Nitrosamines crisis in pharmaceuticals-Insights on toxicological implications,root causes and risk assessment:A systematic review

The presence of N-nitroso compounds,particularly N-nitrosamines,in pharmaceutical products has raised global safety concerns due to their significant genotoxic and mutagenic effects.This systematic review investigates their toxicity in active pharmaceutical ingredients(APIs),drug products,and pharmaceutical excipients,along with novel analytical strategies for detection,root cause analysis,reformulation strategies,and regulatory guidelines for nitrosamines.This review emphasizes the molecular toxicity of N-nitroso compounds,focusing on genotoxic,mutagenic,carcinogenic,and other physiological effects.Additionally,it addresses the ongoing nitrosamine crisis,the development of nitrosamine-free products,and the importance of sensitive detection methods and precise risk evaluation.This comprehensive overview will aid molecular biologists,analytical scientists,formulation scientists in research and development sector,and researchers involved in management of nitrosamine-induced toxicity and promoting safer pharmaceutical products.

Early prediction of major depression in chronic hepatitis C patients during peg-interferon α-2b treatment by assessment of vegetative-depressive symptoms after four weeks

AIM: To study the predictive value of the vegetative- depressive symptoms of the Zung Depression Rating Scale for the occurrence of depression during treatment with peg-interferon α-2b of chronic hepatitis C (CHC) patients. METHODS: The predictive value of vegetative- depressive symptoms at 4 wk of treatment for the occurrence of a subsequent diagnosis of major depressive disorder (MDD) was studied in CHC patients infected after substance use in a prospective, multi- center treatment trial in Belgium. The presence of vegetative-depressive symptoms was assessed using the Zung Scale before and 4 wk after the start of antiviral treatment. RESULTS: Out of 49 eligible patients, 19 (39%) developed MDD. The area under the ROC curve of the vegetative Zung subscale was 0.73, P = 0.004. The sensitivity at a cut-point of > 15/35 was 95% (95% CI: 74-100). The positive predictive value equalled 44% (95% CI: 29-60). CONCLUSION: In this group of Belgian CHC patients infected after substance use, antiviral treatment caused a considerable risk of depression. Seven vegetativedepressive symptoms of the Zung scale at wk 4 of treatment predicted 95% of all emerging depressions, at a price of 56% false positive test results.

Mothers overcoming remorse to care for self and baby:An emerging concept

Objectives:Mothers with substance use disorder(SUD)experience a range of emotions such as feeling ostracized,diminished,and distressed while watching their baby experience withdrawal from substances.Being fully present in the now moment is to trust self to do what is best by moving beyond perceived boundaries to care for self and baby.The process of concept building arose from nursing practice encounters in a special care nursery(SCN)for babies who experienced withdrawal from substances.Method:Liehr and Smith’s 10-phase concept building approach was used to guide the development of this concept.Concept building began with a practice story.The emerging concept was named,core qualities identified,and supported through a literature review.The middle range theory of uncertainty in illness was chosen to serve as theoretical support for the concept.A model was created to provide clarity on the relationships within the concept.Result:A mini-saga was gathered from a mother in the SCN whose newborn had experienced withdrawal from substances.The minisaga follows:Due to the baby’s discomfort and judging eyes of the staff,she was unable to mother her baby.As the baby recovered,she asked for help,comforted her baby,and gained confidence to move beyond perceived boundaries to become the mother she envisioned.Overcoming perceived boundaries to attend to self and baby is trusting oneself to do what is best in spite of feeling ostracized,diminished,and distressed while watching baby withdraw from substances.Conclusion:This concept provides the perspective of mothers with SUD through intermodernism from experiences in nursing practice.The Uncertainty in Illness theory further allows practitioners to gain an understanding of the role uncertainty plays in this unique situation.

A Brief Introduction to Researches on Treatment of Hormone-dependent Asthma with Traditional Chinese Medicine

In recent years, with the establishment of the theory of air passage inflammation concerning the pathologic mechanism of asthma, the glucocorticoid hormone (referred to hereafter only as hormone for short), a strong inflammation killer, has become a fundamental medication for treatment of asthma. However, long period of hormone administration will result in general side effects in the whole body as well as hormone dependence, which has now become a hard problem for physicians. Now a non-hormone medication of immunosuppressant has been chosen in western medicine to treat asthma as a replacement or partial replacement of hormone. Nevertheless, its therapeutic effect is not reliable and its side effects severe, hence hardly acceptable to patients. Traditional Chinese medicine (TCM) always adheres to the principle of holistic treatment and has a great advantage in the treatment of this disease. TCM doctors have made some trials and researches in this area and obtained some accomplishments. The following is a brief account of general researches on the treatment of asthma with TCM.

Psychoactive Substance Use and Disabled People: An Integrative Review

This study aimed to analyze the evidence available in the literature about psychoactive substance use by persons with disabilities. We used integrative review of literature in SciELO, PubMed, SCOPUS, BDENF, and PsychINFO databases, with the descriptors: pessoas com deficiência;transtornos relacionados a uso de substancias;disabled persons;and substance-related disorders. Twelve articles were included in the sample. Data were analyzed and discussed descriptively. The studies’ results, with scientific evidence, were synthesized on two main themes: substance use by people with disabilities, and access of people with disabilities to treatment for substance-related disorders. The scientific evidences identified in studies reported disability as a risk factor for substance abuse, and also reported that disabled persons did not have access to treatment and rehabilitation services for substance abuse. Finally, the studies analyzed pointed to the need for scientific research on this topic.

CLINICAL OBSERVATION ON 25 CASES OF HORMONE DEPENDENT BRONCHIAL ASTHMA TREATED BY ACUPUNCTURE

The clinical observation revealed that the asthmatic symptoms in most of the patients began to be improved after several acupuncture treatments with the dosage of the drug gradually reduced. Generally, the dose of cortisone per os was decreased by 2 mg every 10 days, while that of aerosol was controlled by the patients themselves according to the condition of the disease. The symptoms in most of the patients were markedly improved after 15 treatments, but the treatment should be continued for another 10 times to consolidate the curative effect. Thus, each asthmatic patient needs to receive approximately 30 sessions of acupuncture treatment, lasting about 3 months. Thereafter, in order to prevent its relapse, the treatment should be administered 10 times each year in the summer season. It is worthy to be mentioned that, in this series, there was a female patient who suffered from anaphylactic asthma induced by dog's hair. She received 10 sessions of acupuncture treatment with no any improvement. In this case, the acupuncture treatment should not be given any longer. There were another two children patients aged 5 and 7 years respectively, for them the above method of acupuncture treatment was difficult to be used. Therefore, the auricular pressing method combined with cupping was adopted instead. The auricular points selected were Shenmen, Lung, Large Intestine, sensitive point, Pingchuan, Subcortex, and Kidney. 5 points were used each time, and pressed with the seeds of Vaccaria which were changed every 3 days. The patients were asked to press each of the points themselves 3 times a day (each time by 20 pressings). And Dazhui (Du 14), Feishu (UB 13), Pishu (UB 20) and Shenshu (UB 23) were cupped for 5 min. each time. The auricular pressing and cupping therapies may also be added for adult patients to strengthen the curative effect. The 25 cases of hormone dependent bronchial asthma were treated by acupuncture, yielding a markedly effective rate of 56% with a total effective rate of 96%, indicating that good therapeutic results can also be expected in the western countries for those cases who have already been treated with hormones.