scholarly journals Adverse Drug Reactions and Expected Effects to Therapy with Subcutaneous Mistletoe Extracts (Viscum albumL.) in Cancer Patients

2014 ◽  
Vol 2014 ◽  
pp. 1-11 ◽  
Author(s):  
Megan L. Steele ◽  
Jan Axtner ◽  
Antje Happe ◽  
Matthias Kröz ◽  
Harald Matthes ◽  
...  

Background.In Europe, mistletoe extracts are widely used as a complementary cancer therapy. We assessed the safety of subcutaneous mistletoe as a conjunctive therapy in cancer patients within an anthroposophic medicine setting in Germany.Methods.A multicentre, observational study was performed within the Network Oncology. Suspected mistletoe adverse drug reactions (ADRs) were described by frequency, causality, severity, and seriousness. Potential risk factors, dose relationships and drug-drug interactions were investigated.Results.Of 1923 cancer patients treated with subcutaneous mistletoe extracts, 283 patients (14.7%) reported 427 expected effects (local reactions <5 cm and increased body temperature <38°C). ADRs were documented in 162 (8.4%) patients who reported a total of 264 events. ADRs were mild (50.8%), moderate (45.1%), or severe (4.2%). All were nonserious. Logistic regression analysis revealed that expected effects were more common in females, while immunoreactivity decreased with increasing age and tumour stage. No risk factors were identified for ADRs. ADR frequency increased as mistletoe dose increased, while fewer ADRs occurred during mistletoe therapy received concurrent with conventional therapies.Conclusion.The results of this study indicate that mistletoe therapy is safe. ADRs were mostly mild to moderate in intensity and appear to be dose-related and explained by the immune-stimulating, pharmacological activity of mistletoe.

2017 ◽  
Vol 8 (6) ◽  
pp. 199-210 ◽  
Author(s):  
Paulo Henrique Santos Andrade ◽  
Adriano da Silva Santos ◽  
Carlos Adriano Santos Souza ◽  
Iza Maria Fraga Lobo ◽  
Wellington Barros da Silva

Background: The main objective of the present systematic review is to identify potential risk factors for adverse drug reactions (ADRs) through prospective cohort studies in pediatric inpatients. Methods: The data search was done in the following electronic databases PubMed/MEDLINE; Scopus; LILACS and Web of Science from the earliest record until 31 May 2015. Two reviewers independently screened each study and one of them assessed the methodological quality according to the Newcastle–Ottawa scale for cohort studies. The data extraction was conducted according to Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative for cohort studies. Results: The only risk factor observed in all studies was the increase in the number of prescription drugs. However, other factors were identified, such as the increase in the length of stay or the number of low- or high-risk drugs prescribed, use of general anesthesia and oncological diagnosis. The cumulative incidence of ADR was 16.4% (95% confidence interval: 15.6 to 17.2). The main professional responsible for ADR identification was the pharmacist and the dominant category among the ADRs were gastrointestinal disorders. In addition, analgesics, antibacterial agents and corticosteroids were the drug classes commonly associated with ADRs. The methodology used in this study was tried to homogenize the data extracted; however, this was not sufficient to correct the discrepancies so it was not possible to perform a meta-analysis. Conclusions: The increase in the number of prescription drugs was the main risk factor in this population. However, additional studies are required to identify the risk factors for ADRs in pediatric inpatients.


2019 ◽  
Vol 08 (02) ◽  
pp. 130-133
Author(s):  
S. George Sneha ◽  
Kalpana Simhadri ◽  
Viswam K. Subeesh ◽  
S. Varghese Sneha

Abstract Objectives: The objective of this study was to study the predictors of adverse drug reactions (ADRs) among geriatric patients in the Department of Medical Oncology. Methods: A hospital-based prospective observational study was carried out among 153 inpatients in the Department of Medical Oncology for 6 months. Patients above 60 years of age with a confirmed history of malignancy were included in the study. The potential risk factors for ADR were defined in relation to the patient and chemotherapeutic regimen and relationship between them was assessed by univariate and multivariate logistic regression analysis. Results: Among 153 patients, 94 (64.43%) experienced ADRs. The mean ADR per patient was 0.88 ± 1.2. The common ADRs found were alopecia (30.18%) and diarrhea (28.68%). Risk estimates revealed that there was a significant association between smokers (odds ratio [OR] = 10.326; 95% confidence interval [CI] 2.345–45.47, P = 0.001), alcoholics (OR = 10.897; 95% CI 2.479–47.902, P = 0.001), increasing age (OR = 2.22; 95% CI 1.698–2.909, P = 0.001), overweight (OR = 16.68; 95% CI 2.179–127.741, P = 0.001), and male participants (OR = 0.143; 95% CI 0.05–0.390 P = 0.001) with the development of ADRs. The risk of carboplatin (OR = 13.359; 95% CI 3.056–58.406 P = 0.001) and 5-fluorouracil (OR = 1.938 95% CI 1.266–2.935 P = 0.001) use and occurrence of ADRs were also found to be high. Conclusion: The study findings showed that smoking, alcohol consumption, age more than 70 years, and overweight had a high risk for developing ADRs in geriatric patients who underwent chemotherapy. The independent risk factors identified should be targeted for preventive measures to improve anticancer agent prescription and reduce the risk of ADRs.


2021 ◽  
pp. 1-9
Author(s):  
Christian Gessner ◽  
Karin Potthoff ◽  
Nikolaj Frost

<b><i>Background/Aim:</i></b> Chemotherapy-induced neutropenia is a common and serious complication in cancer patients receiving myelosuppressive chemotherapy. This analysis was undertaken to evaluate the effectiveness and safety of prophylaxis with lipegfilgrastim, a glycoPEGylated granulocyte colony-stimulating factor, in lung cancer patients undergoing chemotherapy in real-world clinical practice. <b><i>Methods:</i></b> Data from two European non-interventional studies (NIS NADIR and NIS LEOS) investigating lipegfilgrastim for primary and secondary prophylaxis were pooled. Outcomes included the incidence of chemotherapy-induced neutropenia and febrile neutropenia (FN), use of anti-infectives and antimycotics, and adverse events and their relationship to lipegfilgrastim. <b><i>Results:</i></b> The safety population included 361 patients with lung cancer (median age, 66 years [range, 36–88]), of whom 322 had received 2 or more consecutive cycles of lipegfilgrastim (efficacy population [primary prophylaxis, 75.5%; secondary prophylaxis, 16.5%]). Almost 40% of the patients were considered to have a high risk (&#x3e;20%) of FN, and around 60% had an intermediate risk (10–20%). For all cycles, FN was reported in 3 patients (0.9%), neutropenia in 14 (4.3%), and grade 4 neutropenia in 9 (2.8%). Anti-infectives were used in 27 patients (8.4%) and antimycotics in 6 (1.9%). The incidence rates were lower for the patients’ first cycle (FN, 0.4%; neutropenia, 0.8%; grade 4 neutropenia, 0.8%; anti-infectives, 0.6%; antimycotics, 0.6%). Adverse drug reactions considered lipegfilgrastim related were reported in 35 patients (9.7%), and serious adverse drug reactions in 10 (2.8%). None of the fatal events reported in 28 patients (7.8%) were lipegfilgrastim related. <b><i>Conclusion:</i></b> Lipegfilgrastim administered to patients with lung cancer undergoing chemotherapy in real-world clinical practice showed similar effectiveness and safety to that reported in published pivotal trials.


2014 ◽  
Vol 23 (4) ◽  
pp. 1091-1097 ◽  
Author(s):  
Naomi Iihara ◽  
Takayuki Nishio ◽  
Tetsuko Goda ◽  
Hideaki Anzai ◽  
Masatoshi Kagawa ◽  
...  

2019 ◽  
Vol 29 (1) ◽  
pp. 111-121 ◽  
Author(s):  
Waldemar Greil ◽  
Xueqiong Zhang ◽  
Hans Stassen ◽  
Renate Grohmann ◽  
René Bridler ◽  
...  

2021 ◽  
Vol 5 (7) ◽  
pp. RV5-RV10
Author(s):  
Yashika Kaushal ◽  
Ratibha Kausal ◽  
Isha Sharma

Methotrexate is a type of disease-modifying anti-rheumatic drug (DMARD). It is used to reduce activity of the immune system for people who have certain conditions. Methotrexate is a chemotherapy agent and immune system suppressant. Its use may be limited by concerns regarding its adverse reactions. The occurrence of adverse drug reactions in some cases leads to the therapy discontinuation. Although adverse drug reactions (ADR) of methotrexate generally do not pose a serious threat to the health of patients and a reduction in the dose of methotrexate leads to their elimination, in some cases severe toxicities of the drug occur unpredictably. These facts explain the need for close monitoring of the patient’s condition and the identification of potential risk factors for drug toxicity on the part of different organs and functional systems. The purpose of this review is to detail about safety and tolerability of methotrexate.


2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Luis A. Sánchez-Hurtado ◽  
Nancy Hernández-Sánchez ◽  
Mario Del Moral-Armengol ◽  
Humberto Guevara-García ◽  
Francisco J. García-Guillén ◽  
...  

Objective. The aim of this study was to estimate the incidence of delirium and its risk factors among critically ill cancer patients in an intensive care unit (ICU). Materials and Methods. This is a prospective cohort study. The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) was measured daily at morning to diagnose delirium by a physician. Delirium was diagnosed when the daily was positive during a patient’s ICU stay. All patients were followed until they were discharged from the ICU. Using logistic regression, we estimated potential risk factors for developing delirium. The primary outcome was the development of ICU delirium. Results. There were 109 patients included in the study. Patients had a mean age of 48.6 ± 18.07 years, and the main reason for admission to the ICU was septic shock (40.4%). The incidence of delirium was 22.9%. The mortality among all subjects was 15.6%; the mortality rate in patients who developed delirium was 12%. The only variable that had an association with the development of delirium in the ICU was the days of use of mechanical ventilation (OR: 1.06; CI 95%: 0.99–1.13;p=0.07). Conclusion. Delirium is a frequent condition in critically ill cancer patients admitted to the ICU. The duration in days of mechanical ventilation is potential risk factors for developing delirium during an ICU stay. Delirium was not associated with a higher rate of mortality in this group of patients.


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