Application of motherwort stasis-removing decoction for treating postpartum placenta and fetal membrane residues

Abstract

The invention relates to application of a motherwort stasis-removing decoction to treatment of postpartum placenta and fetal membrane residues. The invention provides a motherwort stasis-removing decoction and application thereof. The clinical effect and safety of the motherwort stasis-removing decoction on postpartum placenta and fetal membrane residue patients are researched through clinical research. The motherwort stasis-removing decoction has a remarkable clinical curative effect on postpartum placenta and fetal membrane residues, and can promote discharge of the residual placenta and fetal membrane, shorten the duration of postpartum bloody lochia, promote involution of uterus and reduce the risk of postpartum infection.

Description

Technical Field

[0001] The present invention relates to the field of medicine, and particularly to the use of Yimu Xiayu Decoction for treating retained placenta and fetal membranes after childbirth. Background Art

[0002] Retained placenta and fetal membranes after childbirth refer to the incomplete expulsion of the placenta and fetal membranes from the uterus after childbirth in women, manifested clinically as continuous lochia or bleeding, accompanied by abdominal pain, and even fever. Retained placenta and fetal membranes may occur during natural vaginal delivery, and are more likely to occur in women with a history of multiple uterine cavity operations. Retained placenta and fetal membranes after childbirth can lead to poor involution of the uterus and increase the risk of puerperal infection. If the fetal membrane tissue remains in the uterine cavity for too long, the remaining fetal membrane tissue will degenerate, necrose, organize, and even cause massive bleeding. At present, the problem of retained fetal membranes after childbirth remains an object of concern in puerperal diseases, and it has important social and economic significance for the effective treatment of partial retained fetal membranes after childbirth.

[0003] Currently, in clinical practice, Western medicine for treating retained placenta and fetal membranes after childbirth mostly uses drugs such as oxytocin and mifepristone, and the clinical effect is not good. The "gold standard" for Western medicine treatment of this disease is uterine curettage, but it causes greater damage to parturients, prolongs the postoperative recovery time, and is prone to complications such as postpartum infection. Therefore, it is often used as an alternative option. Seeking a safe and effective method is the key to treating retained fetal membranes after childbirth. In recent years, traditional Chinese medicine has played an important role in the treatment of retained placenta and fetal membranes after childbirth, with high safety and being easily accepted by patients.

[0004] Therefore, based on the characteristics of retained placenta and fetal membranes and the limitations of Western medicine treatment, it is particularly important to select an effective and targeted traditional Chinese medicine formula. Summary of the Invention

[0005] To solve the above problems, the present invention provides the application of Yimu Xiayu Decoction in the preparation of drugs for treating retained placenta and fetal membranes after childbirth. It can effectively promote the discharge of residual tissue, shorten the duration of bloody lochia, and promote uterine involution.

[0006] In a first aspect, the present invention provides the application of Yimu Xiayu Decoction in the preparation of drugs for treating retained placenta and fetal membranes after childbirth.

[0007] In some embodiments, the Yimu Xiayu Decoction is prepared from motherwort, astragalus, chuanxiong, angelica, peach kernel, Chinese honey locust spine, cyathula root, alligator vine fruit, bupleurum, dried tangerine peel, and roasted licorice root.

[0008] In some embodiments, the Yimu Xiayu Decoction is prepared from 60 parts of motherwort, 15 parts of astragalus, 15 parts of chuanxiong, 15 parts of angelica, 10 parts of peach kernel, 15 parts of Chinese honey locust spine, 15 parts of cyathula root, 15 parts of alligator vine fruit, 3 parts of bupleurum, 8 parts of dried tangerine peel, and 5 parts of roasted licorice root.

[0009] In some embodiments, the Yimu Xiayu Decoction is prepared from 60 g of Leonurus japonicus, 15 g of Astragalus membranaceus, 15 g of Ligusticum chuanxiong, 15 g of Angelica sinensis, 10 g of Prunus persica, 15 g of Gleditsia sinensis spine, 15 g of Cyathula officinalis, 15 g of Liquidambar formosana Hance, 3 g of Bupleurum chinense, 8 g of Citrus reticulata Blanco, and 5 g of roasted Glycyrrhiza uralensis Fisch.

[0010] In some embodiments, the Yimu Xiayu Decoction is an oral decoction.

[0011] In some embodiments, the preparation method of the Yimu Xiayu Decoction is as follows: Take traditional Chinese medicines, add 2 - 3 times the amount of water, decoct 2 - 3 times, each time for 20 - 30 min, filter, and concentrate the filtrate.

[0012] In some embodiments, the treatment is to continuously take the medicine for 1 week after childbirth.

[0013] In some embodiments, the patients with retained placenta and fetal membranes after childbirth are those with retained placenta and fetal membranes after vaginal delivery of a full - term single fetus.

[0014] In some embodiments, the patients with retained placenta and fetal membranes after childbirth are primiparas or multiparas.

[0015] Beneficial effects

[0016] The Yimu Xiayu Decoction uses Leonurus japonicus as the main medicine, which has the effects of contracting the uterus to stop bleeding, promoting blood circulation to remove blood stasis, and removing stasis to generate new blood. It is combined with Astragalus membranaceus to replenish qi and nourish blood. When qi moves, blood moves, promoting the discharge of lochia; Angelica sinensis nourishes blood and promotes blood circulation, regulating menstruation and relieving pain; Ligusticum chuanxiong, Prunus persica, and Liquidambar formosana Hance promote blood circulation to remove blood stasis and relieve pain; Gleditsia sinensis spine attacks the blood vessels and removes stasis and discharges pus; Cyathula officinalis guides the medicine downward and also promotes blood circulation; Bupleurum chinense and Citrus reticulata Blanco soothe the liver and regulate qi; roasted Glycyrrhiza uralensis Fisch. tonifies the middle qi and harmonizes all the medicines; all the medicines together play the role of replenishing qi and nourishing blood, removing stasis and relieving pain.

[0017] The present invention first uses the Yimu Xiayu Decoction to treat retained placenta and fetal membranes after childbirth, which can effectively promote the discharge of residual tissue, accelerate the discharge of lochia, shorten the duration of bloody lochia, promote uterine contraction and involution, enhance immunity, and reduce postpartum infection. Therefore, it is worthy of popularization and application in clinical practice.

[0018] The effective rate of the Yimu Xiayu Decoction of the present invention in treating retained placenta and fetal membranes after childbirth is much higher than that of traditional western medicine treatment.

[0019] The present invention uses natural traditional Chinese medicines, with small side effects and high safety for patients. Detailed implementation manners

[0020] The following further elaborates on the present invention in combination with the scheme and specific implementation manners. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0021] The traditional Chinese medicines are commercially available. The Xinshenghua Granules are from Jiangsu Rongyu Pharmaceutical Co., Ltd. (National Drug Approval No. Z20163013).

[0022] Embodiment 1:

[0023] Preparation of Yimu Xiayu Decoction: Take 60g of Leonurus japonicus, 15g of Astragalus membranaceus, 15g of Chuanxiong, 15g of Angelica sinensis, 10g of Peach Kernel, 15g of Gleditsia sinensis, 15g of Cyathula capitata, 15g of Rhizoma Smilacis Glabrae, 3g of Bupleurum chinense, 8g of Tangerine Peel, and 5g of Radix Glycyrrhizae Preparata. Add 2 times of water, decoct twice, filter and concentrate to obtain 400ml of decoction for later use.

[0024] Example 2: Clinical evaluation of the effect of Yimu Xiayu Decoction in treating postpartum placental fetal membrane retention

[0025] 1. Materials and methods

[0026] 1.1 General data A total of 154 patients with postpartum placental membrane retention after vaginal delivery of full-term singleton in our obstetric ward from June 2022 to June 2024 were selected. The 154 patients were randomly divided into an observation group and a control group, 77 cases in each group. The age of the observation group was 22-40 years old, with an average of (29.51±4.34) years old; the parity was 0-1 times, 32 cases of primiparity, and 35 cases of multiparity; the age of the control group was 22-40 years old, with an average of (29.38±4.55) years old; the parity was 0-1 times, 33 cases of primiparity, and 34 cases of multiparity. There was no significant difference in the general data between the two groups (t>0.05).

[0027] 1.2 Diagnostic criteria

[0028] 1.2.1 Western medicine diagnostic criteria: Refer to the national planning textbook "Obstetrics and Gynecology" (8th edition) for general higher education undergraduates: This disease can be diagnosed when there is retained placenta and fetal membranes with or without lower abdominal pain after delivery, and pregnancy complicated by uterine fibroids, placenta accreta, and postpartum hemorrhage is excluded.

[0029] 1.2.2 TCM diagnostic criteria: formulated with reference to the Blood Stasis Syndrome in the Guiding Principles for Clinical Research of New Chinese Medicines (2002 edition) and the National TCM Gynecology textbook for higher TCM colleges. Main symptom: lower abdominal pain. Secondary symptoms: ① small amount of lochia, stagnation and stagnation; ② dark purple lochia; ③ pale complexion; ④ chest and flank pain; ⑤ ecchymoses on the tongue, purple or dark red; ⑥ deep, tight or stringy pulse. The diagnosis can be made if both the main and secondary symptoms are met.

[0030] 1.3 Inclusion criteria ① Meet the diagnostic criteria of traditional Chinese medicine and Western medicine; ② Vaginal delivery of full-term single-baby pregnancy; ③ No abnormalities in prenatal examinations; ④ Residual placenta and fetal membranes as indicated by midwifery records or B-ultrasound examination within 3 days after delivery; ⑤ Age >21 years and ≤43 years; ⑥ Informed consent and voluntary participation; Only those who meet the above 7 criteria can participate in the experiment.

[0031] 1.4 Exclusion criteria: ① Those with a blood loss of more than 500 ml within 24 hours after vaginal delivery; ② Those with complications of placenta adhesion and accreta or blood flow signals shown on CDFI; ③ Those suspected of various gynecological inflammatory diseases during pregnancy or postpartum period; ④ Those suspected of pelvic tumors or trophoblastic tumors and endometriosis; ⑤ Those with comorbid mental illness; ⑥ Those with comorbid serious cardiovascular and cerebrovascular diseases, blood system diseases, etc.; ⑦ Those with obvious abnormal liver and kidney function or comorbid liver disease and kidney disease; ⑧ Those who are allergic to Western or Chinese medicine.

[0032] 1.5 Exclusion criteria, dropout and termination criteria: ① patients with severe complications or adverse reactions during the experiment; ② patients who do not adhere to treatment or take medication as ordered by the doctor; ③ patients who voluntarily request to withdraw from the experiment; ④ patients who naturally drop out or are lost to follow-up.

[0033] 1.6 Treatment

[0034] The observation group was given Yimu Xiayu Decoction prepared in Example 1, 1 dose per day, taken warm in 2 times, and taken continuously for 1 week after delivery.

[0035] The control group was given Xinshenghua Granules, 2 packets each time, 3 times a day, for 1 week after delivery.

[0036] 1.7 Observation indicators and efficacy assessment

[0037] 1.7.1 The same ultrasound physician and the same instrument (vaginal ultrasound) were used to measure the residual area of tissue in the uterine cavity on the 3rd, 10th and 42nd day after delivery to determine whether the residual tissue had been completely expelled.

[0038] 1.7.2 Lochia Conditions and duration of bloody lochia;

[0039] 1.7.3 Height of uterine fundus The same physician measured the height of uterine fundus on the 3rd and 10th days after delivery. Methods: After the patient emptied her bladder, she lay flat on her back and massaged the uterine fundus for 1 minute. Then, a soft ruler was used to measure the length from the upper edge of the pubic symphysis to the uterine fundus along the midline of the abdomen of the parturient and the data were recorded to calculate the height of uterine fundus (cm);

[0040] 1.7.4 Incidence of uterine curettage Comparison of the incidence of uterine curettage 14 days after delivery (the indication for uterine curettage is a single bleeding > 100 mL, and the reduction of residual volume before and after treatment is less than 30%).

[0041] 1.7.5 Postpartum infection rate Fasting venous blood was collected to collect infection-related factors CRP and PCT (infection was defined as CRP>8.0mg / L or PCT>0.04ng / mL), and the infection rates of the two groups were compared before and after treatment.

[0042] 1.7.6 The TCM syndrome scores refer to the "Guiding Principles for Clinical Research of New Chinese Medicines" (2002 Edition): Main symptoms: The abdominal pain is divided into 0, 2, and 4 points according to mild, moderate, and severe degrees; Sub-symptoms: ① Amount of lochia: little is 0 point, moderate is 1 point, large is 2 points; ② Color of lochia is purplish-dark: none is 0 point, having is 1 point; ③ Complexion is pale and bluish: none is 0 point, having is 1 point; ④ Chest and hypochondrium distending pain: none is 0 point, having is 1 point. The tongue coating and pulse condition are not scored.

[0043] 1.7.7 Efficacy determination: Recovery: The residual tissue in the uterine cavity is completely discharged by B-ultrasound examination 10 days after delivery, and the TCM syndrome integral drops by more than 80%; Effective: The area of the residual tissue in the uterine cavity decreases by more than 50% by B-ultrasound 10 days after delivery, and the TCM syndrome integral drops by more than 30%; Ineffective: Not meeting the above criteria.

[0044] Treatment effective rate = (recovery + effective) / total number of cases × 100%.

[0045] 1.8 Statistical methods

[0046] SPSS 25.0 statistical software is used for analysis. Measurement data are expressed as mean ± standard deviation. Paired t-test is used for comparison before and after treatment in the same group, independent sample t-test is used for comparison between groups, count data are expressed as percentage, chi-square test is used, and rank data are used for R test or rank sum test. When P < 0.05, the difference is considered statistically significant.

[0047] 2 Results

[0048] 2.1 Comparison of the maximum diameter of the residual tissue in the uterine cavity on the 3rd day, 10th day, and 42nd day after delivery between the two groups There was no significant statistical difference in the area of the residual tissue in the uterine cavity between the two groups on the 3rd day and 42nd day after treatment (P > 0.05); The area of the residual tissue in the uterine cavity of the observation group was smaller than that of the control group on the 10th day after delivery, and the difference was statistically significant (P < 0.05). See Table 1.

[0049] Table 1 Area of the residual tissue in the uterine cavity after delivery ( cm2)

[0050]

[0051] 2.2 Comparison of the uterine fundus height on the 3rd day and 10th day after delivery and the duration of postpartum bloody lochia between the two groups The uterine fundus height of the observation group was smaller than that of the control group on the 3rd day after treatment, and the difference was statistically significant (<0.05); There was no significant statistical difference in the uterine fundus height between the two groups on the 10th day after treatment (P > 0.05); The duration of postpartum bloody lochia of the observation group was smaller than that of the control group after treatment, and the difference was statistically significant (P < 0.05). See Table 2.

[0052] Table 2 Comparison of the uterine fundus height after delivery

[0053]

[0054] 2.3 Comparison of the number of cases of uterine curettage at 14 days after delivery between the two groups The uterine curettage rate of the observation group was lower than that of the control group at 14 days after delivery after the two groups were treated, and the difference was statistically significant (P < 0.05). See Table 3.

[0055] Table 3 Comparison of the number of cases of uterine curettage at 14 days after delivery [case (%)]

[0056]

[0057] 2.4 Comparison of TCM syndrome scores between the two groups before and after treatment The TCM syndrome scores of the two groups were significantly lower after treatment than before treatment, and the difference was statistically significant (P < 0.05); there was no statistically significant difference in the TCM syndrome scores of the two groups before treatment (P > 0.05); the TCM syndrome scores of the observation group were significantly lower than those of the control group after treatment, and the difference was statistically significant (P < 0.05). See Table 4.

[0058] Table 4 TCM syndrome scores of the two groups before and after treatment ( score)

[0059]

[0060] 2.5 Comparison of the clinical efficacy between the two groups after treatment. The total effective rate of the observation group was better than that of the control group after the two groups were treated, and the difference was statistically significant (P < 0.05). See Table 5.

[0061] Table 5 Clinical efficacy of the two groups before and after treatment [case (%)]

[0062]

[0063] 2.6 Comparison of the postpartum infection rate between the two groups There was no statistically significant difference in the postpartum infection rate of the two groups after treatment (P > 0.05). See Table 6.

[0064] Table 6 Postpartum infection rate of the two groups after treatment [case (%)]

[0065]

[0066] 2.7 Comparison of adverse reactions between the two groups after treatment There was no statistically significant difference in the adverse reactions of the two groups after treatment (P > 0.05). See Table 7.

[0067] Table 7 Incidence of adverse reactions of the two groups after treatment [case (%)]

[0068]

[0069] 3. Conclusion

[0070] This study shows that Yimu Xiayu Decoction can better reduce the residual area of placental and fetal membranes, restore the height of the uterine fundus, shorten the duration of lochia rubra, reduce the curettage rate, and improve the TCM syndrome scores compared with Xinshenghua Granules in the treatment of retained placental and fetal membranes after childbirth. In addition, the postpartum infection rate and adverse reaction rate are both low. This indicates that the curative effect of Yimu Xiayu Decoction is significantly better than that of Xinshenghua Granules, and Yimu Xiayu Decoction has a stronger effect of supplementing qi and nourishing blood, promoting qi circulation and dredging meridians.

[0071] In summary, Yimu Xiayu Decoction in the treatment of retained placental and fetal membranes after childbirth can effectively promote the discharge of residual tissues, accelerate the discharge of lochia, shorten the duration of lochia rubra, promote uterine contraction and involution, enhance immunity, reduce postpartum infection and have fewer side effects. Therefore, it is worthy of popularization and application in clinical practice.

[0072] Unless otherwise defined, all professional and scientific terms used in this article have the same meaning as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to the described content can be applied to the present invention. The preferred methods and materials described in this article are only for demonstration purposes and do not limit the content of this application.

Claims

1. The application of Yimu Xiayu Decoction in the preparation of drugs for treating postpartum placental and fetal membrane residues.

2. The application according to claim 1, characterized in that The Yimu Xiayu Decoction is made from Leonurus japonicus, Astragalus membranaceus, Ligusticum chuanxiong, Angelica sinensis, Prunus persica, Gleditsia sinensis spine, Cyathula officinalis, Liquidambar formosana Hance, Bupleurum chinense, Citrus reticulata Blanco, and roasted Glycyrrhiza uralensis Fisch.

3. The application according to claim 2, characterized in that, The Yimu Xiayu Decoction is made from 60 parts of Leonurus japonicus, 15 parts of Astragalus membranaceus, 15 parts of Ligusticum chuanxiong, 15 parts of Angelica sinensis, 10 parts of Prunus persica, 15 parts of Gleditsia sinensis spine, 15 parts of Cyathula officinalis, 15 parts of Liquidambar formosana Hance, 3 parts of Bupleurum chinense, 8 parts of Citrus reticulata Blanco, and 5 parts of roasted Glycyrrhiza uralensis Fisch.

4. The application according to claim 3, characterized in that, The Yimu Xiayu Decoction is made from 60 g of Leonurus japonicus, 15 g of Astragalus membranaceus, 15 g of Ligusticum chuanxiong, 15 g of Angelica sinensis, 10 g of Prunus persica, 15 g of Gleditsia sinensis spine, 15 g of Cyathula officinalis, 15 g of Liquidambar formosana Hance, 3 g of Bupleurum chinense, 8 g of Citrus reticulata Blanco, and 5 g of roasted Glycyrrhiza uralensis Fisch.

5. The application according to claim 1, characterized in that The Yimu Xiayu Decoction is an oral decoction.

6. The application according to claim 1, characterized in that, The preparation method of the Yimu Xiayu Decoction is as follows: Take traditional Chinese medicines, add 2 - 3 times the amount of water, decoct for 2 - 3 times, each time for 20 - 30 minutes, filter, and concentrate the filtrate to obtain it.

7. The application according to claim 1, characterized in that, The patients with postpartum placental and fetal membrane residues are those with placental and fetal membrane residues after vaginal delivery of full - term singleton.

8. The application according to claim 1, wherein The patients with postpartum placental and fetal membrane residues are primiparous or multiparous.

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