scholarly journals Genetic polymorphisms and drug interactions modulating CYP2D6 and CYP3A activities have a major effect on oxycodone analgesic efficacy and safety

2010 ◽  
Vol 160 (4) ◽  
pp. 919-930 ◽  
Author(s):  
CF Samer ◽  
Y Daali ◽  
M Wagner ◽  
G Hopfgartner ◽  
CB Eap ◽  
...  
Keyword(s):  
Drug Interactions ◽  
Genetic Polymorphisms ◽  
Analgesic Efficacy ◽  
Major Effect ◽  
Efficacy And Safety

Review on the Clinical Pharmacology of Hydroxychloroquine Sulfate for the Treatment of COVID-19

2020 ◽  
Vol 21 (6) ◽  
pp. 427-435 ◽  
Author(s):  
Cheng Cui ◽  
Siqi Tu ◽  
Valerie Sia Jie En ◽  
Xiaobei Li ◽  
Xueting Yao ◽  
...  
Keyword(s):  
Drug Interactions ◽  
Clinical Efficacy ◽  
Relevant Literature ◽  
The United States ◽  
Efficacy And Safety ◽  
Open Label ◽  
Infected People ◽  
Treatment Regimens ◽  
Therapeutic Drugs

Background: As the number of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infected people is greatly increasing worldwide, the international medical situation becomes very serious. Potential therapeutic drugs, vaccine and stem cell replacement methods are emerging, so it is urgent to find specific therapeutic drugs and the best treatment regimens. After the publications on hydroxychloroquine (HCQ) with anti- SARS-COV-2 activity in vitro, a small, non-randomized, open-label clinical trial showed that HCQ treatment was significantly associated with reduced viral load in patients with coronavirus disease-19 (COVID-19). Meanwhile, a large prophylaxis study of HCQ sulfate for COVID-19 has been initiated in the United States. HCQ offered a promising efficacy in the treatment of COVID-19, but the optimal administration is still being explored. Methods: We used the keyword "hydroxychloroquine" to conduct a literature search in PubMed to collect relevant literature on the mechanism of action of HCQ, its clinical efficacy and safety, pharmacokinetic characteristics, precautions for clinical use and drug interactions to extract and organize information. Results: This paper reviews the mechanism, clinical efficacy and safety, pharmacokinetic characteristics, exposureresponse relationship and precautions and drug interactions of HCQ, and summarizes dosage recommendations for HCQ sulfate. Conclusion: It has been proved that HCQ, which has an established safety profile, is effective against SARS-CoV-2 with sufficient pre-clinical rationale and evidence. Data from high-quality clinical trials are urgently needed worldwide.

scholarly journals Effects of CYP2D6 genetic polymorphisms on the efficacy and safety of fluvoxamine in patients with depressive disorder and comorbid alcohol use disorder

2018 ◽  
Vol Volume 11 ◽  
pp. 113-119 ◽  
Author(s):  
Mikhail S Zastrozhin ◽  
Elena A Grishina ◽  
Nataliya P Denisenko ◽  
Valentin Yu Skryabin ◽  
Dmitry D Markov ◽  
...  
Keyword(s):  
Alcohol Use ◽  
Depressive Disorder ◽  
Genetic Polymorphisms ◽  
Alcohol Use Disorder ◽  
Efficacy And Safety

scholarly journals Evaluation on immediate analgesic efficacy and safety of Kai-Hou-Jian spray (children’s type) in treating sore throat caused by acute pharyngitis and tonsillitis in children: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yan-ning Ma ◽  
Cheng-liang Zhong ◽  
Si-yuan Hu ◽  
Qiu-han Cai ◽  
Sheng-xuan Guo
Keyword(s):  
Clinical Trial ◽  
Sore Throat ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Effective Rate ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acute Pharyngitis ◽  
Randomized Controlled ◽  
Parallel Group

Abstract Background Acute pharyngitis and tonsillitis are common respiratory diseases for which children seek medical care. Their main clinical manifestation is sore throat which interferes with patients’ quality of life. However, there is no proven effective or safe method to treat it. It is necessary to find an excellent strategy to reduce sore throat and reduce the burden of acute illness. We designed the randomized controlled trial with the characteristics of traditional Chinese medicine (TCM) to determine the clinical positioning of Kai-Hou-Jian spray (children’s type) (KHJS) through evidence-based research. This trial aims to evaluate the immediate analgesic efficacy of KHJS on sore throat caused by acute pharyngitis and tonsillitis (wind-heat syndrome/heat exuberance in lung and stomach syndrome) in children and to observe its safety. Methods/design This is a prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. It will include 240 children with acute pharyngitis/tonsillitis from 7 study sites across China. All participants are randomly assigned to two parallel treatment groups, one with KHJS and the other with placebo sprays, for 5 consecutive days. The primary outcome is the time of analgesic onset. Secondary outcomes include duration of analgesic effect, area under time curve of 0–3 h Wong-Baker FACES Pain Rating Scale (WBS) score (AUC0-3 h), rate of analgesic onset, rate of disappearance of sore throat, changes of WBS score (in days), effective rate of pharyngeal signs, and effective rate of TCM syndrome. The incidence of adverse events during the trial is the primary safety outcome. In addition, vital signs and laboratory tests before and after medication are monitored. Discussion To our knowledge, this will be the first clinical trial to explore the immediate analgesic efficacy of a Chinese patent medicine spray for acute pharyngitis/tonsillitis induced sore throat in children in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it prove the efficacy and safety of KHJS in the treatment of sore throat caused by acute pharyngitis/tonsillitis in children, but it might also provide evidence for the treatment of acute sore throat with Chinese herbal medicine. Trial registration A multicenter, randomized, double-blind, very low-dose, parallel controlled trial for the immediate analgesic effect and safety of Kai-Hou- Jian spray (children's type) in the treatment of sore throat caused by acute pharyngitis and tonsillitis in children. Chinese Clinical Trial Registry ChiCTR2000031599. Registered on 5 April 2020

scholarly journals ANalgesic Efficacy and safety of MOrphiNe versus methoxyflurane in patients with acute myocardial infarction: the rationale and design of the ANEMON-SIRIO 3 study: a multicentre, open-label, phase II, randomised clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e043330
Author(s):  
Aldona Kubica ◽  
Agata Kosobucka ◽  
Piotr Niezgoda ◽  
Piotr Adamski ◽  
Katarzyna Buszko ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Analgesic Efficacy ◽  
Randomised Clinical Trial ◽  
Ethical Standards ◽  
Loading Dose ◽  
Efficacy And Safety ◽  
Open Label ◽  
Analgesic Treatment ◽  
Open Label Phase ◽  
St Elevation

IntroductionThe unfavourable influence of morphine on the pharmacokinetics of ticagrelor resulting in weaker and retarded antiplatelet effect in patients with acute coronary syndrome (ACS) has been previously shown. Replacing morphine with methoxyflurane, a potent, non-opioid analgesic agent, that does not weaken or delay the effect of antiplatelet agents may improve the clinical efficacy of treatment of patients with ACS.MethodsThe ANEMON-SIRIO 3 study was designed as a multicentre, open-label, phase II, randomised clinical trial aimed to test the analgesic efficacy and safety of methoxyflurane in patients with ACS. The study population will comprise patients with ST-elevation myocardial infarction or non-ST-elevation ACS admitted to the study centres with typical chest pain requiring analgesic treatment. Before percutaneous coronary intervention (PCI) for the patients with index ACS will be randomly assigned in 1:1 ratio to receive methoxyflurane administered by inhalation, or to obtain morphine administered intravenously. Analgesic treatment will be followed by 300 mg loading dose of aspirin and 180 mg loading dose of ticagrelor. Patients will be assessed with regard to pain intensity according to the Numeric Pain Rating Scale at baseline, 3 min after study drug administration and immediately after PCI. Moreover, patients will be actively monitored with regard to the occurrence of side effects of evaluated therapies, as well as adverse events that may be related to insufficient platelet inhibition (no-reflow phenomenon assessed immediately after PCI, administration of GPIIb/IIIa inhibitors during PCI, acute stent thrombosis).Ethics and disseminationThe study will be conducted in six Polish clinical centres from the beginning of in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.Trial registration detailsClinicalTrials.gov, NCT04476173.

scholarly journals Intrathecal betamethasone for cancer pain: A study of its analgesic efficacy and safety

2018 ◽  
Vol 63 (5) ◽  
pp. 659-667
Author(s):  
Hitoshi Taguchi ◽  
Keiko Oishi ◽  
Koh Shingu ◽  
Hideo Matsumoto ◽  
Munehiro Masuzawa
Keyword(s):  
Cancer Pain ◽  
Analgesic Efficacy ◽  
Efficacy And Safety

Combined oral contraceptives and treatment of new coronavirus infection (COVID-19): aspects of drug interactions

2021 ◽  
Vol 19 (1) ◽  
pp. 149-158
Author(s):  
O.A. Limanova ◽  
◽  
L.E. Fedotova ◽  
O.A. Gromova ◽  
◽  
...  
Keyword(s):  
Drug Interactions ◽  
Oral Contraceptives ◽  
Ethinyl Estradiol ◽  
Antihypertensive Drugs ◽  
Efficacy And Safety ◽  
Antiinflammatory Drugs ◽  
Combined Oral Contraceptives ◽  
Chlormadinone Acetate ◽  
Coronavirus Infection ◽  
Oral Hypoglycemic Drugs

This article discusses the problem of drug interactions between combined oral contraceptives on the example of Belara® (30 μg of ethinyl estradiol + 2 mg of chlormadinone acetate; Gedeon Richter, Hungary) and medications recommended for the treatment of new coronavirus infection (COVID-19) and concomitant disorders at the pharmacodynamic and pharmacokinetic levels with an assessment of the efficacy and safety of therapy for females. We described safe, potentially dangerous, and dangerous combinations of these drugs. Key words: new coronavirus infection (CAVID-19), combined oral contraceptives, antiviral drugs, antibacterial drugs, antiinflammatory drugs, anticoagulants, migraine drugs, antihypertensive drugs, oral hypoglycemic drugs, essential micronutrients, pharmacodynamic and pharmacokinetic interactions

An Open-Label, Analgesic Efficacy and Safety of Pituitary Radiosurgery for Patients With Opioid-Refractory Pain: Study Protocol for a Randomized Controlled Trial

Neurosurgery ◽  
2017 ◽  
Vol 83 (1) ◽  
pp. 146-153 ◽  
Author(s):  
Pierre-Yves Borius ◽  
Stéphanie Ranque Garnier ◽  
Karine Baumstarck ◽  
Frédéric Castinetti ◽  
Anne Donnet ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Relief ◽  
Cancer Pain ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Standards Of Care ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label

Abstract BACKGROUND Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. OBJECTIVE To assess the analgesic efficacy compared with standard of care is the primary goal. The secondary objectives are to assess ophthalmic and endocrine tolerance, drug consumption, quality of life, and mechanisms of analgesic action. METHODS The trial is multicenter, randomized, prospective, and open-label with 2 parallel groups. This concerns patients in palliative care suffering from nociceptive or mixed cancer pain, refractory to standard opioid therapy. Participants will be randomly assigned to the control group receiving standards of care for pain according to recommendations, or to the experimental group receiving a pituitary GammaKnife (Elekta, Stockholm, Sweden) radiosurgery (160 Gy delivered in pituitary gland) associated with standards of care. Evaluation assessments will be taken at baseline, day0, day4, day7, day14, day28, day45, month3, and month6. EXPECTED OUTCOMES We could expect pain improvement in 70% to 90% of cases at day4. In addition we will assess the safety of pituitary radiosurgery in a vulnerable population. The secondary endpoints could show decay of opioid consumption, good patient satisfaction, and improvement of the quality of life. DISCUSSION The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life.

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