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BACKGROUND: We previously reported that REBACIN effectively eliminates persistent high-risk human papillomavirus (hrHPV) infection. Here, we conducted a prospective multicenter cohort study to evaluate the safety and effectiveness of REBACIN, taking into account factors such as specific hrHPV subtype and patient's age. METHODS: According to inclusion/exclusion criteria and participant willingness, 3252 patients were divided into REBACIN group while 249 patients into control group. Patients in REBACIN group received one course treatment of intravaginal administration of REBACIN while no treatment in control group. After drug withdrawal, participants in both groups were followed up. RESULTS: The clearance rate of persistent hrHPV infection in REBACIN group was 60.64%, compared to 20.08% in control group. Specifically, the clearance rates for single-type infection of HPV16 or HPV18 were 70.62% and 69.23%, respectively, which was higher than that of HPV52 (59.04%) or HPV58 (62.64%). In addition, the single, double, and triple/triple+ infections had a clearance rate of 65.70%, 53.31%, and 38.30%, respectively. Moreover, 1635 patients under 40 years old had a clearance rate of 65.14%, while it was 55.08% for 1447 patients over 40 years old. No serious adverse effects were found. CONCLUSION: This study confirmed that REBACIN can effectively and safely eliminate persistent hrHPV infection, which the clearance rate of HPV16/18 is higher than that of HPV52/58, the clearance rate of single-type infection is higher than that of multiple-type infections, and the clearance rate in young patients is higher than that in elder patients, providing a guidance for REBACIN application in clearing hrHPV persistent infection in real-world settings. CLINICAL TRIAL REGISTRATION: Chinese Clinical Trial Registry Registration Number: ChiCTR1800015617 http://www.chictr.org.cn/showproj.aspx?proj=26529 Date of Registration: 2018-04-11.
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Infecções por Papillomavirus , Displasia do Colo do Útero , Neoplasias do Colo do Útero , Feminino , Humanos , Idoso , Adulto , Papillomavirus Humano , Estudos de Coortes , Estudos Prospectivos , Papillomavirus Humano 16 , Papillomavirus Humano 18 , Infecções por Papillomavirus/tratamento farmacológico , Papillomaviridae , GenótipoRESUMO
The widespread prevalence of Pelvic Organ Prolapse (POP) and the paucity of ongoing treatments prompted us to develop a unique rat model combining ovariectomy and simulated vaginal delivery. We hypothesized that the tissue changes caused by low hormone levels and mechanical stretch could complement each other. Thus, the combined model can potentially mimic the collagen metabolism of vaginal wall tissue as well as mechanical stretch properties to complement disease progression in POP. Ovariectomy with sequential simulated vaginal delivery was performed on rats in the modeling group. Sham surgeries were performed as control. At 2, 4, and 12 weeks after modeling, the vaginal tissues of rats were evaluated by Masson's trichrome staining, Picro-Sirius red staining, immunohistochemistry, western blotting, and uniaxial tensile tests. Compared to the control group, the vaginal tissues of the model rats showed an atrophic epithelial layer and loose collagen fibers. The smooth muscle fibers were ruptured, smaller in diameter, and disorganized. The ratio of collagen type I/III significantly increased, but the contents of both Collagen I and III decreased. The expression of metalloproteinases 2 and 9 in the tissues increased, and the expression of tissue inhibitors of metalloproteinases 1 and 2 decreased. The tangent modulus of the tissues was significantly increased in the model rats. We verified a novel method to establish a pelvic organ prolapse model in rats. This approach combined the advantages of low hormone levels and mechanical stretch effects.
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Prolapso de Órgão Pélvico , Feminino , Humanos , Ratos , Animais , Prolapso de Órgão Pélvico/metabolismo , Colágeno Tipo I/metabolismo , Colágeno Tipo III/metabolismo , Ovariectomia , HormôniosRESUMO
Considering the limitations of medical science and the risks associated with medical treatments, we need to re-examine the connotation of medical science from the perspective of philosophy. Medical science is the natural expression of human kindness and human nature of rescuing the dying and healing the wounded. It is a combination of the natural sciences, social sciences, and humanities. From the perspectives of medical philosophy and humanistic care, this article expounds the concepts and ideas of evidence-based, translational, and precision medicine in modern medicine and emphasizes the importance of avoiding new technical bureaucracy, paying attention to achieving a holistic view and systematic understanding, and avoiding biases in development because of the loss of the humanistic spirit in modern medical practice.
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Medicina , Ciências Humanas , Humanos , Medicina/tendências , Filosofia MédicaRESUMO
Objective To investigate the clinical characteristics of preadolescent and adolescent female patients with ovarian mass combined with dysplasia of secondary sexual characteristics. Methods This study retrospectively analyzed 18 cases of ovarian mass combined with dysplasia of secondary sexual characteristics aged 0-19 years admitted to Peking Union Medical College Hospital from January 2012 to November 2019.By analyzing the clinical manifestations,surgical methods,postoperative pathology,therapies and prognosis of the cases,we summarized the diagnosis and treatment ideas. Results Among the 18 cases,7(7/18,38.9%)developed secondary sex signs before puberty,including 5 cases showing precocity(including 2 cases of juvenile granulosa cell tumor,1 case of gonadoblastoma,1 case of ovarian follicular cyst,and 1 case of 46,XY simple gonadal dysplasia combined with dysgerminoma)and 2 cases presenting masculine manifestations(1 case of steroid cell tumor and 1 case of sclerosing stromal tumor).The rest 11(11/18,61.1%)cases showed abnormal development of secondary sexual characteristics during puberty,including 8 cases with masculine manifestations or abnormal menstruation after menarche(7 cases with sex cord stromal cell tumor and 1 case with cystic granulosa cell tumor),2 cases with primary amenorrhea(1 case with androgen insensitivity syndrome combined with testicular sertoli cell tumor and 1 case with endometriosis cyst combined with reproductive tract malformation),and 1 case diagnosed as 46,XX gonadal dysplasia with serous cystadenoma and no secondary sexual development during puberty. Conclusions Sex hormone levels should be actively tested in the case of prepubertal secondary sexual characteristics appearing early,pubertal secondary sexual characteristics being abnormal(underdevelopment),and/or menstrual abnormalities.Imaging examination should be performed to exclude ovarian organic lesions,and chromosome karyotype analysis should be performed if necessary.The diagnosis of ovarian mass in preadolescent and adolescent females with related symptoms should first be alerted to cord stromal cell tumor.It is recommended to rule out the possibility of combined reproductive tract malformation in the adolescent patients with primary amenorrhea.Chromosome examination should be conducted to rule out the possibility of gonadal dysplasia in the adolescent patients with primary amenorrhea and/or no development of secondary sexual characteristics.
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Neoplasias Ovarianas , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Hiperplasia/complicações , Lactente , Recém-Nascido , Neoplasias Ovarianas/patologia , Estudos Retrospectivos , Adulto JovemRESUMO
INTRODUCTION AND HYPOTHESIS: This study aimed to investigate the evaluation and management of complications after pelvic floor reconstructive surgery for pelvic organ prolapse in China. METHODS: Complications of pelvic floor reconstructive surgery for pelvic organ prolapses from 27 institutions were reported from November 2017 to October 2019. All complications were coded according to the category-time-site system proposed by the International Urogynecological Association (IUGA) and the International Continence Society (ICS). The severity of the complications was graded by the Clavien-Dindo grading system. Four scales were used to evaluate patient satisfaction and quality of life after management of the complications: the Patient Global Impression of Improvement (PGI-I), the Pelvic Floor Impact Questionnaire Short Form (PFIQ-7), the Pelvic Organ Prolapse Symptom Score (POP-SS), and a 5-point Likert-type scale that evaluated the patient's choice of surgery. RESULTS: Totally, 256 cases were reported. The occurrence of complications related to transvaginal mesh (TVM) and laparoscopic sacrocolpopexy (LSC) had a significantly longer post-surgery delay than those of native tissue repair surgery (p < 0.001 and p = 0.010, respectively). Both PFIQ-7 and POP-SS score were lower after management of complications (p < 0.001). Most respondents (81.67%) selected very much better, much better, or a little better on the PGI-I scale. Only 13.3% respondents selected unlikely or highly unlikely on the 5-point Likert-type scale. CONCLUSIONS: The occurrence of complications related to TVM surgery and LSC had a longer post-surgery delay than native tissue repair surgery. Long-term regular follow-up was vital in complication management. Patient satisfaction with the management of TVM complications was acceptable.
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Prolapso de Órgão Pélvico , Procedimentos de Cirurgia Plástica , Feminino , Procedimentos Cirúrgicos em Ginecologia/efeitos adversos , Humanos , Prolapso de Órgão Pélvico/cirurgia , Complicações Pós-Operatórias/etiologia , Qualidade de Vida , Procedimentos de Cirurgia Plástica/efeitos adversos , Estudos Retrospectivos , Telas Cirúrgicas/efeitos adversos , Inquéritos e Questionários , Resultado do TratamentoRESUMO
INTRODUCTION AND HYPOTHESIS: This study aimed to compare the expression levels of extracellular matrix (ECM) and apoptosis proteins in the uterosacral ligament (USL) of patients with and without pelvic organ prolapse (POP). METHODS: The USL were obtained from patients with POP-Q ≥ III (n = 35) and without POP (n = 20). Immunohistochemistry (IHC) staining and RT-qPCR were conducted to assess the protein and mRNA levels, respectively. The levels of type I collagen (COLI), type III collagen (COLIII), matrix metalloproteinase (MMP)1, MMP2, MMP9, tissue inhibitor of metalloproteinase (TIMP)1, TIMP2, estrogen receptor (ER)α, ERß and apoptosis-related gene B cell lymphoma 2 (Bcl-2)-associated agonist of cell death (Bad) and Bcl-2-associated X (Bax) in the USL were analyzed. RESULTS: The protein expression and mRNA levels of MMP2 and MMP9, mRNA levels of BAD and BAX, and protein expression of active cleaved-Caspase3 were significantly higher in the POP group. There were no evident differences in COLIII, MMP1 or ERß expression at either the mRNA or protein level or in TIMP1, TIMP2 or Caspase3 by IHC between the two groups. However, obvious decreases in COLI and ERα were evident at both the mRNA and protein levels in the POP group, and the mRNA levels of TIMP1 and TIMP2 were also decreased compared to those of the control group. CONCLUSION: ECM in the USL tissues of POP patients is remodeled compared with non-POP patients and is characterized by decreased synthesis and increased degradation of collagen; moreover, the levels of the main proteins involved in apoptosis are increased in POP tissue.
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Proteínas da Matriz Extracelular , Prolapso de Órgão Pélvico , Apoptose , Feminino , Humanos , Ligamentos , Prolapso de Órgão Pélvico/genética , ÚteroRESUMO
OBJECT: To evaluate the efficacy of dydrogesterone for the treatment of premenopausal patients with endometrial polyps (EPs). METHODS: A single-center, open-label, prospective, single-arm clinical treatment trial was conducted in patients of reproductive age with EP(s). Patients were prescribed dydrogesterone from day 15 to day 24 of the menstrual cycle over a period of 3 months. At the 3-month follow-up, the efficacy of dydrogesterone was evaluated based on changes in self-report symptoms and ultrasonographic characteristics. The predictive factors of efficacy as well as the predictive value of the significant factors were also assessed. RESULTS: A total of 60 patients were included. Improvements in both symptoms and ultrasound findings occurred in 31 patients, achieving an efficacy rate of 51.67%. Of 41 patients with clinical presentations, 39 (95.1%) reported improvements in symptoms. In terms of ultrasound findings, 33 (55%) of patients demonstrated improvements. Significant decreases were observed in the mean endometrial thickness (1.17 ± 0.33 cm vs 0.90 ± 0.35 cm, p < .001) and polyp size (1.10 ± 0.34 cm vs 0.74 ± 0.65 cm, p = .001) after the application of dydrogesterone. Age (p = .006), polyp size (p = .006), and blood flow within polyps (p = .035) were significant predictors of dydrogesterone efficacy. These factors, when combined, demonstrated a good predictive value ([area under the curve (AUC)=0.81]). CONCLUSION: Dydrogesterone is effective in the management of EPs in premenopausal patients. Age, polyp size and blood flow should be taken into consideration when prescribing dydrogesterone for this population of women.
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Didrogesterona/uso terapêutico , Pólipos/tratamento farmacológico , Progestinas/uso terapêutico , Doenças Uterinas/tratamento farmacológico , Adulto , Feminino , Humanos , Pré-Menopausa , Estudos Prospectivos , Ultrassonografia , Doenças Uterinas/diagnóstico por imagemRESUMO
AIM: Conventional endometrial examination by dilatation and curettage (D&C) is not accepted by many patients because it is associated with pain and risk of injury and typically requires anesthesia and hospitalization. While several less invasive endometrial screening tools have been developed, their diagnostic value is generally inferior to D&C. Therefore, the purpose of this study was to evaluate the effectiveness of a new, minimally invasive device, called the ES Sampler, for outpatient endometrial screening. METHODS: This was a single-blind study of 96 patients (age: 36.8 ± 8.1 years) who attended Peking Union Medical College Hospital from March 2015 to August 2016. Specimens were collected from each participant using the ES Sampler, followed by traditional D&C by hysteroscopy, and evaluated by histology and/or cytology. The sampling adequacy, sensitivity, specificity, positive and negative predictive value, and diagnostic accuracy were compared, and patient acceptability was assessed. RESULTS: Compared to traditional D&C, the ES Sampler exhibited 99.0% sampling adequacy, and the combined (histology and cytology) results demonstrated 88.9% sensitivity, 95.6% specificity, 88.9% positive predictive value, 95.6% negative predictive value, and 93.7% accuracy. Moreover, the majority of study participants reported mild or no pain associated with the ES Sampler, and blood loss was minimal. CONCLUSIONS: Our findings suggest that the minimally invasive ES Sampler is a reliable and accurate endometrial screening tool that is easily accepted by patients. The ES Sampler could be useful for screening high-risk patients who may need further, more invasive examination, thereby conserving medical resources and minimizing patient discomfort.
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Hiperplasia Endometrial , Neoplasias do Endométrio , Adulto , Biópsia , Dilatação e Curetagem , Hiperplasia Endometrial/cirurgia , Neoplasias do Endométrio/cirurgia , Endométrio , Feminino , Humanos , Sensibilidade e Especificidade , Método Simples-CegoRESUMO
PURPOSE: The study aimed to investigate the clinical characteristics and prognostic factors of stage IC ovarian clear cell carcinoma (OCCC). METHODS: The Surveillance, Epidemiology, and End Results (SEER) database was accessed for medical records of patients with stage IC OCCC from 1992 to 2016. The clinical and prognostic features of stage IC OCCC from several therapeutic perspectives were identified with Kaplan-Meier method and Cox proportional hazards model. RESULTS: Totally, 1079 patients were enrolled for the analysis. The median age was 55 (range 24-91) years. 850 (78.8%) patients were treated with chemotherapy, 877 (81.3%) received lymph node (LN) dissection, and 20 (1.9%) underwent radiotherapy. LN dissection (P = 0.501) and chemotherapy (P = 0.130) did not significantly impact cancer-specific survival (CSS). Among patients younger than 45 years, 23 received fertility-sparing surgery (FSS). No significant difference in CSS was observed between the FSS and non-FSS group (P = 0.523). Bilateral tumor (P < 0.001) and larger tumor size (P = 0.010) were significantly and independently associated with poor CSS. Older age (P = 0.001), bilateral tumor (P < 0.001), and larger tumor size (P = 0.005) were significantly and independently associated with poor overall survival (OS), while LN dissection (P = 0.005) was significantly and independently associated with better OS. Significant differences in CSS (P = 0.005) and OS (P < 0.001) were observed between the low- and high-risk groups, which were divided by median risk score. CONCLUSION: LN dissection and chemotherapy did not significantly impact CSS, while LN dissection was an independent prognostic factor for OS. Convincing evidence from clinical trials with a large number of patients are further required to develop treatment guidelines.
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Carcinoma Epitelial do Ovário/patologia , Preservação da Fertilidade/métodos , Procedimentos Cirúrgicos em Ginecologia/métodos , Neoplasias Ovarianas/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma Epitelial do Ovário/epidemiologia , Carcinoma Epitelial do Ovário/terapia , Feminino , Humanos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasias Ovarianas/epidemiologia , Neoplasias Ovarianas/terapia , Prognóstico , Programa de SEER , Adulto JovemRESUMO
OBJECTIVES: Since other genital infections enhance HIV susceptibility by inducing inflammation and evidence suggests that the vaginal microbiome plays a functional role in the persistence or regression of high-risk human papillomavirus (HPV) infections, we investigated the relationship between the composition of the vaginal microbiota and the risk of high-risk HPV infection. METHODS: The study included 151 healthy women (65 HPV-positive and 86 HPV-negative) aged 20-65 at enrollment. Total genome DNA from samples was extracted using the hexadecyltrimethylammonium bromide (CTAB) CTAB method. The vaginal microbiota composition was determined by sequencing barcoded 16S rDNA gene fragments (V4) on Illumina HiSeq2500. RESULTS: Of the 30 most abundant bacteria at the genus level, we found only six bacteria with a statistical difference between HPV-positive and HPV-negative women: Bacteroides, Acinetobacter, Faecalibacterium, Streptococcus, Finegoldia, and Moryella. Lactobacillus was the predominant genus and was detected in all women, but there was no significant difference between the two groups for L. iners, L. jensenii, and L. gasseri. Furthermore, we found 26 types of bacteria with a statistical difference at the species level between the two groups. Anaerobic bacteria such as Bacteroides plebeius, Acinetobacter lwoffii, and Prevotella buccae were found significantly more frequently in HPV-positive women, which is the most important finding of our study. CONCLUSION: Our findings suggest a possible role for the composition of the vaginal microbiota as a modifier of high-risk HPV infection, and specific microbiota species may serve as sensors for changes in the cervical microenvironment associated with high-risk HPV infection. The exact molecular mechanism of the vaginal microbiota in the course of high-risk HPV infection and cervical neoplasia should be further explored. Future research should include intervention in the composition of the vaginal microbiota to reverse the course of high-risk HPV infection and the natural history of cervical neoplasia.
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Bactérias/classificação , Bactérias/isolamento & purificação , Papillomaviridae/isolamento & purificação , Infecções por Papillomavirus/microbiologia , Vagina/microbiologia , Vagina/virologia , Adulto , Bactérias/genética , China/epidemiologia , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Infecções por Papillomavirus/epidemiologia , Infecções por Papillomavirus/virologia , Prognóstico , Fatores de Risco , Microambiente Tumoral , Adulto JovemRESUMO
AIM: This study aimed to compare the outcomes of pelvic floor muscle training (PFMT) between postpartum and non-postpartum women with stress urinary incontinence (SUI) and to detect potential factors that may influence these outcomes. METHODS: A total of 54 and 79 participants were recruited into postpartum (PP group) and non-postpartum (non-PP group) groups, respectively. A physiotherapist treated the participants twice a week for 6-8 weeks. At baseline and 6 and 12 months after treatment, the 1-h pad weight test (PWT), vaginal contraction pressure (VCP), and Incontinence Impact Questionnaire Short Form (IIQ-7) were assessed by an evaluator or physiotherapist. The primary outcome was PWT improvement. The participants whose PWT improvement reached a >50% reduction relative to baseline were considered responders. Secondary outcomes included VCP, IIQ-7 score, and patient satisfaction rate. RESULTS: The PWT improvement was 87.04% (95%CI: 0.78, 0.96) in the PP group at 1-year follow-up, which was significantly better than the 72.15% improvement (95%CI: 0.62, 0.82) in the non-PP group (OR = 2.591, 95%CI: 1.018, 6.595, P = 0.041). Changes in VCP and BMI were significant predictors of responders in the regression analysis. As the change in VCP increased by 1 cmH2 O, the efficiency increased by 4.2% (OR = 1.042, 95%CI: 1.010, 1.070). The change in BMI increased by 1 kg/m2 , and the efficiency decreased 23.0% (OR = 0.770, 95%CI: 0.633, 0.937). CONCLUSIONS: The outcome of PFMT in postpartum participants with SUI was better than that in non-postpartum participants. Women with more improvements in VCP and weight loss showed better amelioration of SUI symptoms after PFMT.
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Tratamento Conservador , Satisfação do Paciente , Diafragma da Pelve/fisiopatologia , Modalidades de Fisioterapia , Incontinência Urinária por Estresse/terapia , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Período Pós-Parto , Pressão , Estudos Prospectivos , Resultado do Tratamento , Incontinência Urinária por Estresse/fisiopatologiaRESUMO
To study the microbiological contamination of kitchen dishcloths in Chinese housholds, 1010 'in-use' kitchen dishcloths were collected from residential premises in Beijing and Shanghai, and they were sent to the laboratory for microbiological quality analysis. The aerobic plate counts for dishcloths were 10-109 cfu/cm2 in the range of 150 cfu/cm2 to 1.776×109 cfu/cm2 (Beijing) and 62.5 cfu/cm2 to 8.75×108 cfu/cm2 (Shanghai). Nineteen species of bacteria were detected in the dishcloths, most of which were conditional pathogenic bacteria. This study found a significant difference in the aerobic plate counts of dishcloths with regard to type, number of the days used, activities used for, and some family factors. The findings of the study highlight the potential for contamination of kitchen dishcloths within homes.
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Hospitais , Programas de Rastreamento , Lesões Intraepiteliais Escamosas Cervicais/diagnóstico , Displasia do Colo do Útero/diagnóstico , Feminino , HumanosRESUMO
OBJECTIVE: To evaluate the clinical role of dilation and curettage (DC) in the diagnosis of ectopic pregnancy (EP). METHODS: We retrospectively reviewed the clinical data of 108 patients with pregnancy of unknown location who underwent a DC with an abnormal rise in ß-human chorionic gonadotropin (ß-HCG) level and without visible intrauterine pregnancy (IUP) on transvaginal ultrasound and 24 patients who did not receive DC with ß-HCG>5 000 IU/L.The final diagnosis depended on ß-HCG trend review after DC and the pathologic and laparoscopic findings. RESULTS: Overall, 65.3% of the patients were finally diagnosed with EP and 34.7% were found to have a nonviable IUP.Those with EP had significantly higher initial ß-HCG than those with nonviable IUP.IUP patients were more likely to have had a history of delivery.Among the patients with ß-HCG<2 000 IU/L, 40.0% of EP and 11.0% of IUP had endometrial echo complex no more than 5 mm (P=0.035). In ß-HCG<2 000 IU/L and 2 000 IU/L<ß-HCG<5 000 IU/L groups, the diagnostic rate of EP was 42.6% and 68.3% respectively (P=0.012). Among the patients with ß-HCG>5 000 IU/L, there was no significant difference between those with DC and those without DC (96.7% vs.96%, P=0.915). CONCLUSIONS: Ultrasound findings such as a thin endometrial echo complex and the presence of pelvic mass are associated with but are not diagnostic of an ectopic pregnancy.The patients with the suspected diagnosis of EP are 2 000 IU/L<ß-HCG<5 000 IU/L, whereas DC remains important valuable to differentiate EP from nonviable IUP and to avoid misdiagnosis and unnecessary exposure to methotrexate. Because EP is the common final diagnosis in most of the patients with ß-HCG>5 000 IU/L and pelvic mass and without intrauterine gestational sac, the value of DC decreases and laparoscopy can be considered directly.
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Curetagem , Gravidez Ectópica/patologia , Adulto , Feminino , Humanos , Gravidez , Estudos Retrospectivos , Adulto JovemRESUMO
OBJECTIVE: To assess the efficacy and safety of Sanjie Analgesic Capsule (SAC) in Chinese patients with endometriosis-associated pain. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled trial conducted at 15 centers between November 2013 and July 2017 in China. Eligible 323 patients with endometriosis were randomized at a 3:1 ratio to the SAC group (241 cases) and placebo group (82 cases) by stratified block randomization. Patients in the SAC or placebo groups were given SAC or placebo 1.6 g 3 times per day, orally, respectively since the first day of menstruation for 3 consecutive menstrual cycles. The primary endpoint was clinical response to dysmenorrhea evaluated using a 10-point Visual Analogue Scale at 3 and 6 months. The secondary endpoint was the pain score evaluated by VAS (chronic pelvic pain, defecation pain, and dyspareunia) at 3 and 6 months, and the pain recurrence rate at 6 months. Adverse events (AEs) were recorded during the study. RESULTS: A total of 241 women were included in the SAC group, and 82 were in the placebo group. Among these women, 217 (90.0%) and 71 (86.6%) completed the intervention, respectively. At 3 months, overall response rate (ORR) was significantly higher in women administered SAC (80.1%) compared with those who received a placebo (30.5%, P<0.01). Six months after treatment, the ORR for dysmenorrhea was 62.7% in the SAC group and 31.7% in the placebo group (P<0.01). Chronic pelvic pain and defecation pain were significantly improved by SAC compared with placebo (both P<0.05). The incidence rates of total AEs events in the SAC and placebo groups were 6.6% and 9.8%, respectively, and no significant difference was shown between the two groups (P=0.339). CONCLUSION: SAC is well-tolerated and may improve dysmenorrhea in women with endometriosis-associated pain. (Trial registration: ClinicalTrials.gov, No. NCT02031523).
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Analgésicos , Cápsulas , Medicamentos de Ervas Chinesas , Endometriose , Humanos , Feminino , Endometriose/tratamento farmacológico , Endometriose/complicações , Método Duplo-Cego , Adulto , Medicamentos de Ervas Chinesas/uso terapêutico , Medicamentos de Ervas Chinesas/efeitos adversos , Analgésicos/uso terapêutico , Analgésicos/efeitos adversos , Resultado do Tratamento , Dismenorreia/tratamento farmacológico , Dor/tratamento farmacológico , Dor/etiologia , Dor Pélvica/tratamento farmacológico , Dor Pélvica/etiologia , Medição da Dor , Adulto Jovem , PlacebosRESUMO
STUDY QUESTION: What are the psychometric properties in mainland China of the 30-item Endometriosis Health Profile (EHP-30) translated into simplified Chinese? SUMMARY ANSWER: The simplified Chinese version of the EHP-30 is a valid, reliable and acceptable tool for the measurement of the health-related quality of life (HRQoL) of women with endometriosis in the context of mainland China. WHAT IS KNOWN ALREADY: Endometriosis can critically affect women's HRQoL. The EHP-30 is currently the most reliable instrument to measure the HRQoL in women with endometriosis. STUDY DESIGN, SIZE, DURATION: This cross-sectional study was conducted in a tertiary referral university hospital from February 2012 to August 2012 in Beijing, P. R. China. PARTICIPANTS/MATERIALS, SETTING, METHODS: The translation and cultural adaptation of the EHP-30 was performed according to accepted guidelines. The study included 336 women with endometriosis. Psychometric evaluation included factor analysis, convergent validity, measurement of internal consistency, item-total correlations and data completeness, descriptive statistics, and the determination of floor and ceiling effects. MAIN RESULTS AND THE ROLE OF CHANCE: Factor analysis confirmed the validity of the five-factor structure of the EHP-30 core questionnaire, which explained 79.51% of the total variance. The correlations of related subscale scores between EHP-30 and Short Form-36 were all significant. Cronbach's α for internal consistency across each scale ranged 0.89-0.97 for the core questionnaire and 0.80-0.96 for the modular questionnaire. No <97.67% of data completeness was achieved. Floor effects were observed in three scales: self-image (19.64%), children (26.67%) and medical profession (15.19%). No ceiling effects were found. The control and powerlessness scale had the highest median score (54.17) in the core questionnaire, whereas the infertility module (median = 56.25) had the highest score in the modular section. LIMITATIONS, REASONS FOR CAUTION: The study was conducted in a referral centre for the treatment of endometriosis, thereby leading to overrepresentation of severe symptoms of endometriosis. Furthermore, the test-retest reliability and responsiveness of the questionnaire were not evaluated in this study. WIDER IMPLICATIONS OF THE FINDINGS: Our study addresses the urgent need for a valid and reliable instrument to measure the HRQoL of female patients with endometriosis in mainland China. STUDY FUNDING/COMPETING INTEREST(S): This work was supported by grants to J. Leng from the Key Project for Clinical Faculty Foundation, Ministry of Health, China (2010). None of the authors has any conflict of interest to declare.
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Endometriose/fisiopatologia , Endometriose/psicologia , Qualidade de Vida , Adulto , China , Estudos Transversais , Endometriose/etnologia , Análise Fatorial , Feminino , Hospitais Universitários , Humanos , Infertilidade Feminina/etiologia , Idioma , Pessoa de Meia-Idade , Projetos Piloto , Escalas de Graduação Psiquiátrica , Psicometria/métodos , Reprodutibilidade dos Testes , Índice de Gravidade de Doença , Adulto JovemRESUMO
OBJECTIVE: Clinicopathological characteristics and possible prognostic factors among women with endometrioid epithelial ovarian cancer (EEOC) with or without concurrent endometriosis were investigated. STUDY DESIGN: A search of medical charts at Peking Union Medical College Hospital from 2000 through 2012 identified patients with EEOC with or without endometriosis. RESULTS: Of 188 patients with EEOC, concurrent endometriosis was identified in 32 (17.0%). Patients with concurrent endometriosis were approximately 5 years younger, more likely to be premenopausal, more likely to have an early stage of EEOC, and less likely to have high-grade tumors compared to those without endometriosis. The univariate analysis showed that concurrent endometriosis was a significant prognostic factor for disease-free survival, but this association did not remain in the multivariate analysis. CONCLUSION: Women with EEOC and concurrent endometriosis showed distinct characteristics and had longer disease-free survival when compared to those without endometriosis.
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Endometriose/complicações , Neoplasias Epiteliais e Glandulares/mortalidade , Neoplasias Ovarianas/mortalidade , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma Epitelial do Ovário , Estudos de Coortes , Intervalo Livre de Doença , Feminino , Humanos , Pessoa de Meia-Idade , Neoplasias Epiteliais e Glandulares/patologia , Neoplasias Ovarianas/patologia , Prognóstico , Modelos de Riscos ProporcionaisRESUMO
OBJECTIVES: To explore the differences between women with endometriosis associated ovarian cancer and typical epithelial ovarian cancer. STUDY DESIGN: The medical charts of total 226 patients with epithelial ovarian cancer treated at Peking Union Medical College Hospital between March 2011 and March 2012 were reviewed. Histology evaluation determined endometriosis associated ovarian cancer (n = 17) or non-endometriosis associated ovarian cancer (n = 209). RESULTS: Compared with non-endometriosis associated ovarian cancer, patients with endometriosis associated ovarian cancer were proved: (1) to be younger and more likely to be premenopausal at diagnosis of epithelial ovarian cancer (P = .03 and .005, respectively); (2) to have lower preoperative serum level of Ca125 (mean: 122.9 vs 1377.5 U/mL, P < .001) and more likely to display normal Ca125 level (P < .001); (3) to be identified at the earlier stage (stage I, P < .001); (4) to have completely different distribution of histological subtypes (significant overrepresentation of clear cell and endometrioid carcinoma). CONCLUSION: As such, patients with endometriosis associated ovarian cancer differ from non-endomertiosis associated ovarian cancer in many of their critical clinical and biologic characteristics.
Assuntos
Endometriose/complicações , Neoplasias Epiteliais e Glandulares/etiologia , Neoplasias Ovarianas/etiologia , Adolescente , Adulto , Fatores Etários , Idoso , Antígeno Ca-125/sangue , Carcinoma Epitelial do Ovário , Feminino , Humanos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasias Epiteliais e Glandulares/sangue , Neoplasias Epiteliais e Glandulares/patologia , Neoplasias Ovarianas/sangue , Neoplasias Ovarianas/patologia , Estudos Retrospectivos , Fatores de Risco , Adulto JovemRESUMO
OBJECTIVE: To evaluate the efficacy of high-intensity focused ultrasound (HIFU) and cortical hormone in the treatment of non-neoplastic epithelial disorders of vulva. METHODS: A total of 268 cases with pathologically diagnosed non-neoplastic epithelial disorders of vulva were randomly allocated into two groups of high-intensity focused ultrasound (HIFU) (n = 119) and cortical hormone (n = 124). And 25 cases became lost to follow-ups. Their signs, symptoms and quality-of-life were assessed before treatment, 1 month post-treatment and 3 months post-treatment. And the relationship was analyzed between pathologic type, age, course and efficacies. RESULTS: Their signs, symptoms and quality-of-life improved in both groups after 1 and 3 month. Compared with drug therapy, HIFU showed superior results in lesion amelioration at 1 month with significantly statistical difference and so did lesion amelioration and therapeutic effect at 3 month. And the efficacy of HIFU was better in those with >10-year disease course and pathologically diagnosed lichen sclerosus in 3 months. CONCLUSIONS: HIFU is both safe and effective in the treatment of non-neoplastic epithelial disorders of vulva.
Assuntos
Halcinonida/uso terapêutico , Terapia por Ultrassom , Doenças da Vulva/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , Terapia por Ultrassom/métodos , Adulto JovemRESUMO
OBJECTIVE: To investigate the pathogenesis of endometriosis by studying endometriosis coexisting with variable genital tract anomalies and analysis the association between obstructive or non-obstructive anomalies with endometriosis. METHODS: From January 2000 to April 2010, a total of 67 cases of endometriosis coexisting with genital tract anomalies undergoing treatment in Peking Union Medical College Hospital were studied retrospectively. RESULTS: According to subtypes of concurrent genital tract anomalies, 67 cases were divided into 19 cases in obstructive group and 48 cases in non-obstructive group.(1) Age and symptoms:the mean age were (22 ± 8) years in obstructive group and (32 ± 7) years in non-obstructive group, which reached statistical difference (P < 0.05). The major symptoms were dysmenorrheal or chronic pelvic pain (14/19) and amenorrhea (8/19) in obstructive group.However, in non-obstructive group, the major symptoms were dysmenorrheal or chronic pelvic pain (31%, 15/48) and infertility (35%, 17/48) and abortion (21%, 10/48).(2) Degree and incidence of endometriosis:the moderate or severe endometriosis was 11/19 in obstructive group and 40% (19/48) in non-obstructive group, which did not show statistical difference (P > 0.05). The incidence of peritoneal endometriosis, ovarian endometriosis, adenomyosis did not show significant difference between two groups (all P > 0.05). The rate of moderate or severe endometriosis coexisting with duplex uterus, uterus bicornis and uterus septus did not show significant difference in non-obstructive group (P > 0.05). CONCLUSIONS: The severity of endometriosis showed no association with obstructive anomalies. The results implied that there might be other factors involved in pathogenesis of endometriosis.
Assuntos
Endometriose , Laparoscopia , Adenomiose , Dismenorreia/epidemiologia , Feminino , Humanos , Dor PélvicaRESUMO
OBJECTIVE: To study the relationship between the clinic-pathological features and pain symptoms in patients with endometriotic cyst (EM). METHODS: The medical data of symptoms, laparoscopy and pathology examination in 416 patients with endometriosis were studied retrospectively. All cases were divided into two groups on the existence of ovarian endometrioma, including 338 patients in cyst group and 78 cases in non-cyst group. The relationship between clinical symptoms and location and type of endometrioma was studied. RESULTS: (1) Serum CA125 level: the level of CA125 were (61 ± 39) kU/L in cyst group (28 ± 24) kU/L in non-cyst group, which reached statistical difference (P < 0.01). (2) Pathological features: among 338 cases, 34.0% of cyst were on left side (115/338), 26.3% were right side (89/338), and 39.6% were on both side (134/338). And 95.8% (324/338) of cases were combined with the other type of endometriosis, which were 48.5% (164/338) with peritoneal endometriosis, 47.3% (160/338) with deep infiltrating endometriosis (DIE). In cystic patients, the incidences of endometriosis lesion were 13.9% (47/338) on the uterine surface, 38.5% (130/338) on obstruction of cul-de sac, 40.5% (137/338) on utero-sacral ligament of DIE, which were significantly higher than 5.1%, (4/78), 9.0% (7/78) and 28.2% (22/78) in noncyst group. (3) Pain symptom: the incidence and degree of dysmenorrhea and dyschezia had no statistical difference between two groups (P > 0.05), and the incidence of chronic pelvic pain (CPP) of 24.6% (83/338) and dyspareunia of 29.9% (101/338) in the cyst group were significantly lower than 35.9% (28/78) and 44.9% (35/78) in non-cyst group (P < 0.05). The incidence of dysmenorrheal was 85.1% (114/134) in cases with bilateral cyst, which was higher than 74.0% (151/204) in cases with single cyst. The incidence of dysmenorrheal and dyschezia in moderate-severe adhesion was 89.0% (138/155) and 18.7% (29/155), which was significantly higher than 68.8% (126/183) and 8.2% (15/183) in mild adhesion. In the patients cyst existed with DIE, the risk of dysmenorrheal, CPP, dyspareunia, and dyschezia were obviously raised (OR respectively was 5.17, 3.01, 3.05, 2.75). CONCLUSIONS: The endometriotic cyst often co-exists with other type of endometriotic lesions. Ovarian endometrioma was associated with lesion localized on uterine surface, cul-de-sac, sacrum ligament. The risk of all the pain symptoms would be raised when the endometriotic cyst co-exit with the DIE lesions. So the treatment for DIE lesions was as same important as the endometriotic lesions in order to relieve pain symptoms and delay the relapse.