ABSTRACT
The efficacy and safety of the low dose monophasic oral contraceptive (OC) combination containing 30 micrograms of ethinylestradiol (EE) and 2.0 mg of dienogest (DNG) (EE/DNG) was evaluated in a prospective, open-label, multicenter, uncontrolled, phase III trial. The trial was carried out in six hospitals by 36 investigators in the Czech Republic, and included 557 healthy women (aged 18-35 years), over 12 cycles, with a total of 6051 cycles. EE/DNG provided a reliable ovulation inhibition. The contraceptive efficacy study showed an adjusted Pearl index of 0.198 on the basis of three pregnancies occurring during 6051 cycles. EE/DNG provided good cycle control, reduced the incidence of intermenstrual bleedings, the intensity of menstrual bleeding and frequency of dysmenorrhea. Due to the antiandrogenic properties of the progestogen component DNG, EE/DNG improved androgen-related conditions, such as skin blemishes, hair greasiness and acne vulgaris. From 108 women with acne, 62 (57%) improved after the 6th cycle, and 16 (15%) were healed. Similar changes were found after cycle 12. Breast tenderness and headache were the most frequent of the common complaints due to treatment with EE/DNG. The frequency of all complaints decreased steadily over time. Only 7.7% of subjects discontinued due to adverse reactions. No thrombophlebitic events were noticed.
Subject(s)
Contraceptives, Oral, Combined/therapeutic use , Cytochrome P-450 CYP1A1/therapeutic use , Nandrolone/analogs & derivatives , Nandrolone/therapeutic use , Steroid Hydroxylases/therapeutic use , Adolescent , Adult , Breast Diseases/chemically induced , Contraceptives, Oral, Combined/administration & dosage , Contraceptives, Oral, Combined/adverse effects , Cytochrome P-450 CYP1A1/administration & dosage , Cytochrome P-450 CYP1A1/adverse effects , Depression/chemically induced , Drug Administration Schedule , Female , Gastrointestinal Diseases/chemically induced , Headache/chemically induced , Humans , Nandrolone/administration & dosage , Nandrolone/adverse effects , Prospective Studies , Skin Diseases/chemically induced , Steroid Hydroxylases/administration & dosage , Steroid Hydroxylases/adverse effects , Treatment Failure , Treatment OutcomeABSTRACT
In 210 patients divided in 7 groups depending on surgical disease or pregnancy the authors estimated pH of the gastric content during the preoperative period. It was found that pH was below 2.5, i.e. the acid level of the gastric content was high enough to present a hazard for appearance of Mendelson's syndrome, should eventual regurgitation or aspiration occur during or after general anesthesia. In an effort to prevent aspiration syndrome, apart from the most reliable and well know precaution "empty stomach", the authors suggest premedication with antacid drugs before the operation. They have applied Almagel A or Cimetidin 30 min before the operative intervention. The acid level of the gastric juice was thus reduced for about 1 1/2 hours to pH levels higher than the critical 3.5, so that in the event of eventual regurgitation and aspiration the gastric content would not cause severe respiratory injury. With their suggestion for use of antacid drugs during the preoperative period the authors expand the preoperative preparation of the patient for general anesthesia with set purpose to prevent respiration (Mendelson's) syndrome.
