Research Studies
• Acute Toxity Test for Leucozepin
• Acute Toxity Test for Relazovac
• Acute Toxity Test for Apazin
• Leukogenic Studies of Leucozepin
• Sedative Studies of Relazovac
• Appetizing Studies of Apazin
• Clinical Study on Leucozepin
Clinical Study on Leucozepin™
Abstract:
The therapeutic effect of Leucozepin™ Compound, a natural herbal product, on white blood cell count was observed in fifty-nine patients with tumors of advanced stages after chemo- or radiotherapy treatments. Among forty-one cases with leukopenia before treatment, leukocyte count was back to normal in thirty-one cases after treatment. The counts pre- and post-treatment were (2.8±0.6)×109/L and (5.9±1.4)×109/L respectively *P*0.01). In eighteen patients with normal leukocyte count before treatment, the counts of seventeen cases were still normal after treatment. The time for leukocyte recovery was 8.0 days on average, while that of twenty-three patients who did not take Leucozepin™ Compound was 20.6±1.8 days. The results indicated that the Leucozepin™ Compound has leukocytogenic effect and could alleviate the inhibition of chemotherapy or radiotherapy on hemopoietic function of bone marrow.
Leukopenia induced by the arrest of bone marrow is commonly toxic and has side effects in the treatment of malignant tumors with chemo- or radiotherapy, which affects therapeutic efficiency in varying degrees. To study the effect of Leucozepin™ Compound, a natural herbal product, on leukocyte count, fifty-nine advanced tumor patients treated by Leucozepin™ Compound were observed from March 2002 to May 2002.
Materials & Methods:
1. Clinical data: Eighty-two patients with malignant tumors of advanced stages confirmed by pathological and other examinations (B ultrasonic wave, CT) were enrolled into this clinical trial. The treated group had fifty nine patients (male 29, female 30), aged 22 years to 93 years (average age 54 years), including:
17 Pulmonary Carcinoma Patients
18 Mammary Cancer Patients
6 Carcinoma of Stomach Patients
3 Carcinoma of Colon Patients
15 Other Tumors Patients, such as oophoroma, carcinoma of esophagus, carcinoma of kidney, carcinoma of urinary bladder, etc.
The control group had 23 patients (male 12, female 11), aged 27 years to 87 years, average age 56 years. All patients had been treated with chemo- or radiotherapy and the therapeutic programs varied by the nature of the diseases. The main chemotherapy medicines were Cyclophosphamide, Cisplatin, 5-fluorouracil, Adriamycin. Irradiation of 60Co or linear accelerate was radiotherapy. The patients’ physical strength ranged between 0—3 grade.
2. Therapeutic methods: Patients of the treated group took Leucozepin™ Compound, which was composed of Astragalus, Spatholobus, Reishi Mushroom, Codonopsis, Dong Quai, Rehmannia, Polygonatum, Psoralea, Ligustrum, Bai-zhu Atractylodes, Poria, Lycium, Tangerine, Dendrobium, and Chinese Licorice. The compound was dissolved in water for oral dose, one dose daily for seven days for one course of treatment. Patients of the control group did not take any leukocytogenic medicine. The change of leukocyte count and improvement of clinical symptoms pre- and post-treatment were observed.
Results:
1. Criterion of therapeutic evaluation: Clinical efficacy was based on leukocyte count first measured on the eighth day after treatment. If patients with leukopenia or nonleukopenia pre-treatment returned to normality post-treatment, this was regarded as having efficacy. Leukocyte counts were divided into four grades:
0 grade ( WBC *4.0×109/L)
I* grade [WBC (3~3.9) ×109/L]
II grade [WBC (2~2.9) ×109/L]
III grade [WBC (1~1.9)×109/L]
2. Among 59 patients, 41 patients were with leucopenia and the other 18 patients’ leukocyte counts were normal (0 grade). Of the 41 patients:
I grade - 21 patients
II grade - 18 patients
III grade - 2 patients
After treatment, the leukocyte count improvement was as follows:
37 patients to 0 grade
3 patients to I grade
1 patient to III grade
In eighteen patients with normal leukocyte count, there were seventeen patients continuing normal and one patient at I grade. There was significant difference between pre- and post-treatment and the compound could remarkably increase WBC (white blood cell).
The leukocyte counts pre-and post-treatment were (2.8±0.6)×109/L and (5.9±1.4)×109/L respectively *P*0.01). The result showed significant difference between pre- and post-treatment.
3. Comparing the time for leukocyte recovery between two groups: The time for the treated group was 8.0 days on average, while that for the control group was 20.6±1.8 days. The results showed Leucozepin™ Compound could effectively shorten the time for leukocyte recovery.
4. Improvement of clinical symptoms: After treatment, the clinical symptoms had been alleviated or disappeared in most patients.
Discussion:
Studying TCM-based natural herbal product of alleviating toxic responses of chemo- or radiotherapy is an important method to enhance tumor therapeutic efficiency. Traditional Chinese Medicine takes the view that chemo- or radiotherapy act as noxious heat, which damages yin and consumes primordial energy and bodily fluid. This eventually leads to disorder of the functional activities of the viscera, exhausting the source of life activity, and resulting in deficiency syndrome of both vital energy and yin emerge during treatment. It is considered in TCM that leukopenia induced by chemo-or radiotherapy belongs to asthenia-syndrome. The main pathogenesis connects closely with functions of spleen and kidney, which are critical in alleviating toxic responses. The basic principle of treatment is benefiting vital energy and nourishing blood and supporting the healthy energy.
Leucozepin™ Compound is composed of many kinds of traditional Chinese ingredients, which replenish essence and support the healthy energy. The experimental studies indicated Leucozepin™ Compound could promote normal macrophage phagocytic functions in mice, strengthen humoral and cellular immunity and advance the hemopoietic function of bone marrow in mice. Leucozepin™ Compound, based on the above mechanism has definite therapeutical effects on leukopenia induced by chemo- or radiotherapy. The compound provides a protected effect and could improve some clinical symptoms, and it can benefit those who are undergoing chemo -or radiotherapy treatments.
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