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With the rapid development of nanotechnology, the research and development of nanomedicines have become one of the development directions of drug innovation. Nanomedicines have special physical and chemical properties, such as nanoscale effects and nanostructure effects, so they have special biological properties, which may change the pharmacokinetic profiles such as absorption and tissue distribution of drug molecules, and thus affect their safety and effectiveness. There are many special concerns on the non-clinical safety evaluation of nanomedicines at the basis of ordinary drug because of the particularity of nanomedicines. On August 25, 2021, China issued Guidance on Non-clinical Safety Evaluation for Nanomedicines(interim). This article interprets comprehensively the guidance, focuses on the key points of non-clinical safety evaluation for nanomedicines, and expounds combined with some cases, aiming to provide reference for drug researchers.
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Amid the modernization and internationalization of traditional Chinese medicine(TCM), the safety of TCM has attracted much attention. At the moment, the government, scientific research teams, and pharmaceutical enterprises have made great efforts to explore methods and techniques for clinical safety evaluation of TCM. Although considerable achievements have been made, there are still many problems, such as the non-standard terms of adverse reactions of TCM, unclear evaluation indicators, unreasonable judgment methods, lack of evaluation models, out-of-date evaluation standards, and unsound reporting systems. Therefore, it is urgent to further deepen the research mode and method of clinical safety evaluation of TCM. Based on the current national requirements for the life-cycle management of drugs, this study focused on the problems in the five dimensions of clinical safety evaluation of TCM, including normative terms, evaluation modes, judgment methods, evaluation standards, and reporting systems, and proposed suggestions on the development of a life-cycle clinical safety evaluation method that conformed to the characteristics of TCM, hoping to provide a reference for future research.
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Medicine, Chinese Traditional/adverse effects , Social ChangeABSTRACT
Objective:To evaluate the efficacy and safety of Biapenem in very elderly patients(≥85 years old)with respiratory infections, and to provide a basis for rational use of Biapenem.Methods:A retrospective study was conducted on patients ≥85 years old, who had received Biapenem and undergone relevant laboratory tests from January 2016 to December 2017.Results:A total of 194 patients, with an average age of (88.5±3.1)years were enrolled.The rate of clinical effectiveness for infection treatment was 66.5%(129/194).Logistic regression analysis showed that blood urea nitrogen(BUN)≥8.2 mmol/L( OR=2.404, 95% CI: 1.425-4.065, P=0.001)and Biapenem monotherapy( OR=1.995, 95% CI: 1.175-3.386, P=0.006)were independent risk factors for treatment failure, while other factors, such as underlying diseases, body temperature, previous drug use, alanine aminotransferase levels and aspartate aminotransferase levels, showed no clear association with clinical outcomes.BUN showed significant elevations from pretreatment(8.6 ± 5.1)mmol/L to post-treatment(10.3 ± 9.8)mmol/L( t=-3.362, P=0.001).Adverse drug reactions were observed in 11.9%(23/194)patients, and all these were mild or intermediate. Conclusions:Biapenem is efficacious and safe when used for the treatment of respiratory infections in very elderly patients, and BUN level monitoring during treatment is recommended.
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The European Union released Guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicinalproducts rev.1 in July 2016.It is noteworthy in the guideline that the test data can be replaced by the literature when the herbal medicine products are applied for registration and according to the scientific strength of the literature,different indications can be approved.This paper introduces the main contents of the guideline and is expected to inspire the research and supervision of Chinese materia medica and phytomedicine in China.
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Objective:The application of a combined ultrasound and pneumatic lithotripter for cholelithiasis was investigated.Methods:A total of 59 cases of cholelithiasis diagnosed by ultrasonography and CT were included in the study.All the patients had surgical treatment from January 2013 to December 2015,in which 30 patients were treated with a combined ultrasound and pneumatic lithotripter protocol (EMS group),and 29 patients were treated with traditional choledochoscope protocol(control group).All the patients were followed up for 3 months postoperation.The outcomes of patients in EMS group and control group were compared.Results:The postoperative stone free rate after the first operation is higher in EMS group than in control group(P＜0.05).The operation time and total lengths of hospital stay were shorter in EMS group than in control group(P＜0.05).There was no significant difference in intraoperative hematobilia rate,intraoperative bile duct injury rate,postoperative biliary tract infection rate,hepatic biochemical index and mortality between two groups(P＞0.05).Conclusion:The combined ultrasound and pneumatic lithotripter is useful for treatment of cholelithiasis.
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To further evaluate the safety of ginkgo diterpene lactone meglumine injection in the clinical use in ischemic stroke patients. Clinical safety study was conducted in 82 clinical units and 6 300 cases were completed and included from June 2013 to December 2014 by using multicenter, prospective, open and uncontrolled design methods for clinical research. A total of 29 cases of adverse reactions were observed in the experiment. Adverse reaction ratio (ADR) was 0.46%, and about 86.21% (25 cases) of them was mild with transient response which could be alleviated or disappeared without intervention; about 13.79% (4 cases) was moderate, including 2 cases of headache, 1 case of dizziness and 1 case of rash; no serious adverse reactions were found. The adverse reactions occurred in this study were pre-known adverse reactions or common adverse reactions of Chinese medicine injection. The overall incidence of adverse reactions was low, and the risk was controllable.
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Introducción: la educación en ciencias de la salud ha requerido adaptaciones de acuerdo a necesidades de la población, y así muchos programas de estudios han adoptado el modelo de competencias. Se hace necesario demostrar la adquisición del conocimiento práctico desarrollándose actividades con seguridad y destreza que permita la atención clínica efectiva. Objetivo: analizar niveles de destreza y seguridad autoreportados y rendimiento obtenido por estudiantes de la carrera de Obstetricia y Puericultura de la Universidad de Concepción, Chile, que entrenan competencias obstétricas, además con simulación clínica. Métodos: se realizó estudio no experimental, analítico y relacional, en 127 estudiantes de la carrera de Obstetricia y Puericultura de la Universidad de Concepción, en el año 2014. Se aplicó encuesta para medir destreza con escala tipo Likert posterior al entrenamiento de competencias obstétricas en modalidad preclínica, y la seguridad en modalidad clínica y se relacionó con el rendimiento obtenido. Se realizó análisis descriptivo y relacional. Resultados: 119 estudiantes respondieron las encuestas para destreza y 115 para seguridad. Las competencias obstétricas fueron 30, de complejidad variable, con resultados diversos. Las destrezas altas se relacionan con seguridad alta, sin embargo no todas las competencias siguen este curso. La destreza no se relaciona con rendimiento. Conclusiones: las competencias obstétricas son diversas en complejidad, con diferentes niveles de destreza y seguridad, algunas muy altas y otras más bajas, sin embargo algunas importantes presentan niveles más bajos que los esperados. Es necesario ordenar los niveles de complejidades. La evaluación de los estudiantes no se relaciona con el logro de competencias, se hace necesario establecer instrumentos adecuados(AU)
Introduction: The education of health sciences has required adjustments according to the needs of the general population and therefore most programs have adopted models based on competencies. It is necessary to demonstrate the acquisition of practical knowledge developed with regards to safety and skill that allows for more effective clinical care. Objective: To analyze the self-reported levels of skill and safety and the assessments obtained by students of midwifery at University of Concepcion, Chile. They train in obstetric skills mainly via clinical simulation. Method: Analytical and relational, non-experimental study with non-probabilistic by 119 volunteer midwifery students at the university at the University of Concepcion in 2014. A Likert type scale survey was administered post practical trainings in preclinical and clinical settings which was correlated with the student's performances. A descriptive and relational analysis was executed. Results: 119 students completed the surveys for skill level and 115 for security of procedures. There were 30 obstetric skills practical trainings, all of varying degrees of complexity with mixed results. High levels of skill are related to high levels of security but not all of their competencies follow this pattern. The level of skill does not relate to performance. Conclusions: Obstetric skills are diverse in terms of complexity, with diferent levels of skill and safety, mostly high for both, but some are not important. It is necessary to sort the levels of complexity. The evaluation of students is not related to the achievement of competencies. It is necessary to establish appropriate measuring instruments(AU)
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Humans , Professional Competence , Child Care , Clinical Competence , Perinatal Care , Midwifery/trends , Students , Gynecology/education , Obstetrics/educationABSTRACT
Safety,efficacy and quality control are the three essential elements for drugs,including traditional Chinese medicine(TCM). Currently,rapid development of life sciences,medicine and phar?macy provides new prospects for TCM. Considering the long history of TCM application,modern phar? macology and toxicology, global standards and expectations on the safety of TCM, how to evaluate the safety of TCM scientifically has become a key to the research and development of TCM. This review aims to discuss current technical requirements of non-clinical safety study of TCM as well as the challenges.
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There is an increasing demand for neonatal and juvenile animal toxicity studies during the research and development of new drugs. In this paper,we discussed general evaluation parameters of pediatric non-clinical safety with pediatric drugs,such as growth and development and food intake,and paramenters of other organs and systems, such as the central nervous system,reproductive system, behavior evaluation in combination with our own experience. In addition,the characteristics of non-clin?ical safety evaluation of new traditional Chinese medicine materia medica used for juvenile animals were analyzed. This paper is intended reference for non-clinical safety evaluation of pediatric drugs and to gain some experience related to formulation of new guidelines.
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At present,the various levels of safety evaluations of traditional Chinese medical (TCM) injections were in force in post-marketing clinical researches,while the process quality is guaranteed with difficulty.Therefore,it is requisite to call for technical guidance.By drawing lessons from the international experience of drug marketing safety evaluation and the related methods,we proposed the key techniques of quality control for clinical safety evaluation of TCM injections from the three aspects:preparation,implementation and summarization of researches,combining with the characteristics of TCM injections.The key techniques contained some scientific problems,ethics,publicity,data management,statistical analysis,specification report,etc.This paper comprehensively introduced the requisite technologies and methods over research quality,laying a foundation for the studies of post-marketing clinical safety evaluation of TCM injections.
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Aim: The present study aims to investigate the perceptions of basic life support (BLS), motivations for learning BLS and self-evaluations of the ability to practice BLS skills in radiological technologists clinically working in Mie prefecture, Japan. Methods: A cross-sectional questionnaire survey was conducted on 489 radiological technologists (RTs) living in Mie prefecture, Japan, from August to December 2014. The responded questionnaire was collected from 158 RTs (recovery rate: 32%) with written informed consent. Results: Almost one third of the RTs (32.3%) had encountered cardiopulmonary arrest during a radiological examination. The percentage of those who ‘understood’ the purpose and method of BLS reached 71.5%. Approximately half of the respondents considered the ability to practice BLS ‘practicable’, while the remaining half considered it to be ‘difficult’. All RTs knew of the term ‘AED’, and 98.7% ‘understood’ the purpose of AEDs and how to handle them. Similarly, 92.4% of them responded that they were ‘practicable’ to use AEDs. Although sixty percent of RTs had undertaken a BLS training course, only three quarters of them considered themselves ‘practicable’ BLS and 65.6% had no confidence in their BLS skills. Moreover, 39.2% of RTs had not undertaken a BLS training course, and only 9.7% responded ‘practicable’ for practice of BLS among those with training course experience. None of RTs who had not undertaken a BLS training course answered ‘fully confident’ and 95.2% had no or little confidence in their BLS skills. Conclusion: In this study, it is considered that many RTs understand the purpose and handling of AEDs and have the ability to use an AED. The majority of the RTs participating in a BLS training course are ‘practicable’ to practice BLS, though they felt ‘little confidence’ about their BLS skill level. In contrast, the majority of RTs with no experience of attending a BLS training course were not able to practice BLS. Therefore, a BLS training course is very crucial for obtaining the ability to practice BLS, although there is a necessity to improve the content of BLS training course.
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Objective. Due to the importance of controlling ectoparasites, associated with the necessity of technical knowledge on the safety of topical treatment with organophosphates, pyrethroids and piperonyl butoxide to the animal organism, this bioassay was carried out to evaluate the clinical safety of the association of dichlorvos (45%) + cypermethrin (5%) + piperonyl butoxide (25%) administered by spray on the skin of cattle, through the study of clinical parameters, biochemical, haematological and behavioral changes. Materials and methods. Sixteen crossbred animals with a mean age of 18 months, males and females grouped into two treatments with eight animals each: T1 (1:800 v/v) and T2 (1:200 v/v). Were collected blood samples at six different times: before treatment (BT), 24, 48, 72, 96 and 192 hours post treatment (HPT). Results. The antiparasitic association administered by spray on the skin did not result in changes in the enzymatic activity of ALT, AST, GGT and ALP, as well as in serum albumin, triglycerides, cholesterol, urea and creatinine, demonstrating the safety of this antiparasitic compound for maintaining hepatic and renal functionality. The erythrocyte, leukocyte and platelet studies showed no changes caused by treatments, and no clinical signs and behavioral changes were observed after treatment. Conclusions. These findings demonstrated good safety margin for spray treatment on the skin with this antiparasitic compound, even when administered at a dilution of 1:200 v/v, which is four times the dose recommended for ectoparasite control.
Objetivo. Debido a la importancia del control de ectoparásitos en bovinos, asociado a la necesidad de conocimientos técnicos sobre la seguridad del tratamiento tópico con organofosforados, piretroides y butóxido de piperonilo, se realizó este bioensayo para la evaluación de la seguridad clínica de la asociación de diclorvos (45%) + cipermetrina (5%) + butóxido de piperonilo (25%), administrado por aspersión en la piel del ganado bovino, a través del estudio de los parámetros clínicos, bioquímicos, hematológicos y comportamentales. Materiales y métodos. Dieciséis animales entre machos y hembras cruzados con edad media de 18 meses, agrupados en dos tratamientos de ocho animales cada uno: T1 (1:800 v/v) y T2 (1:200 v/v). Fueron colectadas muestras de sangre en seis momentos diferentes: antes del tratamiento (BT), 24, 48, 72, 96 y 192 horas post tratamiento (HPT). Resultados. La asociación antiparasitaria administrada por aspersión en la piel no alteró la actividad enzimática de ALT, AST, GGT y FA, así como la albúmina, triglicéridos, colesterol, urea y creatinina, que demuestra la seguridad de este compuesto antiparasitario en la función renal y hepática. El análisis de eritrocitos, leucocitos y plaquetas no mostraron cambios en los tratamientos, tampoco fueron observados signos clínicos y de comportamiento post tratamiento. Conclusiones. Estos resultados demostraron buen margen de seguridad en el tratamiento por aspersión en la piel con este compuesto antiparasitario, incluso cuando se administra en una dilución de 1:200 v/v, que es cuatro veces la dosis recomendada para el control de ectoparásitos.
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Cattle , Organophosphates , Piperonyl Butoxide , Pyrethrins , Sprinkle IrrigationABSTRACT
OBJECTIVE: To investigate the local release and blood levels of etimicin from etimicin-loaded bone cement (ELBC) implants and their nephrotoxicity in rabbits. METHODS: Handmade cylindrical ELBC implants were quantitatively prepared and surgically implanted in rabbit femoral medullary cavity. The drug concentrations in local bone and surrounding tissues were determined. Blood levels of drug released from ELBC implants were determined at different time intervals post-implantation. The pharmacokinetic parameters of ELBC implants were calculated by using Phoenix WinNonlin 6.3 software. Blood urea nitrogen and serum creatinine in rabbits were determined using automatic biochemistry analyzer before and after drug administration to assess the nephrotoxicity. RESULTS: The major pharmacokinetic parameters of ELBC implants were as follows; t1/2 (13.2±4.71) h; tmax (4.44±0.88) h; ρmax (7163.153±1673.618) ng·mL-1. The drug concentrations of ELBC implants in local bone marrow were (226.14±60.20), (16.00±11.40), and (5.98±1.97) μg·g-1 after implantation for 1, 2, and 4 weeks, respectively. The corresponding concentrations of drug in the cortex of bone tissues were (54.68±36.98), (3.95±1.73), and (1.39±0.77) μg·g-1, respectively. The levels of blood urea nitrogen and serum creatinine had no significant change after the treatment of ELBC implants. CONCLUSION: Compared with intramuscular injection, ELBC implants result in sustained drug release, maintain drug concentration in local tissues higher than the minimum inhibitory concentration against most infectious bacteria for at least one month, and display lower nephrotoxicity, indicating a good prospect for clinical use.
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Objective To determine the safety of the fetal olfactory ensheathing cell(OEC) transplantation in patients with chronic spinal cord injury (SCI) by examination of the magnetic resonance imaging (MRI). Methods A prospective clinical study involving 16 patients with chronic SCI was designed to investigate the feasibility and biological safety of the fetal OEC transplantation in treatment of SCI. The olfactory bulbs from the 3-4-month-old aborted human fetuses following the strict ethical guidelines were harvested and trypsinized down to single fetal OEC. These cells were then cultured for 12-17 days and were prepared for a clinical use. From November 2001 to December 2002, 16 patients with chronic SCI were randomly enrolled. The patients suffered from SCI for 1.5-8 years (average 4.3 years) after the injury. The suspension (50 μl) containing about 1×106 fetal OECs was transplanted by an injection into the patients' spinal cords above and below the injury site. All the patients were assessed before the transplantation and were followed up with MRI for 29-42 months (average 38 mon) after the transplantation. Results No cell-related adverse effects were observed in any patient during the follow-up period. The follow-up with MRI did not reveal any development of optic glial tumor, tumor-like mass, new hemorrhage, edema, expanding cyst, new cyst formation, infection or disruption of the neural structure in the transplant site of all the patients. Conclusion This is the first clinical study demonstrating the long-term safety of the OEC therapy for SCI. The results indicate that our protocol is feasible and safe in treatment of patients with chronic SCI within 38 months after the injury. Although the size of the samples for our study was not big enough, the positive results of the study have encouraged us to make a further research in this field.