Occurrence Rate Of Adverse Events Research Articles

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.

Optimal timing for removing a laryngeal mask airway in patients with special needs

ObjectiveWhether a laryngeal mask airway (LMA) should be removed under deep anesthesia or after awakening from general anesthesia remains controversial. Among patients with special needs, removing an LMA after awakening might be difficult because they may be unable to follow instructions during LMA removal. Thus, requirements of patients with special needs must be taken into consideration while deciding on LMA removal. This study aimed to determine optimal timing of LMA removal after dental treatment under general anesthesia in disabled patients by comparing adverse event occurrence rates. MethodsBetween February and December 2018, we randomly categorized 80 disabled patients administered general anesthesia into two groups, namely, the Deep group (40 patients, LMA removed under deep anesthesia) or the Preawake group (40 patients, LMA removed in the Preawake state). Anesthesia in both groups comprised propofol (PROP) and remifentanil (RMFT), and flexible LMAs were used. Dental anesthesiologists assessed the frequency of adverse events, both during and immediately after LMA removal. ResultsClenching, gross body movement, and difficult ventilation were more frequently seen in the Preawake group than in the Deep group (P < 0.05; χ2 test). The rate of coughing, although higher in the Preawake group, was not significantly different between the groups. Laryngospasm occurred in one case in the Preawake group, but the event was insignificant and was responsive to 40 mg PROP administration. ConclusionsAmong disabled patients requiring general anesthesia with PROP and RMFT for dental treatment, LMA should be removed under deep anesthesia to minimize adverse events.

Application of comprehensive unit-based safety program model in the inter-hospital transfer of patients with critical diseases: a retrospective controlled study

BackgroundTo explore the effect of applying a comprehensive unit-based safety program (CUSP) in the intrahospital transfer of patients with critical diseases.MethodsA total of 426 critically ill patients in the first affiliated Hospital of Anhui Medical University from August 2018 to February 2019 were divided into two groups according to the time of admission. Overall, 202 patients in the control group were treated with the routine transfer method, and 224 patients in the observational group were treated with the transfer method based on the CUSP model. The safety culture assessment data of medical staff, the occurrence rate of adverse events and related causes, the time of transfer, and the satisfaction of patients’ relatives to the transfer process were compared before and after implementation of the transfer model between the two groups.ResultsBefore and after the implementation of the CUSP mode transfer program, there were significant differences in the scores of all dimensions of the safety culture assessment of medical staff (P < 0.05), and the occurrence rate of adverse events and the causes in the observational group were significantly lower than those in the control group (disease-related, staff-related, equipment-related, environment-related) (P < 0.05). The transfer time for Computed Tomography (CT), Magnetic Resonance Imaging (MRI), operating room, and the interventional room was significantly shorter in the observational group than that in the control group (P < 0.05), while the satisfaction of relatives to the transfer process was significantly higher than those in the control group (P < 0.05).ConclusionThe implementation of CUSP model for the intrahospital transfer of critically ill patients can significantly shorten the in-hospital transfer time, improve the attitude of medical staff towards safety, reduce the occurrence rate of adverse events, and improve the satisfaction of patients’ relatives to the transfer process.

Preoperative video distraction alleviates separation anxiety and improves induction compliance of preschool children: a randomized controlled clinical trial

Objective: To explore the effect of video distraction on preoperative separation anxiety and induction compliance of preschool children receiving strabismus surgery under general anesthesia. Methods: In this prospective trial, 80 children aged 3 to 6 years scheduled for strabismus surgery under inhalation anesthesia were randomly allocated to one of two groups, a control group and a video distraction group, with 40 cases in each group. Children in the video distraction group continuously watched videos from waiting in the holding area, separating with parents, entering the operating room and induction of anesthesia, while children in the control group didn't watch videos during the same process. The modified Yale Preoperative Anxiety Scale (mYPAS) of children were recorded upon arriving at the holding area(T1)and separating with parents(T2). Induction Compliance Checklist (ICC) score was recorded when the anesthesia induction was performed. The emergence time, the occurrence rate of adverse events in post-anesthesia care unit (PACU) including nausea and vomiting, laryngospasm, severe cough, hypoxemia and sinus bradycardia, incidence of postoperative adverse reactions such as pain, dizziness, nausea and vomiting and lethargy, the parents' satisfaction of anesthesia were also assessed. Results: There were no significant difference in mYPAS score and the proportion of mYPAS score>30 between 2 groups at T1 (all P>0.05). At T2, the mYPAS score and the proportion of mYPAS score>30 in video distraction group were (34.41±13.23) and 52.50%, which were lower than those in control group (50.64±20.96, 87.50%) with statistically significant difference (all P<0.05). The ICC score of video distraction group was lower than that of the control group, which was (1.83±2.26) vs (4.03±2.99), and the difference was statistically significant (P<0.05). The proportion of children with ICC score=0 in video distraction group was 37.50%, which was higher than that in the control group (12.50%), while the proportion of children with ICC score=4-10 was lower than that of the control group, which was 17.50% vs 45.00%, and the difference was statistically significant (P<0.05). No significant intergroup differences were observed in emergence time, incidence of adverse events in PACU, and incidence of postoperative adverse reactions (P>0.05). The parents' satisfaction of anesthesia in the video distraction group was (9.23±0.89), which was higher than that in the control group (8.63±1.23), with statistically significant (P<0.05). Conclusion: Preoperative video distraction alleviates separation anxiety, improves induction compliance of preschool children receiving strabismus surgery under general anesthesia, and increases the parents' satisfaction of anesthesia.

Clinical Observation on 98 Cases of Hematological Malignancies Treated with Autologous Hematopoietic Stem Cell Transplantation Cryopreserved By Ladder-Style Freezing from Low Temperature Refrigerator to Liquid Nitrogen

Background: Programmed cooling - 196℃ liquid nitrogen preservation and non- programmed cooling - 80℃ low temperature refrigerator preservation have been widely used in Auto- HSCT. Programmed cooling and - 196℃ liquid nitrogen preservation can set the rate of temperature fall in advance and standardize the cooling process, reducing the damage to hematopoietic stem cells caused by temperature fall. But programmed cooling is a time-consuming process and it needs to purchase expensive control rate freezer. Non- programmed cooling - 80℃ low temperature refrigerator preservation is easy to operate, but it cannot keep a long preservation period. Since 2002, we tried combining two preservation methods into one: first we placed freezer bags in - 80℃ low temperature refrigerator and then placed them in -196℃ liquid nitrogen tank for long-term preservation, with the purpose of prolonging the cryopreservation of stem cells.Method:We observed the influence of cryopreservation of hematopoietic stem cells with ladder-style freezing from low temperature refrigerator to liquid nitrogen in transplantation treatment of hematological malignancies, and analyzed the survival condition of patients after hematopoietic stem cell transplantation.We retrospectively analyzed the clinical datas of 98 patients with hematological malignancies treated by hematopoietic stem cell transplantation from 2002-01 to 2016-12 in our center.Results: 98 patients, 56 males and 42 females, aged 14-69 years (avenge age36.46±14.19 years). Disease subtypes: 10 cases of acute lymphoblastic leukemia(ALL), 24 cases of acute non- lymphoblastic leukemia(ANLL) , 11 cases of multiple myeloma(MM), 53 cases of malignant lymphoma(ML). One case failed in implantation due to intracranial hemorrhage and the other 97 cases all succeeded in hematopoietic reconstitution. The median survival time was 47 months and the average follow-up time was 50.11 months. The average time needed to neutrophil count ≥0.5×109/L was 9.24±1.89d, and the average time needed to platelet count≥20×109/L without platelet transfusion for 3 days was 11.04±1.84d. The median survival time was 47.6 months (1~80 months). The overall survival rates of 1 year, 3-year and 5-year were (97.2±1.9) %, (84.2±4.6) % and (77.8±5.6) %, respectively. PFS (progression-free survival) of patients in 3 years and 5 years were (74.4±5.1)% and (61.2±6.2)% (Figure1), which is consistent with data reported by other transplantation centers. In this study, it is found that the application of auto-HSCT has significantly improved OS and PFS of patients with acute leukemia, malignant lymphoma and multiple myeloma, but there is no significant difference in OS and PFS among three groups(Figure2)(P=0.537). The survival condition of CR1 patients was better than no-CR1 patients(Figure3). The complication about transplantation mainly were digestive tract symptoms. 9.18% patients complicated with liver function injury and 58.16% patients got infection.We continuously improved cryophylactic agent and obtained cryoprotectant formed by 3%hydroxyethyl starch, 4% albumin and 5% DMSO to replace the traditional 10% DMSO cryoprotectant used in programmed cooling. During stem cell infusion, the occurrence rate of complication was 8.16%, significant lower than the occurrence rate of adverse events occurring in the usage of 10% DMSO cryoprotectant.Conclusions: ladder-style freezing from low temperature refrigerator to liquid nitrogen with cryoprotectant that is formed by 3% hydroxyethyl starch, 4% albumin and 5% dimethyl sulfoxide (DMSO) for cryopreservation of hematopoietic stem cells. It can reach the same clinical transplantation effect with traditional programmed cooling freezing method in autologous hematopoietic stem cells transplantation (auto-HSCT) and can effectively improve OS, PFS of hematological malignancies. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Post-Marketing Surveillance with a Biosimilar of Rituximab (Novex®) in Argentina

IntroductionNovex® is a biosimilar of Rituximab approved in Argentina having the same indications as the reference product (Mabthera®/Rituxan®). It is commercialized by Laboratorio Elea and since its commercial launch the first national pharmacovigilance plan for a Biosimilar mAb has been implemented.Material and MethodsIn order to detect deviations from expected frequencies of adverse events, a prospective treatment registry for NOVEX® was implemented since beginning of commercialization (November 26th, 2014). The Data Lock Point for this report is June 30th, 2017. Physicians registered the following information for each patient: age, gender, indication, dosing, dose frequency and date of treatment initiation and finalization. Treatment outcome and all Adverse Event detected were registered and coded using MedDRA dictionary.ResultsOne-hundred and eighty physicians have participated in this surveillance program. A total of 525 individual records, with at least 1 follow up point, were collected and included in analysis.The percentage of female patients was 52%. Age range was 10 - 90 years with a mean age of 63.3 years. The majority of patients have received NOVEX® due to a hematological disease (91.2% of cases) (table 1).Treatment duration ranged from 154 to 309 days (IQR), with mean of 239 days and median of 214 days. The number of cycles varied from 1 to 12 with a mean of 5.7.Twenty-four individual Case Safety Reports (ICSRs) were collected, with 29 Adverse Events, and the relative frequency of ICSR was 4.6%. Occurrence rates of adverse events were 1.2 per 100 administered cycles, and 0.022 per 100 treatment days. Fourteen serious adverse events (SAE) were collected and most of them were acute infusion related reactions.The most frequently reported AEs were:· Acute Infusion Related Reaction (14)· Arrhythmia (3)· Pneumonia (2)· Stroke (2)During the program, we detected 41 treatments with rituximab that were started before the launch of the product. Assuming these treatments had begun with Mabthera, this implies the occurrence of interchangeability in this subgroup.Because of the special interest of this condition, the frequency of ICSRs was analyzed. Two ICSRs were reported, with a relative frequency of 4.9 % (CI95%: 1.7 - 11.5%), which was similar to the whole frequency of the program. Therefore, it was considered that there were no significant differences in the level of reports in the group with interchangeability compared to the general group.ConclusionsThis post-marketing surveillance demonstrates a similar incidence of adverse events after the use of rituximab biosimilar when compared to the published data related to the reference product. Therefore, in terms of tolerability, this biosimilar product has a similar safety profile of that of the reference product. This data is consistent with the high similarity demonstrated during preclinical in vitro and in vivo characterization and the clinical efficacy and safety profile demonstrated in the comparative clinical trial. [Display omitted] DisclosuresPenna:Laboratorio ELEA: Employment. Fernández:Laboratorio ELEA: Employment. Spitzer:Laboratorio ELEA: Employment. Millan:mAbxience: Employment. Gomez:Laboratorio ELEA: Employment.

Effectiveness and Safety of Moxibustion Robots on Primary Dysmenorrhea: A Randomized Controlled Pilot Trial.

To conduct a pilot trial to explore the effectiveness and safety of moxibustion robots in treating primary dysmenorrhea (PD) and evaluate its feasibility in clinic. A total of 70 participants with PD were allocated to either moxibustion robot (MR) group (35 cases) or manual moxibustion (MM) group (35 cases) using computer-generated randomization. One acupoint Guanyuan (CV 4) was selected to receive moxa heat stimulation. Two groups of participants were given 3 menstrual cycles of MM and MR treatment respectively (once a day, 5 days a session) and received another 3 menstrual cycles follow-up. The degree of pain was evaluated by short-form McGill pain questionnaire (SF-MPQ) and the symptoms of dysmenorrhea were evaluated by Cox Menstrual Symptom Scale (CMSS). The safety was measured by the occurrence rate of adverse events (AEs), including burns (blisters, red and swollen), itching, bowel changes, menstrual cycle disorder, menorrhagia and fatigue, etc. RESULTS: A total of 62 patients completed the trial, 32 in MR group and 30 in MM group. Compared with baseline, scores of SF-MPQ and CMSS significantly decreased in both groups (P<0.05), and no significant difference was observed between the two groups in the 3rd and 6th menstrual cycles (P>0.05). The total occurrence rate of AEs in MR group was 2.1%, which was significantly lower than MM group (7.2%, P<0.05). MR has the same effect as MM at SF-MPQ and CMSS in patients with PD. However, MR is safer than MM (Trial registration No. ChiCTR1800018236).

External beam radiotherapy with or without californium-252 neutron brachytherapy for treatment of recurrence after definitive chemoradiotherapy

We aimed to evaluate the application of external beam radiotherapy (EBRT) combined with californium-252 (252Cf) neutron intraluminal brachytherapy (NBT) in patients with local recurrent esophageal cancer after definitive chemoradiotherapy (CRT). Sixty-two patients with local recurrent esophageal squamous cell carcinoma after definitive CRT were retrospectively analyzed; 31 patients underwent NBT+EBRT, and 31 received EBRT alone. The response rate; 1-, 2-, and 3-year overall survival rates; and adverse event occurrence rates were compared between these two patient groups. The response rate was 83.87% (26/31) in the NBT+EBRT group and 67.74% (21/31) in the EBRT group (p < 0.001). The 1-, 2-, and 3-year overall survival rates were 80.6%, 32.3%, and 6.5%, respectively, in the EBRT group, with a median survival time of 18 months. The 1-, 2-, and 3-year overall survival rates were 83.8%, 41.9%, and 6.9%, respectively, in the NBT+EBRT group, with a median survival time of 19 months. The differences between the groups were not significant (p = 0.352). Regarding acute toxicity, no incidences of fistula or massive bleeding were observed during the treatment period. The incidences of severe and late complications were not significantly different between the two groups (p = 0.080). However, the causes of death for all patients differed between the groups. Our data indicate that 252Cf-NBT+EBRT produces favorable local control for patients with local recurrent esophageal cancer after CRT, with tolerable side effects.

Ibrutinib Plus Fludarabine, Cyclophosphamide, and Rituximab As the Treatment for Chronic Lymphocytic Leukemia/ Small Lymphocytic Leukemia: A Single-Center Real World Study

Purpose: To evaluate the safety and efficacy of ibrutinib plus fludarabine, cyclophosphamide, and rituximab (iFCR) as the treatment for chronic lymphocytic leukemia (CLL)/ small lymphocytic leukemia (SLL) patients, we conducted time-limited, minimal residual disease (MRD)-driven real world study in The First Affiliated Hospital of Nanjing Medical University Methods: We enrolled patients aged 18 to 65 years old with CLL/SLL who required treatment. Oral Ibrutinib was given continuously (420 mg/day) from day 0, and patients were administered intravenously rituximab (375mg/m2 in day 0 of cycle 1; 500mg/m2 in day 0 of cycle 2-3), fludarabine (25mg/m2, days 1-3) and cyclophosphamide (250mg/m2, days 1-3), every 28-day cycles. All the patients received 3 cycles of iFCR in the first stage. Interim analysis was done according to the 2018 iwCLL criteria and MRD was detected by flow cytometry. Patients who achieved complete response (CR) or partial response (PR) with low MRD level (L-MRD, 10-4-10-2) or undetectable MRD (uMRD) level (&amp;lt;10-4) in peripheral blood (PB) were given 3 times of rituximab or the 4th cycle of iFCR, and then turned to ibrutinib maintenance. Patients who achieved PR with high MRD level (&amp;gt;10-2) in PB or bone marrow (BM), or with diameter of residual lymph node larger than 3cm were administered another 3 cycles of iFCR (6 in all) and followed by ibrutinib maintenance. The primary endpoint was the proportion of patients who achieved uMRD in the PB after 3 cycles of iFCR. The secondary endpoint was overall response rate (ORR), complete response rate (CR) and the number of adverse events (AE). Results: Between May 2019 and June 2020, 29 CLL/SLL patients were enrolled in this cohort with 27 CLL and 2 SLL. 26 of patients were the previously untreated and 3 of patients were relapse or treated before. The median age of patients was 53 years old. Unmutated IGHV was detected in 14 (50.0%) of 29 patients, 4 patients had del(17p) and/or TP53 mutation (13.8%), 7 patients had del(11q) (24.1%), 7 had NOTCH1 mutation (24.1%) and 7 had MYD88 mutation (24.1%). 8 patients (30.8%) were classified as low-risk group according to CLL-IPI, with 9 in intermediate-risk group (34.6%), 5 in high-risk group (19.2%) and 4 in very-high risk group (15.4%). At data cutoff (1st July, 2020), the median follow-up and treatment time was seven months (1-13 months) with 23 patients had completed at least two cycles of iFCR. At interim analysis, the ORR was 100% with 8 patients achieved CR (34.8%), 3 achieved CRi (13.0%) and 12 achieved PR (52.2%). 57.1% (12/21) achieved uMRD in both PB and BM, among which 6 of them (28.6%) achieved CR/CRi and 6 achieved PR (28.6%). All four patients with TP53 abnormalities achieved PR and two of them (50.0%) achieved uMRD in both PB and BM. One of 6 patients with del(11q) achieved CR (16.7%) and five achieved PR (83.3%), with 2 achieved uMRD in both PB and BM (33.3%). Among 13 assessable patients with unmutated IGHV, four of them achieved CR (30.8%) and nine achieved PR (69.2%), with 5 achieved uMRD in both PB and BM (38.5%). 18 patients had turned to ibrutinib maintenance with 12 of them finished 4th cycle of iFCR or 3 additional cycles of rituximab and could be assessed further. 10 of the patients achieved CR/CRi (83.3%) and 2 achieved PR (16.7%), with 8 achieved uMRD in both PB and BM (66.7%). The most common hematological toxicity events were neutropenia and thrombocytopenia and the non-hematological toxicity events were nausea and vomiting. The occurrence rate of grade 3 to 4 neutropenia and agranulocytic fever were 51.9% (15/29) and 17.2% (5/29) respectively. The most common ibrutinib-related AE were purpura, rash and diarrhea. The occurrence rate of AE induced discontinued ibrutinib more than 7 days, discontinued ibrutinib fewer than 7 days and ibrutinib decrement were 20.7%(6/29), 17.2%(5/29) and 20.7%(6/29) respectively. Conclusion: MRD-driven Ibrutinib plus FCR could achieve high response rate with uMRD in yonger fit patients with CLL/SLL, with manageable toxicity. Ibrutinib plus FCR could be one of the most promising choice as a time-limited regimen in the new drug era. Disclosures No relevant conflicts of interest to declare.

Plasma mycophenolic acid concentration and the clinical outcome after lung transplantation.

The therapeutic drug monitoring of mycophenolic acid (MPA) has been investigated for renal and heart transplantations; however, its usefulness in lung transplantation is unclear. The MPA area under the plasma concentration-time curve (AUC) was calculated in 59 adult lung transplant recipients. The MPA AUC0-12 s were compared among the three groups determined by the presence of adverse events (no events, infection, and chronic lung allograft dysfunction [CLAD]). Next, MPA AUC0-12 thresholds for the adverse events were identified by receiver operating characteristic analysis. Cumulative occurrence rate of the adverse events was compared between two groups (adequate and inadequate groups) according to the thresholds. The MPA AUC0-12 s in the no event, infection, and CLAD groups were 30.3±6.5, 36.8±10.7, and 20.6±9.6µg·h/mL, respectively (P=.0027), while the tacrolimus trough levels were similarly controlled in the groups. The thresholds of MPA AUC0-12 for the occurrence of infection and CLAD were 40.5 and 22.8µg·h/mL, respectively. The cumulative occurrence rate of adverse events of adequate group (15.3%) was significantly lower than that of inadequate group (56.0%) (P=.0050). The MPA AUC0-12 may affect the occurrence of adverse events in lung transplant recipients.

Pocket-creation method improves efficacy of colorectal endoscopic submucosal dissection: a system review and meta-analysis.

The pocket-creation method (PCM) is a new strategy for endoscopic submucosal dissection (ESD). The aim of this system review is to evaluate the clinical efficacy and safety of PCM-ESD compared to conventional ESD (C-ESD) for colorectal neoplasm lesions. We performed literature search using MEDLINE, EMBASE and CENTRAL database from inception to 15 February 2020. Studies provided comparison between PCM-ESD and C-ESD for colorectal neoplasm lesions were included. En bloc resection rate, R0 resection rate, occurrence rate of adverse events and operation speed/time were extracted from included studies. Pooled risk difference with 95% confidence intervals (CIs) was calculated in meta-analysis. Three cohort studies and one randomized control trial (RCT) were included, which contained 432 colorectal lesions removed by PCM-ESD and 959 lesions resected by C-ESD. PCM-ESD achieved significantly higher en bloc/R0 resection rate than C-ESD in cohort studies with pooled risk differences of 0.05 (CI, 0.03-0.07, I2 = 34%) and 0.14 (CI, 0.04-0.24, I2 = 83%). However, comparison of en bloc/R0 resection rate between two surgery strategies could not be estimated in RCT. Pooled results in cohort studies and data from RCT revealed comparable occurrence rate of adverse events between PCM-ESD and C-ESD. Measurements and outcomes of operation time/speed varied between the included studies and no consistent conclusion could be achieved in this aspect. The results indicate that PCM-ESD is an effective and well-tolerated treatment for colorectal neoplasm lesions and may be a superior treatment to C-ESD in en bloc/R0 resection rate.

Drug-Eluting Beads versus Lipiodol Transarterial Chemoembolization for the Treatment of Hypovascular Hepatocellular Carcinoma: A Single-Center Retrospective Study.

PurposeTo evaluate the efficacy and safety of drug-eluting beads transarterial chemoembolization (DEB-TACE) and conventional TACE (C-TACE) in treating hypovascular hepatocellular carcinoma (HCC).Materials and MethodsThe medical records based on HCC patients who underwent TACE from January 2016 to June 2019 were reviewed in the study. The diagnosis of hypovascular HCC was conducted by two senior radiologists according to imaging. We evaluated the adverse events (AEs), objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) in the study.ResultsA total of 98 patients with hypovascular HCC were included in the study. 46 patients underwent DEB-TACE treatment, and 52 patients underwent C-TACE treatment. The PFS of DEB-TACE group and C-TACE group was 12.0 months and 7.0 months (P < 0.001), and OS was 21.0 months and 14.0 months (P = 0.035), respectively. In addition, DEB-TACE group had better ORR (76.1% vs 40.4%, P < 0.001) and DCR (91.3% vs 75.0%, P = 0.033) compared to C-TACE group. The occurrence rate of AEs showed no difference between the two groups (67.3% vs 57.7%, P = 0.323). Furthermore, we found that DEB-TACE can be identified as a positive independent prognostic factor for improved PFS and OS.ConclusionDEB-TACE, as an effective treatment, can yield better objective response rate, similar safety profile and improved survival for hypovascular HCC patients compared to C-TACE.

Describing adverse events in Swiss hospitalized oncology patients using the Global Trigger Tool.

Background and aimsThe occurrence rate of adverse events (AEs) related to care among hospitalized oncology patients in Switzerland remains unknown. The primary objective of this study was to describe, for the first time, the occurrence rate, type, severity of harm, and preventability of AEs related to care, reported in health records of hospitalized hematological and solid‐tumor cancer patients in three Swiss hospitals.MethodsUsing an adapted version of the validated Global Trigger Tool (GTT) from the Institute for Healthcare Improvement, we conducted a retrospective record review of patients discharged from oncology units over a 6‐week period during 2018. Our convenience sample included all records from adult patients (≥18 years of age), diagnosed with cancer, and hospitalized (>24 hours). Per the GTT method, two trained nurses independently assessed patient records to identify AEs using triggers, and physicians from the included units analyzed the consensus of the two nurses. Together, they assessed the severity and preventability of each AE.ResultsFrom the sample of 224 reviewed records, we identified 661 triggers and 169 AEs in 94 of them (42%). Pain related to care was the most frequent AE (n = 29), followed by constipation (n = 17). AEs rates were 75.4 per 100 admissions and 106.6 per 1000 patient days. Most of the identified AEs (78%) caused temporary harm to the patient and required an intervention. Among AEs during hospitalization (n = 125), 76 (61%) were considered not preventable, 28 (22%) preventable, and 21 (17%) undetermined.ConclusionAbout half of the hospitalized oncology patients suffered from at least one AE related to care during their hospitalization. Pain, constipation, and nosocomial infections were the most frequent AEs. It is, therefore, essential to identify AEs to guide future clinical practice initiatives to ensure patient safety.

Resection of the gastric submucosal tumor (G-SMT) originating from the muscularis propria layer: comparison of efficacy, patients\u2019 tolerability, and clinical outcomes between endoscopic full-thickness resection and surgical resection

Background and aimsEndoscopic full-thickness resection (EFTR) has been increasingly applied in the treatment of gastric submucosal tumors (G-SMTs) with explorative intention. This study aimed to compare the efficacy, tolerability, and clinical outcomes of EFTR and surgical intervention for the management of muscularis propria (MP)-derived G-SMTs.MethodsBetween September 2011 and May 2019, the clinical records of patients with MP-derived G-SMTs undergoing EFTR at our endoscopic unit were collected. A cohort of people with primary MP-derived G-SMTs treated by surgery was matched in a 1:1 ratio to EFTR group with regard to patients’ baseline characteristics, clinicopathologic features of the tumor and the procedure date. The perioperative outcomes and follow-up data were analyzed.ResultsIn total, 62 and 62 patients were enrolled into the surgery and EFTR group, respectively, with median follow-up of 786 days. The size of G-SMTs (with ulceration) ranged from 10 to 90 mm. For patients with tumor smaller than 30 mm, surgery and EFTR group presented comparable procedural success rate (both were 100%), en bloc resection rate (100% vs. 94.7%), tumor capsule rupture rate (0% vs. 5.3%), and pathological R0 resection rate (both were 100%). EFTR had a statistically significant advantage over surgery for estimated blood loss (3.12 ± 5.20 vs. 46.97 ± 60.73 ml, p ≤ 0.001), discrepancy between the pre- and postprocedural hemoglobin level (5.18 ± 5.43 vs. 9.84 ± 8.25 g/L, p = 0.005), bowel function restoration [1 (0–5) vs. 3 (1–5) days, p ≤ 0.001], and hospital cost (28,617.09 ± 6720.78 vs. 33,963.10 ± 13,454.52 Yuan, p = 0.033). The patients with tumor larger than 30 mm showed roughly the same outcomes after comparison analysis of the two groups. However, the clinical data revealed lower en bloc resection rate (75.0% vs. 100%, p = 0.022) and higher tumor capsule rupture rate (25.0% vs. 0%, p = 0.022) for EFTR when compared to surgery. The procedure time, duration of postprocedural fasting and antibiotics usage, and hospital stay of the two groups were equivalent. The occurrence rate of adverse events within postoperative day 7 were 74.2% and 72.6% after EFTR and surgery, respectively (p = 1.000). No complications occurred during the follow-up.ConclusionFor treatment of MP-derived G-SMTs (with or without ulceration), our study showed the feasibility and safety of EFTR, which also provided better results in terms of procedural blood loss, the postoperative bowel function restoration and cost-effectiveness when compared to surgery, whereas the surgery was superior in en bloc resection rate for G-SMTs larger than 30 mm. The postprocedural clinical outcomes seemed to be equivalent in these two resection methods.

Acquired angioedema induced by angiotensin-converting enzyme inhibitors - experience of a hospital-based allergy center.

Angiotensin-converting enzyme inhibitors (ACEIs) represent an important group of pharmacological compounds, largely prescribed for more than 30 years. They have been extensively evaluated in clinical trials, demonstrating significant reduction of morbidity and mortality of patients with cardiovascular diseases, mainly high blood pressure, myocardial infarction, heart failure and stroke. Besides their beneficial effects and a general good safety profile, it was proven that ACEIs might also induce adverse effects in some patients, most notably angioedema (AE) and chronic cough. The occurrence rate of adverse events induced by ACEIs is low, but the number of suffering patients is relatively high, since ACEIs is one of the most frequently prescribed medication worldwide. The aim of our study was to evaluate clinical pattern, risk factors and general management of ACEI-induced angioedema in a cohort of patients addressed for allergist evaluation in one university hospital in Romania, during a period of 32 months. It was found that ACEI-induced angioedema (ACEI-AE) represented more than half of the total number of patients addressed for angioedema without urticaria, with variable clinical and time-patterns. Most of the patients were referred by general practitioners (GPs) with diagnosis of urticaria or other skin allergy and continued to take ACEIs for months and years after onset of angioedema. We concluded that the awareness of acquired, non-allergic angioedema induced by ACEI therapy in medical practice is still low and there is a need for improved knowledge and interdisciplinary collaboration in this field.

Safety and Efficacy Evaluation of Traditional Chinese Medicine (Qingre-Lishi-Yishen Formula) Based on Treatment of Regular Glucocorticoid Combined with Cyclophosphamide Pulse in Children Suffered from Moderately Severe Henoch-Schonlein Purpura Nephritis with Nephrotic Proteinuria.

Objective At present, the most appropriate management of Henoch–Schonlein purpura nephritis (HSPN) with nephrotic-range proteinuria still remains controversial; thus, the purpose of this study is to evaluate safety and efficacy of traditional Chinese medicine (TCM), Qingre-Lishi-Yishen Formula (QLYF), integrated with regular oral glucocorticoid and cyclophosphamide intravenous pulse therapeutic regimen in children suffered from moderately severe HSPN with nephrotic proteinuria. Methods From 1 January 2012, to 1 January 2016, totally 150 hospitalized children suffered from HSPN with nephrotic proteinuria were included. All were treated with glucocorticoid and cyclophosphamide, and 100 of them were treated with integrative traditional Chinese decoction QLYF. Patients were followed up for 2 years. Rate of adverse event occurrence, short-term clinical effects, long-term clinical effects, and TCM therapeutic evaluation were all compared. Results Total adverse event rate was lower in the QLYF group (χ2 = 5.357, p = 0.022); rates of respiratory infection, urinary infection, poor appetite, hepatotoxity, cardiotoxicity, and neutropenia were all decreased in patients who received QLYF (p = 0.022); rates of respiratory infection, urinary infection, poor appetite, hepatotoxity, cardiotoxicity, and neutropenia were all decreased in patients who received QLYF (p = 0.022); rates of respiratory infection, urinary infection, poor appetite, hepatotoxity, cardiotoxicity, and neutropenia were all decreased in patients who received QLYF (p = 0.022); rates of respiratory infection, urinary infection, poor appetite, hepatotoxity, cardiotoxicity, and neutropenia were all decreased in patients who received QLYF (p = 0.022); rates of respiratory infection, urinary infection, poor appetite, hepatotoxity, cardiotoxicity, and neutropenia were all decreased in patients who received QLYF (p = 0.022); rates of respiratory infection, urinary infection, poor appetite, hepatotoxity, cardiotoxicity, and neutropenia were all decreased in patients who received QLYF (Conclusion Compared with merely using regular oral glucocorticoid plus cyclophosphamide pulse therapeutic regimen, the therapeutic regimen that integrates QLYF with the abovementioned western medicine might be a safe means to decrease the occurrence rate of adverse events and improve short-term and long-term clinical effects in children who suffered from moderately severe HSPN with nephrotic proteinuria.

CN31 - Adverse events in oncology and haemato-oncology inpatients of Swiss hospitals: A descriptive study

BackgroundThe occurrence rate of adverse events (AEs) in hospitalised cancer patients in Switzerland remains unknown. The Institute for Healthcare Improvement (IHI) Global Trigger Tool (GTT) is among the most used methods to identify AEs. However, the GTT lacks oncology-specific triggers. Therefore, we developed a GTT-based Swiss Oncology Trigger Tool (SOTT), which included two modified GTT modules (“Cares” and “Medication”) and a new “Oncology” module. Objective We applied the SOTT to describe the occurrence rate, nature, level of harm and preventability of AEs reported in health records of four Swiss inpatient oncology and haemato-oncology units. MethodsWe reviewed records of discharged patients over a 6-week period using the method recommended by the IHI for the GTT. To identify documented AEs, two nurse reviewers analysed records using the SOTT. Identified AEs were subsequently validated by physician reviewers, and those occurring during hospitalisation were classified regarding the incurred level of harm and their preventability. ResultsWe reviewed 224 records, 150 for oncology and 74 for haemato-oncology. Ninety-four of them (42%) contained at least one AE. In total we identified 169 AEs 100 for oncology and 69 haemato-oncology. Overall, we calculated a rate of 76 AEs/100 admissions and 108 AEs/1000 patients-days. “Pain related to care” was the most frequent AE reported (n=29), followed by “Constipation” (n=17) and “Anaemia” (n=9). Most AEs were categorized as having caused temporary harm, either requiring an intervention (n=98) or prolonging the hospital stay (n=25). Two required an intervention to sustain the patient’s life. Exactly 78/125 (61%) were considered non-preventable, 28/125 (22%) preventable and 19/125(15%) undetermined. ConclusionsThis is the first Swiss study to identify and categorise AEs in the oncology setting. The application of the SOTT showed a relatively high rate of harm related to care, but only 22% were considered as preventable. The description of AEs with the SOTT might be an opportunity to prioritize the development of novel interventions to avoid or limit the impact of AEs on cancer patients’ lives. Legal entity responsible for the studyManuela Eicher. FundingHas not received any funding. DisclosureAll authors have declared no conflicts of interest.

Efficacy and safety of nivolumab in 100 patients with recurrent or metastatic head and neck cancer – a retrospective multicentre study

Background: No large-scale retrospective studies have examined the efficacy and safety of nivolumab.Objective: This retrospective study aimed to investigate the efficacy and safety of nivolumab administered to patients in multiple facilities.Material and methods: The primary endpoint was overall response rate (ORR) and secondary endpoints were progression-free survival (PFS) and overall survival (OS). For safety, adverse event occurrence rates by grade, deaths and severe adverse events were investigated. OS and PFS were also examined according to whether immune-related adverse events (irAEs) appeared. Statistical analysis was conducted using log-rank testing, with values of p < .05 considered significant.Results: Nivolumab was administered to 100 patients with a history of receiving platinum-based drugs. ORR was 13.5% and disease control rate was 49.0%. Median PFS was 3.7 months. Median OS was 9.6 months. For all grades, irAEs occurred in 30 patients. The 1-year survival rate in the subgroup without irAEs was 34.0%, compared to 52.6% with irAEs (p = .041).Conclusions and significance: The 1-year survival rate was better in patients who developed irAEs. This is a new finding for head and neck cancer. Appearance of irAEs could also be used as an indicator of expected therapeutic effect in head and neck cancer.

Bi-monthly hepatic arterial infusion chemotherapy as a novel strategy for advanced hepatocellular carcinoma in decompensated cirrhotic patients.

Background and AimsWe previously reported the comparable efficacy of bi-monthly hepatic arterial infusion chemotherapy (B-HAIC) to that of sorafenib chemotherapy for the treatment of advanced hepatocellular carcinoma (aHCC) in patients with compensated cirrhosis. In this study, we demonstrate the efficacy of B-HAIC in patients with decompensated cirrhosis.MethodsForty-five patients with aHCC refractory to transcatheter arterial chemo-embolization (TACE) were treated with B-HAIC and were divided into two groups according to hepatic functional reserve (Child-Pugh grade). Overall survival period, treatment response, and adverse events in each group were analyzed.ResultsEfficacy and disease control rates in the Child-Pugh B group (n=24; 21% and 71%, respectively) were not significantly impaired compared the Child-Pugh A group (n=21; 38% and 67%, respectively). Median survival time and survival rate at 12 months in the Child-Pugh B group were 422 days and 58.3%, respectively, whereas those in the Child-Pugh A group were 567 days and 70.8%, respectively. Importantly, the hepatic functional reserve of patients did not worsen in either group during the treatment period. Furthermore, the occurrence rate of adverse events leading to discontinuation of anti-tumor treatment was not significantly increased in the Child-Pugh B group.ConclusionsGiven the preservation of hepatic functional reserve afforded by B-HAIC chemotherapy in patients with decompensated cirrhosis, B-HAIC might be an acceptable alternative strategy for aHCC patients who do not respond to TACE.