米索前列醇和PG05配伍米非司酮终止早孕的临床多中心随机比较试验

本研究为一项由十个单位参加的多中心临床试验，随机比较了三种用药方案：１．米非司酮２５ｍｇＱ１２ｈ×５＋ＰＧ０５１ｍｇ阴道塞药（组Ⅰ），２．米非司酮，同前十米索６００μｇ（组Ⅱ），３．米非司酮２００ｍｇ＋米索６００μｇ（组Ⅲ）终止早孕的安全性、有效性和可接受性。结果显示完全流产率为９４．２２％（９１３／９６９），其中组Ⅲ为９１．５０％，明显低于组Ⅰ（９５．２２％）和组Ⅰ（９６．１２％）（Ｐ＝０．０２５）；失败率为１．６５％（１６／９６９），其中组Ⅲ为３．５２％，显著高于组Ⅰ（１．３７％）、组Ⅱ（０％）（Ｐ＝０．００１）；不完全流产率为２．８９％（２８／９６９），失访（结局不明）率为１．２４％（１２／９６９），三组间均无明显差异（Ｐ＞０．０５）；自应用ＰＧ至孕囊排出时间，三组分别为３．０６±１．６５，２．８１±２．７５，３．２１±１．６１ｈ（Ｘ±ＳＤ），组Ⅱ稍短于其他两组，其差异有统计学意义（Ｐ＜０．０５）；阴道出血持续时间和转经时间无明显组间差异（Ｐ＞０．０５）。９０％以上的对象均对药物流产方法表示满意。结果提示米索配伍米非司酮的安全性、有效性和可接受性令人满意；米非司酮低剂量多次给药与米索有较好的协同作用。     

Comparison of Sublingual Misoprostol With Lidocaine Spray for Pain Relief in Office Hysteroscopy: A Randomized,Double-Blind,Placebo-Controlled Trial

Study ObjectiveTo compare the effectiveness of sublingual misoprostol with lidocaine pump spray for office hysteroscopy.DesignPremenopausal women who had an indication for office hysteroscopy were included in this randomized, double-blind, placebo-controlled study. Eighty-two patients were evaluable for the final analysis.SettingA tertiary referral center.PatientsPremenopausal women who had an indication for office hysteroscopy were included. Eighty-two patients were evaluable for the final analysis.InterventionsPatients were randomized to receive either sublingual misoprostol and placebo of lidocaine or lidocaine pump spray applied to the cervix and placebo of misoprostol.Measurements and Main ResultsWhen compared with the lidocaine group, patients in the misoprostol group reported less pain by the immediate visual analog scale scores (2.2 ± 0.98 vs 2.6 ± 0.99, p = .030), whereas visual analog scale scores at 10 minutes were similar between groups (2.1 ± 0.98 vs 2.36 ± 1.06, p = .156).ConclusionSublingual misoprostol is more effective than lidocaine spray in pain reduction during office hysteroscopy. Misoprostol may cause vaginal spotting, which may impair the vision during hysteroscopy especially just after the menstrual period. Preventive measures should be taken to make the procedure pain free because the physician may underestimate pain perception during the procedure.     

米非司酮合并米索前列醇房事后避孕临床多中心研究

在黄体早、中、晚期应用米非司酮合并米索前列醇与单用米非司酮进行房事后避孕临床多中心比较性研究。５４１名自愿接随机序号参加本研究的健康、月经规律妇女，组Ⅰ口服米非司酮２５ｍｇ，ｑ１２ｈ共４次，第三天上午加服米索前列醇０．４ｍｇ，妊娠率为０．４％。组Ⅱ单服米非司酮２５ｍｇ，ｑ１２ｈ，共４～６次，妊娠率为３％。二者差异有显著性（Ｐ＜０．０５）。两者引起出血类型和时间均与正常月经相似，且无明显副反应发生，错过了服用传统房事后避孕药时，采用本研究的方法可不考虑性生活时间、次数。这种方法提供了一种新型有效避孕方法。     

米非司酮配伍米索前列醇终止10～16周妊娠的临床多中心随机比较性研究

目的探索米非司酮合并米索前列醇（米索）终止１０～１６周妊娠最佳剂量及最佳给药途径。方法将来自上海２４所医院的２００７例孕１０～１６周要求药物终止妊娠的妇女,随机分成４种不同的治疗组。组Ⅰ：５１１例,米非司酮７５ｍｇ每天１次,连服２天（总量１５０ｍｇ）,第３天晨口服米索０．６ｍｇ,每３～４小时重复１次,最多３次;组Ⅱ：４９１例,米非司酮１００ｍｇ每天１次,连服２天（总量２００ｍｇ）,米索用法同组Ⅰ;组Ⅲ：５１９例,米非司酮用法同组Ⅰ,第３天晨阴道内放置米索０．６ｍｇ,每１２小时重复１次,最多３次;组Ⅳ：４８６例,米非司酮用法同组Ⅱ,米索用法同组Ⅲ。结果４组２４小时内的流产成功率分别为８８．６％、８９．４％、９０．９％和９４．０％。组Ⅳ的成功率明显高于组Ⅰ和组Ⅱ。２４小时内流产成功者米索的用量,阴道给药者比口服给药者明显减少（Ｐ＜０．００１）,胃肠道副反应发生率也明显降低（Ｐ＜０．０５）。结论口服米非司酮２００ｍｇ合并阴道放置米索,是较好的药物终止１０～１６周妊娠的方法,可作为一种常规方法推荐在临床应用。     

米非司酮联合米索前列醇用于终止早期妊娠和治疗稽留流产的效果比较

目的：探讨并比较米非司酮联合米索前列腺醇用于终止早期妊娠和治疗稽留流产的效果和安全性。方法：选择2008年5月至2013年5月于我院就诊的孕10～16周要求终止妊娠和稽留流产病例为研究对象,分为早期妊娠组和稽留流产组,两组患者均给予同剂量的米非司酮和米索前列腺醇序贯治疗,观察和比较两组患者的流产效果以及不良反应。结果：稽留流产组患者的完全流产率低于早期妊娠组,胎体排出后24h阴道出血量多于早期妊娠组,差异有统计学意义（P〈0．05）,但两组患者口服米索前列腺醇到胎体排出的时间间隔及不良反应差异无统计学意义（P〉0．05）。结论：米非司酮联合米索前列腺醉用于治疗稽留流产效果和安全性值得肯定。     

米非司酮配伍米索前列醇终止子宫肌瘤患者早孕的探讨

目的 :探讨米非司酮配伍米索前列醇终止子宫肌瘤患者早孕的可行性、有效性。方法 :92例早孕合并子宫肌瘤的健康妇女给予米非司酮 1 5 0 mg配伍米索前列醇 1 0 0 0 μg终止妊娠。结果 :完全流产率为 89.1 % ,出血时间平均为 1 1 .89± 6.87d。多因素分析提示肌瘤大小对孕囊排出时间、出血时间有影响 ,孕囊大小对出血时间有影响。但肌瘤位置、个数对药流结局、出血时间和转经时间均无明显影响。结论 :米非司酮配伍米索前列醇终止子宫肌瘤患者早孕是可行、有效、安全的     

米非司酮配伍米索前列醇终止畸形子宫早孕63例临床分析

目的 :探讨米非司酮配伍米索前列醇终止畸形子宫早孕的临床疗效。方法 :对 6 3例早孕合并畸形的流产病例均采用药物流产方法 ,即 :米非司酮 75mg× 2 (早 50 mg,晚 2 5mg)口服 ,d 3晨空腹服米索前列醇 6 0 0μg。结果 :完全流产率 44 /6 3(6 9.8% ) ,不全流产率 1 7/6 3(2 7.6 % ) ,失败 2 /6 3(3.2 % )。对 1 7例不全流产、2例失败者行刮宫及吸宫术 ,手术操作容易 ,穿孔率及漏吸率为 0。B超用于诊断畸形子宫正确率高。结论 :米非司酮配伍米索前列醇终止畸形子宫早孕的方法较理想 ,B超是诊断子宫畸形较理想的手段     

Platelet-Rich Plasma (PRP) Improves Erectile Function: A Double-Blind,Randomized, Placebo-Controlled Clinical Trial

BackgroundAnimal studies postulate that platelet-rich plasma (PRP) injections improve key elements of the pathophysiologic mechanisms leading to erectile dysfunction (ED).AimTo conduct the first double-blind, randomized, placebo-controlled trial assessing the efficacy and safety of PRP injections in patients with mild and moderate ED.MethodsSixty sexually active patients with mild and moderate ED were randomly assigned to two sessions, with a one-month difference, of 10 mL PRP (n = 30) or placebo (n = 30) intracavernosal injections. An FDA-approved separation system was used. Patients were evaluated at 1, 3 and 6 months after completion of the treatment protocol. A per-protocol analysis was applied. All participants withheld any ED treatment during the trial.OutcomesThe achievement of minimal clinically important difference (MCID) in the International Index of Erectile Function – Erectile Domain (IIEF-EF) from baseline to 6 months after final treatment. Erectile function at all time points, as well as safety of PRP injections, were also evaluated.ResultsAt 6 months, a MCID was achieved by 20/29 (69%) patients in the PRP group compared to 7/26 (27%) in the placebo group. The risk difference between the two groups was 42% (95%CI: 18?66), P < 0.001 and the baseline-adjusted mean between-group-difference in the IIEF-EF score was 3.9 points (95%CI: 1.8?5.9). Similarly, a statistically significant difference of both the number of participants attaining a MCID and the IIEF-EF score was also observed at the 1- and 3-month evaluation between the two groups. Accordingly, patients receiving PRP were more satisfied with the treatment. No adverse events were observed during the study period.Clinical implicationsIntracavernosal PRP injection therapy used as outlined in this trial appears to be a safe and effective short-term treatment for the management of mild to moderate ED.Strengths & LimitationsWe conducted the first clinical trial exploring the role of PRP in the management of ED. Conversely, our findings lack external validity due to single-center design. Furthermore, our results cannot be extrapolated to other PRP separation systems.ConclusionsPRP intracavernosal injections may be a promising addition to the urologist's armamentarium for the management of ED. Still, further high-quality studies are warranted to corroborate our findings. Evangelos P, Mykoniatis I, Pyrgidis N, et al. Platelet-Rich Plasma (PRP) Improves Erectile Function: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial. J Sex Med 2021;18:926–935.     

Intrauterine Instillation of Tranexamic Acid in Hysteroscopic Myomectomy: A Double-Blind,Placebo-Controlled,Parallel-Group Randomized Clinical Trial

Study ObjectiveTo evaluate the hemostatic effect of intrauterine instillation of tranexamic acid (TXA) with the distention medium during hysteroscopic myomectomy.DesignProspective, parallel-group, double-blind, placebo-controlled randomized clinical trial.SettingEarly Cancer Detection Unit in Ain Shams University Maternity Hospital, Cairo, Egypt.PatientsEighty women with type 0 or I submucous myoma undergoing hysteroscopic myomectomy using unipolar resectoscope.InterventionsThe participants were randomly assigned to receive either 1 g of TXA for every 1000 mL of the distending medium (intervention group) or 10 mL of placebo (10 mL of 1.5% glycine) in the same form inside every 1000 mL of the distention medium.Measurements and Main ResultsThe primary outcome was a change in hemoglobin level 24 hours after surgery compared with preoperative values, and the secondary outcomes were the surgeon's rating of intraoperative bleeding and the quality of operative view, the duration of surgery, the volume of injected media, intraoperative complications, and the completion of myomectomy in 1 procedure. The mean difference in hemoglobin level was 1.11 ±.58 g/dL in the TXA group and 1.46 ± 0.61 g/dL in the placebo group (p = .015). The quality of hysteroscopic view was better in the TXA group (p = .001), with good operative view in 23 (60.5%) cases in TXA vs 8 (20.5%) in the placebo group. The surgeon's rating of bleeding as excessive was reported in 1 (2.6%) case in the TXA group and in 9 (23.1%) cases in the placebo group. There was no difference between the groups regarding the duration of surgery, the volume of injected media, completion of myoma resection in 1 session, and intraoperative complications. Three cases of uterine perforation with the thermal loop were reported, and all were associated with poor operative field in the placebo group.ConclusionIntrauterine instillation of TXA with the distention medium during hysteroscopic myomectomy resulted in a statistically significant decrease in hemoglobin level 24 hours after surgery, albeit with minimal clinical significance. TXA resulted in better visualization of the field throughout the procedure.     

Comparison of the Effect of Intravenous Tranexamic Acid and Sublingual Misoprostol on Reducing Bleeding After Cesarean Section: A Double-Blind Randomized Clinical Trial

The Journal of Obstetrics and Gynecology of India - To evaluate the effects of intravenous tranexamic acid (TA) and sublingual misoprostol on reducing bleeding after cesarean section. One hundred...     

复方米非司酮配伍米索前列醇终止早期妊娠临床疗效的Meta分析

目的:系统评价复方米非司酮配伍米索前列醇终止早期妊娠的临床效果。方法:根据系统评价原则进行计算机检索,并通过筛选与质量评价,对符合要求的文献利用REVMAN 5.0进行数据分析,绘制森林图。结果:共纳入了11个随机对照试验(randomized controlled trial,RCT),Meta分析结果显示:试验组(复方米非司酮组)对比对照组(米非司酮组)有提高完全流产率[OR=2.60,95%CI(1.77,3.82),P<0.001]和缩短阴道出血时间的优势,差异有统计学意义[WMD=-2.66,95%CI(-3.28,-2.04),P<0.001]。试验组有减少阴道出血量的趋势,但组间比较差异无统计学意义[SMD=-4.46,95%CI(-10.98,2.05),P=0.18]。结论:复方米非司酮配伍米索前列醇终止早期妊娠的临床疗效优于米非司酮,具有提高完全流产率、缩短出血时间的优势。     

延长米非司酮配伍米索前列醇序贯用药时间预防流产后出血的研究

目的　探讨米非司酮配伍米索前列醇终止早孕的最佳剂量方案 ,以预防流产后出血。方法　对 16 12例妊娠≤ 49天 ,要求药物终止妊娠的妇女 ,按 2∶1随机分为观察组、对照组。观察组1118例 ,米非司酮首次剂量 5 0mg ,继后每 12h 1次 ,每次 2 5mg(共 6d) ,总剂量 30 0mg ,于用药第 3天晨加用米索前列醇 6 0 0 μg,第 4～ 6天晨各加服 2 0 0 μg,总量 12 0 0 μg。对照组 494例 ,米非司酮首次剂量 5 0mg ,继后每 12h 1次 ,每次 2 5mg ,总剂量 15 0mg ,于用药第 3天晨加服米索前列醇 6 0 0 μg。 结果　观察组与对照组完全流产率分别为 98 39%和 88 0 6 % ;不全流产率 1 43 %和 10 73 % ,流产失败率为 0 18%和 1 2 1% (P <0 0 0 0 1)。两组出血时间分别为 (8 2± 2 8)d和 (12 3± 3 9)d(P <0 0 0 1) ,10d内止血率为 87 45 %和 5 7 47% (P <0 0 0 0 1) ,两组副反应比较 ,差异无显著性 (P >0 0 5 )。结论　低剂量分次服用并延长米非司酮并米索前列醇用药时间可提高完全流产率 ,缩短药物流产后出血时间 ,且不增加副反应     

Double-Blind Placebo-Controlled Treatment Trial of Chlamydia trachomatis Endocervical Infections in Pregnant Women

Objective: The purpose of this study was to determine if treatment of pregnant women with Chlamydia trachomatis infection would lower the incidence of preterm delivery and/or low birth weight.Methods: Pregnant women between the 23rd and 29th weeks of gestation were randomized in double-blind fashion to receive either erythromycin 333 mg three times daily or an identical placebo. The trial continued until the end of the 35th week of gestation.Results: When the results were examined without regard to study site, erythromycin had little impact on reducing low birth weight (8% vs. 11%, P = 0.4) or preterm delivery (13% vs. 15%, P = 0.7). At the sites with high persistence of C. trachomatis in the placebo-treated women, low birth weight infants occurred in 9 (8%) of 114 erythromycin-treated and 18 (17%) of 105 placebo-treated women (P = 0.04) and delivery <37 weeks occurred in 15 (13%) of 115 erythromycin-treated and 18 (17%) of 105 placebo-treated women (P = 0.4).Conclusions: The results of this trial suggest that the risk of low birth weight can be decreased by giving erythromycin to some women with C. trachomatis. Due to the high clearance rate of C. trachomatis in the placebo group, these data do not provide unequivocal evidence that erythromycin use in all C. trachomatis-infected women prevents low birth weight.     

米非司酮配伍前列腺素抗早孕的临床试验

上海市15个单位合作完成米非司酮配伍前列腺素抗早孕，按常规筛选对象共1884例。米非司酮分次给药共150mg，第3天随机给于PG05栓1mg置后穹窿或米索前列醇0．6mg顿服。结果完全流产率95．1％。效果与不同产地的米非司酮和不同前列腺素无差异；与以往人流或自然流产史、体重、胚囊直径、孕妇血色素、有无恶心呕吐等有关。药流副反应轻。完全流产后平均出血时间14．91±7．66d。药流后的对象满意度达85％以上。说明本法抗早孕安全有效、反应轻，建议通过培训、掌握常规，在有抢救条件的基层医疗单位推广应用。     

A Randomized,Double-Blind,Placebo-Controlled Trial of Oral Pregabalin for Relief of Shoulder Pain after Laparoscopic Gynecologic Surgery

Study ObjectiveTo investigate the efficacy of pregabalin for the relief of postoperative shoulder pain after laparoscopic gynecologic surgery.DesignProspective, randomized, double-blind, placebo-controlled trial (Canadian Task Force classification I).SettingTertiary referral center, university hospital.PatientsFifty-six women undergoing elective laparoscopic gynecologic surgery between June 2012 and March 2013.InterventionsWomen in the study group received 75 mg pregabalin 2 hours before surgery and then every 12 hours for 2 doses, and women in the control group received an identical capsule and the same dosage of placebo.Measurements and Main ResultsVisual analog scale (VAS) scores for shoulder pain and surgical pain at 24 and 48 hours after surgery were evaluated as primary outcome. Postoperative analgesics used and drug-related adverse events were also monitored. Patients in the pregabalin group had significantly lower postoperative VAS scores for shoulder pain at 24 hours, compared with the placebo group (median, 23.14 [range, 13.67–32.61] vs 37.22 [27.75–46.64]; p = .04), and required less analgesic (p = .01). There were no significant differences in VAS scores for surgical pain and adverse events between the 2 groups (p = .56).ConclusionsPerioperative administration of 75 mg pregabalin significantly reduced postoperative laparoscopic shoulder pain and amount of analgesic used.     

单用16，16－双甲基－反式△~2－PGE_1及加用丙酸睾丸酮抗早孕的临床研究

本文为了进一步验证丙酸睾丸酮（简称丙睾）在药物抗早孕中的作用，使用随机双盲法，将１５１例早孕妇女分为两组，丙睾＋１６，１６－双甲基－反式△２－ＰＧＥ１（简称ＯＮＯ８０２）组，肌注丙睾３００ｍｇ后用ＯＮＯ８０２阴道检１ｍｇ，每６ｈ重复一次，总量为４ｍｇ。对照组使用外观完全相同的安慰剂代替丙睾，ＯＲＯ８０２的用法相同。结果示丙睾＋ＯＮＯ８０２组完全流产，不全流产和失败率分别为７３．３％、１２．０％和１４．７％；对照组为５２．６％、１９．７％和２７．６％（Ｐ＜０．０５）。ＯＮＯ８０２的平均用量分２．３８±１．１９ｍｇ和２．８６±１．１１ｍｇ（Ｐ＜０．０１）。两组引～流时间各为７．Ｚｈ及８．６ｈ，平均流血时间各为１４及１７９。说明丙睾确实能减少前列腺素药物的用量和提高其抗早孕的临床效果。     

Erythropoietin Treatment under Polychemotherapy in Patients with Gynecologic Malignancies: A Prospective, Randomized, Double-Blind Placebo-Controlled Multicenter Study

In order to examine the influence of erythropoietin (rHuEPO) on serum hemoglobin levels, transfusion requirements, and quality of life in patients with gynecologic malignancies under polychemotherapy and chronic tumor anemia (hemoglobin <11 g/dl), we performed a prospective, randomized, double-blinded placebo-controlled clinical trial. Between October 1992 and October 1993, 35 patients from 5 gynecologic departments were entered into this trial. Inclusion criteria were hemoglobin level <11 g/dl, ferritin level >29 ng/ml, stool negative for occult blood, and life expectancy for more than 3 months. Patients received either 150 U/kg body wt rHuEPO (Erypo by Cilag-Janssen) sc three times a week for 12 weeks (n= 23) or a placebo (n= 12). If the hemoglobin levels of the 4th, 8th, or 12th week were >2 g/dl above the baseline value and/or >12 g/dl, the patient was classified as a responder. Patients who required blood transfusions (hemoglobin <8 g/dl, erythrocytes <3 × 10⁶/ml, or clinical symptoms of anemia) were classified as nonresponders. A nonvalidated quality of life questionnaire was completed by the patient at the beginning of the treatment and then every fourth week before receiving chemotherapy. In the rHuEPO group 56.6% of the patients responded to the treatment (χ²= 10.79,P= 0.001) and only 5 patients (21.7%) required blood transfusions, whereas 8 of 12 patients in the placebo group (66.6%) had to be transfused (χ²= 6.81,P= 0.009). Quality of life did not differ significantly between the rHuEPO group and the placebo group of patients. Within the rHuEPO group those patients that responded showed a significant increase in physical activity after response in comparison to the preresponsive phase (P= 0.02, pairedttest). We therefore concluded that rHuEPO significantly increases serum hemoglobin levels and decreases transfusions requirements while maintaining quality of life in patients with gynecological malignancies who are undergoing polychemotherapy.     

Optimal Dose of Vaginal Misoprostol for Cervical Ripening before Hysteroscopy: A Randomized Double-Blind Study

Study Objective

To evaluate the optimal dose of vaginal misoprostol (200 and 400?µg) for cervical priming before operative hysteroscopy.

二种单剂量米非司酮合并使用ONO802终止早孕的随机比较性研究

本研究接纳停经５６天以内的健康早孕妇女１００例，分别服用ＲＵ４８６５０ｍｇ或２００ｍｇ，合并ＯＮＯ８０２０．５ｍｇ或１ｍｇ．随机分成Ａ、Ｂ二组（Ａ组又分１、２组，ＲＵ４８６５０ｍｇ加用ＯＮＯ８０２０．５ｍｇ或１ｍｇ；Ｂ组也分为二组，为３、４组，ＲＵ４８６２００ｍｇ加用ＯＮＯ８０２０．５ｍｇ或１ｍｇ）观察完全流产率、出血量与出血持续时间，以探索最安全、有效的抗早孕药物。结果显示：Ａ组完全流产率８０．０％，Ｂ组完全流产率９６．０％，服用ＲＵ４８６后阴道开始流血时间及胚囊排出时间，流产后阴道出血持续时间及转经天数二组间无明显差异。     

A Randomized,Single Blind,Placebo-Controlled Trial for the Pain Reduction During the Outpatient Hysteroscopy After Ketoprofen or Intravaginal Misoprostol

Study ObjectiveTo assess the efficacy of ketoprofen vs intravaginal misoprostol for pain relief during outpatient hysteroscopy.DesignProspective, randomized, single-blind, placebo-controlled clinical trial (Canadian Task Force classification I).SettingTertiary medical center.PatientsOne hundred fifty women referred for hysteroscopy between January and October 2013.InterventionsWomen were randomized to receive vaginal misoprostol, 400 μg, with 100 mL of 5% intravenous glucose (misoprostol arm); intravenous ketoprofen, 50 mg/mL, in 100 mL 5% glucose with intravaginal placebo (ketoprofen arm); or vaginal placebo tablets, 100 mL 5% intravenous glucose (placebo arm) before outpatient hysteroscopy.Measurements and Main ResultsA visual analog scale (VAS) was used for 1-dimensional pain assessment. Patients were asked to mark a VAS score before, during, and at 5 and 15 minutes after the procedure. Median VAS scores during and directly after the anesthesia-free hysteroscopy were significantly lower in the misoprostol group than in the ketoprofen (p = .02) or placebo (p = .006) groups. There were no statistical differences between the 3 arms in median VAS score assessed at 15 minutes after the procedure (p = .16). There were no differences in procedure time between groups (p = .16).ConclusionWhen administrated 4 hours before the procedure, 400 μg vaginal misoprostol seems to reduce the pain during and immediately after hysteroscopy. The effect does not depend on patient age, hormone status, parity, or type of outpatient hysteroscopy (operative or diagnostic).