RU2398535C1 - Method of carrying out endoscopic hemostasis in case of acute gastroduodenal hemorrhage - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to surgery and gastroenterology, and can be used in treatment of patients with acute gastroduodenal hemorrhage. For this purpose fibrogasteroduodenoscopy is performed. Additionally through endoscope canal to source of hemorrhage brought is double-lumen Teflon catheter, through which during 5-7 minutes flow insufflation with ozone-oxygen mixture with concentration 90-100 mg/l and rate of gas flow 250 l/min, is carried out. Excessive waste gas mixture is removed to destructor.

EFFECT: method allows to increase efficiency and safety of endoscopic hemostasis due to ensuring local anti-hypoxia and systemic antioxidant effect with introduction of said mixture in definite mode.

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Description

The invention relates to medicine, can be used in surgery, endoscopy.

Known methods of endoscopic hemostasis, consisting in the infiltration of the submucosal layer with solutions of vasoconstrictor drugs, diathermocoagulation, application of adhesive compositions and clipping of a bleeding vessel in an ulcer (Gralnek IM, Barkun AN, Bardou M. Management of Acute Bleeding from a Peptic Ulcer // N. Engl. J. .Med. - 2008. - Vol. 359. - P.928-937). These methods have several disadvantages. Thus, the infiltration of vasoconstrictor drugs can contribute to the occurrence of local hypoxia, leading to the progression of ulcerogenesis and the development of relapse of bleeding (Thomopoulos K.S., Theocharis GJ, Vagenas K.A., Danikas DD at all. Predictors of hemostatic failure after adrenaline injection in patients with peptic ulcers with nonbleeding visible vessel // Scand. J. Gastroenterol. - 2004. - Vol. - 3 9. - P.600-604). Multipolar diathermocoagulation, being the contact method of hemostasis, has a destructive effect not only on the bleeding vessel, but also on the surrounding tissue of the ulcer defect, which also does not contribute to its healing (Sung JJ, Tsoi K.K., Lai LH, Wu JC, Lau JY Endoscopic clipping versus injection and thermo-coagulation in the treatment of non-variceal upper gastrointestinal bleeding: a meta-analysis // Gut. - 2007. - Vol.56. - P.1364-1373). When using a monopolar probe in the zone of ulcerative thinning of the wall of a hollow organ, there is a threat of its perforation (Skroubis G., Thomopoulos K., Danikas D., Nikolopoulou V., Vagian C. Factors related to failure of endoscopic hemostasis in Forest IIA gastroduodenal bleeding ulcers // Eur. Surg. Res. - 2004 .-- Vol. 36. - P.5).

The use of synthetic adhesive compositions, in particular cyanoacrylates, as a result of their ultrafast and strong polymerization often destroys expensive endoscopic equipment. In addition, the application of cyanoacrylates to biological tissue leads to the formation of pronounced infiltrate, which significantly complicates or complicates the implementation of surgical intervention. The widespread use of biocomposite drugs, in particular fibrin glue, is hindered by its high cost and the risk of transmission of infection pathogens (Musinov I.M., Stoyko Yu.M. Role of endoscopic hemostasis in the treatment of patients with gastroduodenal ulcer bleeding // Actual issues of thoracic, cardiovascular and abdominal surgery: Sat. thesis. academic and practical conference dedicated to the 100th anniversary of the Department of Surgery at St. Petersburg State Medical University named after Academician I.P. Pavlov. - St. Petersburg. - 2001. - P.150) .

Clipping is only possible with clear visualization of a bleeding vessel in an ulcer and is ineffective for stopping erosive bleeding, requires expensive supplies (Marmo R, Rotondano G, Piscopo R, Bianco MA at all. Dual therapy versus monotherapy in the endoscopic treatment of high-risk bleeding ulcers : a meta-analysis of controlled trials // Am. J. Gastroenterol. - 2007. - Vol. 102. - P.279-289). A common drawback of the methods used is the relatively high frequency of bleeding relapse (12-40%) due to separation of a blood clot after an endoscopic stop (Jensen DM, Kovacs T.O., Jutabha R., et all. Randomized trial of medical or endoscopic therapy to prevent recurrent ulcer hemorrhage in patients with adherent clots // Gastroenterology. - 2002. - Vol.123. - P.407-413). In this case, postoperative mortality in conditions of repeated hemorrhage reaches 30-75% (Ermolov A.S., Tveritneva L.F., Uteshev N.S. et al. Analysis of the results of treatment of gastric ulcer and duodenal ulcer complicated by bleeding // Materials of the All-Russian scientific conference of general surgeons, combined with the plenum of the problem commissions RAMS "Emergency surgery" and "Infection in surgery" of the Interdepartmental Scientific Council for Surgery. - Rostov-on-Don, 2008. - P.46-48).

One of the most effective methods of endoscopic hemostasis today is argon plasma coagulation (Mashkin M.A., Khoyrysh A.A., Efanov A.V. et al. Effectiveness of argon plasma coagulation in the treatment of acute gastroduodenal bleeding // Gastroenterology. - 2004. - No. 4. - P.57; GVStiegmann Endoscopic Approaches to Upper Gastrointestinal Bleeding // The American Surgeon. - 2006. - Vol. 72. - P.11-115). The main advantages of the method are non-contact, a lower level of local hypoxia, achieved due to the affinity of argon plasma for zones of high electrical conductivity (liquid blood and fresh blood clots), minimal damage to surrounding tissues, less chance of perforation of the organ wall. The disadvantages of the argon plasma coagulation method are: stretching of the walls of the organ when applying argon, the possibility of emphysema at the point of contact of the probe with the tissue, the possibility of interference on the monitor screen (Kuzmin-Krutetskiy M.I., Artemov V.V., Styazhkin E.N. Application analysis the first domestic argon plasma coagulator in the treatment of gastrointestinal bleeding // Materials of the scientific-practical conference “Actual issues of emergency endoscopy.” - St. Petersburg, 2001). An absolute contraindication to the use of argon plasma coagulation in case of ulcerative bleeding is the presence of an implanted heart rate driver (Efanov A.V. Efficiency of endoscopic argon plasma coagulation in the treatment of ulcerative gastroduodenal bleeding // Abstract of dissertation for the degree of candidate of medical science - Tyumen. 2006. - 24 p.) The limitation to the widespread use of argon plasma coagulation is the high cost of the equipment.

Currently, in the literature there is information about the local hemostatic effect of the use of the ozone-oxygen mixture. There is a method of correcting indicators of the hemostatic system, which involves the use of low doses of ozone to obtain a hypocoagulation effect and high ones to activate hemostasis (Okrut I.E., Kontorshchikova K.N., Maslennikov O.V., Pavlovskaya E.E. RF patent № 2166949, A61K 33/00, A61K 33/14, A61P 7/02, publ. 05.20.2001). The method provides for the possibility of external hemostasis in surgical patients with an open wound due to its chipping and aeration with an ozone-oxygen mixture with an ozone concentration of 3500-5000 μg / l, allowing to halve the duration of bleeding.

Along with hemostatic ozone, it also has anti-inflammatory effects (G. Valacchi, V. Bocci Studies on the biological effects of ozone: 10. Release of factors from ozonated human platelets // Mediators of Inflammation. - 1999. - Vol.8. - P.205 -209), improves trophic processes, and also exhibits an eradication effect against Helicobacter pylory (Gulman MI, Vinnik Yu.S., Miller SV, Yakimov SV and others. Correction of homeostasis in acute pancreatitis by the method ozone therapy. - Krasnoyarsk: Znak, 2003. - 178 p.).

A known method of enteral use of medical ozone, including the introduction of ozonized physiological solution into the lumen of the small intestine through a nasointestinal probe, rectal insufflation of the ozone-oxygen mixture to decontaminate the gastrointestinal tract (Vinnik Yu.S., Peryanova O.V., Yakimov S.V., Anishina OV The method of decontamination of the gastrointestinal tract using ozone in patients with pancreatic necrosis (RF Patent No. 2194513, A61K 33/00, 33/14; A61P 31/00, published on December 20, 2002).

Closest to the proposed invention by the mechanism of exposure is a method for the prevention and treatment of stress damage to the gastrointestinal tract in critically ill patients (RF Patent No. 2290913, A61H 7/00, A61K 33/00, A61P 1/04, publ. 10.01. 2007), which consists in the sequential enteral use of ozonized saline, rectal insufflation of the ozone-oxygen mixture, as well as parenteral, subcutaneous administration of ozone and application of ozonized oil. This method allows to reduce the frequency of development of stressful ulcers of the gastrointestinal tract in patients in critical conditions due to the elimination of tissue hypoxia, but does not suggest the possibility of stopping bleeding due to the use of low concentrations of ozone.

The objective of the invention is to increase the efficiency and safety of endoscopic hemostasis, reduce the frequency of recurrence of bleeding, simplify the procedure, reduce material costs for the treatment of patients.

The problem is solved due to the fact that in addition to the bleeding source, a two-lumen fluoroplastic catheter is carried out for 5-7 minutes, flow insufflation of the ozone-oxygen mixture with a concentration of 90-100 mg / l and a gas flow rate of 250 l / min, the excess exhaust gas mixture is taken into destructor.

The method is as follows: for patients with a clinical picture of acute gastroduodenal bleeding after gastric lavage, fibrogastroduodenoscopy is performed and, if there are signs of ongoing bleeding (Forrest IB) or unstable hemostasis (Forrest IIA-C), a double-lumen fluoroplastic catheter is additionally fed to the bleeding source through the working channel of the endoscope which for 5-7 minutes carry out flow insufflation of an ozone-oxygen mixture with a concentration of 90-100 mg / l and a gas flow rate of 250 l / mi , The excess waste gas mixture is withdrawn in a destructor. To obtain the ozone-oxygen gas mixture, the UOTA 60-01 ozone generator (Medozon, Moscow) is used. The condition of patients is monitored dynamically with fibrogastroduodenoscopy performed on days 2, 5, 7 after admission and an assessment of the free radical oxidation rate (by the method of iron-induced luminol-dependent chemiluminescence of blood serum) on days 1, 3, 5, 7 after the start of ozone therapy.

Among the examined were persons of both sexes aged 23 to 68 years. The first group (n = 23) included patients undergoing treatment for ulcerative gastroduodenal bleeding who underwent endoscopic ozone hemostasis. The second group (n = 25) consisted of patients who used injection and application methods for endoscopic hemostasis: infiltration under the mucous layer with 0.1% adrenaline hydrochloride solution and / or applying HemoCompact hemostatic glue.

In each group, men made up three quarters. Statistical analysis did not reveal significant differences in the demographic composition of the groups (Table 1).

Tab. one Distribution of patients by gender and age Group The first (n = 23), abs. /% The second (n = 25), abs. /% Floor Male 17 / 73.9% 18/72% Female 6 / 26.1% 7/28% Age 23-30 years 3/13% 5/20% 31-40 years old 3/13% 5/20% 41-50 years old 6/26% 7/28% 51-60 years old 7 / 30.4% 5/20% 61-68 years old 4 / 17.4% 3/12%

Analysis of the distribution of patients according to the location of the source of bleeding also did not reveal significant differences between the groups. In both groups, the most common source of bleeding was duodenal ulcers (Table 2).

A comparative analysis of the time from the onset of bleeding to the time of hospitalization, as well as the state of hemostasis upon admission, did not show significantly significant differences. So, the average time from the manifestation of bleeding to the moment of admission to the hospital in patients of the first group was 52.0 ± 4.1 hours, in patients of the second group - 49.9 ± 5.3 hours (p> 0.05).

During the initial endoscopic examination, signs of ongoing bleeding (Forrest IB) were found in 6 patients of the first group (26.1%) and 5 patients of the second group (20%) (p> 0.05). Unstable hemostasis (Forrest IIA - Forrest IIC) was detected in 17 patients of the first group (73.9%) and 20 patients of the second group (80%) (p> 0.05).

Tab. 2. Distribution of patients by localization of the source of bleeding Source of bleeding The first group, abs. /% The second group, abs. /% Duodenal ulcer 15 / 65.2% 18/76% Stomach ulcer 7 / 30.4% 6/24% The combination of stomach ulcers and duodenum 1 / 4.3% TOTAL 23/100% 25/100%

All patients included in the study underwent a complex of intensive hemostatic and antiulcer therapy, including intravenous infusion of 5% aminocaproic acid, histamine H ₂ receptor blockers, proton pump inhibitors and eradication therapy, correction of water-electrolyte balance, and, according to indications, replacement transfusion of donor components blood.

In the second group, despite the use of injection and application hemostasis and their combination, the implementation of a complex of intensive conservative measures, five patients had indications for surgical treatment. Indications for surgery were: continuing bleeding in one (4%), relapse of bleeding in two (8%), high risk of relapse of bleeding in two more patients (8%). Surgical activity was 20%.

The volume of the operation was selected individually; in the absence of contraindications, they sought to perform an organ resection as a more radical and reliable intervention. In the first 48 hours from admission, three patients (60%) were operated on due to ongoing bleeding or due to a high risk of relapse. Two more patients (40%) were operated on in a delayed order (for 3-7 days) in connection with a relapse of bleeding. In the postoperative period, two patients died (postoperative mortality was 40%).

Using medical ozone, the final primary hemostasis was achieved in 21 patients (91.3%). During a dynamic endoscopic examination on days 2, 5, and 7, there were no signs of ongoing bleeding and the threat of its relapse.

The results of luminol-dependent iron-induced chemiluminescence of blood serum indicate a systemic antioxidant effect of enteric ozone therapy (Table 3). Upon admission to the hospital, the maximum amplitude of the activated glow and the coefficient of antioxidant activity of blood serum did not have significant differences in the groups. In patients of the second group, despite carrying out a complex of intensive measures and endoscopic hemostasis, comparatively high rates of chemiluminescence intensity were observed during the entire observation period, indicating a high activity of free radical oxidation.

In patients of the first group, the endoscopic use of medical ozone was accompanied by a systemic effect: the coefficient of antioxidant activity of blood serum by the end of the first week in the hospital was two times higher than normal, thereby compensating for the persistent hyperproduction of reactive oxygen species

Tab. 3 Chemiluminescent parameters of serum peroxidative homeostasis in patients with acute gastroduodenal ulcer bleeding Study time, days Serum chemiluminescence parameter (multiplicity to the age norm value) The maximum amplitude of chemiluminescence Antioxidant activity coefficient First group Second group P1 First group Second group P2 one 3.24 ± 0.3 * 3.21 ± 0.3 * > 0.05 1.57 ± 0.1 * 1.62 ± 0.1 * > 0.05 3 2.87 ± 0.4 * 3.56 ± 0.3 * <0.05 1.75 ± 0.2 * 1.84 ± 0.2 * > 0.05 5 2.13 ± 0.3 * 2.95 ± 0.3 * <0.05 1.94 ± 0.2 * 1.52 ± 0.1 * <0.05 7 1.93 ± 0.2 * 2.81 ± 0.2 * <0.05 2.17 ± 0.2 * 1.58 ± 0.2 * <0.05 Note: * - significance of differences compared with normal values at P <0.05, p1 - significance of differences in I max values in patients of the first and second groups, p2 - significance of differences in K values in patients of the first and second groups

In two patients (8.7%) of the first group, the continuing high risk of repeated bleeding due to insufflation of the ozone-oxygen mixture required urgent surgery (Table 4). There were no emergency operations in the group. Surgical activity for ulcerative gastroduodenal bleeding in the group was 8.7%. There were no complications in the postoperative period; there were no fatal outcomes.

Table 4 The results of treatment of patients with acute gastroduodenal ulcer bleeding Result, abs. number of patients /% The first group (N = 23) The second group (N = 25) Achieved persistent hemostasis 21 / 91.3% * 20/80% Ongoing bleeding 0 fourteen%) Relapse developed on the 2-7th day 0 2 (8%) Predicted relapse 2 (8.7%) 2 (8%) Operational activity 2 (8.7%) * 5 (20%) Postoperative mortality (abs /% of the operated) 0 2 (40%) Inpatient Duration 10.3 ± 0.3 fps * 16.6 ± 0.4 fps Note: * - significance of differences compared with the comparison group at P <0.05

Thus, the use of medical ozone made it possible to increase the efficiency of endoscopic hemostasis from 80% to 91.3%, reduce the frequency of completed and predicted relapses from 16% to 8.7%, and reduce surgical activity from 20 to 8.7%. The duration of patients in the surgical hospital decreased from 16.6 ± 0.4 in the second to 10.3 ± 0.3 days in the first group (p <0.05). This happened due to a reduction in the number of patients operated on, as well as a decrease in the frequency and number of relapses of bleeding, which made it possible to arrange discharge to the outpatient stage of treatment at an earlier date.

We conducted a comparative assessment of material costs for the treatment of patients of the first and second groups. For this purpose, the difference in the actual costs of treatment and the analysis of the prevented losses for surgical treatment were taken into account.

The total economic effect was calculated using the following formula:

Δhir. q / d × price 1 q / d. + (Δchir. Activity × cost of operation) / 100;

where Δ f / d - the difference in the length of stay in the surgical hospital (6.3 f / d); Δhir. activity - the difference in operational activity (11.3%); the price of 1 c / d is 686 rubles, the average cost of one operation is 3117 rubles.

Cost reduction per patient of the first group amounted to 4681.0 rubles. For 23 treated with the use of medical ozone, savings amounted to 107,663.2 rubles, which offset the cost of acquiring an ozone therapy unit.

The achieved positive effect can be explained by the antihypoxic, antioxidant and eradication mechanisms of exposure to medical ozone.

Thus, the advantages of the proposed method are high efficiency and safety, reducing the frequency of recurrence of bleeding, technical simplicity, significant economic effect.

Claims (1)

A method for carrying out endoscopic hemostasis in acute gastroduodenal bleeding, including performing fibrogastroduodenoscopy, characterized in that in addition to the bleeding source, a double-lumen fluoroplastic catheter is carried out for 5-7 minutes, flow-through insufflation of an ozone-oxygen mixture with a concentration of 90-100 mg / l and a gas flow rate of 250 l / min, excess exhaust gas mixture is diverted to the destructor.