Abstract
Objective:To explore the treatment of obese patients with different preconditioning combined with ovulation induction Application value of polycystic ovary syndrome (PCOS).
Methods:122 obese patients with PCOS in our hospital from January 2019 to May 2021 were selected and randomly divided into groups, 61 in each example. Both groups received ovulation induction therapy (Diane-35, Orlistat Capsule, Clomiphene), metformin group received metformin, and myo-inositol group received myo-inositol for 3 consecutive cycles. The effects of ovulation induction, pregnancy outcomes, adverse reactions, and body mass index (BMI), lipid metabolism indexes, sex hormone levels, and oxidative damage indexes before and after pretreatment were counted in the two groups. Results After pretreatment, BMI, HOMA-IR, LH, and FSH in the two groups were lower than those before pretreatment (P<0.05). The levels of MDA and 8-iso-PGF2α in the two groups were lower than those in the metformin group, and the levels of TAS were higher than those in the metformin group (P<0.05). Statistical significance (P>0.05); the incidence of adverse reactions in the inositol group was 1.64% lower than that in the metformin group (14.75%, P<0.05). Conclusions Inositol and metformin combined with ovulation induction have similar effects in the treatment of obese PCOS. The former can effectively correct lipid metabolism disorders, reduce oxidative stress and reduce adverse reactions.
Keywords:polycystic ovary syndrome; obesity; preconditioning; ovulation induction; inositol
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The main clinical manifestations of polycystic ovary syndrome (PCOS) are obesity, oligomenorrhea, infertility, insulin resistance, etc. Among them, obese patients account for 30%-50% of the total number of patients. %, if not actively controlled, it can aggravate hyperinsulinemia, induce metabolic syndrome, and then lead to miscarriage, premature birth and other adverse pregnancy outcomes [1-3]. At present, lifestyle adjustment is the first-line treatment for obese PCOS patients, but only relying on lifestyle adjustment has limited effect on weight loss and improvement of endocrine metabolism [4]. “Chinese Guidelines for Diagnosis and Treatment of Polycystic Ovary Syndrome” recommends: Orlistat should be used for poor weight loss, Diane-35 should be used if hyperandrogenism is not effective, and insulin augmentation should be used if pancreatic islet function is not effective. sensitizer [5]. Metformin and inositol are both insulin sensitizers. The former is effective in treating obese PCOS, but long-term oral administration has obvious gastrointestinal reactions. Although the latter is used in PCOS [6], its efficacy and safety still lack long-term efficacy. , Multi-center, large-sample clinical study verified that this study innovatively compared the effects of metformin and inositol combined with ovulation induction therapy in obese PCOS patients, in order to determine a reasonable plan for the prevention and treatment of the disease.
1. Materials and Methods
1.1
General information
Selected 122 cases of obesity in our hospital from January 2019 to May 2021 type PCOS patients. Inclusion criteria: meet the diagnostic criteria for PCOS [7]: oligomenorrhea or amenorrhea, clinical manifestations of hyperandrogenism, polycystic changes in one or both ovaries on ultrasound; body mass index (BMI) ≥ 28kg/m2; age 20~ 35 years old; all infertile patients; bilateral fallopian tubes are unobstructed, uterine tissue structure is normal, and all have reproductive wishes; the patients are aware of this study and voluntarily sign the informed consent form. Exclusion criteria: abnormal liver and kidney; intolerance to the drug in this study; participating in other clinical trials; other diseases causing hyperandrogenism; concomitant sexually transmitted diseases; genitourinary infection; other gynecological diseases (endometriosis, uterine fibroids) ; Infertility caused by other diseases. Random number table method grouping, each 61 cases. It can be seen from Table 1 that there was no significant difference in age, course of disease, clinical manifestations and other data between the two groups (P>0.05). This study was approved by the hospital ethics committee.
1.2
method
The two groups were controlled by diet and exercise. On the 3rd to 5th day of menstruation, Diane-35 was orally administered (Guangzhou Branch of Bayer Health Care Co., Ltd., Chinese medicine Zhunzi J20140114, specification: 2mg Cyproterone acetate, 0.035mg ethinyl estradiol/tablet), tablet/time, 1 time/d, oral orlistat capsule (Zhongmei Huadong Pharmaceutical Co., Ltd., approved by Chinese medicine H20100190, specification: 0.12g/capsule) , 0.12g/time, 3 times/d; the metformin group was orally administered with metformin (Deyuan Pharmaceutical Co., Ltd., H20080252, specification: 0.5g/tablet), 0.5g/time, 2 times/d; the inositol group was orally administered Inositol (Bactolac Pharmaceutical, Inc, specification: 0.5g/tablet), 0.5g/time, 2 times /d. The 2 groups were continuously treated for 3 cycles, and 21d was a cycle. Clomiphene (Gote Pharmaceutical Co., Ltd., import drug registration number: H20140688, specification: 50mg/tablet) for ovulation induction.
1.3
Observation indexes
The indexes were evaluated before and after pretreatment in both groups. (1) In the fasting state, draw 2 mL of cubital venous blood, centrifuge at 3000 r/min for 15 min, take the supernatant, store it in a -20 ℃ refrigerator for testing, serum luteinizing hormone (LH), follicle stimulating hormone (follicle-stimulatinghormone, FSH) were determined by radioimmunoassay; total antioxidant status (totalantioxidantstatus, TAS), human 8-iso-prostate F2α (8-iso-PGF2α), malondialdehyde (malondialdehyde, MDA) were determined by enzyme-linked immunosorbent assay Determination by adsorption method; triglycerides (triglyceride, TG), total cholesterol (total cholesterol, TC), fasting blood-glucose (FPG) and fasting insulin (fastinginsulin, FINS) were all determined by Hitachi automatic analyzer 3110 [Hitachi Diagnostic Products (Shanghai) Co., Ltd.]. Calculate the Insulin Resistance Index (HOMA-IR). HOMA-IR=(FPG×FINS)/22.5.
The height and weight were recorded at the same time, and the body mass index (BMI) was calculated. (2) The ovulation induction effect includes the ovulation rate and the number of dominant follicles. (3) Pregnancy outcomes include pregnancy rate, miscarriage rate, and ectopic pregnancy rate. Pregnancy assessment criteria: intrauterine gestational sacs or ectopic gestational sacs can be seen on transvaginal ultrasonography. (4) Adverse reactions include nausea, vomiting, diarrhea, abdominal pain, etc.
1.4
Statistical methods
SPSS 22.0 was used to process data, measurement data was expressed as (x±s), t test, count data was expressed as n (%), χ2 test, P <0.05 indicates a statistically significant difference.
2. Results
2.1
BMI, lipid metabolism and insulin function indicators
It can be seen from Table 2 that there was no significant difference in BMI and HOMA-IR between the two groups before and after pretreatment (P>0.05), and the BMI and HOMA-IR of the two groups after pretreatment were lower Before pretreatment (P<0.05); there was no significant difference in TC and TG between the two groups before pretreatment (P>0.05),
pretreatment After treatment, the TC and TG of the two groups were lower than those before pretreatment, and the inositol group was lower than the metformin group (P<0.05).
2.2
Sex hormone levels
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It can be seen from Table 3 that there was no significant difference in the levels of LH and FSH between the two groups before and after pretreatment (P>0.05). The level of FSH was lower than that before pretreatment (P<0.05).
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Oxidative damage indicators
It can be seen from Figure 1 that the comparison of the levels of MDA, 8-iso-PGF2α and TAS between the two groups before pretreatment showed that there were significant differences. There was no statistical significance (P>0.05), the levels of MDA and 8-iso-PGF2α in the two groups after pretreatment were lower than those before pretreatment, the levels of TAS were higher than those before pretreatment, and the levels of MDA and 8-iso-PGF2α in the inositol group were lower In the metformin group, the TAS level was higher than that in the metformin group (P<0.05).
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The effect of ovulation induction
It can be seen from Table 4 that there was no significant difference in the ovulation rate and the number of dominant follicles between the two groups (P >0.05).
2.5
Pregnancy outcome
It can be seen from Table 5 that the pregnancy rate, miscarriage rate and ectopic pregnancy rate of the two groups Compared, the difference was not statistically significant (P>0.05).
2.6
Adverse reactions
It can be seen from Table 6 that the incidence of adverse reactions in the inositol group was lower than that in the metformin group ( P<0.05).
3, discussion
In recent years, more and more scholars believe that the occurrence and development of PCOS is related to insulin resistance, especially in obese patients. As the disease progresses, islet B cells compensatory secrete more insulin, induce hyperinsulinemia, and aggravate glucose and lipid metabolism. Disorders, reduce the probability of conception, and endanger the physical and mental health of patients[8-9]. In the past, most of the clinical treatments were lifestyle adjustment and ovulation induction (orlistat capsules, Diane-35), which were effective in weight loss and improvement of high androgen symptoms. However, there are still some limitations in the effect on insulin resistance. On this basis, strengthening insulin function intervention in obese PCOS patients is expected to improve the overall treatment effect and promote good disease outcomes[10-11].
Metformin It is the most widely used insulin sensitizer in clinical practice. Its main mechanism of action is as follows: it affects the process of human lipid synthesis and metabolism through energy regulation, reduces the levels of TG and TC in the blood, reduces the body fat content, and achieves weight loss; it can stimulate tyrosine Kinase activity, improve the utilization of glucose by surrounding tissue cells, reduce hepatic glucose transfusion, increase insulin sensitivity, reduce insulin resistance, and promote ovulation[12-13]. A large number of studies have confirmed that metformin is effective in the treatment of obese PCOS patients. However, the long-term application of gastrointestinal adverse reactions is high, and the acceptance of patients and their families is low [14-15]. Inositol is an emerging insulin sensitizer, and foreign research on inositol in the treatment of PCOS has been carried out for 20 years. In recent years, a Mate analysis has shown that inositol is similar to metformin in terms of islet function, sex hormones, ovulation induction effect and pregnancy outcome, and has unique advantages in improving lipid metabolism and adverse reactions [16], but the comparison of the two There are few studies, and this study carried out an innovative discussion and analysis on this, and found that there was no significant difference in BMI, HOMA-IR, LH, FSH, ovulation induction effect, and pregnancy outcome between the two groups, which is consistent with the above research viewpoints, and fully supports the combination of inositol. The effectiveness and feasibility of ovulation induction therapy in obese patients with PCOS. The possible mechanism is as follows: the active components of myo-inositol are myo-inositol and D-chiro-inositol, and myo-inositol can regulate glucose intake and participate in follicular estrogen signaling. D-chiro-inositol can reduce insulin resistance, regulate sex hormone levels, promote egg development and maturation, and improve pregnancy outcomes; D-chiro-inositol can participate in insulin-induced androgen synthesis, repair insulin metabolism signaling pathways, and correct glucose metabolism imbalances. Alcohol can promote T biosynthesis, directly improve ovarian function, increase Oocyte quality and promote pregnancy. It is worth noting that PCOS patients have insulin resistance in multiple parts of the body, but it has not been detected in ovarian tissue. It is revealed that inositol may improve insulin resistance through non-insulin signaling pathways, and the specific mechanism still needs further research [17]. This study also found that the levels of TC and TG and the incidence of adverse reactions in the inositol group after pretreatment were lower than those in the metformin group (P<0.05), suggesting that compared with metformin, inositol can significantly reduce the level of blood lipids in obese PCOS patients and reduce the occurrence of adverse reactions risk. The occurrence and development of PCOS is closely related to oxidative damage, and oxidative damage will destroy the normal structure and function of follicles and affect the conception of patients [18-19]. MDA is a typical indicator of oxidative stress. Sun Junli et al. [20] pointed out that the level of MDA in infertile patients with PCOS is higher than that in healthy people, and the elevated level indicates that the antioxidant load exceeds the body's own and affects follicular development. 8-iso-PGF2α is a lipid peroxide, which is relatively stable in vivo and is considered to be a sensitive indicator for evaluating oxidative stress in vivo. TAS mainly reflects the total antioxidant status, and statistical changes in its level are helpful to accurately understand the degree of oxidative stress injury in the body. Zhao Minying et al[21] scholars found that 8-iso-PGF2α and TAS were abnormally expressed in PCOS patients, and tended to normal levels after treatment. Whether inositol can achieve the purpose of treating diseases by regulating oxidative stress is still unknown. In this study, an innovative discussion and analysis was carried out. It was found that the levels of MDA and 8-iso-PGF2α in the inositol group were lower than those in the metformin group after preconditioning higher than the metformin group (P<0.05), it can be seen that inositol combined with ovulation induction therapy can reduce oxidative stress in obese patients with PCOS, and regulate the levels of MDA8-iso-PGF2α and TAS, which is related to the protective effect of inositol on oxidative stress. , can improve antioxidant enzyme activity, restore mitochondrial membrane potential, protect mitochondrial function, and reduce cellular oxidative damage. However, this study is the first to explore the effect of inositol on oxidative stress indicators in obese PCOS patients, and further research is needed to confirm its specific mechanism and long-term differences. In conclusion, inositol and metformin combined with ovulation induction have similar effects in the treatment of obese PCOS. Inositol is more effective than metformin in correcting lipid metabolism disorder, reducing oxidative stress and reducing adverse reactions, and it is worthy of clinical promotion and application.
References: omitted
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