少腹逐瘀颗粒联合屈螺酮炔雌醇治疗子宫内膜异位症的临床研究

目的探讨采用少腹逐瘀颗粒联合屈螺酮炔雌醇治疗子宫内膜异位症的临床疗效。方法选取中山医院青浦分院2015年3月—2016年3月收治的子宫内膜异位症患者121例,随机分成对照组(60例)和治疗组(61例)。对照组患者口服屈螺酮炔雌醇片,1片/次,1次/d,月经来潮后第5天服用,连续使用至下次月经来潮为1个周期;治疗组患者在对照组基础上口服少腹逐瘀颗粒,0.6 g/次,2次/d。两组患者连续治疗3个月经周期。评价两组患者临床疗效,同时比较治疗前后两组患者CA125水平、痛经评分、盆腔包块体积、痛觉、生育能力、复发率和不良反应。结果治疗后,对照组的临床总有效率为81.67%,显著低于治疗组患者的96.72%,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者CA125水平、痛经评分和盆腔包块直径均明显降低(P0.05);且治疗后治疗组患者的CA125水平、痛经评分和盆腔包块直径比对照组降低的更明显(P0.05)。随访1年发现,治疗组患者复发率明显低于对照组(P0.05),且治疗组生育能力明显强于对照组(P0.05),痛觉人数明显少于对照组(P0.05)。治疗期间,对照组患者的不良反应发生率为21.67%,明显高于治疗组患者的6.56%,两组比较差异具有统计学意义(P0.05)。结论少腹逐瘀颗粒联合屈螺酮炔雌醇治疗子宫内膜异位症疗效显著,安全性高,具有一定的临床推广应用价值。     

Efficacy and tolerability of estradiol 1 mg and drospirenone 2 mg in postmenopausal Korean women: a double-blind, randomized, placebo-controlled, multicenter study

Objectives

The aim of this study was to demonstrate that the therapeutic efficacy of an estradiol 1 mg/drospirenone 2 mg (E2/DRSP) preparation is superior to a placebo in postmenopausal Korean women with hot flushes and other climacteric symptoms, and to demonstrate that this treatment is both safe and tolerable.

Methods

This was a double-blind, randomized, placebo-controlled, multicenter study over four 28-day treatment cycles. A total of 158 subjects were screened and 90 women were randomized into two treatment groups (E2/DRSP group, n = 45; placebo group, n = 45). The primary efficacy parameter was the individual relative change of hot flushes. The secondary efficacy parameters such as other climacteric, urogenital symptoms and vaginal bleeding patterns were also evaluated, and the occurrence of any adverse events was noted. In addition, physical, gynecological examinations and laboratory analyses were performed at the beginning and end of the study.

Results

The mean number of hot flushes per week during treatment weeks 3–16 decreased by 48.1% during treatment with placebo, and by 84.4% during treatment with E2/DRSP (p < 0.001). The E2/DRSP combination also reduced the incidence and intensity of menopausal symptoms in postmenopausal women. Most of adverse events was mild or moderate degree of intensity. None of the parameters measured in the study, including laboratory analyses, physical and gynecological examinations, vital signs, and weight, led to any concerns of safety.

Conclusions

The E2 1 mg/DRSP 2 mg combination tested in the study was efficacious and safe in the treatment of hot flushes and other climacteric symptoms in postmenopausal Korean women.     

药物流产不全清宫后服用屈螺酮炔雌醇片的临床疗效评价

目的探讨药物流产不全清官术后即日口服屈螺酮炔雌醇片的临床疗效。方法将64例药物流产不全清宫后患者随机分为两组,观察组32例．在预防感染及促进子宫收缩的基础上于清宫后即日口服屈螺酮炔雌醇片,连续服用21d;对照组32例,仅术后口服同剂量同种抗生素预防感染及促进子宫收缩3d。结果观察组子宫内膜恢复明显优于对照组（P〈0．05）,出血量明显减少,出血时间明显缩短,月经恢复快,宫颈管粘连及官腔粘连的发生率低。结论药物流产不全清宫后即日口服屈螺酮炔雌醇片可以促进子宫内膜修复,月经复潮快,可降低药物流产不全清宫后并发症的发生率,可作药物流产清宫后的常规用药。     

屈螺酮炔雌醇与其他口服避孕药治疗多囊卵巢综合征的系统评价

目的 系统评价屈螺酮炔雌醇（EE/DRSP）与其他口服避孕药治疗多囊卵巢综合征（PCOS）的疗效及其安全性.方法 按照Cochrane系统评价原则,采用相关检索策略检索Cochrane临床对照试验数据库（CENTRAL）、EMBASE、MEDLINE和中文期刊全文数据库（CNKI）、维普中文期刊数据库（VIP）及万方等数据库与中国生物医学文献数据库（CBM）（检索时间自建库至2013年5月30日）以及相关国际性临床试验网站中,纳入屈螺酮炔雌醇与其他口服避孕药治疗PCOS疗效比较的随机对照试验（RCT）.评价纳入RCT研究的方法学质量,采用RevMan 5.2软件对有关数据进行Meta分析.结果 通过相关文献检查,共计7篇文献符合本研究纳入标准,共计纳入受试者为535例.本组纳入文献中,6篇为中等质量文献,1篇为低质量文献.与口服避孕药甲羟孕酮（MPA）治疗PCOS的疗效比较,屈螺酮炔雌醇可显著改善PCOS患者的多毛症状,提高性激素结合球蛋白（SHGB）及高密度脂蛋白（HDL）水平,降低促黄体生成素（LH）、总胆固醇（Tch）及总三酰甘油（TG）水平,但可显著增加空腹胰岛素（FINS）水平,且差异均有统计学意义（P＜0.05）.屈螺酮炔雌醇与炔雌醇去氧孕烯（EE/DSG）、炔雌醇醋酸环丙孕酮（EE/CPA）对改善PCOS患者的多毛、体质量、高雄激素血症情况比较,差异均无统计学意义（P＞0.05）;但屈螺酮炔雌醇对脂代谢的保护作用优于炔雌醇去氧孕烯、炔雌醇醋酸环丙孕酮,且差异有统计学意义（P＜0.05）.与炔雌醇醋酸氯地孕酮（EE/CMA）治疗PCOS的疗效比较,屈螺酮炔雌醇可显著改善患者的高雄激素血症情况及多毛症状,且差异均有统计学意义（P＜0.05）.与炔雌醇孕二烯酮（（EE/GSD）治疗PCOS的疗效比较,屈螺酮炔雌醇可显著改善患者的高雄激素血症情况,且差异有统计学意义（P＜0.05）.屈螺酮炔雌醇治疗PCOS的不良反应发生率?     

屈螺酮炔雌醇片用于人工流产术后的疗效及安全性

目的:探讨屈螺酮炔雌醇片用于人工流产术后的疗效及安全性。方法:选取人工流产治疗的妇女90例,随机分为观察组(n=45例)与对照组(n=45例)。两组患者均在门诊手术室行人工流产术,术后予以口服抗生素预防感染及益母草颗粒促进宫缩等治疗。观察组患者加用屈螺酮炔雌醇片口服1片/d,连服21d,月经来潮第5d开始第2周期,连用6个周期。结果:观察组患者术后阴道流血时间、阴道流血量及月经恢复时间明显少于或短于对照组(P0.05),术后3周子宫内膜恢复明显优于对照组(P0.05)。观察组术后盆腔感染和宫腔组织残留各1例;对照组术后出现并发症8例(盆腔感染和宫腔粘连各3例和宫腔组织残留2例)。观察组患者术后并发症发生率明显少于照组(P0.05)。对照组和观察组发生不良反应2例和5例,症状均较轻,两组不良反应发生率比较差异不明显(χ2=0.62,P0.05)。结论:屈螺酮炔雌醇片用于人工流产术后疗效确切,可减少术后阴道出血量并缩短阴道出血时间,加快月经周期恢复,减少术后并发症,安全性较好。     

两种单向复方口服避孕药对经前期综合征影响的研究

目的观察两种单向口服避孕药(OCs)优思明和妈富隆对育龄妇女经前期综合症(PMS)的影响。方法将自愿服用COC避孕的妇女随机分为两组,其中优思明(DRSP/EE)组47例,妈富隆(DSG/EE)组19例。两组均从月经周期第1天开始服药,1片/d,连续服用21天,之后停药7天。两组均连续服用6个周期(28天/周期)。两组对象在研究开始前及6个月经周期后各完成1份相同的经期不适问卷(MDQ)。计算服用避孕药前和服药6个周期后各组MDQ平均得分和平均得分的变化。结果①服药6个周期后,优思明组经前期水潴留和注意力损害评分、月经期水潴留评分比妈富隆组有显著性改善(P<0.05)。②优思明组服药6个周期后,经前期水潴留和消极情绪评分,月经期水潴留评分比服药前有显著性下降(P<0.05)。妈富隆组服药6个周期后,经前期消极情绪比服药前有显著性下降(P<0.05)。结论两种COC对PMS均有一定的改善作用;口服避孕药优思明比妈富隆对PMS的改善作用更加显著,这与DRSP抗盐皮质激素作用有关。     

A comparative study of monophasic oral contraceptives containing either drospirenone 3 mg or levonorgestrel 150 microg on premenstrual symptoms

This open-label randomized study compared the effects of two combined oral contraceptives (OCs) containing 3 mg drospirenone (DRSP)/30 microg ethinyl estradiol (EE) with 150 microg levonorgestrel (LNG)/30 microg EE on the prevalence and changes from baseline of premenstrual symptoms after six cycles. The symptoms were measured using the Women's Health Assessment Questionnaire. Subjects receiving DRSP/EE had fewer prevalence of premenstrual symptoms than those receiving LNG/EE after six cycles. A significantly lower score of negative affect category in the premenstrual phase was demonstrated in those receiving DRSP/EE more than LNG/EE. The DRSP/EE group showed a greater improvement of mean scores from baseline in the premenstrual phase compared with those who received LNG/EE on negative affect as seen in the items on anxiety, irritability, feeling sad or blue and weight gain in the category of water retention. In conclusion, OCs containing DRSP have beneficial effects in reducing the prevalence of premenstrual symptoms especially the symptoms of negative affect and weight gain, particularly when compared to LNG/EE. Hence, it should be recommended for women who are susceptible to these adverse symptoms.     

Different oral contraceptives and voice quality--an observational study

The classical literature on endocrine effect on voice considers oral contraceptives (OCs) as a risk factor for voice. However, recent studies revealed no adverse effect of new-generation OCs on voice. It was also suggested that OCs could improve specific voice characteristics via different mechanisms. The aim of the present study was to evaluate the effect of OCs on voices of women who use different formulations containing drospirenone (n=10), desogestrel (n=9) and gestodene (n=10). Acoustic voice measures of the 29 women were evaluated twice during the menstrual cycle. Fundamental frequency, frequency as well as amplitude stability and noise characteristics were measured using a computerized voice analysis program. Results indicated that vocal stability and quality were similar in the three groups tested. Marginal differences were observed between the drospirenone group and the other two groups. This preliminary observational study indicates that although drospirenone was previously shown to reduce water retention, this effect was not found to directly influence voice characteristics of women who use OCs.     

Short-term variations in bone remodeling markers of an oral contraception formulation containing 3 mg of drospirenone plus 30 microg of ethinyl estradiol: observational study in young postadolescent women

The clinical study of treated subjects and nontreated controls was made in healthy eumenorrheic young postadolescent women volunteers in the Department of Obstetrics and Gynaecology at Cagliari University, to investigate whether an oral contraceptive (OC) containing drospirenone (3 mg) plus ethinyl estradiol (30 microg) (DRSP+EE) can affect bone metabolism. Control group (n = 26) and OC group (n = 28) women did not differ in age, body mass index, waist-to-hip ratio and main outcome measures [urinary levels of deoxypyridinoline and pyridinoline, serum levels of osteocalcin, bone specific alkaline phosphatase (bSAP), total testosterone (total-T), sex hormone-binding globulin (SHBG), progesterone and bone mineral density (BMD) at the heel]. The control group was studied at the luteal phase (LP) during both the first and the sixth menstrual cycle; the OC group was studied during the first cycle at the LP, and on days 16-18 of the sixth cycle of DRSP+EE treatment. At the sixth cycle, in the control group, the main outcome measures did not change compared to baseline. In the OC group, deoxypyridinoline, pyridinoline, osteocalcin, bSAP, total-T and progesterone levels were reduced, whereas SHBG levels were increased. The BMD was unchanged compared to baseline. The results suggest that 6-month DRSP+EE treatment decreases bone turnover.     

Effects of an antiandrogenic oral contraceptive on appetite and eating behavior in bulimic women

High androgen levels in women with bulimia nervosa may promote bulimic behavior. The aim of the present study was to investigate the effects of an antiandrogenic oral contraceptive (OC) on appetite and eating behavior in women with bulimia nervosa compared to healthy controls. Twenty-one women with bulimia nervosa and 17 healthy controls matched for age and body mass index participated in the study. Basal and meal-related appetite and secretions of the satiety peptide cholecystokinin (CCK) and the appetite-stimulating peptide ghrelin were studied before and after 3 months of treatment with an antiandrogenic OC (30 microg ethinyl estradiol combined with 3 mg drospirenone). Bulimic behavior was evaluated in relation to changes in hormone levels. Before treatment, bulimic women had higher frequency of menstrual disturbances, acne and hirsutism and higher levels of testosterone but lower meal-related CCK secretion than controls. OC treatment reduced meal-related hunger and gastric distention in bulimics. CCK secretion in response to the meal was unchanged in bulimic women but decreased in the controls. Ghrelin secretion was comparable between groups and did not change in response to OC treatment. The treatment improved bulimic behavior in relation to a decline in testosterone levels in the entire group. Our results support the suggestion that androgens play a role in bulimic behavior. Treatment with an antiandrogenic OC may serve as a new strategy for treatment of bulimia nervosa and particularly in those patients with hyperandrogenic symptoms.