PMID- 31032272
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220408
IS  - 2305-5839 (Print)
IS  - 2305-5847 (Electronic)
IS  - 2305-5839 (Linking)
VI  - 7
IP  - 6
DP  - 2019 Mar
TI  - A real-world study on adverse drug reactions to Xuebijing injection: hospital 
      intensive monitoring based on 93 hospitals (31,913 cases).
PG  - 117
LID - 10.21037/atm.2018.09.26 [doi]
LID - 117
AB  - BACKGROUND: Although we have made tremendous medical advances in recent decades 
      in modern antibiotics and supportive therapies, the treatment of sepsis has not 
      experienced such rapid advancement. Xuebijing injection (XBJ) is a Chinese 
      prescription consisting of Carthamus tinctorius, Radix paeoniae rubra, Ligusticum 
      wallichii, Radix salviae miltiorrhizae and Radix angelicae sinensis. Clinical 
      experience suggests that XBJ may provide a solution in the management of sepsis. 
      However, the safety of this treatment is still controversial. This study aims to 
      detect the occurrence of XBJ-related adverse drug reactions (ADRs) among 
      individuals in clinical practice. METHODS: From the clinical application of XBJ 
      in a real-world setting, patients in 93 hospitals using XBJ were monitored 
      between August 2013 and August 2016. There was no limit on the treatment course 
      and dosage. From data obtained in interviews or telephone follow-ups with 
      hospitalized patients, the circumstances of patients' adverse events (AEs) during 
      the course of drug treatment and during the 7 days after drug withdrawal were 
      recorded and encoded by MedDRA18.0. The likelihood of ADRs was determined by the 
      criteria of the Uppsala Monitoring Centre. Statistical analyses were performed by 
      SAS9.2 software. RESULTS: In total, 31,913 participants enrolled, and none were 
      lost to follow-up. AEs (suspected ADRs) occurred in 234 participants. ADRs 
      occurred in 96 participants, and the incidence was 0.3%. The ADRs with the top 
      three frequencies were skin pruritus (0.116%), erythra (0.066%) and chest 
      tightness (0.044%). There was no significant relationship between ADRs and 
      solvents (P=0.149), route of administration (P=0.640), unhealthy addiction 
      (P=0.069), allergy (P=0.535), first use of XBJ (P=0.161) or dosage (P=0.743). 
      There was a significant relationship between ADRs and irrigating syringe 
      (P<0.0001) and fluid dripping too quickly (P=0.019). CONCLUSIONS: This 
      large-scale survey of hospitalized patients found that the incidence of ADRs was 
      occasional (0.3%), while most of the ADRs were relatively mild or non-serious. 
      XBJ should be administered rationally and according to its instructions to 
      prevent the occurrence of ADRs.
FAU - Zheng, Rui
AU  - Zheng R
AD  - Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, 
      Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, 
      China.
FAU - Wang, Hui
AU  - Wang H
AD  - Evidence-based Medicine Center, Institute of Traditional Chinese Medicine, 
      Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
FAU - Liu, Zhi
AU  - Liu Z
AD  - Evidence-based Medicine Center, Institute of Traditional Chinese Medicine, 
      Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
FAU - Wang, Xiaohui
AU  - Wang X
AD  - Tianjin Taicheng Yaozhong Biomedical Technology Co. LTD, Tianjin 300110, China.
FAU - Li, Jing
AU  - Li J
AD  - Tianjin Taicheng Yaozhong Biomedical Technology Co. LTD, Tianjin 300110, China.
FAU - Lei, Xiang
AU  - Lei X
AD  - Tianjin Taicheng Yaozhong Biomedical Technology Co. LTD, Tianjin 300110, China.
FAU - Fan, Yilin
AU  - Fan Y
AD  - Tianjin CLINDA Medical Technology Co. LTD, Tianjin 300384, China.
FAU - Liu, Si
AU  - Liu S
AD  - Tianjin Chase Sun Pharmaceutical Co. LTD, Tianjin 300170, China.
FAU - Feng, Zhiqiao
AU  - Feng Z
AD  - Tianjin Chase Sun Pharmaceutical Co. LTD, Tianjin 300170, China.
FAU - Shang, Hongcai
AU  - Shang H
AD  - Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, 
      Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, 
      China.
AD  - Institute of Integration of Traditional Chinese and Western Medicine, Guangzhou 
      Medical University, Guangzhou 510182, China.
LA  - eng
PT  - Journal Article
PL  - China
TA  - Ann Transl Med
JT  - Annals of translational medicine
JID - 101617978
PMC - PMC6465439
OTO - NOTNLM
OT  - Adverse drug reaction (ADR)
OT  - Xuebijing injection (XBJ)
OT  - hospital intensive monitoring (HIM)
OT  - real-world study
COIS- Conflicts of Interest: S Liu and ZQ Feng are employees of Chase Sun 
      Pharmaceuticals. The other authors have no conflicts of interest to declare.
EDAT- 2019/04/30 06:00
MHDA- 2019/04/30 06:01
PMCR- 2019/03/01
CRDT- 2019/04/30 06:00
PHST- 2019/04/30 06:00 [entrez]
PHST- 2019/04/30 06:00 [pubmed]
PHST- 2019/04/30 06:01 [medline]
PHST- 2019/03/01 00:00 [pmc-release]
AID - atm-07-06-117 [pii]
AID - 10.21037/atm.2018.09.26 [doi]
PST - ppublish
SO  - Ann Transl Med. 2019 Mar;7(6):117. doi: 10.21037/atm.2018.09.26.