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OBJECTIVE@#To evaluate the effectiveness and safety of Zhenqi Buxue Oral Liquid (ZQ), progesterone capsules, and their combination in treating oligomenorrhea and hypomenorrhea with qi-blood and Kidney (Shen) essence deficiency.@*METHODS@#This was a prospective, randomized, multi-center controlled trial between June 2022 to December 2022. Ninety-six oligomenorrhea and hypomenorrhea patients with qi-blood and Shen essence deficiency were randomly assigned to receive ZQ (ZQ group, 29 cases), progesterone capsules (PG group, 32 cases), or the combined Chinese and Western medicine (COM group, 31 cases) at a ratio of 1:1:1. Patients in the ZQ or PG group took daily 10 mL twice a day of ZQ or 200 mg once a day of progesterone capsules for 10 consecutive days on day 15 of the menstrual cycle respectively, and patients in the COM group received the same ZQ combined with progesterone capsules. The treatment course lasted for 3 months and follow-up was performed at 1 and 3 months after the end of treatment. Primary endpoint was the menstrual Traditional Chinese Medicine Syndrome Scale (TCMSS) scores. Secondary endpoints included pictorial blood loss assessment chart (PBAC) scores, clinical efficacy rate, 36-item Short Form Health Survey (SF-36) scores, sex hormones and thickness of endometrium. Adverse events (AEs) were recorded.@*RESULTS@#TCMSS scores after 1- and 3-month treatment in all groups were significantly lower than those at baseline (P<0.05). Only TCMSS scores after 3-month treatment in the ZQ and COM groups continuously decreased compared with those after 1-month treatment in the same group (P<0.01). TCMSS scores after 3-month treatment in the ZQ and COM groups were significantly lower than those in the PG group (P<0.05, P<0.01). Compared with baseline, PBAC scores in the ZQ and COM groups after 3 months of treatment were also significantly higher (both P<0.01). The total effective rates of TCM syndrome of 3-month treatment were significantly improved in all groups compared with that after 1 month of treatment (P<0.05). The total effective rate of the COM group was the highest in the 3rd month of treatment and significantly higher than that of PG group alone (P<0.05). Compared with baseline, only the SF-36 scores of COM group were significantly improved after 3 months of treatment (P<0.05). No serious adverse reactions were observed after treatment.@*CONCLUSIONS@#The combination of ZQ and PG, or ZQ only had better effects on reducing TCMSS scores compared with PG, and COM showed the higher total effective rate compared with monotherapy. Besides, COM could effectively improve menstrual blood loss and quality of life. ZQ combined with PG may be an effective and safe option for oligomenorrhea and hypomenorrhea patients with qi-blood and Shen essence deficiency.
Subject(s)
Female , Humans , Progesterone/therapeutic use , Qi , Oligomenorrhea/drug therapy , Quality of Life , Prospective Studies , Medicine, Chinese Traditional , Drugs, Chinese Herbal/adverse effects , Capsules , KidneyABSTRACT
Diminished ovarian reserve (DOR), generally defined as a decreased number or quality of oocytes, has a significant impact on quality of life and fertility in women. In recent years, the incidence of DOR has been increasing and the ages of patients are younger. The search for an effective DOR treatment has emerged as one of the preeminent research topics in reproductive health. An effective DOR therapy would improve ovarian function, fertility, and quality of life in patients. In this review we evaluated DOR treatment progress both in Western medicine and Chinese medicine, and elucidated the characteristics of each treatment.
Subject(s)
Female , Humans , Medicine, Chinese Traditional , Ovarian Reserve , Quality of Life , Oocytes , Treatment Outcome , Infertility, Female/therapyABSTRACT
Objective: To explore the pharmacological basis and mechanism of Buxue Yimu pills (BYP) in the treatment of anaemia in women from the perspective of metabolomics and network analysis. Materials and Methods: Forty-six women of reproductive age with haemoglobin 70-110 g/L were recruited. Blood samples were collected before and after 4 weeks of oral BYP treatment to assess the changes in haemoglobin, coagulation function, and iron metabolism indices. An integrated analysis of metabolomics (liquid chromatography mass spectrometry) and network analysis was performed to identify the potential pharmacodynamic mechanisms of BYP. Results: After BYP treatment, the haemoglobin level of patients significantly increased from 93.67 ± 9.77 g/L to 109.28 ± 12.62 g/L (p < 0.01), while no significant changes were found in iron metabolism and coagulation-related indicators. A total of 22 differential metabolites were identified after metabolomics analysis, which were mainly related to the inhibition of inflammation and oxidative stress. Integrating pharmacodynamics and metabolomics, a network of drug-active components-targets-metabolic pathways-metabolomics was established. Acetylcholinesterase, phospholipase A2 group IIA, and phospholipase A2 group IVA may be the most promising therapeutic targets. Conclusion: BYP can inhibit inflammation and oxidative stress as well as promote haematopoiesis, potentially improving anaemia.
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BACKGROUND@#Obesity and insulin resistance (IR) are common features of polycystic ovary syndrome (PCOS). Metformin (MET) increases insulin sensitivity, but it is associated with unsatisfactory weight loss. The glucagon-like peptide-1 receptor agonist exenatide has been shown to reduce weight and IR in patients with diabetes. This study aimed to explore the therapeutic effects of exenatide once-weekly (QW) combined with MET on body weight, as well as metabolic and endocrinological parameters in overweight/obese women with PCOS.@*METHODS@#Fifty overweight/obese women with PCOS diagnosed via the Rotterdam criteria were randomized to one of two treatment groups: MET (500 mg three times a day [TID]) or combination treatment (COM) (MET 500 mg TID, exenatide 2 mg QW) for 12 weeks. The primary outcomes were anthropometric changes associated with obesity, and the secondary outcomes included changes in reproductive hormone levels, glucose and lipid metabolism, and C-reactive protein.@*RESULTS@#Forty (80%) patients completed the study. COM therapy was superior to MET monotherapy in reducing weight (P = 0.045), body mass index (BMI) (P = 0.041), and waist circumference (P = 0.023). Patients in the COM group on an average lost 3.8 ± 2.4 kg compared with 2.1 ± 3.0 kg in the MET group. In the COM group, BMI and waist circumference decreased by 1.4 ± 0.87 kg/m2 and 4.63 ± 4.42 cm compared with 0.77 ± 1.17 kg/m2 and 1.72 ± 3.07 cm in the MET group, respectively. Moreover, levels of fasting glucose, oral glucose tolerance test (OGTT) 2-h glucose, and OGTT 2-h insulin were significantly lower with COM therapy than with MET (P < 0.050). Mild and moderate gastrointestinal reactions were the most common adverse events in both groups.@*CONCLUSIONS@#COM therapy was more effective than MET alone in reducing body weight, BMI, and waist circumference, and improving insulin sensitivity in overweight/obese women with PCOS, with acceptable short-term side effects.@*TRIAL REGISTRATION@#ClinicalTrials.gov, NCT04029272. https://clinicaltrials.gov/ct2/show/NCT04029272.
Subject(s)
Female , Humans , Exenatide/therapeutic use , Metformin/therapeutic use , Obesity/drug therapy , Overweight , Polycystic Ovary Syndrome/drug therapyABSTRACT
Objective To investigate the molecular protective mechanisms of myocardial hypertrophic preconditioning by mitochondrial quantitative proteomics. Methods Fourteen C57BL6/ J male mice were randomly divided into sham group(n = 6) and cardiac hypertrophy preconditioning group(n = 8). The murine model of cardiac hypertrophy preconditioning was established by imposing transverse aortic constriction for 3 days and debanding the aorta for 4 days. Three mice from sham group and four mice from cardiac hypertrophy preconditioning group were randomly selected for proteomic analysis, and the remaining mice were used for functional and morphological experiments. The cardiac function was detected by echocardiography, and mechanical properties of cardiomyocytes were assessed using a SoftEdge Myocam. Cardiac morphology and mitochondrial ultrastructure were detected by pathological sections and transmission electron microscopy. The most significant mitochondrial proteins were screened by label-free quantitative proteomics and analyzed by bioinformatics analysis. Western blotting was used to verify the expression changes. Results Compared with the sham group, there were no significant changes in cardiac function and myocardial tissue morphology in the cardiac hypertrophy preconditioning group. However, electron microscopy analyses showed that the density of mitochondrial cristae increased in cardiac hypertrophy preconditioning group. Proteomic analysis screened 20 differentially expressed mitochondrial proteins. Bioinformatics analysis revealed that differentially expressed proteins were mainly related to mitochondrial ribosomal proteins. Western blotting results of key proteins were consistent with proteomic analysis. Conclusion Myocardial hypertrophic preconditioning can promote the energy metabolism of myocardial mitochondria, which may be related to the transcription, processing and transportation of mitochondrial oxidative phosphorylation complex mediated by mitochondrial ribosomal proteins.
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OBJECTIVE@#To evaluate the effects of Chinese medicine Dingkun Pill () alone or in combination with Diane-35 on patients with polycystic ovary syndrome (PCOS).@*METHODS@#This is a prospective randomized controlled trial conducted at Peking Union Medical College Hospital Beijing, China, from December 2016 to September 2017. Totally 117 PCOS patients were randomly assigned to the Dingkun Pill group (38 cases), Diane-35 group (40 cases), or combined group (39 cases). Patients in the Dingkun Pill group or Diane-35 group took daily 7 g of oral Dingkun Pill or 1 tablet of oral Diane-35, respectively, for 21 consecutive days followed by 7 drug-free days. And the combined group received a combination of Dingkun Pill and Diane-35. The treatment course was 3 months. Fasting plasma glucose and insulin, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), free fatty acids (FFA) and sex hormones were analyzed, quantitative insulin sensitivity check index (QUICKI) was calculated, and menstruation and acne scores were recorded at baseline and after 3-month treatment.@*RESULTS@#Compared with before treatment, QUICKI decreased significantly in the Dingkun Pill and combined groups after 3-month treatment (P0.05).@*CONCLUSIONS@#Dingkun Pill showed better effects than Diane-35 in improving insulin sensitivity, lowering TC and FFA. Diane-35 was more efficient in regulating menstruation and lowering androgen than Dingkun Pill. Combination of Dingkun Pill and Diane-35 may be a better choice to regulate menstruation, lower androgens while improve glucose metabolism in PCOS patients. (Registered on ClinicalTrials.gov, registration No. NCT03264638).
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OBJECTIVE@#To assess the efficacy and safety of the Chinese medicine Dingkun Pill (, DKP) on insulin resistance in women with polycystic ovary syndrome (PCOS).@*METHODS@#A total of 117 women with PCOS were randomly assigned to Group A (38 women), Group B (40 women), or Group C (39 women) in a randomization sequence with SAS software and a 1:1:1 allocation ratio using random block sizes of 6, and were given 7 g of oral DKP daily (Group A), 1 tablet of Diane-35 orally daily (Group B), or 7 g of oral DKP daily plus 1 tablet of Diane-35 orally daily (Group C). Patients took all drugs cyclically for 21 consecutive days, followed by 7 drug-free days. The treatment course for the 3 groups was continued for 3 consecutive months. Oral glucose tolerance tests (OGTT) were performed before treatment and again after 2 and 3 months of therapy, respectively, and homeostasis model assessment for insulin resistance (HOMA-IR) and quantitative insulin sensitivity check index (QUICKI) were calculated.@*RESULTS@#Of 117 women with PCOS, 110 completed the entire course of therapy: 35 in Group A, 36 in Group B, and 39 in Group C. After treatment, all three groups showed significant decreases in fasting glucose: at 1 h glucose decreased significantly in Group A (by 0.5 ± 1.4 mmol/L, P=0.028) and Group C (by 0.5 ± 1.2 mmol/L, P=0.045); while showing a tendency to increase in Group B (by 0.4 ± 1.9 mmol/L, P=0.238). HOMA-IR decreased significantly in Group C [by 0.5 (-2.2 to 0.5) mIU mmol/L, P=0.034]. QUICKI was significantly increased in Groups A and C (by 0.009 ± 0.02, P=0.033 and by 0.009 ± 0.027, P=0.049, respectively), while no change was observed in Group B. Repeated-measure ANOVA showed that the absolute changes in all parameters (except for glucose at 1 h), including glucose and insulin levels at all time-points during OGTT and in HbA1c, HOMA-IR, and QUICKI, were not significantly different among the 3 groups after treatment (P>0.05).@*CONCLUSION@#DKP or DKP combined with Diane-35 produce a slight improvement in insulin sensitivity compared with Diane-35 alone in PCOS patients (Trial Registration: ClinicalTrials.gov, NCT03264638).
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Infertility with diminished ovarian reserve(DOR) is a major problem in the field of reproductive health and it has attracted great attention worldwidely.Function deficiency of the kidney is one of the fundamental pathogenesis for DOR.Traditional Chinese medicines(TCMs) have a long history with rich experience for the treatment of infertility.Some TCMs are very effective in the treatment of kidney deficiency for infertility with DOR.The integrated TCMs and western medicine,and combination of disease differentiation and syndrome differentiation may help for diagnosis and treatment of infertility with DOR.We adopt the concept of unified treatment for special disease,and the methods and principle of treatment can be used.Therefore,we adopt the TCM concept of kidney-tonifying,blood-nourishing,liver-dispersing and spleen-invigorating.The TCMs kidney-tonifying formulae are added and subtracted.TCMs can regulate the reproductive function via multiple systems for simultaneous conditioning of follicular development and ovulation.At the same time,a hypothesis of " simultaneous conditioning of follicular development and ovulation" was proposed.Two-stage therapy with integrated TCMs and western medicine has been used,mainly for increasing the number of eggs,and improving follicle quality.The goal is to achieve simultaneous conditioning of follicular development and ovulation and ultimately for effective treatment of infertility with DOR.
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<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of Heyan Kuntai Capsule (, HYKT) and hormone therapy (HT) on perimenopausal syndromes (PMSs).</p><p><b>METHODS</b>From 2005 to 2008, 390 women with PMSs were recruited from 4 clinic centers. The inclusion criteria included ages 40 to 60 years, estradiol (E2) below 30 ng/L, and follicle stimulating hormone (FSH) above 40 IU/L, etc. The patients were randomly assigned to HYKT group or HT group by random number table method, administrated HYKT or conjugated estrogen with/without medroxyprogesterone acetate tablets for 12 months. During treatment, the patients were interviewed quarterly, Kupperman Menopausal Index (KMI) scores, hot flush scores, insomnia scores, Menopause-Specific Quality of Life (MENQOL) scores and adverse effects were used for evaluating drug efficacy and safety respectively. The last interview was made at the end of 12-month treatment RESULTS: After treatment, KMI scores of HYKT group and HT group were both significantly decreased compared with baseline (P <0.01) and there was no significant difference between groups (P >0.05), except that KMI of HYKT group was higher after 3-month treatment (P <0.05). After treatment, hot flush and insomnia scores were both improved significantly in two groups (P <0.01); and HT had a better performance than HYKT in improving hot flush (P <0.05). MENQOL were significantly improved in both groups after treatment (P <0.01); but there was no significant difference between two groups (P >0.05). The incidence of adverse event in the HYKT group was much lower than that in the HT group (P <0.01).</p><p><b>CONCLUSIONS</b>HYKT could effectively relieve PMSs and improve patients quality of life without severe adverse reactions. Although HYKT exerted curative effects more slowly than hormone, it possessed better safety profile than hormone.</p>
Subject(s)
Adult , Female , Humans , Middle Aged , Combined Modality Therapy , Drugs, Chinese Herbal , Estrogen Replacement Therapy , Hot Flashes , Drug Therapy , Perimenopause , Quality of Life , Treatment OutcomeABSTRACT
Objective To analyze the clinical features of 17α-hydroxylase deficiency and explore the appropriate timing and methods of surgical treatment. Methods We retrospectively analyzed the clinical data of patients with complete 17α-hydroxylase deficiency,containing Y chromosome material in their karyotype,adimitted to Peking Union Medical College Hospital from January 2004 to December 2014. Results Thirty patients with complete 17α-hydroxylase deficiency were included. Their social gender were all female and the mean age at diagnosis was (16.1±2.7) years. Twenty-six patients (86.7%) presented with primary amenorrhea and hypertension. The development of secondary sexual characteristics was poor and their uterus was absent. The levels of gonadotropin,progesterone,and adrenocorticotropic hormone were elevated in all patients and the levels of estradiol,testosterone,and cortisol were decreased. All patients had undergone laparoscopic gonadectomy. Most (86.7%) of the gonads were located in abdomen,while 13.3% were in inguinal canal. Histopathology confirmed that gonadal malignancy was obsetved in two patients (6.7%): one with leydig cell tumor and the other with sertoli cell tumor. Conclusions Patients with complete 17α-hydroxylase deficiency have specific clinical features. Early diagnosis and timely laparoscopic gonadectomy are critical to prevent gonadal malignancy.
Subject(s)
Adolescent , Female , Humans , Adrenal Hyperplasia, Congenital , General Surgery , Amenorrhea , Hypertension , Karyotyping , Retrospective Studies , Steroid 17-alpha-HydroxylaseABSTRACT
<p><b>BACKGROUND</b>Menopausal hormone therapy (MHT) has been proven to have beneficial effects on several components of metabolic syndrome. However, the effects vary according to different regimens, dosages, and duration of MHT. The aim of the study was to evaluate the effect of standard-dose 0.625 mg conjugated equine estrogen (CEE) and half-dose 0.3 mg CEE daily with different progestogens in a continuous sequential regimen on postmenopausal metabolic parameters in generally healthy postmenopausal women.</p><p><b>METHODS</b>A prospective, open-label, randomized controlled clinical trial was conducted between February 2014 and December 2015. Totally 123 Chinese postmenopausal women with climacteric symptoms were included in this study and were randomly assigned to three groups: Group A received CEE 0.3 mg/micronized progesterone (MP) 100 mg daily; Group B received CEE 0.625 mg/MP 100 mg daily; and Group C received CEE 0.625 mg/dydrogesterone 10 mg daily. Drugs were given in a continuous sequential pattern. The duration of treatment was 12 months. Clinical, anthropometrical, and metabolic variables were measured. Data were analyzed according to intention-to-treat analysis, using Student's t-test and analysis of variance.</p><p><b>RESULTS</b>A total of 107 participants completed the 12-month follow-up and were included in the data analysis. At 12 months of treatment, high-density lipoprotein cholesterol and apolipoprotein A significantly increased, and low-density lipoprotein cholesterol, fasting glucose, and glycosylated hemoglobin significantly decreased in Groups B and C, compared with baseline (all P < 0.05). Among the three groups, only Group C showed significantly increased triglycerides compared with baseline (1.61 ± 0.80 mmol/L vs. 1.21 ± 0.52 mmol/L, P = 0.026). Each group showed a neutral effect on total cholesterol, lipoprotein A, apolipoprotein B, and fasting insulin levels. No cardiovascular and venous thromboembolic events occurred in the three groups.</p><p><b>CONCLUSIONS</b>Among Chinese postmenopausal women, half-dose CEE was not sufficient to induce a favorable lipid and carbohydrate profile compared with standard-dose CEE. Adding natural MP may counterbalance the TG-increasing effect of CEE.</p><p><b>TRIAL REGISTRATION</b>ClinicalTrials.gov, NCT01698164; https://clinicaltrials.gov/ct2/show/NCT01698164?term=NCT01698164&rank=1.</p>
Subject(s)
Female , Humans , Middle Aged , Apolipoproteins B , Blood , Blood Pressure , Body Composition , Dydrogesterone , Therapeutic Uses , Estrogens, Conjugated (USP) , Therapeutic Uses , Insulin , Blood , Lipoprotein(a) , Blood , Metabolic Syndrome , Blood , Drug Therapy , Postmenopause , Progesterone , Therapeutic Uses , Triglycerides , BloodABSTRACT
Objective To summarize the clinical features of XO/XY gonadal dysgenesis. Method We retrospectively analyzed the clinical data of patients with XO/XY gonadal dysgenesis admitted to Peking Union Medical College Hospital from January 2008 to May 2015. Results Totally 32 patients with XO/XY gonadal dysgenesis were included. The social gender was female in all subjects and the age 6 to 33 years. Patients presented mainly with primary amenorrhea or short stature,and usually had specific somatic signs of Turner's syndrome. The breast development of 27 patients (84.38%) was less than level 3. The armpit hair was sparse or absent in 28 patients (87.5%) and the pubic hair was sparse or absent in 26 patients (81.25%).Other findings include naive vulva (n=18,56.25%)) and enlarged clitoris (n=5,15.63%). The average level of follicle stimulating hormone was (78.56±35.62) mIU/ml,the luteinizing hormone level was (20.23±11.35) mIU/ml,the estradiol level was (9.94±8.21) pg/ml,and the testosterone level was (0.24±0.18) ng/ml. All patients received prophylactic gonadectomy. The histopathology results showed a variety of gonads,and gonadal malignancy were observed in 4 patients.Conclusions Patients with XO/XY gonadal dysgenesis manifest primary amenorrhea or short stature,poorly developed secondary sexual characteristics,and elevated gonadotropin level. The gonads have increased risk of gonadal malignancy.
Subject(s)
Adolescent , Adult , Child , Female , Humans , Young Adult , Estradiol , Blood , Follicle Stimulating Hormone , Blood , Gonadal Dysgenesis, 46,XY , Luteinizing Hormone , Blood , Retrospective Studies , Testis , Congenital Abnormalities , Testosterone , Blood , Turner SyndromeABSTRACT
<p><b>BACKGROUND</b>It is now recognized that Cimicifuga foetida (C. foetida) extract is effective in alleviating menopausal symptoms. But the durations reported were usually short. The aim of this study was to investigate the effects of C. foetida extract therapy and different estrogen and progesterone sequential therapies, on the breasts of early postmenopausal women.</p><p><b>METHODS</b>This was a prospective randomized trial. Ninety-six early menopausal women were recruited and randomly assigned into three groups treated with different therapies for 2 years. Patients were given C. foetida extract in Group A, estradiol valerate and medroxyprogesterone acetate in Group B, and estradiol valerate and progesterone in Group C. Ultrasonography was used to monitor changes in breast during treatment.</p><p><b>RESULTS</b>In comparing breast glandular section thickness before and after 1 and 2 years of treatment, no significant difference was observed in Group A (11.97 ± 2.84 mm vs. 12.09 ± 2.58 mm and 12.61 ± 3.73 mm, P > 0.05); in Group B glandular section thickness had increased significantly (10.98 ± 2.34 mm vs. 11.84 ± 2.72 mm and 11.90 ± 3.33 mm, P < 0.05) after treatment, the same as Group C (11.56 ± 3.03 mm vs. 12.5 ± 3.57 mm and 12.22 ± 4.39 mm P < 0.05). In comparing breast duct width before and after 1 and 2 years of treatment, no significant difference was seen in Group A (1.07 ± 0.19 mm vs. 1.02 ± 0.18 mm and 0.98 ± 0.21 mm, P > 0.05); in Group B the duct width had a downward trend after treatment (0.99 ± 0.14 mm vs. 0.96 ± 0.22 mm and 0.90 ± 0.18 mm, P < 0.05), the same as Group C (1.07 ± 0.20 mm vs. 1.02 ± 0.17 mm and 0.91 ± 0.19 mm, P < 0.05). The nodules detected before treatment had disappeared after 1-year of treatment or exhibited no distinct changes in the three groups. However, new breast nodules had appeared after 2 years of treatment: There was one case in Group A, two cases in Group B and four cases in Group C, with breast hyperplasia after the molybdenum target check.</p><p><b>CONCLUSIONS</b>In early postmenopausal patients, C. foetida extract therapy and estrogen and progesterone therapy at low doses did not increase the incidence of malignant breast tumors.</p>
Subject(s)
Adult , Female , Humans , Male , Middle Aged , Breast , Breast Neoplasms , Drug Therapy , Cimicifuga , Chemistry , Estrogens , Therapeutic Uses , Hormone Replacement Therapy , Plant Extracts , Pharmacology , Postmenopause , Progestins , Therapeutic Uses , SoftwareABSTRACT
<p><b>BACKGROUND</b>Despite great reduction of in-stent restenosis, first-generation drug-eluting stents (DESs) have increased the risk of late stent thrombosis due to delayed endothelialization. Arsenic trioxide, a natural substance that could inhibit cell proliferation and induce cell apoptosis, seems to be a promising surrogate of sirolimus to improve DES performance. This randomized controlled trial was to evaluate the efficacy and safety of a novel arsenic trioxide-eluting stent (AES), compared with traditional sirolimus-eluting stent (SES).</p><p><b>METHODS</b>Patients with symptoms of angina pectoris were enrolled and randomized to AES or SES group. The primary endpoint was target vessel failure (TVF), and the second endpoint includes rates of all-cause death, cardiac death or myocardial infarction, target lesion revascularization (TLR) by telephone visit and late luminal loss (LLL) at 9-month by angiographic follow-up.</p><p><b>RESULTS</b>From July 2007 to 2009, 212 patients were enrolled and randomized 1:1 to receive either AES or SES. At 2 years of follow-up, TVF rate was similar between AES and SES group (6.67% vs. 5.83%, P = 0.980). Frequency of all-cause death was significantly lower in AES group (0 vs. 4.85%, P = 0.028). There was no significant difference between AES and SES in frequency of TLR and in-stent restenosis, but greater in-stent LLL was observed for AES group (0.29 ± 0.52 mm vs. 0.10 ± 0.25 mm, P = 0.008).</p><p><b>CONCLUSIONS</b>After 2 years of follow-up, AES demonstrated comparable efficacy and safety to SES for the treatment of de novo coronary artery lesions.</p>
Subject(s)
Aged , Female , Humans , Male , Middle Aged , Arsenicals , Therapeutic Uses , Coronary Angiography , Coronary Artery Disease , Diagnostic Imaging , General Surgery , Drug-Eluting Stents , Follow-Up Studies , Oxides , Therapeutic Uses , Percutaneous Coronary Intervention , Methods , Polymers , Chemistry , Sirolimus , Therapeutic UsesABSTRACT
Objective To study the effect of myocardial bridge oppression on blood flow, positive pressure, circumferential stress and shear stress of the coronary artery. Methods The original myocardial bridge simulative device was greatly improved to be able to measure multi-hemodynamic parameters, such as normal stress, circumferential stress and shear stress, so as to exactly simulate real blood dynamics environment with the common effect of several stresses, and comprehensively investigate the relationship between hemodynamics and atherosclerosis of mural coronary artery under the combined effects of several stresses. Results The results from the myocardial bridge simulative device indicated that the hemodynamic abnormalities were mainly located in the proximal end of mural coronary artery, and the mean and oscillation values of normal stress at the proximal end were increased by 27.8% and 139%, respectively, showing a significant increase with the intensification of myocardial bridge oppression. Conclusions It is myocardial oppression that causes the hemodynamic abnormity of proximal coronary artery, which is quite important for understanding the hemodynamic mechanism of coronary atherosclerotic diseases and valuable for studying pathological effects and treatments of the myocardial bridge in clinic.
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<p><b>BACKGROUND</b>It is now recognized that Cimicifuga foetida extract is effective in alleviating menopausal symptoms. But the durations reported were usually short. This paper compares the clinical effects of different regimens of three-month course on climacteric symptoms in Chinese women, so as to evaluate the efficacy and safety of Cimicifuga foetida extract.</p><p><b>METHODS</b>This was a prospective, randomized trial. Ninety-six early menopausal women were recruited and randomly assigned into 3 groups to take different kinds of medicine for 3 months; participants were given Cimicifuga foetida extract daily in group A (n = 32), given estradiol valerate and progesterone capsule cycle sequentially in group B (n = 32), and given estradiol valerate and medroxyprogesterone acetate cycle sequentially in group C (n = 32). The questionnaires of Kupperman menopause index, Menopause-Specific Quality of Life, and Hospital Anxiety and Depression Scale were finished before and after the treatment. The status of vaginal bleeding and breast tenderness was recorded every day.</p><p><b>RESULTS</b>Eighty-nine participants (89/96, 92.7%) completed the treatment. Kupperman menopause index decreased after taking the medicine for 3 months in each group (with all P < 0.001), but the score after the treatment was higher in group A than in the other 2 groups. Except for the score of sexual domain in group A (P = 0.103), the scores of all domains of the Menopause-Specific Quality of Life decreased significantly after the treatment in all groups (with all P ≤ 0.01). Score of anxiety decreased significantly in group A (P = 0.015) and B (P = 0.003). Incidence of breast tenderness was 12.9% (4/31) in group A, 36.7% (11/30) in group B, and 14.3% (4/28) in group C. Incidence of vaginal bleeding was 6.5% (2/31) in group A, 26.7% (8/30) in group B, and 82.1% (23/28) in group C.</p><p><b>CONCLUSIONS</b>Cimicifuga foetida extract is effective and safe in the treatment of menopausal syndrome. It is worth extending its use in the treatment of climacteric complaints, especially among those having contradiction for hormone replacement therapy.</p>
Subject(s)
Female , Humans , Middle Aged , Cimicifuga , Hot Flashes , Drug Therapy , Menopause , Psychology , Phytotherapy , Plant Extracts , Therapeutic Uses , Prospective Studies , Quality of Life , Uterine HemorrhageABSTRACT
<p><b>OBJECTIVE</b>To investigate late stent malapposition or vessel remodeling post chitosan/heparin layer-by-layer self assembly coating stent (LBL) implantation in porcine.</p><p><b>METHODS</b>A total of 32 stents [bare metal stent (BMS, n = 9), sirolimus-eluting stent (SES, n = 11) and LBL (n = 12)] were implanted into coronary arteries of 16 porcine. Intravascular ultrasound (IVUS) was performed immediately after stenting and at 1 month after stenting to measure vessel area (VA), stent area (SA) and lumen area (LA). Neointima area (NA) was measured at 1 month post stenting by IVUS to detect signs of stent malapposition and to determine remodeling index (RI). Histopathology was performed at 1 month post stenting to observe vessel wall structure and stent malapposition status.</p><p><b>RESULTS</b>No sign of stent malapposition was detected, VA and SA/LA were similar among groups immediately after stent implantation. At 1 month follow-up, none of three groups showed stent malapposition. VA, SA, NA and LA were (7.30 ± 0.77), (6.83 ± 0.76), (1.40 ± 0.96) and (5.43 ± 0.88) mm(2) in LBL group, (7.13 ± 0.69), (6.63 ± 0.71), (0.28 ± 0.35) and (6.34 ± 0.89) mm(2) in SES group, (7.48 ± 0.70), (7.00 ± 0.52), (2.69 ± 1.58) and (4.31 ± 1.28) mm(2) in BMS group. VA and SA were similar among groups (all P > 0.05). LA in LBL group was smaller than SES group (P < 0.01) and significantly larger than in BMS group (P < 0.05).NA in LBL group was larger than SES group (P < 0.01) and significantly smaller than in BMS group (P < 0.05).RI in LBL, SES and BMS groups was 0.95 ± 0.07, 1.02 ± 0.04 and 0.98 ± 0.04 (P > 0.05).</p><p><b>CONCLUSIONS</b>There is no late stent malapposition or abnormal remodeling post LBL, SES and BMS implantation up to 1 month in this porcine model. LA in LBL group is smaller than SES group and larger than BMS group at 1 month after implantation in this porcine model.</p>
Subject(s)
Animals , Chitosan , Coronary Restenosis , Diagnostic Imaging , Therapeutics , Coronary Vessels , Diagnostic Imaging , Drug-Eluting Stents , Heparin , Swine , Ultrasonography, InterventionalABSTRACT
<p><b>BACKGROUND</b>Few studies have given suggestions on appropriate individual progesterone dosage in patients with progesterone deficiency. This study was designed to provide a reference for the clinical use of oral progesterone by exploring the relationship among Body Mass Index (BMI), dosage of progesterone, and serum progesterone concentration. Many gynecology and obstetrics doctors are unfamiliar with progesterone treatment. Our study is intended to help determine the dosage of oral progesterone.</p><p><b>METHODS</b>This was a block randomized, open-label, prospective clinical trial. Eighty women undergoing cessation of menses were recruited, given oral progesterone therapy for 10 consecutive days. They were randomly assigned to four groups (four different doses of progesterone, n = 20): group A 100 mg/d, group B 200 mg/d, group C 300 mg/d, and group D 400 mg/d.</p><p><b>RESULTS</b>Seventy-four patients (92.5%, 74/80) completed the study. It was observed that administration of progesterone significantly increased serum progesterone concentration in the four groups (all P < 0.001). And there is a positive correlation between the increase and dosage (r(p) = 0.613, P < 0.001). A further linear regression analysis found the major regression equation: when 18.5 kg/m(2) ≤ BMI < 24 kg/m(2), Y = 8.4820×10(0.003X) (R(2) = 0.425, P < 0.001); Y was the increase of serum progesterone concentration in nmol/L, and X was the dosage of oral progesterone in mg/d.</p><p><b>CONCLUSIONS</b>Serum progesterone levels went up linearly as the dosage increased. The higher the patient's BMI, the higher dosage would be needed to achieve the same serum progesterone concentration. The appropriate dosage of oral progesterone for different patients can be roughly calculated in light of the results of this study.</p>
Subject(s)
Adult , Female , Humans , Administration, Oral , Body Mass Index , Menstruation Disturbances , Drug Therapy , Progesterone , Therapeutic UsesABSTRACT
<p><b>BACKGROUND</b>Adenomyoma is a very serious disease which influence the quality of life and leads to the infertility, and hysterectomy at the end. Unfortunetly, we still have no effective way to treat this kind of diseases. This study was aimed to evaluate the efficacy and surgical characteristics of modified adenomyomectomy.</p><p><b>METHODS</b>This is a retrospective study and the subjects were collected in the past 5 years. We divided the subjects by the two different surgical procedures. Cases of adenomyoma patients who underwent conservative surgery, modified adenomyomectomy or wedge resection of the adenomyoma lesion were distributed to two groups retrospectively. Surgical characteristics, symptom relief, and recurrence were analysed in each group.</p><p><b>RESULTS</b>General characteristics, including operation time, blood loss, and postoperative complication were similar in both groups. In the modified adenomyometomy group, the median follow-up time was 27.6 months and the rate of relief of dysmenorrhea and menorrhagia symptoms were 91.2% and 40.0%, respectively. In the wedge resection group, the rate of reliefe of dysmenorrhea and menorrhagia symptoms were 88.9% and 50.0%, respectively. Patients in both groups had statistically significant symptom relief, but there was no statistical difference between them. During the following time, ultrasonography relapse rate in modified modified adenomyomectomy group is significantly lower than the wedge resection group 15.0% vs. 69.2% (P < 0.001). The relapse rate, in terms of symptoms, was 5.0% in the modified adenomyomectomy group, which was similar to the relapse rate in the wedge resection group. In terms of reproductive outcome, 33.3% of the patients with infertility complications in the modified adenomyomectomy group became pregnant. Among them, the rate of pregnancy by assisted reproductive techniques was 45.5%, which was significantly higher than the rate of natural pregnancy, 23.1% (P = 0.039).</p><p><b>CONCLUSION</b>Modified adenomyomectomy appears to be a safe and effective operative method that shows advantages in reducing the rate of relapse after surgery.</p>
Subject(s)
Adult , Female , Humans , Adenomyoma , Diagnostic Imaging , General Surgery , Retrospective Studies , Treatment Outcome , Ultrasonography , Uterine Neoplasms , Diagnostic Imaging , General SurgeryABSTRACT
<p><b>OBJECTIVE</b>We aimed to perform a meta-analysis of clinical trials on the efficacy of autologous bone marrow-derived cells (BMCs) transfer for patients with chronic ischemic heart disease.</p><p><b>METHODS</b>We searched MEDLINE, EMBASE, and Cochrane database through September 2009. Eligible studies were randomized controlled trials of autologous BMCs infusion in patients with chronic ischemic heart disease. We gathered information about left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV) and death, and did a random-effect meta-analysis to obtain summary effect estimates for outcomes. The pooled analyses were performed and forest plots were generated with RevMan 5.0 software. Heterogeneity was assessed by meta-regression with STATA 10.0 software. Additionally, subgroup analysis was performed to compare the effect of intracoronary BMCs transfer with intramyocardial cell injection on LVEF.</p><p><b>RESULTS</b>Eleven trials with 490 participants were identified. There were 268 patients in BMCs group, and 222 in control group. In control group, the patients received saline injection or autologous plasma injection or no injection. BMCs transfer was performed via intracoronary transfer or intramyocardial injection. Compared with controls, BMCs transfer significantly improved LVEF by 4.63% (95%CI 2.42 to 6.84; P < 0.01). BMCs transfer was also associated with significant reductions in LVEDV (standardized mean difference -0.55, 95%CI -0.94 to -0.17, P = 0.005) and LVESV (standardized mean difference -0.45, 95%CI -0.73 to -0.17, P = 0.002). In addition, BMCs treatment was associated with a significant effect on death (OR 0.42, 95%CI 0.18 to 1.01, P = 0.05). Subgroup analysis indicated that intramyocardial cell injection was preferred due to its more significant improvement of LVEF than intracoronary cell therapy. Meta-regression suggested the existence of a negative association between baseline LVEF and LVEF change.</p><p><b>CONCLUSION</b>BMCs infusion is associated with a significant improvement in LVEF, and an attenuation of left ventricular remodeling.</p>