Protocol optimization and quality control of large-scale acupuncture clinical trial for infertility / 中国针灸

The design of research protocol and quality control are the key to ensure the quality of clinical trial. A randomized clinical trial regarding the effects of medication combined with acupuncture on live birth rate in polycystic ovary syndrome (PCOS), which was initially designed as a comparative effectiveness research, then added with an acupuncture control group and finally became a factorial analysis, is taken as an example to explain the protocol design and optimization process, demonstrating the high level of methodology design and international recognization. By a series of measurements, such as unified purchase of acupuncture equipment, multiple trainings and assessments for acupuncturists' knowledge and operation standardization, in-site supervision of local center experts, the standard operation of acupuncture could be ensured and the credibility and scientificity of research results could be improved.

higher response of vascular endothelial growth factor and angiotensin-II to human chorionic gonadotropin in women with polycystic ovary syndrome

This research investigated the response of vascular active factors, vascular endothelial growth factor [VEGF] and angiotensin-II [AT-II] to ovarian stimulation during 24 hours in patients with polycystic ovary syndrome [PCOS]. In this clinical trial study, 52 patients with PCOS and 8 control cases were stimulated with human chorionic gonadotropin [HCG] on the 4th to 7th day of the patients' natural or induced menstrual cycles. We measured VEGF and AT-II by radioimmunoassay before the injection [0 hour] and 3, 8, 12, 18 and 24 hours after the stimulation. After ovarian stimulation, there was substantially higher level of VEGF in typical PCOS patients than the other three groups at the 3 hour time point [p<0.05], while there were no significant differences in VEGF at all the other time points among the four groups. As for AT-II, before and at all time points after the ovarian stimulation, it seemed that the AT-II levels in patients' sera with different phenotypes of PCOS by the Rotterdam criteria were all higher than in the control group although the differences were not statistically significant. The level of AT-II in typical PCOS patients was also significantly higher than the other three groups at the 3 hour time point [p<0.05], while no significant differences at all the other time points among the four groups were observed. The response to the stimulation varied among patients with different phenotypes of PCOS according to the Rotterdam criteria. Serum VEGF and AT-II were possible contributors to an increased risk of developing ovarian hyperstimulation syndrome [OHSS] in patients with typical PCOS during the early follicular phase [3 hours] after ovarian stimulation [Registration Number: NCT02265861]

Ovarian insulin resistance and regulation of traditional Chinese medicine cryptotanshinone in mice / 医学研究生学报

Objective The insulin pathways within ovary are in close relationship with female reproductive ability .The arti-cle was to observe the effects of ovarian insulin resistance on ovarian function and the effects of cryptotanshinone (CRY) on ovarian in-sulin resistance. Methods All mice were randomly divided into saline group (isotonic saline), DEX a group (isotonic saline plus DEX), CRY a group(isotonic saline plus DEX plus cryptotanshinone ), 10 in each group.The degree of insulin resistance was tested on each rat, along with the measurement of disintergrations per minute (DPM), ovulation rate and serum hormone level .After 20 fe-male mice were put to death , their ovaries were randomly divided into 4 groups:blank control group ( blank culture solution ) , DEX b group (DEX), CRY b group(DEX plus cryptotanshinone ), and WT group (DEX plus cryptotanshinone plus wortmannin ), 8 in each group. Murine ovaries in each group were cultured in vitro to test the number of ovarian glucose and the serum hormone level . Results After in- sulin resistance took place in murine ovaries , significant statistical difference was found between DEX a group and saline group as to 2-deoxy-D-[1,2-3H]-glucose, liver, adipose and ovarian tissues (P<0.05).Ovaries in CRY a group increased significantly compared with DEX a group([2805.2 ±921.5]DMP/mg vs [1183.2 ±382.2]DMP/mg, P<0.01 ).Compared with DEX a group(37.5 ± 7.0, 5.0 ±1.8), the ovulation rate and the average corpus luteum in saline group (26.3 ±5.9, 3.5 ±1.6) and CRY group (27.2 ± 6.3,3.8 ±0.9) decreased (P<0.05).In comparison to DEX a group, the estrogen and progestogen levels in saline group and CRY a group decreased significantly(P<0.05).The expression level of AKT2 protein in DEX a group was much lower than that in saline group([0.39 ±0.01] vs [0.77 ±0.03], P<0.05).The glucose uptake in ovarian tissues cultured in vitro in blank control group , DEX b group, CRY b group and WT group was respectively (3447.2 ±1245.2)DMP/mg, (1183.2 ±382.2) DMP/mg, (2805.2 ± 921.5) DMP/mg, and (1364.2 ±292.3) DMP/mg.DEX b group decreased significantly compared with blank control group , DEX b group and WT group decreased significantly in comparison to CRY b group (P<0.05).In comparison to blank control group, the me-dium testosterone level increased and the protesteron level decreased significantly in DEX b group (P<0.05). Conclusion Tradi-tional Chinese medicine cryptotanshinone can relieve ovarian insulin resistance in vitro and in vivo , and it may exert insulin sensitivza-tion through PI3K pathway.

Value of qualitative research in polycystic ovary syndrome / 中华医学杂志(英文版)

<p><b>OBJECTIVE</b>This article aims to introduce the benefits of qualitative research and to discuss how such research can be applied to the study of polycystic ovary syndrome (PCOS).</p><p><b>DATA SOURCES</b>Relevant articles were published in English as of May 2013 from Pubmed. Terms "polycystic ovary syndrome/PCOS, qualitative research and methodology" were used for searching.</p><p><b>STUDY SELECTION</b>Articles studying PCOS with qualitative methods were reviewed. Articles associated with the use of qualitative research in clinical research were cited.</p><p><b>RESULTS</b>Six qualitative studies related to PCOS were found in the literature search. These studies addressed different aspects in PCOS women including their womanhood, lived experience, information need, and experience of treatment with acupuncture. Five of these six studies used phenomenology as guiding theory.</p><p><b>CONCLUSION</b>Quantitative research has been the dominant approach in the field so far, qualitative research is relevant to the advancement of PCOS.</p>

Exploration of cultivation pattern for gynecologic compound talents / 国际中医中药杂志

Gynecologic personnel training is an important part of traditional Chinese medicine(TCM) of qualified personnel in the new century. With the opportunities and challenges in these years, improving the quality of TCM Gynecologic personnel training to adapt to economic and social development has great significance. For the situation of Gynecologic students difficult to word, and poor ability to adapt clinical reasons, we propose a five complex combination of moral, intellectual, research, economics, thinking education model, training Gynecologic compound talents, educating more skilled talents for medical practice.

Research on Traditional Chinese Medicine Syndrome and Treatment Rules of Literature Information Data Based on Polycystic Ovary Syndrome / 世界科学技术-中医药现代化

This study was aimed to mine correlation between the cause and traditional Chinese medicine ( TCM ) syndrome of polycystic ovary syndrome ( PCOS ) from different angles and at different levels . The study found that the inherent laws of the cause and syndrome by the application of different statistical methods and data mining methods . The literature information database of PCOS was searched . And the Microsoft Office Excel and the Microsoft Office Access were used in the establishment o the database . And the SPSS17 . 0 was used as the statistical software . The Medisc-3S system was used as the mining tools to discover the rules between etiology and syndrome . The function of frequency statistics and complex networks were used to discover and summarize the TCM syndrome and treatment of PCOS . The TCM syndrome and treatment of PCOS were discov-ered and summarized according to the statistical results . And the results showed that three reasons of etiology and pathogenesis of PCOS contained kidney-deficiency , phlegm-dampness , and blood-stasis . The five types of TCM syndrome included spleen-kidney deficiency , kidney-deficiency and blood-stasis , spleen-deficiency and phlegm-dampness , kidney-deficiency and phlegm-dampness , kidney-deficiency and liver stagnation . It was concluded that the treatment should be mainly from kidney-tonification and assisted with blood-activation and phlegm-removing . The association rules and complex networks of data mining methods were applied in the lit-erature research of PCOS . The results provided literature references and statistical evidences for the phlegm-dampness accumulation in the uterus as the pathogenesis of PCOS , and the methods of kidney-tonification , blood-activation and phlegm-removing as the treatment principles .

"Clinical Research on Traditional Chinese Medicine Can Have ""Breakthrough""" / 世界科学技术-中医药现代化

This article was inspired by the paper that Clinical Research of Traditional Chinese Medicine NeedsA Breakthrough, which was written by Shang Hongcai. This article took the 11th Five-year Plan of the National Science and Technology Support Project and the National Public Welfare Projects of Chinese Medicine, which were undertaken by the Heilongjiang Gynecology , which is one of the National Trial Bases of Chinese Medicine as an example to illustrate the Chinese medicine clinical trial management , achievement producing , and realization of achievement transformation . The emphasis should be made on the optimization of Chinese medicine clinical trial from the topic selection , operation mode and quality control . A comprehensive and detailed management system should be worked out to ensure the smooth conduction of clinical trials. The clinical research results should be clarified to achieve high quantity and quality outputs . The article was aimed to provide references for the development and breakthrough of Chinese medicine clinical trials .

Discussion on Protocol Design and Implementation of Effect on Live Birth Rate of Polycystic Ovary Syndrome Treatment with Acupuncture Combined with Clomiphene Citrate / 世界科学技术-中医药现代化

Protocol design and implementation are important steps for clinical trial . This article discussed key issues on effect of live birth rate by polycystic ovary syndrome ( PCOS ) treatment with acupuncture combined with clomiphene citrate in the randomized controlled trial ( RCT ) process . For example , the trial designs ( i . e . , trial design characteristics , selection of featured therapeutic effect index ) , clinical trial implementation ( i . e . , or-ganization construction , quality control , and etc . ) . This summarization provided references for the design and implementation of clinical trial plan .

Disorder of Tiangui (kidney essence) and reproductive dysfunction in patients with polycystic ovary syndrome / 中西医结合学报

Traditional Chinese medicine (TCM) usually views polycystic ovary syndrome (PCOS) as a menstrual disease or infertility disease. Reproductive dysfunction in PCOS is characterized by ovarian androgen excess and disturbance of follicular development, and its main clinical manifestations include delayed menstruation, scant menstruation, amenorrhea or infertility. Insulin resistance is a key pathological mechanism of PCOS. "Tiangui" (kidney essence) as a sex-stimulating essence in female in TCM theory, is essential to the menstruation and pregnancy of women. The disturbance of Tiangui (including time, status and rhythm) would result in female reproductive problems. Current studies of Tiangui indicate that ovary is the target organ of PCOS treatment, and its functional characteristics are consistent with the properties of Tiangui in time frame, state form and rhythm cycle. It is then concluded that ovarian dysfunction in PCOS can be expressed as disorder of Tiangui.

Regulation of synthesis function of porcine ovarian granulose cells by mitogen-activated protein kinase signaling pathway / 中华妇产科杂志

Objective To investigate the role of mitogen-activated protein kinase(MAPK)signaling pathway regulating synthesis function of steroid hormone of porcine ovarian granulose cells.Methods Porcine ovarian granulose cells were cultured in medium added with dimethyl sulfoxide(DMSO)at concentration of 50μmol/L or with MAPK inhibitor PD98059 (PD) for 48 hours.Then,granulose cells in DMSO medium were added with activator of adenylate cyclase(20 μmoL/L)or blank agent for next 48 hours incubation,which were defined as observation group 1 and control group 1,similarly,granulose cells in PD medium were also added with activator of adenylate cyclase(20 μmol/L)or blank agent for next 48 hours,which were defined as observation group 2 and control group 2.The level of estradiol(E_2),progesterone (P)and testosterone (T) were detected by chemoluminescence.The mRNA expression of 17alpha-hydroxylase/17,20-lyase (CYP17) and aromatase P450 (P450 arom) were assessed by RT-PCR.Results (1)Hormone expression:the level of T,P and E_2 were(29.5±2.5)nmol/L,(80±5)nmol/L,(49±4) pmol/L in control group 1 and(42.3±3.4)nmol/L,(170±15)nmol/L,(75±6)pmol/L in control group 2,which showed significant difference(P<0.05).In the mean time,the level of T, P and E_2 were (106.2±7.6)nmol/L,(210±16)nmol/L,(130±11)pmol/L in observation group 2 and(47.2±3.5)nmol/L,(130±6)nmol/L,(81±6)pmol/L in observation group 1,which also reach statistical difference(P<0.05).(2)The expression of enzyme:the expression of CYP17 mRNA was inereased by 50% and P450 arom mRNA was decreased by 20% between control group 1 and 2. However, the mRNA expression of P450 arom and CYPI7 were upregulated remarkably, especially, the expression of CYP17 mRNA were increased by 125%. Conclusion MAPK signaling pathway plays an inhibitory role in regulating synthesis of steroid hormone of ovarian granulose cell.

Induction of insulin resistance induced by PI-3K inhibitor in porcine granulosa cells / 中华妇产科杂志

Objective To investigate the biological effects of insulin resistance(IR)on the porcine granulosa cells which iS induced by wortmannin,the PI-3K inhibitor and mediated by key molecules including GLUT4 and MAPK during insulin signaling.Methods The model of IR porcine granulosa cell was established in in vitro culture by treatment of wortmannin,and was assessed the amount of3H glucose uptake as well as medium glucose levels by glucose oxidase method.The protein and mRNA expression of GLUT4 and MAPK were evaluated by immunofluorescence and RT-PCR respectively.Resuits The glucose intake was decreased by 40% with treatment of wortmannin at 1.5 μmol/L(P＜0.05).GLUT4 and MAPK were localized mainly to cytoplasm of grantdose cells.When granulosa cells were insulin resistant,the expression of GLUT4 was down-regulated whereas MAPK was up-regulated as compared with the controls.Conclusions Wortmannin treatment can lcad to decreased expression of GLUT4 and increase of IR granulose cells.This metabolic phenotype could induce increased expression of MAPK and mitogenic potential,indicating the cross-talk between two pathways of insulin signaling within ovarian cells.

Influence of leptin signal transducting system on ovary function in the db/db mouse / 中华内分泌代谢杂志

Four genotypic mice were constructed, by ovary transplantation, with body leptin receptor (LR) + and ovary LR - in Group A, body LR + and ovary LR + in Group B, body LR - and ovary LR + in Group C, as well as body LR - and ovary LR - in Group D respectively. Mice in C and D groups showed significant differences in glucose and fat metabolism as well as ovarian function as compared with A and B groups. Leptin signal transducting system exists in the ovary. Ovarian failure was induced by hyperlipidemia and lowered gonadotropin levels, but not by defective leptin signal within ovaries in the db/db mice.

Effects of ginseng total saponins on nerve growth factor expression in rat with estradiol valerate-induced polycystic ovaries / 中西医结合学报

OBJECTIVE: To investigate the effect of ginseng total saponins (GTS) on expression of nerve growth factor in rat with polycystic ovaries. METHODS: A total of thirty rats were randomly divided into normal control group, untreated group and GTS group. Polycystic ovaries were induced by a single intramuscular injection of 4 mg estradiol valerate (EV) in rats of the untreated group and GTS group. The rats in the GTS group were administered 50 mg/kg GTS every other day by intraperitoneal injection for 30 days after the EV injection. The expressions of NGF in the ovaries, pituitary and hippocampus were observed by method of immunohistochemistry. RESULTS: Comparison with the normal control group revealed that the expressions of NGF in ovaries, pituitary and hippocampus of rats in the untreated group were increased (P<0.05). The ovarian morphology of the GTS group was almost as normal as that of the normal control group. As compared with the untreated group, the expression of NGF in ovaries of the rats in GTS group was obviously decreased (P<0.05), while the expression of NGF in pituitary and hippocampus showed on difference. CONCLUSION: GTS can decrease the expression of NGF in ovary tissue in rats with polycystic ovaries induced by EV, which may be its mechanism in lessening the polycystic ovary.

Multicentre Investigation of the Traditional Chinese Medicine Named YanTing Medincinal Broth on Retention Enema Treatment of Chronic Pelvic Inflammatory Disease / 医学研究杂志

Objective To evaluate the clinical effectiveness and the safety of the traditional chinese medicine named YanTing Medincinal Broth on retention enema treatment of chronic pelvic inflammatory disease.Methods The research method of random,multicentre and parallel contrast were used.There are 92 cases divided into retention enema group and suppository contrast group at random,there are 47 cases in retention enema group and 45 cases in contrast group.Respectively use retention enema method with YanTing Medincinal Broth and the other method with KangFu inflammation eliminated suppository to treat the chronic pelvic inflammatory disease.The course of the treatment are all 10 days.Traditional chinese medicine syndrome and clinical physical signs are observed before and after the treatment in every group,the contrast curative effect are observed at the same time.Results Traditional chinese medicine syndrome and clinical physical signs are all improved than before treatment(P

Therapeutic effects of Jinqi Jiangtang tablet on women with polycystic ovary syndrome / 中西医结合学报

OBJECTIVE: To observe the therapeutic effects of Jinqi Jiangtang Tablet (JQJTT), a commonly prescribed recipe for type 2 diabetes in traditional Chinese medicine, on obese women with polycystic ovary syndrome (PCOS). METHODS: Twenty-four obese women with PCOS were prescribed JQJTT for 3 months and the changes of carbohydrate metabolism and biochemical indicators, including menstrual cycle, body mass index (BMI), the level of blood sex hormone, area under curve (AUC) of glucose and insulin during oral glucose tolerance test (OGTT), and testosterone responses during human chorionic gonadotrophin stimulation ovary test were observed. RESULTS: After treatment, there were significantly reductions in BMI (P<0.05), serum glucose level at 30 min during OGTT (P<0.05) and testosterone levels at eighteen hours during human chorionic gonadotrophin stimulation ovary test (P<0.05). In addition, nine patients had improved cycles among sixteen completed patients, and one patient with clomifene resistance got pregnant with response to clomifene treatment. CONCLUSION: The beneficial effects of JQJTT may result from improvement of carbohydrate metabolism and reduction in androgen biosynthesis in women with PCOS.

Regulation of Tiangui and viscera function / 中华中医药杂志

Tiangui,a specific terms in TCM,is a special material that can regulate human reproduction and development. It stems from congenital kidney essence and is nourished by acquired nutrients with the nature of time-limit,rhythmicity and status. Tiangui promotes abundant CHONG meridian with unobstructed REN meridian,participates in the production and regulation of menstruation,and prepares for conception of women. According to the holism of TCM,person is a unified whole,Tiangui's generation and functional role must be completed under the condition of normal five viscera' function,especially the sufficient kidney essence,although the 'to'and 'exhaustion'of Tiangui is directly affected and regulated by congenital kidney essence. Therefore the synergistic effect of the five viscera can not be ignored on Tiangui,although the congenital kidney essence occupies an important position.

ZHU Dan-xi’s discussion on obese female reproductive dysfunction from phlegm-dampness constitution / 中华中医药杂志

Phlegm is an important etiopathogenisis of female reproductive dysfunction in TCM.ZHU Dan-xi put forward the famous constitution theory of "phlegm in fat people",and there was internal regularity in pathogenesis of wemen with phlegm-dampness constitution.His viewpoint guided the clinical treatment objectively and provided a solid theorectical basis of preventing and treating female reproductive dysfunction induced by phlegm-dapness.Therefore,this paper will discuss the relationship between phlegm-dampness constitution and female reproductive dysfunction from the characteristics of pglegm-dampness constitute,correlation of obesity and pglegm-dampness constitute,and so on.

Regulation of berberine and dioscin in expression of glucose metabolism molecular in trophoblast cells / 中华中医药杂志

Objective:To discuss the regulation of berberine and dioscin extracted from traditional Chinese medicine in the expression of protein moleculer related with glucose metabolism in trophoblast cells,such as IRS-1,P1-3K,Glut1,PPAR ?. Methods:To culture the chorion trophoblast cell in the early pregnancy,to induce cells to suffer glucose metabolism obstacle with the use of WortmaninnTake advantage of berberine and dioscin extracted from the Chinese traditional medicine with intervention,simultaneously set the troglitazone(T) and dimthyl(R) for the control group. Detect the gene expression with the use of RT-PCT,simutaniously detect the protein expression in molecular level. Examine the expression in the protein level with the technique of Western blot in combination with the technique of LSM for the expression location of protein moleculer related.Results:① With the induction of WT,the glucose metabolism inside the tropholast cells becomes abnormal,compared with normal(P

Advance of mini-invasive treatments of uterine leiomyoma / 医学研究生学报

Uterine leiomyoma is the most common benign tumour of reproductive system of wommen.In recent years,the mini-trauma technology represented by laparoscope and hysteroscope is popularized in the application to treatment of uterine leiomyoma,such as LH,LM,HM and UAE put forward recently,etc.They all have many advantages,little trauma,less pain,rapid recovery and shorter duration of hospitalization.But indication,method of operation and complication have nothing in common with each other.This text is a survey at the point.

Transrectal color Doppler ultrasonography detection of the haemodynamic changes within ovarian stromal blood flow in patients with polycystic ovary syndrome / 医学研究生学报

Objective: To observe the haemodynamic changes within ovarian stromal blood flow in patients with polycystic ovary syndrome(PCOS). Methods: 41 patients with PCOS and 10 ovulatory women underwent transrectal ultrasound associated with Doppler flow measurement of the artery within ovarian stroma during the early follicular phase (days 2-5 of the menstrual cycle) or any day in patients with amenorrhea . Results:The peculiar vascular pattern wich one prominent blood vessel showed passing through the ovarian stroma from ovary gate. This sign was observed in all ovaries in patients with PCOS.There was no significiant difference in Vmax、PI、RI between left and right ovary.The Vmax,PI,RI of the right ovarian stromal artery were (18.99?3.12)cm/s, 0.74?0.12, 0.50?0.03 respectively. The indices of the left ovarian stromal artery were (18.76?3.23)cm/s, 0.75?0.11, 0.49?0.04 respectively. Conclusion: Vascularization of the ovarian stroma is prominent in patients with PCOS than in the control. The decreased vascular resistance to ovarian stromal perfusion in patients with PCOS may lead to perfusion increasment. TRS can be used as a non-invasive, convenient, and sensitive method for assessing the blood flow within the ovarian stroma.