Clinical studies of BCG-PSN injection in the treatment of allergic skin diseases have been conducted. The immunomodulatory agent, developed by Joseph, aims to broaden access to treatments for skin diseases and enhance clinical applications of new immunomodulatory agents such as Siqikang injection (produced by Changsha Jiuzhitang Biological Pharmaceutical Co., Ltd.). Among 243 cases treated for various skin diseases, there were 122 cases of chronic urticaria, 72 cases of eczema, 16 cases of herpes zoster, 13 cases of neurodermatitis, and several cases of psoriasis. Due to the smaller number of cases for herpes zoster, neurodermatitis, and psoriasis, these are not analyzed here. This report focuses on the clinical observation of chronic urticaria and eczema.
### Materials and Methods:
#### 1. Subjects
243 dermatology and allergy clinic patients were randomly divided into two groups:
- **Treatment Group:**
- Chronic urticaria: 60 cases (42 males, 18 females). Age range: 6 to 62 years. Duration: 4 months to 15 years, average 2 years and 5 months.
- Eczema: 42 cases (30 males, 12 females). Age range: 1 to 65 years. Duration: 2 to 4 years, average 1 year and 7 months.
- **Control Group:**
- Chronic urticaria: 62 cases (37 males, 25 females). Age range: 10 to 72 years. Duration: 6 months to 16 years, average 3 years.
- Eczema: 30 cases (14 males, 16 females). Age range: 1 to 57 years. Duration: 6 months to 3 years and 5 months, average 1 year.
#### 2. Treatment Protocol
- **Control Group:** Given antihistamines (terfenadine or astemizole) plus topical antipruritic agents for conventional treatment.
- **Treatment Group:** Conventional therapy plus BCG-PSN injection (produced by Jiuzhitang Biological Pharmaceutical Co., Ltd., specification/support 0.5 mg). Each dose: 1 mg, intramuscular injection three times a week, one course of treatment lasts 3 weeks, repeated every 2 to 3 courses.
#### 3. Efficacy Evaluation Criteria
- **Complete Cure:** Skin lesions completely subsided, symptoms disappeared.
- **Significant Improvement:** Skin lesions subsided ≥ 70%, almost no conscious disorder.
- **Effective:** Skin lesions subsided ≥ 30%, mild itching symptoms.
- **Ineffective:** No significant change in skin lesions and symptoms.
### Results
The clinical efficacy of the two groups is shown in Tables 1 and 2. For the treatment of 60 cases of chronic urticaria with Siqikang, the results indicate that the efficient rate (complete cure + significant improvement + improvement) was significantly higher in the treatment group compared to the control group (P < 0.05).
### Discussion
Chronic urticaria and eczema are allergic diseases. Conventional treatments with older antihistamines have some side effects and are widely tolerated. New antihistamines are expensive and only temporarily alleviate symptoms without controlling recurrence. Siqikang injection, as a new generation of immunomodulating agents, contains more than 10 kinds of ancient Smilax acid, polysaccharides, and other immunoreactive substances. By enhancing the balance between cellular and humoral immunity, it activates the monocyte-macrophage system, stabilizes fat cells, and closes lgE anti-Xing, thereby improving immune function in patients, enhancing disease resistance, and anti-allergic capacity to achieve the purpose of preventing disease recurrence.
Clinical applications of Siqikang in treating chronic bronchitis, asthma, and allergic rhinitis have been reported. This study shows that Siqikang can also achieve satisfactory effects in treating urticaria and eczema without side effects, making it worthy of clinical application.