RESUMO
OBJECTIVE:To provide reference for drug use labeling for pregnant and lactating women. METHODS:The drug package inserts were collected from Linxi Hospital of Kailuan General Hospital during Jul. 2013-Dec. 2015. The information about drug use labeling for pregnant and lactating women was analyzed statistically. RESULTS:Among 762 drug package inserts,pack-age inserts which were not labeled with or labeled with indefinite drug use information for pregnant and lactating women accounted for 31.89% and 52.76% respectively. Among package inserts of 361 domestic chemical drugs and biological products,339 Chinese patent medicine and 62 imported drug,package inserts which were not labeled or labeled with indefinite drug use information for pregnant and lactating women accounted for 22.99% and 25.21%,44.54% and 88.50%,14.52% and 17.74%,respectively. CON-CLUSIONS:Except for poor drug use labeling for pregnant and lactating women in package inserts package,there still are other problems,such as items listed dispersedly,presentation content not consistent. Compared with imported drugs,the missing informa-tion for pregnant and lactating women are obvious in drug package inserts of domestic chemical drugs and biological products,and severe in those of Chinese patent medicine. It is recommended that drug manufacturers should strengthen drug tracing and monitor-ing after listed,and update and revise related content of package inserts timely;drug administration department should strengthen drug package inserts supervision,and unify and standardize labeled content management of drug use.
RESUMO
OBJECTIVE:To observe the efficacy and safety of Fuyanxiao effervescent tablet in the treatment of damp-heat pour-ing downward syndrome of fungal vaginitis. METHODS:80 patients with damp-heat pouring downward syndrome of fungal vagini-tis were randomly divided into control group and observation group. Control group was given one Nystatin vaginal suppository,and the drug was given in the third day after the menstrual period ending,once every night;observation group was given one Fuyanx-iao effervescent tablet,and the drug was given in the third day after the menstrual period ending,once every night. 2%-4% Sodi-um bicarbonate solution was used for vulva cleaning before taking the medicine at night,then patients kept lying flat to let the med-icine going into the vaginal depths. There were totally 3 treatment courses with 7 days each. During the treatment,sexual activities and antibiotics were prohibited. The clinical efficacy,TCM symptom scores,vaginal lactobacillus positive rate and recurrence rate before and after treatment,and incidence of adverse reactions in 2 groups were observed. RESULTS:There were no significant dif-ferences in the total effective rate,recurrence rate and incidence of adverse reactions (P>0.05). Before treatment,there were no significant differences in the TCM symptoms and vaginal lactobacillus positive rate(P>0.05);after treatment,TCM symptoms in 2 groups were significantly lower than before,genital itching,leucorrhea color-quality and lower abdomen pain in observation group were significantly lower than control group,vaginal lactobacillus positive rate in observation group were significantly higher than before and control group,the differences were statistically significant (P0.05). CONCLUSIONS:Fuyanxiao effervescent tablet shows good efficacy in the treat-ment of damp-heat pouring downward syndrome of fungal vaginitis and improve clinical symptoms,with no recurrence rate and good safety.