Adverse Effects In Groups Research Articles

Evaluation of the therapeutic efficacy of high-intensity focused ultrasound ablation combined with different drugs in the treatment of adenomyosis

Objectives To observe the therapeutic efficacy of high-intensity focused ultrasound (HIFU) combined with different pharmacological treatments for adenomyosis. Materials and methods A total of 126 patients with adenomyosis who underwent HIFU combined with pharmacological treatment were retrospectively reviewed. Patients were treated with either dienogest (DNG) (Group A, N = 38) or GnRH-a (Group B, N = 88) for three months after HIFU, and received levonorgestrel-releasing intrauterine systems (LNG-IUS) at the end of the third month. Visual Analog Scale (VAS) and Pictorial Blood Loss Assessment Chart (PBAC) scores were used for evaluating symptom improvement. Results After propensity score matching (1:2), 38 patients were included in Group A and 76 in Group B. All patients showed significant improvement in VAS and PBAC scores after HIFU, but the PBAC score of Group A was significantly higher than that of patients in Group B at 18 months [11.50 (1.00, 29.50) vs. 0.00 (0.00, 16.50), p < 0.01] and 24 months [4.00 (0.25, 27.75) vs. 0.00 (0.00, 12.75), p = 0.04] after HIFU. Furthermore, patients in Group B had a greater uterine volume reduction at 24 months after HIFU than that of patients in Group A [51.00 (27.00, 62.00) vs. 30.00 (17.00, 42.75, p = 0.02)]. However, the adverse effects in Group A were lower than those in Group B [7 (15.79) vs. 35 (46.05), p < 0.01]. No significant difference was observed in the recurrence rate between the two groups. Conclusions HIFU combined with DNG and LNG-IUS is a safe and effective treatment for patients with adenomyosis.

Group 5 Pulmonary Hypertension: Multiple Systemic Diseases, Multiple Mechanisms of Pulmonary Hypertension, and Multiple Management Challenges

: Group 5 pulmonary hypertension (PH) with unclear and/or multifactorial mechanisms includes a wide variety of conditions associated with PH, and the mechanisms by which PH develops vary dramatically depending on the underlying condition. Indeed, in many group 5 conditions, such as sarcoidosis, multiple distinct drivers of PH are present concurrently in a single patient, with the predominant factor depending on the predisposing disease phenotype. For this reason, thorough diagnostic evaluation to most accurately phenotype every patient with group 5 PH is essential. Treatment of these patients should begin by fully characterizing and optimizing the management of their underlying disease, often in conjunction with disease experts. Initial targets of PH treatment include identifying and correcting factors that worsen PH, such as volume overload and hypoxemia, as well as a complete PH evaluation, searching for other undiagnosed causes of PH (e.g., congenital heart disease or chronic thromboembolic disease). Data to guide treatment with therapies specific to pulmonary arterial hypertension (PAH) are inadequate for any specific recommendations, and adverse effects in group 5 patients are common. If these therapies are considered, evaluation by a multidisciplinary team that includes a PH specialist is recommended. Factors in the selection of PAH therapies should include consideration of the dominant physiologic features of the underlying disease, the severity of hemodynamic and right ventricular abnormalities, the risk of adverse drug effects, and any known contraindications to PAH-specific medications based on the underlying condition. Vigilant monitoring following initiation of PAH-specific therapy is critical, as the clinical effects are hard to predict, and untoward events, such as uncovering pulmonary veno-occlusive disease, may occur. Collaborative care by a multidisciplinary team of experts is key to the management of this challenging patient population.

COMPARISON OF SAFETY AND EFFICACY OF ORAL PROGESTERONE WITH LEVONORGESTREL INTRAUTERINE SYSTEM IN MANAGEMENT OF DYSFUNCTIONAL UTERINE BLEEDING

The retrospective study was conducted in the Department of Obstetrics and Gynaecology, Nishtar Medical Hospital, Multan, to compare the safety and efficacy of oral progesterone and levonorgestrel-releasing intrauterine system (LNG-IUS) for the management of DUB. The study was conducted on 90 patients who fulfilled the inclusion criteria. Participants were randomly divided into groups A (LNG-IUS) and B (oral progesterone). The primary outcomes were Pictorial blood loss assessment chart (PBAC) scores. Secondary outcomes were the evaluation of adverse effects and Hb levels. A comparison of the mean PBAC score showed that LNG-IUS significantly reduced PBAC scores (P&lt; 0.0001). Comparison of post-treatment HB levels showed that LNG-IUS significantly increased Hb level, and the difference between both groups was statistically significant (P&lt; 0.0001). After 6 months, the incidence of adverse effects in group B was 60%, while in group A was 40%. However, hypomenorrhea was more prevalent in group A. It can be concluded that LNG-IUS is a more effective and safe treatment choice for Dub compared to oral progesterone.

Application of a topical collagen agent after tooth extraction to control hemostasis should be immediate and not delayed: a comparative randomized trial

Objective: The main objective was to demonstrate that the delay of placement of a collagen-based hemostatic cylindrical dressing, here ETIK COLLAGENE, affects postoperative bleeding. Other objectives were to evaluate the safety of this medical device. Material and methods: 38 patients under antithrombotic treatment and consulting for tooth extraction were included. The antithrombotic treatment was maintained. Patients were randomized: In group 1: the hemostatic dressing ETIK COLLAGENE was applied immediately after the tooth extraction and curettage; the surgeon assessed the presence of bleeding (Yes/No) every 30 s up to a total time of 8 min, then he sutured. In group 2: the bleeding was assessed every 30 s up to a total time of 8 min immediately after the tooth extraction and curettage, then the surgeon placed ETIK COLLAGENE before suturing. Seven days later, patients were asked about the occurrence of bleedings and adverse events. Results: The mean bleeding time after tooth extraction was of 1:13 ± 0:49 (min: sec) and 3:39 ± 3:06 respectively in the group 1 and in the group 2; the difference between groups is 2:26 (95% CI [0:52 – 4:01]) in favor to the group 1 (p = 0.0144). There were significantly more adverse effects in group 2. Conclusions: The delay in placement of ETIK COLLAGENE after extraction has an impact on bleeding time and postoperative adverse events: these parameters are reduced in a statistically significant way when the placement is performed immediately after the end of the curettage rather than after an 8 min delay.

Short-term stretched penile length analysis for subsequent erectile dysfunction after robotic-assisted radical prostatectomy with bilateral neurovascular bundle preservation

ABSTRACT Introduction Stretched Penile Length (SPL) is observed to shrink after radical prostatectomy (RP) and has chances resuming the length as long as 12 months. Objective To assess the short-term SPL change from patients after robotic-assisted radical prostatectomy (RARP) with bilateral neurovascular bundle (NVB) preservation and experiencing subsequent erectile dysfunction (ED). Effects from tadalafil, post-operative androgen deprivation therapy (ADT), and no medication or intervention are compared. Methods From April to December 2018, patients developing ED (IIEF-5&amp;lt;22) after RARP with bilateral NVB preservation were included. SPL was measured as length from pubic symphysis to external urethral opening. Tadalafil 5 mg once daily (Group 1), postoperative ADT (Group 2) and control group (Group 3) were classified. Postoperative ADT was prescribed during the whole periods of 6 months for surgical adverse effects in group 2. Follow-ups were arranged 2 weeks after operation in the first time, and then every month up to 6 months. Student t test, chi-square test and SAS 9.4 were utilized to see if significant difference when p&amp;lt;0.05. Results With 64 men, 1 was excluded for preoperative ADT use. SPL-related comparisons were listed at Table 1. Preoperative SPL was measured without differences. Generally, in 6-month span, more men were with increased SPL in group 1 than in group 3, and also more with deterioration compared to group 3 (p=0.048). Same trend was observed in group 2 compared to group 3 (p=0.036). Men in group 1 (at the time deciding to take tadalafil) experienced a worse shortening SPL than group 3 (the 30–day change after operation) (p&amp;lt; 0.0001). Significantly improvement on SPL between before (7.93±1.89 (median: 7.5) cm) and after (8.59±2.17 (median:9) cm) tadalafil in group 1 (p=0.037) and also significantly improved against the SPL change from post-operative 30-day to 5-month of group 3 (p=0.004). Conclusions In our analysis, 63.7% of subsequent ED after RARP with bilateral NVB preservation would experience SPL shortening around 3 cm (around 30% of preoperative SPL) if only observation in 6 months after operation. Postoperative ADT for 6 months would contribute to approximately additional 15% shortening rates with the same degree. Significant improvement around 1 cm (around 10% of the preoperative SPL) on SPL was observed after tadalafil 5 mg once daily with median 4-month prescription. Disclosure Work supported by industry: no.

The Added Value of Postoperative Neurotrophins/Peptide Mixture in Treating L5 Motor Weakness in Lumbar Disc Prolapse: A Preliminary Report of Multicenter Randomized Controlled Study

Background Data: Neurotrophins/peptide mixture is a porcine brain-derived peptide preparation with pharmacodynamic properties similar to those of endogenous neurotrophic factors. No study has evaluated the postoperative role of neurotrophins/peptide mixture in the recovery of postdiscectomy motor weakness. Purpose: This study aims to evaluate the effect of postoperative neurotrophins/peptide mixture treatment on the recovery of L5 motor weakness after lumbar discectomy compared to placebo. Study Design: Prospective randomized controlled study (preliminary report). Patients and Methods: In total, 15 patients (group I) with L5 weakness who received a postdiscectomy adjuvant neurotrophins/peptide mixture were compared to group II (15 postdiscectomy patients with L5 weakness) treated with a placebo. The whole patient population was followed up at 2 weeks, 1, 3, and 6 months, and 1 year for assessment of motor recovery. Results: The mean postoperative MRC score was significantly improved in both groups; however, the improvement was faster in group I than in group II. The mean MRC score improvement was significantly higher in group I than that in group II at 2 weeks and 1, 3, and 6 months; however, it was statistically insignificant at 1 year. At 1-year follow-up, 80 % of cases in group I had improved motor power up to grade 5 compared to 40 % of cases in group II. The rest of the patients reached grade 4 in both groups. There was no motor deterioration after improvement in either group. There were no reported drug-related adverse effects in group I. Conclusion: Neurotrophins/peptide mixture may be an efficient and safe adjunctive postoperative treatment for discogenic L5 motor weakness. It may accelerate recovery of nerve injury in an acute setting, which may be a result of accelerating nerve regeneration; however, the overall improvement was comparable to placebo. (2022ESJ2601)

Comparison of Caudal Bupivacaine and Bupivacaine-tramadol Combination for Postoperative Analgesia in Children Undergoing Lower Abdominal Surgeries

Objective: The aim of current study is to determine the effectiveness of caudal bupivacaine and bupivacaine-tramadol combination for postoperative analgesia in children undergoing lower abdominal surgeries. Study Design: Randomized Control trial Place and Duration: Department of Anesthesiology Surgical ICU &amp; Pain Management Ghulam Muhammad Mahar Medical College, Sukkur and Lahore General Hospital, Lahore, during the period from March 2021 to August 2021. Methods: There were 110 children of both genders with ages 2-8 years undergoing lower abdominal surgery were included in this study. A detailed demographics of enrolled patients, including age, sex, and weight were computed after obtaining informed written consent from each individual. Patients were equally divided in two groups. Group I had 55 patients and received combination of tramadol (1 mg/kg) and bupivacaine (0.5 ml/kg of 0.25%) and group II received only bupivacaine 0.5 ml/kg of 0.25% after induction of anesthesia in caudal epidural space. Post-operatively pain score, requirement of rescue analgesia and sedation score was assessed and compared among both groups. SPSS 24.0 was used to analyze complete data. Results: There majority males 35 (63.6%) in group I and 32 (58.2%) in group II. In group I mean age of the patients was 5.9±4.61 years and in group II mean age were 4.8±9.44 years. Mean weight of the patients in group I was 17.6±4.52 kg and in group II mean weight was 19.5±7.34 kg. During the first 24 hours, we noticed a reduced pain score in the bupivacaine–tramadol group. When it comes to postoperative analgesia, the bupivacaine-tramadol group had much longer analgesia durations and a significantly lower need for rescue analgesia with p value &lt;0.003. Postoperative frequency of adverse effects in group II was greater found in 4 (7.3%) cases as compared to group I in 1 (1.8%) patients. Conclusion: In children having abdominal surgery, we found that caudal tramadol with bupivacaine provided more extended and better quality postoperative analgesia than plain bupivacaine. Keywords: Tramadol, Bupivacaine, Abdominal Surgery, Pain Score, Rescue Analgesia

Clinical effects of two different doses of duloxetine compared to conventional analgesic therapy in patients with osteoarthritis knee

Background: Pain is the leading symptom of knee osteoarthritis (OA) leading to significant morbidity and decreased quality of life. Duloxetine, a selective serotonin norepinephrine reuptake inhibitor, has been demonstrated to have a centrally acting analgesic effect. Aims and Objectives: To evaluate the efficacy and safety of two different doses of duloxetine and compare with conventional pharmacotherapy in treatment of chronic pain due to osteoarthritis of knee. Materials and Methods: 90 patients with symptomatic knee OA were randomly divided into 3 groups to receive duloxetine 40 mg &amp; 3g paracetamol/day (Group A), duloxetine 20 mg &amp; 3g paracetamol/day (Group B) and paracetamol 3gm/day (Group C). Patients were followed up for 6 months to assess pain relief and functional improvement. Visual Analogue Scale (VAS) for assessing pain intensity and Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire physical function subscale for assessing physical function were used. Results: Reduction in VAS score from baseline was significantly high in groups A and B as compared to C at 1 month, 3 months and 6 months. Reduction in WOMAC score from baseline were also significantly high in groups A and B as compared to C at 1 month, 3 month and 6 months. Adverse effects in Group A were significantly high as compared to group B and C. Patients discontinuing due to adverse effects were significantly high in group A. Conclusion: Lower dose of duloxetine is associated with significant pain reduction and improved function with lesser adverse effects in patients with pain due to knee OA.

A Herbal Formula in the Therapy of Acute Postviral Rhinosinusitis.

Objective:To assess the effects and adverse events of preparation Sinulan forte® containing extracts of five medicinal plants in comparison to mometasone furoate nasal spray (MFNS) in therapy of acute postviral rhinosinusitis (APRS).Methods:We included 46 APRS patients in this prospective investigation and randomized to two groups. The patients in group 1 (n=23) received MFNS 200 μg two times/day for ten days, and patients in group 2 (n=23) received Sinulan forte®, tablets 225 mg per os, two times/day also for ten days. We evaluated the total symptom score (TSS), the separate scores for individual symptoms (nasal congestion, rhinorrhea, postnasal discharge, facial pain, impaired sense of smell), the quality-of-life outcome, and the findings from nasal endoscopy (edema of the nasal mucosa, nasal secretion) prior and after the therapy.Results:Significantly lower absolute post-treatment scores and better relative improvement were identified for TSS, nasal congestion, facial pain, loss of the sense of smell, edema of the mucosa and nasal secretion in patients receiving herbal preparation (group 2). However, lower absolute post-treatment score and better relative improvement were found for rhinorrhea and postnasal drip in group 1. Clinically important differences were found regarding the TSS and endoscopic findings, with no adverse effects in group 2, but in group 1 two patients had mild nasal bleeding and two had sensation of dryness in the nasal mucosa.Conclusion:Herbal product Sinulan forte® can be a safe and effective treatment for APRS. Our results suggest no adverse events of this herbal preparation in comparison to intranasal corticosteroid spray therapy.

Iontophoretic delivery of methotrexate in the treatment of palmar psoriasis: A randomised controlled study.

Palmoplantar psoriasis is a localised variant of psoriasis. Topical therapy is the preferred treatment modality, but in severe and recalcitrant cases, systemic drugs like methotrexate are prescribed, with potential for significant adverse effects. Iontophoresis is gaining popularity in enhancing the transdermal delivery of drugs in ionic state. This study was undertaken to evaluate and compare the efficacy of topical methotrexate by iontophoresis technique with clobetasol propionate 0.05% ointment in the treatment of palmar psoriasis. This was a prospective randomised controlled study conducted on patients with palmar psoriasis. Group 1 patients (n=31) were treated with once weekly iontophoretic delivery of methotrexate over 6 sittings, and group 2 patients (n=31) were treated with clobetasol propionate 0.05% ointment, twice daily for 6weeks. Severity of palmar psoriasis was assessed by modified Palmoplantar Pustular Psoriasis Area and Severity Index (m-PPPASI), and treatment was considered as satisfactory when there was >50% improvement. Sixty two patients were recruited, of which 50 completed the study. Eight out of 25 (32%) patients in group 1 and 12 out of 25 (48%) patients in group 2 showed satisfactory improvement at the end of 6weeks. However, this difference was statistically not significant (P=0.25). Burn injury was noted in 12 (48%) group 1 patients with no adverse effects in group 2. Iontophoretic delivery of methotrexate is a promising therapeutic modality, the efficacy of which is comparable to that of clobetasol propionate ointment in the treatment of palmar psoriasis.

P.803 The effect of CACNA1C genotype on CACNA1C methylation and the association with cortisol release and perceived stress

Dose–effect and dose–response assessments are important to the overall risk assessment process by providing a quantitative estimation of the relationship between dose/exposure and the occurrence of adverse effects from human exposure to metallic species. This chapter defines the concepts of dose–effect and dose–response relationships, discusses the importance of identifying the critical effect and estimates the critical concentration for toxicity in the critical organ. It further describes how to use these concepts in quantitation of the overall relationship between external exposure, internal exposure/dose, and the likelihood of occurrence of adverse effects in groups or populations. This chapter gives definitions of the no-observed-adverse-effect level, benchmark dose, and its lower confidence limit, which are important concepts in risk assessment. It further describes various approaches to estimate a low (acceptable) risk to humans, based on experimental and epidemiological data. The chapter gives special emphasis on quantitative estimation of dose–response relationships based on the mechanism of action and toxicokinetic and toxicodynamic modeling and describes results of such modeling in terms of dose–response curves. It includes discussions of the use of adverse outcome pathways.

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.

Efficacy of patient-controlled intravenous analgesia with hydromorphone hydrochloride plus flurbiprofen axetil after endoscopic sinus surgery

Objective: To evaluate the efficacy of patient-controlled intravenous analgesia (PCIA)with hydromorphone hydrochloride plusflurbiprofen axetil after endoscopic sinus surgery(ESS). Methods: One hundred patients of American Society of Anesthesiologists physical status Ⅰ or Ⅱ, scheduled for ESS under total intraveous anesthesia with postoperative PCIA in Beijing Tongren Hospital from October 2015 to April 2016 were randomly divided into 3 groups according to the different formula of PCIA pumpin each group: Group A (hydromorphone hydrochloride 1 μg·kg(-1)·h(-1)+ flurbiprofen axetil 200 mg), Group B(hydromorphone hydrochloride 2 μg·kg(-1)·h(-1)), Group C( hydromorphone hydrochloride 1 μg·kg(-1)·h(-1)). The dosage of PCIA in each group was calculated for 50 h, and was diluted in 100 ml normal saline. All the pump was set up background infusion at a rate of 2 ml/h with a 2 ml bolus dose and a 15 min lock-time.Visual analogue scale (VAS) and Ramsay sedation scores at time points of postoperative 1, 4, 8, 12, 24, 48 h, the number of attempts to press bolus and rate of adverse effects within 48 h were recorded. The differences were compared among the groups. Results: VAS at postoperative 1, 4, 8, 12 h in Group A was (1.9±0.6), (1.8±0.6), (1.6±0.6), and (1.2±0.4) respectively, in Group B was (1.8±0.4), (1.7±0.7), (1.6±0.6), and (1.3±0.5) respectively, in Group C was (2.5±0.9), (1.7±0.7), (1.6±0.6), and (1.3±0.5) respectively. The difference among each group were statistically significant (F=8.661, 3.105, 4.903, 13.846, P<0.05). VAS in Group A was similar to that in Group B(P>0.05), but was lower than that in Group C(P<0.05). The number of attempts to press bolus within 48 h in group A was 1.4±1.0, which was less than in Group C(2.2±1.8 , P<0.05). Ramsay sedation score at postoperative 1, 4, 8 h in Group A was (2.4±0.6), (2.2±0.6), and (2.2±0.4) respectively, in Group B was (2.8±0.7), (2.6±0.7), and (2.4±0.6) respectively, in Group C was (2.3±0.6), (2.1±0.4), and (2.1±0.2) respectively. The difference among each group were statistically significant (F=5.660, 6.782, 7.141, P<0.05). Ramsay sedation score in group A was similar to that in Group C(P>0.05), but was lower than that in Group B(P<0.05). The total rate of adverse effects in Group A was 8.8%, which was similar to that in Group C (9.1%, χ(2)=0.001, P>0.05), but was significantly lower than that in Group B (42.5%, χ(2)=9.99, P<0.05). Conclusion: 1 μg·kg(-1)·h(-1) hydromorphone hydrochloride plus 200 mg flurbiprofen axetil is effective on PCIA for patients after ESS and can reduce the dosage of hydromorphone hydrochloride and the rate of adverse effects as well.

Chronic stress is associated with reduced circulating hematopoietic progenitor cell number: A maternal caregiving model

BackgroundChronic psychological stress is a risk factor for cardiovascular disease and mortality. Circulating hematopoietic progenitor cells (CPCs) maintain vascular homeostasis, correlate with preclinical atherosclerosis, and prospectively predict cardiovascular events. We hypothesize that (1) chronic caregiving stress is related to reduced CPC number, and (2) this may be explained in part by negative interactions within the family. MethodsWe investigated levels of stress and CPCs in 68 healthy mothers – 31 of these had children with an autism spectrum disorder (M-ASD) and 37 had neurotypical children (M-NT). Participants provided fasting blood samples, and CD45+CD34+KDR+ and CD45+CD133+KDR+ CPCs were assayed by flow cytometry. We averaged the blom-transformed scores of both CPCs to create one index. Participants completed the perceived stress scale (PSS), the inventory for depressive symptoms (IDS), and reported on daily interactions with their children and partners, averaged over 7 nights. ResultsM-ASD exhibited lower CPCs than M-NT (Cohen’s d=0.83; p⩽0.01), controlling for age, BMI, and physical activity. Across the whole sample, positive interactions were related to higher CPCs, and negative interactions to lower CPCs (allp’s<0.05). The adverse effects of group on CPCs were significantly mediated through negative interactions with the child (indirect β=−0.24, p⩽0.01). In the full model, greater age (β=−0.19, p=0.04), BMI (β=−0.18, p=0.04), and negative interactions with the child (β=−0.33, p<0.01) were independently associated with lower CPCs. M-ASD had a less healthy lipid profile (total cholesterol/HDL), which in turn, was associated with lower CPCs. ConclusionsChronic stress adversely impacts CPC number, an early-stage biomarker that predicts subclinical atherosclerosis and future CVD events, independent of traditional cardiovascular risk factors and inflammatory factors. Among maternal caregivers, child-related interpersonal stress appears to be a key psychological predictor of stress-related CVD risk.

Long term effect and safety of Wharton's jelly-derived mesenchymal stem cells on type 2 diabetes.

Cellular therapies offer novel opportunities for the treatment of type 2 diabetes mellitus (T2DM). The present study evaluated the long-term efficacy and safety of infusion of Wharton's jelly-derived mesenchymal stem cells (WJ-MSC) on T2DM. A total of 61 patients with T2DM were randomly divided into two groups on the basis of basal therapy; patients in group I were administered WJ-MSC intravenous infusion twice, with a four-week interval, and patients in group II were treated with normal saline as control. During the 36-month follow-up period, the occurrence of any adverse effects and the results of clinical and laboratory examinations were recorded and evaluated. The lack of acute or chronic adverse effects in group I was consistent with group II.. Blood glucose, glycosylated hemoglobin, C-peptide, homeostasis model assessment of pancreatic islet β-cell function and incidence of diabetic complications in group I were significantly improved, as compared with group II during the 36-month follow-up. The results of the present study demonstrated that infusion of WJ-MSC improved the function of islet β-cells and reduced the incidence of diabetic complications, although the precise mechanisms are yet to be elucidated. The infusion of WJ-MSC may be an effective option for the treatment of patients with type 2 diabetes.

Enteral nutrition before bowel preparation improves the safety of colonoscopy in the elderly

Adverse events during colonoscopy are more likely to occur in elderly. To avoid the adverse events without decreasing the bowel cleanliness is still an unsolved problem. The aim of this study was to determine the effect of enteral nutrition before colonoscopy in a randomized controlled trail. A total of 108 patients over sixty-five years of age and indicated for colonoscopy were randomized into four groups. Group 1 received a solution of two packages of polyethylene glycol electrolyte powder dissolved in 2000 mL water. Group 2 received 500 mL of enteral nutrition plus polyethylene glycol of the same dosage as in group 1. Group 3 received 200 mL of 25% magnesium sulfate solution. Group 4 received 500 mL of enteral nutrition plus 25% magnesium sulfate solution of the same dosage as in group 3. The intestinal cleaning and various physiological indications were measured before, after bowel preparation, and during colonoscopy. No significant difference in the quality of colon cleansing was found among the four groups. The incidence of adverse effects in groups 2 and 4 was less than in groups 1 and 3. Additional enteral nutrition in elderly patients before bowel preparation did not affect the quality of colon cleansing. However, the process can significantly reduce the incidence of adverse effects.

Efficacy and Safety of Adjunctive Zonisamide in Adult Patients with Refractory Partial-Onset Epilepsy

Clinical studies have reported that zonisamide is effective for a wide range of seizure types, including refractory partial-onset seizures. However, there have been no reported studies of the efficacy of zonisamide in the Chinese population to date. The aim of the present study was to evaluate the efficacy and safety of zonisamide in the treatment of adult Chinese patients with refractory partial-onset epilepsy. This was a randomized, double-blind, placebo-controlled trial conducted over a 16-week period. 104 patients with refractory partial-onset epilepsy were enrolled. Participants were randomly assigned to receive add-on zonisamide or placebo. Zonisamide was titrated to a target dosage of 300 or 400 mg/day. Seizure frequency and adverse effects were documented. 102 patients completed the trial. Zonisamide showed significantly greater efficacy compared with placebo (responder rate 55.8% vs 36.0%, p<0.05), including 55.2% (16 of 29 patients) in the zonisamide 300 mg/day arm and 56.5% (13 of 23 patients) in the zonisamide 400 mg/day arm. Zonisamide 300 and 400 mg/day showed similar efficacy (p>0.05). Moreover, similar efficacy of zonisamide was found in the control of complex partial seizures, simple partial seizures and secondary generalized seizures. There was no difference in the incidence of adverse effects between zonisamide and placebo. Reported adverse effects in the zonisamide group involved the digestive system (32.5% of total adverse effects in the group) [including transient increases in liver enzymes (27.8%)], weight changes (30.2%), the haematological system (15.1%), neurological/psychiatric effects (10.3%), the urinary system (7.9%) and the cardiovascular system (4.0%). Only digestive system adverse effects constituted a significantly higher proportion of adverse effects in the zonisamide group than in the placebo group (32.5% vs 30.2%, p<0.05). Zonisamide 300-400 mg/day is effective and well tolerated as an adjunctive drug in adult Chinese patients with refractory partial-onset epilepsy.

The effects of pegylated interferon/lamivudine therapy on auditory functions in patients with chronic hepatitis B

Objectives The aim of this study was to assess the effects of pegylated interferon monotherapy and pegylated interferon + lamivudine combination therapy on auditory functions in patients with chronic hepatitis B (CHB) infection. Methods A total of 54 patients with a diagnosis of CHB were grouped into four treatment groups: patients in Group 1 received pegylated interferon-alpha 2a; patients in Group 2 received pegylated interferon-alpha 2a + lamivudine; patients in Group 3 received pegylated interferon-alpha 2b, and patients in Group 4 received pegylated interferon-alpha 2b + lamivudine treatment. The auditory system (using standard and high frequency audiometry) and the vestibulocochlear adverse effects including otalgia, tinnitus, vertigo and imbalance were assessed immediately before the onset of the study, and at the 12th, 24th, and 48th weeks of the study. Results A mean elevation of auditory threshold of 1–10 dB was found in all treatment groups when the thresholds at the onset of the study and the thresholds at the 12th, 24th, and 48th weeks were compared. However, the elevations were not significant. The elevations were mostly at high frequencies (10,000, 12,000 and 16,000 Hz). The most common vestibulocochlear adverse effects related to treatment were tinnitus, vertigo, imbalance, and otalgia, respectively. Tinnitus was the most common adverse effect in Group 2, vertigo was the most common in Group 3, imbalance was at equal frequency in Group 2 and 3, and otalgia was the most common adverse effect in Group 2 ( p > 0.05). Conclusion There were no significant auditory adverse effects in the treatment groups. We think that it may be beneficial to monitor the auditory functions in patients receiving PEG-IFN treatment because of the mild elevation in the auditory thresholds (although not significant).

Efficacy and Tolerability of Split-Dose Magnesium Citrate: Low-Volume (2 Liters) Polyethylene Glycol vs. Single- or Split-Dose Polyethylene Glycol Bowel Preparation for Morning Colonoscopy

Preparation regimens for morning colonoscopy are suboptimal. The aim of this study was to test the efficacy and tolerance of a split-dose magnesium citrate-low-volume (2 liters) polyethylene glycol (PEG) regimen for morning colonoscopy. A total of 232 patients were randomly assigned to receive 4 liters PEG (day before procedure; group 1, n=79), 2 liters PEG (day before procedure) followed by another 2 liters PEG (day of procedure; group 2, n=80), or magnesium citrate (250 ml, day before procedure) followed by 2 liters PEG (day of procedure; group 3, n=73). The quality of bowel cleansing, tolerability, and adverse effects in group 3 were compared with those in groups 1 and 2. Satisfactory bowel preparation was more frequently reported for group 3 than for group 1 (75% vs. 51%, P=0.001) and was similar to that for group 2 (75% vs. 76%, P=0.896). A significantly greater proportion of patients in group 3 graded their overall satisfaction as satisfactory compared with group 1 (43% vs. 23%, P=0.010), and the proportion was similar to that in group 2 (43% vs. 35%, P=0.133). Patients in group 3 were more willing to repeat the same preparation regimen, if necessary, than those in group 1 (93% vs. 48%, P<0.001) or group 2 (93% vs. 62%, P<0.001). The split-dose magnesium citrate-low-volume (2 liters) PEG regimen was more efficient than and preferred to the conventional regimen of 4 liters of PEG, and it was equally efficient as, but, again, preferred to the split-dose (2+2 liters) regimen for morning colonoscopy.

Raquianestesia com morfina versus raquianestesia sem morfina associada a bloqueio do nervo pudendo: avaliação da analgesia e complicações em hemorroidectomias

INTRODUÇÃO: Recentemente, alguns autores têm relatado que o bloqueio do nervo pudendo com uso de ropivacaína proporciona boa analgesia pós-operatória. Assim, considerou-se de interesse a comparação de dois métodos anestésicos verificando a analgesia pós-operatória e as complicações. OBJETIVO: Comparar duas técnicas anestésicas (raquianestesia com morfina versus raquianestesia sem morfina associada com bloqueio do nervo pudendo) para hemorroidectomia quanto à analgesia pósoperatória e complicações. MATERIAIS E MÉTODOS: Foram estudados 40 pacientes provenientes do ambulatório de Coloproctologia do Hospital Regional de Mato Grosso do Sul no período de março a outubro de 2008. Todos os pacientes foram randomizados por sorteio imediatamente antes de se iniciar a intervenção cirúrgica e foram distribuídos em dois grupos: Grupo 1: 20 pacientes submetidos à raquianestesia com morfina com 0,15µg associado com bupivacaína hiperbárica 10mg; - Grupo 2: 20 pacientes submetidos à raquianestesia com bupivacaína pesada 10mg associado ao bloqueio do nervo pudendo bilateral com agulha para raquianestesia 27G utilizando ropivacaína 10mg/ml diluída em 10ml de água destilada. RESULTADOS: Avaliou-se 40 pacientes, sendo 21 do sexo feminino. A idade média foi de 52 anos, variando de 21 a 72 anos. Apenas no grupo 1 observou-se complicações, sendo a principal prurido, seguida de retenção urinária e cefaléia. Após 6 horas da cirurgia, a média do nível de dor foi 1,55 no grupo 1 e 1,4 no grupo 2. Após 12 horas da cirurgia as médias foram 1,75 e 0,15 nos grupos 1 e 2, respectivamente. CONCLUSÃO: A hemorroidectomia realizada com associação de raquianestesia sem morfina e bloqueio do nervo pudendo utilizando ropivacaína proporcionou melhor efeito analgésico no período de 12 horas após a cirurgia e não apresentou complicações nesta casuística, mostrando-se superior à raquianestesia com morfina.