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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Drug Regulation01:25

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Psychosurgery, the surgical alteration or permanent removal of brain tissue to alleviate severe psychological conditions, stands as one of the most radical and controversial treatments in the history of mental health care. Its development and application have evolved significantly, marked by dramatic shifts in scientific understanding and ethical perspectives.
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Parenteral Drug Delivery Systems: Injectables, Implants, and Infusion Devices01:28

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Parenteral drug delivery systems play a crucial role in modern therapeutics by enabling the direct administration of drugs into the systemic circulation, bypassing the gastrointestinal tract. These systems are particularly valuable for poorly absorbed oral medications that are unstable in the digestive environment or require rapid onset or sustained therapeutic levels. Delivery is achieved through intravenous, intramuscular, or subcutaneous routes, each selected based on the drug's properties...
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Drug Toxicity: Risk factors01:24

Drug Toxicity: Risk factors

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Adverse Drug Reactions (ADRs) are potential complications that arise during pharmacotherapy, influenced by multiple risk factors. Age plays a significant role; both neonates and the elderly are at heightened risk due to their respective immature and diminished metabolic and elimination processes. Gender also impacts ADRs, with females experiencing a 1.5 to 1.7-fold greater risk than males, which may be linked to pharmacokinetic, pharmacodynamic, and hormonal differences. Notably, neonates, the...
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Calculating drug dosage and accumulation in multiple-dose regimens is crucial for achieving therapeutic efficacy while avoiding toxicity. This involves determining the plasma drug concentrations over time to optimize dosing schedules. The principle of superposition is fundamental in this process, allowing for the prediction of drug concentration in plasma following multiple doses based on single-dose data.The principle of superposition asserts that the plasma concentration-time curves from...
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[Systematic review on safety of sofren injection].

Yi Que1,2, Yan-Ming Xie1, Xing Liao1

  • 1Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.

Zhongguo Zhong Yao Za Zhi = Zhongguo Zhongyao Zazhi = China Journal of Chinese Materia Medica
|September 21, 2017
PubMed
Summary

This review found sofren injection generally safe, with few adverse drug reactions (ADRs) like headache or dizziness reported in 5,872 patients. Long-term safety monitoring is recommended for this drug.

Keywords:
Chinese medicine injectionsafety evaluationsofren injectionsystematic review

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Area of Science:

  • Pharmacology
  • Clinical Medicine
  • Evidence-Based Practice

Background:

  • Sofren injection is used in clinical practice.
  • Comprehensive evaluation of its drug safety is essential.

Purpose of the Study:

  • To systematically review and evaluate the drug safety of sofren injection based on existing clinical studies.

Main Methods:

  • Systematic review of seven databases.
  • Inclusion/exclusion criteria applied to extract data from 63 articles (58 RCTs, 3 non-RCTs, 2 case reports).
  • Quality assessment of included studies and extracted information.

Main Results:

  • A total of 5,872 patients were included.
  • 23 cases of adverse drug reactions (ADRs) were reported (0.39%).
  • Most common ADRs included headache, palpitations, and dizziness, primarily affecting the nervous and cardiovascular systems. No serious adverse events were identified.

Conclusions:

  • Sofren injection demonstrates a favorable safety profile with a low incidence of ADRs.
  • Caution is advised during clinical application, and long-term safety monitoring and regulated clinical use are necessary.