Retrospective Analysis Of The Clinical Application Of Toxic Traditional Chinese Medicine Decoction Pieces in Elderly Outpatient Patients
Feb 08, 2025
ABSTRACT:
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The use of toxic Chinese medicine is one of the forms of Chinese medicine compound prescriptions and one of the characteristics of Chinese medicine theory. It shows the distinctive characteristics of Chinese doctors in the past dynasties in preventing and treating diseases [1]. Toxic Chinese medicine has a definite effect and strong medicinal properties, and plays an irreplaceable role in the clinical treatment of certain difficult and serious diseases or people with specific constitutions [2]. However, the therapeutic window of toxic Chinese medicine is narrow. For example, if the selection of medicine is not suitable for the indication, the use of overdose, and the combination of multiple toxic Chinese medicines are very likely to cause adverse reactions, even endangering life, and bring safety risks to the clinical treatment of patients [3]. Elderly patients belong to the special drug population. With the increase of age, their organ functions show physiological decline, their ability to metabolize drugs decreases, and their sensitivity to drugs increases, which can easily cause drug accumulation poisoning and increase the risk of adverse drug reactions [4]. Based on a large number of TCM prescriptions and case data stored in the hospital information system, this study conducted a retrospective statistical analysis on the use of toxic TCM pieces by elderly patients in the outpatient clinic of Shaoxing TCM Hospital, summarized the use patterns of toxic TCM by elderly patients and the problems in the use process, in order to provide data reference for the safe and rational use of toxic TCM pieces by elderly patients in the clinical practice.
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1 Data and methods
1.1 Data source
The data of this study comes from all prescription data of toxic TCM pieces for elderly patients (age ≥ 60 years old) in the outpatient clinic of Shaoxing TCM Hospital from June 2022 to June 2023, including patient age, gender,
clinical diagnosis, name of toxic TCM, and dosage, and collected and sorted them out and statistically analyzed the data.
1.2 Methods
All outpatient prescriptions of elderly patients from June 2022 to June 2023 were extracted from the hospital information system of the author's hospital and the Hangzhou Yiyao Rational Drug Use System. Based on the relevant laws and regulations such as the 2020 edition of the Chinese Pharmacopoeia Part I[5] (hereinafter referred to as the Chinese Pharmacopoeia), the "Zhejiang Province Traditional Chinese Medicine Processing Standards" (2015 edition)[6] (hereinafter referred to as the Zhejiang Province Processing Standards), the "Hospital Prescription Review Management Standards (Trial)"[7], the "Prescription Management Measures"[8] and the "Traditional Chinese Medicine Prescription Format and Writing Standards"[9], Microsoft Excel 2019 software was used to enter the patient's age, gender, clinical diagnosis, toxic Chinese medicine name, dosage, number of prescriptions, etc. in the toxic Chinese medicine decoction piece prescriptions of Shaoxing Traditional Chinese Medicine Hospital, and a retrospective analysis of the toxic Chinese medicine decoction piece prescriptions was performed.
2 Results
2.1 Basic information on the use of toxic Chinese herbal medicines in outpatient clinics
From June 2022 to June 2023, a total of 44,943 prescriptions for Chinese herbal medicines were used for elderly patients in the outpatient clinic of Shaoxing Hospital of Traditional Chinese Medicine, involving 12,946 prescriptions for toxic Chinese herbal medicines, accounting for 28.81% of the total number of prescriptions. There were 17,474 prescription items for toxic Chinese herbal medicines (the number of prescription items refers to the number of times each toxic Chinese herbal medicine appeared in the prescription), of which 12,659 were for oral use and 4,815 were for external use. The Chinese Pharmacopoeia and Zhejiang Province Processing Specifications both use three levels of toxic, toxic, and slightly toxic for toxic Chinese herbal medicines. According to statistics, elderly patients used a total of 41 toxic and slightly toxic Chinese herbal medicines, and no highly toxic Chinese herbal medicines were used. Among the currently used varieties, 25 are from the Chinese Pharmacopoeia, including 14 poisonous and 11 mildly poisonous ones; 16 are from the Zhejiang Province Processing Specifications, including 7 poisonous and 9 mildly poisonous ones. The results are shown in Table 1.
2.2 Prescription distribution characteristics of toxic Chinese herbal medicines
2.2.1 Age and gender distribution of elderly patients involved in toxic Chinese herbal medicine prescriptions
A total of 17,474 toxic Chinese herbal medicine items were collected, involving patients aged 60 to 99 years old, with an average age of 68.90 years old. Among them, the 60-69 age group used the most toxic Chinese herbal medicines (accounting for 60.37% of the toxic Chinese herbal medicine items and 16.85% of the total prescriptions); the gender distribution involved 8,682 prescription items for male patients (accounting for 49.69% of the toxic Chinese herbal medicine items), and 8,792 prescription items for female patients (accounting for 50.31% of the toxic Chinese herbal medicine items). The results are shown in Table 2.
2.2.2 Distribution of the top 15 diseases ranked by the number of toxic Chinese herbal medicine prescription items
Taking the first TCM diagnosis in the prescription diagnosis of toxic Chinese herbal medicines for outpatient elderly patients as the disease diagnosis, the statistical results show that the use of toxic Chinese herbal medicines for outpatient elderly patients is mostly concentrated in meridian limbs, lung system, spleen and stomach system diseases, and the specific diseases involved are arthralgia diseases, cough diseases, low back pain diseases, accumulation diseases and tendon injuries, etc. The results are shown in Table 3.
Table 1: Toxic TCM Decoction Pieces
| Source | Toxic | Mildly Toxic | Total Quantity |
|---|---|---|---|
| Imported from China | Aconite, prepared aconite, Pinellia ternata, Croton seed, Strychnos, Sophora flavescens, etc. | Rhubarb, Ephedra, Licorice, Angelica, Astragalus, etc. | 25 |
| Locally Available in Zhejiang Province | Arsenolite, Realgar, Toad venom, etc. | Rhubarb, Pinellia, Fritillaria, etc. | - |
Table 2: Age and Gender Distribution of Toxic Traditional Chinese Medicine Decoction Pieces in Elderly Outpatient Patients
| Age Group | Prescriptions (Male) | Prescriptions (Female) | Total Prescriptions | Percentage of Total Prescriptions (%) | Percentage of Total Patients (%) |
|---|---|---|---|---|---|
| 60-69 | 4,923 | 5,626 | 10,549 | 60.37 | 16.85 |
| 70-79 | 2,864 | 3,042 | 5,906 | 31.48 | 9.26 |
| 80-89 | 656 | 692 | 1,348 | 7.18 | 2.12 |
| 90-99 | 83 | 87 | 170 | 0.97 | 0.27 |
| Total | 8,526 | 9,447 | 17,973 | 100.00 | 28.50 |
| Rank | Disease Diagnosis | Number of Prescriptions | Percentage of Total TCM Toxic Prescriptions (%) |
|---|---|---|---|
| 1 | Stroke-Related Diseases | 1,075 | 19.87 |
| 2 | Cough-Related Diseases | 587 | 10.85 |
| 3 | Lumbar Diseases | 504 | 9.32 |
| 4 | Accumulation Diseases | 494 | 9.13 |
| 5 | Traumatic Injuries | 394 | 7.28 |
| 6 | Fever-Related Diseases | 374 | 6.91 |
| 7 | Digestive Diseases | 365 | 6.75 |
| 8 | Stomach Diseases | 591 | 5.91 |
| 9 | Dampness-Related Diseases | 501 | 5.91 |
| 10 | Joint Swelling Diseases | 389 | 5.79 |
| 11 | Damp-Heat Related Diseases | 502 | 5.77 |
| 12 | Coldness Diseases | 179 | 3.25 |
| 13 | Heat Diseases | 502 | 2.38 |
| 14 | General Weakness | 175 | 2.04 |
| 15 | TCM Poisoning | 179 | 1.02 |
2.3 Use of toxic Chinese herbal medicines
2.3.1 Number of prescription items, proportion, TCM diagnosis and main clinical applications of toxic Chinese herbal medicines in outpatient elderly patients. The clinical application of toxic Chinese herbal medicines in outpatient elderly patients is divided into oral and external use. Among them, 40 toxic Chinese herbal medicines are used for oral use, and 14 toxic Chinese herbal medicines such as Artemisia argyi, processed Chuanwu, and processed Caowu are also used for external use. The main clinical applications of oral toxic Chinese herbal medicines involve the respiratory system, digestive system, nervous system and endocrine system. The clinical application of external toxic Chinese herbal medicines is concentrated on musculoskeletal system and skin diseases. The results are shown in Table 4.
2.3.2 Overdose of toxic Chinese herbal medicines
This study used the upper limit of dosage prescribed by the Chinese Pharmacopoeia or the Zhejiang Provincial Processing Specification as the criterion for overdose of toxic Chinese herbal medicines, and referred to the setting of Chang Xinnan et al. [10] and Liu Shuyu et al. [11]. The proportion of overdose (%) = the number of entries that exceeded the upper limit of dosage of the toxic herbal medicine / the total number of entries containing the toxic herbal medicine × 100%, the degree of overdose (times) = the actual clinical dose of the overdose toxic herbal medicine / the upper limit of the prescribed dosage, and the average degree of overdose (times) = the total degree of overdose of the toxic herbal medicine / the total number of entries containing the toxic herbal medicine. The larger the overdose multiple, the higher the degree of overdose. The results showed that there were 2,834 prescriptions for oral overdose of toxic Chinese herbal medicines in outpatient clinics, of which 22 kinds of herbal medicines, including Sheliugu, Tripterygium wilfordii, and Sophora flavescens, were overdose. The largest proportion of overdose was Sheliugu, which was 100.00%, and the highest average overdose was processed Aconitum carmichaelii, which was 3.00 times the upper limit of the dose. The results are shown in Table 5.
2.3.3 Combined use of toxic Chinese herbal medicines
There were 7,897 prescriptions for combined use of ≥2 toxic Chinese herbal medicines in outpatient elderly patients, of which 4,395 were oral and 3,502 were external. There were 5,156 prescriptions for combined use of 2 toxic Chinese herbal medicines (accounting for 65.29%), with the highest frequency of combined oral use of scorpion and centipede. There were 1,617 articles (accounting for 20.48%) that contained 3 toxic Chinese medicines in combination, with the most frequent combination of Artemisia argyi, processed Radix Aconiti Kusnezoffii, and Radix Difengpi for external use. When ≥4 toxic Chinese medicines were used in combination, and the frequency of combination was >10, the usage was external use. There were 544 articles (accounting for 6.89%) that contained 4 toxic Chinese medicines in combination, with Artemisia argyi, processed Radix Aconiti Kusnezoffii, processed Radix Aconiti Kusnezoffii, and Agkistrodon acutus being the main combination, and there were 580 articles (accounting for 7.34%) that contained 5 toxic Chinese medicines in combination, with Artemisia argyi, processed Radix Aconiti Kusnezoffii, processed Radix Aconiti Kusnezoffii, and Agkistrodon acutus being the main combination. The results are shown in Table 6.
