Jilin Province Great Great Pharmaceutical Co. LTD

Jilin Province Broadwell Pharmaceutical Co., LTD. Welcome you!

Service hotline:+86-431-85639055

博大伟业
imgboxbg

HEALTH SCIENCE

Your current location:
Homepage
/
/
/
A comprehensive strategy for the selection of artificial ulcer mucosal protective drugs after ESD

A comprehensive strategy for the selection of artificial ulcer mucosal protective drugs after ESD

  • Categories:Stomach healthy
  • Author:
  • Origin:
  • Time of issue:2020-12-03
  • Views:0

(Summary description)

A comprehensive strategy for the selection of artificial ulcer mucosal protective drugs after ESD

(Summary description)

  • Categories:Stomach healthy
  • Author:
  • Origin:
  • Time of issue:2020-12-03
  • Views:0
Information

  Gastric cancer and Helicobacter pylori (Hp) infection are inextricably linked. Relevant studies have shown that more than 75% of sporadic gastric cancers are related to Hp infection. Among gastric cancer patients in my country, the positive rate of Hp is about 80%.

  Endoscopic submucosal dissection (ESD) has been widely used in the treatment of early gastric cancer. Although ESD shows better integrity and effectiveness than endoscopic mucosal resection, it has greater and deeper artificial iatrogenicity after surgery. Ulcers are one of the risk factors for delayed bleeding.

  At the same time, in recent years, a large number of studies have confirmed that gastric mucosal lesions should be treated with ESD. For patients with Hp infection, active and effective methods must be adopted for Hp eradication before and after ESD treatment. Because Hp eradication therapy can effectively promote ulcer healing after ESD, improve the rate of ulcer healing and the quality of ulcer healing, and a large number of studies have confirmed that eradication of Hp can significantly reduce the occurrence of postoperative metachronous gastric cancer and improve their stomachs in patients undergoing ESD treatment. The degree of gland atrophy.

  Then, for patients undergoing ESD treatment for gastric mucosal lesions, how to choose preoperative or postoperative Hp eradication programs? And for the healing of artificial ulcers after ESD, how to improve the healing rate and quality of ulcers? So as to reduce postoperative metachronous gastric cancer happened. Among the above-mentioned problems, mucosal protective agents play an important role in the management of patients after ESD. The ideal mucosal protective drugs can improve the healing rate and quality of healing, and can participate in the Hp eradication treatment plan without affecting the operation and operation of ESD treatment. Judgment of postoperative complications. So, what is this ideal mucosal protective drug?

  A study of Clin Gastroenterol in 2020 is as follows:

  Objective: To evaluate the effectiveness of polyprezinc (PZ) combined with proton pump inhibitor (PPI) in the treatment of artificial ulcers associated with endoscopic submucosal dissection (ESD), and to compare it with the positive control drug Rebamipide (RM) .

  Research background: ESD is widely used in the treatment of early gastric cancer, but there are no clear and unified guidelines for the treatment of large and deep artificial iatrogenic ulcers after ESD. Studies have confirmed that polyprezinc can effectively promote ulcer healing and improve the quality of ulcer healing.

  Research method: Adopt prospective, randomized, parallel controlled, non-inferiority trial design. 210 subjects with postoperative ESD ulcers were randomly divided into two groups, and they were given polyprezinc (150mg/d) combined with pantoprazole (40mg/d) and rebamipide (300mg/d) combined with pantoprazole. Prazole (40mg/d) treatment. Observe the ulcer healing rate and ulcer condition 4 weeks after operation. Χ², Fisher's exact test and Student’t test were used to analyze the data.

  Results: The primary endpoint is the ulcer healing rate at 4 weeks after surgery, the ITT analysis (90.3%VS91.4%), and the PP analysis (89.9%VS91.1%). The results showed that the effectiveness of the treatment group and the positive control group was not significant (P=0.531), but there was a significant difference in the Hp eradication rate between the two groups.

  Conclusion: The efficacy of polyprezinc on iatrogenic ulcers after ESD is comparable to that of positive control drugs. The ulcer healing rate is as high as about 90%, and it can significantly improve the eradication rate of Hp.

  method

  1.1 Subject screening

  Yonsei University School of Medicine in South Korea conducted a prospective randomized controlled study on patients with early gastric cancer undergoing ESD treatment.

  Inclusion criteria (1) 20-80 years old; (2) Patients who are pathologically diagnosed as gastric cancer or adenoma meet ESD standards. Exclusion criteria (1) Use PPI, H2 receptor antagonist or other mucosal protective drugs within 2 weeks before enrollment; (3) Take non-steroidal anti-inflammatory drugs (including aspirin) and steroid drugs within 2 weeks before enrollment (3) History of upper gastrointestinal surgery; (4) History of allergies to PPI, Rebamipide and Zuprezine; (5) Severe cardiovascular, renal, liver, neurological or psychological diseases.

  1.2 Study design (sample size, randomization and follow-up)

  Using a non-inferiority trial design, a one-sided test to calculate the sample size, a total of 218 subjects were enrolled. The subjects were randomly divided into two groups (PPI+PZ and PPI+RM). All subjects received intravenous injection of 40 mg pantoprazole, bid 1-2 days after ESD. From the third day, the treatment group: PPI+PZ group, oral pantoprazole 40mg, polyprezinc 75mg bid, PPI+RM group oral pantoprazole 40mg, rebamipide 100mg bid, treatment for 4 weeks. The subjects underwent endoscopic follow-up at 4 weeks after surgery to assess the degree of ulcer healing, adverse events and medication compliance. According to the protocol analysis, subjects with low drug compliance (<80%) and taking the drugs mentioned in the exclusion criteria were excluded.

  1.3 Evaluation of primary and secondary efficacy indicators

  The main therapeutic index is the ulcer healing rate at 4 weeks, which is calculated as follows: [(initial ulcer area-ulcer area at 4 weeks)×100/initial ulcer area]. The secondary efficacy index is the proportion of subjects determined by ulcer stage (scarring) and the quality of ulcer healing in 4 weeks. Ulcer staging was assessed using Sakita and Fukutomi classification methods, described as active phase (A1, A2), healing phase (H1, H2), and scar phase (S1, S2).

  1.4 Statistical analysis

  Use χ² test and Fisher's exact test to compare categorical parameters, and Student’t test to compare continuous variables. Logistic regression analysis was used to evaluate the risk factors affecting the healing rate of ulcers, and P<0.05 had a significant difference.

  Result

  2.1 Polyprezinc in the treatment of Helicobacter pylori infection

  218 subjects were randomly divided into PPI+RM group and PPI+PZ group. Among them, 8 subjects withdrew from the study due to delayed bleeding (1 in the PPI+RM group) and additional surgery. 210 subjects (106 in the PPI+RM group and 104 in the PPI+PZ group) who completed the study protocol were included in the comprehensive analysis. After exclusion according to the research protocol (such as drug compliance <80% or the prohibited drugs in the taking protocol), 100 subjects in the PPI+RM group and 99 subjects in the PPI+PZ group were included in the treatment analysis. There was no significant difference between the two groups in terms of age, gender, histopathology, tumor location, gross morphology, tumor diameter, ulcer size, en bloc resection rate, and operation time.

  Helicobacter pylori (Hp) positive was significantly more in the PPI+RM group than in the PPI+PZ group, indicating that polyprezine is superior to rebamipide in eradicating Helicobacter pylori.

  2.2 Ulcer healing rate

  The average ulcer healing rate of all subjects 4 weeks after surgery was 90.5%. ITT analysis (91.4%VS90.3%, P=0.523) and PP analysis (91.1%VS89.9%, P=0.531), between the two groups There was no significant difference in ulcer healing rate 4 weeks after operation (Table 2).

  In the ITT analysis (10.4%, 9.6%, P=0.953) and the PP analysis (9.0%, 7.1%, P=0.846), there was no significant difference between the two groups in the scar formation stage after 4 weeks.

  2.3 Subgroup analysis of iatrogenic ulcer healing rate

  Through subgroup analysis to evaluate the risk factors that affect ulcer healing rate, there are no significant predictors of ulcer healing rate in the PPI+RM group and PPI+PZ group.

  In addition, the independent factors predicting the ulcer healing rate >90.5% were evaluated in a multivariate analysis. The results showed that the operation time is an independent factor affecting the ulcer healing rate.

  Discussion studies have shown that the effectiveness of polyprezinc on ESD iatrogenic ulcers is comparable to that of the positive control drug Rebamipide, and its ulcer healing rate is as high as 90% in 4 weeks. At the same time, after 4 weeks of follow-up, we were also pleasantly surprised to find that the number of H. pylori infections in the polyprezin group was significantly lower than that in the control group. This further confirmed that the polyprezinc group had additional effects on Hp eradication for patients undergoing ESD treatment for early gastric cancer. Benefit.

  Compared with the positive control drug Rebamipide 100mg tid, Polyprezinc 75mg bid has better patient compliance. Early and related studies have shown that polyprezinc combined with PPI can effectively reduce the incidence of ulcer basal protrusion after ESD and improve the quality of ulcer healing. At the same time, the polyprezinc quadruple eradication program is different from the bismuth quadruple anti-Hp treatment. Melancholy occurs due to medication, which affects the judgment of delayed bleeding after ESD. It can be seen that Relaisen (polyprezinc particles) is the best choice for ESD-related ulcers to improve the quality of ulcer healing. At the same time, it can have significant additional benefits for patients with Hp infection and reduce postoperative metachronism The incidence of gastric cancer.

Scan the QR code to read on your phone

Jilin Province Great Great Pharmaceutical Co. LTD

Service hotline

+86-431-81158731

CONTACT US

Jilin Province Great Great Pharmaceutical Co. LTD

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

Liaoyuan Production Base: No. 158 Fortune Road, Liaoyuan Economic Development Zone, Jilin Province

Tel:+86-437-6998023

Changchun R&D Center: No. 3786 Juye Street, Jingyue Development Zone, Changchun City, Jilin Province
Tel:+86-431-81158731(Marketing center)

Tel:+86-431-81158756(Research and development center)

Beijing Office: Room 901, Building F, Kaixuan City, 170 Beiyuan Road, Chaoyang District, Beijing
Tel:+86-10-58236233

Medication consultation, feedback on medication adverse reaction, and user complaint telephone:0437-5029815 

NO PUBLIC

Jilin Province Great Great Pharmaceutical Co. LTD

Scan and follow the official official account

Copyright © Jilin Province Great Great Pharmaceutical Co. LTD        吉ICP备20002630号

Website construction:300.cn Changchun   management     

Jilin Province Great Great Pharmaceutical Co. LTD