triplet group). The primary endpoint was the complete response (CR) in the overall phase (OP) (0–120 h) between quadruple group and triplet group. The secondary endpoints were the CR in the acute phase (AP) (0–24 h) and delayed phase (DP) (25–120 h) between two groups. The first time of vomiting was also compared by Kaplan–Meier curves. The impact of chemotherapy-induced nausea and vomiting (CINV) on the quality of life was assessed by the Functional Living Index-Emesis (FLIE). Aprepitant-related adverse effects (AEs) were also recorded.Results(1) The primary endpoint CR during OP was 76.0% (45/59) vs 67.0% (41/61) between the quadruple group and triplet group (P = 0.271). The secondary endpoint CR during the AP was significantly higher in the quadruple group than in the triplet group, which was 100.0% (59/59) vs 93.0% (57/61) (P = 0.045). The difference of CR during delayed phase between the groups was especially higher in the quadruple group compared to the triplet group (76.0% (45/59) vs 67.0% (41/61) (P = 0.271)). The rate of patients who achieved total protection in the overall phase was also higher in the quadruple group than the triplet group (28.8% (17/59) vs 23.0% (14/61) (P = 0.463)). During the OP, the incidence of no vomiting in the quadruple group and the triplet group was 93.2% (55/59) vs 80.3% (49/61) (P = 0.038), respectively. (2) Kaplan–Meier curves of time to first emesis were obviously longer in the quadruple group compared with the triplet group (P = 0.031). According to FLIE, no impact of CINV on daily life was defined as total score of questionnaire > 108; this study exhibited identical life quality between two groups. (3) The most common aprepitant- or olanzapine-related AEs included sedation, fatigue, and constipation. The occurrences between two groups were identical.ConclusionIt may been recommended that 5 mg olanzapine plus tropisetron and dexamethasone, omitting aprepitant triplet regimen as an alternative therapy in prevention CINV induced by multiple-day cisplatin chemotherapy due to the excellent CINV control rate and safety.

Interobserver Reliability in the Radiological Evaluation of Flatfoot (Pes Planus) Deformity: A Cross-Sectional Study

This study was planned for analyzing the interobserver reliability on the diagnosis of flatfoot. This study aims to evaluate the interobserver reliability of the digital radiography of flatfoot patients. Eight parameters were used in digital x-rays within the as statistically in 2 groups. Study group includes 34 patients. Two groups were formed four medical specialists as 2 orthopedists and 2 radiologists. Two orthopedists made measurements on x-ray viewing as calcaneal pitch (CP) as CP floor, calcaneus-1 metatarsal angle, calcaneus-5 metatarsal angle; longitudinal arch angles (LAAs) as medial and lateral LAAs, Tomeno-Meary angle (TMA), anteroposterior and lateral CYMA line. The intraclass correlation coefficient (ICC) analysis was performed. Fleiss Kappa and Kappa was used to investigate the reliability of qualitative data between 2 observers. ICCs were in high levels for CP floor, calcaneus-1 metatarsal angle, calcaneus-5 metatarsal angle. ICCs of TMA was in high levels, also. ICCs of LAA-medial and LAA-lateral were not in high levels as other measurements. In the CYMA line (anteroposterior and lateral) Kappa was 0.140 for right feet in the quadruple group (p = .045; .458; and .314). Kappa was 0.197 for left feet in the quadruple group (p = .005; .146; .377). The ICCs was excellent for CP angles and TMA in all groups. LAAs as medial and lateral longitudinal arch angle had not high ICC's. CYMA line had significant p values in the quadruple group. But not in orthopedists and radiologists.

Tetracycline-levofloxacin versus amoxicillin-levofloxacin quadruple therapies in the second-line treatment of Helicobacter pylori infection.

The Maastricht V/Florence Consensus Report recommends amoxicillin-fluoroquinolone triple or quadruple therapy as a second-line treatment for Helicobacter pylori infection. An important caveat of amoxicillin-fluoroquinolone rescue therapy is poor eradication efficacy in the presence of fluoroquinolone resistance. The study aimed to investigate the efficacies of tetracycline-levofloxacin (TL) quadruple therapy and amoxicillin-levofloxacin (AL) quadruple therapy in the second-line treatment of H.pylori infection. Consecutive H. pylori-infected subjects after the failure of first-line therapies were randomly allocated to receive either TL quadruple therapy (tetracycline 500mg QID, levofloxacin 500mg QD, esomeprazole 40mg BID, and tripotassium dicitrato bismuthate 300mg QID) or AL quadruple therapy (amoxicillin 500mg QID, levofloxacin 500mg QD, esomeprazole 40mg BID, and tripotassium dicitrato bismuthate 300mg QID) for 10days. Post-treatment H.pylori status was assessed 6weeks after the end of therapy. The study was early terminated after an interim analysis. In the TL quadruple group, 50 out of 56 patients (89.3%) had successful eradication of H.pylori infection. Cure of H.pylori infection was achieved only in 39 of 52 patients (69.6%) receiving AL quadruple therapy. Intention-to-treat analysis showed that TL quadruple therapy achieved a markedly higher eradication rate than AL quadruple therapy (95% confidence interval: 4.8% to 34.6%; p=0.010). Further analysis revealed that TL quadruple therapy had a high eradication rate for both levofloxacin-susceptible and resistant strains (100% and 88.9%). In contrast, AL quadruple therapy yielded a high eradication for levofloxacin-susceptible strains (90.9%) but a poor eradication efficacy for levofloxacin-resistant strains (50.0%). The two therapies exhibited comparable frequencies of adverse events (37.5% vs 21.4%) and drug adherence (98.2% vs 94.6%). Ten-day TL quadruple therapy is more effective than AL quadruple therapy in the second-line treatment of H. pylori infection in a population with high levofloxacin resistance.

COMPARISON OF EFFECTIVENESS OF STANDARD TRIPLE THERAPY VERSUS BISMUTH-BASED THERAPY FOR THE MANAGEMENT OF PEPTIC ULCER DISEASE DUE TO HELICOBACTER PYLORI

Objective: Helicobacter pylori is the primary agent causing peptic ulcer, therefore imposing a significant impact on health elated quality of life, consequently affecting nearly 50% of global population. The objective of this study is to determine and assess the effectiveness of triple therapy versus bismuth containing quadruple therapy for eradication of peptic ulcer disease due to H. pylori.&#x0D; Methods: A prospective randomized observational study was conducted at Princess Esra Hospital, Department of Gastroenterology for a period of 6 months. A total of 100 patients were randomly allocated in tow groups. The data were assessed using various parameters. H. pylori eradication was validated using rapid urease test done at the start treatment 4 weeks after the completion.&#x0D; Results: A total of 100 patients were recruited in the study. In triple therapy group medication adherence rate was found to be 82% in triple and 92% in quadruple therapy. The eradication rate was assessed using Chi-square test it was 82% and 97% in triple and quadruple therapy group, respectively. Hence, the difference was found to be statistically significant value &lt;0.005. In addition, increased recurrence rate has been observed in triple therapy (17%) in contrast with quadruple therapy (2%).&#x0D; Conclusion: Addition of bismuth to significant triple therapy improves cure rates with minimal side effects. Interestingly, we observed that when bismuth was added, it produced a significant higher eradication rate (97%) when compared with standard triple therapy (82%). According to our study, bismuth is highly effective treatment of peptic ulcer disease.

Effect of body mass fluctuation on the prognosis of atrial fibrillation

Objective To investigate the effect of body mass fluctuation on the prognosis of patients with atrial fibrillation. Methods The patients diagnosed with atrial fibrillation in the People′s Hospital of Xinjiang Uygur Autonomous Region from 2012 to 2014 were selected.Among the 540 patients, the patients were divided into normal body(BMI ≤ 25 kg/m2), overweight (25 kg/m2<BMI<30 kg/m2) and obesity (BMI ≥ 30 kg/m2) according to the baseline body mass.The median body mass fluctuation of the three groups was 2.40 kg, and according to the median body mass fluctuations, the patients were divided into two groups: the high body mass fluctuation group and the low body mass fluctuation group.Changes of body mass were observed and the incidence of cardiac death, acute coronary syndrome, chronic heart failure, cerebral embolism and peripheral vascular embolization were monitored. Results During the follow-up period, as the increased of body mass fluctuation, the incidence rate of end point events also increasing continuously.The main end point event was used as the composite end point (HR(95%CI): 1.03 (1.06~1.15); P=0.02), including the cardiogenic death (HR(95%CI): 1.04 (1.09~1.12); P=0.03), the incidence of acute coronary syndrome (HR(95%CI): 1.04 (0.96~1.08); P=0.06) and the heart failure incidence (HR(95%CI): 95%CI: 1.04 (1.01~1.09), P=0.04). The secondary endpoint as composite endpoint (HR(95%CI): 1.16 (1.15~1.31); P=0.01), including the cerebral embolism (HR(95%CI): 1.21 (1.23~1.54); P=0.01) and the peripheral vascular embolism (HR(95%CI): 1.03 (0.91~1.03); P=0.01). After adjusting for all confounding factors, the quartile group with the highest body mass fluctuations was 6.2% higher in the main endpoint event than the lowest body quartile and 14.2% higher in the secondary endpoint.The occurrence of major endpoint events and secondary endpoint events in the quadruple group with high body mass fluctuation was significantly higher than that in the quadruple group with the lowest body mass fluctuation(main endpoint: 4.4% vs 10.6%; (HR(95%CI): 1.86 ( 1.53 ~ 2.41); P<0.01; secondary endpoints: 15.6% vs 29.8%; (HR(95%CI) 2.12 (1.56 ~ 3.58); P<0.01). The main endpoint events were cardiogenic death (HR(95%CI): 1.85 (1.73~2.3); P<0.01); incidence of acute coronary syndrome (HR(95%CI): 1.02 (0.94~1.35); P=0.08); incidence of heart failure (HR(95%CI): 1.48 (1.28~1.62); P<0.01); secondary endpoint events were cerebral embolism (HR(95%CI): 2.23 (1.93~3.91). (P<0.01), peripheral vascular embolism (HR(95%CI): 1.05 (0.96~1.42); P=0.13). For patients with normal body mass, body mass fluctuations had no significant effect on prognosis (main endpoints: 6.1% vs 5.3%; (HR(95%CI): 1.04 (0.94 ~ 1.43); P=0.064; secondary endpoint : 16.7% vs 17.4%; (HR(95%CI): 1.12 (0.84~ 1.09); P=0.072), but for overweight and obese patients, the greater the fluctuation of body mass, the higher the incidence of adverse events (main endpoint: super-recombination: 5.8% vs 11.2%; (HR(95%CI): 1.532 (1.135 ~ 3.156); P<0.001; obese group: 8.3% vs 15.1%; (HR(95%CI): 1.584 (1.258~3.489); P<0.001; secondary end points: super recombination: 17.1% and 21.3%; (HR(95%CI): 341.00 ( 1.132~ 1.984); P=0.013; obese group: 19.4% and 25.2%; (HR(95%CI): 1.315 (1.128~2.123); P=0.018). Conclusion Body mass fluctuations can significantly affect the prognosis of patients with atrial fibrillation and has a greater impact on patients with overweight and obesity. Key words: Atrial Fibrillation; Body mass; Fluctuations; Prognosis

Influence of different timing of Saccharomyces boulardii combined with bismuth quadruple therapy for Helicobacter pylori eradication

Objective: To assess the efficacy and safety of different opportunity of Saccharomyces boulardii (S. Boulardii) Sachets combined with bismuth quadruple therapy for Helicobacter pylori(H. pylori)eradication. Methods: This experiment was a prospective study. A total of 300 H. pylori-infected patients were enrolled and randomized assigned into three groups. Quadruple therapy group received pantoprazole 40 mg+bismuth potassium citrate capsule 220 mg+amoxicillin 1 000 mg+furazolidone 100 mg, bid, oral for 14 days. The simultaneous probiotic group received pantoprazole 40 mg+bismuth potassium citrate capsule 220 mg+amoxicillin 1 000 mg+furazolidone 100 mg+S. Boulardii Sachets 500 mg,bid,oral for 14 days.There after probiotic group:S.Boulardii Sachets was added on the first day after the end of 14 days in the quadruple group, for 500 mg, bid 14 days. The eradication rates and adverse reactions of the three groups were compared. Results: The eradication rates of H.pylori were 89.0%,90.4% and 91.3% in the quadruple therapy group, the simultaneous probiotic group and the there after probiotic group according to Per-protocol(PP) analysis,respectively,with no statistical difference (P=0.870). According to intention-to-treat(ITT)analysis, 81.0%, 85.0% and 84.0%, respectively, the difference was not statistically significant (P=0.732).The overall incidence of adverse reactions and the incidence of diarrhea and nausea in the simultaneous probiotic group, and the there after probiotic group were lower than those in the quadruple group(P<0.05),and the difference was statistically significant.The overall incidence of adverse reactions and diarrhea in the simultaneous probiotic were lower than those in the there after probiotic group (P=0.021, P=0.007), and the difference was statistically significant. Conclusions: S. Boulardii Sachets combined with quadruple therapy at the same time or after eradication treatment can not improve the H.pylori eradication rate,but can reduce the overall incidence of adverse reactions and the incidence of diarrhea and nausea. It is safer to add S. Boulardii Sachets at the same time than after eradication therapy.

Attention skill development program’s effects on children in terms of attention skill acquisition during preschool term

This research is carried out to reveal the effects of ‘‘Attention Skill Development Program During Preschool Term’’ on attention skill of 60-72 months of children. In this way, efficiency of ‘‘Education Program for Supporting Attention Skill’’ was revealed trough quantitative data collected according to Solomon Quadruple Group Model, which was chosen among experimental designs. Qualitative data were collected to support quantitative data. Within this scope, exploratory design was used as one of the research models. Study group of the research consisted of randomly and voluntarily selected 60-72 months of 80 children attending independent pre-primary schools tied to Ministry of National Education in Kars City Centre during 2016-2017 academic year. In the research, for gathering personal information about children and their families, ‘Personal Information Form’ was used as a data collecting tool, and for evaluating attention skill of children, ‘‘Attention Gathering Test of Five Years old Children’’(Frankfurter Test Für Funjahrige Konzentration –FTF-K) was used, whose reliability studies were already done by the researcher. When the scores of experiment and control groups were compared in terms of attention gathering skill, a meaningful difference to the advantage of Experiment groups was found.

Comparative study on eradication therapy of 1 440 newly diagnosed patients with Helicobacter pylori infection

Objective To evaluate the efficacy and safety of common therapy and individualized treatment in newly diagnosed patients with Helicobacter pylori (H. pylori) infection. Methods From March 2008 to February 2010, September 2013 to April 2014, January to October 2015, a total of 1 440 patients with H.pylori infection who received eradication therapy and with complete clinical data were retrospectively enrolled. Each was 350 cases in individualized treatment group, clarithromycin and bismuth containing quadruple therapy group and concomitant therapy group. A total of 100 cases were in standard triple therapy group, 90 cases in sequential therapy group, and 200 cases in levofloxacin and bismuth-containing quadruple therapy group. The eradication rate of H.pylori, incidence of adverse events and compliance rate were compared in the six groups. Chi square test was performed for statistical analysis. Results The results of intention-to-treat analysis indicated that there was no statistically significant difference in H.pylori eradication rates among six groups (χ2=0.985, P=0.323). However, the results of modified intention-to-treat analysis showed that H.pylori eradication rate of individualized treatment group was the highest (92.5% (282/305) and 93.3% (278/298)), second was levofloxacin and bismuth-containing quadruple therapy group (90.3% (167/185) and 91.6% (164/179)), and the differences were statistically significant (χ2=11.285 and 13.981, both P<0.01). There was statistically significant difference in indcidence of adverse events among the six groups (χ2=5.692, P=0.018), the incidence of adverse events in levofloxacin and bimuth-containing quadruple therapy group was lowest (16.2% (30/185)), and second was individualized treatment group (21.0% (64/305)). There was statistically significant difference in compliance rates among the six groups (χ2=4.712, P=0.023), the compliance rates of standard triple therapy group and sequential therapy group were highest (100% (100/100) and 100% (90/90)), and second was individualized treatment group (97.7% (298/305)). Conclusions Both the levofloxacin and bimuth-containing quadruple therapy group and individualized treatment group can effectively eradicate H.pylori infection. The former may be safe and effective to patients unable to receive individualized therapy. Key words: Helicobacter pylori; Eradication rate; Compliance; Safety; Individualized

Is a Single dose of Prophylactic Antibiotics Sufficient in Patients with Acute Non-Complicated Appendicitis?

Background: Acute appendicitis is one of the most common acute surgery events. Its main treatment is surgery. However medical management before and after the surgery has an important impact on the treatment. Objective: The aim of study was evaluating the outcomes of single dose and quadruple doses of prophylactic antibiotic therapy in patients with acute non-complicated appendicitis. Methods: This randomized double blind clinical trial was carried out on 294 patients in single dose (136 patients) and the quadruple doses (158 patients) groups. In single dose group, a dose of 1g Cefazolin + 500mg Metronidazole was prescribed intravenously about half an hour before surgery. The quadruple doses group received three more doses after surgery. Two groups were followed for fever, erythema, seroma, wound infection, intra-abdominal abscess formation and readmissions within one month after discharge. Results: The mean age of patients was 31±5.14 years. 203(69%) of patients were men while 91(31%) were women. There were no significant statistical differences between groups in age, sex and body mass index (BMI) variables. No significant statistical differences were observed during surgery and hospitalization period between two groups. In the single dose group, wound infection was 8(5.9%), while it was 6(3.8%) in the quadruple doses group; hence, there were no significant statistical differences in this regard. There was no abdominal abscess in groups. There were significant statistical differences regarding erythema, seroma and antibiotics consumption costs between groups. Conclusion: A single dose of prophylactic antibiotics is sufficient in patients with acute suppurative non-complicated appendicitis.

Ten-day Sequential Therapy versus Bismuth Based Quadruple Therapy as Second Line Treatment for Helicobacter pylori Infection

Ten-day sequential therapy has been evaluated as the first line therapy for Helicobacter pylori eradication but studies on sequential therapy as a second line therapy is lacking. The aim of this study was to compare the efficacy of 10-day sequential therapy and quadruple therapy as second line treatment for H. pylori eradication after failure of standard triple therapy. Patients who did not respond to standard triple therapy for H. pylori eradication were assigned to either 10-day sequential or bismuth based quadruple therapy as second line treatment from January 2009 to December 2014 at Yeungnam University Medical Center. Post treatment H. pylori status was determined by rapid urease test, giemsa staining, or (13)C-urea breath test. Eradication rate and side effects of both therapies were compared. A total of 158 H. pylori infected patients were included and 70 patients were treated by bismuth based quadruple therapy and 88 patients by 10-day sequential therapy. Age and sex were not significantly different between the two groups. Eradication rate was 84.3% (59/70) in quadruple group and 56.8% (50/88) in sequential group. Side effects occurred significantly higher in quadruple group than sequential group (27.1% vs. 11.4%, p=0.011). For second line H. pylori eradication after failure of standard triple therapy, bismuth based quadruple therapy showed significantly higher H. pylori eradication rate than 10-day sequential therapy. Further prospective studies are needed to evaluate the efficacy of 10-day sequential therapy as a second line H. pylori eradication treatment.

Helicobacter pylori Eradication Rate of Quadruple Theraphy in Jeju Island in the Middle of the First Decade of 2000 years

Background/Aims: On previous study, the H. pylori eradication rate by triple therapy was 68.2 % in Jeju. We perform thisstudy to estimate the eradication rate of quadruple therapy fo rthe treatment failure group of the triple therapy.Methods: From January 1, 2005 to August 31, 2007, We investigated the medical record for adult patient received quadrupletherapy including proton pump inhibitor (PPI), bismuth, tetracycline, metronidazole because of failed OAC triple therapy. Wecollected data and compared the eradication rate for sex, age,p lace of residence, kind of PPI, and treatment periods.Results: Total 105 patient was enrolled (M:F=60:45, Mean age±SD 58.0±12.5). The overall eradication rate was 79.0%. Therewere no significant difference of eradication rate in differen tgroup of sex, place of residence, age, PPI, duration of treatemnt.Conclusions: The H. pylori eradication rate of quadruple therapy was 79.0% in Jeju island. We could not found any significantfactor influencing to quadruple therapy.

Clinical observation on ilaprazole containing ten-day standard quadruple therapy and sequential therapy in the treatment of two hundred cases of chronic gastritis with Helicobacter pylori infection

Objective To investigate the clinical efficacy of ilaprazole and bismuth combined ten-day standard quadruple therapy and sequential therapy in the treatment of patients with Helicobacter pylori （H .pylori）infected chronic gastritis.Methods A total of 200 patients with H .pylori-positive chronic gastritis diagnosed by gastroendoscopy examination and rapid urease test （RUT）were randomly divided into standard quadruple therapy group and sequential therapy group,100 cases in each group.One group received ilaprazole,bismuth,amoxicillin-clavulanatepotassium and ofloxacin 10-day standard quadruple therapy, and the other group received ilaprazole, amoxicillin-clavulanatepotassium, ofloxacin and furazolidone 10-day sequential therapy.In four to six weeks after the therapy,the condition of H .pylori eradication was detected by a 14 C-urea breath test.The improvement of clinical symptoms and adverse effects were also observed. Normal distributed and variance homogenized measurement data were compared by t test,while unordered categorical data were analyzed by chi-square test and the exact probability method,and categorical data were compared by two independent sample rank sum test.Results The per-protocol analysis values of H .pylori eradication rates of the standard quadruple therapy group and the sequential therapy group were 88.54%（85/96）and 87.23%（82/94）,respectively,while the intention-to-treat analysis values were 85 .00%（85/100）and 82.00%（82/100 ）,respectively.The effective rates of symptomatic relief of upper abdominal pain,acid regurgitation,heart burning in the standard quadruple therapy group and the sequential therapy group were 95 .83%（92/96）and 95 .74%（90/94）,respectively. The incidence of adverse effects which weve very mild was 6.25 % （6/96 ） and 7.44% （7/94 ）, respectively.There was no statistically significant difference in the above three factors between the two groups （all P 〉0.05）.Conclusions Ilaprazole and bismuth combined 10-day standard quadruple therapy and sequential therapy in the treatment of patients with H .pylori positive chronic gastritis both achieves high rates of H .pylori eradication and symptom relief with mild adverse effects. Key words: Ilaprazole; Standard quadruple regimen; Sequential regimen; Helicobacter pylori; Eradication

The drug resistance situation of Helicobacter pylori infection in Meizhou and the treatment countermeasures

Objective To understand the Helicobacter pylori （ Hp） infection eradication rate of standard tri-ple therapy in Guangdong Meizhou and the drug resistance situation for metronidazole ,clarithromycin ,amoxicillin and levofloxacin ,in order to look for the treatment countermeasures in Hp eradication failure .Methods 297 cases of Hp positive patients because of gastrointestinal symptoms to our hospital examined from April 2011 and March 2013,were randomly assigned into three standard triple therapy groups：A （ OCA ） group and B （ OCM ） group and C （ OCL ） group.The Hp eradication rate was analyzed .Patients with primary treatment failure were selected as group D （OBAL）,proceed to （PPl＋B＋A＋L）7 d therapy,the Hp eradication rate was analyzed .230 Hp strains were isola-ted and cultured from 297 cases received the first eradication therapy and 87 cases received again eradication therapy . The minimum inhibitory concentration （MIC） of metronidazole,clarithromycin,amoxicillin and levofloxacin were tested by E-test,in order to determine the resistance of these four antibiotics in clinical isolated Hp strains .Results With intention-to-treat（ITT） analysis,the Hp eradication rates of group A （OCA）,group B（OCM） and group C（OCL） were 72.0%（72/100）,63.0%（63/100） and 72.2%（70/97）,respectively.With per-protocol（PP） analysis,the Hp eradication rates of group A （OCA）,group B（OCM） and group C（OCL） were 72.7%（72/99）,64.3%（63/98）,73.7%（70/95）,respectively.The eradication rate among three standard triple therapy groups had no obvi-ous difference （ITT：P=0.278,PP：P=0.288,P〉0.05）.With ITT analysis,the Hp eradication rate in the quadrup-le therapy group D（OBAL） was 92.0%（80/87）.With per-protocol（PP） analysis,the Hp eradication rate in the quadruple therapy group D（OBAL） was 97.6%（80/82）,which was higher than that of the three standard triple ther-apy groups（ITT：P=0.000,PP：P=0.000）.In 230 clinical isolated Hp strains,the resistant rates of levofloxacin,amoxicillin,clarithromycin and metronidazole were 6.08%（14/230）,6.52%（15/230）,25.65%（59/230）, 70.87%（163/230）,respectively.Of those 37 strains were mixed resistance,the mixed resistant rate was 16.09%（37/230）.The resistant rate of metronidazole was higher than levofloxacin , amoxicillin and clarithromycin （ P =0.000,P〈0.01）,the resistant rate of clarithromycin was higher than levofloxacin and amoxicillin （P=0.000）,no statistically significant difference between amoxicillin and levofloxacin （P=0.848）.Conclusion The Hp resistance is similar to the national average in Guangdong Meizhou ,the eradication rate of standard triple therapy is lower than 80%,contain bismuth agent of quadruple therapy is good rescue therapy . Key words: Helicobacter pylori; Drug sensitive test; Drug resistance,bacterial; Rescue therapy