Focus on mucosal healing, choose Polyprezinc
- Categories:Stomach healthy
- Time of issue:2020-12-02
Focus on mucosal healing, choose Polyprezinc
- Categories:Stomach healthy
- Time of issue:2020-12-02
The pathogenesis of ulcerative colitis (UC) is currently unclear. It is a chronic and recurrent intestinal inflammatory disease characterized by diffuse inflammation and ulcers. The main goal of clinical treatment of UC is to improve mucosal symbiosis. The interaction between the flora and the intestinal mucosa prevents the activation of lymphocytes, up-regulates or produces regulatory T cells, inhibits inflammation, inhibits inflammatory cytokines, and repairs damaged mucosa. Patients with UC often have watery or bloody diarrhea in the rectal mucosa. Generally speaking, moderate to severely active UC is treated with intravenous glucocorticoid (CS), but CS alone requires a longer time to achieve mucosal healing. The persistent inflammatory response causes clinical symptoms of mucosal damage, such as bloody diarrhea and abdominal pain. Through epithelial restoration, cell proliferation and migration, mature epithelial cell differentiation regulates the mucosal healing process. To achieve rapid mucosal healing for inflammatory bowel disease (IBD) is a very important point in relieving clinical symptoms and shortening the duration of hospitalization. Although the repair of damaged tissues is very important, only a few literature reports the treatment of rapid mucosal repair. Studies have reported that trefoil peptides can be upregulated and play an important role in the protection and repair of IBD mucosa, and hepatocyte growth factor (HGF) regulates the proliferation and migration of intestinal epithelial cells and accelerates intestinal mucosal healing.
Zinc is an important mineral for the human body, and it plays a variety of important functions in the human body, including wound healing, improving taste and transporting vitamin A. It has been found in animal studies that zinc can repair damaged tissues and has proven to prevent gastric ulcers. As we all know, the serum zinc concentration of IBD patients decreases, and the serum zinc is insufficient in patients with continuous active phase. Polyprezinc (Polaprezinc, PZ, a chelate composed of zinc ions and L-carnosine) is a mucosal protective agent and is widely used clinically to treat gastric ulcers. Polyprezinc can protect the gastric mucosa from a variety of stresses in a dose-dependent manner, such as ethanol, monochloramine, histamine, hydrochloride-aspirin, indomethacin, water immersion pressure, burn shock and ischemia reperfusion, etc. . PZ also induces mucosal protection by stimulating mucus production, antioxidant activity, membrane stabilizing activity, and inducing heat shock protein 70. Recent studies have shown that insulin-like growth factor-I (IGF-I) is one of the important factors that zinc plays a role in wound healing. The purpose of this study is to explore the effectiveness of polyprezinc enema administration in patients with ulcerative colitis.
1 Materials and methods
This study is a randomized, investigator-blinded, placebo-controlled clinical study conducted by JiKei University Hospital. A total of 28 patients were enrolled from February 2009 to October 2011, and all patients signed informed consent. book. The study was approved by the ethics committee of JiKei University. The hospital conducted this study in accordance with the Declaration of Helsinki (revised in 1989). Inclusion criteria: patients diagnosed with UC based on clinical, endoscopic and histological criteria. Patients with moderate to severe active UC, Mayo score 6-12 points (the score ranges from 0-12, the higher the score, indicating that the disease is more active), colonoscopy is moderate to severe active disease ( Mayo endoscopy score at least 2 points or corrected Matts endoscopy score at least 3 points (scores range from 1 to 6, higher scores indicate more serious disease activity. Exclusion criteria: diagnosis of uncertain colitis, Crohn Disease (CD) or clinical examination suggesting CD (ie fistula or granuloma during biopsy).
1.2 Experimental design
The daily therapeutic dose of polyprezinc for peptic ulcer treatment is 50mg, so the purified water suspension containing 150mg polyprezinc is enema (total volume is 100ml). The patients were randomly divided into groups with polyprezinc and placebo enema (100ml enema) for 1 week. In addition to the conventional induction therapy, such as CS and IM, polyprezinc enema is a conventional medication, and the patient needs to stay supine for at least 10 minutes after each enema administration. All patients were given conventional induction therapy for CS and IM, IM including azathioprine and tacrolimus. If the patient's clinical symptoms and laboratory data deteriorate significantly, the treatment is deemed to have failed.
1.3 Test evaluation
To evaluate the clinical recurrence of patients with UC, past medical history, combined medication history, and the following symptoms (increased bowel movements, rectal bleeding, tenesmus and abdominal pain). Eligible UC patients were evaluated by Mayo score and modified Matts endoscopy classification at admission (day 1) and 1 week later (day 8) (Figure 2). At the same time, the histological lesion activity was evaluated according to its Matts pathology score (the score ranges from 1-5, the higher the value, the more serious the disease activity)
1.4 Safety analysis
Perform safety analysis through hematological examination (liver function, kidney function) and physical examination. Serum zinc concentration, liver and kidney functions were measured at baseline (day 1) and 1 week later (day 8) at the time of enrollment. 1.5 Statistical analysis The main efficacy index is clinical remission at 1 week, and the secondary efficacy index is mucosal healing and pathological remission at 1 week. Mayo score, Matts endoscopic grading and Matts pathological grading results are expressed as mean ± standard deviation. Statistical analysis adopts t test and chi-square test; P<0.05 has a significant difference.
2 Results and analysis
2.1 Patient characteristics
28 patients were randomly divided into 2 groups, 18 patients were enrolled in the polyprezinc group, and 10 patients were enrolled in the placebo group. One patient in the polyprezinc group was excluded from the study due to continuous cyclosporin infusion. There was no significant difference in basic population data and medical history between the two groups;
2.2 Mayo rating
The Mayo scores at baseline and on day 8 were the polyprezinc group: 9.1±1.6 and 5.8±2.7 (P=0.00004); the placebo group: 7.4±2.1 and 8.9±1.7 and (p=0.009), after 1 week of treatment The Mayo scores of the two groups improved significantly, and the polyprezinc treatment group was more effective than the placebo group. At baseline and on day 8, the number of active bowel movements in the polyprezinc group was 6.1±3.2 and 3.9±3.6 (P = 0.001), and the placebo group was 6.5±3.1 and 4.0±2.1 (P = 0.014). On the 8th day, 2 patients in the polyprezinc group had clinical remission (Mayo score of 0 or 1), and no remission occurred in the placebo group. Compared with the control group, the clinical remission rate (Mayo score decreased by more than 3 points) and remission status (Mayo score 0 or 1) in the polyprezinc group increased significantly (12 out of 17 patients experienced remission), and the placebo group (10 patients) Remission occurred in 1 of the patients, p = 0.002). The addition of polyprezinc treatment to conventional induction therapy is very effective in accelerating the recovery of UC symptoms.
All eligible patients underwent endoscopy at baseline (day 0) and 1 week after treatment (day 8). As shown in Figure 4, the endoscopy results of the polyprezinc group were significantly improved. Diffuse deep ulcers were formed before treatment, and severe mucosal inflammation was seen, which was significantly improved after polyprezine treatment.
A 28-year-old female patient was treated with PZ for 1 week. The rectum, sigmoid colon and descending colon under the microscope (day 1) are as shown in the picture above, and after 1 week (day 8), as shown in the picture below: Corrected Matts "endoscopy score" is shown in the picture: Pre=Before treatment ; Post=After 1 week of treatment.
Compared with the baseline, the PZ group had a significant improvement in the rectal endoscopy score on day 8 (baseline 4.4±1.0, 3.5±0.9 on day 8; P = 0.004), sigmoid colon (4.5±1.0, 3.9±1.2; P = 0.03) and descending colon (4.2±1.2, 3.7±1.3; P = 0.04). In the placebo group, compared with the rectal baseline score, the endoscopic score was not significantly improved on the 8th day (4.3±1.1, 3.8±0.7; P = 0.14), descending colon (4.4±1.1, 4.2±1.2; P = 0.34), but The sigmoid colon score (4.8±0.9, 4.4±1.1; p=0.04) improved.
2.4 Histological examination
Compared with the baseline, the histological examination results of the PZ group after treatment were significantly improved. Before treatment, crypt abscess, mucosal surface peeling, goblet cell necrosis, glandular apoptosis, and obvious inflammatory cell infiltration were seen (Figure 6A, 6C). The histological results were significantly improved after 1 week of PZ treatment (from Figure 6A-6D). Compared with the baseline level in the PZ group, the histological score of the rectum on day 8 was significantly improved (baseline 3.8 ± 0.7, day 8: 2.8 ± 1.0, P = 0.005), sigmoid colon (3.5 ± 0.6, 2.5 ± 0.7, P = 0.0008) And descending colon (3.4±0.8, 2.6±0.7, P = 0.001). In the placebo group, compared with the baseline score, the histological scores of the rectum (4.3±0.8, 2.4±0.8, P = 0.0007) and descending colon (3.9±0.9, 2.4±0.9; p = 0.002) on day 8 were also significant Improvement, but no improvement in the sigmoid colon (3.6 ± 1.1, 2.6 ± 0.8; p = 0.08). There was no significant difference in histological results between the Zinc polyprene group and the placebo group.
During the 1-week PZ enema treatment, the patient did not discontinue the drug due to adverse reactions, hematological toxicity, and biochemical changes related to liver and kidney function. AST and ALT increased significantly after treatment in both groups (AST; PZ: baseline 16.3±11.0, day 8 29.3±29.9 (P=0.014), placebo group: baseline 14.0±3.52, 8 days later 23.7±11.6 (P=0.04) ), alanine aminotransferase; PZ: baseline 15.6±15.1, 8th day 33.5±44.9 (P=0.034), placebo group: baseline 14.6±7.69, 8th day 39.2±21.9 (P=0.005); Evaluation of other drugs for liver damage, such as steroids and total parenteral nutrition (Table 4). In the PZ group, the serum zinc concentration increased significantly after treatment (baseline 79.2±17.5, 90.6±13.8 on day 8; p=0.04), but It remains within the normal range. Therefore, it shows that there is no adverse reaction to PZ enema treatment.
Ulcerative colitis (UC) patients received polyprezinc treatment for 1 week, their endoscopic results, pathological results and Mayo score were all significantly improved, and the patient's clinical regression and remission were more significant. The endoscopic and pathological examination results of the area covered by polyprezinc enema (rectum to descending colon) have also been significantly improved, indicating that polyprezinc combined with conventional induction therapy can speed up mucosal healing and relieve symptoms in UC patients. The serum zinc concentration of IBD patients decreases, and the patients in the continuous active phase have insufficient serum zinc. Although polyprezinc enema increases the serum zinc concentration, its value remains within the normal range, indicating that it has good safety Sex. The latest clinical guidelines for the treatment of UC point out that its treatment goals have shifted from symptomatic treatment to mucosal healing. Relaisen (Polyprezinc Granules) can quickly repair damaged mucosa, combined with conventional induction therapy, has become a new way to treat UC, which can shorten the length of hospitalization, reduce the number of defecations, and improve the quality of life of patients.
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