Occurrence Rate Of Adverse Events Research Articles

The use of Panax notoginseng saponins injections after intravenous thrombolysis in acute ischemic stroke: a systematic review and meta-analysis.

As a bioactive metabolite preparation widely used in acute ischemic stroke (AIS), the efficacy and safety of Panax notoginseng saponins injections (PNSI) in patients with AIS after intravenous thrombolysis remain to be evaluated. This study included randomized controlled trials published before 26 April 2024 in 8 databases. AIS patients who received intravenous thrombolysis were included. The control group receiving conventional treatment and the treatment group receiving additional PNSI. Primary outcomes were selected as mortality, disability, and adverse events. Secondary outcomes were selected as all-cause mortality, improvement of neurological deficit, quality of life, and cerebral injury indicators. The revised Cochrane Risk of Bias tool was used to assess risk of bias. Risk ratio (RR) and mean differences (MD) were calculated for binary variables and continuous variables, respectively, based on a 95% confidence interval (CI). A total of 20 trials involving 1,856 participants were included. None of them reported mortality or disability. There was no significant difference in the adverse events [RR: 1.04; 95% CI: 0.60 to 1.81] and hemorrhagic transformation [RR: 0.99; 95% CI: 0.36 to 2.70] between the two groups. Compared to the control group, the treatment group had a better effect in neurological improvement assessed by National Institutes of Health Stroke Scale [MD: -2.91; 95% CI: -4.76 to -1.06], a better effect in activities of daily living changes in Barthel Index [MD: 9.37; 95% CI: 1.86 to 16.88], and a lower serum neuron-specific enolase level [MD: -2.08; 95% CI: -2.67 to -1.49]. For AIS patients undergoing intravenous thrombolysis, the use of PNSI improved neurological deficits and enhanced activity of daily living in the short term without increasing the occurrence rate of adverse events. However, due to the moderate to very low certainty of evidence, it is advisable to conduct high-quality clinical trials to validate the findings of this study. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=466851, Identifier CRD42023466851.

Neoadjuvant docetaxel, oxaliplatin, and S-1 plus surgery followed by adjuvant docetaxel and S-1 for patients with large type 3 or type 4 gastric cancer: Short-term outcomes of the phase II OGSG1902 trial.

4031 Background: Patients with large type 3 (≥8 cm) or type 4 gastric cancer (GC) face a dismal prognosis, necessitating the development of multidisciplinary treatment, including neoadjuvant chemotherapy. We present the short-term results from the OGSG1902 (jRCTs051190060) trial, where resectable large type 3 or type 4 GC patients were treated with neoadjuvant docetaxel (DTX)/oxaliplatin (L-OHP)/S-1 (DOS) plus surgery and adjuvant DTX/S-1 (DS) therapy. Methods: Untreated large type 3 or type 4 GC patients without distant metastasis other than positive peritoneal lavage cytology (CY), aged 20-80 years, and with ECOG PS 0-1, were enrolled. Patients received three cycles of DTX (40 mg/m2, day1) + L-OHP (100 mg/m2, day1) + S-1 (80 mg/m2, day1-14) every 3 weeks, followed by gastrectomy with D2 lymph node dissection and 1-year DS therapy. The primary end point was the 3-year progression-free survival (PFS) rate. The secondary end points included PFS time, overall survival time, pathological response rate, response rate according to RECIST version 1.1, neoadjuvant chemotherapy completion rate, R0 resection rate, protocol completion rate, CY negative conversion rate, adverse event occurrence rate, and nutritional evaluation. Results: Forty-eight patients (pts) were enrolled from 2019 to 2022. The neoadjuvant chemotherapy completion rate was 91.7%, pathological response rate (≥Grade 1b) was 66.7%, response rate according to RECIST version1.1 for 10 pts with measurable lesions was 50.0%, CY negative conversion rate for nine CY positive pts was 88.9%, R0 resection rate was 89.6%, and the protocol completion rate was 45.8%. Adverse events (≥CTCAE Grade 3) during neoadjuvant DOS included neutropenia in 18 pts (38%), febrile neutropenia in one pt (2%), nausea in five pts (10%), diarrhea in six pts (13%), and anorexia in 18 pts (38%). Gastrectomy was performed in 47 pts [total/distal gastrectomy: 32(68%)/15(32%)]. Major postoperative complication (≥Clavien-Dindo Grade IIIa) was observed in one pt (2%), including pleural infection. Adverse events (≥CTCAE Grade 3) in 39 patients receiving adjuvant DS therapy included neutropenia in 16 pts (41%), anemia in five pts (13%), nausea in one pt (3%), diarrhea in two pts (5%), anorexia in nine pts (23%), fatigue in three pts (8%), and febrile neutropenia in four pts (10%). No treatment-related deaths were observed. Conclusions: Neoadjuvant DOS therapy for large type 3 or type 4 GC demonstrates promising efficacy with high histological response and acceptable adverse events. Future analysis of survival outcomes is planned. Clinical trial information: jRCTs051190060 .

Pediatric Sedation in Dutch Dental Clinics: The Influence of Guideline Modifications on Adverse Events.

Background: Dental fear and uncooperative behavior can hinder dental treatment quality. Pediatric Procedural Sedation and Analgesia (PPSA) is used to facilitate treatment when the coping capacity is exceeded. Out-of-hospital PPSA has been associated with more adverse outcomes compared to when it is used in hospital-based settings. The updated Dutch PPSA guidelines have increased costs and raised concerns about the accessibility of specialized high-quality dental care for children in the Netherlands. This study aimed to investigate the impact of the updated 2017 guidelines on the occurrence rate of adverse events during PPSA in twelve Dutch dental clinics. Methods: The data of 25,872 children who were treated at twelve dental clinics between 1997 and 2019 were analyzed. A logistic two-level mixed-effects model was used to estimate the updated guidelines' impacts on adverse events. Results: The OR of the occurrence rate of an adverse event adjusted for age, weight, and duration of treatment was 0.75 (95% CI 0.64-0.89) after the implementation of the updated guidelines. This outcome was significant with p = 0.001, indicating a protective effect. Conclusions: Our findings demonstrate that there was a significant reduction in adverse events after the implementation of the updated guideline and highlight the importance of adhering to evidence-based practices in out-of-hospital dental clinics.

Therapeutic outcome of combination therapy using immune-checkpoint inhibitors and tyrosine kinase inhibitors for metastatic non-clear-cell renal cell carcinoma.

We aimed to clarify the therapeutic outcome of combination therapy using immune-checkpoint inhibitors (ICIs) and/or tyrosine kinase inhibitors (TKIs) for meta-static non-clear-cell renal cell carcinoma (nccRCC). We have been retrospectively investigating the therapeutic efficacy and prognosis in 36 patients with metastatic nccRCC undergoing combination therapy using two ICIs, ipilimumab plus nivolumab (ICI-ICI), and ICI plus TKI (ICI-TKI), at Kobe University and affiliated institutions since 2018. Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and adverse event (AE) were compared. The first-line regimen was ICI-ICI in 26 cases and ICI-TKI in 10 cases. The ORRs in the ICI-ICI and ICI-TKI groups were 34.6 and 30.0%, respectively (p=0.9433). The 50% PFS for the ICI-TKI group was 9.7 months, significantly longer than that for the ICI-ICI group (4.6 months, p=0.0499), and there was no significant difference in OS between groups (p=0.3984). There was no significant difference in the occurrence rate of AE for below grade 2 (p=0.8535), nor above grade 3 (p=0.3786) between the ICI-ICI and ICI-TKI groups. From our analysis of real-world data, a better outcome of PFS was expected in the ICI-TKI group compared with that in the ICI-ICI group, while there was no significant difference in OS or ORR.

Comparing verum and sham acupoint catgut embedding for adults with obesity: A systematic review and meta-analysis of randomized clinical trials.

Previous clinical trials have reported that acupoint catgut embedding (ACE) is a useful modality for weight loss. However, no study has specifically investigated the effectiveness and safety of comparing verum and sham ACE in adults with obesity. Thus, this study aimed to evaluate the effectiveness and safety of comparing verum and sham ACE in obese adults. A comprehensive literature search was conducted in the electronic databases of PUBMED, EMBASE, Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wanfang, China Science and Technology Journal Database, and China Biomedical Literature Service System from inception to April 1, 2022. Randomized clinical trials that focused on evaluating the effectiveness of comparing verum and sham ACE in adults with obesity were included. The primary outcomes included reduction in body weight, body mass index, hip circumference, and waist circumference. The secondary outcomes consisted of a decrease in body fat percentage and the occurrence rate of adverse events. The methodological quality of the included randomized clinical trials was evaluated using the Cochrane Risk-of-bias tool. Statistical analysis was performed using RevMan 5.4 software. Six trials involving 679 adults with obesity were included in this study and entered in the data analysis of systematic review and meta-analysis. Results of the meta-analysis revealed significant reduction in body weight (mean difference [MD] = -1.68, 95% confidence intervals (CI) [-2.34, -1.01], I2 = 51%, P < .001), body mass index (MD = -0.51, 95% CI [-0.81, -0.21], I2 = 74%, P < .001), hip circumference (MD = -1.11, 95% CI [-1.67, -0.55], I2 = 0%, P < .001), waist circumference (MD = -2.42, 95% CI [-3.38, -1.45], I2 = 68%, P < .001), and decrease in body fat percentage (MD = -0.83, 95% CI [-1.30, -0.36], I2 = 16%, P < .001) in comparing verum and sham ACE. However, no significant difference was identified in AEs (odds ratio = 1.53, 95% CI [0.80, 2.95], I2 = 0%, P = .20) between the 2 groups. ACE is effective in the treatment of obesity in adults with safety profile. Further studies with higher quality and larger sample size are warranted to confirm the current findings.

Comparative analysis of recurrence rates between intravesical gemcitabine and bacillus Calmette-Guérin induction therapy following transurethral resection of bladder tumors in patients with intermediate- and high-risk bladder cancer: A retrospective multicenter study.

This study investigated the efficacy of intravesical gemcitabine as an alternative to bacillus Calmette-Guérin (BCG) therapy. Data were retrospectively collected across seven institutions from February 1999 to May 2023. Inclusion criteria included patients with intermediate- or high-risk non-muscle invasive bladder cancer (NMIBC) who underwent transurethral resection of bladder tumors (TURBT) and received at least four sessions of intravesical gemcitabine or BCG induction therapy. Patient characteristics, complete remission (CR), occurrence, and progression rates were compared. In total, 149 patients were included in this study (gemcitabine, 63; BCG, 86). No differences were apparent between the two groups in baseline characteristics, except for the follow-up period (gemcitabine, 9.2±5.9 months vs. BCG, 43.9±41.4 months, p<0.001). There were no consistent significant differences observed between the two groups in the 3-month (gemcitabine, 98.4% vs. BCG, 95.3%; p=0.848), 6-month (94.9% vs. 90.0%, respectively; p=0.793) and 1-year CR rates (84.2% vs. 83.3%, respectively; p=0.950). Also, there was no significant statistical difference in progression-free survival between the two groups (p=0.953). The occurrence rates of adverse events were similar between the groups (22.2% vs. 22.1%; p=0.989); however, the rate of Clavien-Dindo grade 2 or higher was significantly higher in the BCG group (1.6% vs. 16.3%, respectively; p<0.001). Intravesical gemcitabine demonstrated efficacy comparable to BCG therapy for the first year in patients with intermediate- and high-risk NMIBC. However, long-term follow-up studies are warranted.

Occurrence of adverse events after magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) therapy in symptomatic uterine fibroids—a retrospective case-control study

Objectives Our study aims at the comprehensive analysis of adverse events (AEs) in patients with symptomatic uterine fibroids (UFs) who underwent magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) in the last 6 years in one of the major Polish centers performing this type of therapy. Methods The presented retrospective case-control study was conducted in the Department of Obstetrics and Gynecology, Pro-Familia Hospital, Rzeszów in cooperation with the Second Department of Obstetrics and Gynecology, Center of Postgraduate Medical Education, Warsaw. The study enrolled 372 women with symptomatic UFs who underwent MR-HIFU and reported AEs during or after the procedure. The occurrence of particular AEs was analyzed. Statistical comparison of two cohorts (patients with and without AEs) was conducted based on epidemiological factors, UF characteristics, fat layer thickness, the presence of abdominal scars and technical parameters of the procedure. Results The overall mean occurrence rate of AEs was 8.9% (n = 33). No major AEs were reported. The only statistically significant risk factor of AEs was the treatment of type II UFs according to Funaki (OR 2.12, CI 95%, p = 0.043). Other investigated factors did not have a statistically significant influence on AE occurrence. Abdominal pain was the most common AE. Conclusion Our data showed that MR-HIFU seemed to be a safe procedure. The AE rate after the treatment is relatively low. According to the obtained data it seems that the occurrence of AEs does not depend on the technical parameters of the procedure and the volume, position and location of UFs. Further prospective, randomized studies and with long follow-up are necessary to confirm the final conclusions.

Effectiveness of dexmedetomidine on postoperative cognitive dysfunction in elderly patients with fracture: A systematic review.

Previous studies have explored the effectiveness of dexmedetomidine on postoperative cognitive dysfunction (POCD) in elderly patients with fracture. However, no systematic review has addressed this issue. Thus, this systematic review investigated the effectiveness of dexmedetomidine on POCD in elderly patients with fracture. In this study, we searched electronic databases of PubMed, EMBASE, Cochrane Library, China National Knowledge Infrastructure, Wang Fang and China Science and Technology Journal Database from their initiation to July 1, 2022. We considered randomized controlled trials of dexmedetomidine on POCD in elderly patients with fracture in this study. Primary outcome was measured by mini-mental state examination. Secondary outcomes were measured by total occurrence rate of postoperative cognitive dysfunction, occurrence rate of delirium, visual analogue scale and occurrence rate of adverse events. A total of 10 studies involving 969 elderly patients with fracture are included in this study. Meta-analysis results showed that there were significant differences on mini-mental state examination at 1-day post-surgery [mean difference (MD) = 2.17; random 95% confidence interval (CI), 1.06, 3.28; P < .001; I²=98%], 3-day post-surgery (MD = 2.70; random 95% CI, 1.51, 3.89; P < .001; I²=98%), and 7-day post-surgery (MD = 1.21; random 95% CI, 0.50, 1.93; P < .001; I²=86%), total occurrence rate of postoperative cognitive dysfunction (odds ratio [OR] = 0.26; fixed 95% CI, 0.11, 0.60; P = .002; I²= 0%), occurrence rate of delirium (OR = 0.29; fixed 95% CI, 0.11, 0.78; P = .01; I²= 0%), visual analogue scale (MD = -1.23; random 95% CI, -1.74, -0.72; P < .001; I²=95%), and occurrence rate of adverse events (OR = 0.32; fixed 95% CI, 0.20, 0.50; P < .001; I²= 0%) between the 2 groups. The results of this study showed that dexmedetomidine could effectively manage POCD in elderly patients with fracture. However, the overall quality of included trials is not too high. Thus, the present findings should be cautiously referred.

Median Effective Dose of an Etomidate-Propofol Mixture with Dezocine in Inhibiting the Response to Gastroscope Insertion: Gender Differences in a Randomized Controlled Study Using Dixon’s Up-and-Down Method

What Is Known and Objective. Appropriate doses of sedatives are crucial for a successful, painless upper gastrointestinal endoscopy. Hence, we conducted a randomized controlled study to explore the effects of dezocine on the median effective dose (ED50) of the etomidate-propofol (E-P) mixture in prohibiting response to gastroscope insertion in patients of different genders. Methods. Patients aged 18–65 years enrolled in the study of the American Society of Anesthesiologists (ASA) with physical status I or II undergoing elective gastroscopy were included. Patients were randomly assigned to the male normal saline group (MS group), male dezocine group (MD group), female normal saline group (FS group), and female dezocine group (FD group). All patients were anesthetized with an E-P mixture of 1 : 1. The FD and MD groups were intravenously injected (i.v.) 50 µg/kg dezocine 5 min before anesthesia, while the FS and MS groups were injected with an equal volume of normal saline 5 min before anesthesia. According to the preexperiment, the initial dose of the E-P mixture for the FD and MD groups was 0.4 and 0.3 mL/kg for the FS and MS groups. The variation proportion was set as 0.9 between dosages. Dixon’s up-and-down method was adopted to confirm the dose of the E-P mixture for the next patient, which was reduced if the insertion was performed successfully; otherwise, the dose was increased. Centered isotonic regression was employed to determine the ED50 and 90% confidence interval (CI) values of the E-P mixture in the four groups. The total amount of E-P mixture consumed was recorded as well as the adverse events of patients. Results. The ED50 and 90% CI of the MS, MD, FS, and FD groups were 0.315 (0.285–0.349), 0.206 (0.175–0.237), 0.329 (0.305–0.355), and 0.207 (0.188–0.227) mL/kg, respectively. The MD group was &lt;MS group ( P ≤ 0.001 ), and the FD group was &lt;FS group ( P ≤ 0.001 ); no statistical difference was observed between the MS and FS groups and MD and FD groups. Dezocine reduced the total amount of E-P mixture consumed and the overall incidence of adverse events. What Is New and Conclusion. Dezocine significantly decreased the ED50 of the E-P mixture in inhibiting the response of patients to gastroscope insertion and the occurrence rate of adverse events. Further, gender had no impact on the ED50 of the E-P mixture.

Endosonography-Guided Versus Percutaneous Gallbladder Drainage Versus Cholecystectomy in Fragile Patients with Acute Cholecystitis-A High-Volume Center Study.

Background and Objectives: Acute cholecystitis is a frequent cause of admission to the emergency department, especially in old and frail patients. Percutaneous drainage (PT-GBD) and endosonographic guided drainage (EUS-GBD) could be an alternative option for relieving symptoms or act as a definitive treatment instead of a laparoscopic or open cholecystectomy (LC, OC). The aim of the present study was to compare different treatment groups. Materials and Methods: This is a five-year monocentric retrospective study including patients ≥65 years old who underwent an urgent operative procedure. A descriptive analysis was conducted comparing all treatment groups. A propensity score was estimated based on the ACS score, incorporated into a predictive model, and tested by recursive partitioning analysis. Results: 163 patients were included: 106 underwent a cholecystectomy (81 laparoscopic (LC) and 25 Open (OC)), 33 a PT-GBD and 21 EUS-GBD. The sample was categorized into three prognostic groups according to the adverse event occurrence rate. All patients treated with EUS-GBD or LC resulted in the low risk group, and the adverse event rate (AE) was 10/96 (10.4%). The AE was 4/28 (14.2%) and 21/36 (58.3%) in the middle- and high-risk groups respectively (p &lt; 0.001). These groups included all the patients who underwent an OC or a PT-GBD. The PT-GBD group had a lower clinical success rate (55.5%) and higher RR (16,6%) when compared with other groups. Conclusions: Surgery still represents the gold standard for AC treatment. Nevertheless, EUS-GBD is a good alternative to PT-GBD in terms of clinical success, RR and AEs in all kinds of patients.

Efficacy and Safety of Radium-223 for Castration-resistant Prostate Cancer With Bone Metastasis Before and After Docetaxel.

Radium-223 (Ra-223) therapy provides a survival benefit for castration-resistant prostate cancer (CRPC) patients with bone metastasis. The optimal timing of using Ra-223 has not been determined. We evaluated the efficacy and safety of Ra-223 before and after docetaxel (DOC) therapy. We retrospectively reviewed 36 CRPC patients with bone metastasis who were treated with Ra-223 in our institution and satellite hospitals. Ra-223 was used before DOC (pre-DOC group) in 17 patients (47%) and after DOC (post-DOC group) in 19 patients (53%). The treatment completion rate of 6 cycles, progression-free survival (PFS), cause-specific survival (CSS) and occurrence rate of adverse events were compared between the groups. The median follow-up duration was 45 months. In the pre-DOC compared with the post-DOC group, treatment completion rate was significantly higher (94% vs. 52%, p<0.01), PFS was significantly longer (median: 8 vs. 5 months, p=0.024) and CSS was significantly longer (median: 32 vs. 15 months, p=0.028). The difference in CSS was significant in multivariate analysis. In the pre-DOC compared with the post-DOC group, the occurrence rate of grade ≥3 adverse events tended to be lower (6% vs. 36%, p=0.322), and the CSS tended to be longer (median: not reached vs. 45 months, p=0.208). Ra-223 could be used more safely and more effectively for CRPC patients with bone metastasis before than after DOC therapy.

Dexamethasone for the treatment of acute respiratory distress syndrome: A systematic review and meta-analysis.

Background:This meta-analysis aimed to evaluate the efficacy and safety of dexamethasone in the treatment of acute respiratory distress syndrome (ARDS).Methods:A systematic search of electronic databases was carried out from inception to May 1, 2022, including PUBMED, EMBASE, Cochrane Library, Wangfang, VIP, and CNKI. Other searches were also checked for dissertations/theses and the reference lists of the included studies. Two team members examined all citations and selected eligible articles. Randomized controlled trials (RCTs) reporting the efficacy and safety of dexamethasone for the treatment of ARDS were included, and the quality of eligible RCTs was assessed using the Cochrane Risk of Bias Tool. If necessary, we conducted data synthesis and meta-analysis. The primary outcome was all-cause mortality. Secondary outcomes were mechanical ventilation duration (day), ventilator-free status at 28 days; intensive care unit (ICU) free (day), ICU mortality, hospital mortality, sequential organ failure assessment (SOFA) as mean and range, SOFA as No. of patients, peak airway pressure (cmH2O), arterial oxygen pressure (mm Hg), days with PaO2 > 10kPa, PaO2, and the occurrence rate of adverse events.Results:Four studies involving 702 patients were included in this analysis. This study showed that dexamethasone could significantly reduce all-cause mortality (odds ratio (OR) = 0.62, 95% confidence interval (CI) [0.44, 0.88], I2 = 30%, P < .001), and decrease ventilator-free status at 28 days (MD = 3.65, 95% CI [1.49, 5.80], I2 = 51%, P < .001). No significant differences in occurrence rates of adverse events were found between dexamethasone and routine or standard care.Conclusions:Evidence from the meta-analysis suggests that dexamethasone is an effective and relatively safe treatment for all-cause mortality and ventilator-free status at 28 days in patients with ARDS. Owning to the small number of eligible RCTs, the conclusions of present study are warranted in the future study.

Attitudes of Critical Care Nurses towards Teamwork and Patient Safety in Saudi Arabia: A Descriptive Cross-Sectional Assessment.

The study aimed to assess the teamwork and safety attitudes among the critical care unit (CCU) nurses in Saudi Arabia. A descriptive cross-sectional study was carried out in public tertiary hospitals in Al-Madinah, Saudi Arabia. All participants answered a three-part questionnaire that included demographic data, a teamwork attitude questionnaire (T-TAQ), and the Safety Attitudes Questionnaire (SAQ). The analysis revealed that the majority of the nurses were female, n = 52 (76.5%), and almost half of the nurses were aged from 29 to 39 years, n = 29 (42.6%). Teamwork attitude values are found to be relatively stable in all subscales, ranging from 1.63 (SD = 1.23) to higher at 2.92 (SD = 1.32). Of the six dimensions of SAQ, job satisfaction (M = 70, SD 21.46) had the highest positive rate and was approached with a positive attitude, followed by teamwork (M = 66.09, SD 15.12) and safety climate (M = 67.11, SD 17.70). The analysis also shows work experience was the influencing factor of teamwork attitude and safety attitude of nurses, recording beta values of 0.24, p < 0.05 and 0.10, p < 0.001, respectively. The results also identified an association between teamwork and safety attitudes. The study reflected the positive attitudes towards teamwork and less positive attitudes toward patient safety among critical care nurses in Saudi Arabia. Collaborative team performance among nurses improves the medical care quality and patients’ safety, decreasing the occurrence rate of adverse events.

Compound Biejia-Ruangan tablet as an adjunctive therapy to entecavir for chronic hepatitis B complicated with hepatic fibrosis: A systematic review and meta-analysis of randomized controlled trials.

Background:The compound Biejia-Ruangan tablet (CBRT), as an adjunctive therapy to entecavir, is a potential treatment for hepatic fibrosis (HF) in patients with chronic hepatitis B (HBV). However, the present study yielded inconsistent results. In this systematic review and meta-analysis, we comprehensively investigated the efficacy and safety of CBRT as an adjunctive modality to entecavir for the treatment of HBV infection complicated with HF.Methods:We searched the Cochrane Library, PubMed, Embase, CNKI, VIP, CBM, and Wangfang databases through April 1, 2022, for randomized controlled trials (RCTs) assessing the effect and safety of CBRT as an adjunctive modality to entecavir for HBV complicated with HF. The primary outcomes were biochemical parameters of serum hyaluronic acid, laminin (LN), pretype-III collagen (PC-III), and type IV collagen (IV-C). The secondary outcomes were liver function indices of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBiL) levels, total effect rate, and occurrence rate of adverse events. Two researchers independently conducted study selection, data extraction, and quality assessment. Statistical analysis was performed using the RevMan 5.3 software.Results:Eight RCTs involving 747 patients were included. Compared with entecavir monotherapy, CBRT as an adjunctive therapy to entecavir exerted more encouraging effect in serum levels of hyaluronic acid (mean difference [MD] = –28.15; 95% confidence interval [CI]: –43.82 to –12.47; P < .001), LN (MD = –29.46; 95% CI: –50.69 to –8.23; P < .001), PC-III (MD = –11.83; 95% CI: –19.43 to –4.23; P < .001), and IV-C (MD = –19.62; 95% CI: –29.76 to –9.49; P < .001); levels of serum ALT (MD = –16.83; 95% CI: –26.30 to –7.36; P < .001), AST (MD = –20.52; 95% CI: –33.11 to –7.93; P < .001), and TBiL (MD = –7.54; 95% CI: –11.58 to –3.49; P < .001); and total effect rate (odds ratio = 3.53; 95% CI: 1.71–7.29; P < .001). Meta-analysis results also showed that CBRT as an adjunctive therapy to entecavir had a lower occurrence rate of adverse events (odds ratio = 0.54; 95% CI: 0.22–1.34; P < .001) than entecavir alone.Conclusion:The results of this study showed that CBRT as an adjunctive modality to entecavir may benefit HBV patients complicated with HF. High-quality RCTs are needed to confirm the current findings in the future.

The CX-DZ-II intelligent electronic stimulator for neck pain caused by cervical spondylosis: A two-center, randomized, controlled, and non-inferiority trial.

BackgroundElectroacupuncture (EA) has been commonly used for the management of neck pain caused by cervical spondylosis (NPCS); however, current electrical instruments have limitations on intelligence, digitalization, and visualization. The intelligent electronic stimulator (CX-DZ-II) is a digital device with an evidence-based diagnosis and treatment system. This study aimed to investigate the efficacy and safety of the CX-DZ-II intelligent EA instrument for NPCS.Materials and MethodsA total of 164 patients with NPCS [mean age (SD), 49.48 (13.47) years] were randomly assigned to receive 8 sessions (over 2 weeks) EA of the intelligent electronic stimulator (CX-DZ-II) or the regular electronic stimulator (SDZ-II). The primary outcome was the change of the visual analog scale (VAS) from baseline to 2 weeks of treatment. Secondary outcomes included mean scores of the VAS after each treatment in 1 week, responder rate, drug-usage rate of non-steroidal antipyretic analgesics (NSAAs), the occurrence rate of adverse events (AEs), proportions of apparatus with defect during treatment, and excellent rate of apparatus.ResultsThe intelligent electronic stimulator (CX-DZ-II) was non-inferior to the regular electronic stimulator (SDZ-II) for changes from baseline in the VAS [3.36 vs. 3.23, with a difference of 0.17 (95% CI, −0.36 to 0.69), P < 0.025 for non-inferiority]. No between-group differences were found in outcomes of VAS in 1 week, overall responders, and drug-usage rate of NSAAs. The defect rate and excellent rate of the instrument were similar in the CX-DZ-II and SDZ-II groups. Adverse events occurred in 9 (10.84%) patients in the CX-DZ-II group and 4 (5.00%) patients in the SDZ-II group.ConclusionThe intelligent electronic stimulator (CX-DZ-II) was non-inferior to the regular electronic stimulator (SDZ-II) in relieving neck pain. The intelligent electronic stimulator (CX-DZ-II) is a promising non-inferior alternative instrument for NPCS.Clinical Trial Registration[https://clinicaltrials.gov/], identifier [NCT030 05301].

Neoadjuvant docetaxel, oxaliplatin and S-1 therapy for the patients with large type 3 or type 4 gastric cancer (OGSG1902): protocol of a multi-center, phase II study

BackgroundLarge type 3 and type 4 gastric cancers have extremely poor prognoses. To address this, neoadjuvant chemotherapy may be a promising approach. The phase III JCOG0501 study, conducted to confirm the superiority of neoadjuvant S-1 plus cisplatin followed by D2 gastrectomy over upfront surgery, showed no survival benefit for neoadjuvant S-1 plus cisplatin. In Korea, the PRODIGY study, which was a phase III study of neoadjuvant docetaxel plus oxaliplatin plus S-1 (DOS) followed by surgery and adjuvant S-1 versus surgery and adjuvant S-1 for gastric cancer of T2-3N+ or T4Nany, showed that progression-free survival (PFS) was significantly superior in the neoadjuvant DOS arm. Therefore, DOS therapy may be a promising candidate for preoperative chemotherapy for large type 3 or type 4 gastric cancer.MethodsPreoperative docetaxel 40 mg/m2 and oxaliplatin 100 mg/m2 will be intravenously administered on day1 every three weeks. S-1 will be orally administered 80 mg/m2 on days 1–14 of a 21-day cycle. Patients will receive three courses of treatment and gastrectomy with ≥D2 lymph node dissection. Postoperative S-1 plus docetaxel therapy (DS) will be administered according to the JACCRO GC-07 (START-2) study. The primary endpoint is the 3-year PFS rate. Secondary endpoints include PFS time, overall survival time, pathological response rate, response rate according to RECIST version1.1, proportion of completion of neoadjuvant chemotherapy, R0 resection rate, proportion of completion of surgery, proportion of completion of protocol treatment, proportion of negative conversion of CY, adverse event occurrence rate, and nutritional evaluation. The null hypothesis for the 3-year PFS rate is 45% and the expected value is 60%. The total sample size is 46 considering that the registration period and follow-up period are two and three years, respectively.DiscussionThis is a prospective, multicenter, single-arm, open-label, phase II trial assessing the efficacy and safety of preoperative DOS and postoperative DS for large type 3 or type 4 gastric cancer. The results will inform future phase III trials and are expected to lead to new treatment strategies for large type 3 or type 4 gastric cancer.Trial registrationRegistered with Japan Registry of Clinical Trials on October 11, 2019 (jRCTs051190060).

Clinical Benefits of Early Concurrent Use of Cryoprecipitate and Plasma Compared With Plasma Only in Bleeding Trauma Patients.

The effectiveness of cryoprecipitate (Cryo) in trauma has not been well established; the benefits of Cryo might have been overestimated in previous studies since the difference in the total amount of administered clotting factors was not considered. We aimed to evaluate the benefits of the concurrent use of Cryo in combination with fresh frozen plasma (FFP) for bleeding trauma patients. Retrospective cohort study. The American College of Surgeons Trauma Quality Improvement Program database between 2015 and 2019. Patients who received greater than or equal to 5 units of packed RBCs and at least 1 unit of FFP within the first 4 hours after arrival to a hospital were included and dichotomized according to whether Cryo was used within the first 4 hours of hospital arrival. None. The outcomes of patients treated with Cryo and FFP were compared with those treated with FFP only using propensity score-matching analysis. The dose of administered clotting factors in each group was balanced. The primary outcome was inhospital mortality, and the secondary outcome was the occurrence rate of adverse events. A total of 24,002 patients (Cryo+FFP group: 6,018; FFP only group: 17,984) were eligible for analysis, of whom 4,852 propensity score-matched pairs were generated. Significantly lower inhospital mortality (1,959 patients [40.4%] in the Cryo+FFP group vs 2,142 patients [44.1%] in the FFP only group; odds ratio [OR], 0.86; 95% CI, 0.79-0.93) was observed in the Cryo+FFP group; no significant difference was observed in the occurrence rate of adverse events (1,857 [38.3%] vs 1,875 [38.6%]; OR, 1.02; 95% CI, 0.94-1.10). Several sensitivity analyses showed similar results. Cryo use combined with FFP was significantly associated with reduced mortality in bleeding trauma patients. Future randomized controlled trials are warranted to confirm these results.

Analysis of Hospital-Level Readmission Rates and Variation in Adverse Events Among Patients With Pneumonia in the United States

It is known that hospitalized patients who experience adverse events are at greater risk of readmission; however, it is unknown whether patients admitted to hospitals with higher risk-standardized readmission rates had a higher risk of in-hospital adverse events. To evaluate whether patients with pneumonia admitted to hospitals with higher risk-standardized readmission rates had a higher risk of adverse events. This cross-sectional study linked patient-level adverse events data from the Medicare Patient Safety Monitoring System (MPSMS), a randomly selected medical record abstracted database, to the hospital-level pneumonia-specific all-cause readmissions data from the Centers for Medicare & Medicaid Services. Patients with pneumonia discharged from July 1, 2010, through December 31, 2019, in the MPSMS data were included. Hospital performance on readmissions was determined by the risk-standardized 30-day all-cause readmission rate. Mixed-effects models were used to examine the association between adverse events and hospital performance on readmissions, adjusted for patient and hospital characteristics. Analysis was completed from October 2019 through July 2020 for data from 2010 to 2017 and from March through April 2022 for data from 2018 to 2019. Patients hospitalized for pneumonia. Adverse events were measured by the rate of occurrence of hospital-acquired events and the number of events per 1000 discharges. The sample included 46 047 patients with pneumonia, with a median (IQR) age of 71 (58-82) years, with 23 943 (52.0%) women, 5305 (11.5%) Black individuals, 37 763 (82.0%) White individuals, and 2979 (6.5%) individuals identifying as another race, across 2590 hospitals. The median hospital-specific risk-standardized readmission rate was 17.0% (95% CI, 16.3%-17.7%), the occurrence rate of adverse events was 2.6% (95% CI, 2.54%-2.65%), and the number of adverse events per 1000 discharges was 157.3 (95% CI, 152.3-162.5). An increase by 1 IQR in the readmission rate was associated with a relative 13% higher patient risk of adverse events (adjusted odds ratio, 1.13; 95% CI, 1.08-1.17) and 5.0 (95% CI, 2.8-7.2) more adverse events per 1000 discharges at the patient and hospital levels, respectively. Patients with pneumonia admitted to hospitals with high all-cause readmission rates were more likely to develop adverse events during the index hospitalization. This finding strengthens the evidence that readmission rates reflect the quality of hospital care for pneumonia.

Comparison of Radiation Exposure between Endoscopic Ultrasound-Guided Hepaticogastrostomy and Hepaticogastrostomy with Antegrade Stenting.

Fluoroscopy forms an essential part of endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) and hepaticogastrostomy with antegrade stenting (EUS-HGAS). To date, no study has assessed and compared radiation exposure between EUS-HGS and EUS-HGAS. This study aimed to compare the radiation exposure parameters between EUS-HGS and EUS-HGAS. This retrospective single-center cohort study included consecutive patients who underwent EUS-HGS or EUS-HGAS from October 2017 to March 2019. The air kerma (AK: mGy), kerma–area product (KAP: Gycm2), fluoroscopy time (FT: min), and procedure time (PT: min) were assessed and compared between the two procedures. Altogether, 45 and 24 patients underwent EUS-HGS and EUS-HGAS, respectively. The median AK, KAP, FT, and PT were higher in the EUS-HGAS group than in the EUS-HGS group. A comparison revealed no difference in the technical success rate, complications rate, adverse event occurrence rate, and re-intervention rate between both procedures. This is the first report in which radiation exposure was used as a comparative parameter between EUS-HGS and EUS-HGAS. This study revealed that radiation exposure is significantly higher in EUS-HGAS than in EUS-HGS. Increased awareness on radiation exposure is warranted among gastroenterologists so that they choose the procedure with lower radiation exposure in cases where both procedures are indicated.

The Effectiveness and Adverse Events of Amitriptyline and Aripiprazole in Very Elderly Patients With BMS.

Burning mouth syndrome (BMS) is defined by chronic oral burning sensations without any corresponding abnormalities. Besides amitriptyline, aripiprazole has been reported as a possible medication to manage BMS. However, especially for elderly patients, the adverse events of these medications would be a problem. The aim of the present study was to investigate the differences in the effectiveness and adverse events of amitriptyline and aripiprazole in very elderly patients with BMS. This is a retrospective comparative study of 80 years old and older patients with BMS who were initially treated with amitriptyline or aripiprazole and who were new outpatients of our department from April 2017 to March 2020. All clinical data, including sex, age, comorbid physical diseases, comorbid psychiatric disorders, the prescribed doses (initial, maximum, and effective dose), prognosis, and adverse events, were collected from their medical charts. Each medication was selected considering their medical history. Amitriptyline was prescribed in 13 patients (11 women, 82.3 ± 2.1 years old) and aripiprazole was prescribed in 27 patients (26 women, 84.2 ± 3.8 years old). There were no significant between-group differences in sex, age, duration of illness, pain intensity, salivation, and psychiatric comorbidity at the first examination. Amitriptyline clinically improved more patients (7 patients, 53.8%) with the effective dose of 10 (7.5, 15.0) mg than aripiprazole (11 patients, 40.7%) of which the effective dose was 1.0 (0.5, 1.5) mg, although there were no significant between-group differences. The adverse events of amitriptyline were found in 9 patients (69.2%) and most patients had constipation (46.2%). For aripiprazole, 7 patients (25.9%) showed adverse events, most of them reported sleep disorder (11.1%). Amitriptyline had significantly longer duration taking medication (p = 0.021) and lower discontinuation (p = 0.043) despite of higher occurrence rate of adverse events (p = 0.015) compared to aripiprazole. These results suggest that both psychopharmacotherapies with a low dose of amitriptyline and aripiprazole are effective for the very elderly patients with BMS. Furthermore, aripiprazole may have some advantages in the adverse events compared to amitriptyline; however, the low dose amitriptyline monotherapy may have more benefit in the effectiveness and tolerability over prudent collaboration with primary physicians.