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Ruilaisheng-the "scavenger" of iatrogenic ulcers

Ruilaisheng-the "scavenger" of iatrogenic ulcers

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

(Summary description)

Ruilaisheng-the "scavenger" of iatrogenic ulcers

(Summary description)

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

  Preface

  With the development and wide application of endoscopic technology, the detection rate of early tumors in the digestive tract has been greatly improved. A large number of studies have shown that endoscopic treatment of patients with early gastrointestinal tumors can achieve the same effect as surgical treatment. At present, endoscopic submucosal dissection (ESD) has been recognized as a minimally invasive treatment and standard method for early gastric cancer and precancerous lesions. It has the advantages of less trauma and quicker recovery after surgery. However, ESD can cause a series of iatrogenic ulcers and bleeding. Studies have shown that proton pump inhibitors (PPIs) are more effective than histamine H2 receptor antagonists in preventing gastric ulcer bleeding caused by ESD. At present, mucosal protective agents have been used to treat upper digestive tract ulcers. Polaprezinc (PZ), a chelate composed of zinc ions and L-carnosine, is a brand-new mucosal protective agent, which is widely used clinically to treat gastric ulcers. A meta-analysis study showed that PPIs combined with rebamipide to treat ESD-induced ulcers is more effective than PPI alone, and mucosal protective agents can improve the healing rate of ESD-induced ulcers. A number of studies have also investigated the therapeutic effect of polyprezinc and other mucosal protective agents combined with PPI on ESD-induced ulcers. This study conducted a systematic review and meta-analysis of published randomized controlled trials (RCTs) to evaluate the efficacy of PPI combined with mucosal protective agents on ulcers.

  1 Materials and methods

  1.1 Method

  Before conducting meta-analysis, make a plan, including search strategy, research selection criteria, relevant data extraction methods, research quality evaluation methods and statistical methods.

  1.2 Search strategy

  Using the electronic database PubMed, the Cochrane Library of Japan and Igaku-Chuo-Zasshi (1950-June 2014) systematically searched for documents with the following word combinations: (endoscopic submucosal dissection or ESD) and (mucosal protective agent, mucosa Defensive agents, rebamipide, icafibrate sodium, polyprenol, sucralfate, alginate, pronool, sapiproxone, teprenone, isoladine, misoprostol and Aluminum magnesium).

  1.3 Inclusion and exclusion criteria

  Inclusion criteria: (1) Study type: randomized controlled trial; (2) Population: patients receiving ESD treatment; (3) Intervention: actively participating in PPI plus mucosal protective agent treatment; (4) Control group: PPI monotherapy; (5) Results: Report the cure rate of ESD-induced ulcers.

  "Exclusion criteria: (1) Non-randomized controlled trials; (2) Rebamipide taken in the control group; (3) No report of ulcer healing rate; (4) Repeated publications, case reports and reviews.

  1.4 Data extraction

  Standardized data extraction table to extract data such as research quality, use of endoscopic treatment, drug duration, patient follow-up time, gender and age of registered subjects. Key results data were extracted from all included studies. All articles are independently qualified by 2 reviewers. Resolve differences by consulting the third reviewer.

  1.5 Results evaluation

  The main observation index is ESD-induced ulcer healing rate. Ulcer staging was classified by Sakita and Miwa: active phase (A1 and A2), healing phase (H1 and H2) and scar (S1 and S2). S phase is defined as the healing of artificial ulcers. The secondary result is safety, which is analyzed by evaluating the complication rate.

  1.6 Methodological quality assessment

  Use Cochrane Intervention System Review Manual for methodological quality assessment. Two reviewers review all studies and evaluate the six key factors that affect the quality of RCTs, including sequence generation, allocation hiding, blinding of participants and result evaluators, management of final incomplete result data, completeness of result reports, and impact Potential factors of effectiveness.

  1.7 Statistical analysis

  Analyze data through StatsDirect statistical software. Calculate the odds ratios (ORs) of the ulcer healing rate and compare it with the ulcer healing rate of PPI plus mucosal protective agent. A random effects model was used to calculate the summary OR and 95% confidence interval (CI). A subgroup analysis was performed on each mucosal protective agent and divided into patients who received 4 weeks and 8 weeks of treatment. To assess statistical stability, a sensitivity analysis was performed to evaluate low-quality studies. Finally, funnel chart asymmetry is used to detect publication bias in meta-analysis, and Egger’s regression test is used to measure funnel chart asymmetry.

  2 Results and analysis

  2.1 Literature search

  After adjusting for duplicates, there are 63 studies. Among them, 20 irrelevant topics, 5 reviews, 4 case reports and 8 animal studies were deleted according to the exclusion criteria. Studies lacking randomization (n=6), control group (n=7), and ulcer healing rate report (n=2 conference abstract) were excluded. Finally, 11 studies (8 full texts and 3 conference abstracts) were systematically reviewed and meta-analyzed.

  2.2 Characteristics and quality of qualified studies

  The overall risk of the 8 studies in the paper is low. The three conference abstracts are at risk of unclear bias. Six randomized controlled trials (3 full texts and 3 abstracts) did not describe the specific methods of random sequence generation and allocation concealment. The blind evaluation methods of 7 studies (4 full texts and 3 abstracts) are not described. These three abstracts did not fully evaluate the incomplete results, nor did they fully evaluate how selective results reporting was avoided. All eight papers have no other bias.

  2.3 Efficacy analysis

  266 of the 581 patients (45.8%) received mucosal protective agent treatment, of which 199 (34.4%) did not receive mucosal protective agent treatment (OR 2.28, 95% CI 1.57-3.31, p<0.0001). There is no significant heterogeneity between the test results (χ²=13.0, p=0.225, I²=23%).

  In a subgroup analysis based on the duration of treatment, we found that treatment was performed at 4 weeks (OR 2.19, 95% CI 1.43-3.34, p=0.003) and 8 weeks (OR 3.03, 95% CI 1.42-6.48, p=0.0043, In Figure 4), PPI plus mucosal protective agent is more effective in treating ESD-induced ulcers than PPI alone.

  2.4 Adverse events

  Three trials reported adverse events. One patient in the PPI group had bleeding from an artificial iatrogenic ulcer after ESD, and no other serious adverse events occurred.

  2.5 Sensitivity analysis and publication bias

  To analyze the statistical sensitivity of the meta-analysis, 3 low-quality studies (conference abstracts) were excluded. The exclusion of these 3 studies did not significantly change the results of the meta-analysis (OR 2.40, 95% CI 1.58-3.65, p <0.0001). The funnel chart has an almost symmetrical distribution, and the funnel chart suggested by Iger's regression test is not significantly asymmetry (P=0.15), indicating that there is not a lot of evidence of publication bias.

  Discuss

  It can be seen that PPI plus mucosal protective agent is better than PPI monotherapy in treating ESD-induced ulcers. Mucosal protective agent Relaisheng (Polyprezinc particles) promotes ulcer healing through prostaglandin-independent cell protection, antioxidant activity, leukocyte inactivation and membrane stabilization. In addition, polyprezinc can induce the production of IGF-I, thereby promoting mucosal wound healing. Iatrogenic ulcers caused by ESD after PPI treatment will heal quickly, and the basal protrusion of the ulcer will appear during the healing period. Although it is different from cancer recurrence, it will cause patients’ concerns. Therefore, ulcers caused by ESD have no basal protrusion Very important. Studies have shown that PPI combined with polyprezinc can greatly reduce the incidence of such ulcer base protrusions and improve the quality of healing. Relaisheng (Polyprezinc Granules) combined with PPI to treat iatrogenic ulcers caused by endoscopy has significant curative effect and greatly improves the quality of ulcer wound healing. It is recommended to be widely used in clinical practice.

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