1.Safety Content Analysis and Suggestions for Enhancement of Chinese Medicines Containing Bitter Almond
Jingjing HAN ; Nina DOU ; Rui JIN
Herald of Medicine 2025;44(5):738-743
Objective To explore the problems arising from the safety content in the instructions of Chinese patent medicines containing bitter almonds and to make suggestions.Methods By searching the Chinese patent medicines containing bitter almonds in the"National Basic Medical Insurance,Work Injury Insurance and Maternity Insurance Drug List(2022)"of the Medication Assistant and Yaozhi Online,the article collated their primary functions,composition,adverse reactions,contraindi-cations to medication,warnings,and precautions.The article entered the collected information into the Excel 2021 version,analyzed the summarized data,and made suggestions for the safety warning information in the instructions of Chinese patent medicines con-taining bitter almonds based on the results of the statistics.Results Among the 1 381 kinds of patent medicines listed in the"National Basic Medical Insurance,Work Injury Insurance,and Maternity Insurance Drug List(2022)",there are 67 varieties of Chinese patent medicines containing bitter almonds,and there were missing safety contents in the collected instructions.Among them,only five types were clearly labeled with specific contents of warnings,17 types were clearly labeled with adverse reactions,24 types were clearly labeled with contraindications,and 58 types were clearly labeled with precautions.However,in terms of the content of bitter almonds and prescription ratio,the maximum daily dosage of 2 out of 67 Chinese patent medicines containing bit-ter almonds exceeded the dosage of the Chinese Pharmacopoeia,and the prescription ratio of 14 Chinese patent medicines excee-ded 10%;in terms of the combination and dosing,25 out of 67 Chinese patent medicines containing bitter almond were dosed with other poisonous traditional Chinese medicines,and the above medicines have high safety risks.The information on their safety should be increased,and their safety information should be increased.Conclusions The safety-related warnings in the instruc-tions for Chinese patent medicines containing bitter almonds are not comprehensive enough.It is recommended to strengthen the management of the whole life cycle of drugs,increase the warnings of level 1 high-risk varieties,and improve adverse reactions,contraindications,and precautions according to the Technical Guiding Principles for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions(Trial).
2.Safety Content Analysis and Suggestions for Enhancement of Chinese Medicines Containing Bitter Almond
Jingjing HAN ; Nina DOU ; Rui JIN
Herald of Medicine 2025;44(5):738-743
Objective To explore the problems arising from the safety content in the instructions of Chinese patent medicines containing bitter almonds and to make suggestions.Methods By searching the Chinese patent medicines containing bitter almonds in the"National Basic Medical Insurance,Work Injury Insurance and Maternity Insurance Drug List(2022)"of the Medication Assistant and Yaozhi Online,the article collated their primary functions,composition,adverse reactions,contraindi-cations to medication,warnings,and precautions.The article entered the collected information into the Excel 2021 version,analyzed the summarized data,and made suggestions for the safety warning information in the instructions of Chinese patent medicines con-taining bitter almonds based on the results of the statistics.Results Among the 1 381 kinds of patent medicines listed in the"National Basic Medical Insurance,Work Injury Insurance,and Maternity Insurance Drug List(2022)",there are 67 varieties of Chinese patent medicines containing bitter almonds,and there were missing safety contents in the collected instructions.Among them,only five types were clearly labeled with specific contents of warnings,17 types were clearly labeled with adverse reactions,24 types were clearly labeled with contraindications,and 58 types were clearly labeled with precautions.However,in terms of the content of bitter almonds and prescription ratio,the maximum daily dosage of 2 out of 67 Chinese patent medicines containing bit-ter almonds exceeded the dosage of the Chinese Pharmacopoeia,and the prescription ratio of 14 Chinese patent medicines excee-ded 10%;in terms of the combination and dosing,25 out of 67 Chinese patent medicines containing bitter almond were dosed with other poisonous traditional Chinese medicines,and the above medicines have high safety risks.The information on their safety should be increased,and their safety information should be increased.Conclusions The safety-related warnings in the instruc-tions for Chinese patent medicines containing bitter almonds are not comprehensive enough.It is recommended to strengthen the management of the whole life cycle of drugs,increase the warnings of level 1 high-risk varieties,and improve adverse reactions,contraindications,and precautions according to the Technical Guiding Principles for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions(Trial).
3.Toxic epidermal necrolysis due to levofloxacin injection
Kuixia CHEN ; Dan PAN ; Li LI ; Nina DOU ; Kexin ZHAO
Adverse Drug Reactions Journal 2020;22(9):537-538
A 77-year-old male patient received intravenous infusion of levofloxacin 0.5 g for preventing infection before transrectal prostate biopsy. Three hours after the infusion finished, erythema with pruritus appeared on his trunk, buttocks and limbs. Two days later, the patient developed fever, aggravated rash, and large area of blisters. Three days later, the blisters were broken and Nikolsky sign was positive. Toxic epidermal necrolysis was diagnosed, which was considered to be related to levofloxacin. Symptomatic treatments including combination use of glucocorticoid and human immunoglobulin and skin wound care were given. Fifteen days later, his rash completely subsided and the skin wound healed basically.
4.Toxic epidermal necrolysis due to levofloxacin injection
Kuixia CHEN ; Dan PAN ; Li LI ; Nina DOU ; Kexin ZHAO
Adverse Drug Reactions Journal 2020;22(9):537-538
A 77-year-old male patient received intravenous infusion of levofloxacin 0.5 g for preventing infection before transrectal prostate biopsy. Three hours after the infusion finished, erythema with pruritus appeared on his trunk, buttocks and limbs. Two days later, the patient developed fever, aggravated rash, and large area of blisters. Three days later, the blisters were broken and Nikolsky sign was positive. Toxic epidermal necrolysis was diagnosed, which was considered to be related to levofloxacin. Symptomatic treatments including combination use of glucocorticoid and human immunoglobulin and skin wound care were given. Fifteen days later, his rash completely subsided and the skin wound healed basically.

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