Incidence Rate Of Adverse Effects Research Articles

Immunogenicity and Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (IndoVac®) as a Heterologous Booster Dose against COVID-19 in Indonesian Adolescents.

Adolescents are vulnerable to Coronavirus disease 2019 (COVID-19) infections; thus, their antibodies should be maintained above the protective value. This study aimed to evaluate the immune response and safety to the SARS-CoV-2 protein subunit recombinant vaccine (IndoVac®) as a heterologous booster dose against COVID-19 in Indonesian adolescents. This open-label prospective intervention study enrolled 150 clinically healthy adolescents aged 12-17 years who had received complete primary doses of the CoronaVac® vaccine from Garuda Primary Care Centres in Bandung City. The result of immunogenicity was presented with a 95% confidence interval (CI) and analyzed with t-tests from 14 days and 3, 6, and 12 months. The neutralizing antibody geometric mean titers (GMTs) (IU/mL) at baseline and 14 days after booster dose were 303.26 and 2661.2, respectively. The geometric mean fold rises (GMFR) at 3, 6, and 12 months after booster dose were 6.67 (5.217-8.536), 3.87 (3.068-4.886), and 2.87 (2.232-3.685), respectively. Both the neutralizing antibody and IgG antibody were markedly higher in the adolescents than in the adults at every timepoint. The incidence rate of adverse effects (AEs) until 28 days after booster dose was 82.7%, with a higher number of local events reported. Most reported solicited AEs were local pain followed by myalgia with mild intensity. Unsolicited AEs varied with each of the incidence rates < 10%, mostly with mild intensity. Adverse events of special interest (AESI) were not observed. At the 12-month follow-up after the booster dose, four serious adverse events (SAEs) not related to investigational products and research procedures were noted. This study showed that IndoVac® has a favorable immunogenicity and safety profile as a booster in adolescents and that the antibody titer decreases over time.

Combination immunochemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: a systematic review and meta-analysis

ObjectiveTo evaluate the efficacy and safety of combination immunochemotherapy regimens for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).DesignMeta-analysis and systematic review.Data sourcesPubMed, Embase,...

Moderate sedation by total intravenous remimazolam-alfentanil vs. propofol-alfentanil for third molar extraction: A prospective randomized controlled trial.

BackgroundOral dental treatment cause anxiety, fear, and physical stress. This study aimed to investigate the efficacy and safety of moderate sedation by remimazolam with alfentanil vs. propofol with alfentanil in third molar extraction.MethodsThis single-center, randomized, single-blind clinical trial included 100 adults who underwent third molar ambulatory extraction. All patients had continuous infusion of Alfentanil 0.2 μg/kg/min. Group remimazolam with alfentanil (group RA) had an induction dose of 80 μg/kg and maintenance dosage of 5 μg/kg/min. In group propofol with alfentanil (PA group), propofol was infused at an initial concentration of 1.8 μg/mL under target controlled infusion (TCI) mode and a maintenance concentration of 1.5 μg/mL. The incidence rates of adverse effects were recorded and compared. Depth of sedation was assessed using the modified observer alertness/sedation assessment (MOAA/S) and entropy index. Recovery characteristics were recorded and complications observed for next 24 h.ResultsThe incident of adverse events 6 (12%) in the group RA was lower than the group PA 25 (50%) [Mean difference 0.136 (95%CI, 0.049–0.377); P < 0.05], with no serious adverse events during the sedation procedure. The incidence of injection pain in group RA was significantly lower than that in group PA [4 vs. 26%, mean difference 0.119 (95%CI, 0.025–0.558); P = 0.004]. Before starting local anesthesia, the mean arterial pressure, heart rate, and respiratory rate of the PA group were lower than those of the RA group. None of the patients required further treatments for a decreased heart rate, blood pressure, or low SpO2. The rate of moderate sedation success was 100% in both groups. The MOAA/S score was similar between the groups indicating that the depth of sedation was effective. Group RA had significantly shorter recovery and discharge times than those of group PA.ConclusionsRemimazolam with alfentanil is a safer and more effective alternative for ambulatory sedation and can reduce recovery and discharge time and the incidence of perioperative adverse events compare with propofol.Clinical trial registrationhttp://www.chictr.org.cn/index.aspx, identifier: ChiCTR2200058106.

Comparison of the post-marketing safety profile between influenza and COVID-19 vaccines: An analysis of the vaccine adverse event reporting system

The global coronavirus disease (COVID-19) epidemic can be partially managed by vaccines; however, the public must be informed about the safety of COVID-19 vaccines to avoid hesitancy. Therefore, it is important to know the safety profile of the COVID-19 vaccine by comparison to that of a well-known vaccine, such as the influenza vaccine. Hence, this retrospective descriptive study was conducted to evaluate and compare the number of adverse effects (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS) for both COVID-19 and influenza vaccines, identify the most common AEs of each vaccine, and compare the frequency and outcomes of using COVID-19 and influenza vaccines in the U.S. population. Surveillance reports from 1st December 2020 to 8th October 2021 of both vaccines were retrieved from the U.S. VAERS. A total of 544,025 and 15,871 reports of post-COVID-19 and - influenza vaccine AEs were reported to the VAERS, respectively. Females reported > 58% and nearly 70% of influenza - and COVID-19 vaccine-associated AEs, respectively. The estimated incidence rates of AEs associated with COVID-19 and influenza vaccines in the U.S. were 1.36 and 0.12 per 1,000 persons, respectively. The incidence of AEs was higher among COVID-19 vaccine recipients than that among influenza vaccine recipients. COVID-19 vaccine recipients have a two-fold higher risk of mortality and life-threatening events than influenza vaccine recipients. However, most of the reported AEs were similar between the two vaccines in terms of symptoms.

Lamotrigine in the maintenance treatment of bipolar disorder.

Bipolar disorder is a chronic mental disorder with repetitive mania/hypomania as well as depressive episodes, which eventually results in marked impairment in overall functioning and health-related quality of life. A worldwide prevalence rate of 2.4% has been reported. The risk of suicide is higher in people with bipolar disorder than those with other mental disorders. Therefore, effective management of bipolar disorder in the maintenance period is warranted to minimizethe risk of relapse or recurrence. Although lithium has been the standard treatment of bipolar disorder for many years, it is associated with adverse effects and teratogenicity. Lamotrigine is approved to be expected for prevention of recurrence for the maintenance treatment of bipolar disorder. In addition, lamotrigine is as effective as lithium. Therefore, we performed a systematic review to confirm the efficacy and safety of lamotrigine in the maintenance treatment of bipolar disorder. To assess the efficacy and tolerability of lamotrigine in the maintenance treatment of bipolar disorder. We searched Ovid MEDLINE, Embase, PsycINFO, the Cochrane Common Mental Disorders Group's Specialized Register (CCMDCTR) and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception to 21 May 2021. We also searched international trial registries and contacted experts in the field. We included randomized controlled trials enrolling adults with bipolar disorder who were treated with lamotrigine, placebo or lithium. Two reviews authors independently checked the eligibility of studies and extracted data using a standardized form. Data extractedincluded study characteristics, participant characteristics, intervention details, settings, and outcome measures in the term of efficacy and tolerability. Study information were then entered into RevMan web. We included 11 studies with a total of 2314 participants in this review; 1146 were randomized to lamotrigine, 869 were randomized to placebo and, 299 to lithium. We rated all studies as having an unclear risk of bias in at least one domain of Cochrane's tool for assessing risk of bias, with the most commonly observed weaknessbeing selection bias (random sequence generation and allocation concealment). We judgedfive studies to be ata high risk of detection bias (blinding of outcome assessment). These potential biases pose as major threat to the validity of the included studies in this review. Outcomes of efficacy showed a possible advantage of lamotrigine over placebo. The estimated risk ratio (RR) for recurrence of manic symptom atoneyear as measured by the Young Mania Rating Scale (YMRS) was 0.67, (95% confidence interval (CI) 0.51 to 0.87; 3 studies, 663 participants; low-certaintyevidence) in favor of lamotrigine. The RR of clinical worsening with the need for additionalpsychotropic treatment(RR 0.82, 95% CI 0.70 to 0.98; 4 studies, 756 participants) based on moderate-certainty evidence. The possible benefits of lamotrigine were also seen for the outcome of treatment withdrawal due to any reason at 6-12 months after treatment(RR 0.88, 95% CI 0.78 to 0.99; 4 studies, 700 participants; moderate-certaintyevidence).Regarding tolerability, our analyses showed that the incidence rates of adverse effects were similar between the lamotrigine group and the placebo group(short-term effect: RR 1.07, 95% CI 0.81 to 1.42; 5 studies, 1138 participants; very low-certainty evidence;long-term effect: RR 0.97, 95% CI 0.77 to 1.23; 4 studies, 756 participants; moderate-certaintyevidence). In the comparison between lamotrigine and lithium, efficacy was similar between groups except for recurrence of mania episode at one year. Recurrence of manic symptoms was higher in the lamotrigine group than that of the lithium group (RR 2.13, 95% CI 1.32 to 3.44; 3 studies, 602 participants; moderate-certainty evidence). Analysis of adverse effects at 6-12 months showed that a lower proportion of participants experienced at least one adverse effect when treated with lamotrigine compared to lithium (RR 0.70, 95% CI 0.51 to 0.96; 4 studies, 691 participants; moderate-certainty evidence). Low- to moderate-certainty evidence collectively suggests that lamotrigine may be superior to placebo as a treatment modality for bipolar disorder. In comparison to lithium, people with bipolar disorder seem to tolerate lamotrigine better in the long run; however, the demonstrated efficacy in the maintenance of bipolar disorder was similar between the two groups.

Monitoring Adverse Effects of Antipsychotics and Antidepressants: A Population Based Study

Abstract: Aim: To monitor the nature and incidences adverse effects of both antipsychotics and antidepressants medicines in the psychiatry outpatient department. Objectives: Reporting the incidences of adverse effects and to establish the frequency of a specific class of drug. Identifying the system affected and the assessment of the management of the adverse effects by the physician. For the study, we have adopted Global Assessment Scale (GAS), Simpson-Angus Extra pyramidal Side Effects Scale (SAS) and The Antidepressant Side-Effect Checklist (ASEC). Materials and Methods: A prospective cohort study carried out in the psychiatry out-patient department. All the patients attending psychiatry outpatient department enrolled based on the pre-specified inclusion criteria and monitored for adverse effects. Causality also assessed by WHO-UMC causality assessment system and Naranjo Causality Assessment. Results: The incidence rate of adverse effects (46.07%) and 560 adverse effects documented. Weight gain (n=29, 9.2%) followed by drowsiness (n=27, 4.82%) are most commonly reported adverse effects. Atypical antipsychotics (n=279, 49.82%) were the most common class of psychotropic drugs implicated in adverse effects. Escitalopram (n=93, 37.80%) followed by olanzapine (n=53, 21.54%) associated with a maximum number of adverse effects. Central nervous system (n=225, 40.17%) was the most affected organ system followed by gastrointestinal system (n=130, 23.21%). Conclusion: Study revealed moderate incidences of adverse effects in patients attending the psychiatry outpatient department. Majority of the adverse effects reported during the study were mild in nature and not preventable. The role of a clinical pharmacist clearly elucidated regular intensive monitoring of adverse effects may improve the quality of patients’ care, reduction in the treatment cost and augmentation of the medication adherence among patients. Key words: Adverse effects, Pharmacovigilance, Antipsychotics, Antidepressants, Extra pyramidal side effects.

Comparable Efficacy and Safety of Teriflunomide versus Dimethyl Fumarate for the Treatment of Relapsing-Remitting Multiple Sclerosis.

Background The aim of this observational study is to investigate the efficacy and safety of two approved oral disease-modifying therapies (DMTs) in patients with remitting-relapsing multiple sclerosis (RRMS): dimethyl fumarate (DMF) vs. teriflunomide (TRF). Methods A total of 159 RRMS patients (82 on TRF and 77 on DMF) were included. The expanded disability status scale (EDSS), confirmed disability improvement (CDI), confirmed disability progression (CDP), and annualized relapse rate (ARR) were evaluated for the two-year period prior to enrollment in our study. The drug-associated adverse effects (AEs) were recorded. We conducted propensity matching score to compare the efficacy between TRF and DMF. Results After matching for the confounders, TRF- and DMF-treated groups were not different in terms of EDSS (P value = 0.54), CDI (P value = 0.80), CDP (P value = 0.39), and ARR (P value >0.05). TRF discontinuation occurred in 2 patients (2.43%) due to mediastinitis and liver dysfunction, while a patient (1.29%) discontinued DMF due to depression. Incidence rate of AEs in the TRF-treated group was 81.4%: hair thinning (hair loss) (62.9%), nail loss (20.9%), and elevated aminotransferase (14.8%) were the most common AEs; in DMF-treated patients, AEs were 88.2% with predominance of flushing (73.2%), pruritus (16.9%), and abdominal pain (16.9%). Conclusion Based on our findings, DMF is as efficacious and safe as TRF for the treatment of RRMS in our Iranian study population. Multicentric studies need to corroborate these findings in other populations.

Safety of apatinib plus S-1 for advanced solid tumor as palliative treatment.

The aim of the present study was to explore the safety of apatinib plus S-1 in treating advanced solid tumors after failure of two or more lines of chemotherapy. A total of 33 patients with advanced cancer treated between April 2016 to March 2019 were retrospectively analyzed. Of these, 13 patients had non-small cell lung cancer (NSCLC), 13 patients had SCLC, 4 patients had esophageal cancer and 3 had cervical cancer. All patients were treated with apatinib 250 mg once daily combined with S-1 60 mg/m2 twice daily for 14 days, repeated every 3 weeks. Adverse reactions were observed until aggravation of adverse reactions beyond the tolerable range or disease progression, and the survival rate and clinical benefits were calculated. The results suggested that the incidence rate of adverse effects (grade 3-4) was 45.5% (15/33). The top three severe adverse effects were hypertension (15.2%), thrombocytopenia (12.1%) and proteinuria (9.1%). A total of 2 patients with lung squamous-cell carcinomas died of severe pulmonary hemorrhage. Other adverse reactions were tolerated in the cohort. A total of 10 patients achieved partial response and the objective response rate was 30.3%. Furthermore, 13 patients achieved stable disease and 10 patients had progressive disease, and accordingly, the disease control rate was 72.7%. In conclusion, apatinib plus S-1 for advanced solid tumor patients as palliative treatment have a certain efficacy and was relatively safe but should be used with caution in patients with squamous-cell lung carcinoma and the efficacy and safety requires further assessment.

The Necessity of Clinical Rh Phenotypic Serological Detection and Homotypic Infusion in Patients with Repeated Blood Transfusion.

BackgroundThis study analyzed the distribution of Rh serological phenotype in people living in Hangzhou, China, and assessed the necessity of its routine clinical detection and homotypic infusion.Material/MethodsBlood donors and patients who might need blood transfusion were enrolled into the study, and ABO and 5 major Rh serological antigens (C, c, D, E, and e) were routinely detected. The consistent ABO and Rh serological phenotype blood was transfused between the blood donors and recipients. Irregular antibodies were screened and identified in patients before the blood transfusion. Then, the transfusion adverse effects were monitored and compared with the previous data in the hospital.ResultsThe phenotypic frequencies of Rh blood groups were D>C>E>c>e. The CCDee was the most common phenotype and CcdEe was the least common. The detection rate of unexpected antibodies gradually increased, while the unexpected antibodies slowly decreased in the Rh system. There was a correlation between the isotypic infusion of 5 Rh antigens and the detection rate of antibodies in the Rh system (R=0.845). The adverse effects of blood transfusion declined from 19.95% in 2011 with just homotypic ABO infusion to 3.098% in 2019 with the transfusion of homotypic ABO and the 5 major Rh serological antigens.ConclusionsThe consistency of the transfusion with ABO and 5 significant Rh serological antigens could prevent and decrease the high frequency production of isoantibodies, which is of vital importance in reducing the incidence rate of adverse effects in patients receiving transfusions.

Application of chronic illness trajectory model-based nursing interventions in patients undergoing radiotherapy after surgery for brain glioma

Objective To explore the applicability of chronic illness trajectory model-based nursing interventions in patients undergoing radiotherapy after surgery for brain glioma. Methods Totally 100 patients receiving radiotherapy after surgery for brain glioma in the Third People's Hospital of Hubei Province from January 2015 to January 2018 were selected and divided into observation (n=50) and control (n=50) groups according to the random number table. Patients in the control group received routine care, while patients in the observation group received nursing interventions based on the chronic illness trajectory model. Self-Anxiety Scale (SAS) , Self-Depression Scale (SDS) , Connor-Davidson Resilience Scale (CD-RISC) , Brief Fatigue Inventory (BFI) , European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QOL-C30) and Jalowiec Coping Scale (JCS) were used to measure negative emotions, mental resilience, cancer-related fatigue, coping style and quality of life of the patients in both groups, and the incidence rate of adverse effects after radiotherapy were compared between the two groups. Results The SAS and SDS scores in the observation group were (43.57±4.49) and (46.19±4.82) , lower than (52.04±5.31) and (53.16±5.47) in the control group. The CD-RISC score in the observation group was (71.38±7.29) , higher than (68.14±6.75) in the control group. There were statistically significant differences between the two groups (P<0.05) . The observation scored higher in terms of palliative care and avoidance and lower in self-dependence, optimism, seeking support and emotional catharsis in JCS than the control group (P<0.05) . The scores in physical function, emotional function, social function, role function and cognitive function in EORTC QOL-C30 and its total score were higher in the observation group than in the control group (P<0.05) . The incidence rate of adverse effects was 12.00% in the observation group, lower than 30.00% in the control group (P<0.05) . Conclusions Nursing interventions based on the chronic illness trajectory model can enhance mental resilience and quality of life in patients receiving radiotherapy after brain glioma surgery, ameliorate their negative emotions and cancer-related fatigue, improve their coping style, and reduce the incidence of adverse effects following radiotherapy. Key words: Neurological glioma; Radiotherapy; Quality of life; Mental resilience; Negative emotion; Cancer-related fatigue; Coping style; Chronic illness trajectory model

Effects of intelligent nursing and transfusion system on transfusion management in patients with growth hormone adenoma complicated with cardiomyopathy

Objective To evaluate the effects of the intelligent nursing and transfusion system on transfusion management in patients with growth hormone adenoma complicated with cardiomyopathy. Methods The patients with growth hormone adenoma complicated with cardiomyopathy treated in the Department of Neurosurgery in a ClassⅢ Grade A hospital from January 2018 to May 2019 were selected. Totally 78 patients receiving conventional transfusion management from January to October 2018 were included into the control group, while 70 patients admitted from November 2018 to May 2019 after the intelligent nursing and transfusion system was applied were included into the experimental group. The incidence rate of adverse effects in transfusion, correct rate of transfusion speed, incidence rate of arrhythmia and patients' compliant rate in terms of transfusion were evaluated between the two groups. Results The incidence rate of adverse effects in transfusion in the experimental group was 5.7%, lower than 16.7% in the control group. The correct rate of transfusion speed was 97.0% in the experimental group, higher than 89.3% in the control group, and there was statistically significant difference between the two groups (P 0.05) . The compliant rate about transfusion was 5.7% in the experimental group, lower than 16.7% in the control group, and there was statistically significant difference between the two groups (P<0.05) . Conclusions The intelligent nursing and transfusion system can improve transfusion management in clinical practice, which not only reduce the incidence rate of adverse effects in transfusion and improve the transfusion safety in patients with growth hormone adenoma complicated with cardiomyopathy, and also reduce the compliant rate about transfusion and improve patients' satisfaction. Key words: Growth hormone adenoma; Cardiomyopathy; Venous transfusion; Intelligent nursing and transfusion system; Transfusion management; Informatization

The clinical efficacy and safety of oral compound glycyrrhizin in adult patients with mild-to-moderate active alopecia areata: A randomized controlled study

IntroductionThe efficacy of the current therapy for alopecia areata (AA) remains unsatisfactory, due to disease recurrence and drug side effects. This study was designed to evaluate the clinical efficacy, recurrence rate, and safety of the new therapy with oral glycyrrhizin in adult patients with mild to moderate active AA. MethodsThis was a randomized controlled trial using two oral tablets of 25 mg glycyrrhizin three times per day (tid) for test group (65 patients), or two oral tablets of 25 mg cystine tid for the control (56 cases). Patients in both groups were also treated with topical 0.05% halometasone cream twice daily (bid). The treatment period was 24 weeks, including 12 weeks of active therapy, followed by another 12 weeks of observation. ResultsThe complete regrowth rate and total efficacy of the test group were significantly higher than the control group (16.92% vs. 5.36%, and 63.08% vs. 30.36%, p < 0.05). In particular, the total efficacy in glycyrrhizin-treated moderate or short-duration patients was significantly higher than the control (53.33% vs. 11.11%, and 72.70% vs. 26.47%, p < 0.05). During the follow-up period, the recurrence rate was 12.3% (8/65) in the test group, lower than that of the control. The incidence rate of adverse effects between the two groups was not statistically different (9.23% vs.10.71%, p > 0.05), and no severe adverse events were observed. ConclusionsGlycyrrhizin treatment is safe and effective for adult patients with mild to moderate active AA. This therapy has higher therapeutic efficacy in patients with moderate AA or short duration of the disease.

Efficacy and safety profile of intravenous tocilizumab versus intravenous abatacept in treating female Saudi Arabian patients with active moderate-to-severe rheumatoid arthritis

To compare the efficacy and safety of tocilizumab with those of abatacept in patients with active rheumatoid arthritis not responding to anti-tumor necrosis factor therapy. A prospective, open-label study was carried out on adult females with moderate-to-severe rheumatoid arthritis. Patients were randomly assigned to receive either intravenous tocilizumab or abatacept treatment. History taking, clinical examination, and laboratory evaluation were done at baseline and during a 24-week period of follow-up. Disease activity was calculated using the DAS28-ESR score. The incidence of accompanying adverse events was evaluated and all statistical analyses were performed by InStat. One hundred thirty-two patients were enrolled and classified randomly into the tocilizumab (n = 68) and abatacept (n = 64) groups. By week 24, the mean DAS28-ESR was significantly reduced in both groups (P < 0.0001) in association with significant reductions in CRP, ESR, and HAQ scores. No significant difference in the incidence rate of adverse effects appeared between both study groups. However, there were marked declines in the hemoglobin levels (P = 0.003) and neutrophil count (P = 0.002) together with significant elevations in systolic blood pressure (P = 0.002), liver enzymes (P = 0.001), total cholesterol (P = 0.001), and high-density lipoproteins (P = 0.002) in the tocilizumab group compared with the abatacept group. Both intravenous abatacept and tocilizumab significantly decreased the disease activity and improved the physical function in rheumatoid arthritis patients who failed to respond to anti-tumor necrosis factor therapy. Although the efficacy of both drugs was similar, abatacept showed a more promising short-term safety profile since it was associated with less adverse effects and better laboratory outcomes.

Effects of innovative nursing device on venipuncture in infusion children patients

Objective To explore the effects of innovative nursing device on reducing re-injection rates of venipuncture in infusion children patients. Methods Totally 480 children patients receiving transfusion admitted in the First People's Hospital of Shangqiu from October 2016 to March 2018 were selected and numbered according to the order of admission. Then they were divided into the control group (n=240) and the observation (n=240) according to the random number table. Patients in the control group were nursed with conventional nursing device, while patients in the observation group were treated with innovative nursing device. The effects of transfusion were compared between the two groups. Results The re-injection rate of venipuncture of the observation group was 6.33% (15/240) , the time of successful puncture was (1.19±0.33) min, and the incidence rate of adverse effects was 13.33% (32/240) , lower than those of the control group, the difference was statistically significant (P<0.05) . The nursing satisfaction of the observation group were better than those of the control group, the difference was statistically significant (P<0.01) . Conclusions Innovative nursing device can effectively reduce the re-injection of venipuncture in preschool children patients and improve nursing satisfaction and transfusion safety. Key words: Innovation and promotion; Children, preschool; Venepuncture; Re-injection rate; Nursing device

Efficacy and complications of intravesical instillation of BCG for prevention of recurrence of moderate and high-risk non muscle invasive bladder cancer

Objective To assess the efficacy and side effects of intravesical instillation of BCG after transurethral resection of the bladder tumor (TURBT) in non-muscle invasive bladder cancer (NMIBC) patients. Methods The clinical data of patients treated with BCG 120 mg per course induced perfusion or more after TURBT from December 2013 to October 2016 in 18 hospitals of northeast China region, were analyzed retrospectively. The first part, data of 106 patients with moderate, high-risk NMIBC were collected. A total of 83 patients were male, while the other 23 patients were female. The average age was 66.7 years old.The clinical staging were T1 in 86(81.1%) cases, Ta in 20(18.9%) cases and carcinoma in situ in 6(5.7%)patients. Intravesical instillation of BCG was executed after transurethral resection of the bladder tumor. The incidence rate of recurrence and progression during more than 6 months’ follow-up time were observed. Multivariate analyses were done by using logistic analysis and Cox proportional hazards regression model with Kaplan-Meier method. The second part, treatment compliance of 276 patients with bladder cancer, including moderate/high-risk NMIBC in 263 cases, moderate/high-risk NMIBC followed with renal pelvis/ureteral carcinoma in 8 cases were and moderate/high-risk NMIBC with renal pelvis/ureteral carcinoma in 5 cases who treated with BCG after the surgeries, were observed. Patients consisted of 211 males and 65 females with average age of 68.3 years. Results With a median follow-up of 12 months, 9(8.5%) patients experienced tumor recurrence and 2(1.9%)patients were found progression in the first part. The one-year cancer free recurrence rate of the patients was 91.5%. Statistically significant prognostic factors for recurrence identified by multivariable analyses were prior recurrence of the tumors (OR=3.214, 95%CI 0.804-12.845, P=0.099). In the second port, an incidence rate of adverse effects was 64.1% (177/276). The Ⅲ/Ⅳ degree complications were occurred in 11 patients and satisfactory outcomes achieved with active treatment. A total of 36 patients withdrawal with the major causes were recurrence and progression of bladder tumor in 12 cases (4.4 %), 9 cases (3.3 %) with economic reasons and 11 cases(4.0%)with serious complications. Conclusions NMIBC patients treated with intravesical BCG therapy have approving cancer free recurrence rates and acceptable adverse effects. Prior recurrence may be prognostic factor of recurrence after intravesical BCG therapy. Key words: Non-muscle invasive bladder cancer; Bacillus Calmette Guerin; Recurrence; Adverse effects

Multiinstitutional prospective observational study of stereotactic radiosurgery for patients with multiple brain metastases from non-small cell lung cancer (JLGK0901 study-NSCLC).

OBJECTIVEPrevious Japanese Leksell Gamma Knife Society studies (JLGK0901) demonstrated the noninferiority of stereotactic radiosurgery (SRS) alone as the initial treatment for patients with 5-10 brain metastases (BMs) compared with those with 2-4 BMs in terms of overall survival and most secondary endpoints. The authors studied the aforementioned treatment outcomes in a subset of patients with BMs from non-small cell lung cancer (NSCLC).METHODSPatients with initially diagnosed BMs treated with SRS alone were enrolled in this prospective observational study. Major inclusion criteria were the existence of up to 10 tumors with a maximum diameter of less than 3 cm each, a cumulative tumor volume of less than 15 cm3, and no leptomeningeal dissemination in patients with a Karnofsky Performance Scale score of 70% or better.RESULTSAmong 1194 eligible patients, 784 with NSCLC were categorized into 3 groups: group A (1 tumor, n = 299), group B (2-4 tumors, n = 342), and group C (5-10 tumors, n = 143). The median survival times were 13.9 months in group A, 12.3 months in group B, and 12.8 months in group C. The survival curves of groups B and C were very similar (hazard ratio [HR] 1.037; 95% CI 0.842-1.277; p < 0.0001, noninferiority test). The crude and cumulative incidence rates of neurological death, deterioration of neurological function, newly appearing lesions, and leptomeningeal dissemination did not differ significantly between groups B and C. SRS-induced complications occurred in 145 (12.1%) patients during the median post-SRS period of 9.3 months (IQR 4.1-17.4 months), including 46, 54, 29, 11, and 5 patients with a Common Terminology Criteria for Adverse Events v3.0 grade 1, 2, 3, 4, or 5 complication, respectively. The cumulative incidence rates of adverse effects in groups A, B, and C 60 months after SRS were 13.5%, 10.0%, and 12.6%, respectively (group B vs C: HR 1.344; 95% CI 0.768-2.352; p = 0.299). The 60-month post-SRS rates of neurocognitive function preservation were 85.7% or higher, and no significant differences among the 3 groups were found.CONCLUSIONSIn this subset analysis of patients with NSCLC, the noninferiority of SRS alone for the treatment of 5-10 versus 2-4 BMs was confirmed again in terms of overall survival and secondary endpoints. In particular, the incidence of neither post-SRS complications nor neurocognitive function preservation differed significantly between groups B and C. These findings further strengthen the already-reported noninferiority hypothesis of SRS alone for the treatment of patients with 5-10 BMs.

Application of quality control circle activities in preventing adverse effects of subcutaneous injection in patients with cardiovascular disease

Objective To explore the value of quality control circle (QCC) activities in predicting the adverse effects of low-molecular-weight heparin by subcutaneous injection in patients with cardiovascular disease. Methods The clinical data of totally 300 patients with cardiovascular disease (conventional nursing group) who received low-molecular-weight heparin by subcutaneous injection before QCC activities were carried out (from October 2015toApril 2016) and another 300 patients (QCC group) receiving low-molecular-weight heparin by subcutaneous injection after QCC activities were carried out (from May 2016toNovember 2016) in Nanyang City Center Hospital were retrospectively collected. The incidence rate of adverse effects of subcutaneous injection were compared before and after QCC activities, the average length of hospital stay, total expense and the number of compliant were compared between the two groups. Results The incidence rates of adverse effects of low-molecular-weight heparin by subcutaneous injection in QCC group and conventional nursing group were 1.0% and 8.0%, respectively (χ2=17.103, P<0.001) . The average length of hospital stay and total expense were (10.5±2.1) d and (5 134.8±268.4) yuan, respectively, which both were lower than those of conventional nursing group (t=10.067, 33.563; P<0.001) . There was no compliant due to adverse effects of low-molecular-weight heparin by subcutaneous injection in QCC group, whereas there were 12 complaints in conventional nursing group (P<0.05) . Conclusions QCC activities are valuable to some extent in preventing adverse effects of low-molecular-weight heparin by subcutaneous injection. Key words: Injection, subcutaneous; Quality control circle; Department of Cardiovascular Medicine; Low-molecular-weight heparin; Adverse effect

Efficacy and safety of cholecalciferol-augmented anti-tuberculosis therapy for treatment of naïve patients with pulmonary tuberculosis: A randomized, controlled, clinical study

Background/objectiveVitamin D deficiency may contribute to the therapeutic failure of antituberculosis therapy (ATT). The aim of this study is to explore the role of adding cholecalciferol to the standard ATT in improving the therapeutic outcome among the naïve patients with pulmonary tuberculosis (TB). MethodsA randomized, controlled, clinical study, which included 496 naïve patients with pulmonary TB, was carried out. The patients were randomly allocated to two groups. Group-A included 247 patients who received ATT, while group-B included 249 patients who received ATT with cholecalciferol. ResultsThe rate of therapeutic failure among the study population was 29.4%; it was significantly lower among patients of group-B compared to those of group-A (22.1% (95% CI 14.7–26.2) vs 38.1% (95% CI 31.5–46.1), p 0.036). In addition, the rate of early therapeutic response was significantly higher among patients of group-B compared to those of group-A (35.3% (95% CI 29.6–42.3) vs 19.4% (95% CI 15.1–24.6), p 0.041). Incidence rate of adverse effects was 19.3%; it was higher (although not statistically significant) among patients of group-A compared to those of group-B (21.9% vs 16.9%). ConclusionsIn conclusion, cholecalciferol-augmented ATT can be more efficacious in treating naïve patients with pulmonary TB compared to the standard ATT. In addition, adding vitamin D3 to ATT provides extra protection against the hepatic and muscular adverse effects of ATT.

Tepid massage for febrile children: A systematic review and meta-analysis.

This study aimed to examine the effect of tepid massage in febrile children comparing with other fever management. Experimental studies published in English were included; quasi-experimental research studies were also included in consideration of rare experimental studies in Korean. The search strategy sought to identify published research reports in the English language and covered all major databases up to 2016. The methodological quality of each study was assessed by 2 independent reviewers using a Scottish Intercollegiate Guidelines Network's Methodology Checklist. Means and standard deviations were used for continuous variables, and standardized mean difference was used for variables of different scales. Heterogeneity was assessed using the I2 statistics after visual reviewing with forest plots. This study reviewed mainly the effect of tepid massage on temperature compared with the use of antipyretics, along with other adverse effects in relation with fever management. The results revealed no significant effect of tepid massage on temperature in febrile children. In addition, incidence rates of adverse effects including chills, goose pimples, and discomfort were higher in tepid massage groups. This meta-analysis showed the need for re-verification of commonly used practice including the use of tepid massage and proper body temperature measurement.

Clinical efficacy and safety of escitalopram in the treatment of depressed elderly patients with insomnia

Objective To investigate the clinical efficacy and safety of escitalopram in the treatment of depressed elderly patients with insomnia. Methods According to the digital table, 60 depressed elderly patients with insomnia were selected and randomly divided into the control group and the observation group, 30 cases in each group.The control group was treated by citalopram, the observation group was treated by escitalopram, the two groups were treated for 8 weeks.The depression and sleep quality were tested by HAMD and PSQI before and after treatment, and the incidence of adverse reactions and the total clinical efficacy were compared between the two groups in the same time. Results Compared with pre-treatment, the HAMD scores in the control group and observation group were decreased from (26.76±3.47)points and (26.53±3.44)points to (13.48±1.36)points and (18.25±2.15)points respectively; the PSQI scores were decreased from (26.76±3.47)points and (26.53±3.44)points to (13.48±1.36)points and (18.25±2.15)points respectively, and the differences were statistically significant(all P<0.05). After treatment, compared with the control group, the HAMD score(t=10.270, P=0.000) and PSQI score(t=-7.712, P=0.000) in the observation group were significantly lower.The incidence rate of adverse effects was lower(χ2=0.425, P=0.935) and the total effective rate was higher, but without statistically significant differences(χ2=2.785, P=0.426). Conclusion Escitalopram can improve the depression of elderly depression patients with insomnia, improve sleep quality with high safety. Key words: Depressive disorder; Sleep initiation and maintenance disorders; Escitalopram; Middle aged; Aged