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注射用微囊化醋酸甲地孕酮疗效及安全性的随访研究并对其避孕机制的探讨

A follow-up study of the efficacy and safety of injectable microencapsulated megestrol acetate and a discussion on its contraceptive mechanism.

作者信息

Han Z Y, Xiao R Q

出版信息

Int J Gynaecol Obstet. 1985 Jun;23(3):207-11. doi: 10.1016/0020-7292(85)90106-7.

DOI:10.1016/0020-7292(85)90106-7
PMID:2865183
Abstract

A monthly injectable microencapsulated contraceptive was developed by the researchers of the School of Pharmacy of Sichuan Medical College, and a comparative clinical study was undertaken by the Sichuan Cooperative Research Group. It has been found that the microencapsulated compound consisting of 15 mg megestrol acetate and 5 mg estradiol valerate is associated with the lowest incidences of menstrual disturbances and other side effects. This is a follow-up report on the 434 women who used this 'optional' dosage of compound by before-and-after comparisons and by comparisons with two other groups of women: 41 women who were given the compound with the same dosage combination but with microencapsular coat dissolved, and 20-30 women who were using a non-steroidal contraceptive method such as IUDs, barrier or rhythm methods. The microencapsulated compound was highly effective in preventing accidental pregnancies. All except two of the 119 women who discontinued the medication experienced normal menstruation within 3 months. The study did not show changes in blood pressure, liver function, glucose tolerance level and plasma concentration of cholesterol in women using the compound. Cervical smears and breast examination also showed no evidence of epithelial abnormality or breast tumors. This new delivery system of microencapsulated injections affects the cervical mucus function, and inhibits ovulation as well as implantation of fertilized ovum.

摘要

四川医学院药学院的研究人员研发出了一种每月注射一次的微囊化避孕药,四川合作研究小组进行了一项对比临床研究。已发现,由15毫克醋酸甲地孕酮和5毫克戊酸雌二醇组成的微囊化复合物,月经紊乱及其他副作用的发生率最低。这是一份对434名使用这种“可选”剂量复合物的女性的随访报告,通过前后对比以及与另外两组女性进行比较:41名接受相同剂量组合但微囊包膜已溶解的复合物的女性,以及20 - 30名使用宫内节育器、屏障或节律法等非甾体避孕方法的女性。微囊化复合物在预防意外怀孕方面非常有效。在119名停药的女性中,除两人外,其他人在3个月内月经都恢复正常。该研究未显示使用该复合物的女性血压、肝功能、糖耐量水平和血浆胆固醇浓度有变化。宫颈涂片和乳房检查也未显示上皮异常或乳腺肿瘤的迹象。这种新的微囊化注射给药系统会影响宫颈黏液功能,并抑制排卵以及受精卵着床。

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1
A follow-up study of the efficacy and safety of injectable microencapsulated megestrol acetate and a discussion on its contraceptive mechanism.注射用微囊化醋酸甲地孕酮疗效及安全性的随访研究并对其避孕机制的探讨
Int J Gynaecol Obstet. 1985 Jun;23(3):207-11. doi: 10.1016/0020-7292(85)90106-7.
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Clinical evaluation of intramuscular injection of microencapsulated compound megestrol acetate.微囊化复方醋酸甲地孕酮肌肉注射的临床评价
Int J Gynaecol Obstet. 1984 Aug;22(4):319-24. doi: 10.1016/0020-7292(84)90091-2.
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Menstrual regulation by sequential hormone therapy.序贯激素疗法对月经的调节作用
West J Surg Obstet Gynecol. 1964 May-Jun;72:160-3.
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[Determination of megestrol acetate and estradiol valerate in injection of microencapsulated compound megestrol acetate by secondary derivative spectrophotometry].
Hua Xi Yi Ke Da Xue Xue Bao. 1991 Mar;22(1):87-9.
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Effects of a single contraceptive Silastic implant containing nomegestrol acetate on ovarian function and cervical mucus production during 2 years.含醋酸诺美孕酮的单一避孕硅橡胶植入剂对两年内卵巢功能和宫颈黏液分泌的影响。
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[Blood levels of megestrol acetate following injection of the microencapsulated compound megestrol acetate and its effect on pituitary-ovarian function].[注射微囊化醋酸甲地孕酮后其血药浓度及其对垂体-卵巢功能的影响]
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Combination injectable contraceptives for contraception.复方注射用避孕药用于避孕。
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Comparative studies of the ethynyl estrogens used in oral contraceptives. VII. Effects with and without progestational agents on ultracentrifugally fractionated plasma lipoproteins in humans, baboons, and beagles.口服避孕药中使用的乙炔基雌激素的比较研究。VII. 有和没有孕激素对人类、狒狒和比格犬超速离心分离的血浆脂蛋白的影响。
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J Steroid Biochem. 1984 Jan;20(1):217-29. doi: 10.1016/0022-4731(84)90208-5.

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