RU2774610C1 - Method for predicting recurrence of ulcerative gastroduodenal bleeding - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to abdominal surgery and gastroenterology, and can be used to predict the risk of recurrent ulcer bleeding. The shock index (SI), the number of erythrocytes, total protein, urea, localization of the ulcer and the type of hemostasis according to Forrest are determined. Each sign is evaluated in points. SI 1.0 or more is scored as 1 point. The number of erythrocytes less than 3.0*10¹² is estimated as 1 point; a total protein of 58 g/l or less is scored as 4 points; urea more than 8 mmol/l is estimated as 4 points. The localization of the ulcer along the lesser curvature of the stomach is estimated as 2 points. Localization on the back wall of the duodenal bulb - as 3 points. The condition of the bottom of the Forrest 2A ulcer is estimated as 2 points. The condition of the bottom of the ulcer Forrest 2C or 3 - as minus 3 points. Carry out the summation of points, while additionally determine the number of platelets and activated partial thromboplastin time (APTT). The number of platelets less than 150*109 is estimated as 2 points; APTT 40 seconds or more is estimated as 2 points. After that, with a sum of 9 to 19 points, a high risk of recurrent bleeding is predicted. With a sum of -3 to 8 points, a low risk of recurrent bleeding is predicted.

EFFECT: method provides the possibility of improving the accuracy of the forecast by taking into account the factors of the hemostasis system.

1 cl, 1 tbl, 4 ex

Description

The invention relates to medicine, namely to abdominal surgery and gastroenterology, and can be used to assess the risk of recurrent bleeding from gastroduodenal ulcers.

The problem of ulcerative bleeding does not lose its relevance today. The incidence remains at a consistently high level in the world and in Russia, averaging 20 to 50 cases per 100,000 population, depending on the region. Mortality also remains high, reaching 6% worldwide. The main reasons for unsatisfactory results of treatment are considered to be the age of patients, the presence of severe comorbidity, and recurrent bleeding. Recurrent ulcer bleeding occurs in 12.4-17.3% of cases. Mortality after recurrent bleeding is several times higher and reaches more than 20%. Surgical treatments undertaken at the height of recurrence are also accompanied by increased postoperative mortality. Predicting the recurrence of ulcerative bleeding is one of the important components in the treatment of such patients.

A known method for predicting recurrent bleeding after endoscopic hemostasis, based on the method of endo-ultrasonography. After performing endoscopic hemostasis, endoscopic ultrasonography is performed in the bottom of the ulcer and its edges in order to determine closely spaced vascular structures [RF patent No. 2201143, 2003]. The method allows to indirectly assess the effectiveness of endoscopic hemostasis and the risk of recurrent bleeding. The main disadvantage of this method is the need for expensive high-tech equipment in the clinic - endoscopes with ultrasonography function. This equipment is not available in the vast majority of clinics, which indicates the possibility of using this method only in large republican and regional hospitals. Also, this method takes into account only the endoscopic criterion, not taking into account clinical and laboratory data.

A known method for predicting the possibility of recurrent bleeding in the treatment of peptic ulcer, which is based on determining the value of the color tone of the gastric mucosa. The patient is subjected to video gastroscopy, color images of the gastric mucosa are obtained, and the hue value of the video image is determined in the HSL color system, which can take a value from 0 to 360 degrees. If the color tone lies in the range below 10 degrees, a conclusion is made about the risk of recurrent bleeding [RF patent No. 2315543, 2008]. The limitation of this method is the need to use video gastroscopes with the ability to capture images, the possibility of using fibrogastroscopes is excluded. To obtain good image quality, it is necessary that the gastric mucosa be "clean", which is unlikely in the setting of emergency gastroscopy against the background of bleeding ulcers. Also, this method takes into account only the endoscopic criterion, not taking into account clinical and laboratory data.

A known method for predicting the risk of recurrence of bleeding from chronic gastroduodenal ulcers, based on clinical and endoscopic examination of the patient and the determination of the scoring risk factors with the calculation of the score. The risk of recurrent bleeding is predicted if the score is equal to or greater than 0. If the score is less than 0, there is no risk of relapse. 19 different clinical, laboratory and endoscopic criteria were used as risk factors [RF patent No. 2248177, 2005]. Moreover, the scoring of the criteria is different for gastric and duodenal ulcers. According to the authors, the method demonstrates a sufficiently high prediction accuracy, but the test was carried out on a retrospective group, which does not allow us to judge the reliable accuracy of the method. A serious limitation of the method is the fact that it is applicable only for chronic ulcers, and cannot be used for acute ulcers. At the same time, in 20-30% of cases, bleeding occurs precisely from an acute ulcer. Also noteworthy is the significant complexity in calculating the number of points (19 criteria), which complicates the use of the method in everyday work and in urgent surgery, where minutes count.

The closest analogue of the invention is a method for predicting the recurrence of ulcerative bleeding on a scale that takes into account clinical, laboratory and endoscopic data. The following variables were used as risk factors - shock index (SHI) equal to or greater than 1 (+1 point), erythrocytes less than 3.0 (+1 point), total protein equal to or less than 58 g/l (+4 points), urea more than 8 mmol/l (+4 points), localization of the ulcer along the lesser curvature of the stomach (+2 points) or along the posterior wall of the duodenal bulb 12 (+3 points), Forrest endotype 2A (+2 points), Forrest endotypes 2C and 3 (-3 points). With a total score of 7 or more points, a high risk of recurrence of ulcerative bleeding was predicted [Sh.V. Timerbulatov, M.V. "Ulcerative gastroduodenal bleeding. Stratification of the risk of developing adverse outcomes" // Journal of Endoscopic Surgery, 2019, V. 25, No. 6, pp. 5-11.]. The scale demonstrated a good quality of the prognosis of ulcer bleeding recurrence, but, in our opinion, it has a drawback associated with the lack of criteria characterizing the hemostasis system.

The objective of the invention was to develop an effective, affordable and easy-to-use, based on objective evaluation criteria, method for predicting the recurrence of ulcerative bleeding, both from chronic and acute ulcers.

The technical result when using the invention is to increase the accuracy of the forecast by taking into account the factors of the hemostasis system.

A retrospective case-control study was conducted to identify criteria influencing the onset of rebleeding. 240 patients with bleeding ulcers were included in the study. The patients were divided into 2 groups. The main group included 52 patients who had recurrent bleeding. The control group included 188 patients who did not relapse. The groups were comparable in terms of gender and age. Statistical analysis was carried out to identify factors influencing the onset of recurrent bleeding. The test was carried out according to the following criteria - age, gender, type of vomiting (fresh blood or "coffee grounds"), presence of melena, ulcer history, alcohol history, heart rate (HR), systolic blood pressure (SBP), shock index (SHI) , the number of red blood cells, hemoglobin, urea, creatinine and total blood protein, activated partial thromboplastin time (APTT), PTT, type of ulcer (acute or chronic), localization of the ulcer, type of hemostasis according to Forrest classification. The presence of association was identified using standard statistical tools. It was found that the following clinical, laboratory and endoscopic criteria influence the onset of rebleeding:

1) Shock index - Mann-Whitney U-test p=0.002.

2) Erythrocytes - Student's t-test p=0.02.

3) Urea - Mann-Whitney U-test p<0.001.

4) Total protein - Mann-Whitney U-test p<0.001.

5) APTT - Mann-Whitney U-test p<0.001.

6) Platelets - Mann-Whitney U-test p<0.001.

7) Ulcer localization:

- according to the lesser curvature of the stomach - Pearson's chi-square test p=0.014, OR=2.4 (95% CI: 1.2-4.7)

- along the posterior wall of the duodenal bulb 12 - Pearson's chi-square test p=0.002, OR=3.8 (95% CI: 1.7-8.7)

8) The condition of the bottom of the ulcer:

- Forrest 2A - Pearson's chi-square test p=0.003, OR=3.2 (95% CI: 1.5-6.5)

- Forrest 2C or 3 - Pearson's chi-square test p<0.001, OR=0.2 (95% CI: 0.1-0.6)

Cut-off points were calculated for scale variables. The method of constructing ROC curves was used to calculate cutoff points. The cut-off point was the value of the variable at which the maximum values of sensitivity and specificity were the highest or the Youden index was the highest. The following threshold values of discrete variables were adopted: 1) erythrocytes less than 3.0*10 ¹² ; 2) urea more than 8 mmol/l; 3) total protein is equal to or less than 58 g/l; 4) APTT more than 40 seconds; 5) platelets less than 150*10 ⁹ ; 6) SI equal to or greater than 1.0.

In order to assess the contribution of each variable to the onset of the predicted event (recurrent bleeding), the method of discriminant analysis was used, on the basis of which a scoring of 8 factors associated with the onset of recurrent bleeding was performed (table).

If the total score is between 9 and 19 points, the patient has a high risk of rebleeding. In the case when the total score is from -3 to 8 points, the risk of rebleeding is low.

The indicators of the new scale were calculated for each patient. The minimum value was -3 points, the maximum 19 points. In group 1, the median was 11 points (interquartile range (IR) from 8 to 12 points). In group 2, the median was 3 points (IR from 0 to 6 points). Differences between groups are statistically significant (p<0.001).

The maximum value of the Youden index is achieved at a scale value of 8 points and is 0.725, while N=94.3%, C=78.2%. The point of intersection of H and S is at the level of 83% with a scale value of 9 points. A scale value of 9 points was taken as the cut-off point.

In the group of patients with a score less than 9, rebleeding occurred in 4 out of 152 (2.6%). In the group of patients with a score of 9 or higher, rebleeding occurred in 52 of 88 (56.8%) cases. The differences are statistically significant (p<0.001). The chance of developing rebleeding in patients of the study group with a score of 9 or more is 53 times higher (95% CI: 18.1-157.4).

The proposed method for predicting the risk of recurrence of ulcerative bleeding is as follows. When a patient with ulcerative gastroduodenal bleeding is admitted to the emergency department, a physical examination is performed, including measurement of blood pressure and heart rate, and a shock index is determined. Blood sampling is carried out to perform clinical and biochemical analysis, coagulogram. According to emergency indications, gastroscopy is performed, the localization of the ulcer and the level of bleeding according to the Forrest classification are established. The number of erythrocytes less than 3.0*10 ¹² is estimated as 1 point, 3.0*10 ¹² and more - 0 points; urea more than 8 mmol/l is estimated as 4 points, 8 mmol/l and less - 0 points; total protein 58 g/l or less is estimated as 4 points, more than 58 g/l - 0 points; platelets less than 150*10 ⁹ are evaluated as 2 points, 150*10 ⁹ and more - 0 points; APTT 40 seconds or more is estimated as 2 points, less than 40 seconds - 0 points; SI 1.0 or more is estimated as 1 point, less than 1.0-0 points; localization of the ulcer along the lesser curvature of the stomach is estimated as 2 points, localization along the posterior wall of the duodenal bulb - as 3 points, other localizations - 0 points; the condition of the bottom of the ulcer Forrest 2A is assessed as 2 points, the condition of the bottom of the ulcer Forrest 2C or 3 - as minus 3 points, other endotypes - 0 points. The number of points for each criterion is calculated, after which the points are summed up. With a sum of 9 to 19 points, a high risk of recurrent bleeding is predicted. With a sum of -3 to 8 points, a low risk of recurrent bleeding is predicted.

The essence of the invention is illustrated by the following clinical examples.

Example 1

Patient A., aged 45, was admitted to the emergency department with a clinic of gastroduodenal bleeding with complaints of tarry stools, weakness, dizziness. Sick for about 24 hours.

Upon admission - a state of moderate severity, pallor of the skin, blood pressure - 100/60 mm Hg, heart rate - 110 per minute, shock index - 1.1. According to the results of laboratory studies: the number of red blood cells - 3.2 * 10 ¹² , hemoglobin - 106 g / l, platelets - 210 * 10 ⁹ , urea - 12.7 mmol / l, total protein - 60 g / l, APTT - 41 s .

Performed emergency gastroscopy - revealed a chronic ulcer of the lesser curvature of the stomach, with signs of stopped bleeding with the presence of a blood clot at the bottom of the ulcer - Forrest 2B.

Given the stopped nature of bleeding, the patient underwent conservative therapy. On the 2nd day of treatment, there was a sharp deterioration in the condition - a drop in blood pressure, vomiting of fresh blood. With signs of recurrence of ulcerative bleeding, the patient is taken for emergency surgical treatment - a laparotomy, gastrotomy, and suturing of the ulcer were performed. In the early postoperative period, cardiac arrest, resuscitation measures are not effective, biological death is stated.

For the analysis of this clinical case, a scoring of the criteria was made:

Shock index >1.0 - YES - +1 point

Erythrocytes <3.0*10 ¹² - NO - 0 points

Platelets <150*10 ⁹ - NO - 0 points

Total protein <58 g/l - NO - 0 points

Urea >8 mmol/l - YES - +4 points

APTT >40 s - +2 points

Ulcer of the lesser curvature of the stomach - YES - +2 points

Forrest 2B - 0 points

Sum: 1+4+2+2=9 points

The patient was predicted to be at high risk of rebleeding from a chronic ulcer. The patient was shown urgent surgical treatment, without waiting for the recurrence of bleeding. In this case, one of the reasons for the unsatisfactory result of treatment was an unreasonably long expectant management.

Example 2

Patient N., 53 years old, was taken to the emergency department with complaints of "coffee grounds" vomiting, liquid tarry stools, weakness, dizziness. Sick for about 24 hours.

Upon admission, the condition was assessed as severe, pallor of the skin, blood pressure - 90/60 mm Hg, heart rate - 117 per minute, shock index - 1.3. According to the results of laboratory studies - the number of red blood cells - 2.5 * 10 ¹² , hemoglobin - 86 g / l, platelets - 145 * 10 ⁹ , urea - 10.5 mmol / l, total protein - 55 g / l, APTT - 45 s .

Performed emergency gastroscopy - revealed a chronic ulcer of the posterior wall of the bulb 12 of the duodenum, with signs of stopped bleeding with the presence of a thrombosed vessel at the bottom of the ulcer - Forrest 2A.

Given the stopped nature of bleeding, the patient underwent conservative therapy. 20 hours after hospitalization, against the background of ongoing conservative therapy, there was a sharp deterioration in the condition - a drop in blood pressure, vomiting of fresh blood, liquid melena in large quantities. With signs of recurrence of ulcerative bleeding, the patient is taken for emergency surgical treatment - a laparotomy, duodenotomy, and suturing of the ulcer were performed. In the early postoperative period, cardiac arrest, resuscitation measures are not effective, biological death is stated.

For the analysis of this clinical case, a scoring of the following criteria was made:

Shock index >1.0 - YES - +1 point

Erythrocytes <3.0*10 ¹² - YES - +1 point

Platelets <150*10 ⁹ - YES - +2 points

Total protein <58 g/l - YES - +4 points

Urea >8 mmol/l - YES - +4 points

APTT >40 s - +2 points

Ulcer of the posterior wall of the 12th duodenum - YES - +3 points

Forrest 2A - +2 points

Sum: 1+1+2+4+4+2+3+2=19 points

The patient was predicted to have a high risk of recurrent bleeding from a chronic duodenal ulcer. As in the first example, the patient was shown urgent surgical treatment, without waiting for the recurrence of bleeding.

Example 3

Patient S., aged 51, was admitted to the emergency department with a clinic of gastroduodenal bleeding with complaints of coffee grounds vomiting, tarry stools, and weakness. Sick for about 12 hours. Upon admission - a state of moderate severity, blood pressure - 100/70 mm Hg, heart rate - 96 per minute, shock index - 0.9. According to the results of laboratory studies - the number of red blood cells - 3.3 * 10 ¹² , hemoglobin - 117 g / l, platelets - 210 * 10 ⁹ , urea - 9.0 mmol / l, total protein - 63 g / l, APTT - 43 s .

Performed emergency gastroscopy - revealed an acute ulcer of the anterior wall of the body of the stomach, with signs of stopped bleeding with the presence of a stump of a thrombosed vessel at the bottom of the ulcer - Forrest 2A.

For the analysis of this clinical case, a scoring of the following criteria was made:

Shock index >1.0 - NO - 0 points

Erythrocytes <3.0*10 ¹² - NO - 0 points

Platelets <150*10 ⁹ - NO - 0 points

Total protein <58 g/l - NO - 0 points

Urea >8 mmol/l - YES - 4 points

APTT >40 s - YES - 2 points

Localization of the ulcer along the lesser curvature of the stomach or the posterior wall of the duodenum - NO - 0 points

Forrest 2A - YES - 2 points

Amount: 8 points

The patient was predicted to have a low risk of rebleeding from the ulcer. The patient is admitted to the surgical department, where conservative therapy is carried out. There is no recurrence of bleeding during the treatment period. The patient was discharged with improvement on the 5th day of treatment.

Example 4

Patient D., 57 years old, was admitted to the emergency department with a clinic of gastroduodenal bleeding with complaints of coffee grounds vomiting, tarry stools. Sick for about 12 hours.

Upon admission - a state of moderate severity, pallor of the skin, blood pressure - 120/70 mm Hg, heart rate - 88 per minute, shock index - 0.7. According to the results of laboratory studies - the number of red blood cells - 3.1 * 10 ¹² , platelets - 245 * 10 ⁹ hemoglobin - 98 g / l, urea - 7.2 mmol / l, total protein - 60 g / l, APTT - 30 s.

Performed emergency gastroscopy - revealed a chronic ulcer of the antrum of the stomach, with signs of stopped bleeding with the presence of hematin at the bottom of the ulcer - Forrest 2C.

For the analysis of this clinical case, a scoring of the following criteria was made:

Shock index >1.0 - NO - 0 points

Erythrocytes <3.0* 10 ¹² - NO - 0 points

Platelets <150*10 ⁹ - NO - 0 points

Total protein <58 g/l - NO - 0 points

Urea >8 mmol/l - NO - 0 points

APTT >40 s - NO - 0 points

Localization of the ulcer along the lesser curvature of the stomach or the posterior wall of the duodenum - NO - 0 points

Forrest 2C - YES - minus 3 points

Amount: - 3 points

The patient was predicted to have a low risk of rebleeding from the ulcer. The patient is admitted to the surgical department, where conservative therapy is carried out. There is no recurrence of bleeding during the treatment period. The patient was discharged with improvement on the 7th day of treatment.

To adequately assess the effectiveness of the proposed method, a prospective study was conducted, which included 100 patients with ulcerative bleeding. As a result of the application of the proposed method, 64 patients had a low risk of recurrent bleeding. Relapse occurred in only 1 patient. In 36 patients, a high risk of recurrent bleeding was predicted. Of these, 25 patients had rebleeding, 11 did not. The sensitivity of the proposed method was 96.2%, the predictive value of a negative result was 98.44%. The specificity was 85.1%. In the same group, the patient was predicted the recurrence of bleeding using the method of the prototype. A low risk of rebleeding was predicted in 61 patients - of these, 4 relapsed and the remaining 57 did not. In 39 patients, a high risk of rebleeding was predicted - of these, 24 relapsed, and the remaining 15 did not. Thus, the sensitivity of the prototype method was 85.7%, the specificity was 79.2%. Thus, it was possible to improve the quality of the forecast, the sensitivity increased from 85.7% to 96.2%, the specificity from 79.2% to 85.1%.

The proposed method is feasible and reproducible in any hospital and does not require special expensive equipment. There are no criteria in the method that can be affected by the subjective assessment of an individual specialist. The advantage of the developed method is that it can be used for both chronic and acute ulcers. Also, the method is not overloaded with a large number of criteria, and a complex multi-stage counting system, assuming only a binary answer (yes or no). The proposed prediction method is recommended for use in clinical practice.

Claims (1)

A method for predicting the risk of recurrent ulcer bleeding, including determining the shock index (SHI), the number of erythrocytes, total protein, urea, localization of the ulcer and the type of hemostasis according to Forrest, scoring each symptom, namely: SHI 1.0 or more is evaluated as 1 point , the number of erythrocytes less than 3.0*10 ¹² is estimated as 1 point; a total protein of 58 g/l or less is scored as 4 points; urea more than 8 mmol/l is estimated as 4 points; localization of the ulcer along the lesser curvature of the stomach is estimated as 2 points, localization along the posterior wall of the duodenal bulb - as 3 points; the condition of the bottom of the ulcer Forrest 2A is evaluated as 2 points, the condition of the bottom of the ulcer Forrest 2C or 3 - as minus 3 points; summation of points, characterized in that the number of platelets and activated partial thromboplastin time (APTT) are additionally determined, and the number of platelets less than 150*10 ⁹ is estimated as 2 points; APTT of 40 seconds or more is estimated as 2 points, after which, with a sum of 9 to 19 points, a high risk of recurrent bleeding is predicted; with a sum of -3 to 8 points, a low risk of recurrent bleeding is predicted.