Amro chemical fiber provides a solution for reversing liver fibrosis

From April 20 to 23, 2023, the "2023 Xi 'an Conference on Digestive Liver Disease", sponsored by China Health Promotion Foundation and co-organized by National Clinical Medical Research Center for Digestive Diseases, Autoimmune Hepatology Group of Chinese Medical Association and Immune Hepatology Group of Shaanxi Medical Association, was held. The treatment prospect of liver disease in China was discussed.

The treatment of chronic liver disease includes etiology treatment, liver fibrosis and cirrhosis treatment, cirrhosis complications treatment and liver cancer monitoring. Liver fibrosis is the repair response after chronic liver injury, and the process of liver fibrosis cannot be completely inhibited after treatment for the cause of chronic liver disease, so it is very important to deal with liver fibrosis. In this meeting, under the leadership of Professor Nan Yuemin of the Third Hospital of Hebei Medical University, Professor Zhou Xinmin of Xijing Hospital of Air Force Military Medical University explained in depth the difficulties and countermeasures faced by the treatment of liver fibrosis after etiology control, and demonstrated the cutting-edge solution strategy brought by Anluo chemical fiber, a major scientific and technological project in China's "Twelfth Five-Year Plan" and "thirteenth Five-Year Plan".

Etiological treatment could not completely inhibit intrahepatic inflammation and fibrosis

Patients with chronic liver disease often develop liver fibrosis, cirrhosis and liver cancer because of the inflammatory response and hepatic stellate cell activation in the process of self-repair. In general, the cause of chronic liver disease is controlled or eliminated, which allows the liver to regenerate and repair itself, reversing fibrosis. However, clinical etiological treatment cannot completely inhibit the development of intrahepatic inflammation and fibrosis: for example, in the standard treatment of autoimmune cirrhosis (AIH) and primary biliary cirrhosis (PBC), the progression of fibrosis in patients with poor response is significantly higher than that in patients with poor response, and about 30% to 40% of PBC patients in the clinic have poor response to standard treatment. For patients with chronic hepatitis B (CHB), only 1/3~1/2 patients with liver fibrosis Ishak score improved after one year of single antiviral treatment, which is far from meeting clinical needs. Therefore, for patients with chronic liver disease who still have a progressive trend, only the treatment is not enough, and it is necessary to combine anti-fibrosis drugs.

Multi-target, multi-pathway anti-fibrosis mechanism of Anlo chemical fiber

Anluo chemical fiber has shown good results in anti-fibrosis in the national "Twelfth Five-Year Plan" and "thirteenth Five-Year Plan" major special project research, and has been approved by China's drug Administration for the treatment of chronic hepatitis B patients with early and mid-stage cirrhosis. The team of Academician Zhuang Hui and Professor Liu Xueen of Peking University Health Science Center revealed the specific mechanism of its action through basic research. Amro can significantly inhibit the production of transforming growth factor TGFβ1 and the influence of the corresponding Smads signaling pathway, thus inhibiting the activation of hepatic stellate cells (HSC). At the same time, it can promote the expression of protective hepatocyte factor PPARγ and inhibit the pro-fibrotic pathway NF-κB/IκBα. It can also enhance the expression of MMP-13 and inhibit the expression of MMP-2 and TIMP-1/2. Through the above-mentioned multi-target and multi-pathway mechanisms, Anluo chemical fiber plays an anti-fibrosis role and improves liver function, which provides a theoretical basis for a series of clinical studies and clinical applications.

The foundation was laid for the major projects of the 12th Five-Year Plan

The national "Twelfth Five-Year" major science and technology special project for the topic of Anluo chemical fiber was explored from the Western medicine group and the Chinese medicine group. In the Western medicine group, led by Professor Wang Guiqiang/Zhao Hong of Peking University First Hospital and Professor Jia Jidong/You Hong of Beijing Friendship Hospital, 25 units across the country participated in the study, exploring the establishment of non-invasive diagnostic criteria/models for HBV-related liver fibrosis, and exploring the reversal of hepatitis B fibrosis/cirrhosis by Anluo chemical fiber. In this randomized, open (pathologically blind), controlled, multicenter, prospective study of Entecavir (ETV) combined with ALHX to reverse the progression of liver fibrosis/cirrhosis: Seventy-six patients with F < 3 at baseline were included. The stabilization rate of ETV+ALHX combined group (55.32%) at 78 weeks was significantly higher than that of ETV monotherapy group (31.03%) by 24.29% (P=0.039). In addition, 143 patients with baseline F≥3 were included, and the 78-week treatment improvement rate in the ETV+ALHX combined group (54.74%) was significantly increased by 21.41% (P=0.016) compared with that in the ETV monotherapy group (33.33%). Based on this, an expanded sample size study was conducted for this patient group during the 13th Five-Year Plan period. This study suggests that amro combined with entecavir can significantly improve the improvement rate of liver fibrosis in hepatitis B virus infected patients, and has a tendency to improve the stability rate of liver fibrosis and reduce the progression rate.

In the TCM group, led by Professor Chi Xiaoling of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, the TCM dialectical treatment of blocking hepatitis B-related liver fibrosis study was a double-blind, randomized, placebo-controlled trial with the participation of 18 units across the country. A total of 270 patients with mild liver fibrosis (G<2, S≤2) with chronic hepatitis B were included, including 180 patients in the amro chemical fiber treatment group and 90 in the control group. After 48 weeks of treatment, 147 patients (106 patients in the treatment group and 41 patients in the control group) completed secondary liver puncture. The results showed that compared with the control group, the FibroScan value of the amlo chemical fiber group was significantly lower (5.63±2.33 vs. 6.54±3.80, P=0.036), and the pathological stage reversal rate of liver fibrosis was higher after 48 weeks of treatment (37.7% vs. 19.5%, P=0.037). The treatment of liver depression and spleen deficiency, blood stasis type CHB mild liver fibrosis (G<2, S≤2) patients have a good effect.

In general, the two major science and technology research projects of Chinese and Western medicine in the Twelfth Five-Year Plan have the characteristics of combined (Chinese and Western medicine)/non-combined (Chinese and Western medicine alone) and blind/open (blind reading). A total of 760 patients were included in traditional Chinese and Western medicine, comprehensively covering mild, moderate and severe liver fibrosis and cirrhosis, and have obvious advantages in disease course coverage and sample size. Evidence-based evidence is more convincing.

We have consolidated our achievements in the major projects for the 13th Five-Year Plan

On the basis of the achievements of the "Twelfth Five-Year Plan" major science and technology projects, in 2018, the national "Thirteenth Five-Year Plan" major science and technology projects of Anluo Chemical Fiber "Clinical Efficacy evaluation of the primary prevention and treatment program of TCM Syndrome Differentiation to block and reverse chronic Hepatitis B liver fibrosis" (Chinese Medicine group) and "Accurate Diagnosis and reversal of Hepatitis B liver fibrosis/cirrhosis Research" (Western Medicine group) were officially launched. The Western Medicine group, led by Peking University First Hospital, aims to conduct an expanded sample size study in patients with F≥3 and develop a treatment regimen to reverse significant liver fibrosis/cirrhosis.

A total of 585 CHB patients eligible for enrollment were included in the study from 33 clinical units, including 393 cases in the ETV+ALHX group and 192 cases in the ETV monotherapy group. After 98 weeks of treatment, 202 cases in the ETV+ALHX group and 94 cases in the ETV group were finally included in the analysis. The results showed that the improvement rate of inflammation before and after treatment in the ETV+ALHX group was significantly improved compared with that in the ETV group (66.83% vs 52.13%, P=0.0158) and the reversal rate of liver fibrosis in baseline F3-4 patients before and after treatment (49.01% vs 17.19%, P=0.020). In addition, there were 1 F0 patient and 17 F1 patients in the ETV+ALHX group, while only 3 F1 patients in the ETV group, suggesting a stronger reversal of liver fibrosis in the combined group. Therefore, for CHB patients with significant liver fibrosis, it is recommended to start antiviral therapy along with anti-fibrosis therapy to delay or reverse the liver fibrosis process.

A number of studies continue to write the legend, Amro chemical fiber improved patient survival for 5 years

A meta-analysis involving 26 articles and 2663 patients with hepatitis B cirrhosis at Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, showed that Amro combined with Entecavir (1339 cases in ETV+ALHX group) reduced portal vein diameter, spleen thickness, and improved the improvement rate of portal vein diameter and splenic vein diameter. Both were significantly better than Entecavir monotherapy (1324 cases in ETV group), with statistical significance (P<0.05), and high safety. It is suggested that the combination of entecavir and amro is of great significance in the treatment of liver fibrosis and delaying the progression of liver cirrhosis.

On the basis of delaying the disease progression of patients, the combination of amro and Entecavir further improved the survival rate of patients. A 5-year efficacy analysis of Entecavir combined with Entecavir in treatment of 56 patients with decompensated hepatitis B cirrhosis in Yuxi People's Hospital of Yunnan Province showed that the 5-year survival rate of Entecavir combined with Entecavir was 67.85% (38/56). Compared with 26.19% (11/42) in Entecavir monotherapy group, it was significantly increased by 41.66% (P < 0.01), which improved the survival rate of patients, and had important clinical significance for the recovery and stability of patients with decompensated hepatitis B cirrhosis.

Follow evidence-based guidelines and norms

Based on the national "Twelfth Five-Year Plan" and "Thirteenth Five-Year Plan" major science and technology projects and a series of clinical studies in the efficacy and safety of excellent performance, coupled with Academician Zhuang Hui, Professor Liu Xueen team's perfect explanation of drug action mechanism, Anluo chemical fiber has been recognized and recommended by major guidelines and consensus related to liver disease in China, creating a new clinical treatment standard. Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 edition), Guidelines for the Prevention and Treatment of Esophageal and Gastric varices Bleeding with Portal Hypertension in Cirrhosis (2022 edition), Guidelines for the Diagnosis and Treatment of Cirrhosis (2019 edition), Guidelines for the Diagnosis and Treatment of Ascites and Related Complications in Cirrhosis (2017 edition), Guidelines for the Clinical Diagnosis and Treatment of Traditional Chinese Medicine -- Liver Fibrosis (2019 edition), etc National guidelines all recommend its use to relieve or reverse liver fibrosis. The guidance of the major guidelines for clinical standardized treatment will further enhance the normative and therapeutic level of liver fibrosis treatment in China and improve the benefit of patients.

Amro Chemical fiber participated in the COVID-19 traditional Chinese medicine emergency project

Based on the perfect mechanism and outstanding efficacy of amro chemical fiber against liver fibrosis, the National Administration of Traditional Chinese Medicine launched the safety and effectiveness analysis of AmRO chemical fiber in the treatment of patients recovering from Covid-19, using a prospective, multi-center, open, randomized and controlled study. With Peking University Hospital as the core, Wuhan Pulmonary Hospital, Ezhou Central Hospital, the First Affiliated Hospital of Bengbu Medical College, Fuyang Second People's Hospital, Guangzhou Eighth Hospital and other clinical units gave amro chemical fiber treatment (66 cases) and basic treatment (26 cases) to patients with negative nucleic acid test after treatment of Covid-19 infection and pulmonary fibrosis indicated by CT images. The results showed that after 6 months of treatment, the lung CT scores of patients in the amro chemical fiber group were significantly decreased compared with baseline (P=0.046), and the completion rate of 6-minute walking test was significantly increased compared with baseline (P=0.002). The standard treatment group showed no significant difference from baseline, bringing more weapons to the fight against COVID-19.