The expanding needs on lipid-lowering treatment in patients with acute coronary syndrome by applying newly issued definition of extreme high-risk by Chinese Society of Cardiology / 中华心血管病杂志

Objective: To assess the expanding needs on lipid-lowering treatment in patients with acute coronary syndrome (ACS) by applying newly issued definition of extreme high-risk, which is proposed by Chinese expert consensus on lipid management of extreme high-risk atherosclerotic cardiovascular disease (ASCVD) patients of Chinese Society of Cardiology (CSC). Methods: Data of this study was derived from the Improving Care for Cardiovascular Disease in China (CCC) project, which was a case-based nationwide registry study and launched as a collaborative initiative by the American Heart Association and the CSC. The project consecutively recruited ACS patients from158 tertiary hospitals and 82 second hospitals across China, and detailed clinical information of patients was collected. This study enrolled ACS inpatients in CCC project from November 2014 to July 2019. The proportion of extreme high-risk patients, their characteristics, mean LDL-C levels at admission, the gap between measured LDL-C level and the new target, and lipid-lowering therapy at discharge were assessed. Results: Among 104 516 ACS inpatients enrolled in this study, 75.1% (78 527/104 516) met the criteria of extreme high-risk and were expected to achieve the new LDL-C goal. Among patients at extreme high-risk, 21.2% (16 651/78 527) had multiple severe ASCVD events and 78.8% (61 876/78 527) had 1 severe ASCVD event and at least two high-risk factors. For the extreme high-risk patients, the mean level of LDL-C at admission was (2.8±1.0) mmol/L, prevalence of LDL-C ≥1.4 mmol/L was 93.4% (73 307/78 527) and the median gap between LDL-C level at admission and the target of 1.4 mmol/L was 1.3 (0.8, 2.0) mmol/L. If LDL-C could be further reduced to 50% of the admission level, we estimated that 55.6% (43 632/78 527) of the extreme high-risk patients would achieve the new LDL-C goal. Among 40 875 patients with information about discharge statin dosage, 93.5% (28 004/29 947) of the extreme high-risk patients were prescribed with statins at discharge, and among them 95.1% (26 632/28 004) received statin monotherapy and 91.1% (25 501/28 004) were at moderate doses of statins. Conclusion: About three fourth of inpatients with ACS were categorized as extreme high-risk based on the new definition of CSC expert consensuses, nine out of ten patients at extreme high-risk didn't achieve the new LDL-C target at admission, and the intensity of lipid-lowering therapy was insufficient in clinical practice. There are substantially expanding needs for implementing more intensive and effective lipid-lowering strategies.

Uso de fármacos durante el embarazo / Drug use during pregnancy

La información sobre seguridad de fármacos en la gestación es abundante, pero existe poca evidencia científica, por razones éticas muy pocos ensayos clínicos se han realizado y publicado. Todo esto ha traído como consecuencia que se sobredimensione el peligro de los fármacos en el embarazo, limitando su uso razonable en enfermedades crónicas de gestantes, y, en el otro extremo, que se prescriba la medicación libremente desconociendo el verdadero riesgo que implica administrarlos en el momento y en la dosis inadecuada. La presente revisión describe la manera en que los cambios fisiológicos en el embarazo modifican considerablemente la farmacocinética de la medicación. Se evalúa el verdadero riesgo potencial de teratogénesis de los fármacos, los criterios específicos para considerarlos como factor etiológico. Se comenta la clasificación de la Administración de Alimentos y Medicamentos estadounidense (FDA, por sus siglas en inglés), los criterios de su clasificación, sus limitaciones, su limitada vigencia actual y la propuesta de nuevas reglas para etiquetar los fármacos en donde considera evaluación clínica, exposición inadvertida y riesgo disponible. Se realiza la descripción de los riesgos de la medicación de más frecuente uso en las patologías más comunes en el embarazo. Se comenta la correcta manera de informar a la paciente expuesta a supuestos teratógenos, con la finalidad de no afectar la percepción del riesgo. Hay que considerar que los fármacos prescritos con mayor frecuencia se pueden administrar con relativa seguridad durante el embarazo, indicando los que sean estrictamente necesarios, restringiéndolos en el primer trimestre, prefiriendo los de seguridad comprobada, utilizando la menor dosis eficaz durante el menor tiempo posible, evitando utilizar varios fármacos y vigilando sus efectos colaterales y complicaciones

There is plenty of information about drug safety during pregnancy, but there is little scientific evidence on this topic. Due to ethical reasons, very scarce clinical assays have been conducted and published. This situation has resulted in the exaggeration of drug risk during pregnancy, thus limiting its reasonable use for chronic diseases in pregnant women. At the other extreme, it has resulted in the careless prescription of drugs not acknowledging the real risk involved in administering them in the inappropriate dose and moment. This review article describes how physiological changes during pregnancy modify significantly the pharmacokinetics of drugs. The real potential risk of drug-induced teratogenesis and the specific criteria for considering them an etiological factor are evaluated. The U.S. Food and Drug Administration (FDA) pregnancy categories' criteria, limitations, and limited current validity are discussed, as well as its proposal of new regulations on drug labeling, considering clinical evaluations, unnoticed exposure, and risks. The risks associated with the most frequently used drugs for the most common diseases during pregnancy are described. The correct way to tell the patient exposed to suspected teratogens is discussed, in order to avoid affecting risk perception. It should be considered that the administration of the most frequently prescribed drugs is relatively safe during pregnancy. Nevertheless, only those strictly necessary must be prescribed, their consumption must be limited during the first trimester, those proven safety must be preferred, the minimum effective dose during the shortest time possible must be used, the administration of several drugs must be avoided, and side effects and complications must be monitored

Application of risk category system to evaluate the treatment outcome of locoregionally advanced nasopharyngeal carcinoma treated by intensity-modulated radiation therapy alone / 中华放射医学与防护杂志

Objective To explore the feasibility of employing a risk category system in evaluating the treatment outcome of locoregionally advanced nasopharyngeal carcinoma (NPC) treated by intensitymodulated radiation therapy (IMRT) alone,and offering evidence for relevant perspective studies.Methods Totally 185 locoregionally advanced NPC patients were divided into high-risk and low-risk groups for evaluation and comparison.The patients who met at least one of the following criteria were defined as high-risk group and others as low-risk group:GTVnx ＞ 30 cm3;Clinical stage T4N2M0;multiple neck node metastases with 1 node size ＞4 cm,and N3 with any T stage.Results With a median follow up of 110.9 months (6.7-152.4 months),the 5-year overall survival,locoregional relapse-free survival,distant metastasis-free survival for the high-risk group vs.the low-risk group were 61.0％ vs.90.5％ (x2 =30.298,P＜0.05),78.3％ vs.91.5％ (x2 =6.352,P＜0.05)and 71.6％ vs.92.0％ (x2 =16.346,P ＜0.05).Conclusions As a simple and practicable method,the risk category system is helpful for discriminating locoregionally advanced nasopharyngeal carcinoma with different risk-group of treatment failure and in further perspective clinical research.

Categoría de bajo riesgo de infección bacteriana severa en niños febriles, una propuesta / Proposal of category of low risk of severe bacterial infection in febrile children

INTRODUCCIÓN: diversos algoritmos se han aplicado en la evaluación de los niños con fiebre sin causa aparente; estos algoritmos han cambiado dramáticamente, y las conductas agresivas de los años 1980 al 1990 han dado paso a la identificación del niño con bajo riesgo de infecciones bacterianas severas. OBJETIVO: demostrar la utilidad de la categoría de bajo riesgo de infección bacteriana severa, para predecir quiénes serían los niños febriles con menos posibilidades de presentar estas infecciones. MÉTODOS: siguiendo las tendencias modernas, se diseñó esta investigación. Se realizó una revisión retrospectiva de la totalidad de los 855 niños febriles, clasificados inicialmente como bajo riesgo de infecciones bacterianas severas, entre 1 a 36 meses de edad, incluidos en las bases de datos de la investigación titulada Las categorías de riesgo de infección bacteriana severa: un procedimiento predictivo para evaluar los niños febriles, y su generalización (1996-2012), para comprobar la utilidad de la categoría bajo riesgo para predecir los niños sin infecciones bacterianas severas y precisar los resultados finales de su evolución. RESULTADOS: el 92,5 % de los niños (791) no presentaron infecciones bacterianas severas, solamente el 7,5 % (64 niños) mostraron estas infecciones. El 80,3 % de estos fueron seguidos en sus hogares, y los restantes ingresados en el hospital. Los valores predictivos negativos y la especificidad de la categoría bajo riesgo resultaron en valores ideales de 100 %. CONCLUSIONES: la mayoría de los niños febriles evaluados como bajo riesgo no presentaron infecciones bacterianas severas, y fueron seguidos en sus hogares, por lo que resultó un procedimiento excelente para predecir los niños febriles con menos probabilidad de padecer estas infecciones y con una satisfactoria previsibilidad clínica.

INTRODUCTION: several algorithms have been applied to evaluate children with fever without apparent cause. These algorithms have drastically changed and the aggressive treatments applied in 1980-1990 decade have made way to identification of febrile children at low risk of severe bacterial infections. OBJECTIVE: to show the advantages of the category of low risk of severe bacterial infection to predict febrile children with lower probabilities of presenting with these infections. METHODS: this research work was designed according to modern tendencies. A retrospective review of all 855 febrile children was made. They were one to 36 months-old, initially classified as low risk of severe bacterial infections and included in the databases of a research called Categories of Risk of Severe Bacterial Infection: Predictive Procedure to Evaluate Febrile Children and Its Generalization (1996-2012), in order to verify the usefulness of low risk category to predict children without severe bacterial infections and precise over the final results of their progression. RESULTS: in the group, 92.5 % of children (791) had no several bacterial infections; just 7.5 % (64) suffered them. Of these febrile children, 80.3 % were followed-up at home and the rest was admitted to the hospital. The negative predictive values and the specificity of the low risk categories resulted in ideal values of 100 %. CONCLUSIONS: Most of the febrile children evaluated as low risk did not show severe bacterial infections and were followed-up at home, so this was an excellent procedure to predict febrile children at lower risk of suffering these infections, with satisfactory clinical prevision.

Nerve Conduction Study Findings and Risk Category of Diabetic Foot Screening Test

OBJECTIVE: To assess the correlation between the risk categories of diabetic foot screening test by 5.07 Semmes- Weinstein monofilament and the findings of standard nerve conduction studies of upper and lower extremities. METHOD: We studied 74 patients who were consulted to our department to rule out the diabetic neuropathy. We classified the patients to 4 risk groups by foot screening test using 5.07 Sememes-Weinstein monofilament, and performed the standard nerve conduction studies of upper and lower extremities. The risk categories of foot screening tests were compared to the findings of the nerve conduction studies. RESULTS: When the risk category becomes higher, there were more delay in latencies (motor and sensory potentials of median and ulnar nerve, sensory potentials of sural and superficial peroneal nerve, median and peroneal F-wave), slower conduction velocities (median, ulnar, peroneal, posterior tibial nerve) and lower amplitudes (motor and sensory potentials of media and ulnar nerve, peroneal and posterior tibial nerve, sural nerve) (p<0.05). Except for the amplitude of ulnar nerve and the latencies of peroneal and ulnar nerve, there were significant differences in the nerve conduction study data between the risk group 3 and the risk group 0 (p<0.05). CONCLUSION: We confirmed that the risk category of diabetic foot screening test by Semmes-Weinstein monofilament can meaningfully reflect the severity of diabetic neuropathy. We also suggest that it is necessary to pay attention to the nerve conduction study in the patients with history of foot ulcer.

Foot Screening Tests with Semmes-Weinstein Monofilament in Diabetic Inpatients

OBJECTIVE: To determine the prevalence of each risk category for diabetic foot ulcer by foot screening test with Semmes-Weinstein monofilament and to evaluate the correlation of the risk category with clinical data in diabetic inpatients. METHOD: Foot screening tests with Semmes-Weinstein monofilament was performed in 90 diabetic inpatients to determined the risk category for diabetic foot ulcer. An average age of patients was 55 years, and an average duration of the disease was 11 years. The correlation of risk category was evaluated with age, duration of the disease, FBS (fasting blood glucose) level, HbA1c value, and complications of diabetes including retinopathy, peripheral polyneuropathy, and renal failure. RESULTS: Patients with risk category 0 had no loss of protective sensation in 34.4% of cases. Patients with risk category 1, 2, and 3 had loss of protective sensation in 16.7%, 28.9% and 20% of cases, respectively. The older a patient was and the longer the duration of the disease was, the higher the risk category was significantly (p<0.05). There was no significant correlation of risk category with FBS level and HbA1c value. Among the complications associated with diabetes, retinopathy and peripheral polyneuropathy significantly correlated with risk category (p<0.05), but renal failure was not significantly associated. CONCLUSION: The foot screening test with Semmes-Weinstein monofilament should be helpful for proper management of diabetic foot in inpatient.