RU2755389C1 - Method for choosing a medical aid in patients with extrauterine pregnancy - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to gynecology, operative gynecology, obstetrics. Before treatment, the patient is determined: age (A), the number of previous pregnancies (P), the presence of extrauterine pregnancies in the anamnesis (EP), the presence of adhesions in the small pelvis (AD), the level of the β-subunit of human chorionic gonadotoropin in the blood serum (β- HCG), the sides of the indication according to the ultrasound scanning of the pelvic organs (S), the presence/absence of symptoms of acute abdomen (AA). Then, the prognostic coefficients of the effectiveness of the treatment of extrauterine pregnancy are calculated according to the stated formulas: treatment with methotrexate (PCE₁), salpingectomy (PCE₂) and salmingotomy (PCE₃). The values ​​of the predictive coefficients are compared. And if PCE₁ is simultaneously greater than PCE₂ and PCE₃, then methotrexate treatment is chosen. If PCE₂ is simultaneously greater than PCE₁ and PCE₃, then salpingectomy is performed. If PCE₃ is simultaneously greater than PCE₁ and PCE₂, then salpingotomy is performed.

EFFECT: invention provides a simplification and increased objectification of the choice of medical benefits in patients with an extrauterine pregnancy between salpingotomy, salpingectomy and treatment with methotrexate by assessing the complex of the most significant data.

1 cl, 1 tbl, 3 ex

Description

The invention relates to medicine, namely to gynecology, operative gynecology, obstetrics.

A known method for determining the effectiveness of a conservative method for the treatment of ectopic pregnancy (Fernandez N., Lelaidier C, Thouvenez V., Frydman R. The use of a pretherapeutic, predictive score to determine inclusion criteria for the non-surgical management of ectopic pregnancy // Human Reproduction - 1991. - Vol. 6, No. 7. - P. 995-998), based on the patient's consideration of the following parameters: gestational age, β-hCG level, progesterone level, intensity of abdominal pain, hematoperitoneum volume, hematosalpinx diameter. With a score of less than 12, a conservative treatment success of more than 80% is predicted.

There is a known method for predicting success when using a single dose of methotrexate (Elito J. Jr., Reichmann AP, Uchiyama MN, Camano L. Predictive score for the systemic treatment of unruptured ectopic pregnancy with a single dose of methotrexate // International Journal of Gynecology and Obstetrics . - 1999. - Vol. 67, No. 2. - P. 75-79), in which the authors developed a scale based on the determination of the level of β-hCG, ultrasound data, the size of the ectopic pregnancy and the data of color Doppler scanning. In a small study (40 patients), patients who scored more than 5 points successfully responded to therapy in 97% of cases.

There is a method of differentiated organ-preserving treatment of progressive tubal pregnancy in the interstitial section of the fallopian tube (analogue), depending on the data of complex ultrasound and the level of human chorionic gonadotropin in the patient's plasma (options) (Patent for invention of the Russian Federation No. 2643108). This method presents options for using a combination of methotrexate with bilateral embolization of the uterine arteries in the localization of an ectopic pregnancy in the interstitial section of the fallopian tube.

The known method of differentiated organ-preserving treatment of cervical pregnancy and pregnancy in the uterine scar after cesarean section (analogue), depending on the data of complex ultrasound and the level of human chorionic gonadotropin in the patient's plasma (Patent for the invention of the Russian Federation No. 2640191). This method presents options for using a combination of methotrexate with bilateral embolization of the uterine arteries in the localization of ectopic pregnancy in the cervix and uterine scar after cesarean section.

The purpose of the proposed method is to simplify and increase the objectification of the choice of medical benefits in patients with ectopic pregnancy between salpingotomy, salpingectomy and treatment with methotrexate.

This goal is achieved by the fact that the patient before treatment determines the following data: age (TCD), the number of previous pregnancies (B), the presence of ectopic pregnancies in the anamnesis (VL), the presence of an adhesive process in the small pelvis (SP), additionally take into account the data of biochemical analysis blood levels of the β-subunit of human chorionic gonadotoropin in blood serum (β-hCG), the side of the indication according to ultrasound scanning of the pelvic organs (HF), the presence / absence of symptoms of acute abdomen (OB). And then, using these data, the predictive coefficients of the effectiveness of different methods of treating ectopic pregnancy are calculated: treatment with methotrexate (GTCEO, salpingectomy (SCE ₁ ) and salmingotomy (SCE ₃ ), as the values of the discrimination equation according to the formulas:

TCD - age: years;

β-hCG - the level of β-subunit of human chorionic gonadotropin in blood serum: IU / l;

B - a history of pregnancy: 101 - absence, 102-1 pregnancy, 103-2 pregnancies, 104-3 pregnancies, 105 - 4 or more pregnancies;

VB - a history of ectopic pregnancies: 101-absence, 102-1 pregnancy, 103-2 pregnancies, 104-3 pregnancies, 105-4 or more pregnancies;

СН - nidation side: 101 - left side, 102 - right side;

SP - adhesion process of the small pelvis: 101 - absence, 102 - presence;

OJ - signs of an acute abdomen: 101 - absence, 102 - presence;

KOH ₁ = 272.3; KOH ₂ = 351.75; KOH ₃ = 367.62.

After that, the values of the prognostic coefficients are compared: PCE ₁ , PCE ₂ and PCE ₃ . And if PCE _{1 is} simultaneously greater than PCE ₂ and PCE ₃ , then treatment with methotrexate is chosen; if PCE _{2 is} simultaneously greater than PCE ₁ and PCE ₃ , then salpingectomy is performed; and if SCE _{3 is} simultaneously greater than SCE ₁ and SCE ₂ , then salpingotomy is performed.

The novelty of the proposed solution lies in the fact that for the first time in patients with an ectopic pregnancy, the choice of a medical aid is carried out using prognostic coefficients, determined taking into account clinical and laboratory, instrumental, physical and anamnestic data.

Technical solutions having features that coincide with the distinctive features of the proposed method have not been identified, which allows us to conclude that the proposed method meets the criterion of "inventive step".

In the process of developing the method, examination and treatment of 548 patients with ectopic pregnancy, who are under examination and treatment in the gynecological department, were carried out. Of these, 363 patients were operated on by laparoscopic salpingectomy, 145 laparoscopic salpingotomy, 40 were treated with methotrexate. The examination included obtaining anamnestic, physical, instrumental and laboratory data of the patient.

The data were processed using the statistical software package STATISTIC A (Data analysis software system, StatSoft, Inc. 2014) version 10.0. Discriminant analysis was used. The most significant parameters for assessing the state were identified, discriminating the sample into groups and allowing to identify criteria for the effectiveness of laparoscopic salpingectomy, salpingotomy and treatment of ectopic pregnancy with methotrexate. Discriminant analysis data for significant physical and laboratory data are shown in Table 1.

The proposed method for choosing a medical aid for patients with an ectopic pregnancy is as follows:

The following parameters are determined at the patient's admission: age (TCD) in years and the level of β-subunit of human chorionic gonadotropin (β-hCG) in blood serum in IU / L; in the history: the number of previous pregnancies (B), the presence of ectopic pregnancies (EW) and adhesions in the small pelvis (SP); side of nidation (HF), symptoms of acute abdomen (OJ).

At the same time, if it is revealed that the patient did not have any pregnancies in the anamnesis (B), then the value "101" is assigned; if there was 1 pregnancy - value "102"; if 2 - "103"; if 3 - "104"; if there are 4 or more pregnancies - "105".

When determining a history of ectopic pregnancies (EW), the following values are assigned: "101" - in the absence of an ectopic pregnancy; "102" - if there was 1 ectopic pregnancy; "103" - 2; "104" - 3; "105" - if 4 or more ectopic pregnancies in history.

If a patient has an adhesion process in the small pelvis (SP), the value "102" is assigned, and in its absence - "101".

If it is determined that the nidation (CH) has occurred from the left side, then the value "101" is assigned; and on the right - "102".

If there are no symptoms of acute abdomen (OJ), then assign the value "101", and if there are - "102".

Then the predictive efficiency coefficient is calculated for each medical benefit as the value of the discrimination equation according to the formulas:

- for treatment with methotrexate (SCE ₁ ):

- for salpingectomy (PCE ₂ ):

- for salmingotomy (PCE ₃ ):

where:

TCD - age: years;

β-hCG - the level of β-subunit of human chorionic gonadotropin in blood serum: IU / l;

B - a history of pregnancies: 101 - absence, 102 - 1 pregnancy, 103 - 2 pregnancies, 104 - 3 pregnancies, 105 - 4 or more pregnancies;

WB - history of ectopic pregnancies: 101 - absence, 102 - 1 pregnancy, 103 - 2 pregnancies, 104 - 3 pregnancies, 105 - 4 or more pregnancies;

СН - nidation side: 101 - left side, 102 - right side;

SP - adhesion process of the small pelvis: 101 - absence, 102 - presence;

OJ - signs of an acute abdomen: 101 - absence, 102 - presence;

KOH ₁ = 272.3; KOH ₂ = 351.75; KOH ₃ = 367.62.

By solving these equations for each medical aid, the corresponding value is obtained.

Then, the values of the prognostic coefficients are compared: PKE ₁ PKE ₂ and PKE ₃ . And if PCE _{1 is} simultaneously greater than PCE ₂ and PCE ₃ , then treatment with methotrexate is chosen; if PCE _{2 is} simultaneously greater than PCE ₁ and PCE ₃ , then treatment with salpingectomy is chosen; and if PCE _{3 is} simultaneously greater than PCE ₁ and PCE ₂ , then salpingotomy treatment is chosen.

The proposed method for choosing a medical aid in patients with an ectopic pregnancy is illustrated by the following examples of its clinical use.

Example 1. Patient M., 28 years old, case history No. 11775, was admitted to the gynecological department of the GBUZ YaO OPTs in the direction of an outpatient doctor with suspected ectopic pregnancy. On admission, she complained of periodic pulling pains in the lower abdomen, more in the left iliac region, smearing bleeding from the genital tract against the background of delayed menstruation for 11 days. Considers herself pregnant, urine test for pregnancy is positive. I went to a gynecologist at a private medical center with complaints of bloody discharge from the genital tract. Ultrasonography of the pelvic organs was performed, according to which, a progressive left-sided tubal pregnancy with cardiac activity of the embryo. The patient was referred for inpatient treatment. Anamnesis: pregnancy 2, real; there were no gynecological diseases. The somatic history is not burdened. Upon admission, the condition is satisfactory, the skin is pink, visible mucous membranes are clean. BP 120/70 mm. Hg, PS 64 per minute, rhythmic, NPV 20 per minute, T 36.7 ° C. The abdomen on palpation is soft, painless, symptoms of peritoneal irritation are negative. Urination is not disturbed, the stool was a day ago, decorated. Discharge from the genital tract is dark bloody, insignificant. Special examination: the external genital organs are developed correctly, hair growth is female. Examination in the mirrors: the vaginal part of the cervix is cylindrical, the mucous membrane is cyanotic, the external os of the cervical canal is slit-like, the discharge from the canal is dark bloody, insignificant. Bimanual: the body of the uterus is not enlarged, in the correct position, soft consistency, mobile, painless on palpation. The appendages on both sides are not determined, on the left, on palpation in the area of the appendages, there is slight soreness. Vaginal vaults do not overhang. A preliminary diagnosis was made: left-sided tubal pregnancy. According to the clinical management protocol, an ultrasound scan of the pelvic organs was performed, in which there is no data for a uterine pregnancy, a fetal egg with cardiac activity in the projection of the left fallopian tube is determined. A general, biochemical blood test was prescribed with the study of the β-subunit of hCG in the blood serum, the level of which was 1200 IU / L. Considering the presence of signs of progressive left-sided tubal pregnancy, confirmed by ultrasound examination of the pelvic organs and the result of a blood test for β-hCG, diagnostic laparoscopy is indicated for the patient. Three discriminant equations were solved to determine the prognostic coefficient:

As a result of solving 3 equations, the maximum value in the third equation was obtained, which means that for this patient, laparoscopic salpingotomy should be the optimal method of treatment. A diagnostic laparoscopy was performed, a left-sided tubal pregnancy was found in the ampullar section of the fallopian tube, in the abdominal cavity about 40 ml of liquid blood. A salpingotomy was performed, the ectopic pregnancy was removed, hemostasis was sufficient, the fallopian tube was preserved. The postoperative period was uneventful. A control blood test for β-hCG was performed on the 4th day; the level dropped to 38 IU / L. The patient was discharged in satisfactory condition under the supervision of a doctor at the Women's Consultation with a recommendation to control the level of β-hCG every 7 days up to 2 negative values.

Example 2. Patient O., 27 years old, case history No. 10660, was delivered by an SME to the gynecological department of the GBUZ YaO OPC with complaints of acute pain in the lower abdomen, more on the right, appearing within 1 hour, delayed menstruation 12 days, dark bloody discharge from the genital tract. From the anamnesis: considers herself pregnant, pregnancy test is positive, did not plan pregnancy. Special medical history: pregnancies were 2, childbirth - 1, abortion - 1. There were no gynecological diseases. The somatic history is not burdened. Upon admission: the condition of moderate severity, the skin is pale, the visible mucous membranes are clean. BP 107/59 mm. Hg, PS 91 per minute, tense, NPV 23 per minute, T 36.9 ° C. The abdomen is somewhat distended, tense, on palpation, positive symptoms of irritation of the peritoneum in the lower sections, more in the right iliac region, are determined. Urination is not disturbed, the stool was in the morning, shaped. With a special examination: the external genital organs are developed correctly, hair growth is female. Examination in the mirrors is painful, the vaginal part of the cervix is cylindrical, the mucous membrane of the vagina and cervix is cyanotic, the external os of the cervical canal is slit-like, discharge from the cervical canal is dark bloody, insignificant. Bimanual: palpation is difficult due to pain in the posterior vaginal fornix. The posterior fornix overhangs, sharply painful on palpation. The uterus and appendages are not clearly defined. A preliminary diagnosis was made: impaired right-sided ectopic pregnancy. Performed according to the clinical protocol, ultrasound scanning of the pelvic organs with transvaginal and transabdominal transducers, complete blood count, biochemical blood test with the study of blood serum for the β-subunit of hCG. According to the ultrasound scan of the pelvic organs, a disturbed right-sided tubal pregnancy, in the posterior space of about 300 ml of fluid (blood), in the lateral pockets of the abdominal cavity and subphrenic space — the presence of fluid (blood). According to the study of blood serum for the β-subunit of hCG-2300 IU / l. The patient underwent emergency surgery. According to generally accepted clinical guidelines, the patient was shown diagnostic laparoscopy. Three discriminant equations were solved to determine the prognostic coefficient:

As a result of solving 3 equations, the maximum value in the second equation was obtained, which means that for this patient, laparoscopic salpingectomy should be the optimal method of treatment. Diagnostic laparoscopy was performed, about 400 ml of liquid blood and clots were found in the abdominal cavity. The right fallopian tube is cyanotic, sharply thickened in the ampulla, with a rupture area and bleeding. A salpingectomy was performed. In the postoperative period, anemia of mild severity (Hb 101 g / l) was revealed; antianemic therapy with iron preparations was prescribed. She was discharged on the 4th day after the operation in satisfactory condition under the supervision of the Women's Consultation.

Example 3. Patient Ch., 36 years old, case history No. 10426, turned to the emergency room of the gynecological department of the GBUZ YaO OPC with complaints of spotting spotting from the genital tract against the background of delayed menstruation for 9 days. From the anamnesis: considers herself pregnant, urine pregnancy test positive, desired pregnancy. Special history: pregnancy 1, real. The gynecological history is not burdened. The somatic history is burdened with appendectomy by laparotomic access 2 years ago. Upon admission: the condition is satisfactory, the skin is clean, pink. HELL 115/65 mm. Hg, PS 62 per minute, rhythmic, T 37 ° C, NPV 18 per minute. The abdomen is not distended, soft, painless on palpation, symptoms of peritoneal irritation are negative. Urination was not disturbed, the stool was shaped. Special examination: the external genital organs are developed correctly, hair growth is female. Examination in the mirrors: the mucous membrane of the vagina and the vaginal part of the cervix is cyanotic, the vaginal part of the cervix is conical, the discharge from the cervical canal is bloody, insignificant. Bimanual: the body of the uterus is in the correct position, slightly enlarged, soft, mobile, painless on palpation. On the right, the appendages are not defined, the area above them is painless. On the left, in the area of the appendages, pastiness is determined, on palpation, slight pain is determined. The posterior fornix does not overhang, its palpation is painless. A preliminary diagnosis has been made: short term pregnancy, miscarriage that has begun; suspicion of an ectopic pregnancy. In order to clarify the diagnosis, according to the protocol for the management of patients with suspected ectopic pregnancy, an ultrasound scan of the pelvic organs was performed, a general clinical blood test, a biochemical test with the determination of the level of the β-subunit of hCG in the blood serum. Conclusion of USS: no data for uterine pregnancy were found, signs of left-sided tubal pregnancy. Blood test for β-subunit of hCG-870 IU / l. Given the availability of data for left-sided tubal pregnancy, according to the protocol for the management of an ectopic pregnancy, conservative management with the use of methotrexate is possible. Three discriminant equations were solved to determine the prognostic coefficient:

The patient was treated with methotrexate intravenously at a dose of 50 mg with 200 ml of saline, once. In dynamics, a decrease in the level of β-hCG in blood serum occurred up to the 4th day after administration to 66 IU / L. The patient was discharged in satisfactory condition under the outpatient supervision of an antenatal clinic with a recommendation to control the β-hCG level every 7 days up to 2 negative values corresponding to the absence of pregnancy.

The proposed method is applied in the gynecological department of the State Budgetary Healthcare Institution of YAO "Regional Perinatal Center" to select the most effective medical treatment for patients with ectopic pregnancy.

Claims (13)

The method of choosing a medical aid in patients with an ectopic pregnancy, which consists in taking into account the following data in the patient before treatment: age (TCD), the number of previous pregnancies (B), the presence of ectopic pregnancies in history (VL), the presence of an adhesive process in the small pelvis (SP) , characterized in that they additionally take into account the data of the biochemical blood test on the level of the β-subunit of human chorionic gonadotoropin in the blood serum (β-hCG), the side of nadation according to the ultrasound scanning of the pelvic organs (HF), the presence / absence of symptoms of acute abdomen (OB) , then the prognostic coefficients of efficiency are calculated for different medical aids: treatment with methotrexate (SCE ₁ ), salpingectomy (SCE ₂ ) and salpingotomy (SCE ₃ ), as the values of the discrimination equation according to the formulas: PKE ₁ = (VZR × 5.10) - (β-hCG × 10.77) - (B × 172.75) + (VN × 271.6) - (CH × 1.41) + (SP × 2, 64) - (coolant × 2.25) -KON ₁ PKE ₂ = (VZR × 2.31) - (β-hCG × 5.89) + (B × 186.24) + (VN × 174.69) - (CH × 4.2) + (SP × 4, 99) - (coolant × 4.32) -KON ₂ PKE ₃ = (VZR × 4.47) - (β-hCG × 4.0) + (B × 179.59) + (VN × 196.07) + (CH × 4.5) + (SP × 4, 20) + (coolant × 4.00) -KON ₃ , where TCD - age: years; β-hCG - the level of β-subunit of human chorionic gonadotropin in blood serum: IU / l; B - a history of pregnancies: 101 - absence, 102 - 1 pregnancy, 103 - 2 pregnancies, 104 - 3 pregnancies, 105 - 4 or more pregnancies; WB - history of ectopic pregnancies: 101 - absence, 102 - 1 pregnancy, 103 - 2 pregnancies, 104 - 3 pregnancies, 105 - 4 or more pregnancies; СН - nidation side: 101 - left side, 102 - right side; SP - adhesion process of the small pelvis: 101 - absence, 102 - presence; OJ - signs of an acute abdomen: 101 - absence, 102 - presence; KOH ₁ = 272.3; KOH ₂ = 351.75; KOH ₃ = 367.62; and if PCE _{1 is} simultaneously greater than PCE ₂ and PCE ₃ , then treatment with methotrexate is chosen; if PCE _{2 is} simultaneously greater than PCE ₁ and PCE ₃ , then salpingectomy is performed; and if SCE _{3 is} simultaneously greater than SCE ₁ and SCE ₂ , then salpingotomy is performed.