Complicaciones perianales causadas por agentes modeladores inyectados en glúteos / Perianal complications caused by gluteal injection of modeling agents

En este reporte presentamos tres pacientes en quienes ocurrieron condiciones inflamatorias perianales tardías, luego de la administración de sustancias modeladoras no identificadas en los glúteos. El diagnóstico inicial y supuesto no fue correcto, ya que no se investigó durante la evaluación preliminar el antecedente de la administración de elementos modeladores. Recomendamos que los pacientes con patologías inflamatorias del ano, sobre todo aquellos cuyo curso es extraño, se les pregunte acerca de la administración de agentes modeladores en los glúteos. Esta práctica puede contribuir a la eficacia del diagnóstico de manifestaciones perianales caracterizadas por flogosis, que se presentan de forma inusual. (AU)

In this report we present three patients in which late perianal inflammatory conditions occurred after administration of unidentified modeling agents to the buttocks. The initial diagnosis was not correct because of the administration of modeling agents was not investigated during the initial eval-uation. We recommend inquiring patients with inflammatory pathologies of the anus, especially those whose course is unusual, about the adminis-tration of modeling agents to the buttocks. This approach can contribute to the efficiency of the diagnosis of perianal complaints characterized by inflammation, but rare in its appearance. (AU)

Surveys on Suspected Adverse Effects Related to Coronavirus Disease 2019 Vaccination and the Impact of Early Publication of Results / 医薬品情報学

Objective: The coronavirus disease 2019 (COVID-19) vaccine was a specially approved pharmaceutical in Japan in February 2021. However, several people were concerned about its safety. Therefore, we conducted a survey on our hospital staff with suspected adverse effects related to COVID-19 vaccines and promptly published the results on our website. Methods: The current study included hospital staff who received the COVID-19 vaccine. A questionnaire survey on suspected adverse effects was conducted after each vaccination from the first to the fifth dose. Data on the survey results were promptly posted on the hospital’s website. The number of hits and time spent on the site were also evaluated. Then, we examined. the media (newspapers and television) that reported our findings and the content of their coverage. Results: There were no new findings regarding suspected adverse effects of the COVID-19 vaccines. An article published on our website on June 18, 2021, received more than 9,000 page views with an average time spent of > 3 min. Four media outlets reported on our hospital’s articles from June to July 2021, when public interest in the first and second doses of the vaccine was high. Conclusion: The early release of the survey results has provided a source of information for people who want to obtain safety information regarding the adverse effects of the COVID-19 vaccine.

Evaluation of drug treatment awareness among caregivers and patients of chronic kidney disease: unexplored determinant in patient care

Background: Chronic kidney disease (CKD) patients are prescribed multiple drugs to slow disease progression and prevent complications mandating adherence to therapy. Lack of awareness about drug treatment is one of the contributors to nonadherence. Hence the study was conducted to explore the awareness of patients and caregivers towards CKD treatment. Methods: The study was a cross sectional questionnaire-based study conducted among 300 CKD patients (150 dialysis/150 non-dialysis) and 100 caregivers (50 of dialysis / 50 of non-dialysis patients) attending nephrology OPD at a tertiary care hospital.Patient /caregiver awareness about drug treatment was assessed usinga prevalidated drug awareness questionnaire (8 items). The items were scored as correct response=2, no response=0 and incomplete response = -1, accounting the total awareness score as +20 to - 6 Results: The mean awareness score of patients / caregivers was 8.16±3.41 and 8.3±1.6 respectively. Majority (>70%) patients/ caregivers gave accurate responses for the items -specifying number of medicines, medication frequency and regular intake of drugs but awareness regarding action plan for skipped (27% patients, 11% caregivers) or missed doses (22% patients, 15% caregivers) and adverse effects (17% patients, 5% caregivers) was poor. Patients/ caregivers belonging to dialysis group had statistically better awareness then non-dialysis group. Conclusions: Patient /caregiver awareness regarding drug treatment is less than 50% with strikingly low awareness about dose regimen, adverse effects, action plan for missed doses and co morbidities. Patient education programs to reinforce and retain this knowledge need to be implemented in CKD patients.

The Efficacy of Different Triptans for the Treatment of Acute Headache in Pediatric Migraine: A Systematic Review

Background: Serotonin receptors 5-HT1B and 5-HT1D in the cerebral arteries are activated by the 5-hydroxytryptophan agonists (triptans) to relieve the discomfort associated with migraines. Even though triptans are often used to treat acute migraines, there is some debate over their effectiveness. Objective: Our systematic review aimed to evaluate the effectiveness of triptans for acute treatment of migraine in young individuals. Methods: Utilizing the databases of Google Scholar, Cochrane Library, and PubMed, a literature search was conducted, and all papers published till July 2022 were included. This systematic review was carried out following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standards. In addition to the Boolean operators AND, OR, and NOT, the following descriptive terms were also used: “Triptans,” “Pediatric Migraine,” “Migraine disorders,” “Headache,” “Children,” and “Adolescent.” Results: A total of 1047 studies were identified, and 25 articles were finally included in the study. 17 of them were RCTs while the remaining were non-randomized trials. Most studies recruited participants aged between 12-17 years. Among 25 studies, 7 reported sumatriptan use, 3 assessed a combination of sumatriptan and naproxen, 4 were on almotriptan, 1 on eletriptan, 6 on rizatriptan, and 4 on zolmitriptan use. Conclusion: We found that rizatriptan (good tolerability profile with a dose of 5 mg) and sumatriptan (nasal spray, 10 mg and 20 mg) had higher efficiency as compared to other triptans. Regardless of type or dose, all triptans are generally well tolerated by patients, but a few adverse effects such as light-headedness (sumatriptan), nasopharyngitis, and, muscular spasms (sumatriptan/ naproxen), somnolence, and dry mouth (rizatriptan), and dizziness (zolmitriptan group) were reported with the triptans.

Pain and Physiological Stress During Minimally Invasive Surfactant Therapy (MIST) in Very Preterm Infants

Objectives: To evaluate the pain or physiological stress caused during minimally invasive surfactant therapy (MIST) to very preterm neonates. Methods: In this prospective observational study conducted in a tertiary NICU, very preterm neonates were assessed for pain using Premature Infant Pain Profile-Revised (PIPP-R) score before, during and after MIST. Changes in the heart rate and oxygen saturation were also recorded during the procedure. Results: 23 neonates who received MIST were assessed for pain using PIPP-R. Mean (SD) PIPP-R score during MIST was 3.87(1.3), before; 12.83 (1.9), during; and 6.26 (1.0), after the procedure, respectively (all P<0.001). Heart rate and oxygen saturation were also significantly reduced during MIST (P<0.001). Conclusion: The high PIPP-R scores during surfactant administration suggest that MIST can cause moderate to severe pain/discomfort and significant physiological stress in very preterm infants.

Desmopressin Plus Tolterodine vs Desmopressin Plus Indomethacin for Refractory Pediatric Enuresis: An Open-label Randomized Controlled Trial

Objective: To compare the efficacy of desmopressin plus tolterodine (D+T) with desmopressin plus indomethacin (D+I) for treating enuresis in children. Design: Open-label randomized controlled trial. Setting: Bandar Abbas Children’s Hospital, a tertiary care children’s hospital in Iran, from March 21, 2018, to March 21, 2019. Participants: 40 children older than five years with monosymptomatic and non-monosymptomatic primary enuresis resistant to desmopressin monotherapy. Intervention: Patients were randomized to receive either D+T (60 µg sublingual desmopressin and 2 mg tolterodine) or D+I (60 µg sublingual desmopressin and 50 mg indomethacin) every night before bedtime for five months. Outcome: Reduction in the frequency of enuresis was evaluated at one, three, and five months, and response to treatment at five months. Drug reactions and complications were also noted. Results: After adjustment for age, consistent incontinence from toilet training, and non-monosymptomatic enuresis, D+T was significantly more efficacious than D+I; mean (SD) percent in nocturnal enuresis reduction at 1 [58.86 (7.27)% vs 31.18 (3.85) %; P<0.001], 3 [69.78 (5.99)% vs 38.56 (3.31)%; P<0.000], and 5 [84.84(6.21)% vs 39.14 (3.63)%; P<0.001] months showing a large effect. At 5 months, complete response to treatment was only observed with D+T, while treatment failure was significantly higher with D+I (50% vs 20%; P=0.047). None of the patients in either group developed cutaneous drug reactions or central nervous system symptoms. Conclusion: Desmopressin plus tolterodine appears to be superior to desmopressin plus indomethacin for treating pediatric enuresis resistant to desmopressin.

Síndrome de Nicolau / Nicolau syndrome

Resumen El síndrome de Nicolau es una complicación infrecuente de la aplicación parenteral de diversos fármacos. Se caracteriza por la aparición de dolor, seguido de edema, eritema y luego una placa necrótica. Se reporta el caso de un hombre de 31 años que presenta este síndrome luego de la aplicación de penicilina benzatínica intramuscular. La biopsia apoyó el diagnóstico. Recibió tratamiento con enoxaparina y cilostazol con posterior mejoría.

Abstract Nicolau syndrome is a rare complication of the parenteral application of various drugs. It is char acterized by the appearance of pain, followed by edema, erythema, and then a necrotic plaque. We present the case of a 31-year-old male with this syndrome, after the application of intramuscular benzathine penicillin. The diagnosis was supported by the biopsy. He received treatment with enoxaparin and cilostazol with subsequent improvement.

Bradycardia in a pediatric population after sugammadex administration: case series

Abstract Sugammadex is a distinctive neuromuscular reversal drug that acts by encapsulating the neuromuscular relaxant molecule and dislodging it from its site of action. Sugammadex has been approved for pediatric patients over 2 years of age. Although arrhythmias have been reported, there is no report of adverse effects in healthy children, such as severe bradycardia requiring intervention. We report two cases of severe bradycardia immediately after the administration of sugammadex in healthy children. Our aim is to alert to the occurrence of one of the most severe adverse effects of sugammadex, in the healthy pediatric population as well.

Efficacy of Combination of Camrelizumab with Anlotinib as Third-line Therapy for Patients with Advanced Non-small Cell Lung Cancer / 肿瘤防治研究

Objective To investigate the clinical efficacy and related adverse reactions of the combination of camrelizumab with anlotinib as the third-line therapy on advanced non-small cell lung cancer. Methods We retrospectively analyzed the clinical data of 84 patients with advanced non-small cell lung cancer after second-line treatment. According to different treatment methods, 44 patients who received camrelizumab combined with anlotinib were included in the observation group, and 40 patients who received anlotinib alone were included in the control group. The PFS, ORR, DCR and incidence of adverse reactions were analyzed and compared between the two groups. Results The median PFS of the observation group was longer than that of the control group (7.0 vs. 5.6 months, P=0.001). No statistically significant difference was observed in ORR, DCR, the incidence of adverse reactions or the incidence of adverse reactions above grade 3 between two groups (all P > 0.05). Conclusion The clinical efficacy of camrelizumab combined with anlotinib as third-line therapy on advanced non-small cell lung cancer is better than anlotinib alone, and the safety is good.

Research progress on the ocular adverse effects associated with immune checkpoint inhibitor therapy / 中华眼底病杂志

Immune checkpoint inhibitors (ICI) have revolutionized the field of oncology by regulating the interaction between immune cells and cancer cells and promoting the disinhibition of the immune system, thus targeting various types of malignant tumors. However, the regulation of the immune system can also trigger related adverse reactions. Currently, there are no specific clinical guidelines for the treatment of these adverse reactions. Treatment decisions largely depend on clinical judgment and experience.The pathogenesis of ICI-related ocular adverse events is not fully understood at present. Further research on the specific mechanisms of action can provide new insights into the early diagnosis and treatment of ICI-related ocular adverse events.

Antimalarials and macrolides: a review of off-label pharmacotherapies during the first wave of the SARS-CoV-2 pandemic

Abstract We critically analyzed clinical trials performed with chloroquine (CQ) and hydroxychloroquine (HCQ) with or without macrolides during the first wave of COVID-19 and discussed the design and limitations of peer-reviewed studies from January to July 2020. Seventeen studies were eligible for the discussion. CQ and HCQ did not demonstrate clinical advantages that justified their inclusion in therapeutic regimens of free prescription for treatment or prophylactic purposes, as suggested by health authorities, including in Brazil, during the first wave. Around August 2020, robust data had already indicated that pharmacological effects of CQ, HCQ and macrolides as anti-SARS-CoV-2 molecules were limited to in vitro conditions and largely based on retrospective trials with low quality and weak internal validity, which made evidence superficial for decision-making. Up to that point, most randomized and nonrandomized clinical trials did not reveal beneficial effects of CQ or HCQ with or without macrolides to reduce lethality, rate of intubation, days of hospitalization, respiratory support/mechanical ventilation requirements, duration, type and number of symptoms, and death and were unsuccessful in increasing virus elimination and/or days alive in hospitalized or ambulatory patients with COVID-19. In addition, many studies have demonstrated that side effects are more common in CQ-or HCQ-treated patients.

A Study of Adverse Effects Following Administration of Anti-Rabies Vaccination - A Hospital Based Study

Rabies is an acute viral zoonotic disease that affects all warm-blooded animals including mammals and occurs in more than 150 countries and territories. Although rabies is a 100% fatal disease, it can be pre-vented by the use of potent anti-rabies vaccines (ARV). The present study was a hospital based descrip-tive longitudinal study conducted during February 2019 to July 2020 amongst the animal bite patients attending the Anti -Rabies clinic (ARC) of Vardhman Mahavir Medical College and Safdarjung Hospital (VMMC & SJH), New Delhi, to study the adverse events (vaccine reactions) if any following administra-tion of the ARV. The age of the study participants ranged from 2 to 65 years and the mean age was (29.315.2) years. No severe or serious adverse events were reported. Of the minor reactions, the most commonly reported symptom was pain at the injection site (34; 9.4%) followed by occurrence of tingling sensation (29; 8.1%), headache (22; 6.1%) and itching at the injection site (19; 5.3%). These findings corroborate with those found in previous studies in the literature. It was concluded that although there are possible local or mild or systemic adverse reactions to rabies vaccination, but once initiated, rabies prophylaxis should not be interrupted or discontinued.

Adverse effects associated with favipiravir in patients with COVID-19 pneumonia: a retrospective study

ABSTRACT BACKGROUND: Favipiravir is generally used in treating coronavirus disease 2019 (COVID-19) pneumonia in Turkey. OBJECTIVE: To determine the side effects of favipiravir and whether it is a good treatment option. DESIGN AND SETTING: Retrospective study conducted in Atatürk Chest Diseases and Chest Surgery Training and Research Hospital, Ankara, Turkey. METHODS: 357 patients who completed favipiravir treatment at the recommended dose were included. 37 patients with drug side effects and 320 patients without drug side effects were examined in two groups. RESULTS: Side effects were observed in 37 (10.36%) out of 357 patients using favipiravir. The most common side effect was liver dysfunction, in 26 (7.28%) of the patients. The following other side effects were also observed: diarrhea (1.4%), nausea (0.84%), abdominal pain (0.28%) and thrombocytopenia (0.28%). One patient (0.28%) presented both increased transaminases and nausea. CONCLUSION: In this study, it was determined that favipiravir may constitute an alternative for treating COVID-19 pneumonia given that its side effects are generally well tolerated and not serious.

Disulfiram Induced Mania — A Case Report

Disulfiram has been most widely used in patients suffering from alcohol dependence. When taken along with alcohol it can cause various side effects like flushing, drowsiness, rashes, hyperventilation, palpitations etc. Mania due to Disulfiram is an uncommon side effect and there are only a few reports of it. We hereby report a case of the development of Mania in an individual with alcohol dependence following 2 months of treatment with a therapeutic dose of Disulfiram. Before the onset of mania, the patient was abstinent from alcohol for about 2 months, which made substance-induced mania unlikely. The possible mechanism for this is the dopamine hypothesis which suggests that Disulfiram inhibits dopamine-Beta-hydroxylase which is responsible for the conversion of dopamine to Nor-adrenaline and increases the dopamine level which is responsible for psychotic and mania symptoms. This possibility of Disulfiram induced mania should be assessed whenever clinicians encounter patients with dual diagnosis, as this might change the management as such.

Visual loss after aesthetic facial filler injection: a literature review on an ophthalmologic issue / Perda visual após preenchimento facial estético: uma revisão da literatura sobre complicações oftalmológicas

ABSTRACT Dermal filler injection is among facial rejuvenation treatments that have been increasingly used. Despite being a minimally invasive procedure, it can lead to severe complications such as blindness. A review of all cases of filler- -induced visual loss in the world literature was conducted to summarize the mechanisms, anatomical considerations, and clinical ophthalmologic course, current strategies of prevention and management, and trends over the years. We identified 233 cases of filler-induced visual loss, and 172 patients had a severe visual impairment in at least one eye. The typical patients are young women who received injections of hyaluronic acid or autologous fat in the glabella or nose, and the typical presentations were sudden ocular pain, ptosis, and ophthalmoplegia due to vascular occlusion. The findings of this study also suggest an increase in the number of unlicensed professionals performing the procedure. Even though the continued development of dermal fillers has improved the treatment options available, further studies and strategies are necessary to reduce the incidence and minimize the consequences of filler-induced visual loss.

RESUMO O uso de preenchedores dérmicos é uma prática bem estabelecida de rejuvenescimento facial. Embora seja um procedimento minimamente invasivo, pode levar a complicações graves como cegueira. Uma revisão de casos de perda visual pós preenchimento facial estético foi conduzida para descrever os mecanismos, considerações anatômicas, quadro oftalmológico, atuais estratégias de prevenção e manejo, e tendências ao longo dos anos. Foram identificados 233 casos, e 172 pacientes tiveram ao menos um olho com baixa visão ao final do seguimento. O paciente típico é uma mulher jovem submetida a preenchimento de ácido hialurônico na glabela ou nariz, apresentando dor ocular súbita, ptose e oftalmoplegia devido à oclusão vascular. Este estudo também destaca um possível aumento de profissionais não habilitados realizando este procedimento. Apesar do contínuo desenvolvimento dos preenchedores dérmicos e aprimoramento das opções de tratamento disponíveis, mais estudos e estratégias são necessários para reduzir a incidência de complicações e minimizar suas consequências.

Safety & effectiveness of COVID-19 vaccines: A narrative review

There are currently eight vaccines against SARS-CoV-2 that have received Emergency Use Authorization by the WHO that can offer some protection to the world’s population during the COVID-19 pandemic. Though research is being published all over the world, public health officials, policymakers and governments are collecting evidence-based information to establish the public health policies. Unfortunately, continued international travel, violations of lockdowns and social distancing, the lack of mask use, the emergence of mutant strains of the virus and lower adherence by a sector of the global population that remains sceptical of the protection offered by vaccines, or about any risks associated with vaccines, hamper these efforts. Here we examine the literature on the efficacy, effectiveness and safety of COVID-19 vaccines, with an emphasis on select categories of individuals and against new SARS-CoV-2 strains. The literature shows that these eight vaccines are highly effective in protecting the population from severe disease and death, but there are some issues concerning safety and adverse effects. Further, booster shots and variant-specific vaccines would also be required.

Preliminary application of MR-Linac in breast cancer radiotherapy in a single academic center / 中华放射肿瘤学杂志

Objective:To describe a prospective study of pre-operative tumor-bed boost performed at the 1.5 T MR-Linac in combination with adjuvant whole breast irradiation, and a first case, with an accentuation on clinical feasibility and safety.Methods:A phase II, single arm study recruiting early stage patients follows a paradigm that first boosts the tumor bed and then undergoes breast conservative surgery in 2 weeks, and last irradiates the whole breast in 6 weeks. The primary endpoint is ≥ grade 2 acute breast toxicity. A 43 years old patient affected by a breast carcinoma, not special type of the right-sided lateral quadrant, staged cT 2N 0M 0, was planned and treated. The dose, 8 Gy for one time, was calculated by Monaco on CT simulation images. Both the air electron stream effect (ESE) and the electron return effect (ERE) at the presence of 1.5 T magnetic field were evaluated. During the pre-treatment evaluation, we carried out adaptation-to-position adjustment. Results:The normal organ dosimetry is within toleration. The Dmax to the skin, the chin and the right upper arm was 8.44 Gy, 28.5 cGy and 17.8 cGy, respectively. There was no increased toxicity from ERE and ESE, and the treatment was well tolerated without > grade 1 acute toxicity. The patient received breast conservative surgery on day 7 without delayed wound healing.Conclusions:This is the first case successfully treated within a clinical trial by pre-operative tumor-bed boost under 1.5 T MR-Linac in our institution. More participants are needed to validate and optimize the paradigm.

Quality of life in patients with early-stage extra-nodal NK/T cell lymphoma of nasal type after definitive radiation therapy / 中华放射肿瘤学杂志

Objective:To investigate the quality of life in patients with early-stage extra-nodal NK/T cell lymphoma of nasal type (ENKTL) arising from the upper aerodigestive tract, who had remained progression-free survival (PFS) for over 3 months after definitive intensity-modulated radiation therapy (IMRT), and to analyze the factors related to main adverse symptoms.Methods:276 patients who received IMRT from March, 2012 to June, 2021 were included. There were 201 males and 75 females with a median age of 41.5 years (range: 13-81 years) upon diagnosis. Consistent target delineation schemes and similar dose gradients were adopted for IMRT, with a median prescribed dose of 54.6 Gy/26F. Cross-sectional investigation was performed with a modified EORTC QLQ-H&N35 questionnaire, the incidence and severity of adverse symptoms, severity of disease and their influencing factors at each time-point during their survival were statistically analyzed.Results:The median age of patients at the investigation was 46.2 years, and the median PFS after IMRT was 47.2 months (range: 3.1-115.7 months). The most common adverse symptoms included nasal symptoms (incidence rate 63.8%), dry mouth (50%), tooth diseases (47.1%), smell and taste alteration, and sexual apathy, etc. Most symptoms were mild (the average standardized score was 5.50, the full score of 100 indicating the most severe), and could be relieved remarkably over survival time, but some symptoms, such as tooth diseases and sexual apathy, were more obvious and recurred for several years. Age and anti-PD-1 immune therapy influenced the symptom scores, and tooth diseases were closely correlated with dry mouth. Conclusion:The quality of life in patients with early-stage ENKTL after definitive IMRT is high, and the most significant symptoms include nasal symptoms, tooth diseases, and sexual apathy, etc. , which need to be mitigated with more studies.

Efficacy and Safety of Anlotinib Combined with PD-1 Blockades for Patients with Advanced Epithelial Ovarian Cancer / 肿瘤防治研究

Objective To investigate the efficacy and safety of anlotinib combined with PD-1 blockades for patients with advanced epithelial ovarian cancer (EOC). Methods A retrospective study was performed, enrolling 33 patients with advanced EOC who failed standard systematic therapy. All patients were administered with anlotinib combined with PD-1 blockades. The efficacy and safety profile were determined during treatment. Results The objective response rate of the 33 patients was 36.4% (95%CI: 20.4%-54.9%) and the disease control rate of the patients was 81.8% (95%CI: 64.5%-90.0%). The median PFS and OS of the 33-patient cohort were 7.6 months (95%CI: 3.1-12.1) and 19.6 months (95%CI: 15.1-24.1), respectively. The most common treatment-related adverse reactions were fatigue (66.7%), nausea and vomiting (54.5%), hypertension (48.5%), and diarrhea (39.4%). Furthermore, multivariate Cox regression analysis indicated that ECOG performance status and FIGO stage were independent factors for predicting the PFS of the combination regimen for patients with advanced EOC. Conclusion Anlotinib combined with PD-1 blockades preliminarily exhibit satisfactory efficacy and tolerable safety profile for patients with advanced EOC.

Application of antifungal agents in special populations / 中华皮肤科杂志

Antifungal agents have shown good efficacy and tolerability in the general population. However, the antifungal treatment remains a great challenge in some special populations due to their special conditions, such as children, the elderly, pregnant women and patients with hepatic insufficiency. This review summarizes recommendations for the use of common antifungal agents in the above special populations.