Clinical Observation and Safety Evaluation of Zhuang Medicine Xiaoyan Zhiyang Formula for Dermatosis

Wen ZHONG, Xixi QI, Jiangcun WEI, Xian PENG, Fangmei LI

Guangxi International Zhuang Medical Hospital, Nanning 530201, China

Abstract [Objectives] To observe the clinical efficacy and safety of Zhuang Medicine Xiaoyan Zhiyang Formula by retrospective analysis of clinical use. [Methods] A total of 225 cases were collected, including 117 males and 108 females, 115 cases of contact dermatitis and 110 cases of acute eczema. Zhuang Medicine Xiaoyan Zhiyang Formula was administered to 225 patients with contact dermatitis and acute eczema and the clinical efficacy was evaluated. [Results] After one week of treatment, among 225 patients with contact dermatitis and acute eczema, 76 cases were cured (33.78%), 133 cases showed marked response (59.11%), 16 cases (7.11%) were improved, 0 case was ineffective, and the overall response rate was 92.89%. After one week of Zhuang Medicine Xiaoyan Zhiyang Formula treatment, the symptoms of itching, pain and swelling were significantly improved in all patients, and the rash was partially crusted without new symptom, and there were no complications and adverse reactions. [Conclusions] Zhuang Medicine Xiaoyan Zhiyang Formula therapy has a remarkable effect in the treatment of contact dermatitis and acute eczema.

Key words Zhuang Medicine Xiaoyan Zhiyang Formula, Contact dermatitis, Acute eczema, Clinical drug use, Safety evaluation

1 Introduction

Zhuang Medicine Xiaoyan Zhiyang Formula is a Chinese medicine formula for the treatment of skin diseases formulated by Guangxi International Zhuang Medical Hospital for many years on the basis of the basic principles of TCM treatment of diseases "dialectical treatment", and with reference to some of the basic theories of Zhuang medicine. This formula has been successively used in Mingxiu Branch of Guangxi International Zhuang Medical Hospital (formerly Guangxi Zhuang Medical Hospital), Guangxi International Zhuang Medical Hospital processed the formula into decoction and provided it to patients for use, which has definite curative effect and can effectively improve the symptoms of patients.

Zhuang Medicine Xiaoyan Zhiyang Formula consists of six traditional Chinese medicines, namely, Scutellariae Radix (Huangqin), Portulacae Herba (Machixian), Ilicis Rotundae Cortex (Jiubiying), Herba Polygoni Chinensis (Huotanmu), Mahoniae Caulis (Gonglaomu), and Sanguisorbae Radix (Diyu). It has been clinically applied for many years, and has the effect of clearing heat and removing dampness, cooling blood and detoxification, and generating muscle sores, and is used to treat acute dermatitis, eczema, contact dermatitis, burns and other skin diseases. In the long-term clinical work, our team used Zhuang Medicine Xiaoyan Zhiyang Formula to treat acute dermatitis, eczema, contact dermatitis, burns and other skin diseases, and has achieved good results. The Zhuang Medicine Xiaoyan Zhiyang Formula has effect in clearing away heat, eliminate dampness, cooling blood, removing toxic materials, promote granulation, and healing sore; and can be used for treating acute dermatitis, eczema, contact dermatitis, paederus dermatitis, burn, scald, and other dermatoses. We summarized the clinical application of the cases systematically observed in the past three years (2021-2023) in this paper.

2 Basic information of the prescription

2.1 CompositionThe formula consists of Scutellariae Radix 15 g, Portulacae Herba 15 g, Ilicis Rotundae Cortex 15 g, Herba Polygoni Chinensis 15 g, Mahoniae Caulis 15 g, and Sanguisorbae Radix 15 g.

2.2 Usage and dosageIt is decocted with water for external use, diluted with warm water (1：10-1：200), and apply (soak) to the affected part, 1 dose per day, 1-2 times.

2.3 Functions and indicationsIt has effect in clearing away heat and toxic material, cooling blood, expelling pathogenic wind, eliminating dampness, and relieving itching. It can be used for treating dermatoses such as acute dermatitis, eczema, contact dermatitis, paederus dermatitis, and burn and scald.

2.4 Prescription theoryIn the formula, the Ilicis Rotundae Cortex has the effect of clearing away heat and toxic material, reducing swelling and relieving pain, promote diuresis and the like, is used as the sovereign medicinal in the formula, and is mainly used for treating eczema, impetigo, toothache, burn and scald, traumatic injury, traumatic hemorrhage, venomous snake bite and other diseases for external use. Ilicis Rotundae Cortex mainly contains saponins, aromatic compounds, steroids, aldehydes, flavonoids and others. Syringin and Pedunculoside are two typical triterpenoid saponins in Ilicis Rotundae Cortex, which have pharmacological activities such as antibacterial, anti-inflammatory, analgesic and antitumor. Sanguisorbae Radix has the effects of cooling blood, stopping bleeding, detoxifying and healing sores, and is mainly used for treating scald, eczema, sores and carbuncles. The chemical components of Sanguisorbae Radix are mainly tannins, phenolic acids, saponins, flavonoids, steroids and polysaccharides, which have antioxidant, anti-allergic, anti-inflammatory and antibacterial effects. Mahoniae Caulis has the effects of clearing heat, drying dampness and detoxifying, and is mainly used for treating sores, eczema, scalds and the like. The main chemical components of Mahoniae Caulis are alkaloids, flavonoids and volatile oils, which have antibacterial, anti-inflammatory, antiviral and antitumor activities. Portulacae Herba has the effect of clearing heat and detoxification, cooling blood and stopping bleeding, and is clinically used to treat inflammatory bowel disease, acute eczema, shingles, flat warts, uterine bleeding, diarrhea and breast abscess. Portulacae Herba has anti-inflammatory, analgesic, bacteriostatic, hypolipidemic, hypoglycemic, anti-tumor, antioxidant, anti-aging, enhance immunity and other effects, and is widely used in medicine, health food, skin care products and other fields. Scutellariae Radix has the effect of clearing heat and dampness, ephemeral fire and detoxification, and modern research has shown that it has antibacterial, anti-inflammatory, antiviral, antitumor and other pharmacological activities. Herba Polygoni Chinensis has the effect of clearing heat and moisture, cooling blood and detoxification, and has antioxidant, antibacterial, anti-inflammatory, antitumor and other effects. The combination of these medicines has the effect of clearing heat and removing dampness, cooling blood and detoxification, and generating muscle sores, and is used to treat acute dermatitis, eczema, contact dermatitis, cryptoptera dermatitis, burns and other skin diseases.

3 Observation of clinical medication

This clinical observation was formulated and implemented in accordance with the regulations and documents such as theDetailedRulesfortheRecordManagementofTraditionalChineseMedicineandEthnicMedicinePreparationsPreparedbyTraditionalTechnologyinGuangxiMedicalInstitutions, theGuidingPrinciplesforClinicalResearchofNewChineseMedicines, and theTechnicalGuidelinesforClinicalResearchofNewDrugsinSyndromeTraditionalChineseMedicines.

3.1 General dataWe observed 225 outpatients of dermatology at Guangxi International Zhuang Medical Hospital. Among them, 117 were males and 108 were females. In all these patients, 115 cases of contact dermatitis and 110 cases of acute eczema were diagnosed. The oldest was 60 years old, the youngest was 18 years old, the age range was 18-60 years old, and the average age was (33.11±9.34) years old; the course of disease was 1-14 d with an average (5.64±2.82) d. The age and gender distribution of patients are shown in Table 1, and the annual distribution of cases is shown in Table 2, and the distribution of diseases is 115 cases (51.11%) of contact dermatitis and 110 cases (48.89%) of acute eczema.

Table 1 Age and gender distribution of patients

Table 2 Annual distribution of cases

3.2 Diagnostic criteriaThe diagnostic criteria were determined with reference to the relevant contents ofChineseZhuangMedicinepublished by Guangxi Ethnic Publishing House,InternalMedicineofChineseZhuangMedicinepublished by Guangxi Science and Technology Publishing House,StandardsforDiagnosisandTreatmentofDiseasesandSyndromesinChineseZhuangMedicinepublished by Guangxi Ethnic Publishing House,ConciseZhuangMedicineand Traumatology ofZhuanMedicinepublished by China Traditional Chinese Medicine Publishing House.

3.2.1Contact dermatitis. Clinical manifestations: This disease is mainly judged according to the characteristics of skin lesions. Most patients may have a rash with the same shape and scope as the contact site. In severe cases, erythema and swelling can be seen, often accompanied by blisters, bullae, papules, erosion, exudation and other conditions; some patients may also have subacute and chronic dermatitis eczema-like manifestations, such as mild erythema, papules, lichenoid changes, mild pruritus and so on.

3.2.2Diagnostic criteria for acute eczema. Clinical manifestations: Main symptoms: erythema, papules, exudation, erosion, scab, lichenoid and other polymorphous rash with severe pruritus. In acute cases, skin lesions are usually polymorphous, such as flushing, papules, blisters, erosion, exudation, crusts, desquamation, and many forms may exist at the same time. It is characterized by acute onset, self-conscious burning, and severe itching. Skin lesions are often symmetrically distributed, with more common in the head, face, distal extremities, scrotum,etc.It can spread throughout the body. It can develop into subacute or chronic wet sores, and it can be mild and severe, and recur.

Complications: irritability, sleeplessness, lack of breath and lazy speech, self-sweating, poor stools, heavy limbs, dry stools, yellow urine.

Visual signs: the white eye veins of the acute onset of "Leda" are bright red, the edges of the white eye veins are infiltrated and turbid, the boundaries are unclear or the veins are scattered.

Tongue and pulse condition: The tongue is red with yellow greasy or white greasy coating, and the pulse is wiry and slippery or slippery and rapid.

Nail signs: The nail bed is light red or bright red, the nail body is smooth and moist, the nail fold is symmetrical and complete, and the blood color is restored evenly.

3.3 Observation content and method

3.3.1Safety indicators: truthfully fill in the adverse event (AE) report form.

(i) AE report form. Did the subject have an adverse event during the trial? □ No □ Yes. If "Yes", please fill in the following form.

Name of adverse eventOccurrence timeTime: hour, min, Day, Month, YearTime: hour, min, Day, Month, YearTime: hour,min, Day, Month, YearSeverity of adverse event□ Mild □ Moderate □ Severe□ Mild □ Moderate □ Severe□ Mild □ Moderate □ SevereWhether measures have been taken (If yes, please record the combined medication record form)□Yes No□Yes □No□Yes □NoEffect on the dose of the study drug□ Not using □ Discontinue using□ End of using □ Others□ Not using □ Discontinue using□ End of using □ Others□ Not using □ Discontinue using□ End of using □ OthersRelationship with the study drug□ Definitely related □ Likely relat-ed □ Possibly related □ Possibly not related □ Note related□ Definitely related □ Likely relat-ed □ Possibly related □ Possibly not related □ Note related□ Definitely related □ Likely related□ Possibly related □ Possibly not re-lated □ Note relatedWhether the serious adverse event is met (if so, please record the serious adverse event report form)□Yes □No□Yes □No□Yes □NoComplete the following sections at end of adverse events or at the end of the studyThe outcome of the adverse event that occurred□ Still exists □ Alleviated □ Cured □ Not knownDate and time of alleviation/cure:□ Still exists □ Alleviated □ Cured □ Not knownDate and time of alleviation/cure:□ Still exists □ Alleviated□ Cured □ Not knownDate and time of alleviation/cure: Did the subject withdraw from the trial due to this adverse event?□Yes □No□Yes □No□Yes □NoRemarks

(ii) Serious adverse event (SAE)

Type of report□ First report □ Follow-up report □ Summary reportReport date: Name of medical institution and de-partmentTel.:Name of applying unitTel.:Name of the drug for investigationChinese name:English name:Classifications of drugs□ Traditional Chinese medicine □ Chemical drugs□ New biological products □ Radioactive drugs □ Imported □ OthersTypeStage of clinical study□ Stage I □ Stage II □ Stage III □ Stage IV□ Bioequivalence test □Clinical trialsDosage form:Subject informationName abbreviation:Gender:Date of birth:Ethnic group:Disease diagnosis:SAE condition□ Hospitalization □ Extending the hospitalization time □ Disability □ Dysfunction□ Congenital malformations □ Endangering life or death □ OthersSAE occurrence time:SAE severity: □ Mild □ Moderate □ SevereAction taken on the trial drug□ Not using □ Discontinue using □ End of using □ OthersSAE metastasis and progression□ Symptoms disappear (Sequelae □No □Yes) □ Symptoms persist□ Death (time: MonthDay, Year)Relationship between SAE and inves-tigational drug□ Definitely related □ Likely related □ Possibly related□ Possibly not related □ Note relatedUnblinding□ No □ Yes (Unblinding time: MonthDay, Year)Reported SAEDomestic □ Yes□ No□ No details Foreign □ Yes □ No □ No detailsDetails of SAE occurrence and han-dling

3.3.2Criteria for efficacy. The criteria were formulated with reference to theGuidelinesforClinicalResearchofNewChineseMedicinespublished by the Administration of Traditional Chinese Medicine. The evaluation of clinical efficacy is divided into 4 levels: clinically cured, marked response, improved, and ineffective.

Symptom Score Reduce Index (SSRI) =(Total score before treatment-Total score after treatment) Total score before treatment×100%.

(i) Clinically cured: skin lesions disappeared completely and the symptoms disappeared, and the SSRI was ≥ 90%;

(ii) Marked response: most of the skin lesions subsided and the symptoms were significantly relieved, SSRI was 60%-89%;

(iii) Improved: skin lesions were partially improved and symptoms were improved, SSRI was 30%-59%;

(iv) Ineffective: the improvement of skin lesions was not obvious, the symptoms were not improved or aggravated, and the SSRI was <30%.

Response rate=(Basically cured+Marked response)×100%.

3.4 Statistical analysisSPSS software was used. The age, gender, course of disease and other general data of the patients were counted. Ridit analysis was used for rank data,X2test was carried out for technical data, andt(u) test was carried out for measurement data.

4 Analysis of clinical efficacy

4.1 Overall clinical efficacyThe overall clinical overall response rate of 225 patients treated with Zhuang Medicine Xiaoyan Zhiyang Formula was 92.89%, of which 76 cases were cured, 133 cases were markedly effective, 16 cases were improved, and 0 case was ineffective. The specific analysis is shown in Table 3. The main diseases include contact dermatitis and acute eczema, and the overall response rate of each disease is within the range, as shown in Table 4.

Table 3 Curative effect of Zhuang Medicine Xiaoyan Zhiyang Formula after one week of treatment

Table 4 Curative effect of Zhuang Medicine Xiaoyan Zhiyang Formula for different diseases after one week of treatment

4.2 SafetyNo serious adverse events, serious complications and adverse reactions occurred in 225 observed patients after medication.

5 Conclusions

The Zhuang Medicine Xiaoyan Zhiyang Formula has the effects of clearing away toxic heat, removing dampness, expelling pathogenic wind, dredging the channels of dragon fire, regulating the channels of grain and water, softening and resolving hard mass, killing parasites and relieving itching and pain. It can be used for treating dermatoses such as acute dermatitis, eczema, contact dermatitis, paederus dermatitis, and burn and scald. No adverse reaction is found during the medication, and the prescription is safe and effective in clinical application.