Use of combined triamcinolone acetonide enema in the treatment of immune checkpoint inhibitor-related immune enteritis

Abstract

The present invention discloses the use of combined GC triamcinolone enema in the treatment of immune checkpoint inhibitor-related immune enteritis. The present invention proves through clinical trial cases that intravenous administration of GC methylprednisolone combined with (triamcinolone) enema administration is beneficial to the improvement of the condition of immune checkpoint inhibitor-related immune enteritis. Therefore, combined GC (triamcinolone) enema can be used in related fields such as immune checkpoint inhibitor-related immune enteritis. The present invention provides a new drug and treatment idea for the treatment of immune checkpoint inhibitor-related immune enteritis; the present invention opens up a new use for GC (triamcinolone) enema administration and provides a new treatment method for immune checkpoint inhibitor-related immune enteritis, having good clinical application prospects. The combined medication scheme provided by the present invention has been fully clinically verified in terms of its effectiveness and safety; it is easily acceptable to patients and has unique advantages.

Description

Technical Field

[0001] The present invention relates to the use of combined triamcinolone acetonide enema in the treatment of immune checkpoint inhibitor-related immune enteritis, belonging to the field of biomedical technology. Background Art

[0002] Immune-checkpoint inhibitors (ICIs) treatment is prone to trigger ICIs-related immune enteritis. It usually appears within 6 to 8 weeks after the start of tumor immunotherapy, and the incidence rate is about 10-14%. Compared with other types of enteritis (such as ulcerative colitis, bacterial enteritis, ischemic necrotic enteritis, etc.), ICIs-related immune enteritis has its particularity in the pathogenesis, clinical manifestations and treatment methods.

[0003] In terms of the pathogenesis: ICIs-related immune enteritis is caused by the abnormal activation of the immune system, rather than an immune response related to infection or inflammation (the pathogenesis of other common enteritis). Its pathogenesis is related to the mechanism of action of immune checkpoint inhibitor drugs. Immune checkpoint inhibitor drugs activate the immune system by blocking the interaction of immune checkpoint molecules (such as PD-1, PD-L1 or CTLA-4), enhancing the ability to attack tumor cells. However, this immune activity may also lead to the immune system attacking normal tissues, including the intestinal mucosa, triggering enteritis.

[0004] The difference in the pathogenesis also leads to the histological differences between ICIs-related immune enteritis and other enteritis. ICIs-related immune enteritis is typically characterized by lymphocyte infiltration, lymphoid follicle hyperplasia and non-specific inflammatory reactions in the intestinal mucosa. While other enteritis is mostly intestinal mucosal erosion, ulcer formation, inflammatory cell infiltration and tissue destruction.

[0005] In terms of clinical manifestations, although it will present symptoms of diarrhea or colitis like other types of enteritis, including watery diarrhea, abdominal pain, and acute abdomen. However, compared with other enteritis, the symptoms are relatively mild at the onset. Immune checkpoint inhibitor (ICI)-related immune enteritis often shows a higher severity grade at the time of occurrence. Without active anti-inflammatory treatment, the fatality and disability rates are high, and serious life-threatening complications such as toxic megacolon, intestinal ischemia, and intestinal perforation are likely to occur. Currently, the relatively authoritative guidelines for the clinical management of ICI toxicity grade the severity of immune checkpoint inhibitor-related immune enteritis into 5 levels. Mild (G1): The number of bowel movements per day exceeds the baseline by less than 4 times, but there are no symptoms of colitis; Moderate (G2): The number of bowel movements per day exceeds the baseline by 4 - 6 times, with symptoms of colitis, but it does not affect daily life; Severe (G3 - 4): The number of bowel movements per day exceeds the baseline by more than 6 times, with symptoms of colitis, affecting daily life, hemodynamic instability, requiring hospitalization, or presenting other serious complications (such as intestinal ischemia, perforation, toxic colon); G5: Death. At the same time, most patients with ICI-related immune enteritis are cancer patients, and their overall physical conditions such as nutrition, immunity, and psychology are relatively poor. Compared with patients with other enteritis, they are more likely to develop serious systemic complications rather than being limited to the intestine itself.

[0006] In terms of treatment methods, the intolerance or ineffectiveness of the treatment methods for ordinary enteritis often occurs in patients with ICI-related immune enteritis. First of all, other enteritis is usually caused by reasons such as infection, inflammation, or autoimmunity, and the treatment methods mainly involve dealing with the cause or inducement. For example, for enteritis caused by infection, antibiotics or antiviral drugs may be needed. Immune checkpoint inhibitor-related enteritis is caused by the use of immune checkpoint inhibitor drugs. Therefore, the treatment methods mainly involve adjusting or discontinuing the drugs and dealing with the inflammatory reactions related to the abnormal activation of the immune system. Secondly, ICI-related immune enteritis often has a relatively severe onset, which makes the treatment methods effective for other enteritis with milder conditions (such as fluid replacement, immunomodulators, symptomatic supportive treatment, etc.) have little effect in this disease. At the same time, since most patients with ICI-related immune enteritis have relatively poor overall physical conditions, they often cannot tolerate treatment methods for other severe enteritis such as surgical treatment, large-dose fluid replacement, immunomodulators, and high-dose anti-inflammatory treatment.

[0007] At present, for ICIs-related immune enteritis, guidelines and clinical experience still recommend systemic administration (oral or intravenous) of high-dose glucocorticoids (GCs) for treatment. Most guidelines recommend the use of high-dose prednisone / methylprednisolone (1-2 mg / kg / day) orally or intravenously for grade 2 or higher colitis; when grade 2 or higher colitis does not improve within 2-3 days, continue hormone therapy, and it is recommended to add infliximab or vedolizumab. However, this treatment regimen has the following problems: 1) The treatment cycle is long. Under high-dose hormone maintenance, the symptoms of patients are slow to improve and prone to relapse, requiring 4-6 weeks of treatment; 2) The systemic dosage is large, and there is a risk of immunosuppression, which is contrary to the principles of immunotherapy; 3) The hormone response rate is low. For some patients, the symptoms still do not improve after 2-3 days of high-dose hormone shock, and even continue to worsen. It is necessary to consider the addition of highly immunosuppressive biological agents. Therefore, this treatment regimen urgently needs to be optimized to obtain a higher hormone response rate and efficacy, and avoid the possibility of immunosuppression after high-dose and long-duration hormone treatment.

[0008] Enema refers to an external treatment method that injects liquid medicine into the rectum or colon and absorbs it through the intestinal mucosa to achieve the purpose of treatment. This method of administration allows the liquid medicine to be directly absorbed in the intestine, increasing the blood concentration of the lesion. At the same time, the drug acts directly on the ulcer surface, avoiding the damage of gastric acid, playing a role in local anti-inflammatory and protection of the ulcer surface, and can quickly promote the absorption of inflammation and ulcer healing. It is safe, effective, simple and easy to use, and has few adverse reactions.

[0009] Triamcinolone acetonide is a locally acting glucocorticoid with a strong and lasting anti-inflammatory effect. However, there are currently no reports on the use of triamcinolone acetonide in the treatment of ICIs-related immune enteritis. Summary of the invention

[0010] The purpose of the present invention is: to address the technical problem that the current use of hormones to treat ICIs-related immune enteritis has poor efficacy, the present invention provides the use of combined intravenous and enema administration of cortisol in the treatment of ICIs-related immune enteritis, the combined administration method can make up for the limitations of the two in their respective administration, and has clinical advantages. First, enema administration can directly enter the diseased tissue at the distal end of the colorectum, locally deliver a large amount of drugs, help reduce the exposure level of systemic drugs, and then lower the intravenous administration amount to avoid systemic immunosuppression caused by large-dose intravenous administration; second, intravenous systemic administration can make up for the uneven drug distribution caused by simple enema administration due to the high folding and collapse of the colorectal epithelium, thereby improving the therapeutic effect.

[0011] In order to achieve the above-mentioned object, the present invention provides the use of methylprednisolone combined with triamcinolone acetonide enema in the preparation of a drug for treating immune checkpoint inhibitor-related immune enteritis.

[0012] Preferably, the administration method of the drug is systemic administration combined with local administration.

[0013] Preferably, the administration method of methylprednisolone is systemic administration, and the administration method of triamcinolone acetonide is local administration.

[0014] Preferably, the systemic administration method is intravenous administration and / or oral administration, and the local administration method is enema administration.

[0015] Compared with the prior art, the present invention has the following beneficial effects:

[0016] 1. The present invention proves through clinical trial cases that the combination of GCs (triamcinolone acetonide) enema can be beneficial to the improvement of immune checkpoint inhibitor-related immune enteritis. Therefore, the combination of GCs (triamcinolone acetonide) enema can be used in related fields such as immune checkpoint inhibitor-related immune enteritis, providing a new drug and treatment idea for the treatment of immune checkpoint inhibitor-related immune enteritis; the present invention opens up a new use for the enema treatment of GCs (triamcinolone acetonide) and provides a new treatment method for immune checkpoint inhibitor-related immune enteritis, with good clinical application prospects.

[0017] 2. In the present invention, the glucocorticoid treatment is systemic combined with local enema, with complementary advantages; through local enema, GCs directly enter the diseased tissues in the distal colon and rectum, with a high local drug concentration and a low systemic drug exposure level, and good local inflammation control effect, realizing a rapid reduction in systemic GCs treatment and reducing the systemic adverse reactions and immunosuppressive effects of GCs; intravenous systemic administration can make up for the uneven drug distribution caused by the highly folded and collapsed colorectal epithelium during enema administration, further improving the curative effect; the combination of the two can give full play to their respective advantages and make up for the limitations of each other, achieving the effect of "1 + 1 > 2".

[0018] 3. The present invention optimizes the GCs treatment plan for ICIs-related immune enteritis. While trying to improve the curative effect and patient response rate, the present invention fully considers the interference of the immunosuppressive effect of anti-inflammatory drugs on antitumor treatment; the combination of GCs local enema treatment can more effectively control intestinal inflammation, and compared with adding biological agents, it has less immunosuppressive effect on the whole body, and can further reduce the adverse effects of systemic GCs treatment on the patient's antitumor treatment by accelerating symptom relief and reducing treatment time, realizing the overall optimization of the treatment plan.

[0019] 4. The combination of GCs triamcinolone acetonide enema provided by the present invention is safe and effective, with few systemic adverse reactions, and its effectiveness and safety have been fully verified clinically; it is easy to be accepted by patients and has unique advantages. Detailed implementation manners

[0020] To make the present invention more obvious and understandable, the following is a detailed description with preferred embodiments and accompanied by drawings.

[0021] Unless otherwise specified, the test methods used in the following examples are all conventional methods; the materials, reagents, etc. used, unless otherwise specified, are reagents and materials that can be obtained from commercial channels.

[0022] Example 1: Combining triamcinolone enema to accelerate symptom relief and improve treatment efficacy

[0023] Clinical cases of combining triamcinolone enema:

[0024] Drug formula: 1. Triamcinolone enema drug: 100 ml of 0.9%-sodium chloride solution, 1 ml of triamcinolone injection, which contains 40 mg of triamcinolone.

[0025] Six patients with immune checkpoint inhibitor-related immune enteritis were selected. With their informed consent, the patients were treated with intravenous administration of methylprednisolone combined with triamcinolone enema. The patients first received intravenous administration of methylprednisolone, which was gradually increased according to the patient's condition, up to 500 mg / d (within 3-5 days), and the enema drug was added on the day of the highest dose. During enema, the patient took the left lateral position and elevated the buttocks by 10 cm. The drip method was used, and a suction tube was used instead of a steel tube to insert into the anus 25-35 cm, and the liquid medicine was slowly input, and the patient was instructed to take the knee-chest position. The temperature of the liquid medicine was maintained at about 38°C, and the speed of the input liquid was adjusted to one drop per 60 minutes or adjusted according to the patient's tolerance. The enema solution was shaken well to avoid precipitation of the liquid medicine. During the operation, the patient should be asked about any discomfort. After enema, the patient was instructed to stay in bed for 2 hours, and the patient's body position was changed according to different parts of the disease. The patient was instructed not to get out of bed, and the enema solution was retained for as long as possible. After the enema tube was removed, after resting for 2 minutes, the patient was assisted to take the supine position, and the patient's lower abdomen was gently pressed and massaged counterclockwise 10 times, and then the patient was instructed to lie quietly for 30 minutes before getting out of bed.

[0026] The severity of the disease was graded for the patients before treatment (at admission), during treatment (at the maximum dose of intravenous medication), and 7 days after combined enema drug treatment to observe the treatment effect. The severity was divided into 5 grades. Mild (G1): defecation more than 4 times within the baseline per day, but without colitis symptoms; Moderate (G2): defecation more than 4 - 6 times the baseline per day, with colitis symptoms, but not affecting daily life; Severe (G3 - 4): defecation more than 6 times the baseline per day, with colitis symptoms, affecting daily life, hemodynamically unstable, requiring hospitalization, or presenting other serious complications (such as intestinal ischemia, perforation, toxic megacolon); G5: death. Table 1 shows the treatment plans (including intravenous medication doses and enema dosages) for 6 patients and the severity grading before and after treatment. It can be found that adding 40 mg / day of triamcinolone acetonide for local retention enema significantly relieved the diarrhea and abdominal pain symptoms of the patients (Table 1), indicating that combined local enema with cortisol can help accelerate symptom relief and improve the treatment efficacy.

[0027] Table 1 After combined retention enema with triamcinolone acetonide on the basis of intravenous administration of methylprednisolone, manifestations of colitis such as diarrhea and abdominal pain improved

[0028]

[0029] MT: malignant tumor; ICIs: immune - checkpoint inhibitors; ENEM: enema; GC: glucocorticoid; a : Severity grading of the patient's condition at admission; b : At admission, after comprehensive evaluation by the physician, intravenous methylprednisolone administration was started. Due to the insignificant relief of symptoms, the dosage was increased. This value is the maximum dose of GC administration; c : Severity grading of the patient's condition on the day of the maximum dose of GC administration; d : An enema was added on the day of the maximum dose of GCC administration; e : Severity grading of the patient's condition 7 days after combined enema treatment; G0 f : Clinically cured, the patient has no diarrhea and no colitis symptoms.

[0030] Comparative Example 1

[0031] Drug formula: 1. Triamcinolone acetonide enema drug: 100 ml of 0.9% - sodium chloride solution, 1 ml of triamcinolone acetonide injection, which contains 40 mg of triamcinolone acetonide.

[0032] One patient with immune checkpoint inhibitor-related immune enteritis was selected, and with the patient's informed consent, intravenous administration of methylprednisolone combined with triamcinolone enema was performed on the patient. The patient first received intravenous administration of methylprednisolone, and the dose was gradually increased to 240 mg / d within 3 - 5 days according to the condition. The enema drug was added on the day of the highest dose. During the enema, the patient took the left lateral position, raised the buttocks by 10 cm, used the drip method, inserted a suction tube instead of a steel tube into the anus for 25 - 35 cm, slowly infused the liquid medicine, and instructed the patient to take the knee-chest position. The temperature of the liquid medicine was maintained at about 38°C, and the infusion rate was adjusted to one drop per 60 minutes or adjusted according to the patient's tolerance. The enema solution was shaken well to avoid precipitation of the liquid medicine. During the operation, the patient should be asked about any discomfort. After the enema, the patient was instructed to stay in bed for 2 hours, and the patient's body position was changed according to different parts of the disease. The patient was instructed not to get out of bed to keep the enema solution retained for as long as possible. After the enema tube was removed, after a 2-minute rest, the patient was assisted to take the supine position, the patient's lower abdomen was gently pressed, and massaged counterclockwise 10 times. Then the patient was instructed to lie quietly for 30 minutes before getting out of bed to move.

[0033] Before treatment, the patient's disease severity was classified as G3. After 3 - 5 days of simple intravenous administration (gradually increasing to 240 mg / d), the disease severity was still classified as G3, and the condition did not improve. After adding the enema drug, the disease severity was classified as G1, and the condition improved significantly.

[0034] Comparative Example 2

[0035] Drug formula: 1. Triamcinolone enema drug: 100 ml of 0.9% - sodium chloride solution, 1 ml of triamcinolone injection containing 40 mg of triamcinolone.

[0036] One patient with immune checkpoint inhibitor-related immune enteritis was selected, and with the patient's informed consent, intravenous administration of methylprednisolone combined with triamcinolone enema was performed on the patient. The patient first received intravenous administration of methylprednisolone, and the dose was gradually increased to 80 mg / d within 3 - 5 days according to the condition. The enema drug was added on the day of the highest dose. During the enema, the patient took the left lateral position, raised the buttocks by 10 cm, used the drip method, inserted a suction tube instead of a steel tube into the anus for 25 - 35 cm, slowly infused the liquid medicine, and instructed the patient to take the knee-chest position. The temperature of the liquid medicine was maintained at about 38°C, and the infusion rate was adjusted to one drop per 60 minutes or adjusted according to the patient's tolerance. The enema solution was shaken well to avoid precipitation of the liquid medicine. During the operation, the patient should be asked about any discomfort. After the enema, the patient was instructed to stay in bed for 2 hours, and the patient's body position was changed according to different parts of the disease. The patient was instructed not to get out of bed to keep the enema solution retained for as long as possible. After the enema tube was removed, after a 2-minute rest, the patient was assisted to take the supine position, the patient's lower abdomen was gently pressed, and massaged counterclockwise 10 times. Then the patient was instructed to lie quietly for 30 minutes before getting out of bed to move.

[0037] Before treatment, the patient's disease severity was classified as G2. After intravenous administration alone for 3 - 5 days (gradually increasing to 240 mg / d), the disease severity was classified as G1, and the condition improved slightly. After adding the enema drug, the disease severity was classified as G0, and the condition improved significantly, reaching the clinical cure standard.

[0038] Comparative Example 3

[0039] Drug formula: 1. Triamcinolone acetonide enema drug: 100 ml of 0.9% sodium chloride solution, 1 ml of triamcinolone acetonide injection, which contains 40 mg of triamcinolone acetonide.

[0040] One patient with immune checkpoint inhibitor - related immune enteritis was selected. With the patient's informed consent, the patient was treated with intravenous methylprednisolone combined with triamcinolone acetonide enema. The patient first received intravenous methylprednisolone, which was gradually increased to 120 mg / d within 3 - 5 days according to the condition, and the enema drug was added on the day of the highest dose. During enema, the patient took the left lateral position, elevated the buttocks by 10 cm, used the drip - by - drop method, replaced the steel pipe with a suction catheter and inserted it into the anus 25 - 35 cm, slowly infused the liquid medicine, and instructed the patient to take the knee - chest position. The temperature of the liquid medicine was maintained at about 38°C, and the infusion rate was adjusted to one drop per 60 minutes or adjusted according to the patient's tolerance. The enema solution was shaken well to avoid precipitation of the liquid medicine. During the operation, the patient was asked about any discomfort. After enema, the patient was instructed to stay in bed for 2 hours, and the patient's body position was changed according to different parts of the disease. The patient was instructed not to get out of bed to keep the enema solution retained for as long as possible. After removing the enema tube, after resting for 2 minutes, the patient was assisted to take the supine position, the patient's lower abdomen was gently pressed, massaged counterclockwise 10 times, and the patient was instructed to lie quietly for 30 minutes before getting out of bed.

[0041] Before treatment, the patient's disease severity was classified as G3. After intravenous administration alone for 3 - 5 days (gradually increasing to 120 mg / d), the disease severity remained G3, and the condition did not improve. After adding the enema drug, the disease severity was classified as G1, and the condition improved significantly.

[0042] Comparative Example 4

[0043] Drug formula: 1. Triamcinolone acetonide enema drug: 100 ml of 0.9% sodium chloride solution, 1 ml of triamcinolone acetonide injection, which contains 40 mg of triamcinolone acetonide.

[0044] One patient with immune checkpoint inhibitor-related immune enteritis was selected. With the patient's informed consent, the patient was treated with intravenous administration of methylprednisolone combined with triamcinolone acetonide enema. The patient first received intravenous administration of methylprednisolone, which was gradually increased to 500 mg / d within 3 - 5 days according to the condition, and the enema drug was added on the day of the highest dose. During enema, the patient took the left lateral position, elevated the buttocks by 10 cm, and used the drip method. A suction tube was used instead of a steel tube to insert into the anus 25 - 35 cm, and the liquid medicine was slowly infused. The patient was instructed to take the knee-chest position. The temperature of the liquid medicine was maintained at about 38°C, and the infusion rate of the liquid was adjusted to one drop per 60 minutes or adjusted according to the patient's tolerance. The enema solution was shaken well to avoid precipitation of the liquid medicine. During the operation, the patient was asked about any discomfort. After enema, the patient was instructed to stay in bed for 2 hours, and the patient's body position was changed according to different parts of the disease. The patient was instructed not to get out of bed to keep the enema solution retained for as long as possible. After the enema tube was removed, after resting for 2 minutes, the patient was assisted to take the supine position, the patient's lower abdomen was gently pressed, and massaged counterclockwise 10 times. Then the patient was instructed to lie quietly for 30 minutes before getting out of bed to move around.

[0045] Before treatment, the severity of the patient's condition was graded as G3. After intravenous administration alone for 3 - 5 days (gradually increased to 500 mg / d), the severity of the condition was graded as G1, and the condition improved significantly. After adding the enema drug, the severity of the condition was graded as G0, and the condition further improved, reaching the clinical cure standard.

[0046] Control Example 5

[0047] Drug formula: 1. Triamcinolone acetonide enema drug: 100 ml of 0.9% sodium chloride solution, 1 ml of triamcinolone acetonide injection, containing 40 mg of triamcinolone acetonide.

[0048] One patient with immune checkpoint inhibitor-related immune enteritis was selected. With the patient's informed consent, the patient was treated with intravenous administration of methylprednisolone combined with triamcinolone acetonide enema. The patient first received intravenous administration of methylprednisolone, which was gradually increased to 40 mg / d within 3 - 5 days according to the condition, and the enema drug was added on the day of the highest dose. During enema, the patient took the left lateral position, elevated the buttocks by 10 cm, and used the drip method. A suction tube was used instead of a steel tube to insert into the anus 25 - 35 cm, and the liquid medicine was slowly infused. The patient was instructed to take the knee-chest position. The temperature of the liquid medicine was maintained at about 38°C, and the infusion rate of the liquid was adjusted to one drop per 60 minutes or adjusted according to the patient's tolerance. The enema solution was shaken well to avoid precipitation of the liquid medicine. During the operation, the patient was asked about any discomfort. After enema, the patient was instructed to stay in bed for 2 hours, and the patient's body position was changed according to different parts of the disease. The patient was instructed not to get out of bed to keep the enema solution retained for as long as possible. After the enema tube was removed, after resting for 2 minutes, the patient was assisted to take the supine position, the patient's lower abdomen was gently pressed, and massaged counterclockwise 10 times. Then the patient was instructed to lie quietly for 30 minutes before getting out of bed to move around.

[0049] Before treatment, the severity of the patient's condition was classified as G2. After intravenous administration alone for 3 - 5 days (gradually increasing to 40 mg / d), the severity of the condition remained G2 and there was no improvement. After adding the enema drug, the severity of the condition was classified as G0, with significant improvement and reaching the clinical cure standard.

[0050] Comparative Example 6

[0051] Drug formula: 1. Triamcinolone acetonide enema drug: 100 ml of 0.9% sodium chloride solution, 1 ml of triamcinolone acetonide injection containing 40 mg of triamcinolone acetonide.

[0052] One patient with immune checkpoint inhibitor - related immune enteritis was selected and treated with triamcinolone acetonide enema with the patient's informed consent. During enema, the patient took the left lateral position and elevated the buttocks by 10 cm. The drip - by - drip method was used, and a suction tube was used instead of a steel tube to insert 25 - 35 cm into the anus. The liquid medicine was slowly infused, and the patient was instructed to take the knee - chest position. The temperature of the liquid medicine was maintained at about 38°C, and the infusion rate was adjusted to one drop per 60 minutes or adjusted according to the patient's tolerance. The enema solution was shaken well to avoid precipitation of the liquid medicine. During the operation, the patient should be asked about any discomfort. After enema, the patient was instructed to stay in bed for 2 hours, and the patient's body position was changed according to different parts of the disease. The patient was instructed not to get out of bed to keep the enema solution in the body for as long as possible. After removing the enema tube, after resting for 2 minutes, assist the patient to take the supine position, gently press the lower abdomen of the patient, massage counter - clockwise 10 times, and then instruct the patient to lie still for 30 minutes before getting out of bed.

[0053] Before treatment, the severity of the patient's condition was classified as G2. After treatment with the enema drug, the severity of the condition was classified as G1, and the condition improved.

[0054] As described above, it is only the preferred embodiment of the present invention, and there is no limitation in any form and essence to the present invention. It should be pointed out that for those of ordinary skill in the art in this technical field, without departing from the premise of the present invention, several improvements and supplements can still be made, and these improvements and supplements should also be regarded as the protection scope of the present invention.

Claims

1. Use of methylprednisolone combined with triamcinolone enema in the preparation of a medicament for treating immune checkpoint inhibitor-related immune enteritis.

2. The application according to claim 1, characterized in that The administration method of the medicament is systemic administration combined with local administration.

3. The application according to claim 2, wherein The administration method of methylprednisolone is systemic administration, and the administration method of triamcinolone is local administration.

4. The application according to claim 2 or 3, characterized in that, The systemic administration method is intravenous administration and / or oral administration, and the local administration method is enema administration.

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