Application of aspirin in treatment of uterine leiomyoma degeneration during pregnancy
By using low-dose aspirin during pregnancy, the problems of effective analgesia and etiological treatment of uterine fibroid degeneration pain during pregnancy have been solved, achieving safe and long-term pain relief and fibroid growth control, and reducing the risks of surgical treatment and hospitalization rates.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- MATERNAL & CHILD HEALTH HOSPITAL OF HUBEI PROVINCE
- Filing Date
- 2026-07-02
- Publication Date
- 2026-08-04
AI Technical Summary
Currently, there is a lack of effective analgesics that can be safely and long-term without being limited by gestational age to treat pain caused by uterine fibroid degeneration during pregnancy. Traditional drugs have side effects on both mother and child and have limited therapeutic effects.
Low-dose aspirin (preferably 100 mg/day) is used to treat or prevent uterine fibroid degeneration during pregnancy. It is administered orally to relieve pain, improve blood perfusion, inhibit fibroid growth, and reduce red degeneration lesions.
Aspirin significantly shortens pain relief time, improves local blood flow to fibroids, has high safety, can be used long-term, reduces the need for surgical treatment, lowers patient hospitalization rates, and has no obvious side effects on mothers and children.
Smart Images
Figure CN122499175A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of biomedical technology, and in particular to the application of aspirin in the treatment of uterine fibroid degeneration during pregnancy. Background Technology
[0002] Uterine fibroids during pregnancy are a common and increasingly serious complication in obstetrics. The prevalence of uterine fibroids during pregnancy is approximately 1.6%-10.7%, and the prevalence increases significantly with the mother's reproductive age. In recent years, with the relaxation of national birth policies and the increasing age of women giving birth, the incidence of high-risk pregnancies, autoimmune diseases, and recurrent miscarriages has been increasing year by year, leading to a growing patient population with uterine fibroids during pregnancy.
[0003] Although uterine fibroids are usually asymptomatic during pregnancy, hormonal changes during this period often cause them to grow rapidly. This rapid growth can easily lead to a relative reduction in blood perfusion within the fibroid, resulting in local tissue ischemia, necrosis (such as erythropoiesis), and a large release of prostaglandins. The release of prostaglandins triggers severe uterine contractions and abdominal pain; therefore, pain is the most common and characteristic symptom of fibroid degeneration during pregnancy, seriously threatening the safety of both mother and child. Effective drug intervention is urgently needed in clinical practice.
[0004] Currently, clinical treatment options for pain caused by uterine fibroid degeneration during pregnancy are very limited and often ineffective, primarily relying on conservative symptomatic treatment. Existing conservative regimens include using low molecular weight heparin to improve blood perfusion, administering tocolytics for those with uterine contractions, and providing antibiotics to prevent secondary infections when necessary. However, these methods cannot directly and quickly relieve the severe abdominal pain caused by fibroid degeneration. For mild to moderate pain, acetaminophen is mainly used clinically, but its analgesic effect on more severe pain caused by fibroid degeneration is limited. For more severe pain, short-term use of standard doses of opioids or short courses of nonsteroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen and indomethacin) may be necessary, and hospitalization for analgesia may even be required. However, studies have confirmed that opioid use in early pregnancy is closely associated with an increased risk of congenital abnormalities in the fetus. Furthermore, traditional NSAIDs are limited to use in pregnancies before 32 weeks of gestation and can only be used continuously for a maximum of 48 hours. Because these drugs have serious side effects on both mother and child, they can easily cause premature closure of the ductus arteriosus in the fetus, neonatal pulmonary hypertension, oligohydramnios, and fetal / neonatal platelet dysfunction.
[0005] Therefore, in current clinical practice, there are almost no analgesics that are effective, not limited by gestational age, and safe for long-term use for pain caused by uterine fibroid degeneration during pregnancy. This clinical gap leads to some patients failing conservative treatment for fibroid degeneration and ultimately having to switch to surgical treatment, increasing hospitalization rates and surgical risks.
[0006] To address the aforementioned clinical and technical challenges, this invention provides a novel application of aspirin (preferably a low-dose oral aspirin of 100 mg / day) in the treatment or prevention of uterine fibroid degeneration during pregnancy. Summary of the Invention
[0007] The purpose of this invention is to provide the application of aspirin in the treatment of uterine fibroid degeneration during pregnancy, in order to address the problem that in existing clinical techniques, there is almost no analgesic drug that is effective, not limited to gestational age, and can be safely used long-term for pain caused by uterine fibroid degeneration during pregnancy.
[0008] To achieve the above objectives, the present invention adopts the following technical solution:
[0009] The use of aspirin in the preparation of drugs or health products for the treatment and / or prevention of uterine fibroid degeneration during pregnancy.
[0010] The dosage of aspirin in the drug is 50 mg / day to 150 mg / day.
[0011] Preferably, the dosage of aspirin in the drug is 100 mg / day, once daily.
[0012] Any of the following applications of aspirin:
[0013] 1) Prepare drugs or health products to relieve or eliminate abdominal pain caused by degeneration of uterine fibroids during pregnancy;
[0014] 2) To prepare drugs or health products that shorten the relief time of clinical symptoms related to uterine fibroid degeneration;
[0015] 3) Prepare drugs or health products that improve local blood perfusion in the uterus and uterine fibroids, and relieve or reverse ischemia and necrosis of fibroids;
[0016] 4) To prepare drugs or health products that inhibit or slow down the growth rate of uterine fibroids during pregnancy;
[0017] 5) Prepare drugs or health products that reduce the conversion rate of patients who have failed conservative treatment due to uterine fibroid degeneration and have to switch to surgical treatment.
[0018] The reduction in the time to relief of clinical symptoms related to uterine fibroid degeneration includes at least one of the following:
[0019] It shortens the time for uterine contractions to disappear, the time for body temperature to return to normal, the time for abdominal pain to be relieved, and the time for tenderness in the fibroid area to disappear.
[0020] A medicine or health product for treating and / or preventing degeneration of uterine fibroids during pregnancy, said medicine or health product comprising aspirin.
[0021] The present invention has at least the following beneficial effects:
[0022] This invention utilizes aspirin for the treatment and / or prevention of uterine fibroid degeneration during pregnancy. The drug has wide applications during pregnancy, and its long-term use in pregnant women has been well-established. It also offers numerous benefits, including pain relief, improved blood flow, and is not limited by gestational age, allowing for long-term use. This drug can reduce hospitalization rates and can be used as a preventative measure for high-risk groups with uterine fibroid degeneration during pregnancy. Furthermore, treatment with this drug can significantly reduce the number of patients who require surgical intervention due to failure of conservative treatment for fibroid degeneration. Attached Figure Description
[0023] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the following description of the embodiments will be briefly introduced. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0024] Figure 1 This is a graph showing the changes in pain scores in Example 1;
[0025] Figure 2 This is a schematic diagram of the symptom relief time in Example 1;
[0026] Figure 3 This is a schematic diagram of ultrasound assessment of fibroid size in Example 2;
[0027] Figure 4 This is a schematic diagram of the pathological examination results of Example 2. Detailed Implementation
[0028] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.
[0029] This invention provides the use of aspirin in the preparation of drugs for the treatment or prevention of uterine fibroid degeneration during pregnancy.
[0030] In practice, the aspirin is oral low-dose aspirin, with a preferred dose of 100 mg / day (qd).
[0031] This drug can be widely used by pregnant women during the preconception period and pregnancy. The duration of use is not limited to a specific gestational week and can meet the needs of long-term use (e.g., continuous use from the 24th week of pregnancy to the 36th week of pregnancy).
[0032] The technical solution of the present invention and its implementation effects are described in detail below through specific retrospective clinical controlled trials.
[0033] Basic data and grouping of clinical trials:
[0034] Inclusion criteria: Six pregnant women who were hospitalized for pregnancy maintenance due to lower abdominal pain caused by uterine fibroids and who underwent cesarean section and myomectomy at the same time.
[0035] Grouping criteria:
[0036] Aspirin group (the invention group): 6 patients received oral aspirin (100 mg once daily) during pregnancy. The minimum gestational week to start aspirin use was 24 weeks of gestation, and the medication was continued until 36 weeks of gestation. No other analgesics were used in either group.
[0037] The aspirin-free group (control group) consisted of 6 patients who did not receive aspirin treatment during pregnancy.
[0038] Basic treatment: The other routine pregnancy maintenance and symptomatic treatment plans were exactly the same for both groups of patients, including the use of cefazolin sodium to prevent infection and magnesium sulfate to inhibit uterine contractions.
[0039] Example 1: Application of aspirin in relieving abdominal pain caused by degeneration of uterine fibroids during pregnancy and shortening the time to symptom relief.
[0040] This embodiment primarily evaluates the effect of low-dose aspirin on the pain score (VAS score) and the time to relief of major clinical symptoms caused by uterine fibroid degeneration during pregnancy. Among them, the symptom relief mainly examines the time to relief of abdominal pain.
[0041] We divide the pain score into 1-10 levels (from no pain to severe pain), where the higher the score, the more painful it is. The main categories are: mild pain (1-3), moderate pain (4-6), and severe pain (7-10).
[0042] 1.1 Assessment of improvement in pain score (VAS score)
[0043] The VAS scores and the degree of reduction before and after treatment in the two groups of patients are shown in Table 1 and Table 2. Figure 1 As shown.
[0044]
[0045] 1.2 Pain Relief Time Detection
[0046] The individual abdominal pain relief times for the two groups of patients are shown in Table 2 and Figure 2 As shown:
[0047]
[0048] Pain relief time in the non-aspirin group: 3.250±0.758 days; pain relief time in the aspirin group: 1.667±0.408 days.
[0049] The purpose of this embodiment is to demonstrate the clinical efficacy of low-dose aspirin in providing rapid analgesia and symptom relief in treating pain caused by degeneration of uterine fibroids during pregnancy. Data showed that the VAS score in the aspirin group significantly decreased after treatment, and the pain relief time (mean 1.667 days) was significantly shorter than that in the non-aspirin group (mean 3.250 days). This demonstrates that aspirin not only has excellent analgesic effects but also significantly shortens the course of the disease and accelerates symptom relief.
[0050] Example 2: Application of aspirin in controlling the growth of uterine fibroids during pregnancy and improving histopathological degeneration
[0051] This embodiment evaluates the intervention effect of low-dose aspirin on the progression and histological changes of uterine fibroids through imaging (ultrasound assessment of fibroid size) and pathological examination (pathological results).
[0052] 2.1 Ultrasound assessment of the maximum diameter and growth rate of the fibroid
[0053] During early and late pregnancy, the maximum diameter (cm) of uterine fibroids was measured by ultrasound, and their growth rate (cm) during pregnancy was calculated. The results are shown in Table 3. Figure 3 As shown:
[0054]
[0055] Note: Basic ultrasound imaging features: Uterine fibroids appear as round or oval solid nodules with irregular echoes, and can be single or multiple; red degeneration of uterine fibroids shows reduced or absent blood flow; when uterine fibroids undergo cystic degeneration, irregular hypoechoic areas appear within the solid hypoechoic nodules.
[0056] 2.2 Pathological examination results of uterine fibroid removal during cesarean section
[0057] All patients ultimately underwent cesarean section at 38 weeks of gestation, along with myomectomy to obtain tissue samples for histopathological examination. (Reference) Figure 4 .
[0058] In the aspirin-free group, a large number of red degenerations of uterine fibroids were clearly observed in the pathological examination.
[0059] Aspirin group: only a few red degenerations were visible in the tissue pathology, and there was significant proliferation of uterine fibroid cells. The number of red degeneration lesions was significantly reduced compared with the control group.
[0060] The purpose of this embodiment is to demonstrate from a morphological and microscopic pathological perspective that aspirin can effectively inhibit the malignant growth of fibroids and reverse red degeneration. Ultrasound data showed that the overall growth rate of fibroids in the aspirin group was significantly slower than that in the non-aspirin group; pathological examination results directly confirmed that oral low-dose aspirin can effectively improve the red degeneration lesions of fibroids, which is due to aspirin's unique ability to improve blood perfusion in the uterus and fibroid area, alleviating ischemia and necrosis caused by rapid growth.
[0061] Example 3: Maternal and fetal safety assessment of long-term use of low-dose aspirin during pregnancy
[0062] This embodiment assesses the safety of long-term use of low-dose aspirin in the mid-to-late stages of pregnancy by monitoring adverse reactions during patient medication and adverse pregnancy outcomes at delivery (such as postpartum hemorrhage and neonatal Apgar scores).
[0063] 3.1 Monitoring of adverse reactions in pregnant women
[0064] During the approximately 12-week period of continuous medication (from week 24 to week 36 of pregnancy), all 6 patients in the aspirin group underwent strict monitoring for adverse reactions, and none of the patients experienced adverse reactions such as nausea, vomiting, diarrhea, or increased heart rate.
[0065] 3.2 Maternal and Infant Delivery Outcomes and Safety Indicators
[0066] Table 4 shows the postpartum hemorrhage volume and neonatal Apgar scores of the two groups of patients during delivery:
[0067]
[0068] The purpose of this embodiment is to verify the excellent safety of long-term oral administration of 100 mg / day of aspirin during pregnancy, overcoming the limitations of traditional nonsteroidal anti-inflammatory drugs (NSAIDs). Data show that long-term aspirin use did not significantly increase the risk of postpartum hemorrhage (bleeding volume was approximately 350 ml, with no statistically significant difference), and the newborns had perfect Apgar scores (all 10-10-10), with no observed toxic side effects, fully demonstrating its mild pharmacological characteristics and high safety for long-term use during pregnancy.
[0069] The present invention, through clinical trials of the above-described embodiments, demonstrates that 100mg of oral low-dose aspirin exhibits significant and lasting technical effects in the treatment and prevention of uterine fibroid degeneration during pregnancy, effects not found in traditional treatment methods.
[0070] 1. Combining analgesia and etiological treatment: The aspirin used in this invention not only has a significant and rapid analgesic effect, shortening the pain relief time for patients by nearly half (from 3.250 days to 1.667 days), but its core advantage lies in its ability to improve local blood perfusion in the uterus and fibroids, fundamentally combating ischemia and necrosis (red degeneration) caused by relatively reduced blood perfusion, thus significantly reducing red degeneration lesions in pathological examinations. This is a unique advantage that distinguishes it from traditional nonsteroidal anti-inflammatory drugs that only provide symptomatic pain relief.
[0071] 2. Breaking the limitations of gestational age for safe long-term medication: Traditional nonsteroidal anti-inflammatory drugs (NSAIDs) or opioids are strictly limited in their use during pregnancy (ideally <48 hours) and gestational age (before 32 weeks) due to high risks such as fetal organ malformations and premature closure of the ductus arteriosus. The low-dose aspirin used in this invention has milder pharmacological properties. Long-term continuous use during pregnancy (e.g., 24 to 36 weeks) has not shown any adverse maternal reactions and does not increase the risk of postpartum hemorrhage. Neonatal outcomes are excellent, achieving a technological breakthrough of "not limited by gestational age and capable of long-term use."
[0072] 3. Significant preventive and clinical translational value: This drug can be safely and widely used not only by pregnant women during the preconception and pregnancy periods, but also as a preventive drug to reduce the occurrence of uterine fibroid degeneration in high-risk groups with pregnancy complicated by fibroid degeneration. At the same time, it can significantly reduce the proportion of patients who have to switch to surgical treatment due to failure of pregnancy preservation / conservative treatment for fibroid degeneration, thereby effectively reducing the hospitalization rate of patients. It has extremely high clinical application value and economic and social benefits.
[0073] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the claimed invention. The scope of protection claimed by the appended claims and their equivalents is defined.
Claims
1. The use of aspirin in the preparation of drugs or health products for the treatment and / or prevention of uterine fibroid degeneration during pregnancy.
2. The application according to claim 1, characterized in that, The dosage of aspirin in the drug is 50 mg / day to 150 mg / day.
3. The application according to claim 2, characterized in that, The dosage of aspirin in this medication is 100 mg / day, once daily.
4. Any of the following applications of aspirin: 1) Prepare drugs or health products to relieve or eliminate abdominal pain caused by degeneration of uterine fibroids during pregnancy; 2) To prepare drugs or health products that shorten the relief time of clinical symptoms related to uterine fibroid degeneration; 3) Prepare drugs or health products that improve local blood perfusion in the uterus and uterine fibroids, and relieve or reverse ischemia and necrosis of fibroids; 4) To prepare drugs or health products that inhibit or slow down the growth rate of uterine fibroids during pregnancy; 5) Prepare drugs or health products that reduce the conversion rate of patients who have failed conservative treatment due to uterine fibroid degeneration and have to switch to surgical treatment.
5. The application according to claim 4, characterized in that, The reduction in the time to relief of clinical symptoms related to uterine fibroid degeneration includes at least one of the following: It shortens the time for uterine contractions to disappear, the time for body temperature to return to normal, the time for abdominal pain to be relieved, and the time for tenderness in the fibroid area to disappear.
6. A drug or health product for treating and / or preventing degeneration of uterine fibroids during pregnancy, characterized in that, The medicine or health product mentioned includes aspirin.