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Polyprezinc does not reduce "tumor response" and prevents oral mucositis

Polyprezinc does not reduce "tumor response" and prevents oral mucositis

  • Categories:Stomach healthy
  • Author:
  • Origin:
  • Time of issue:2020-12-01
  • Views:0

(Summary description)

Polyprezinc does not reduce "tumor response" and prevents oral mucositis

(Summary description)

  • Categories:Stomach healthy
  • Author:
  • Origin:
  • Time of issue:2020-12-01
  • Views:0
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Preface

  Radiotherapy or combined chemotherapy is a common method for the treatment of head and neck tumors, but radiotherapy and chemotherapy often cause oral mucositis, causing painful mucosal ulcers, accompanied by dry mouth and loss of appetite. In severe cases, symptoms such as dehydration, malnutrition, and weight loss will occur, which will seriously impair the quality of life of patients. Oral mucositis caused by radiotherapy and chemotherapy is mainly the direct toxic effect of drugs on the oral mucosa, followed by oral infections caused by the immunosuppressive effect of chemotherapy. Although the exact mechanism of the cytotoxic effects of radiotherapy and chemotherapy on oral mucosa remains to be elucidated, oxidative stress and the subsequent series of inflammatory cytokines are related to the etiology of oral mucositis. The severity of mucositis in patients with head and neck cancer is positively correlated with the levels of pro-inflammatory factors such as TNF-α, IL-1 and IL-6.

  Polaprezinc (Polaprezinc, PZ) is a chelate composed of zinc ions and L-carnosine, which is clinically used to treat gastric ulcers. Studies have shown that polyprezinc can inhibit TNF-α induction and TNF-α cell signaling, promote the recovery of 5-fluorouracil-induced oral mucositis, and at the same time, it can also improve acetic acid-induced oral mucositis. Therefore, this article investigates the effect of polyprezinc, a gastric mucosal protective drug, on oral mucositis, pain, dry mouth and dysgeusia caused by chemotherapy and radiotherapy in patients with head and neck cancer, and explores whether polyprezinc can prevent head and neck cancer after radiotherapy. Oral mucositis.

  1 Materials and methods

  1.1 Subject

  31 subjects who signed the informed consent form to participate in the study were randomly assigned, 15 in the Azulene control group, and 16 in the Polyprezinc (PZ) group. In Japan, Azulene is used to treat oral mucositis. 1.2 Test method PZ particles (0.5g) are stirred intermittently for 1h and dissolved in 20mL 5% sodium alginate solution. Inject 7 drops of 4% solution into 100 mL of water to prepare Azulene solution. At the beginning of the radiotherapy, the subjects rinsed the mouth with Azulene solution or PZ solution for 3 minutes, and swallowed the PZ solution after gargle, 4 times a day, and continued until the end of the radiotherapy. Compare the effects of PZ and Azulene solution on oral mucositis and related symptoms after radiotherapy for head and neck cancer. 1.3 Evaluation of curative effect index The main curative index is the prevention of oral mucositis; the secondary curative index includes the prevention of pain, dry mouth and dysgeusia, the decrease in taking analgesics due to oral pain, the decrease in the number of patients who cannot take oral intake, and the daily routine Reduction of diet. To evaluate the incidence of mucositis, pain, dry mouth, and dysgeusia, grade the severity according to the Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Adverse reactions were checked weekly, and the worst score during the observation period was included in the data for comparison. The tumor response to radiotherapy and chemotherapy was evaluated by the solid tumor efficacy evaluation criteria (RECIST). 1.4 Statistical analysis Data analysis adopts Windows social science statistical program. Parametric data adopts t test, and nonparametric variables adopts Mann-Whitney U test or Fisher's exact probability test. p<0.05 is statistically significant.

  2 Results and analysis

  2.1 General conditions of subjects

  As shown in Table 1, there were no significant differences between the two groups in terms of gender, age, cancer area, total dose of radiotherapy, number of radiotherapy and chemotherapy, and clinical data. Among them, the serum creatinine level of the control group was significantly lower than that of the PZ group, but the values ​​of all patients did not exceed the upper limit of normal (male: 1.2 mg/dl, female: 0.9 mg/dl). The average total dose of the control group was 58Gy, the irradiation time was 45d, and the PZ group was 51Gy and 37d. 80% of the control group received concurrent chemotherapy, and 56% of the PZ group received concurrent chemotherapy. The most common cancer in both groups was pharynx cancer (33% vs. 44%), followed by laryngeal cancer (27% vs. 25%). Table 1 Patient demographics The control group had oral mucositis, pain and dry mouth, and the incidence of grade ≥ 2 events were 86.7%, 86.7% and 73.3% (Table 2).

  2.2 Polyprezinc relieves symptoms of radiotherapy and chemotherapy patients

  87% of patients in the control group had taste disorders, but the degree was milder than other symptoms, and 53.3% had grade ≥ 2 events. PZ significantly reduced the incidence of oral mucositis grade ≥ 2 events (40%), pain was 33.3% (p=0.003), xerostomia was 13.3% (p=0.001), and taste disorder was 19% (p=0.0002) . The frequency of pain medication was reduced from 100% to 50% (p=0.0025) (Table 3). Table 3 The effect of PZ on analgesic use rate, oral disability rate and dietary intake in patients with head and neck cancer radiotherapy/chemotherapy

  2.3 Polyprezinc prevents oral malabsorption. In addition, the dietary intake of the PZ group was significantly higher than that of the control group (78.8±31.2% of the total diet, mean±SD, and 30.7±37.9%, p=0.002), thus preventing Oral absorption disorder. Therefore, PZ can significantly reduce the risk of oral mucositis and symptoms related to radiotherapy and chemotherapy in patients with head and neck cancer. 2.4 Polyprezinc reduces the risk of disease Figure 1 shows the relative risk of oral diseases and the 95% confidence interval. Polyprezinc treatment reduces oral mucosal risk by 56.7% (grade ≥ 2), 90.6% (grade ≥ 3), pain risk reduction by 63.9% (grade ≥ 2), 81.2% (grade ≥ 3), and dry mouth risk by 83% (Level ≥2), the risk of dysgeusia is reduced by 88.3% (level ≥2), the risk of analgesics is reduced by 50%, and the risk of oral malabsorption is reduced by 68.7%. Figure 1 The forest plot shows the relative risk (RR) and 95% confidence interval (CI). It compares the incidence of oral mucositis, pain, dry mouth, and dysgeusia in patients with head and neck cancer treated with radiotherapy and chemotherapy with PZ and azulene solution. The frequency of analgesic use and the impact of oral intake disorders.

  2.5 Polyprezinc does not reduce tumor response As shown in Table 4, there is no significant difference in the tumor response rate between the control group and the polyprezinc group. The response rate of the polyprezinc group (overall response ± local response) is 88%, and the control group It was 92%, indicating that polyprezinc does not reduce tumor response. Table 4 The effect of PZ on the efficacy of neoadjuvant radiotherapy/chemotherapy for head and neck cancer

  Discuss

  The incidence of radiation oral mucositis in patients with head and neck cancer is as high as 80%. Although radiotherapy and chemotherapy have a high curative effect on head and neck cancer, pain, oral mucositis and dysgeusia often occur, leading to oral intake disorders, thus Need enteral nutrition or intravenous hypernutrition. Studies have shown that polyprezinc can effectively reduce the incidence of oral mucositis, pain, dry mouth and taste disorders for various symptoms caused by radiotherapy for head and neck cancer, without reducing the tumor's response to radiotherapy and chemotherapy. In addition, polyprezinc can also prevent oral eating disorders and food loss, greatly improving the quality of life of patients. Relaisen (Polyprezinc Granules) is a chelate composed of zinc ions and L-carnosine. It is a brand-new mucosal protective agent and is widely used in clinical treatment of gastric ulcers. The protective effect of polyprezinc on oral mucositis caused by radiotherapy can be attributed to its anti-TNF-α effect. Due to the activation of NF-κB after radiation, it subsequently induces a variety of cytokines including TNF-α and the activation of caspases. It is believed to be related to the etiology of radiation oral mucositis. Polyprezinc does not reduce tumor response, and it is highly credible that it is potentially effective in preventing oral mucositis and improving the quality of life of patients.

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Jilin Province Great Great Pharmaceutical Co. LTD
Jilin Province Great Great Pharmaceutical Co. LTD
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