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OBJECTIVES: To explore the characteristics of the occurrence of antineoplastic drug adverse reactions (ADRs) in breast cancer and to utilize a computerized tool to identify early warning indicators of potentially serious ADRs. METHODS: We conducted descriptive statistical analyses of the demographic features, medication use characteristics, and clinical manifestations of suspected ADRs in ADR-exposed patients using data from the Shaanxi Provincial Adverse Drug Reaction Monitoring Center, China, from 2017 to 2021. Using disproportionality methods (reporting odds ratio, proportional reporting ratio, and comprehensive standard method), the relationship between drugs and ADRs was measured. Finally, a web-based clinical prediction model for serious ADRs based on binary logistic regression was developed to estimate individual event probabilities numerically. RESULTS: We developed a new computer-mineable breast cancer-ADR system. In total, 1119 ADR reports were received between 2017 and 2021, with an increasing trend in the number. Antineoplastic medications of natural sources made up the greatest portion of the drug category (530, 38.10%) while targeted drugs' part increased with time. The medicine with the greatest number of ADR cases was docetaxel. Bone marrow failure was the most reported ADR. The disproportionality methods produced 19 signals of disproportionate reporting, two signals of disproportionate reporting were unknown ADRs. The occurrence of serious ADRs was shown to be substantially correlated with gender, platinum drugs, and blood and lymphatic system disorders. The clinical prediction model for serious ADRs had above-moderate discriminatory power (C-index was 0.775). CONCLUSIONS: The number of ADRs to breast cancer antineoplastic drugs was constantly increasing, with docetaxel ranking first, with the majority of ADRs presenting as bone marrow suppression, nausea, and vomiting. Data mining identified 19 signals of disproportionate reporting.
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Antineoplásicos , Neoplasias da Mama , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Humanos , Feminino , Docetaxel , Neoplasias da Mama/tratamento farmacológico , Modelos Estatísticos , Sistemas de Notificação de Reações Adversas a Medicamentos , Prognóstico , Antineoplásicos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , FarmacovigilânciaRESUMO
OBJECTIVES: The popularity of contracted family doctor services in China has been growing in recent years, but community-family-doctor-based type 2 diabetes mellitus (T2DM) intervention programs have yet to be adequately studied. This study was to evaluate the short- and long-term effects of community-family-doctor-based self-management interventions for T2DM and to explore strategies for long-term glycemic control. STUDY DESIGN: This was a randomized controlled trial. METHODS: A total of 144 eligible participants were randomly assigned to intervention and control groups. The control group received only routine community diabetes care, and the intervention group received community-family-doctor-based interventions involving the same standard of care. The interventions lasted for 3 months, and the follow-up was continued for 15 months. Intention-to-treat analysis and generalized estimation equations were then used to determine the short- and long-term effects of the interventions on glycated hemoglobin (HbA1c), diabetes self-management, and medication adherence. RESULTS: There were statistically significantly greater improvements in all aspects of the intervention group after 3 months of intervention. Compared with baseline, changes in the attitude (ß = 0.384, 95% confidence interval [CI; 0.194, 0.574], P < 0.001), practice (ß = 1.751, 95% CI [0.762, 2.739], P = 0.001), and knowledge, attitudes, practice total scores (ß = 2.338, 95% CI [0.682, 3.995], P = 0.006) of patients in the intervention group were statistically significant after 15 months, and the HbA1c (8.19 ± 1.73%), knowledge (16.42 ± 3.21), and medication adherence (5.53 ± 1.76) scores were slightly better than those at baseline, although not statistically significant (P > 0.05). CONCLUSIONS: T2DM self-management interventions based on community family doctors improved patients' HbA1c, diabetes self-management, and medication adherence, did not do so significantly in the long term.
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Diabetes Mellitus Tipo 2 , Médicos , Autogestão , Humanos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hemoglobinas Glicadas , AutocuidadoRESUMO
OBJECTIVES: We aimed to explore the current status of medication adherence, safety awareness and practice among patients with lung cancer. METHODS: We conducted a questionnaire-guided cross-sectional study in Xi'an, Yulin, Hanzhong and Weinan in Shaanxi Province, China, from April to June 2021 for a period of 3 months. The study questionnaire was developed according to previous related studies reported in the literature, and includes basic demographic information and patients' medication safety questions. The data were double-entered using EpiData 3.1 software; descriptive statistics, t-test, analysis of variance, the Kruskal-Wallis test and the Mann-Whitney U-test were performed to analyse the data. RESULTS: A total of 567 participants were included, and 409 valid questionnaires were finally completed, with an effective response rate of 72.13%. More than 80% of patients showed good medication adherence; the average adherence score was 22 ± 2.68 of 25. The average score for medication safety awareness was 16.40 ± 4.41, which was significantly lower than that of medication adherence (p < .001). Only 22.74% of patients always checked their medicines before a nurse administered them; 17.60% of patients never checked their medicines. Few patients actively consulted an health care professional to understand safety information before taking a medication. A significant difference existed in safety awareness scores among age groups (p = .039) and geographic regions (p < .001). Patients with three or more comorbidities had the lowest awareness scores (p = .027). CONCLUSION: We found that patients with lung cancer showed better medication adherence, but their awareness about medication safety was poor. Older patients, those with comorbidities and patients in regions with poor medical resources may have worse awareness about safety. Current medication education for patients should not only aim to improve adherence but should also encourage patients to take greater responsibility for their own safety and to actively participate in their medication safety. Greater systematic and individualized medication safety information is needed for older patients, those with more comorbidities and patients in areas with poor medical resources. PATIENT CONTRIBUTION: We conducted a questionnaire-guided cross-sectional study on hospitalized lung cancer patients in Shaanxi Province to explore the patients' practices related to safety medication, including medication adherence and medication safety awareness.
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Neoplasias Pulmonares , Adesão à Medicação , Estudos Transversais , Pessoal de Saúde , Humanos , Neoplasias Pulmonares/tratamento farmacológico , Inquéritos e QuestionáriosRESUMO
OBJECTIVE: To explore the value of ultrasound-guided percutaneous radiofrequency ablation (RFA) in designing the indication, treatment protocol and operational skills for patients with primary hepatocellular carcinoma (HCC) near the liver surface. METHODS: Sixty-one HCC patients with 69 lesions, confirmed by clinical examination and pathology, underwent percutaneous radiofrequency ablation. The study included 40 cases of liver function Child-Pugh grade A and 21 cases of grade B. The average size of tumors was (3.8 ± 1.2) cm, tumor diameter ≥ 4 cm accounted for 39.1% (27/69 lesions), and the average age was 58.2 years (range, 35-76 years). Taking comprehensive measures, such as intraperitoneal injection of saline adjacent to the tumor before RFA, increasing the puncture sites on the surface of tumor to avoid overlapping of the central portion of tumor, repeated ablation of the needle track to reduce needle tract metastasis, avoid vertical puncture, and other additional measures, to improve the inactivation of tumors adjacent to the liver surface. Enhanced CT/MRI was performed to evaluate the curative effect at 1, 3, 6 and 24 months after the treatment. RESULTS: The inactivation rate of tumor was 98.6% (68/69 lesions) and local recurrence rate was 5.8%(4/69) after RFA. The tumor-related marker AFP was 1 000-1 500 ng/ml before and reduced to (98.5 ± 42.5) ng/ml after radiofrequency ablation, among them returned to normal in 13 cases (21.3%). Since the ablation area was rather small, the level of serum alanine aminotransferase was elevated only to (148.5 ± 38.5) U/ml at one week after RFA and returned to normal at (1.8 ± 0.6) week after RFA. No patient experienced severe liver dysfunction. The local HCC recurrent rate after RFA was 5.8%(4/69 lesions) and intrahepatic heterotopic recurrence rate was 24.6% (15/61). The 20-61 months follow-up showed that the 1-, 2- and 3-year survival rate was 83.6%, 57.3% and 44.2%, respectively. CONCLUSIONS: Ultrasound-guided percutaneous radiofrequency ablation provides an effective minimally invasive treatment for primary HCC near the liver surface. Taking some additional measures such as intraperitoneal injection of saline, increase of percutaneous puncture sites, and avoiding vertical needle puncture, may reduce complications and improve the therapeutic outcome. RFA is one of effective and minimally invasive treatment and causing less liver damage for primary HCC near the liver surface.
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Carcinoma Hepatocelular/cirurgia , Ablação por Cateter/métodos , Neoplasias Hepáticas/cirurgia , Ultrassonografia de Intervenção , Adulto , Idoso , Biomarcadores Tumorais/sangue , Carcinoma Hepatocelular/sangue , Carcinoma Hepatocelular/patologia , Humanos , Fígado/patologia , Neoplasias Hepáticas/sangue , Neoplasias Hepáticas/patologia , Imageamento por Ressonância Magnética/métodos , Pessoa de Meia-Idade , Recidiva Local de Neoplasia , Taxa de Sobrevida , Resultado do Tratamento , Carga TumoralRESUMO
BACKGROUND: China has the highest proportion of lung cancer-related deaths. Drug therapy is the main tool of comprehensive anticancer treatment. However, most studies to date have focused on certain types of targets or immunotherapeutic modalities for drug safety; few studies have addressed the factors that influence ADRs for each type of drug in patients with lung cancer, and even fewer studies have explored the risk factors for certain types of ADRs. Based on it, we comprehensively evaluate the drug safety of patients and provide a clinical reference with a focus on lung cancer. RESEARCH DESIGN AND METHODS: We examined 767 reports of adverse drug reactions (ADRs) in patients with lung cancer and conducted a logistic regression analysis on the risk factors that may cause different types of organ system damage and serious ADRs. RESULTS: The logistic regression identified various independent risk factors for system organ damage, and ADRs involving erythrocyte abnormalities (P < 0.001), respiratory system damage (P < 0.001), and leukocyte and reticuloendothelial system abnormalities (P < 0.001) were more likely to be severe. CONCLUSIONS: Rare adverse reactions and different Clinical medication guidelines for molecular-targeted drugs were identified. These findings had certain practical significance in clinical safe drug use.
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Antineoplásicos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Neoplasias Pulmonares , Humanos , Neoplasias Pulmonares/tratamento farmacológico , Estudos Retrospectivos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Antineoplásicos/efeitos adversos , China/epidemiologia , Sistemas de Notificação de Reações Adversas a MedicamentosRESUMO
BACKGROUND: Establishing effective pharmacovigilance systems globally is challenging due to the need for comprehensive epidemiological data on pharmacovigilance-related events, particularly in countries at different stages of development. AIM: This study aimed to determine magnitude and drivers of change in the global and regional burden of pharmacovigilance-related events from 1990 to 2019, analyzing variations between age groups and sex, providing data support for policymakers to adjust their pharmacovigilance policies. METHOD: Pharmacovigilance-related events were defined as Adverse Effects of Medical Treatment (AEMT) and Drug Use Disorders (DUD) in the Global Burden of Diseases, Injuries, and Risk Factors Study 2019. Time trend analysis utilized joinpoint regression, age-period-cohort model, and decomposition method. Disease burden was measured in incidence, deaths, and disability-adjusted life years (DALYs). RESULTS: The global burden of pharmacovigilance-related events remained high, driven predominantly by population growth. Children and older adults were identified as particularly susceptible groups. Across various regions and periods of the socio-demographic index (SDI), the risk of death from AEMT showed a decreasing trend. In contrast, the incidence of AEMT and both the incidence and death rates from DUD showed a stable or worsening trend. Significant regional disparities in the burden of these diseases were noted between different SDI levels. CONCLUSION: The study underscores the critical need for robust pharmacovigilance systems worldwide. The observed trends in the burden of pharmacovigilance-related events offer a clear direction for countries to refine and strengthen their pharmacovigilance policies and practices.
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OBJECTIVE: To investigate the application of contrast enhanced ultrasound (CEUS) in planning and guiding for radiofrequency ablation (RFA) for metastatic liver carcinoma (MLC). METHODS: One hundred and thirty-five patients with clinically and pathologically diagnosed MLC (from gastrointestinal tumors) were included in the present study, and 104 of them had received CEUS prior to RFA to assess the number, size, shape, infiltration, location and enhancing features of the lesions. Among the 104 patients, 21 (20.1%) were excluded from RFA treatment due to too many lesions or large infiltrative range based on CEUS. The remaining 83 patients with 147 lesions underwent RFA (group A). During the same period, other 31 patients with 102 lesions serving as control group were treated based on findings of conventional ultrasound without contrast (group B). The patients underwent follow-up enhanced CT at the 1st month, and then every 3-6 months after RFA. The tumor was considered as early necrosis if no contrast enhancement was detected in the treated area on the CT scan at the 1st month. RESULTS: In group A, 72 of 147 MLC lesions (48.9%) showed increased sizes on CEUS. Among them, 48 lesions (66.6%) appeared enlarged in arterial phase, and 24 (33.3%) showed enlarged hypoechoic area in parenchymal phase. CEUS showed total 61 additional lesions in 35 patients (42.1%) (ranged from 8 to 15 mm) compared with conventional ultrasound (US), and 42 (68.8%) of them were visualized in parenchymal phase only. There were total 208 lesions in group A underwent RFA with CEUS planning, and the tumor necrosis rate was 94.2% (196/208). In this group, local recurrence was found in 16 lesions (7.7%) during 3-42 months' following up, and new metastases were seen in 30 cases (36.1%). For group B, the tumor necrosis rate was 86.3% (88/102), local recurrence in 17 lesions (16.7%), and new metastases in 13 cases (41.9%). Tumor early necrosis and recurrence rates were significantly different between the two groups (P=0.018, P=0.016, respectively). CONCLUSION: CEUS played an important role in RFA for liver metastases by candidate selecting and therapy planning, which helped to improve the outcome of the treatment.
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It is crucial to investigate the risk factors inherent in the medication process for cancer patients since improper antineoplastic drug use frequently has serious consequences. As a result, the Severity, Occurrence, and Detection rate of each potential failure mode in the drug administration process for patients with lung cancer were scored using the Failure Mode and Effect Analysis (FMEA) model in this study. Then, the risk level of each failure mode and the direction of improvement were investigated using the Slacks-based measure data envelopment analysis (SBM-DEA) model. According to the findings, the medicine administration process for lung cancer patients could be classified into five links, with a total of 60 failure modes. The risk of failure modes for patient medication and post-medication monitoring ranked highly, with unauthorized use of traditional Chinese medicine and folk prescription and unauthorized drug addition (incorrect self-medication) ranking first (1/60); doctor prescription was also prone to errors. The study advises actively looking at ways to decrease the occurrence and difficulty of failure mode detection to continually enhance patient safety when using medications.
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Análise do Modo e do Efeito de Falhas na Assistência à Saúde , Neoplasias Pulmonares , Humanos , Gestão de Riscos , Medição de Risco , Segurança do Paciente , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/epidemiologiaRESUMO
INTRODUCTION: The management of diabetes has become a critical public health issue in China. The development of community-based type 2 diabetes management in China has not yet reached an ideal state, and the most suitable management methods for diabetic patients are still being explored. Few studies have used community-based family doctors to perform interventions of appropriate intensity. This protocol describes a planned randomised controlled trial to evaluate the effectiveness of a family doctor-led intervention model for diabetes self-management and medication adherence in type 2 diabetes mellitus patients. METHODS AND ANALYSIS: This is a Standard Protocol Items: Recommendations for Interventional Trials-compliant cluster randomised controlled trial. The study will be conducted at four CHCs (community health centers). The control group will receive conventional medical services and health education. The intervention group will receive an intervention led by community family doctors based on the conventional medical services and health education. It will include five parts: usual care, a medication reminder, a 4-week plan, a weekly phone interview and a monthly interview. The primary outcomes are changes in fasting blood glucose, glycosylated haemoglobin, self-management knowledge and behaviour, and medication adherence from baseline to the 3rd and 6th months. The secondary outcome is the proportion of people whose blood sugar and glycosylated haemoglobin are under control in the 3rd and 6th months. ETHICS AND DISSEMINATION: The study proposal was approved by the Biomedical Ethics Committee of the Medical Department of Xi'an Jiaotong University (no. 2021-1371). The findings will be published in peer-reviewed journals and presented at scientific conferences. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry, ChiCTR2100051685.