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AIM: To investigate the safety of bioequivalence (BE) studies of orally inhaled drug products (OIDPs) conducted by Phase I clinical Research Center of our hospital. METHODS: The safety data were collected from 482 healthy subjects enrolled in 20 OIDPs BE studies in Wuxi People's hospital from 2017 to 2022. The difference of adverse events (AEs) between test preparation and reference preparation were compared, as well as the influence of gender, age, mechanism of drug action and device type on AE were analyzed. RESULTS: A total of 102 cases of AEs were occurred in 77 subjects (16.0%, 77/482), 87 cases of AEs were related to experimental drugs, all AEs were mild or moderate, and no serious adverse events occurred. There was no difference in the incidence of AE between test preparation and reference preparation. In addition, gender, age, mechanism of drug action and device type had no significant effects on AEs. CONCLUSION: In 20 bioequivalence studies of OIDPs, OIDPs were safe and well tolerated in healthy subjects after dosing, and safety features of generic OIDPs and original drug were basically similar.
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Objective: To analyzed perioperative safety of cytoreductive surgery (CRS) for patients with colorectal cancer peritoneal metastasis (CRPM) and to construct a predictive model for serious advese events (SAE). Methods: A descriptive case-series study was conducted to retrospectively collect the clinicopathological data and treatment status (operation time, number of organ resection, number of peritoneal resection, and blood loss, etc.) of 100 patients with peritoneal metastases from colorectal cancer or appendix mucinous adenocarcinoma who underwent CRS at the Sixth Affiliated Hospital of Sun Yat-sen University from January 2019 to August 2021. There were 53 males and 47 females. The median age was 52.0 (39.0-61.8) years old. Fifty-two patients had synchronous peritoneal metastasis and 48 had metachronous peritoneal metastasis. Fifty-two patients received preoperative neoadjuvant therapy. Primary tumor was located in the left colon, the right colon and the rectum in 43, 28 and 14 cases, respectively. Fifteen patients had appendix mucinous adenocarcinoma. Measures of skewed distribution are expressed as M (range). Perioperative safety was analyzed, perioperative grade III or higher was defined as SAE. Risk factors associated with the occurrence of SAEs were analyzed using multivariate logistic regression. A nomogram was plotted by R software to predict SAE, the efficacy of which was evaluated using the area under the ROC curve (AUC) and correction curves. Results: The median peritoneal cancer index (PCI) score was 16 (1-39). Sixty-eight (68.0%) patients achieved complete tumor reduction (tumor reduction score: 0-1). Sixty-two patients were treated with intraperitoneal hyperthermic perfusion chemotherapy (HIPEC). Twenty-one (21.0%) patients developed 37 SAEs of grade III-IV, including 2 cases of ureteral injury, 6 cases of perioperative massive hemorrhage or anemia, 7 cases of digestive system, 15 cases of respiratory system, 4 cases of cardiovascular system, 1 case of skin incision dehiscence, and 2 cases of abdominal infection. No grade V SAE was found. Multivariate logistic regression analysis showed that CEA (OR: 8.980, 95%CI: 1.428-56.457, P=0.019), PCI score (OR: 7.924, 95%CI: 1.486-42.259, P=0.015), intraoperative albumin infusion (OR: 48.959, 95%CI: 2.115-1133.289, P=0.015) and total volume of infusion (OR: 24.729, 95%CI: 3.956-154.562, P=0.001) were independent risk factors for perioperative SAE in CRS (all P<0.05). Based on the result of multivariate regression models, a predictive nomogram was constructed. Internal verification showed that the AUC of the nomogram was 0.926 (95%CI: 0.872-0.980), indicating good prediction accuracy and consistency. Conclusions: CRS is a safe and effective method to treat CRPM. Strict screening of patients and perioperative fluid management are important guarantees for reducing the morbidity of SAE.
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Adult , Female , Humans , Male , Middle Aged , Adenocarcinoma, Mucinous/therapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Appendiceal Neoplasms/surgery , Colorectal Neoplasms/pathology , Combined Modality Therapy , Cytoreduction Surgical Procedures/methods , Hyperthermia, Induced/methods , Peritoneal Neoplasms/secondary , Retrospective Studies , Survival RateABSTRACT
Clinical trail report is a summary of the process and results of clinical trail, an important basis to support the effectiveness and safety evaluation of drug marketing and an important technical data required for drug registration. Safety analysis is the main part and the most common issue of clinical trial report. In this article, it is summarized and analyzed the common problems found in the safety analysis part of the clinical trial report of new drugs of traditional Chinese medicine(TCM) in combination with the clinical professional evaluation of the application for marketing license of innovative TCM. The common problems in writing the safety aspects of clinical trail reports were summarized and analyzed, including the omissions of adverse events and laboratory test results, the failure to provide a detailed list of laboratory test outliers, the lack of professional depth in the analysis of the causal relationship between adverse events and TCM. In view of the common problems, it is suggested that the drug use degree, adverse events and adverse reactions, as well as laboratory examination should be considered. Check the three dimensions for necessary medical analysis, collation and summary and continuously improve the quality of safety analysis in clinical trial reports.
Subject(s)
Clinical Trials as Topic , Drugs, Chinese Herbal/adverse effects , Medicine, Chinese TraditionalABSTRACT
Objective: To explore the effect of transcatheter arterial chemoembolization(TACE) combined with high intensity focused ultrasound (HIFU) ablation on patients with middle and advanced liver cancer and to analyze its anti-tumor value. Methods: 126 patients with middle and advanced liver cancer who received palliative treatment were selected in the research. According to the different treatment program, they were divided into TACE groups (66 cases) which patients received TACE and TACE combined with HIFU ablation group (60 cases) which patients received the treatment of TACE combined with HIFU ablation. After 4 weeks of treatment, the therapeutic effect of solid tumor and the change of immune function indicator of the two groups were compared. At the same time, the results of follow-up visit were recorded, and adverse reaction of antineoplaston and survival situation were further compared. Results:After treatment, the immune function both of two groups were enhanced, and the cluster of differentiation (CD)3+, CD4+, and CD4+/ CD8+of TACE combined with HIFU ablation group was significantly higher than that of TACE group (t=6.303, t=6.049, t=2.148, P<0.05). While the clinical benefit rate of TACE combined with HIFU ablation group was significantly higher than that of TACE group (Z=2.975, P<0.05), and the survival rate of 1 year and survival rate of 2 years of TACE combined with HIFU ablation group were significantly higher than that of TACE group (x2=3.99, x2=4.33, P<0.05), respectively. On the other hand, the differences of complications, included skin burn, liver function damage and abdominal discomfort, between the two groups were no significant (x2=2.235, x2=0.847, x2=0.019, P>0.05). Conclusion:The technique of TACE combined with HIFU ablation can enhance immune function and the therapeutic effect of antineoplastic, and its advantages includes obvious effect of antineoplastic and safety of usage. Therefore, its application value should be paid higher attention in oncotherapy of solid tumor as this paper's suggestion.
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En el presente trabajo se muestran los resultados de la evaluación de seguridad del centro PET/CT, perteneciente al Instituto de Oncología y Radiobiología en la Habana, con el empleo del método de la matriz de riesgos. En la definición del listado de los sucesos iniciadores participó un equipo multidisciplinario (físicos médicos, radioquímicos, tecnólogos y médicos nucleares). Se consideraron varias etapas teniendo en cuenta el diseño de la instalación, el uso de la instrumentación nuclear, la radiofarmacia, la revisión de la pertinencia de las solicitudes de estudios, la recepción y fraccionamiento de radiofármacos, la producción de radiofármacos de , el manejo del paciente durante la administración de radiofármacos y el posicionamiento del paciente y la desclasificación de desechos radiactivos. Además, se incluyeron sucesos iniciadores relacionados con exploraciones de tomografía de rayos X (CT) para diagnóstico. Se evaluaron los riesgos de accidente en pacientes, público y TOEs. Debido a que la mayoría de los sucesos iniciadores tiene origen en errores humanos (89.5 %), se recomienda fuertemente el entrenamiento del personal antes de su inclusión en el equipo de trabajo, así como la implementación de programas de gestión de calidad basados en normas ISO
The present work shows the results of the safety evaluation of the PET/CT center belonging to the Institute of Oncology and Radiobiology in Havana by using the risk matrix method. A multidisciplinary team (medical physicists, radiochemists, technologists and nuclear physicians) participated in the definition of the list of initiating events. Several stages were considered taking into account the design of the facility, the use of nuclear instrumentation, radiopharmacy, review of the relevance of study requests, radiopharmaceutical reception and dose fractioning, -radiopharmaceuticalsproduction, as well as the management of patient during the administration of radiopharmaceuticals and patient positioning and the declassification of radioactive waste. In addition, initiating events related to X-ray tomography (CT) scans for diagnosis were included. Accident risks were evaluated in Patients, Public and Occupationally Exposed Workers (TOEs). Because most of the initiating events originate from human errors (89.5 %), staff training is strongly recommended prior to inclusion in the work team, as well as the implementation of quality management programs based on ISO standards
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Objective To analyze clopidogrel combined with aspirin therapy of acute cerebral infarction the safety and efficacy of micro brain hemorrhage patients.Methods Select from May 2015 and May 2015 months in the hospital for diagnosis and treatment of 76 cases of acute cerebral infarction combined micro cerebral hemorrhage patient study,observation group in the conventional treatment at the same time giving oral aspirin and clopidogrel,the control group in the conventional treatment at the same time,only to give oral aspirin.To observe the nerve function defect National institutes of Health stroke scale score(National Institute of Health stroke scale,NIHSS)and daily life activities ability pap index,determination of patients' blood plasma viscosity,whole blood low shear viscosity,AA induction and the platelet maximum aggregation rate induced by ADP(MARAA,MARADP),observation records during the treatment patients with adverse reactions,were analyzed.Results Compared with before treatment,the observation group and control group after treatment for 2 weeks,NIHSS score,score and blood related indexes were significantly improved,statistically significant difference(P< 0.05).Compared with control group,the observation group after treatment the NIHSS score,pap score and blood related indexes were significantly improved,total effective rate increased significantly,the differences were statistically significant(P< 0.05).Two groups of adverse drug reactions occurred situation is no statistical difference.Conclusion Clopidogrel in combination with aspirin can effective treatment in patients with acute cerebral infarction combined micro brain hemorrhage,and security.
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Objective of the current study was to investigate the effectiveness and safety of levofloxacin in the treatment of lower respiratory tract infection. The study was carried out in hospital on 120 patients with lower respiratory tract infection from January 2014 to January 2015. Patients were randomly divided into control and observation groups, each group contained 60 patients. The control group was given the routine dose of levofloxacin, whereas the observation group received the high dose of levofloxacin. The clinical effectiveness and incidence rate of untoward reactions between the two groups were statistically analyzed and evaluated. Patients’ cure rate in the observation group was 53.33%, significantly higher than that of the control group which was only 36.67%. Their differences have statistical significance (P<0.05). Observation group demonstrated a very good total effective rate of 93.33%, compared to the control group (78.33%). Their differences have statistical significance (P<0.05). Incidence of adverse reactions in case of both the observation and control group patients, were relatively low, resulting insignificant statistical difference between the groups (P>0.05). This study shows better clinical curative effect of high doses of levofloxacin treating lower respiratory infection with minimum risk. This method, which can significantly improve the quality of patient treatment with low adverse reaction risk, is worth popularizing in clinical use.
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Un accidente es provocado habitualmente por la ocurrencia simultánea de errores humanos y fallas en los equipos. En aplicaciones médicas, la radioterapia es la de mayor riesgo por la complejidad que presentan sus tratamientos en los pacientes. Los diferentes accidentes que han ocurrido en el mundo en esta práctica muestran la necesidad de aplicar análisis de seguridad capaces de identificar y prevenir exposiciones accidentales. En tal sentido, se reconoce la efectividad del método semicuantitativo de “matrices de riesgo”, que consiste en un análisis combinado de la frecuencia de ocurrencia del suceso que da inicio al accidente, la probabilidad de errores humanos o fallas de barreras de seguridad y la gravedad de las consecuencias de los sucesos, lo que permite defi nir criterios de aceptabilidad en base al riesgo. En esta investigación se aplicó este método para realizar un análisis de evaluación de seguridad al servicio de radioterapia de Holguín que posee un equipo de Cobalto- 60 Theratron Phoenix. El estudio permitió cuantificar las defensas que tiene el servicio e identificó los sucesos más significativos que contribuyen al riesgo desde el punto de vista de la seguridad, así como las recomendaciones más apropiadas para reducirlo. Se estimó el riesgo de un gran número de secuencias accidentales provocadas por todos los posibles errores humanos y fallos de equipo en el servicio, donde se apreció que ninguna de las secuencias accidentales fue de riesgo muy alto, lo cual confirmó que no existe riesgo inminente que pudiera provocar un accidente en esta instalación.
An accident is usually caused by the simultaneous occurrence of human errors and equipment failure. In medical applications, the radiation therapy is the increased risk of complexity presented by treatments in patients. The different accidents that have occurred in the world in this practice show the need for safety analysis in order to identify and prevent accidental exposures. In this regard, the effectiveness of the semiquantitative method of “risk matrices”, which consists of a combined analysis of the frequency of occurrence of the event causing the accident, the chance of human errors or failure of the safety barriers, in addition to recognizing the seriousness of the consequences resulting from such events; which defi ne the acceptability criteria based on risk. In this research, this method was applied for safety evaluation analysis of the radiotherapy service at Holguin hospital, which uses a cobalt 60 Theratron Phoenix equipment. The study allowed to quantify the radiotherapy service strengths, to identify the most signifi cant contributors to risk events from the viewpoint of safety, as well as to adopt the most appropriate mitigation measures in order to decrease the ocurrence of such accidents. The risk of a large number of accident sequences caused by all possible human errors and equipment failures in the service was estimated, and it was also observed and consequently concluded that none of the accident sequences was considered as very high risk thus confirming that there is no imminent risk which could result in an accident at this facility.
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Objective of the current study was to investigate the effectiveness and safety of levofloxacin in the treatment of lower respiratory tract infection. The study was carried out in hospital on 120 patients with lower respiratory tract infection from January 2014 to January 2015. Patients were randomly divided into control and observation groups, each group contained 60 patients. The control group was given the routine dose of levofloxacin, whereas the observation group received the high dose of levofloxacin. The clinical effectiveness and incidence rate of untoward reactions between the two groups were statistically analyzed and evaluated. Patients’ cure rate in the observation group was 53.33%, significantly higher than that of the control group which was only 36.67%. Their differences have statistical significance (P<0.05). Observation group demonstrated a very good total effective rate of 93.33%, compared to the control group (78.33%). Their differences have statistical significance (P<0.05). Incidence of adverse reactions in case of both the observation and control group patients, were relatively low, resulting insignificant statistical difference between the groups (P>0.05). This study shows better clinical curative effect of high doses of levofloxacin treating lower respiratory infection with minimum risk. This method, which can significantly improve the quality of patient treatment with low adverse reaction risk, is worth popularizing in clinical use.
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Objective To investigate clinical efficacy of simultaneous integrate boost for glioblastoma with intensity?modulated radiotherapy ( SIB?IMRT). Methods A total of 46 patients with glioblastoma who underwents SIB?IMRT from January 2013 to August 2014,were retrospectively analyzed. Toxicity after completion of SIB?IMRT were assessed. Kaplan?Meier method was used to analyze survival and progression?free survival. Multivariate analyses were performed to determine significant prognostic factors. Results There was no patients delayed by more than grade 3 radiation toxicity. The median overall survival and 1?year survival rates was 69 weeks and 73%,respectively. The progression free survival and 1?year progression?free survival rate were 43 weeks and 39%,respectively. The pattern of failure was identical (9 Local, 7 distant and 0 marginal recurrence). Multivariate analyses show that temozolomide concurrent chemoradiotherapy were independent factors correlated to prognosis. Conclusions The preliminary results demonstrate that SIB?IMRT for glioblastoma appear to be effective and safe. With the limted number of patients in this group,SIB?IMRT could be used for treating glioblastoma with caution,which deserves further study.
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OBJECTIVE:To investigate the characteristics and regularity of lornoxicam related ADR,and to provide reference for rational and safe use of lornoxicam. METHODS:From Jan. 1,2006 to Dec. 31,2013,lornoxicam related ADR reports collect-ed by National ADR Monitoring System in Beijing were analyzed retrospectively about their characteristics and related factors. RE-SULTS:In the statistical period,there were 48 ADR reports related to lornoxicam. The people over 40 years age accounted for 62.5%. 38 patients used lornoxicam by intravenous infusion or intramuscular injection ,accounting for 79.17%. The clinical mani-festations were diverse and complex,in which skin(32.96%)and gastrointestinal damage(25.00%)were more common ADR oc-curred within 30 min,accounting for 35.42%,and it would be better after stopping drug or 1-3 days symptomatic treatment. CON-CLUSIONS:The rational use of lornoxicam can reduce the occurrence of ADR. Suggestion on the use of the drug,is that the pa-tient should be monitored for security,in order to reduce the risk of ADR.
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RESUMEN Entre las más recientes aplicaciones del Análisis Probabilista de Seguridad de la Central Nuclear de Embalse está el Programa de Mantenimiento Orientado a la Seguridad, el cual se ha desarrollado a través de la metodología de Mantenimiento Centrado en la Confiabilidad. Esta aplicación se ha realizado de manera cooperada entre el personal del departamento de seguridad nuclear de la central y especialistas cubanos del Instituto Superior de Tecnologías y Ciencias Aplicadas. Hasta la fecha se han analizado seis sistemas tecnológicos, obteniéndose importantes resultados relacionados con la optimización del programa de mantenimiento preventivo y predictivo aplicado actualmente a dichos sistemas. Algunas tareas de la metodología se han automatizado a través del código MOSEG. Los resultados del estudio se enfocan a la redacción o modificación del contenido de las Planillas de Inspección, priorización de repuestos, reorientación de técnicas de diagnóstico y modificación de frecuencias y de duración de la ejecución de las acciones de mantenimiento.
ABSTRACT One of the most recent applications of Probabilistic Safety Analysis to Embalse NPP is the Safety Oriented Maintenance Program developed through the Realibility Centered Maintenence (RCM) methodology. Such an application was carried out by a cooperated effort between the staff of nuclear safety department of NPP and experts from Higher Institute of Technologies and Applied Sciences of Cuba. So far 6 technological systems have been analized with important results regarding the optimization of preventive and predictive maintenance program of those systems. Some RCM tasks were automated using the MOSEG code. The results of this study were focused on the elaboration and modification of the Preventive Program, prioritization of stocks, reorientation of predictive techniques and modification in the time parameters of maintenance.
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The purpose of this study is to investigate the current status of and to collect the basic informations of musculoskeletal diseases of upper extremities in manufacturing and telecommunication companies. The subjects were 213 workers, consisted Of 98 manufacturing workers and 115 telephoBfi operators. The musculoskeletal ,symptom survey, Job safety analysis (JSA), and medical examinations including neurologic, and'nerve.cqnduction velocity (NCV) test were conducted.: All workers were women in company A, while the other composed of 68(69.4%) men and 30(30.6%) women. The results were as follows: 1. The rates of self-reporting symptoms in each company were 85.2% at the neck, 81.1% at the shoulder joint, 73.0% at the wrist joint and 34.8% at the elbow joint in company A, while 56.1% at the shoulder joint, 51.2% at the neck and 23.5% at the elbow joint in company B in order. 2. No relationship was observed between the work duration and symptom rate in company A, but the highest symptom rate was observed at the neck in 10-19 year work duration group, at the shoulder, elbow and wrist joint in 5-9 year work duration group in company B. 3. Over the 22.8% of total workers in this study having symptoms got medical treatment at the medical clinics or drug stores, but there was no statistical difference between both companies. 4. In company A, 16(13.9%) workers were classified as D category, 12(10.4%) workers as C category and 2(1.7%) workers as R category among 115 workers. And D category was 10(10.2%), C category 31(31.6%) and R category 4(4.0%) among 98 workers in company B. D category means disease category needed futher treatment, C category means disease category needed no treatment and R category means recheck category, needed futher evaluation. 5. The types of musculoskeletal disorders including D, C, and R category were 46 cases(D 13, C 30, R 3) of tension neck .syndrome (TNS), 16 cases (D 3, C 8, R 5) of carpal tunnel syndrome (CTS), 5 cases of De Quervain's disease, 3 cases of lateral epicondylitis, 3 cases of bicipital tendinitis, 3 cases of rotator cuff tendinitis, 2 cases of medical epicondylitis, and 5 cases of cervical disc syndrome. 6. In company A, the total cases of 11 TNS, 8 CTS, 3 De Quervain's disease, 3 lateral epicondylitis, 3 rotator cuff tendinitis and 1 cervical disc syndrome were diagnosed and so were total cases of 35 TNS, 8 CTS and 4 cervical disc syndrome in company B. 7. By stepwise multiple regression analysis with dichotomization of musculoskeletal disease, the following odds ratios were significantly high (p<0.05)-sex (2.707) and age(l.926).
Subject(s)
Female , Humans , Male , Carpal Tunnel Syndrome , Cumulative Trauma Disorders , De Quervain Disease , Elbow , Elbow Joint , Musculoskeletal Diseases , Neck , Odds Ratio , Rotator Cuff , Shoulder , Shoulder Joint , Telecommunications , Tendinopathy , Upper Extremity , Wrist JointABSTRACT
The purpose of this study is to investigate the current status of and to collect the basic informations of musculoskeletal diseases of upper extremities in manufacturing and telecommunication companies. The subjects were 213 workers, consisted Of 98 manufacturing workers and 115 telephoBfi operators. The musculoskeletal ,symptom survey, Job safety analysis (JSA), and medical examinations including neurologic, and'nerve.cqnduction velocity (NCV) test were conducted.: All workers were women in company A, while the other composed of 68(69.4%) men and 30(30.6%) women. The results were as follows: 1. The rates of self-reporting symptoms in each company were 85.2% at the neck, 81.1% at the shoulder joint, 73.0% at the wrist joint and 34.8% at the elbow joint in company A, while 56.1% at the shoulder joint, 51.2% at the neck and 23.5% at the elbow joint in company B in order. 2. No relationship was observed between the work duration and symptom rate in company A, but the highest symptom rate was observed at the neck in 10-19 year work duration group, at the shoulder, elbow and wrist joint in 5-9 year work duration group in company B. 3. Over the 22.8% of total workers in this study having symptoms got medical treatment at the medical clinics or drug stores, but there was no statistical difference between both companies. 4. In company A, 16(13.9%) workers were classified as D category, 12(10.4%) workers as C category and 2(1.7%) workers as R category among 115 workers. And D category was 10(10.2%), C category 31(31.6%) and R category 4(4.0%) among 98 workers in company B. D category means disease category needed futher treatment, C category means disease category needed no treatment and R category means recheck category, needed futher evaluation. 5. The types of musculoskeletal disorders including D, C, and R category were 46 cases(D 13, C 30, R 3) of tension neck .syndrome (TNS), 16 cases (D 3, C 8, R 5) of carpal tunnel syndrome (CTS), 5 cases of De Quervain's disease, 3 cases of lateral epicondylitis, 3 cases of bicipital tendinitis, 3 cases of rotator cuff tendinitis, 2 cases of medical epicondylitis, and 5 cases of cervical disc syndrome. 6. In company A, the total cases of 11 TNS, 8 CTS, 3 De Quervain's disease, 3 lateral epicondylitis, 3 rotator cuff tendinitis and 1 cervical disc syndrome were diagnosed and so were total cases of 35 TNS, 8 CTS and 4 cervical disc syndrome in company B. 7. By stepwise multiple regression analysis with dichotomization of musculoskeletal disease, the following odds ratios were significantly high (p<0.05)-sex (2.707) and age(l.926).