good safety profile
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2021 ◽  
Vol 5 (8) ◽  
pp. RV6-RV8
Author(s):  
Yashika Kaushal ◽  
Ratibha Kaushal

Healthcare professionals and scientists were not able to provide a good answer to the COVID-19 pandemic that shook the whole world. Hydroxychloroquine is an antimalarial drug with a good safety profile. It can be used in pediatric subjects as well as pregnant and breastfeeding women. Hydroxychloroquine is a widely used, essential drug in dermatology. It has got anti-inflammatory, antibacterial, antiviral and immunomodulatory properties. It was globally prescribed to prevent and treat COVID-19 caused by SARS-CoV-2 virus. The use of this drug in treating COVID-19 is debatable and for sure is not indicated in the labelling documents provided by the companies that manufacture this drug. The unnecessary use of this drug also led to short supply. We hereby review its properties, mechanism, safety profile and the issue COVID pandemic has caused to the supply of this drug.


2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Kanokporn Niwatananun ◽  
Wirat Niwatananun ◽  
Sirivipa Piyamongkol ◽  
Darunee Hongwiset ◽  
Chidchanok Ruengorn ◽  
...  

Background. Cissus quadrangularis Linn. (CQ) is a medicinal plant with good evidence for the treatment of hemorrhoids, listed in the Thai National List of Herbal Products in the oral dosage form. Acmella paniculata (Wall ex. DC.) R. K. Jansen. (AP) is a medicinal plant with a local anesthetic effect. Objective. To investigate the potential of rectal suppositories containing CQ and AP extracts to alleviate symptoms of hemorrhoids compared with the commercialized rectal suppository containing hydrocortisone and cinchocaine. Materials and Methods. Hemorrhoid outpatients (n = 105) with different severity grades (I, II, or III) from eight hospitals in northern Thailand were included in this study. Hemorrhoid severity was graded by proctoscopy associated with either anal pain or bleeding related to hemorrhoids or both. The patients were randomly allocated to two groups: CQ-AP group (n = 52) or the commercialized rectal suppository group (n = 53). One suppository was rectally administered twice daily in the morning and at bedtime for seven days. Evaluations were performed by physicians on days 1, 4, and 8 of the study. The primary endpoints were bleeding and prolapse size, while the secondary endpoint was anal pain. Results. Baseline demographics, lifestyle, constipation, number of prolapses, grade of hemorrhoid severity, and duration of experiencing hemorrhoids were comparable in both groups of patients. The effects of CQ-AP and the commercialized rectal suppository on bleeding, prolapse size, and anal pain were comparable. The patients in both groups were satisfied with both products at comparable levels and stated a preference for further use in the case of hemorrhoids recurrence. In terms of safety, the patients in the commercialized rectal suppository group experienced a higher incidence of adverse events, including anal pain and bleeding. Conclusion. Rectal suppositories containing a combined extract of CQ and AP show potential in alleviating hemorrhoidal symptoms with a good safety profile.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Li-rui Sun ◽  
Qiu-shi Guo ◽  
Wei Zhou ◽  
Min Li

AbstractChinese herbal medicine is widely used because it has a good safety profile and few side effects. However, the risk of adverse drug reactions caused by herb-drug interactions (HDIs) is often overlooked. Therefore, the task of identifying possible HDIs and elucidating their mechanisms is of great significance for the prevention and treatment of HDI-related adverse reactions. Since extract from Dioscorea bulbifera L. rhizomes (DB) can cause various degrees of liver damage, it is speculated that HDIs may occur between DB extract and chemicals metabolized or excreted by the liver. Our study revealed that the cardiotoxicity of pirarubicin (THP) was increased by co-administration of DB, and the expression of P-glycoprotein (P-gp) and multidrug resistance-associated protein 2 (Mrp2) in the liver was inhibited by DB extract, which led to the accumulation of THP in heart tissue. In conclusion, there are risks of the co-administration of DB extract and THP. The mechanism of HDIs can be better revealed by targeting the efflux transporters.


Vaccines ◽  
2021 ◽  
Vol 9 (9) ◽  
pp. 1048
Author(s):  
Luigi Cavanna ◽  
Chiara Citterio ◽  
Ilaria Toscani

Patients with cancer are among the most vulnerable groups of the COVID-19 pandemic, whereas vaccinations can represent a cornerstone in overcoming the pandemic itself. However, cancer patients were excluded from clinical trials for COVID-19 vaccinations, and thus the data on the immunogenicity and safety of COVID-19 vaccines in cancer patients are limited. In this systematic review, we assessed the seroconversion rate and the safety of COVID-19 vaccinations in cancer patients. We searched a bibliographic database up until 31 July 2021. Utilizing inclusion criteria, six studies were selected and analyzed for this meta-analysis. This included 621 cancer patients and 256 controls. Results show that patients with solid tumors show adequate antibody responses (>90%), though the antibody titers were significantly lower than those of healthy controls. Similarly, a significantly lower rate of seroconversion was registered in patients with hematologic malignances. The vaccines showed a good safety profile; no grade 3–4 adverse events were registered. This review demonstrates generally high immunogenicity from COVID-19 vaccines in patients with cancer, with better results for solid tumors than hematological malignances, and with a good safety profile.


2021 ◽  
Vol 23 (2) ◽  
pp. 256-259
Author(s):  
Marina I. Sekacheva ◽  
Anastasia S. Fatyanova ◽  
Daur A. Meretukov ◽  
Angelina V Zhilenkova ◽  
Aleksandr S. Rusanov ◽  
...  

Colorectal cancer (CRC) is one of the leading cancers in terms of prevalence and mortality. Almost 1/4 of patients with CRC have metastases at the initial presentation. The survival rate of this group of patients remains low. With the onset of the COVID-19 pandemic, cancer patients have faced difficulties in getting diagnosis or treatment, which could potentially lead to an increase in late-stage tumors and mortality. This situation required changes in approaches to the treatment of cancer patients, such as replacing drugs with tablet forms, schemes with long intervals, and much more. It is known that about 50% of patients with metastatic colorectal cancer survive in satisfactory condition until the 3rd line drug therapy or longer. One of the main drugs for this category of patients is regorafenib, which, thanks to the tablet formulation, has become especially important in the COVID-19 pandemic. In numerous clinical studies, the drug showed an increase in patient overall survival and good safety profile. In addition, there is growing evidence of the effect of regorafenib on tumor sensitivity to treatment with platinum drugs, irinotecan, and EGFR inhibitors.


2021 ◽  
Vol 59 (240) ◽  
Author(s):  
Angela Basnet ◽  
Shiva Kumar Ojha ◽  
Suman Kumar Jha ◽  
Anjana Paudyal ◽  
Manoj Khadka ◽  
...  

Nepal started the COVID-19 vaccination on 27 January 2021 with AstraZeneca/Oxford Coronavirus Disease-19 AZD1222 (Covishield) vaccine to control the Coronavirus disease pandemic. The vaccine has a good safety profile, with cardiovascular complications being rare. Herein we report a rare case of cardiovascular complication following Covishield vaccination in a 33 years old female who had dizziness and elevated blood pressure immediately following vaccination and abnormal electrocardiogram showing T wave inversions followed by left bundle branch block. The patient was kept on observation, following which the blood pressure and electrocardiogram changes were normal by seven days. This cardiovascular complication following the vaccination demands further investigation into the adverse event of the vaccine. However, since the benefit of the vaccine outweighs the risk, World Health Organization has recommended the continuity of the vaccine as of now.


2021 ◽  
pp. annrheumdis-2021-220832
Author(s):  
Xiufang Kong ◽  
Ying Sun ◽  
Xiaojuan Dai ◽  
Li Wang ◽  
Zongfei Ji ◽  
...  

ObjectiveTo compare the treatment efficacy and safety of tofacitinib (TOF) versus methotrexate (MTX) in Takayasu arteritis (TAK).MethodsFifty-three patients with active disease from an ongoing prospective TAK cohort in China were included in this study. Twenty-seven patients were treated with glucocorticoids (GCs) and TOF, and 26 patients were treated with GCs with MTX. The observation period was 12 months. Complete remission (CR), inflammatory parameter changes, GCs tapering and safety were assessed at the 6th, 9th and 12th month. Vascular lesions were evaluated at the 6th and 12th month, and relapse was analysed during 12 months.ResultsThe CR rate was higher in the TOF group than in the MTX group (6 months: 85.19% vs 61.54%, p=0.07; 12 months: 88.46% vs 56.52%, p=0.02). During 12 months’ treatment, patients in the TOF group achieved a relatively lower relapse rate (11.54% vs 34.78%, p=0.052) and a longer median relapse-free duration (11.65±0.98 vs 10.48±2.31 months, p=0.03). Average GCs dose at the 3rd, 6th and 12th month was lower in the TOF group than that in the MTX group (p<0.05). A difference was not observed in disease improvement or disease progression on imaging between the two groups (p>0.05). Prevalence of side effects was low in both groups (3.70% vs 15.38%, p=0.19).ConclusionTOF was superior to MTX for CR induction, a tendency to prevent relapse and tapering of the GCs dose in TAK treatment. A good safety profile for TOF was also documented in patients with TAK.


2021 ◽  
Vol 33 (2) ◽  
pp. 379-382
Author(s):  
Suneel Kumar Kaushal ◽  
Ashok Kumar Patel ◽  
Mukesh Yadav ◽  
Navin Kumar

Background: The COVID-19 pandemic is a global emergency. AEFIs reporting and assessment should be done with high priority as they could change the benefit-risk profile of the vaccine. Objective: To assess adverse effects after COVID-19 vaccination. Methods: This cross-sectional study conducted among 605 heath functionaries taken part from January 2021 to March 2021. Results: The most common AEFI reported was pain at injection site (51.9%). Gender, previous COVID status and perception before vaccination were significantly associated with AEFI. Conclusion: There was no serious adverse event after vaccination. COVID vaccine has a good safety profile.


2021 ◽  
Vol 9 ◽  
Author(s):  
Luca Marelli ◽  
Micol Romano ◽  
Irene Pontikaki ◽  
Maurizio Virgilio Gattinara ◽  
Paolo Nucci ◽  
...  

Objectives: To describe demographic, clinical and therapeutic findings of a large cohort of patients with JIA-associated uveitis in a nationwide referral pediatric rheumatology and uveitis center in Northern Italy.Methods: Retrospective study of 125 patients with JIA-associated uveitis followed from 2009 to 2019. Demographic and rheumatologic features including JIA ILAR classification, age at onset, and laboratory data were recorded. Ocular findings collected were: anatomic location of uveitis, laterality, type, recurrence rate, visual acuity, ocular complications, and local therapy. Systemic therapy with conventional and biologic immunosuppressants, occurrence of adverse events, and duration of treatments were recorded.Results: One hundred and twenty-five patients with JIA-associated uveitis were followed for a meantime of 9.2 (±1.7) years. Oligoarticular JIA was present in 92.8% of patients and anterior uveitis in 96%. The most common ocular complications recorded in our sample were posterior synechiae (37.6%), cataract (20.8%), band keratopathy (19.2%), glaucoma (7.2%), and macular edema (5.6%). Conventional immunosuppressants were used in 75.2% of patients with a mean duration of 9.1 years (±5.4), while biologics were administered in 47.2% of them for a period of 5.4 years. Adverse events (AE) were seen in 23% of patients being treated with Methotrexate, in 10.4% of patients treated with Adalimumab, in 38.5% of patients in therapy with Infliximab, and in 14.3% of patients being treated with Tocilizumab. No AE were reported in patients treated with Golimumab, Certolizumab, Abatacept and Rituximab.Conclusions: An aggressive treatment approach for patients with JIA-associated uveitis ensured a low number of ocular complications with a good safety profile.


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