PMID- 28125608 OWN - NLM STAT- MEDLINE DCOM- 20170809 LR - 20231112 IS - 1932-6203 (Electronic) IS - 1932-6203 (Linking) VI - 12 IP - 1 DP - 2017 TI - Post-Marketing Safety Surveillance of the Salvia Miltiorrhiza Depside Salt for Infusion: A Real World Study. PG - e0170182 LID - 10.1371/journal.pone.0170182 [doi] LID - e0170182 AB - BACKGROUND: Salvia Miltiorrhiza Depside Salt for Infusion (SMDS) is made of a group of highly purified listed drugs. However, its safety data is still reported limitedly. Compared with the clinical trials, its safety in the real world setting is barely assessed. OBJECTIVE: To investigate the safety issues, including adverse events (AEs), adverse events related to SMDS (ADEs), and adverse drug reactions (ADRs) of the SMDS in the real world clinical practice. METHODS: This is a prospective, multicenter, pharmacist-led, cohort study in the real world setting. Consecutive patients prescribed with SMDS were all included in 36 sites. Pharmacists were well trained to standardized collect the patients information, including demographics, medical history, prescribing patterns of SMDS, combined medications, adverse events, laboratory investigations, outcomes of the treatment when discharge, and interventions by pharmacists. Adverse events and adverse drug reactions were collected in details. Multivariate possion regression analysis was applied to identify risk factors associated with ADEs using the significance level (alpha) 0.05. ClinicalTrials.gov Identifier: NCT01872520. RESULTS: Thirty six hospitals were participated in the study and 30180 consecutive inpatients were included. The median age was 62 (interquartile range [IQR], 50-73) years, and male was 17384 (57.60%) among the 30180 patients. The incidences of the AEs, ADEs and ADRs were 6.40%, 1.57% and 0.79%, respectively. There were 9 kinds of new ADEs which were not on the approved label found in the present study. According to the multivariate analysis, male (RR = 1.381, P = 0.009, 95%CI [1.085~1.759]), more concomitant medications (RR = 1.049, P<0.001, 95%CI [1.041~1.057]), longer duration of SMDS therapy (RR = 1.027, P<0.001, 95%CI [1.013~1.041]), higher drug concentration (RR = 1.003, P = 0.014, 95%CI [1.001~1.006]), and resolvent unapproved (RR = 1.900, P = 0.002, 95%CI [1.260~2.866]) were the independent risk factors of the ADEs. Moreover, following the approved indication (RR = 0.655, P<0.001, 95%CI [0.532~0.807]) was associated with lower incidence of ADEs. CONCLUSIONS: SMDS was well tolerated in the general population. The incidences of the AEs, ADEs and ADRs were 6.40%, 1.57% and 0.79%, respectively. Several risk factors of its ADEs have been identified. It is recommended to follow the instructions when prescribing and administrating SMDS in the real world clinical practice. FAU - Yan, Ying-Ying AU - Yan YY AD - Department of Pharmacy, Peking University Third Hospital, 49 North Garden Rd., Haidian District Beijing, China. FAU - Yang, Yi-Heng AU - Yang YH AD - Department of Pharmacy, Peking University Third Hospital, 49 North Garden Rd., Haidian District Beijing, China. FAU - Wang, Wei-Wei AU - Wang WW AD - School of Public Health, Peking University Health Center, 38 Xueyuan Rd., Haidian District, Beijing, China. FAU - Pan, Yu-Ting AU - Pan YT AD - School of Public Health, Peking University Health Center, 38 Xueyuan Rd., Haidian District, Beijing, China. FAU - Zhan, Si-Yan AU - Zhan SY AD - School of Public Health, Peking University Health Center, 38 Xueyuan Rd., Haidian District, Beijing, China. FAU - Sun, Ming-Yang AU - Sun MY AD - Department of Pharmacy, Peking University Third Hospital, 49 North Garden Rd., Haidian District Beijing, China. AD - Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University Health Center, 38 Xueyuan Rd., Haidian District, Beijing, China. FAU - Zhang, Hong AU - Zhang H AD - State Administration of Traditional Chinese Medicine of the People's Republic of China, 55 Xingfu Yicun, Chaoyang District, Beijing, China. FAU - Zhai, Suo-Di AU - Zhai SD AD - Department of Pharmacy, Peking University Third Hospital, 49 North Garden Rd., Haidian District Beijing, China. LA - eng SI - ClinicalTrials.gov/NCT01872520 PT - Clinical Trial PT - Journal Article PT - Multicenter Study DEP - 20170126 PL - United States TA - PLoS One JT - PloS one JID - 101285081 RN - 0 (Depsides) RN - 0 (Sodium Chloride, Dietary) SB - IM MH - Aged MH - China MH - Cohort Studies MH - Depsides/*adverse effects/therapeutic use MH - Drug-Related Side Effects and Adverse Reactions/*epidemiology/physiopathology MH - Female MH - Hospitalization MH - Humans MH - Male MH - Medicine, Chinese Traditional/*adverse effects MH - Middle Aged MH - Salvia miltiorrhiza/*chemistry MH - Sodium Chloride, Dietary/therapeutic use PMC - PMC5268476 COIS- We have the following interests: This study was partially supported by the Shanghai Green Valley Pharmaceutical Co, Ltd. There are no patents, products in development or marketed products to declare. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors. EDAT- 2017/01/27 06:00 MHDA- 2017/08/10 06:00 PMCR- 2017/01/26 CRDT- 2017/01/27 06:00 PHST- 2016/06/25 00:00 [received] PHST- 2016/12/30 00:00 [accepted] PHST- 2017/01/27 06:00 [entrez] PHST- 2017/01/27 06:00 [pubmed] PHST- 2017/08/10 06:00 [medline] PHST- 2017/01/26 00:00 [pmc-release] AID - PONE-D-16-22553 [pii] AID - 10.1371/journal.pone.0170182 [doi] PST - epublish SO - PLoS One. 2017 Jan 26;12(1):e0170182. doi: 10.1371/journal.pone.0170182. eCollection 2017.