应用前列腺素0N0802阴道栓剂引产——182例临床观察

本文报告了182例(早孕、中期妊娠、晚期妊娠、胎死宫内、葡萄胎)应用前列腺素ONO802阴道栓剂引产的临床效果。每隔3小时于阴道后穹窿投药1枚(1毫克/枚)。5枚为一疗程。如不成功,次日再用第二疗程。引产总成功率为90.5%,其中早孕引产成功率为91.6%、中期妊娠88.8%、胎死宫内94.7%。葡萄胎和晚期妊娠100%。在引产成功者中,有83.9%用药1—5毫克;产程在24小时以内者占75%。34例手术终止妊娠者,用药2枚后6小时,宫颈大多已扩张至Hegar 氏10号以上,不需要器械扩宫即能进行手术流产,操作容易,出血量少(平均为12.5毫升)。流产后,一般于二星期内阴道流血停止,6周内月经转复。并发症少,副反应轻。8例再次妊娠者中有2例已足月分娩,新生儿未见异常,故认为前列腺素ONO802阴道栓剂引产是目前较好的引产方法之一。     

A prostaglandin analogue (ONO-802) in treatment of missed abortion, intrauterine fetal death and hydatiform mole: a dose-finding trial

Forty-eight patients affected with missed abortion, intrauterine fetal death and hydatiform mole were treated with vaginal suppositories containing 1 mg of 16,16-dimethyl-trans-delta 2-PGE1 methyl ester (ONO-802). The patients were divided into two treatment groups. The first, Group A, was given one vaginal suppository every 3 h to a maximum of five suppositories. The product of conception was expelled in 95.8% of patients. In Group B the maximum number of suppositories was reduced to three. The product of conception was expelled in 100% of cases and the average duration of treatment was similar to that for the first group. Although side-effects were mild in both groups, they were reduced in the patients of Group B.     

Menstrual regulation with prostaglandin (Pg ONO 802) in Indonesia

This study was conducted to evaluate the safety, efficacy and acceptability of PGE1 vaginal suppositories (Pg ONO 802) in menstrual regulation. Each vaginal suppository contains 1 mg of 16,16 dimethyl-trans-delta 2 PGE1 methyl ester. Five suppositories were inserted as high as possible into the fornix posterior of the vagina at intervals of 3 h. Five hundred thirty four subjects with delay of menses mostly of up to 14 days were included in the study. Blood chemistry was evaluated and urine analysis performed in all subjects. Success of treatment was assessed on two alternative groups of criteria: (A) induction of bleeding by Pg ONO 802; (B) induction of bleeding achieved by Pg ONO 802 and not followed by surgical intervention. The success rate based on criteria A was 98.9%, and on criteria B 86%. If heavy bleeding occurred and signs of pregnancy were found during the trial period, intervention was made by vacuum aspiration or curettage when necessary. If bleeding did not occur and/or pregnancy continued, treatment was declared a failure and pregnancy was terminated by vacuum extraction or curettage. For non-pregnant subjects no intervention was made but careful re-evaluation was carried out. Mean duration of bleeding after Pg ONO 802 treatment was 6.7 days. Side-effects were generally mild. The incidence of diarrhea was 8.8%, nausea 7.8%, headache 5.8%, vomiting 2.8%; abdominal cramp occurred in as many as 66% of subjects. No treatment was given for these side-effects as they were within acceptable limits.(ABSTRACT TRUNCATED AT 250 WORDS)     

二种单剂量RU486合并ONO802终止57～63天妊娠的随机双盲法比较研究

本研究共接纳停经５７～６３ｄ的健康早孕妇女１００例，按随机双盲法分为二组，分别口服ＲＵ４８６２００ｍｇ和６００ｍｇ，４８ｈ后加用阴道栓剂ＯＮＯ８０２１ｍｇ。完全流产率分别为９６．０％和９４．０％；两组各有上例继续妊娠，２００ｍｇ组有１例不全流产，而６００ｍｇ组有２例，两组间无明显差异。２００ｍｇ组一例不全流产者输血２００ｍｌ。用药后副反应都较轻微，无需特殊处理。两组阴道流血量、流血持续时间及转经天数相似。实验结果表明：６００ｍｇ及２００ｍｇ单剂量ＲＵ４８６合并１ｍｇＯＮＯ８０２对终止停经５７～６３ｄ的早孕是有效的；２００ｍｇ单剂量ＲＵ４８６可达到６００ｍｇ同样的效果。     

A clinical study on the termination of early first trimester pregnancy in fifty cases by vaginal administration of 16,16-dimethyl-trans-delta 2-PGE1 methyl ester (ONO-802)]

The results of the termination of 50 cases of early pregnancy (56 days) by vaginal suppositories containing 1 mg of 16,16-dimethyl-trans-delta2-PGE1 methyl ester (ONO-802) are as follows. The pregnant women were kept in the hospital for observation for 24 hours and treated with 1 suppository of ONO-802, 5 doses every 3 hours. Follow-up visits were obligatory within the 1st and 2nd weeks and within the 4th-6th weeks after treatment. Results of the treatment were judged at the 2nd follow-up visit, based on clinical course, pregnancy test, and gynecological examination. The rates of complete abortion, incomplete abortion, and failure of treatment were 76%, 6%, and 18%, respectively. The gastrointestinal side effects were tolerable. The complete abortion rate was only 76% lower than those reported in WHO multicenter studies but comparable with results obtained in Shanghai and Wuhan by using a similar protocol. Again, the successful rate in this group was lower than that reported in Shanghai by using d1-15 methyl PGF2alpha in combination with testosterone propionate, R2323, or Radix Trichosanthis for termination of early pregnancy. The authors believe that the effectiveness of ONO-802 for termination of early pregnancy may be improved by combined treatment with the above drugs. (author's modified)     

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。     

Extraamniotic prostaglandin F2 alpha for intrauterine death and fetal abnormality.

Prostaglandin F2 alpha was administered extraamniotically for termination of pregnancy in 15 cases of intrauterine fetal death between 18 and 39 wk gestation and in 10 cases of fetal abnormality or hydatidiform mole between 16 and 28 wk gestation. Although delivery was achieved with minimal side effects in all cases, the best results were obtained in patients with intrauterine fetal death. It is concluded that discontinuous extraamniotic prostaglandin therapy constitutes a safe and effective approach for the active management of intrauterine fetal death.     

Safety and efficacy of vaginal prostaglandin E2 suppositories in the management of third-trimester fetal demise

Prostaglandin E2 vaginal suppositories are well established in the management of intrauterine fetal demise in the second trimester of pregnancy. However, approval for their use in the third trimester has been withheld pending evaluation of safety and efficacy. In this study 46 patients with intrauterine fetal demise in the third trimester were managed in a similar fashion except that only a 10-mg dose of prostaglandin E2 was employed. Forty-four of the 46 patients were delivered successfully. One patient experienced a cervical laceration that necessitated a hysterectomy; in her, oxytocin was used to supplement the prostaglandin. It appears that prostaglandin E2 vaginal suppositories can be used safely in the management of fetal demise in the third trimester of pregnancy. Use of a lower dose of the medication as well as tocodynamometry is recommended because the absorption of and sensitivity to this medication vary from patient to patient. The frequency of administering the medication should depend on the patient's response rather than on any given formula.     

A randomized trial of oral and vaginal misoprostol to manage delivery in cases of fetal death

OBJECTIVE: To compare the effectiveness and side effects of oral and vaginal misoprostol for the termination of second and third trimester pregnancy with intrauterine fetal death. METHODS: Eighty pregnant women at 16-41 weeks' gestation with intrauterine fetal death were randomized in two groups to receive either 400 micro g of misoprostol orally every 4 hours (n = 40) or 200 micro g of misoprostol vaginally every 12 hours (n = 40) until the termination of pregnancy was completed. The adverse effects, progress, and outcomes of delivery were assessed. RESULTS: The groups were similar in age, weight, height, gestational age, parity, and modified Bishop scores before intervention. The mean induction-to-delivery time in the oral group (13.95 [standard deviation (SD) = 5.63] hours) was significantly shorter than the time in the vaginal group (18.87 [SD = 10.38] hours, P =.001). The number of deliveries within 24 hours after the initial drug administration in the oral group (92.5%) was significantly higher than the number in the vaginal group (67.5%, P <.001), and all delivered within 48 hours after the initial drug administration. However, the gastrointestinal side effects in the oral group was significantly higher than in the vaginal group (P =.005). CONCLUSION: Misoprostol (400 micro g given orally every 4 hours) was more effective than misoprostol (200 micro g given vaginally every 12 hours) for the termination of second and third trimester pregnancy with intrauterine fetal death, but with more gastrointestinal side effects.     

Twin pregnancy with a complete hydatidiform mole and co-existent live fetus: two case reports and review of the literature

Introduction  The aim of this study was to report the clinical features, management, and outcome of two cases of complete hydatidiform mole with a coexisting viable fetus and to review the literature. Case reports  In this article, we report on the well-documented follow-up of two cases of twin pregnancies with complete hydatidiform mole and a normal fetus. Genetic amniocentesis showed normal fetal karyotype in both of two cases. In the first case, a live male infant was delivered by a cesarean section because of severe maternal bleeding at 29 weeks of gestation. In the second case, termination of pregnancy was performed due to early onset of severe preeclampsia and vaginal hemorrhage. Conclusion  The chances of a live birth have been estimated between 30 and 35% and the risk of persistent trophoblastic disease is similar to singleton molar pregnancies in complete mole with coexisting fetus pregnancy. Therefore, in these pregnancies, expectant management instead of termination of pregnancy can be suggested.     

Mid-second-trimester labor induction: concentrated oxytocin compared with prostaglandin E2 vaginal suppositories

A concentrated oxytocin infusion and prostaglandin E2 (PGE2) vaginal suppositories were compared in a retrospective analysis for indicated abortion in the mid-second trimester (17-24 weeks' gestation). Eighty-one women underwent second-trimester pregnancy termination, 59 by PGE2 suppositories and 22 by concentrated oxytocin infusion. Success was achieved by PGE2 in 93% (55 of 59) and oxytocin in 91% (20 of 22). The mean duration of labor was 13.1 hours with PGE2 and 8.2 hours with oxytocin. The mean dose of PGE2 was 65.2 mg; of oxytocin, 200 units. Women who received PGE2 experienced nausea (46%), vomiting (37%), fever (64%), and diarrhea (20%) despite appropriate premedication. Few side effects occurred in the women who were treated with oxytocin. We conclude that concentrated oxytocin infusion seems to be a reasonable alternative to PGE2 vaginal suppositories for induction of labor in the mid-second trimester.     

Internal and external cervical os dilation with vaginal 15-methyl prostaglandin F2 alpha

Changes in the external and internal cervical os after vaginal administration of a suppository containing 1 mg of 15-methyl prostaglandin F2alpha (PGF2alpha) were differentiated in this study of 19 pregnant women prior to a 1st trimester pregnancy termination. Mean age of the women was 20.6 +or- .99, mean parity was .68 +or- .2, and mean gravidity was 2.32 +or- .54. Pregnancies averaged 10 weeks duration. Cervical dilatation before administration averaged 6.89 +or- .45 mm in the external os and 3.37 +or- .43 in the internal os; compared to 10 +or- .44 mm in the external os and 8.05 +or- .57 mm in the internal os 3 hours after administration of suppositories. Mean additional dilatation prior to the procedure was 1.84 +or- .43 mm. 74% of the women experienced diarrhea, 37% had vomiting, 27% cramps, 21% nausea, 26% vaginal pain, and 26% bleeding prior to the procedure. The greater dilatation of the internal os found in the study is comparable to the behavior of the cervix in the uterus near term when lower segment changes often precede the dilatation of the external os.     

0.8 mm控释地诺前列酮栓用于足月胎膜早破促宫颈成熟的多中心研究

目的 探讨0.8 mm控释地诺前列酮栓(其他名称:欣普贝生)用于足月胎膜早破促宫颈成熟的安全性及有效性.方法 采用多中心、前瞻性研究方法,选择孕足月、单胎、头位,宫颈Bishop评分<6分、无严重合并症及引产禁忌证、胎儿情况正常的足月胎膜早破产妇100例为观察组,选择同期条件相同、具备引产指征的180例胎膜完整产妇作为对照组.在无菌操作下,将0.8 mm控释地诺前列酮阴道栓剂1枚横向置于产妇的阴道后穹隆深部,药物放置后产妇卧床2 h.记录两组产妇药物放置至宫缩开始、临产及分娩的时间;药物平均放置时间;胎心率异常、羊水粪染、子宫过度刺激情况及其他不良反应;分娩方式、产程时间、产后出血量及新生儿情况.结果 两组共280例产妇中,26例置药后24 h未临产(9.3%,26/280),其中观察组3例,对照组23例;观察组24 h内临产率为97.0%(97/100),明显高于对照组的87.2%(157/180),两组比较,差异有统计学意义(P<0.01).观察组73例阴道分娩(75.3%,73/97),24例剖宫产分娩(24.7%,24/97);对照组107例阴道分娩(68.2%,107/157),50例剖宫产分娩(31.8%,50/157),两组阴道分娩及剖宫产率比较,差异均无统计学意义(P>0.05).两组药物放置至宫缩开始时间、药物平均放置时间、总产程时间比较,差异也无统计学意义(P>0.05).观察组宫缩过频发生率为11.3%(11/97),对照组为19.1%(30/157),两组比较,差异无统计学意义(x2=2.673,P>0.05);两组均无新生儿窒息发生.结论 0.8 mm控释地诺前列酮栓用于足月胎膜早破促宫颈成熟安全、有效,但用药期间应加强监护.     

First trimester diagnosis of a partial mole with the combined use of ultrasound and chorionic villous sampling

A patient with vaginal bleeding in the first trimester of pregnancy had a serum human chorionic gonadotropin (hCG) titer of 495,132 mlU/ml and an abdominal ultrasound examination revealed an intrauterine gestational sac without a fetal pole. Two and a half weeks later the hCG titer was 385,000 mlU/ml and a fetal pole was visualized. Transabdominal villous sampling was performed because of the suspicion of a partial mole. Histopathologic examination showed hydropic villi and chromosomal studies were consistent with triploidy. The diagnosis of partial mole in the first trimester of pregnancy was made and the pregnancy terminated.     

Ultrasound diagnosis of coexisting molar pregnancy following referral for abnormal serum screen

Complete hydatidiform mole and coexistent fetus is a rare occurrence. We report a case of a patient referred for abnormal serum screen and vaginal bleeding in the second trimester of pregnancy. Ultrasound revealed a cystic and solid mass along the posterior uterine wall with multiple hypoechoic (honeycomb) areas noted, consistent with molar degeneration of the placenta. Separate from this mass was a coexisting viable fetus with normal fetal anatomy and distinct anterior placenta. At delivery, a large cystic mass of placental tissue appeared to be implanted separately from a normal-appearing fetus and placenta. The mass weighed 184 g and contained multiple 1- to 1.5-cm cysts throughout. Microscopic sections revealed hydropic chorionic villi with central cistern formation and nonpolar trophoblastic hyperplasia with atypia, compatible with complete hydatidiform mole. This case illustrates that the diagnosis of coexisting molar pregnancy after referral for abnormal serum screen should be considered, especially if maternal serum beta-human chorionic gonadotropin is high and the patient has vaginal bleeding.     

Clinical study of a new protocol on the termination of early pregnancy by administration of dl-15-methyl prostaglandin F2 alpha in combination with testosterone propionate]

Herein are presented the results of termination of early pregnancy by a new protocol using the administration of dl-15-methyl-prostaglandin F2alpha in combination with testosterone propionate in 956 cases studied between January 1984-July 1985, inclusive. Among them, 507 cases were discussed in detail. A comparative study was made between PG vaginal sponge and PG vaginal suppositories. Testosterone propionate 100 mg was given by intramuscular injection daily for 3 days before the day of PG administration. A piece of sponge or a suppository with dl-15-methyl PGF2alpha at random was placed in the posterior fornix of the vagina. An intramuscular injection of 2 mg of the same PG was subsequently given if the product of conception did not pass out after 6 or 12 hours. The success rate varied from 90.91%-100%. There was neither significant difference of the frequency of complete abortion, incomplete abortion, and failure of treatment between the sponge and suppository groups, nor was any significant difference found between the groups of 6 and 12 hour intervals. The authors feel that although the nonsurgical method of using dl-15-methyl PGF2alpha in combination with testosterone propionate cannot take the place of vacuum aspiration for termination of early pregnancy; it is simple, safe, and highly effective with tolerable side effects and without much influence in the reappearance of normal menstruation and fertility. It is especially suitable for those who have a history of recent abortion, cesarean section, uterine abnormality, or pregnancy with lactation amenorrhea, etc. (author's modified)     

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。     

A comparison between vaginal prostaglandin E2 suppositories and intrauterine extra-amniotic prostaglandins in the management of fetal death in utero

This retrospective study was undertaken to compare the efficacy, side effects, and complications of prostaglandin E₂ (PGE₂) given as a vaginal suppository with those of PGE₂ administered via the intrauterine extra-amniotic route to induce labor after fetal death. The induction-to-delivery intervals were comparable, with 9.2 ± 3.94 hours and 8.6 ± 4.49 hours, respectively. However, the mean total amount of PGE₂ administered was much less via the intrauterine extra-amniotic route (1.8 milligrams) than by the vaginal suppository (45.2 mg). There was a 100% success rate in the patients treated by the intrauterine extra-amniotic route, but only a 91.3% success rate in those patients treated via the vaginal route. The side effects (vomiting, diarrhea, fever) and the complications (incomplete abortion, uterine rupture, oxytocin augmentation) occurred more frequently with the use of PGE₂ as a vaginal suppository. The vaginal route of administration of PGE₂ is somewhat more convenient, but the intrauterine extra-amniotic route may offer a higher degree of efficacy and safety with fewer side effects in the management of fetal death in utero.     

ONO—802阴道给药抗早孕50例临床效果观察

本文报告了停经56天以内的早孕妇女应用ONO-802阴道栓剂抗早孕的临床观察及效果。50例早孕妇女住院观察24小时,阴道投药1枚(1mg/枚),5枚为一疗程。用药后1周、2周、4～6周门诊随访,复查尿HCG、血红蛋白。在第二周随访时判断用药效果。临床结果:总有效率82%,其中完全流产76%,不全流产6%,失败率18%。ONO-802使用方便,副反应轻,是深受广大妇女欢迎的一种非手术终止妊娠的方法。本项试验结果通过与国内PG 联合用药的结果和研究资料对比,ONO-802如果能与丙睾、R2323、天花粉等联合应用,将会提高其抗早孕的有效率。     

Complete hydatidiform mole in a triplet pregnancy coexisting two viable fetuses: case report and review of the literature

We report a rare case of a complete hydatidiform mole with two or more coexisting fetuses where both infants survived without complications. A male infant weighing 1258 g and a female infant weighing 880 g were delivered without complications and discharged 95 days after the birth. The analysis of DNA microsatellite polymorphisms indicated that the mole was of paternal origin and probably homozygous. The mother suffered from multiple pulmonary metastasis of the hydatidiform mole which was detected 3 days after the surgery and was successfully treated with methotrexate. A complete hydatidiform mole with two or more coexisting fetuses produces a dilemma between immediate termination and pregnancy continuation. Although the present case resulted in a favorable outcome, a review of the 14 reported cases suggests that the high fetal loss rate (90%) must be a consideration in the decision regarding management of such a pregnancy.