Incidence Of Common Side Effects Research Articles

Clinical efficacy study of position-responding mandibular advancement device in patients with obstructive sleep apnea.

Although mandibular advancement device (MAD) treatment is effective in patients with obstructive sleep apnea (OSA), there are still some concerns about its potential therapeutic and side effects. Thus, we developed a novel MAD that auto-titrates depending on its position in patients with OSA. Therefore, we conducted a clinical trial to determine the efficacy of an auto-titrating mandibular advancement device (AMAD) for treating OSA. Fourteen patients with OSA were enrolled in this study. Polysomnography (PSG) was conducted at the start of the clinical trial, and PSG with AMAD in situ was performed after three months of treatment. The mean Epworth Sleepiness Scale (ESS) and STOP-Bang scores were 8.21 ± 4.21 and 5.00 ± 1.00, respectively. After 3 months of treating AMAD, STOP-Bang scores improved to 3.75 ± 1.06; however, there was no significant change in ESS scores. Additionally, we found statistically significant improvements in several respiratory parameters in the PSG data after AMAD treatment. The AHI (32.85 ± 21.71 to 12.93 ± 10.70), supine AHI (45.91 ± 23.58 to 15.59 ± 12.76), lateral AHI (13.94 ± 10.95 to .49 ± 7.40), lowest O2 saturation (79.71 ± 6.22 to 84.00 ± 5.71), total arousal number (191.14 ± 112.07 to 86.57 ± 48.80), and arousal index (33.76 ± 21.00 to 15.05 ± 8.42) were recorded. However, there were no significant changes in total sleep time, sleep efficiency, or mean oxygen saturation. Additionally, we did not observe any major side effects during treatment, specifically related to tooth or jaw pain. Our clinical trial revealed that AMAD improved PSG parameters and reduced the incidence of common side effects. Therefore, AMAD may be an effective alternative treatment for OSA.

Efficacy and Safety of Shen Fu Injection Alleviating Chemotherapy-Induced Peripheral Neurotoxicity: A Randomized Controlled Trial

Objective: To analyze the effect of Shenfu injection on Chemotherapy-Induced Peripheral Neuropathy (CIPN) at different stages of tumor chemotherapy. Method: An analysis of 153 patients who were divided into chemotherapy group and combined group was performed chemotherapy within two to six cycles with oxaliplatin or paclitaxel, and combined with or without Shenfu injection. Efficacy evaluation was divided into two phases, including the short-term incidence of CIPN and the long-term incidence of CIPN. Subgroup analysis was performed on the combined group to compare the incidence of CIPN in different usage time of Shenfu injection. Preliminary comparison of the incidence of common side effects. Results: The short-term incidence rates of CIPN in the combined group and chemotherapy group were 27.85% and 66.22%, respectively (P<0.01), and the long-term incidence rates were 17.72% and 45.95%, respectively (P<0.01). In the combined group of 5-6 cycles chemotherapy, divided into two groups according to the time used of Shenfu injection, greater than 3 weeks and less than 3 weeks, and the short-term incidence rates of CIPN were 28.57% and 69.23%, respectively, and the longterm incidence rates of CIPN was 14.29% and 46.15%, respectively. Adverse reactions evaluation showed that the occurrence of bone marrow suppression were 35.44% and 60.81% (P<0.05) in the combined group and chemotherapy group, and there was no significant difference in digestive tract reaction, liver and kidney toxicity. Conclusion: Shenfu injection significantly reduced the incidence of CIPN and had a good security.

Low-Dose Alfentanil Inhibits Sufentanil-Induced Cough During Anesthesia Induction: A Prospective, Randomized, Double-Blind Study.

Cough is one of the most common complications following intravenous administration of sufentanil during anesthesia induction. The study aimed to investigate the protective effect of alfentanil, afentanyl derivative with short onset time and short duration, in reducing sufentanil-induced cough. Eighty patients that scheduled for thyroid surgery under general anesthesia were randomly divided into the alfentanil group and normal saline group, with 40 cases per group. Patients in the alfentanil group received intravenous administration of 2 μg/kg alfentanil prior to sufentanil injection during general anesthesia induction, while the same dose of normal saline was administered in the normal saline group. The outcomes measures included the incidence and severity of cough and common side effects of opioids following the administration of sufentanil during the induction of general anesthesia, intraoperative hemodynamics parameters and major adverse events during anesthesia recovery period. The incidence of cough within one minute after the injection of sufentanil during anesthesia induction was 40% in the normal saline group, and the pretreatment of alfentanil significantly reduced the incidence of sufentanil-induced cough to 5% (p < 0.05). Correspondingly, the patients in the alfentanil group had decreased severity of sufentanil-induced cough compared with the normal saline group (p < 0.05). No significant differences in the incidences of common side effects of opioids (dizziness, nausea and vomiting, chest tightness and respiratory depression) within one minute after sufentanil injection were found (p > 0.05). Furthermore, there were no significant differences between the two groups in intraoperative hemodynamic parameters, extubation time, or the incidences of emergence agitation, respiratory depression, delayed recovery from anesthesia and postoperative nausea and vomiting during Postanesthesia Care Unit stay (p > 0.05). Pretreatment with low-dose alfentanil (2 μg/kg) effectively and safely reduced both the incidence and severity of sufentanil-induced cough during anesthesia induction. Chinese Clinical Trial Registry (identifier: ChiCTR2300069286).

Refractory and Recurrent Idiopathic Granulomatous Mastitis Treatment: Adaptive, Randomized Clinical Trial.

Idiopathic granulomatous mastitis (IGM) is mostly described as an autoimmune disease with higher prevalence among Middle Eastern childbearing-age women. This study aimed to evaluate the best treatment of choice in patients with resistant or recurrent IGM. Patients with established recurrent or resistant IGM who were referred to the Breast Cancer Research Center from 2017 to 2020 were randomly assigned to either one of the following treatment groups: A (best supportive care), B (corticosteroids: prednisolone), and C (methotrexate and low-dose corticosteroids). This adaptive clinical trial evaluated radiological and clinical responses, as well as the potential side effects, on a regular basis in each group, with patients followed up for a minimum of 2 years. A total of 318 participants, with a mean age of 33.52 ± 6.77 years, were divided into groups A (10 patients), B (78 patients), and C (230 patients). In group A, no therapeutic response was observed; group B exhibited a mixed response, with 14.1% experiencing complete or partial responses, 7.7% maintaining stability, and 78.2% experiencing disease progression. Accordingly, groups A and B were terminated due to inadequate response. In group C, 94.3% achieved complete response, 3% showed partial remission, and 2.7% had no response to therapy. Among the entire patient cohort, 11.6% tested positive for antinuclear antibodies, 3.5% for angiotensin-converting enzyme, and 12.3% for erythema nodosum. Notably, hypothyroidism was a prevalent condition among the patients, affecting 7.2% of the cohort. The incidence of common side effects was consistent across all groups. The most effective treatment option for patients with recurrent or resistant IGM is a combination therapy involving steroids and disease-modifying antirheumatic drugs such as methotrexate.

Abstract P1-11-22: Aromatase inhibitors are significantly better tolerated by early stage breast cancer patients 75 or older and with significantly lower early discontinuation rate

Abstract Introduction: Breast cancer is the most common cancer in women. In postmenopausal women with early stage estrogen receptor positive breast cancer, aromatase inhibitors (AI) are a common treatment option. AI's are reported to lead to a high early discontinuation rate in younger post-menopausal women due to poor tolerance. The most common side effects reported to lead to early discontinuation are arthralgia, hot flashes, fatigue, and night sweats. The reported tolerance to AI therapy in women age 75 or older is not well documented. Our study looks at women, ages 75 and older, diagnosed with early stage breast cancer who were placed on adjuvant AI therapy and focuses on tolerability, incidence of common side effects, rate of treatment changes, and on discontinuation rates. Objective: This study evaluates the tolerability, treatment side effects and the discontinuation rate of AI in women over the age of 75 with early stage breast cancer. Methods: Our study is a retrospective chart review of 58 patients' ages 75 to 95 with early stage breast cancer treated with adjuvant AI. Charts of patients were reviewed and duration of treatment, patient reported side effects, treatment changes, and discontinuation rate were recorded. Results: Data analysis showed that 36/55 (65.5%) of patients did not report significant side effects to AI. 6/55 (10.9%) patients required therapy changes due to side effects. 5/6 required one treatment change and 1/6 required multiple treatment changes. In 5/6 therapy was changed to another AI. Only 2/55 (3.6%) of patients discontinued therapy. In both patients who discontinued AI, therapy was discontinued due to medical complications unrelated to AI therapy. Average time to discontinuation was 11 months. The most common reported side effects were arthralgia 9/55 (16.4%), fatigue 3/55 (5.5%), hot flashes 4/55 (7.3%), rash 3/55 (5.5%) and hair thinning 3/55 (5.5%). The most common reported side effect which led to treatment change was arthralgia 4/6 (66.7%). With a median follow up time of 24 months, breast cancer specific mortality was 1/55 (1.8%). Reported Side Effects on AIn=55 patientsPatients who noted symptomsPatients who changed therapy due to symptomsFatigue30Arthralgia94Hot flashes40Rash31Vaginal dryness10Hair thinning31 Conclusion: Our study evaluated the tolerance of AI in older women diagnosed with early stage breast cancer. 36/55 (65.5%) of elderly patients reported no significant side effects suggesting that AI's are well tolerated in this population and the known side effects are significantly less common than previously reported in a younger cohort in whom arthralgia as well as vasomotor symptoms affect as many as 30% of women. This improved tolerance led to a significantly lower early discontinuation rate than previously reported in the younger cohort: discontinuation rate of 3.6% by 24 months in the 75 or older population versus 20% by 24 months in the younger cohort of post-menopausal women treated with AI. Reference: 1 Wagner, L.I., Zhao, F., Goss, P.E. et al. Breast Cancer Res Treat (2018) 169: 537. https://doi-org.proxy.library.stonybrook.edu/10.1007/s10549-018-4713-2 Citation Format: Chaudhry B, Baer L, Kudelka A, Cohen J, Stopeck AT. Aromatase inhibitors are significantly better tolerated by early stage breast cancer patients 75 or older and with significantly lower early discontinuation rate [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-11-22.

Intrathecal hydromorphone instead of the old intrathecal morphine

Intrathecal hydromorphone instead of the old intrathecal morphine

Nurse‐controlled analgesia (NCA) following major surgery in 10 000 patients in a children’s hospital

Patients who received NCA with morphine following major surgery between 1996 and 2008 at Great Ormond Street Hospital, London, UK, were prospectively studied in the postoperative period to determine effectiveness, morphine requirements, incidence of common side effects, and serious adverse events. The morphine NCA regimen and monitoring was according to standard hospital protocols. Data were collected prospectively and subsequently entered by trained personnel into a secure database. Patient demographics, effectiveness and satisfaction rates, morphine requirements, side effects, and serious complications were recorded. 10,079 patients were included. The average age was 4 years old (range 1 day to 20.5 years, median 2.3 years). There were 510 neonates. The average NCA duration was 43.7 h. 1.8% of morphine NCAs were replaced by other methods because analgesia was unsatisfactory. Satisfaction ratings were 'good' or 'very good' for 98% of the remainder. Average daily morphine requirement (mcg x kg(-1) x h(-1)) was related to age, surgical category, and postoperative time. Side effects included PONV (25%), itching (9.4%), depression of respiration, and sedation (4.5%); incidences varied with age, morphine dose, and type of surgery. Serious, potentially life-threatening adverse effects (SAE) were 0.4%. There were no deaths. SAE were significantly greater in neonates (2.5%), relative risk 9.4, P < 0.001. Morphine dose in neonates who experienced SAE was not significantly different from other neonates. NCA with morphine is an acceptable, safe, and effective method of postoperative analgesia for a wide range of ages and types of surgery in our practice. Morphine requirements increase with age, but there was also considerable inter-individual variation within age groups. PONV, itching, sedation, and respiratory depression are expected side effects. SAE are uncommon but the incidence is greatest in neonates.

Endovenous Laser Ablation–Induced Complications: Review of the Literature and New Cases

In the last decade, minimally invasive techniques have been introduced in the treatment of lower extremity varicosities. Of these therapies, endovenous laser ablation is the most widely accepted and used treatment option for insufficient great and short saphenous veins. To present a review of reported common and rare and minor and major complications associated with endovenous laser ablation. A systematic review of studies and case reports on endovenous laser ablation-induced complications. The complications were classified as minor or major according to the Society of Interventional Radiology Standards of Practice Committee guidelines on reporting complications. A case-series of complications after endovenous laser ablation is presented. Ecchymoses and pain are frequently reported side effects of endovenous laser ablation. Nerve injury, skin burns, deep vein thrombosis and pulmonary embolism seldom occur. An exceptional complication is a material or device that by accident remains inside the body after the procedure. Ecchymosis, pain, induration, skin burns, dysesthesia, superficial thrombophlebitis, and hematoma were classified as minor complications. Deep vein thrombosis and nerve injury were classified as major complications. Endovenous laser ablation may be considered a safe treatment of lower extremity varicosities. The incidence of common side effects may decrease with better laser parameters.

Utilities of the Post-anesthesia State derived by the Standard Gamble method in surgical patients

BackgroundThere are no published utilities for the post-anesthesia state obtained by the standard gamble method (SG).MethodsWe obtained utilities for postoperative pain, nausea, vomiting, urinary retention and myalgia from 100 adults prior to elective surgery using SG.Results20% of volunteer participants could not demonstrate a satisfactory understanding of the SG process. Median utilities for each adverse effect were all very close to 1.0, and no statistically significant differences were found between them.ConclusionOur results suggest that the avoidance of anesthesia related side effects and pain is not viewed by patients prior to surgery as being worthy of the taking of even a miniscule risk of death. This may affect the decision to utilize anesthesia techniques that trade a lower incidence of common side effects for a very low but finite risk of a catastrophic complication.

Statistical assessment of adverse experiences associated with the use of oral contraceptives.

Statistical approaches to the evaluation of common side effects and rare but major complications associated with oral contraceptive (OC) use are discussed. The double-blind clinical trial is the traditional approach to assessing the incidence of common side effects associated with various OC preparations and doses. However for various reasons this methodology is not all that frequently employed. 5 major prospective studies on the association of OC use with thromboembolic disorders failed to produce unequivocal results. This was primarily due to inadequate monitoring systems. The structure of prospective and retrospective studies and considerations in the interpretation of the data particularly with regard to the carcinogenic effects of OCs and the influence of OC use on fetal malformations are discussed. Various studies on the association of OC use with thromboembolic disease are reviewed.