[Analysis on off-label use of drugs in pediatric guidelines and consensus published by Chinese authors].

Objective: To understand the current situation regarding pediatric off-label use of drugs recommendations in Chinese clinical practice guidelines and to make recommendations for standardized reporting format regarding off-label use of drugs for children. Methods: This cross-sectional study was carried out by systematically searching the databases for Chinese guideline consensus articles published in journals between 2018 and 2020 and extracting recommendations regarding off-label use of drugs from those articles. The essential characteristics of the included guidelines, the ranking of off-label drug types, the order of drug information, the type of off-label drug use, and the percentage of citation studies on which the recommendations were based were analyzed. Results: Among 108 studies that included Chinese off-label guidelines and consensus, 364 recommendations on pediatric off-label use of drugs were included. The Chinese Medical Association published the most, 48 out of the 108 studies (44.4%), and of those 14 studies (13.0%) were on infectious and parasitic diseases. Of the 364 recommendations on off-label use of drugs, the most commonly addressed drugs were 16 recommendations (4.4%) for cyclosporine A, 11 recommendations (3.0%) for methotrexate , and 11 recommendations (3.0%) for fentanyl. The most commonly addressed drug categories were as follows: 68 recommendations (18.6%) were immune system drugs, 66 recommendations (18.1%) were anti-infectives, and 56 recommendations (15.4%) were oncology drugs. The most commonly addressed drug information accounts were as follows: 364 recommendations (100.0%) were indications, 204 recommendations (56.0%) were dosages, and 198 recommendations (54.4%) were the route of administration. Based on the instructions approved by the Chinese Food and Drug Administration, the main forms of the off-label drug were as follows: 175 recommendations (48.1%) were unapproved indications, 127 recommendations (34.9%) were unapproved populations, and 72 recommendations (19.8%) were unapproved ages. Only 129 recommendations (35.4%) were cited, mainly including clinical guidelines (48 studies, 23.4%), reviews (22 studies, 10.7%), and pediatric randomized controlled trials (22 studies, 10.7%). Conclusions: Off-label use of drugs is commonly recommended in pediatric guidelines and consensus documents written by Chinese authors. However, the reporting of the recommendations varies widely, and the quality of the supporting evidence is poor.

[Laboratory evaluation of automated enzyme linked fluorescent assay for detecting serum specific IgG antibodies against rubella virus].

The VIDAS rubella IgG(RBG) is a new, automated, enzyme-linkad fluorescent assay(ELFA) for detecting IgG antibodies to rubella virus in serum. The purpose of this study was to evaluate the usefulness of the qualitative and quantitative VIDAS RBG as laboratory tests in the rapid detecting anti-rubella IgG antibodies. Simultaneous parallel testing was performed by using the qualitative and quantitative RBG along with RUBAZYME(ABBOTT LABORATORIES) and the standard hemagglutination-inhibition(HI) test(R-HI kit, SEIKEN) on 200 blood samples submitted for anti-rubella IgG antibodies testing from patients at the VGH-Kaohsiung(Mar.-Sep., 1993). The qualitative and quantitative VIDAS RBG and RUBAZYME assay were compared to the standard R-HI test. Significant differences among the sensitivities of these three methods were found (100% sensitivity for the qualitative VIDAS RBG, 88.89% for the quantitative VIDAS RBG and 97.67% for the RUBAZYME). However, the specificities of these three methods were all the same, 100%. With these results we can conclude that the qualitative VIDAS RBG will provide a very good, precise and reliable method to determine serum specific IgG antibodies against rubella virus. Furthermore, the VIDAS RBG is fully automated and time-saving procedures (for every batch of test, it takes 25 minutes with VIDAS RBG, 2.5 hours with RUBAZYME and 4.5 hours with R-HI) in clinical laboratories.