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Clinical and Empirical Study on Therapeutic Effects of Ling-Zhu Granule in Polycystic Ovary Syndrome and Insulin Resistance

Author: MengJun
Tutor: HuangJianLing
School: Guangzhou University of Traditional Chinese Medicine
Course: Chinese Gynecology
Keywords: PCOS Insulin resistance Ling-Zhu granule Metformin Clinical and Empirical
CLC: R271.9
Type: PhD thesis
Year: 2011
Downloads: 100
Quote: 0
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Abstract


BackgroundPolycystic ovarian syndrome(PCOS) is one of most common endocrine disease, The syndrome encompasses a broader spectrum of signs and symptoms, such as elevated serum hyperandrogenism and insulin resistance. In 1935, Stein and Leventhal reported this disease for the first time, so the disease is named the syndrome of Stein-Leventhal too. PCOS is with different phenotypic aspects, Clinical manifestation of PCOS includes anovulatory menoxenia, infertility, hirsutism, acne, obesity, acanthosis nigricans and PCO. The later-day researches covers that PCOS dysfunction oversteps reproductive axis. Insulin resistance is evolving to metabolic syndromes generally. The probability of PCOS patients suffering from metabolic syndromes is 4-11 times than ordinary persons. Not only it impairs function of procreation and incretion, but also is associated with metabolic syndromes, type 2 diabetes, endometrial carcinoma, cardiovascular and cerebrovascular disease。Latest studies reports that insulin resistance is the physiological and pathological key link of PCOS. Most PCOS sufferers are with insulin resistance. The famous professor Li LiYun of GuangDong Province Hospital Of Traditional Chinese Medicine, according to experiences of the ancients and her clinical experiences, created Ling-Zhu granule for PCOS, especially insulin resistance. It is very availability in the clinic.ObjectivesThe aim of this empirical study is to discuss the mechanism target of Ling-Zhu granule ameliorating the follicle basement membrane of PCOS rat, and accelerate the development of the follicle, to illuminate the molecular mechanism of the effect. It could be provide evidences for the clinical treatment and new contents of Traditional Chinese Medicine. The aim of this clinical study is to discuss the clinical curative effect and security of Ling-Zhu granule. The research is according to the comparison of Ling-Zhu granule and Metformin in treatment of patients with polycystic ovary syndrome and insulin resistance.MethodsThis study is basis of Poresky Methods to make the formers of PCO rats. The rats were divided into four groups by randomization and comparison, study group, control group, former group and blank group. This study is to discuss the main mechanism of the development of the follicle and the ovulation failure, to discuss the possible mechanism of Ling-Zhu granule, by observing the targets, such as ovarian configuration, T, insulin, OGTT, the thickness of the follicle basement membrane, the expression of the protein of the follicle basement membrane, the quantity of granular cells and theca cells. According to the RCT and the diagnosis criterion, The clinical study collected 70 patients of from Province Hospital Of Traditional Chinese Medicine, from 2008.9-2011.1 They are divided into two groups by 1:1 randomly, Ling-Zhu granule is given to treatment group including 35 cases, and at the same time Metformin is given to the control group also including 35 cases, two groups are inspected by using Chinese medicine syndromes graded tables and other observe variable index, such as female hormone, blood-fat, blood glucose, insulin, type-B ultrasonic. Lastly, the study data collected to make the data-base is analyzed by the software of SPSS17.0.Results1 Results of empirical study(1)The comparison of the blank group and the succeeded animal model group:The latter surpass the former in these mean observe index, such as OGTT, avoirdupois, T, insulin.(2)The analysis of the animal model succeeded: The rats of ovulation failure account for 80.36%, the dead rats account for 11.67%, and the rats succeeded account for 43.33%.(3)The comparison of the four groups indexes:To the mean of T and insulin, the blank group is distinct statistical differences between the other groups (P<0.05). There is no distinct statistical differences between the others (P>0.05). After the therapy, There is no distinct statistical differences between the four groups of the mean of weight (P>0.05). There is distinct statistical differences between the four groups the mean of insulin and T (P<0.05)(4)The difference of the four groups After the therapy:①weight:There is no distinct statistical differences between the blank group and the former group (P=0.511>0.05), the study group and the control group (P=0.905>0.05), except between other groups (P<0.05). The increase of weight of the study group and the control group is under the others, it has the statistical significance.②T:There is no distinct statistical differences between the blank group and the former group (P=0.962>0.05), the study group and the control group (P=1.000>0.05), except between other groups (P<0.05). The decrease of T of the study group and the control group is under the others, it exists the statistical significance.(5)The comparison of the green weight of uteruses and ovaries:①the green weight of uteruses:the comparison of the blank group and the former group:confidence interval (CI) (-258.0085,-18.3665), except 0, a =0.05, There is distinct statistical differences, there is no distinct statistical differences between other groups. But from The comparison of the mean, the first is the former group, the second is the control group, the third is the study group, the last is the blank group.②the green weight of ovaries: There are no distinct statistical differences between the four groups. But from The comparison of the mean, the first is the former group, the second is the study group, the third is the control group, the last is the blank group. Although it does not exist statistical significance to the data, it exist clinical significance. After the therapy, the green weight of uteruses and ovaries of the former group are more overweight than the others. The last is the blank group. So the green weight of uteruses and ovaries of the rats of "deficiency of kidney with sputum", are distinct overweight than the blank rats. The Ling-Zhu granule and Metformin are effective to lose weight.(6)The comparison of the three proteins of the follicle basement membrane of PCOS rat:With Kruskal-Wallis H method;①CollagenⅣ:the former group is the most of the expression of CollagenⅣ, the second is the study group, the third is the blank group, the last is the control group.②Laminin:The former group is the most of the expression of Laminin, the second is the study group and the control group, the last is the blank group.③Perlecan:There are distinct differences between the four groups. The former group is the most of the expression of Perlecan, the second is the study group and the control group, the last is the blank group.(7)The mean thickness of the follicle basement membrane:There is no distinct statistical differences between the four groups (P=0.261>0.05). The former group is the most thickness of the follicle basement membrane (707.52nm), the study and the control groups are close to the blank group.(8)The quantity of granular cells and theca cells:With Kruskal—Wallis H method; there is no distinct statistical difference between the four groups (P>0.05).(9)Ransmission electron microscope (HitachiH-7500):There are many yellow bodies of the blank and the study groups. It shows ovulation.2 Results of Empirical study(1)BMI、WHR:There is distinct statistical difference between the study group and the control group (P<0.05).(2) Ling-Zhu granule and Metformin can reduce insulin and insulin resistance of the patient of PCOS and insulin resistance.Paired t-test, In fasting blood-glucose, there is distinct statistical difference in the control group (P<0.05), there is statistical significance too. In reducing 2-hour postprandial blood glucose,2-hour postprandial insulin and HOMA—β, the study group has distinct statistical difference (P <0.05) and statistical significance. In reducing fasting insulin and HOMA-IR, they both have distinct statistical difference (P<0.05) and statistical significance.(3)Ling-Zhu granule can reduce TC and increase IIDL-C, Metformin can reduce TG、ApoB. They both can reduce LDL-C.Paired t-test, in reducing TC (P=0.003<0.05), increasing HDL-C (P =0.021<0.05), there is distinct statistical difference in the study group than before. In reducing TG (P=0.008<0.05) and ApoB (P=0.037<0.05), there is distinct statistical difference in the study group than before. In reducing LDL-C, there is distinct statistical difference in the both groups than before (P<0.05).There is no distinct statistical difference in the both groups to ApoA/ApoB.(4)Ling-Zhu granule and Metformin can reduce free testosterone. Metformin can reduce LH/FSH.In reducing LH/FSH, there is distinct statistical difference in the control group than before (P=0.025<0.05).In reducing free testosterone, there is distinct statistical difference in the both groups than before (P <0.05).In reducing LH and increasing E2, there is no distinct statistical difference in the both groups (P>0.05)(5)There is no distinct statistical difference in the both groups in basal body temperature (BBT) with two-phase.Chi-square test, in the BBT with two-phase during the treatment, there is no distinct statistical differences between the two groups (P=1.563> 0.05).(6)Paired t-test, the point of Chinese medicine syndromes graded tables decline in the two groups is no distinct statistical difference (P<0.05). Fat and not-fat:(7)The patient of PCOS and insulin resistance in this study are not all fat.The not-fat patient account for 43.55%(27/62),the study group 51.61% (16/31);the control group 35.48%(11/31)ConclusionThe famous professor Li LiYun of GuangDong Province Hospital of Traditional Chinese Medicine, according to experiences of the ancients and her clinical experiences, declared that "deficiency of kidney with sputum" is the pathogenesis of PCOS, and created Ling-Zhu granule of restoring kidney and eliminating sputum for PCOS. Ling-Zhu granule is very availability in the clinic.This study shows that Ling-Zhu granule is effective to treatment the patient of PCOS of "deficiency of kidney with sputum". Compare to Metformin, there is (P>0.05) in the changes of the weight, free testosterone and insulin of rats. In reducing the green weight of uteruses and ovaries, Metformin is more effective than Ling-Zhu granule. There is clinical significance to the both groups. The both medi distinct statistical differences between the two groups caments are effective to reduce the expression of the three proteins, and to ameliorate the molecular sieve of the follicle basement membrane of PCOS rat. The Metformin is more effective to reduce the expression of the Collagen IV than the study group. There is no distinct statistical difference between the both medicaments in reducing the expression of Laminin and Perlecan. The both medicaments can ameliorate the thickness of the follicle basement membrane, so to ameliorate the molecular sieve of the follicle basement membrane of PCOS rat.In molecular biology, Insulin resistance of restoring kidney and eliminating sputum, can ameliorate the membrane molecular sieve of the follicle basement membrane, accommodate the communication of the two cells, and maintain the balance the function of "LH-theca cells axes and FSH-granular cell axes". It gives new content to the restoring kidney and eliminating sputum of Chinese Medicine, and provides the scientific evidence of the clinical application.This study shows that Ling-Zhu granule is very effective to treat the patient of PCOS and insulin resistance. Compare to Metformin, they are both effective, but have some dissimilarity. In reducing BMI、WHR and Insulin resistance, they both effective. There are no distinct statistical differences between the two groups in reducing fasting insulin and HOMA-IR. In reducing fasting blood glucose, Metformin is more effective. In reducing 2-hour postprandial blood glucose,2-hour postprandial insulin and HOMA—β, Ling-Zhu granule is more effective. Ling-Zhu granule is effective in reducing TC and increasing HDL-C. Metformin is effective in reducing TG and ApoB. They are both effective to reduce LDL-C. They are both effective to incretion, but have some dissimilarity. Ling-Zhu granule is more effective to reduce LH. They both can reduce free testosterone. The point of Chinese medicine syndromes graded tables decline in the two groups is no distinct statistical difference. There is no distinct statistical difference in the both groups in basal body temperature (BBT) with two-phase. A patient is diagnosed, without reference to fat or not, insulin resistance is needed to diagnose.

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CLC: > Medicine, health > Chinese Medicine > Traditional Chinese Medicine Obstetrics and Gynecology > Modern medicine, obstetrics and gynecology disease
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