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Polyprezinc improves the severity of radiation mucositis

Polyprezinc improves the severity of radiation mucositis

  • Categories:Stomach healthy
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  • Time of issue:2020-12-02
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(Summary description)

Polyprezinc improves the severity of radiation mucositis

(Summary description)

  • Categories:Stomach healthy
  • Author:
  • Origin:
  • Time of issue:2020-12-02
  • Views:0
Information

  Preface

  Radiation therapy is very important to the life and health of patients with head and neck cancer, but radiotherapy often causes severe radiation mucositis. Treatment of mucositis can interfere with the entire treatment plan and severely reduce the patient's quality of life (QOL). Amifostine is an anti-radiation agent that can prevent radiation toxicity in patients with head and neck cancer. However, its use is restricted due to its own blood and gastrointestinal toxicity. At present, it is suitable for mucositis caused by radiotherapy and chemotherapy. There is no standardized treatment. Polyprezinc (Polaprezinc PZ) is a chelate composed of zinc ions and L-carnosine, and is widely used clinically to treat gastric ulcers. Studies have shown that polyprezinc has antioxidant and free radical scavenging activity, and has significant effects on mucositis caused by radiotherapy and chemotherapy in patients with acute radiation proctitis and head and neck cancer. This study is a prospective clinical trial designed to evaluate the feasibility of polyprezine in the treatment of mucositis caused by radiotherapy, and to evaluate the effect of polyprezine on radiation mucositis with a controlled study.

  1 Research objects and methods

  1.1 Research subjects From March 2010 to February 2013, 32 subjects who received radiotherapy at Hyogo Medical College Hospital were included, who were pathologically diagnosed with head and neck cancer and planned to receive radical radiotherapy, and signed an informed consent form . Exclude patients undergoing radiotherapy after head and neck cancer. This study was approved by the Ethics Committee of Hyogo Medical College. 1.2 Preparation of polyprezinc oral rinses Polyprezinc (PZ) oral rinses are prepared with carboxyvinyl polymer as a matrix, in order to increase its stability and mucosal adhesion. Adjust the pH to 7.0 with NaHCO3. According to the standard dosage of polyprezinc for the treatment of gastric ulcer (150mg/d), the final concentration of PZ oral rinse was adjusted to 37.5mg/10ml. 1.3 Treatment plan During radiotherapy, use 10ml PZ oral rinse, rinse the oral cavity for 1 min, 4 times/day, no food or drink is allowed within 30 min after treatment, and use sodium sulfonate oral rinse. No other mucosal protection is allowed in the study Agent. The toxicity was evaluated according to the standard version 3.0 of the general terminology of adverse events. 1.4 Case matching analysis In order to evaluate the efficacy of polyprezinc, this study conducted a case matching cohort analysis. The medical records of 30 patients with head and neck cancer who received radiotherapy at Hyogo Medical College Hospital from January 2009 to January 2010 were retrospectively analyzed and compared with the current cohort. Patients in the PZ(-) group received the same radiotherapy protocol as the prospective study of the PZ oral rinse. The oral rinse was combined with sodium sulfonate as supportive treatment, but the PZ(-) group did not receive PZ treatment. One patient in the prospective cohort stopped using the PZ oral rinse on the 3rd day, and withdrew from the radiotherapy and chemotherapy regimen due to severe gastric ulcer at the 5th week, and was excluded from the comparative analysis. 1.5 Statistical analysis data is expressed in median and range. Parametric data adopts t test, and non-parametric variables adopts two-tailed Fisher test. Chi-square test is used for the first time to assess the trend of more than two groups of people. Then Fisher's exact test was used to evaluate the significance of the difference between each group and other groups. The results were estimated by Kaplan-Meier statistics and compared with log-rank test. Statistical analysis uses prism6.0b software. P<0.05 is statistically significant.

  2 Results and analysis

  2.1 Patient characteristics in the prospective study A total of 32 patients were included, including 29 males and 3 females. The average age of the patients was 67 years (41-86 years). The characteristics of the patients are shown in Table 1. One patient developed pharyngeal discomfort on the 3rd day after the start of treatment, and 1 patient developed nausea on the 22nd day and used sodium sulfonate mouthwash without using PZ. The same symptoms appeared, and both of them stopped using the PZ oral rinse. The remaining 30 patients (93.8%) did not cause adverse reactions due to PZ oral rinses, and continued to use them throughout the course of radiotherapy. After the radiotherapy, the level of transaminase did not increase. Table 1 Characteristics of patients in prospective studies

  2.2 Patient characteristics in case-matching analysis

  The characteristics of patients in the   PZ(+) and PZ(-) groups are shown in Table 2. There were no significant differences between the two groups in terms of gender, age, tumor location, and total radiation dose.

  2.3 Polyprezinc reduces the incidence of mucositis and promotes healing

  Figures 1 and 2 show the sequential changes caused by acute radiation mucositis during radiotherapy. PZ oral rinse significantly reduced the incidence of symptoms and macroscopic manifestations, and promoted the repair of radiation mucosal damage, but there was no significant difference between the two groups.

  As shown in Figure 1, PZ can reduce the incidence of severe radiation mucositis. All patients developed acute radiation mucositis. Both groups were examined at the 5th week after the start of radiotherapy. Figure 1A shows that the incidence of grade 3 mucositis in the PZ(+) and PZ(-) groups was 29.0% and 40.0%, respectively (P=0.42), visual observation found that PZ treatment improved mucosal lesions. Figure 1B shows the sequence manifestations of radiation mucositis before and after radiotherapy. Compared with patients in the PZ(-) group, the mucositis in the PZ(+) group recovered in a shorter time.

  PZ reduces the incidence of severe radiation-induced mucositis, which is manifested by the improvement of eating ability. Except for 1 patient in the PZ(+) group, all patients developed mucositis in the 4th week and gradually worsened. Figure 2A, the incidence of grade 3 mucositis in the PZ(+) and PZ(-) groups were 39.3% and 60.7%, respectively (P=0.18); Figure 2B shows the sequence manifestations of radiation mucositis before and after radiotherapy, and PZ(-) Compared with patients in the) group, mucositis in the PZ(+) group recovered in a shorter time, and PZ treatment improved the eating ability and quality of life of the patients. Figure 2 Incidence of Grade 3 Mucositis

  2.4 Polyprezinc does not affect the effect of radiotherapy and increases survival rate

  Analyze the effect of PZ oral rinse on the survival rate of patients. The overall survival rate is shown in Figure 3. Compared with patients in the PZ(-) group, the patients in the PZ(+) group showed a better survival rate (P=0.15).

  There was no significant difference in the overall survival rate, 2-year survival rate, 2-year disease-specific survival rate, or disease-free survival rate between the two groups during the follow-up period: Figure 4A, the overall survival rates of the PZ(+) and PZ(-) groups were respectively 72.7% and 60.7% (P=0.55); Figure 4B, the disease-specific survival rates of the PZ(+) and PZ(-) groups were 80.0% and 71.4%, respectively (P=0.72); Figure 4C, PZ(+) The disease-free survival rates of the PZ(-) and PZ(-) groups were 66.7% and 45.2% (P=0.17), respectively. The PZ(+) group showed better survival results. In addition, patients with a follow-up period of at least 1 year were analyzed for late toxicity. Among the 26 patients in the PZ(+) group and 25 patients in the PZ(-) group, the incidence of osteonecrosis of the jaw was 7.7% and 8.0%, respectively (P=0.97).

  Discuss

  Studies have shown that polyprezinc can reduce the severity of mucositis caused by radiotherapy, reduce the incidence of mucositis, promote mucosal healing, and greatly improve the quality of life of patients; and, in the two-year follow-up after treatment , We have observed that polyprezinc does not affect the effect of radiotherapy treatment, but at the same time significantly increases the survival rate of patients, and has good tolerance.

  Ruilaisheng (Polyprezinc particles) is a chelate compound composed of zinc ions and L-carnosine. It is a mucosal protective agent with dual mechanisms of protection and repair. It works through a variety of cytoprotective mechanisms, including inhibition of lipid peroxidation, reduction of inflammatory cytokine levels, and inhibition of superoxide production. Studies have shown that polyprezinc has a targeted adhesion and repair effect on oral mucositis, and has a significant effect on oral mucositis caused by radiotherapy and chemotherapy, improves patients' eating ability, improves patients' health and quality of life, and has prognosis for patients It has potential benefits and is recommended for widespread clinical use.

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