PMID- 35227782 OWN - NLM STAT- MEDLINE DCOM- 20220419 LR - 20220419 IS - 1872-7573 (Electronic) IS - 0378-8741 (Linking) VI - 292 DP - 2022 Jun 28 TI - Clinical features of adverse events associated with Xiyanping-Ribavirin combination: A systematic review. PG - 115076 LID - S0378-8741(22)00110-6 [pii] LID - 10.1016/j.jep.2022.115076 [doi] AB - ETHNOPHARMACOLOGICAL RELEVANCE: In China, Xiyanping (XYP) has been widely used in combination with Ribavirin (RB) for the treatment of infectious diseases. It has been found that this combination may change the severity of XYP-associated adverse events (AEs). AIM: To provide a comprehensive review about the clinal features of AEs of XYP-RB combination from randomized controlled trials, cohort studies, case-control studies, case reports, case series, and data from the National Adverse Drug Reaction Monitoring Information System (NADRMIS). MATERIALS AND METHODS: Seven electronic databases were searched in March 2021. Articles on AEs associated with XYP published from January 2004 to December 2020 in the NADRMIS were included. Data on the incidence of AEs, distribution of AEs, occurrence time of AEs, type and possible signal of AEs, primary diseases, allergic history, family history of allergies, dosage, and combination interval were extracted. RESULTS: We included 228 cases of AEs with XYP-RB combination (63 cases from randomized controlled trials, 1 from a cohort study, and 164 from the NADRMIS). The most common primary disease was hand-foot-and-mouth disease. The main age distribution was 0-6 years (118 cases, 72%) and 8 cases (6.8%) experienced serious AEs. The combination group showed a significant reduction than the RB group in the incidence of AEs in those with hand-foot-and-mouth disease (risk ratio = 0.54, 95% confidence interval = 0.38-0.78, P = 0.0008) and children with viral pneumonia (risk ratio = 0.36, 95% confidence interval = 0.14-0.95, P = 0.04). Allergic history and infusion interval were not described in the randomized controlled trials. AEs were reported in 57.9% of cases in the first combination (XYP-RB were combined for the first time) (NADRMIS), 56.4% of which were skin and appendage reactions, and the risk signal of skin and appendage reactions was a maximum (Information Component = 6.21). CONCLUSION: The major AE associated with XYP-RB combination was skin and appendage reactions. Most of the combination AEs were pseudo-allergic reactions. These findings suggest that we should increase awareness about the safety of XYP-RB combination treatment and standardize medication protocol, especially for children. Unless absolutely necessary, children should avoid combination therapy. More rigorous high-quality studies are needed to obtain more evidence. CI - Copyright (c) 2022 Elsevier B.V. All rights reserved. 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, Haiyuncang Lane, Dongcheng District, Beijing, 100700, China. Electronic address: zhengrui0904@163.com. FAU - Sun, Yang AU - Sun Y AD - Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Haiyuncang Lane, Dongcheng District, Beijing, 100700, China. Electronic address: ivory10@163.com. FAU - Zhang, Xiaoyu AU - Zhang X AD - Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Haiyuncang Lane, Dongcheng District, Beijing, 100700, China. Electronic address: zbzhangxiaoyu@aliyun.com. FAU - Zhao, Chen AU - Zhao C AD - Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No. 16, Nanxiaojie, Dongzhimennei, Dongcheng District, Beijing, China. Electronic address: zyyzc2007@163.com. FAU - Wang, Pengqian AU - Wang P AD - Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, China. Electronic address: pengqian.wang@163.com. FAU - Chen, Shiqi AU - Chen S AD - Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Haiyuncang Lane, Dongcheng District, Beijing, 100700, China. Electronic address: cheesechen@foxmail.com. FAU - Chen, Zhao AU - Chen Z AD - Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Haiyuncang Lane, Dongcheng District, Beijing, 100700, China. Electronic address: zhaochen@bucm.edu.cn. FAU - Qiu, Ruijin AU - Qiu R AD - Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Haiyuncang Lane, Dongcheng District, Beijing, 100700, China. Electronic address: psddqxn@163.com. FAU - Liang, Aihua AU - Liang A AD - Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, China. Electronic address: ahliang@icmm.ac.cn. 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, Haiyuncang Lane, Dongcheng District, Beijing, 100700, China. Electronic address: shanghongcai@bucm.edu.cn. LA - eng PT - Journal Article PT - Review PT - Systematic Review DEP - 20220225 PL - Ireland TA - J Ethnopharmacol JT - Journal of ethnopharmacology JID - 7903310 RN - 0 (Drugs, Chinese Herbal) RN - 49717AWG6K (Ribavirin) SB - IM MH - Animals MH - Child MH - Child, Preschool MH - Cohort Studies MH - *Drug-Related Side Effects and Adverse Reactions/drug therapy MH - *Drugs, Chinese Herbal/therapeutic use MH - *Foot-and-Mouth Disease/drug therapy MH - Humans MH - Infant MH - Infant, Newborn MH - *Pneumonia, Viral/drug therapy MH - Randomized Controlled Trials as Topic MH - Ribavirin/adverse effects OTO - NOTNLM OT - Adverse drug reaction OT - Herb-drug combination OT - Pseudo-allergic reaction OT - Ribavirin OT - Systematic review OT - Xiyanping EDAT- 2022/03/02 06:00 MHDA- 2022/04/20 06:00 CRDT- 2022/03/01 05:47 PHST- 2021/05/03 00:00 [received] PHST- 2021/12/15 00:00 [revised] PHST- 2022/02/02 00:00 [accepted] PHST- 2022/03/02 06:00 [pubmed] PHST- 2022/04/20 06:00 [medline] PHST- 2022/03/01 05:47 [entrez] AID - S0378-8741(22)00110-6 [pii] AID - 10.1016/j.jep.2022.115076 [doi] PST - ppublish SO - J Ethnopharmacol. 2022 Jun 28;292:115076. doi: 10.1016/j.jep.2022.115076. Epub 2022 Feb 25.