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Effectiveness and safety evaluation of terlipressin in the treatment of intestinal paralysis in end-stage liver disease

BMC Gastroenterology volume 25, Article number: 286 (2025) Cite this article

Abstract

Background and aims

Intestinal paralysis is a common complication in end-stage liver disease (ESLD), our aim is to assess the effectiveness and safety of low-dose terlipressin for treating intestinal paralysis in ESLD.

Methods

The study was divided into two phases, in the exploratory phase, we retrospectively analyzed the clinical data of patients with intestinal paralysis treated with low-dose terlipressin and explored its efficacy. In the clinical research phase, we designed a prospective cohort study, patients with intestinal paralysis were categorized into terlipressin treatment group (low-dose terlipressin was added to the conventional treatment) and conventional treatment group according to their wishes. The remission of intestinal paralysis, time to symptom remission, and differences in adverse reactions were compared between the two groups.

Results

In the exploratory phase, 26 patients were exposed to low-dose terlipressin, 12 were cured, 11 were moderately effective, and 3 were ineffective. The mean time to abdominal bloating remission was 2 days, and the time to anal flatus and feces passage was 1 day. In the clinical research phase, a total of 131 patients were included at baseline, with the exception of one patient who discontinued medication due to severe vomiting, resulting in a final total of 130 patients included in the analysis. The mean time to abdominal pain and bloating remission in the terlipressin treatment group (32/130) was demonstrably shorter compared to the conventional treatment group (98/130) (P < 0.001), the mean time to anal flatus and feces passage was also shorter (P < 0.001), and the remission rate was higher (P < 0.05). The incidence of adverse events was similar.

Conclusions

Low-dose terlipressin treatment could considerably increase intestinal paralysis remission in ESLD patients with intestinal paralysis, and have good safety.

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Introduction

End-stage liver disease (ESLD) is a pathological condition in which liver damage leads to severe dysfunction, mainly encompassing decompensated cirrhosis, advanced hepatic cancer, and liver failure [1, 2]. Patients with end-stage liver disease are mostly reported to undergo portal hypertension, gastrointestinal hemorrhage, decreased intestinal peristalsis, and electrolyte disturbances, which can easily induce and exacerbate the dysfunction of intestinal smooth muscles, autonomic neuropathy, and electrical rhythm disturbance [3,4,5]. Consequently, the normal passage of intestinal contents is hindered, and in some cases, intestinal paralysis may develop. Currently, the main treatment methods for intestinal paralysis include fasting, gastrointestinal decompression, enema. However, patients with end-stage liver disease complicated with intestinal paralysis have obvious symptoms of abdominal distension and abdominal pain, and the conventional treatment scheme has a long course of treatment and limited effect, which leads to poor quality of life and even potential adverse effects on prognosis.

Terlipressin, with vasoconstrictor activity, can decrease portal hypertension and increase renal perfusion, that is now mainly used to treat hepatorenal syndrome, gastrointestinal hemorrhage, refractory hepatic cirrhosis ascites [6,7,8]. We found that diarrhea was the most common adverse reaction, the main concern with intestinal paralysis is the decrease in intestinal peristalsis. Therefore, one assumption arises: whether terlipressin could be used to treat intestinal paralysis by increasing intestinal peristalsis and producing diarrhea?

In clinical practice, when patients with ESLD had suspected intestinal paralysis, we added low-dose terlipressin micro-pump for exploratory treatment on the basis of conventional treatment. The results revealed that most patients exposed to medication could quickly alleviate or remove intestinal paralysis symptoms, thereby improving their clinical prognoses. To further confirm our assumption, firstly we retrospectively collected case data of terlipressin-treated patients with intestinal paralysis for the exploratory treatment before 2021 to evaluate its effectiveness and safety. Then, a prospective study was carried out to analyze risk factors of intestinal paralysis in ESLD. By using low-dose terlipressin combined with conventional therapies to treat intestinal paralysis with ESLD, the effectiveness and safety of these two treatment regimens were compared, with the aim of warranting better treatment options for patients with intestinal paralysis in clinical practice.

Materials and methods

Research subjects

The study can be boiled down to the exploratory phase and the clinical research phase. The exploratory phase, starting from January 2018 to December 2020, we retrospectively analyzed the data of patients receiving terlipressin for treating intestinal paralysis admitted to the Department of Infectious Disease, the Second Affiliated Hospital of Chongqing Medical University. The clinical research phase, a prospective cohort study was conducted from June 2021 to December 2022, patients with ESLD complicated by intestinal paralysis, guided by the inclusion and exclusion criteria were included. Patients were assigned to either the terlipressin group or the conventional treatment group according to their wishes. The general characteristics, clinical manifestations, laboratory testing data of all the patients were collected.

Diagnostic criteria for intestinal paralysis

The diagnosis of intestinal paralysis meets the diagnostic criteria according to the International Classification of Diseases (ICD) [9,10,11]:

  1. 1)

    There are varying degrees of bloating, abdominal pain, vomiting, cessation of anal flatus and feces, without abdominal colic, and progressive worsening pain in the abdomen;

  2. 2)

    Physical examination detects abdominal distension, with some gastrointestinal pattern and peristaltic waves able to be seen, and enhanced or disappeared bowel sounds able to be heard;

  3. 3)

    Abdominal X-ray plain film or CT scan displays pronounced dilation of the intestinal cavity and multiple air-fluid levels in a stepladder distribution, diagnosed with intestinal paralysis.

Inclusion and exclusion criteria

Inclusion criteria: (1) ESLD patients who are hospitalized in the Department of Infectious Disease, the Second Affiliated Hospital of Chongqing Medical University; (2) age ranging from 18 to 75 years old; (3) clinical and imaging examinations show the diagnosis of intestinal paralysis.

Exclusion criteria: (1) patients with a history of abdominal surgery within 3 months; (2) patients diagnosed with spastic intestinal obstruction, mechanical or vascular intestinal obstruction; (3) those who are identified unsuitable for the study by other researchers; (4) patients with diseases of blood system; (5) women who were pregnant or breastfeeding; (6) patients who could not cooperate with treatment.

Treatment for patients with intestinal paralysis

Primary diseases should be given active treatment. Specifically, in addition to intestinal paralysis, patients who also had infectious diseases should receive antibiotic treatment, patients with electrolyte disturbances should be treated to restore electrolyte balance, those with hypoproteinemia should be infused with albumin, and those with ascites should be recommended with diuretics, and even with ascites drainage therapy if necessary. The conventional treatment for intestinal paralysis encompasses fasting, glycerol enema (twice a day), and gastrointestinal decompression determined by the degree of esophageal varices. The terlipressin therapy is defined as the addition of low-dose terlipressin to the conventional treatment (1 mg terlipressin plus 48 ml of 0.9% sodium chloride injection, 4–6 ml/h, once every 8 to 12 h, via continuous intravenous micro-infusion with a pump), with a maximum of 5 days in its course. It has to be immediately discontinued and routine treatment should continue once abdominal bloating has not yet subsided, anal flatus and feces fail to recover after 5 days of treatment, or some serious adverse events occur during the course.

Effectiveness evaluation and observation indicators

Effectiveness evaluation

Cured: (1) clinical symptoms and signs are disappeared; (2) abdominal imaging confirmed no air-fluid level, flatulence accumulation, or other signs of intestinal paralysis.

Moderately effective: (1) symptoms and signs are not completely improved; (2) abdominal imaging suggests that air-fluid levels have not completely disappeared.

Ineffective: no improvement or even deterioration in symptoms or signs is obtained after treatment.

Observation indicators

Improvement rate of intestinal paralysis

(the cured + the moderately effective) / total cases;

Time (days) to the improvement of intestinal paralysis

the duration (days) from the beginning of treatment to the improvement of the patient’s symptoms and signs;

Serious adverse events mainly include [12]:

  1. 1)

    Severe abdominal pain: the visual analog scale displays more than 8/10, necessitating emergency imaging examination and pain medication treatment;

  2. 2)

    Nausea, vomiting, or hematochezia;

  3. 3)

    Persistent diarrhea: the frequency of diarrhea > once per hour;

  4. 4)

    Peripheral ischemia: pale and cyanotic skin;

  5. 5)

    Elevated blood pressure: arterial blood pressure > 140/90 mmHg measured at least three times during treatment;

  6. 6)

    Arrhythmias: bradycardia arrhythmia (heart rate < 45 beats/min); tachycardia arrhythmia (heart rate > 120 beats/min); atrial fibrillation.

Statistical methods

The data were analyzed using the SPSS 25.0 statistical software. The measurement data in line with the normal distribution were expressed as x ± s and the student’s t-test was used to compare the two groups, while continuous variables with non-normal distribution were represented by M (Q1, Q3) and the Mann-Whitney U test was performed for the comparison between two groups. Enumeration data were expressed as a rate, and a chi-square test was used for the comparison between the two groups. Multivariate logistic regression analysis was employed to explore factors associated with remission of intestinal paralysis. A p-value of less than 0.05 was considered statistically significant in differences.

Results

Exploratory phase results

A total of 26 patients with intestinal paralysis treated with low-dose terlipressin from January 2018 to December 2020 were enrolled, including 24 males (92.3%) and 2 females (7.7%), with an average age of 55.0 (49.0, 63.0) years. All patients experienced varying degrees of abdominal distension, and 17 of them had symptoms of cessation of anal defecation or defecation challenges, leading to a clinical diagnosis of intestinal paralysis. Terlipressin was administered to the 26 patients as a continuous intravenous infusion on top of conventional treatment, with a dosage of 1 mg every 8 to 12 h depending on individual tolerance. Following the terlipressin therapy, complete remission of abdominal distension was observed in 12 (46.2%), partial remission in 11 (42.3%), and no remission in 3 (11.5%), resulting in an overall effective rate of 88.5%. The mean time to abdominal distension remission was 2.0 (1.0, 3.0) days and to anal flatus passage was 1.0 (1.0, 1.8) day. No significant adverse reactions were found in any of the patients during the course.

Clinical research phase results

General characteristics of patients with intestinal paralysis

In total, 131 patients with ESLD and intestinal paralysis were enrolled in this phase. 98 were assigned to the conventional treatment group, with 77 males and 21 females. The median age of these patients was 55.0 (47.0, 63.0) years. Among the etiologies of ESLD, patients with HBV totaled 64, HCV 5, alcoholic cirrhosis 16, immune-related cirrhosis 9, and other reasons 4. The remaining 33 patients were included in the terlipressin treatment group, including 30 males and 3 females, with a median age of 55.0 (49.0, 62.5) years. Among the etiologies of ESLD, 22 had HBV, 9 alcoholic cirrhosis, 1 immune-related cirrhosis, and 1 other causes. There were no significant differences in age, sex, etiology, cirrhosis, hepatic cancer, abdominal infection, ascites and Child-Pugh classification between two groups (p > 0.05) (shown in Table 1).

Table 1 General characteristics of patients with intestinal paralysis
Full size table

Effectiveness terlipressin in the treatment of ESLD patients with intestinal paralysis

Statistical analyses reflected that in the terlipressin treatment group, 19 (59.4%) who had intestinal paralysis were cured and 11 (34.4%) were moderately effective, with a total effective rate of 93.8%. In the conventional treatment group, 23 (23.5%) were cured, while 53 (54.1%) were moderately effective, with a total effective rate of 77.6%. The difference in the total effective rate between the two groups was statistically significant (P < 0.05) (shown in Table 2). The 1-day, 3-day, and 5-day cumulative remission rate (39.4% vs. 7.1%, 83.2% vs. 34.7%, 93.8% vs. 55.1%) of terlipressin treatment patients was drastically higher than those in the conventional treatment group (shown in Fig. 1). Among patients with effective treatment, the number of days from the beginning of treatment to abdominal distension remission or the onset of anal flatus and feces passage was compared between the two groups. To be specific, the mean time to abdominal pain and bloating remission in the conventional treatment group was 4.0 (2.0, 6.0) days, while 2.0 (1.0, 3.0) days in the terlipressin treatment group. Additionally, the mean time to anal flatus and feces passage was 3.0 (2.0, 5.0) days in the conventional treatment group, compared with 1.0 (1.0,2.0) day in the terlipressin group. These differences were statistically significant (P < 0.05). Hospital length of stay in the terlipressin group was 22.0 (15.3, 29.5) days and 22.0 (12.0,32.3) days in the conventional treatment group. No statistical significance in the difference in hospital stay between the two groups of patients was shown (P > 0.05) (shown in Table 3).

Table 2 Effectiveness evaluation for the terlipressin treatment group and the conventional treatment group
Full size table
Fig. 1
figure 1

Cumulative remission rate of intestinal paralysis. The 1-day, 3-day, and 5-day cumulative remission rate (39.4% vs. 7.1%, 83.2% vs. 34.7%, 93.8% vs. 55.1%) of terlipressin treatment patients was drastically higher than those in the conventional treatment group

Full size image
Table 3 Comparison of time to symptom remission and hospital stay between the terlipressin treatment group and the conventional treatment group
Full size table

Safety of terlipressin in the treatment of ESLD patients with intestinal paralysis

During the continuous intravenous infusion of low-dose terlipressin, vomiting was present in one of the patients on the second day of treatment, lasting for more than 2 days, on top of other factors, it was considered a side effect of terlipressin, and the medication was discontinued. No serious adverse events were found in other patients(shown in Table 4).

Table 4 Drug-related adverse events in the terlipressin treatment group and the conventional treatment group
Full size table

Analysis of prognosis and influencing factors of ESLD with intestinal paralysis

Influencing factors related to intestinal paralysis remission were analyzed, including ascites, infection, gastrointestinal hemorrhage, paralysis location, clinical manifestations, electrolyte disturbances, and different treatment regimens. Then these factors were included in univariate logistic regression analysis. Furthermore, a multivariate logistic regression equation for factors with P < 0.1 was formed to analyze influencing factors on the prognosis of intestinal paralysis patients. The findings demonstrated that the presence or absence of enema (OR = 7.23, 95% CI 1.58–33.09, P = 0.011), gastrointestinal decompression (OR = 0.23, 95% CI 0.08–0.68, P = 0.008), and use of low-dose terlipressin (OR = 6.51, 95% CI 1.32–31.99, P = 0.021) had statistically significant effects on intestinal paralysis remission (shown in Table 5).

Table 5 Analysis of influencing factors for the prognosis on intestinal paralysis
Full size table

Discussion

The concept of ESLD, first introduced in the 1980s, indicates the late stage of chronic liver damage-induced liver diseases, relying on the hepatic function and morphology. ESLD patients are prone to various complications, including infection, electrolyte disturbances, hepatic encephalopathy, ascites, hepatorenal syndrome, and even death [13, 14], since the severe decompensation of liver function fails to meet their physiological needs. About 50% of patients with decompensated hepatic cirrhosis are reported to die within 2 years [15]. Factors such as severe abdominal infections and electrolyte imbalances can cause intestinal motility disorders, leading to acute intestinal paralysis, which in turn leads to intestinal edema, impaired blood circulation, congestion, ischemia, abnormal mucosal structure and function, and bacterial translocation. As a result, spontaneous peritonitis may occur and even aggravate along with systemic infections, worsening underlying conditions and prognosis.

Based on previous studies, we speculated the potential mechanisms for the development of intestinal paralysis in patients with decompensated hepatic cirrhosis as follows [16,17,18]: (1) Abdominal infections: ESLD with spontaneous bacterial peritonitis may cause intestinal edema [19] and even significant exudation, which can impair intestinal peristalsis, leading to insufficient intestinal motility; Gunnarsdottir et al. found [20] that gastrointestinal motility disorders in patients with hepatic cirrhosis may be associated with bacterial translocation and infection. Following intestinal paralysis, the intestinal mucosal barrier function is further impaired, and intestinal bacterial translocation worsens, so bacteria in the intestinal cavity directly penetrate the intestinal wall to the abdominal cavity, exacerbating spontaneous bacterial peritonitis and even causing systemic infection. (2) Large amounts of ascites and portal hypertension: abnormal intestinal motility is common in patients with hepatic cirrhosis and portal hypertension. Studies have shown that [21, 22], compared with healthy controls, patients with decompensated hepatic cirrhosis have slower intestinal transit. In such patients, inactivation of gastrointestinal hormones is reduced, portal hypertension leads to direct release of gastrointestinal hormones into the bloodstream, and hormone production is increased while excretion is decreased, resulting in elevated levels of gastrointestinal hormones. As gastrointestinal hormones underpin gastrointestinal motility, such elevated levels lead to a range of gastrointestinal dysfunction symptoms, including delayed gastric emptying, anorexia, abdominal distension, and constipation, increasing the susceptibility factors for intestinal paralysis [23]. (3) Portal vein thrombosis: after the formation of portal vein thrombosis, gastrointestinal blood stasis may occur with intestinal blood flow obstruction, leading to intestinal mucosal ischemia and gastrointestinal dysfunction. (4) Hypoalbuminemia: patients with hepatic cirrhosis are likely to develop hypoalbuminemia, which can progress to intestinal wall edema, weakened intestinal peristalsis, and decreased motility. (5) Liver immune function decreases, bacterial translocation occurs, and endotoxemia results in weak intestinal motility function. (6) Hypokalemia: due to ESLD often accompanied by a large amount of ascites, long-term use of potassium diuretics and ascites drainage in clinical practice leads to low-sodium and low-potassium intestinal paralysis. Therefore, vigilance is required for the occurrence of intestinal paralysis in ESLD patients with abdominal infections, pain, and bloating.

Intestinal paralysis is a common acute abdomen. The key to treatment of intestinal paralysis is to restore the function of intestinal peristalsis, maintain the balance of internal and external absorption, and accelerate the anal flatus and feces. Conventional treatment approaches mainly include fasting, gastrointestinal decompression, and antibiotic treatment to avoid gastrointestinal infection. At the same time, treatments are also administered to balance the intestinal and external tension, improve the ischemia and hypoxia of intestinal mucosa, supplement blood flow, and regulate the balance of water, electrolytes, and acid-base. However, these therapies fail to produce desirable results. Moreover, due to the extremely poor coagulation function and liver reserve function, as well as esophageal and gastric varices, patients with ESLD and acute intestinal paralysis are likely to suffer a high risk of bleeding after receiving gastrointestinal decompression. Such patients, therefore, often face treatment challenges, with extremely poor quality of life and a bleak prognosis. With a significant loss of water and electrolytes in the intestinal cavity, severe water-electrolyte and acid-base imbalances can occur, leading to internal environment disturbances, physical condition aggravation, and even death [24].

Terlipressin, as a synthetic, long-acting derivative of the posterior pituitary hormone, can shrink visceral vessels, reduce portal pressure, and increase renal blood flow[6]. Patients display a 20–45% incidence of adverse reactions [1, 12, 24,25,26], and only around 6% of them manifest as severe adverse reactions necessitating drug withdrawal [27]. Diarrhea is one of the most common adverse reaction to terlipressin, some patients even have diarrhea once every hour. Based on these facts above, we propose hypotheses of using terlipressin to treat intestinal paralysis by increasing intestinal peristalsis and causing diarrhea. In the early exploratory treatment, a dosage of 1 mg terlipressin per 8 to 12 h depending on patients’ tolerance was also administered to patients diagnosed with intestinal paralysis via continuous intravenous micro-infusion with a pump, on the basis of conventional treatment. After that, favorable results were evident in the 26 patients, the effective rate of intestinal paralysis remission reached 88.5%. The mean time to abdominal distension remission and anal flatus and feces passage was 2.0 days and 1.0 days, respectively. Based on these results, a prospective study has been designed to evaluate terlipressin’s effectiveness and safety in the treatment of intestinal paralysis patients with advanced liver disease.

Results from the clinical research phase revealed that the total effective rate of the terlipressin treatment group was 93.8%, evidently higher than that of the conventional treatment group (93.8% vs. 77.6%). In the terlipressin group, the mean time to both abdominal pain and bloating remission was 2.0 days, while the mean time to anal flatus and feces passage was 1.0 days. Most of its patients could quickly relieve or remove their intestinal paralysis symptoms within 1 to 3 days of terlipressin treatment. Significant improvement has been made in the clinical prognosis and the overall effective rate of treating intestinal paralysis, leading to a lower incidence of complications.

Almost no serious adverse events were reported in short-term applications of low-dose terlipressin [26]. We speculated that the mechanism of terlipressin in the treatment of intestinal paralysis is: (1) terlipressin shrinks the smooth muscle of visceral blood vessels, reduces visceral blood flow, and thus can alleviate peritonitis-induced intestinal wall edema [6]; (2) terlipressin may act on the intestinal smooth muscle to improve intestinal peristalsis. (3) terlipressin continuously reduces portal pressure, intestinal mucosal edema, bacterial translocation, and related endotoxemia [6].

The multivariate regression analysis reflected that intestinal paralysis remission is associated with the use of enema and gastrointestinal decompression as well as the use of terlipressin. However, as ESLD patients mostly suffer esophageal and gastric varices, they tend to have a higher risk of receiving gastrointestinal decompression. Therefore, on top of the conventional treatment including fasting, anti-inflammatory therapies, nutritional support, and water-electrolyte balance, terlipressin administered to ESLD patients with intestinal paralysis helps shorten the time to abdominal distension remission and alleviate the discomfort and torture produced by abdominal distension and pain, thereby improving their quality of life. The short-term therapeutic effect suggests a satisfactory outcome, and fortunately, no serious adverse effects were seen in our small sample, but vigilance is required given ESLD patients’ fragile condition. We did not track long-term outcomes or recurrences, as our aim was acute management; thus, the lasting impact of terlipressin on patient prognosis remains to be determined. At the same time, because group assignment was not randomized, the findings should be interpreted with caution despite efforts to minimize bias.

Study limitations: (1) non-randomized design/potential selection bias, (2) relatively small sample (especially in the treatment arm), (3) single-center Chinese patient population (which may limit generalizability to other regions or etiologies of ESLD), (4) no long-term outcome data, and (5) no in-depth studies on the mechanism of action of terlipressin. Future studies with expanded number of available samples, preferably randomized or multi-center cohorts, would be conducive to the observation of long-term efficacy and side effects of patients.

Conclusion

In patients with ESLD, special attention should be given to the occurrence of intestinal paralysis in those who also have abdominal infections, significant ascites, increased neutrophil percentage, and low blood potassium levels. Adding low-dose terlipressin to the conventional treatment can considerably shorten the time to symptom remission, increase intestinal paralysis remission, and enhance clinical outcomes in ESLD patients with intestinal paralysis.

Data availability

The datasets used and analysed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

We thank all the patients enrolled in this study for their kindly understanding and supporting. We also thank the faculty of the department of infectious disease who contribute to subjects screening and blood sample collection.

Funding

This work was supported by Remarkable Innovation-Clinical Research Project, The Second Affiliated Hospital of Chongqing Medical University.

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Author notes

  1. Xia Wan and Hua Xu contributed equally to this work.

Authors and Affiliations

  1. Department of Infectious Diseases, Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, the Second Affiliated Hospital, Chongqing Medical University, Chongqing, China

    Xia Wan, Hua Xu, Hu Li, Shan Zhong, Yu Lei, Huan Deng, Xiao Fu & Zhi Zhou

  2. Department of Oncology, Chongqing Hospital of Traditional Chinese Medicine, Chongqing, China

    Hua Xu

  3. Department of Respiratory and Critical Care Medicine, Chongqing University Jiangjin Hospital, Chongqing, China

    Xia Wan

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Contributions

ZZ contributed to the study conception and design. Material preparation and data collection were performed by HL, SZ, YL, HD and XF. The first draft of the manuscript and data analysis were written by XW and HX, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Zhi Zhou.

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Ethics approval and consent to participate

Our study was adhered to the Declaration of Helsinki, and this study protocol was reviewed and approved by the Ethical Committee of Second Affiliated Hospital of Chongqing Medical University, approval number [(2021) 627](Supplemental Material). Written informed consent was obtained from all participants. All authors had access to the study data and had reviewed and approved the final manuscript.

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The authors declare no competing interests.

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Wan, X., Xu, H., Li, H. et al. Effectiveness and safety evaluation of terlipressin in the treatment of intestinal paralysis in end-stage liver disease. BMC Gastroenterol 25, 286 (2025). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12876-025-03910-2

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  • DOI: https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12876-025-03910-2

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BMC Gastroenterology

ISSN: 1471-230X

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