ABSTRACT
OBJECTIVE:To investigate off-label drug use of Ambroxol hydrochloride injection,and to provide reference for further evidence-based evaluation on rationality and standardized management of off-label drug use. METHODS:All medical orders for inpatients receiving Ambroxol hydrochloride injection were selected from 10 hospitals of Guangdong province during Apr. 2014 to Mar. 2015. Situation of drug use in different categories of departments was summarized,the incidence of off-label administation route and off-label dosage were analyzed;according to drug package inserts,prescription daily dose(PDD)and drug utilization in-dex(DUI)were calculated for each category of department,and the degree of off-label dosage was evaluated. RESULTS:A total of 761 821 person·day who used Ambroxol hydrochloride injection was included. Off-label drug use occurred in each category of departments,and the incidence of off-label drug use was 62.10%. The incidence of off-label administration route was 40.51%, mainly atomization inhalation;the incidence of it was the high-est in gynecology and obstetrics department(92.70%).The in-cidence of off-label dosage was 36.30%,and the incidence of it was the highest in cardiothoracic surgery department (85.36%). Departments whose PDDs were higher than the drug package inserts were cardiothoracic surgery department,ICU,surgical department,cardiovascular medicine department,emer-gency department,department of internal medicine and pediatrics department.CONCLUSIONS:Off-label drug use of Ambroxol hy-drochloride injection is common,and the effectiveness,safety and necessity remain controversial,which need to be proved by multi-center randomized controlled prospective trial.
ABSTRACT
OBJECTIVE:To investigate off-label drug use of Ambroxol hydrochloride injection,and to provide reference for further evidence-based evaluation on rationality and standardized management of off-label drug use. METHODS:All medical orders for inpatients receiving Ambroxol hydrochloride injection were selected from 10 hospitals of Guangdong province during Apr. 2014 to Mar. 2015. Situation of drug use in different categories of departments was summarized,the incidence of off-label administation route and off-label dosage were analyzed;according to drug package inserts,prescription daily dose(PDD)and drug utilization in-dex(DUI)were calculated for each category of department,and the degree of off-label dosage was evaluated. RESULTS:A total of 761 821 person·day who used Ambroxol hydrochloride injection was included. Off-label drug use occurred in each category of departments,and the incidence of off-label drug use was 62.10%. The incidence of off-label administration route was 40.51%, mainly atomization inhalation;the incidence of it was the high-est in gynecology and obstetrics department(92.70%).The in-cidence of off-label dosage was 36.30%,and the incidence of it was the highest in cardiothoracic surgery department (85.36%). Departments whose PDDs were higher than the drug package inserts were cardiothoracic surgery department,ICU,surgical department,cardiovascular medicine department,emer-gency department,department of internal medicine and pediatrics department.CONCLUSIONS:Off-label drug use of Ambroxol hy-drochloride injection is common,and the effectiveness,safety and necessity remain controversial,which need to be proved by multi-center randomized controlled prospective trial.
ABSTRACT
<p><b>BACKGROUND</b>Studies on intrathoracic tuberculous lymphadenitis in adults are confined to the preliminary CT findings with ordinary CT and ordinary spiral CT. There has been no deepgoing study of multidetector CT to date. Multidetector CT could contribute to better imaging of intrathoracic tuberculous lymphadenitis in adults. The purpose of this study was to explore the multidetector CT features of intrathoracic tuberculous lymphadenitis in adults, and the correlation with clinical symptoms and pathologic changes.</p><p><b>METHODS</b>Multidetector CT findings from 42 consecutive adult patients with intrathoracic tuberculous lymphadenitis were analyzed retrospectively with regard to locations, sizes, numbers, shapes, margins, and densities reviewing precontrast and enhanced images. CT results were correlated with clinical symptoms and pathologic results (n = 37).</p><p><b>RESULTS</b>One hundred and eighty-five intrathoracic lymph nodes that had tuberculous lymphadenitis in 42 patients were distributed mainly in regions 4R (n = 37), 2R (n = 33), 7 (n = 31) and 10R (n = 21), more than 2 regions were implicated in 34 patients. One hundred and twenty-two (72.2%) of the tuberculous lymphadenitis without confluence were oval or round with clear margins. On precontrast scanning, 78.4% of tuberculous lymphadenitis had a homogeneous density. Seven enhancement patterns were demonstrated in 169 tuberculous lymphadenitis from 37 patients with pathologic results: homogeneous enhancement with no clinical symptom (n = 12), corresponded pathologically to tuberculous hyperplasia without caseous necrosis; heterogeneous enhancement with a small central no enhancement area, slight clinical symptoms (n = 22), tuberculous granulomas with a little caseous necroses; peripheral irregular thick wall enhancement with a central area with no enhancement, slight clinical symptoms (n = 52), tuberculous granulomas with some caseous necroses in the center; peripheral thin rim enhancement with a central area having no enhancement, moderate clinical symptoms (n = 36), a few tuberculous granulomas with a great quantity of caseous necroses in the center; peripheral irregular enhancement without central enhancement, extending outside the capsule, severe clinical symptoms (n = 4), caseous necroses ruptured from capsule; peripheral irregular rim enhancement with central separate enhancement, severe clinical symptoms (n = 40), multiple lymph nodes with liquefaction of caseous necroses were adherent and confluent, rim and separation were tuberculous granulomas; no obvious enhancement, severe clinical symptoms (n = 3). Caseous necrosis was usually associated with little tuberculous granulomas.</p><p><b>CONCLUSIONS</b>The main multidetector CT features of intrathoracic tuberculous lymphadenitis in adults are involvement of multiregional lymph nodes with oval or round shape and clear margins, a basically homogeneous density on precontrast scanning, multiple enhancement patterns, and they correlate closely with clinical symptoms. Multidetector CT could reveal pathological changes of intrathoracic tuberculous lymphadenitis in adults.</p>