Clinical analysis of adverse drug reactions related to coronavirus disease 2019_West China Medical Journal

Authors：

 XU Lei ,  FANG Zhixiong , ZHANG Haiming , HE Lifen , HUANG Changfa , PENG Shuang

Public Health Center, Xiangtan Central Hospital, Xiangtan, Hunan 411100, P. R. China;

Corresponding?author：

XU Lei, Email: xulei0427@sina.com; FANG Zhixiong, Email: fzx8214907@sina.com

Keywords：

Coronavirus disease 2019; Antiviral drugs; Adverse drug reaction; Clinical analysis

DOI：

10.7507/1002-0179.202004105

Video：

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Objective To analyze the clinical characteristics of adverse drug reaction (ADR) caused by 3 kinds of coronavirus disease 2019 drugs, and provide a reference for clinical safe medication. Methods A total of 33 patients with coronavirus disease 2019 admitted to Xiangtan Central Hospital from January 20 to March 5, 2020 were selected as the research objects. The clinical data of patients with ADR during the antiviral process were analyzed retrospectively. The patients’ gender, age, type of medication, combination medication, organs or systems involved, and clinical manifestations were summarized and analyzed. Results A total of 33 patients were enrolled. A total of 21 cases of ADR were reported. The incidence of ADR is higher in patients older than 60 years (80.0%). The most common clinical manifestations are digestive tract symptoms (66.7%). The incidence of ADR is highest in the combination of lopinavir/ritonavir+arbidol+ribavirin (100.0%), followed by the combination of lopinavir/ritonavir+arbidol (85.7%). Abidol and ribavirin each caused 1 case of severe ADR. Conclusion For patients with coronavirus disease 2019, the combination of two or more antiviral drugs should be avoided, and pharmaceutical monitoring should be strengthened for elderly, severe/critical and allergic patients.

Citation： XU Lei, FANG Zhixiong, ZHANG Haiming, HE Lifen, HUANG Changfa, PENG Shuang. Clinical analysis of adverse drug reactions related to coronavirus disease 2019. West China Medical Journal, 2021, 36(10): 1327-1331. doi: 10.7507/1002-0179.202004105 Copy

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5.	陳軍, 凌云, 席秀紅, 等. 洛匹那韋利托那韋和阿比多爾用于治療新型冠狀病毒肺炎的有效性研究. 中華傳染病雜志, 2020, 38(2): 86-89.
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9.	陳清, 張麗蘭, 于德憲, 等. 重組人干擾素α-2b噴霧劑人群試驗的安全性評價. 中華實驗和臨床病毒學雜志, 2005, 19(3): 211-215.
10.	Lu H. Drug treatment options for the 2019-new coronavirus (2019-nCoV). Biosci Trends, 2020, 14(1): 69-71.
11.	Chan KS, Lai ST, Chu CM, et al. Treatment of severe acute respiratory syndrome with lopinavir/ritonavir: a multicentre retrospective matched cohort study. Hong Kong Med J, 2003, 9(6): 399-406.
12.	宋杲, 成夢群, 魏賢文. 新型冠狀病毒(2019-nCoV)治療藥物體內外研究及藥物研發進展. 病毒學報, 2020, 36(2): 300-305.
13.	Chen N, Zhou M, Dong X, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet, 2020, 395(10223): 507-513.
14.	Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet, 2020, 395(10223): 497-506.
15.	Wang D, Hu B, Hu C, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China. JAMA, 2020, 323(11): 1061-1069.
16.	Guan WJ, Ni ZY, Hu Y, et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med, 2020, 382(18): 1708-1720.
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18.	Boriskin YS, Leneva IA, Pécheur EI, et al. Arbidol: a broad-spectrum antiviral compound that blocks viral fusion. Curr Med Chem, 2008, 15(10): 997-1005.
19.	Pshenichnaya NY, Bulgakova VA, Lvov NI, et al. Clinical efficacy of umifenovir in influenza and ARVI (study ARBITR). Ter Arkh, 2019, 91(3): 56-63.
20.	Wang Z, Chen X, Lu Y, et al. Clinical characteristics and therapeutic procedure for four cases with 2019 novel coronavirus pneumonia receiving combined Chinese and Western medicine treatment. Biosci Trends, 2020, 14(1): 64-68.
21.	曹瑜. 鹽酸阿比多爾片在治療急性呼吸道病毒感染中的安全性與有效性觀察. 中國現代藥物應用, 2018, 12(17): 101-103.
22.	Deng P, Zhong D, Yu K, et al. Pharmacokinetics, metabolism, and excretion of the antiviral drug arbidol in humans. Antimicrob Agents Chemother, 2013, 57(4): 1743-1755.
23.	Ramírez-Olivencia G, Estébanez M, Membrillo FJ, et al. Use of ribavirin in viruses other than hepatitis C. A review of the evidence. Enferm Infecc Microbiol Clin (Engl Ed), 2019, 37(9): 602-608.
24.	Cheng WT, Li CK, Leung TF, et al. Ribavirin for SARS in children. Clin Pediatr (Phila), 2004, 43(2): 193-196.
25.	Poutanen SM, Low DE, Henry B, et al. Identification of severe acute respiratory syndrome in Canada. N Engl J Med, 2003, 348(20): 1995-2005.
26.	Loustaud-Ratti V, Stanke-Labesque F, Marquet P, et al. Optimizing ribavirin dosage: a new challenge to improve treatment efficacy in genotype 1 hepatitis C patients. Gastroenterol Clin Biol, 2009, 33(6-7): 580-583.

1. 國家衛生健康委辦公廳, 國家中醫藥管理局辦公室. 關于印發新型冠狀病毒肺炎診療方案(試行第七版)的通知. (2020-03-04)[2020-04-05]. http://www.nhc.gov.cn/xcs/zhengcwj/202003/46c9294a7dfe4cef80dc7f5912eb1989.shtml.
2. Al-Tawfiq JA, Memish ZA. What are our pharmacotherapeutic options for MERS-CoV?. Expert Rev Clin Pharmacol, 2014, 7(3): 235-238.
3. Cao B, Wang Y, Wen D, et al. A trial of lopinavir-ritonavir in adults hospitalized with severe COVID-19. N Engl J Med, 2020, 382(19): 1787-1799.
4. Wang M, Cao R, Zhang L, et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res, 2020, 30(3): 269-271.
5. 陳軍, 凌云, 席秀紅, 等. 洛匹那韋利托那韋和阿比多爾用于治療新型冠狀病毒肺炎的有效性研究. 中華傳染病雜志, 2020, 38(2): 86-89.
6. 中華人民共和國衛生部. 藥品不良反應報告和監測管理辦法. (2011-05-04)[2020-04-05]. https://www.nmpa.gov.cn/xxgk/fgwj/bmgzh/20110504162501325.html.
7. 食品藥品監管總局. 食品藥品監管總局關于印發藥品不良反應報告和監測檢查指南(試行)的通知. (2015-07-02)[2020-03-05]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/fgwj/gzwj/gzwjyp/20150702120001584.html.
8. Vogel M, Rockstroh JK. Safety of lopinavir/ritonavir for the treatment of HIV-infection. Expert Opin Drug Saf, 2005, 4(3): 403-420.
9. 陳清, 張麗蘭, 于德憲, 等. 重組人干擾素α-2b噴霧劑人群試驗的安全性評價. 中華實驗和臨床病毒學雜志, 2005, 19(3): 211-215.
10. Lu H. Drug treatment options for the 2019-new coronavirus (2019-nCoV). Biosci Trends, 2020, 14(1): 69-71.
11. Chan KS, Lai ST, Chu CM, et al. Treatment of severe acute respiratory syndrome with lopinavir/ritonavir: a multicentre retrospective matched cohort study. Hong Kong Med J, 2003, 9(6): 399-406.
12. 宋杲, 成夢群, 魏賢文. 新型冠狀病毒(2019-nCoV)治療藥物體內外研究及藥物研發進展. 病毒學報, 2020, 36(2): 300-305.
13. Chen N, Zhou M, Dong X, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet, 2020, 395(10223): 507-513.
14. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet, 2020, 395(10223): 497-506.
15. Wang D, Hu B, Hu C, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China. JAMA, 2020, 323(11): 1061-1069.
16. Guan WJ, Ni ZY, Hu Y, et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med, 2020, 382(18): 1708-1720.
17. Xu Z, Shi L, Wang Y, et al. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med, 2020, 8(4): 420-422.
18. Boriskin YS, Leneva IA, Pécheur EI, et al. Arbidol: a broad-spectrum antiviral compound that blocks viral fusion. Curr Med Chem, 2008, 15(10): 997-1005.
19. Pshenichnaya NY, Bulgakova VA, Lvov NI, et al. Clinical efficacy of umifenovir in influenza and ARVI (study ARBITR). Ter Arkh, 2019, 91(3): 56-63.
20. Wang Z, Chen X, Lu Y, et al. Clinical characteristics and therapeutic procedure for four cases with 2019 novel coronavirus pneumonia receiving combined Chinese and Western medicine treatment. Biosci Trends, 2020, 14(1): 64-68.
21. 曹瑜. 鹽酸阿比多爾片在治療急性呼吸道病毒感染中的安全性與有效性觀察. 中國現代藥物應用, 2018, 12(17): 101-103.
22. Deng P, Zhong D, Yu K, et al. Pharmacokinetics, metabolism, and excretion of the antiviral drug arbidol in humans. Antimicrob Agents Chemother, 2013, 57(4): 1743-1755.
23. Ramírez-Olivencia G, Estébanez M, Membrillo FJ, et al. Use of ribavirin in viruses other than hepatitis C. A review of the evidence. Enferm Infecc Microbiol Clin (Engl Ed), 2019, 37(9): 602-608.
24. Cheng WT, Li CK, Leung TF, et al. Ribavirin for SARS in children. Clin Pediatr (Phila), 2004, 43(2): 193-196.
25. Poutanen SM, Low DE, Henry B, et al. Identification of severe acute respiratory syndrome in Canada. N Engl J Med, 2003, 348(20): 1995-2005.
26. Loustaud-Ratti V, Stanke-Labesque F, Marquet P, et al. Optimizing ribavirin dosage: a new challenge to improve treatment efficacy in genotype 1 hepatitis C patients. Gastroenterol Clin Biol, 2009, 33(6-7): 580-583.

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