Internal heterosis prescription for dysmenorrhea caused by endometriosis

Abstract

The invention relates to the technical field of medicine, and particularly discloses an endometriosis prescription for dysmenorrhea with endometriosis. Comprising the following raw materials: 10-15 parts of radix salviae miltiorrhizae, 7-10 parts of rhizoma curcumae, 2-3 parts of flos carthami, 7-10 parts of vinegar turtle shell, 10-15 parts of salted radix achyranthis bidentatae, 7-10 parts of rhizoma corydalis, 10-15 parts of prepared fingered citron, 5-8 parts of radix bupleuri, 10-15 parts of radix paeoniae alba, 10-15 parts of caulis spatholobi, 10-15 parts of poria cocos, 7-10 parts of herba taxilli, 7-10 parts of radix dipsaci, 3-5 parts of fructus amomi, 7-10 parts of endothelium corneum gigeriae galli, 10-15 parts of hawthorn and 7-10 parts of liquorice. The agreement prescription of the internal different prescription has obvious curative effects on improvement of dysmenorrhea symptoms of EMs patients, reduction of tentacle nodules and appendage masses, improvement of pelvic cavity states, increase of pregnancy rates and the like, and is safe and free of obvious toxic and side effects.

Description

Technical Field

[0001] The invention relates to the technical field of medicine, and in particular to a prescription for treating dysmenorrhea caused by endometriosis. Background Art

[0002] Endometriosis (EMs) is a long-term chronic pain disease caused by multiple factors. Currently, the treatment of EMs dysmenorrhea in Western medicine mainly focuses on non-steroidal anti-inflammatory drugs (NSAIDS) and hormone drugs. Non-steroidal anti-inflammatory drugs are mainly used for the initial treatment of EMs pain and can relieve dysmenorrhea symptoms, but their effectiveness is limited. They can neither hinder the progression of EMs pain nor inhibit the growth of EMs lesions.

[0003] Hormonal drugs include highly effective progestins, gonadotropin-releasing hormone agonists (GnRH-a), combined hormonal contraceptives, danazol, aromatase inhibitors and progesterone antagonists, etc. However, long-term use of hormonal drugs will lead to a series of side effects, such as irregular vaginal bleeding, liver damage, thrombosis risk and osteoporosis, etc. Once the drug is stopped, EMs will recur. Summary of the invention

[0004] In view of the technical problems mentioned in the background technology, the present invention proposes a prescription for treating dysmenorrhea caused by endometriosis.

[0005] The present invention adopts the following technical solution:

[0006] A prescription for treating dysmenorrhea caused by endometriosis, comprising the following raw materials by weight:

[0007] 10-15 parts of Salvia miltiorrhiza, 7-10 parts of Curcuma zedoaria, 2-3 parts of Carthamus tinctorius, 7-10 parts of Vinegar-soured Turtle Shell, 10-15 parts of Salt Cyathula, 7-10 parts of Corydalis yanhusuo, 10-15 parts of Processed Buddha Hand, 5-8 parts of Bupleurum, 10-15 parts of White Peony, 10-15 parts of Millettia reticulata, 10-15 parts of Poria, 7-10 parts of Viscum album, 7-10 parts of Dipsacus asper, 3-5 parts of Amomum villosum, 7-10 parts of Chicken's Gizzard Stone, 10-15 parts of Hawthorn, and 7-10 parts of Licorice.

[0008] As a further technical solution of the present invention, the following raw materials are included:

[0009] Salvia miltiorrhiza 15g, Curcuma 10g, Carthamus tinctorius 3g, Vinegar turtle shell 10g, Achyranthes bidentata 15g, Corydalis 10g, Processed citron 15g, Bupleurum 8g, White Peony 15g, Millettia reticulata 15g, Poria 15g, Viscum album 10g, Dipsacus asper 10g, Amomum villosum 5g, Chicken gizzard lining 10g, Hawthorn 15g, Licorice 10g.

[0010] As a further technical solution of the present invention, the following raw materials are included:

[0011] Salvia miltiorrhiza 10g, Curcuma 7g, Carthamus tinctorius 2g, Vinegar turtle shell 7g, Achyranthes bidentata 10g, Corydalis 7g, Processed citron 10g, Bupleurum 5g, White Peony 10g, Millettia reticulata 10g, Poria 10g, Viscum album 7g, Dipsacus asper 7g, Amomum villosum 3g, Chicken gizzard lining 7g, Hawthorn 10g, Licorice 7g.

[0012] Compared with the prior art, the present invention has the following beneficial effects:

[0013] In the Neiyi Fang of the present invention, Danshen, Curcuma, and Carthamus tinctorius are the main drugs for promoting blood circulation, removing blood stasis, and relieving pain; Vinegar turtle shell softens and resolves nodules, Corydalis promotes qi and relieves pain, processed citron, Bupleurum, and white peony root soothe the liver and regulate qi, relieve acute pain, and Millettia reticulata promotes blood circulation and removes blood stasis, which are all ministerial drugs; Viscum album and Dipsacus asper are used to tonify the kidney qi and consolidate the foundation, which are all adjuvant drugs; Poria, Amomum villosum, chicken gizzard lining, and Crataegus pinnatifida strengthen the spleen and protect the stomach, and avoid the drugs for promoting blood circulation and promoting qi to damage the spleen and stomach function, and Crataegus pinnatifida can also promote qi and remove blood stasis, which are all adjuvant drugs; Salt Cyathulae leads blood downward, and can also tonify kidney qi and strengthen tendons and bones as the guiding drug, and Licorice harmonizes all the drugs. All the drugs are used together to play the effects of promoting blood circulation and removing blood stasis, softening and resolving nodules, regulating qi and relieving pain, and tonifying the kidney and consolidating the foundation. Clinical observations have found that the Neiyi Fang agreement has obvious therapeutic effects on the improvement of dysmenorrhea symptoms in patients with EMs, the reduction of tender nodules and adnexal masses, the improvement of pelvic state, the increase of pregnancy rate, etc., and is safe and has no obvious toxic and side effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 This is a comparison chart of the VAS scores of dysmenorrhea in the three groups before and after treatment.

[0015] Figure 2 This is a comparison chart of the CMSS scores (severity) of dysmenorrhea in the three groups before and after treatment.

[0016] Figure 3 This is a comparison chart of the CMSS scores (duration) of dysmenorrhea in the three groups before and after treatment. DETAILED DESCRIPTION

[0017] The following is a clear and complete description of the technical solutions in the embodiments of the present invention in conjunction with specific embodiments. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0018] The embodiment of the present invention provides a prescription for treating dysmenorrhea caused by endometriosis, which comprises the following raw materials in parts by weight:

[0019] 10-15 parts of Salvia miltiorrhiza, 7-10 parts of Curcuma zedoaria, 2-3 parts of Carthamus tinctorius, 7-10 parts of Vinegar-soured Turtle Shell, 10-15 parts of Salt Cyathula, 7-10 parts of Corydalis yanhusuo, 10-15 parts of Processed Buddha Hand, 5-8 parts of Bupleurum, 10-15 parts of White Peony, 10-15 parts of Millettia reticulata, 10-15 parts of Poria, 7-10 parts of Viscum album, 7-10 parts of Dipsacus asper, 3-5 parts of Amomum villosum, 7-10 parts of Chicken's Gizzard Stone, 10-15 parts of Hawthorn, and 7-10 parts of Licorice.

[0020] Example 1 - "Neiyifang" formula granule equal dose group (abbreviated as: equal dose granule group)

[0021] A prescription for treating dysmenorrhea caused by endometriosis, comprising the following raw materials:

[0022] Salvia miltiorrhiza 15g, Curcuma 10g, Carthamus tinctorius 3g, Vinegar turtle shell 10g, Achyranthes bidentata 15g, Corydalis 10g, Processed citron 15g, Bupleurum 8g, White Peony 15g, Millettia reticulata 15g, Poria 15g, Viscum album 10g, Dipsacus asper 10g, Amomum villosum 5g, Chicken gizzard lining 10g, Hawthorn 15g, Licorice 10g.

[0023] How to take the medicine: Choose the Chinese medicine granules produced by Guangdong Yifang Pharmaceutical Co., Ltd., take with 100-150ml warm water, start taking it on the 1st to 3rd day after the menstruation is over, 1 dose per day, half an hour after breakfast, take it continuously for 14 days as a course of treatment, and take it for a total of 3 menstrual cycles.

[0024] Example 2-2 / 3 dose group of “Neiyifang” formula granules (abbreviated as: 2 / 3 dose granule group)

[0025] A prescription for treating dysmenorrhea caused by endometriosis, comprising the following raw materials:

[0026] Salvia miltiorrhiza 10g, Curcuma 7g, Carthamus tinctorius 2g, Vinegar turtle shell 7g, Achyranthes bidentata 10g, Corydalis 7g, Processed citron 10g, Bupleurum 5g, White Peony 10g, Millettia reticulata 10g, Poria 10g, Viscum album 7g, Dipsacus asper 7g, Amomum villosum 3g, Chicken gizzard lining 7g, Hawthorn 10g, Licorice 7g.

[0027] Dosage: Same as the “Neiyifang” formula granules and equal dose group.

[0028] Example 3-"Internal Different Prescription" Decoction Group (abbreviated as: Decoction Group)

[0029] Prescription: Salvia miltiorrhiza 15g, Curcuma 10g, Carthamus tinctorius 3g, Vinegar turtle shell 10g (pre-decocted), Achyranthes bidentata 15g, Corydalis 10g, processed citron 15g, Bupleurum 8g, White Peony 15g, Millettia reticulata 15g, Poria 15g, Viscum album 10g, Dipsacus asper 10g, Amomum villosum 5g, Chicken gizzard lining 10g, Crataegus pinnatifida 15g, Licorice root 10g.

[0030] Decoction method and medication method: Use Chinese herbal medicine slices provided by Guangdong Yifang Pharmaceutical Co., Ltd., and prepare decoctions by pharmacists in the Chinese medicine pharmacy of Foshan Foxing Chancheng Hospital according to the traditional decoction method of Chinese herbal medicine, using a Chinese medicine decoction machine produced by Beijing Donghuayuan Medical Equipment Co., Ltd. For the first decoction: add 1080ml of water / dose (6 times the weight of the medicinal materials), soak for 30 minutes, boil over high heat, then switch to medium heat and continue to decoct for 30 minutes, and filter out the liquid medicine; for the second decoction, add 720ml of water / dose of the residue, boil over high heat, then switch to medium heat and continue to decoct for 20 minutes, and filter out the liquid medicine; combine the two decoctions, concentrate into 150ml / dose, and start taking it on the 1st to 3rd day after the menstruation is over, 1 dose per day, half an hour after breakfast, and take it for 14 consecutive days as a course of treatment, for a total of 3 menstrual cycles.

[0031] Experimental research:

[0032] 1. Research Sources

[0033] The case data were obtained from Foshan Foxing Chancheng Hospital. From May 2023 to May 2024, a total of 51 patients with EMs dysmenorrhea due to kidney deficiency and blood stasis syndrome who met the inclusion and exclusion criteria were selected and randomly divided into Neiyifang decoction group (n=17), Neiyifang equal-dose granule group (n=17), and Neiyifang 2 / 3-dose granule group (n=16) using spss23.0 medical statistical software.

[0034] 2. Diagnostic criteria

[0035] 2.1 EM diagnostic criteria: The diagnostic criteria for EM were established according to the 1993 “Guidelines for Clinical Research of New Traditional Chinese Medicines”.

[0036] (1) Clinical diagnosis

[0037] ① Progressive dysmenorrhea;

[0038] ②Discomfort in the lower abdomen and lumbar sacral area during menstruation, which progressively worsens;

[0039] ③ Periodic rectal irritation symptoms, progressively aggravated;

[0040] ④Tender nodules in the posterior fornix, uterosacral ligament, or isthmus of the uterus;

[0041] ⑤ The adnexal adhesion mass is accompanied by a sense of capsule nodularity, and the fallopian tube is unobstructed;

[0042] ⑥ There are obvious changes in the size of the above-mentioned lumps in the appendages before and after menstruation (no anti-inflammatory treatment was used).

[0043] When one of the above points ①, ②, ③ and one of the above points ④, ⑤, ⑥ coexist, it can be used as a clinical diagnosis.

[0044] (2) Diagnosis by abdominal examination

[0045] ① Multiple purple-blue spots are seen in the uterine rectal fossa and retroperitoneum, accompanied by increased peritoneal fluid (often bloody);

[0046] ② The uterosacral ligaments are thickened and gray-white nodules are present, accompanied by loose adhesions, and most of the fallopian tubes are unobstructed;

[0047] ③ The ovarian capsule is thickened, with an uneven surface and adhesions, and often has brown old bleeding patches on the surface. Ovarian puncture produces chocolate-like old blood;

[0048] ④ There are adhesions on the ovaries, but the fallopian tubes are mostly unobstructed.

[0049] (3) Pathological diagnostic criteria: The following evidence is present in the sections: ① endometrial glands; ② endometrial stroma; ③ evidence of intra-tissue bleeding, with the presence of red blood cells, hemosiderin, and local connective tissue hyperplasia to confirm the diagnosis.

[0050] Any one of the following criteria, namely clinical diagnosis, laparoscopic diagnosis, or pathological diagnosis, can be used as the diagnostic criteria for EM. The EM diagnostic criteria in this study are: Any one of the following criteria, namely clinical diagnosis, laparoscopic diagnosis, or pathological diagnosis, can be used as the diagnostic criteria for EM.

[0051] 2.2 Diagnostic criteria for secondary dysmenorrhea in Western medicine: Lower abdominal pain and distension before, during, or after menstruation caused by organic pelvic diseases, accompanied by low back pain or other discomfort, and symptoms seriously affecting the quality of life.

[0052] 2.3 Diagnostic criteria for dysmenorrhea in traditional Chinese medicine: Refer to the diagnostic criteria for dysmenorrhea in TCM Gynecology edited by Zhang Yuzhen in 2007. Women experience periodic lower abdominal pain during or before and after menstruation, or pain in the lumbar region, or even severe pain and fainting.

[0053] 2.4 Diagnostic criteria for kidney deficiency and blood stasis syndrome in traditional Chinese medicine

[0054] Refer to the diagnostic criteria of kidney deficiency and blood stasis syndrome in "Chinese Medicine Gynecology" edited by Zhang Yuzhen in 2007: ① abdominal pain during menstruation, soreness of waist and knees; ② irregular menstruation and infertility; ③ dizziness, tinnitus, and dark complexion; ④ nodules and masses in the pelvic cavity; ⑤ pale tongue, white fur, and deep and thin pulse. If 3 or more of the above items are present, this syndrome can be diagnosed.

[0055] Inclusion criteria

[0056] (1) Patients who meet the diagnostic criteria for EM, dysmenorrhea, and TCM syndromes, and who do not have concurrent infertility and adnexal masses or whose adnexal masses are less than 4 cm.

[0057] (2) Those aged between 18 and 50, with normal menstruation and not yet in menopause;

[0058] (3) The subjects must give their informed consent and voluntarily participate in the study.

[0059] Exclusion criteria

[0060] (1) Those who do not meet the diagnostic criteria or inclusion criteria;

[0061] (2) Those with severe menstrual disorders; those with acute pelvic inflammatory disease, malignant tumors of reproductive organs or local malignant tumors;

[0062] (3) Those who are receiving other research at the same time; those who have used hormone suppression therapy or oral Chinese medicine to treat EM dysmenorrhea and have stopped taking the medicine for less than 3 months;

[0063] (4) Patients with diseases of the heart, liver, kidney and hematopoietic system, and chronic diseases such as diabetes, tuberculosis, hypertension, cancer, etc.

[0064] Observation indicators

[0065] (1) Safety indicators

[0066] ① General physical examination items, including respiration, heart rate, blood pressure, pulse, etc.

[0067] ② Observe blood routine, liver function and kidney function indicators before treatment and 3 months after treatment.

[0068] (2) Efficacy indicators: The changes in the dysmenorrhea intensity scores of EM dysmenorrhea patients were observed before treatment, after one menstrual cycle, after two menstrual cycles, after three menstrual cycles, and on the third day after menstruation. The visual analogue scale (VAS)[8] and the COX Dysmenorrhea Symptom Scale (CMSS)[9] developed by the Chinese Medical Association Pain Society were used for assessment.

[0069] ① Visual Analogue Scale (VAS): The ruler is 10 cm long, with 0 marked on the left end and 10 marked on the right end, for a total of 11 numbers, representing 11 levels of pain from no pain to the most painful. 0 represents no pain and 10 represents unbearable pain. The doctor instructs the patient to mark the point on the ruler that best matches his or her own pain intensity. The pain intensity score is the distance from 0 to the marked point.

[0070] ②COX Dysmenorrhea Symptom Scale (CMSS): The Cox Menstrual Symptom Scale (CMSS) was used to assess the severity of symptoms and the duration of dysmenorrhea. The scale consists of two parts: CMSS-Severity (CMSS-S) and CMSS-Duration (CMSS-T), with a total of 18 observation indicators, including 17 symptoms such as nausea, vomiting, loss of appetite, headache, dizziness, and the duration of dysmenorrhea. All items of CMSS-S are scored on a 5-point scale: 0 for no symptoms, 1 for mild, 2 for moderate, 3 for severe, and 4 for extremely severe. CMSS-T is also scored on a 5-point scale: 0 for no symptoms, 1 for duration <3h, 2 for duration 3-7h, 3 for duration 7-24h, and 4 for duration >24h.

[0071] Statistical processing

[0072] All measurement data are expressed as mean ± standard deviation The count data were expressed as the number of cases (percentage); if it was a continuous variable, the Kruskal Wallis rank sum test was used for analysis of variance between groups; if the count variable had a theoretical number <10, the Fisher exact probability test was used. The main analysis of the treatment effect was based on the principle of the full analysis set, and patients who did not complete the first menstrual cycle were not included in the analysis. A linear mixed model with repeated measurement data was used to estimate the least squares mean differences and 95% CIs before and after treatment, and the interaction between fixed effect covariates (follow-up time and grouping) was adjusted. EmpowerStats statistical software was used for data statistics. The test level α = 0.05.

[0073] Study Results

[0074] 1. Comparison of general information among the three groups of patients

[0075] A total of 51 patients with EMs dysmenorrhea were enrolled in this study and randomly divided into Neiyifang decoction group (n=17), Neiyifang equal-dose granule group (n=17), and Neiyifang 2 / 3-dose granule group (n=16). After the first menstrual cycle, 3 patients dropped out of Neiyifang group, 3 patients dropped out of Neiyifang equal-dose granule group, and 4 patients dropped out of Neiyifang 2 / 3-dose granule group. After the second menstrual cycle, 0 patients dropped out of Neiyifang group, 5 patients dropped out of Neiyifang equal-dose granule group, and 1 patient dropped out of Neiyifang 2 / 3-dose granule group. After the third menstrual cycle, 3 patients dropped out of Neiyifang group, 0 patients dropped out of Neiyifang equal-dose granule group, and 0 patients dropped out of Neiyifang 2 / 3-dose granule group.

[0076] There was no significant difference in age, weight, height, education level, number of pregnancies, number of births, and number of miscarriages among the three groups (P>0.05), which means that the general data among the three groups were consistent and comparable, see Table 1 for details.

[0077] Table 1. Comparison of general information of patients in the three groups

[0078]

[0079]

[0080] 2. Comparison of VAS scores of dysmenorrhea before and after treatment and the difference before and after treatment among the three groups:

[0081] Before treatment, there was no statistically significant difference in the VAS scores of dysmenorrhea among the decoction group, the equal-dose granule group, and the 2 / 3-dose granule group (P>0.05), which means that the baseline VAS scores of dysmenorrhea in the three groups of patients were consistent and comparable before treatment, as shown in Table 2.

[0082] After one menstrual cycle of treatment, the VAS scores of dysmenorrhea in the decoction group, the equal-dose granule group, and the 2 / 3-dose granule group were all lower than those before treatment, and the treatment differences of each group were statistically significant (P < 0.05). The difference β (95CI%) before and after treatment of each group was -1.58 (-2.57, -0.58), -2.06 (-3.07, -1.04), and -2.89 (-4.07, -1.72), respectively; but the difference between the two groups was statistically significant. There was no significant difference between the pre- and post-treatment values ​​between the two groups (P>0.05). The treatment difference β (95CI%) between the decoction group vs the equal-dose granule group, the decoction group vs the 2 / 3-dose granule group, and the equal-dose granule group vs the 2 / 3-dose granule group were -0.48 (-1.94, 0.98), -1.31 (-2.83, 0.21), and -0.83 (-2.38, 0.71), respectively. See Tables 2 and 3 for details. Figure 1 .

[0083] After 2 menstrual cycles of treatment, the VAS scores of dysmenorrhea in the decoction group, the equal-dose granule group, and the 2 / 3-dose granule group were all lower than those before treatment, and the treatment differences of each group were statistically significant (P < 0.05). The difference β (95CI%) before and after treatment of each group was -1.35 (-1.94, -0.76), -0.60 (-1.10, -0.10), and -1.11 (-1.84, -0.38), respectively; but the difference between the two groups was statistically significant. There was no statistically significant difference between the groups before and after treatment (P>0.05). The treatment difference β (95CI%) between the decoction group vs the equal-dose granule group, the decoction group vs the 2 / 3-dose granule group, and the equal-dose granule group vs the 2 / 3-dose granule group were 0.78 (-0.10, 1.67), 0.25 (-0.60, 1.10), and -0.52 (-1.43, 0.39), respectively. See Table 2 and Figure 1 .

[0084] After 3 menstrual cycles of treatment, the VAS scores of dysmenorrhea in the decoction group, the equal-dose granule group, and the 2 / 3-dose granule group were all lower than those before treatment. The differences before and after treatment in each group were statistically significant (P < 0.05). The treatment differences β (95CI%) of each group were -0.73 (-1.20, -0.25), -0.40 (-0.76, -0.03), and -1.21 (-1.64, -0.77), respectively. However, the differences between the two groups were statistically significant. There was no significant difference between the pre- and post-treatment values ​​between the two groups (P>0.05). The treatment difference β (95CI%) between the decoction group vs the equal-dose granule group, the decoction group vs the 2 / 3-dose granule group, and the equal-dose granule group vs the 2 / 3-dose granule group were 0.31 (-0.31, 0.94), -0.48 (-1.08, 0.12), and -0.80 (-1.38, -0.22), respectively. See Tables 2 and 3 for details. Figure 1 .

[0085] The above research results show that after treatment for 1 menstrual cycle, 2 menstrual cycles, and 3 menstrual cycles, the VAS scores of dysmenorrhea in the decoction group, equal-dose granule group, and 2 / 3-dose granule group were significantly lower than before treatment, and the therapeutic effects of the three groups were similar.

[0086] Table 2. Comparison of VAS scores of dysmenorrhea before and after treatment and the difference before and after treatment in the three groups

[0087]

[0088] Note: *P<0.05.

[0089] 3. Comparison of CMSS scores of dysmenorrhea before and after treatment and the difference before and after treatment among the three groups

[0090] 3.1 CMSS-Severity (CMSS-S) comparison

[0091] Before treatment, there was no statistically significant comparison in the CMSS-S scores for dysmenorrhea among the decoction group, the equal-dose granule group, and the 2 / 3-dose granule group (P>0.05), which means that the baseline CMSS-S scores for dysmenorrhea among the three groups of patients before treatment were consistent and comparable, as shown in Table 3.

[0092] After one menstrual cycle of treatment, the CMSS-S scores of dysmenorrhea in the decoction group, the equal-dose granule group, and the 2 / 3-dose granule group were all lower than those before treatment. The differences before and after treatment in each group were statistically significant (P < 0.05). The β (95CI%) of the differences before and after treatment in each group were -7.64 (-12.77, -2.52), -6.00 (-9.42, -2.58), and -5.25 (-10.04, -0.46), respectively. However, the differences between the two groups were statistically significant. There was no statistically significant difference before and after treatment (P>0.05). The beta (95CI%) of the difference in CMSS-S score before and after treatment between the decoction group vs the equal-dose granule group, the decoction group vs the 2 / 3-dose granule group, and the equal-dose granule group vs the 2 / 3-dose granule group were 1.64 (-4.55, 7.84), 2.39 (-4.05, 8.84), and 0.75 (-5.02, 6.52), respectively. See Table 3 and Figure 2 .

[0093] After 2 menstrual cycles of treatment, the CMSS-S scores of dysmenorrhea in the decoction group, the equal-dose granule group, and the 2 / 3-dose granule group were all lower than those before treatment. The differences before and after treatment in each group were statistically significant (P < 0.05). The β (95CI%) of the differences before and after treatment in each group were -5.00 (-7.77, -2.23), -4.40 (-5.89, -2.92), and -3.95 (-6.30, -1.61), respectively. However, there was no statistically significant difference before and after treatment between any two groups (P > 0.05). The β (95CI%) of the differences before and after treatment in the decoction group vs the equal-dose granule group, the decoction group vs the 2 / 3-dose granule group, and the equal-dose granule group vs the 2 / 3-dose granule group were 0.67 and 0.71, respectively.

[0094] (-2.77, 4.10), 1.02 (-2.29, 4.33), 0.34 (-2.51, 6.52), see Table 3 and Figure 2 .

[0095] After 3 menstrual cycles of treatment, the CMSS-S scores of dysmenorrhea in the decoction group, the equal-dose granule group, and the 2 / 3-dose granule group were all lower than those before treatment. The differences before and after treatment in each group were statistically significant (P < 0.05). The treatment differences β (95CI%) of each group were -3.43 (-5.58, -1.29), -2.46 (-4.29, -0.63), and -2.71 (-4.28, -1.15), respectively. However, there was no statistically significant difference before and after treatment between the two groups (P > 0.05). The β (95CI%) of the differences before and after treatment in the decoction group vs the equal-dose granule group, the decoction group vs the 2 / 3-dose granule group, and the equal-dose granule group vs the 2 / 3-dose granule group were 0.10 and 0.23, respectively.

[0096] (-1.68, 3.68), 0.77 (-1.83, 3.37), -0.25 (-2.66, 2.16), see Table 3 and Figure 2 .

[0097] The above research results show that after treatment for 1 menstrual cycle, 2 menstrual cycles, and 3 menstrual cycles, the CMSS-S scores of dysmenorrhea in the decoction group, equal-dose granule group, and 2 / 3-dose granule group were significantly lower than before treatment, and the therapeutic effects of the three groups were similar.

[0098] Table 3. Comparison of CMSS-S scores of dysmenorrhea before and after treatment and the difference before and after treatment in the three groups

[0099]

[0100] Note: *P<0.05.

[0101] 3.2 CMSS-Duration (CMSS-T) Comparison

[0102] Before treatment, there was no statistically significant comparison in the CMSS-T scores for dysmenorrhea among the decoction group, the equal-dose granule group, and the 2 / 3-dose granule group (P>0.05), which means that the baseline CMSS-T scores for dysmenorrhea among the three groups of patients before treatment were consistent and comparable, as shown in Table 4.

[0103] After one menstrual cycle of treatment, the CMSS-T scores of dysmenorrhea in the decoction group, the equal-dose granule group, and the 2 / 3-dose granule group were all decreased compared with those before treatment. The differences before and after treatment in each group were statistically significant (P < 0.05). The β (95CI%) of the differences before and after treatment in each group were -8.43 (-14.39, -2.47), -7.79 (-11.97, -3.60), and -10.33 (-16.30, -4.39), respectively. However, there was no statistically significant difference before and after treatment between any two groups (P > 0.05). The β (95CI%) of the differences before and after treatment in the decoction group vs the equal-dose granule group, the decoction group vs the 2 / 3-dose granule group, and the equal-dose granule group vs the 2 / 3-dose granule group were 1.64 (-4.55, 7.84),

[0104] 2.39 (-4.05, 8.84), 0.75 (-5.02, 6.52), see Table 4 and Figure 3 .

[0105] After 2 menstrual cycles of treatment, the CMSS-T scores of dysmenorrhea in the decoction group, the equal-dose granule group, and the 2 / 3-dose granule group were all lower than those before treatment. The differences before and after treatment in each group were statistically significant (P < 0.05). The β (95CI%) of the differences before and after treatment in each group were -5.00 (-7.77, -2.23), -4.40 (-5.89, -2.92), and -3.95 (-6.30, -1.61), respectively. However, the differences between the two groups were statistically significant. There was no statistically significant difference before and after treatment (P>0.05). The β (95CI%) of the difference in CMSS-T score before and after treatment between the decoction group vs the equal-dose granule group, the decoction group vs the 2 / 3-dose granule group, and the equal-dose granule group vs the 2 / 3-dose granule group were 0.67 (-2.77, 4.10), 1.02 (-2.29, 4.33), and 0.34 (-2.51, 6.52), respectively. See Table 4 and Figure 3 .

[0106] After 3 menstrual cycles of treatment, the CMSS-T scores of dysmenorrhea in the decoction group, the equal-dose granule group, and the 2 / 3-dose granule group were all lower than those before treatment. The differences before and after treatment in each group were statistically significant (P < 0.05). The treatment differences β (95CI%) of each group were -3.43 (-5.58, -1.29), -2.46 (-4.29, -0.63), and -2.71 (-4.28, -1.15), respectively. However, the differences between the two groups were statistically significant. There was no statistically significant difference between the before and after values ​​(P>0.05). The β (95CI%) of the difference between the decoction group vs the equal-dose granule group, the decoction group vs the 2 / 3-dose granule group, and the equal-dose granule group vs the 2 / 3-dose granule group in the CMSS-T score before and after treatment were 1.96 (-1.15, 5.07), 0.76 (-2.24, 3.76), and -1.24 (-3.94, 1.45), respectively. See Table 4 and Figure 3 .

[0107] The above research results show that after treatment for 1 menstrual cycle, 2 menstrual cycles, and 3 menstrual cycles, the CMSS-T scores of dysmenorrhea in the decoction group, equal-dose granule group, and 2 / 3-dose granule group were significantly lower than before treatment, and the therapeutic effects of the three groups were similar.

[0108] Table 4. Comparison of CMSS-T scores of dysmenorrhea before and after treatment and the difference before and after treatment in the three groups

[0109]

[0110] Note: *P<0.05.

[0111] 4. Safety evaluation

[0112] The safety indicators of this study include blood routine (including white blood cell count, neutrophil percentage, red blood cell count, platelet count), liver function, and kidney function (creatinine). There were no obvious abnormalities in the safety indicators of the two groups of patients before and after treatment.

[0113] Different dosage forms of Neiyi Fang (decoction and granule) can significantly improve the dysmenorrhea symptoms of patients with EMs dysmenorrhea, and the two have similar efficacy, which is worthy of clinical promotion and application. In addition, the 2 / 3 dose of Neiyi Fang granule improves the dysmenorrhea symptoms of patients with EMs dysmenorrhea in a similar way to the decoction, that is, the dosage of Neiyi Fang granule can be appropriately reduced.

[0114] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above and that the present invention can be implemented in other specific forms without departing from the spirit or essential features of the present invention. Therefore, the embodiments should be considered exemplary and non-restrictive in all respects, and the scope of the present invention is defined by the appended claims rather than the above description, and it is intended that all changes falling within the meaning and scope of the equivalent elements of the claims be included in the present invention.

[0115] In addition, it should be understood that although the present specification is described according to implementation modes, not every implementation mode contains only one independent technical solution. This description of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment may also be appropriately combined to form other implementation modes that can be understood by those skilled in the art.

Claims

1. A prescription for treating dysmenorrhea caused by endometriosis, characterized in that: By weight, it includes the following raw materials: 10-15 parts of Salvia miltiorrhiza, 7-10 parts of Curcuma zedoaria, 2-3 parts of Carthamus tinctorius, 7-10 parts of Vinegar-soured Turtle Shell, 10-15 parts of Salt Cyathula, 7-10 parts of Corydalis yanhusuo, 10-15 parts of Processed Buddha Hand, 5-8 parts of Bupleurum, 10-15 parts of White Peony, 10-15 parts of Millettia reticulata, 10-15 parts of Poria, 7-10 parts of Viscum album, 7-10 parts of Dipsacus asper, 3-5 parts of Amomum villosum, 7-10 parts of Chicken's Gizzard Stone, 10-15 parts of Hawthorn, and 7-10 parts of Licorice.

2. The Neiyi prescription for treating dysmenorrhea caused by endometriosis according to claim 1, characterized in that: Including the following ingredients: Salvia miltiorrhiza 15g, Curcuma 10g, Carthamus tinctorius 3g, Vinegar turtle shell 10g, Achyranthes bidentata 15g, Corydalis 10g, Processed citron 15g, Bupleurum 8g, White Peony 15g, Millettia reticulata 15g, Poria 15g, Viscum album 10g, Dipsacus asper 10g, Amomum villosum 5g, Chicken gizzard lining 10g, Hawthorn 15g, Licorice 10g.

3. The Neiyi prescription for treating dysmenorrhea caused by endometriosis according to claim 1, characterized in that: Including the following ingredients: Salvia miltiorrhiza 10g, Curcuma 7g, Carthamus tinctorius 2g, Vinegar turtle shell 7g, Achyranthes bidentata 10g, Corydalis 7g, Processed citron 10g, Bupleurum 5g, White Peony 10g, Millettia reticulata 10g, Poria 10g, Viscum album 7g, Dipsacus asper 7g, Amomum villosum 3g, Chicken gizzard lining 7g, Hawthorn 10g, Licorice 7g.

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