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<p><b>OBJECTIVE</b>To evaluate the efficacy and metabolic safety of long-term treatment with ethinyl oestradiol/cyproteroneand desogestrel/ethinyl oestradiol tablets in women with polycystic ovary syndrome (PCOS).</p><p><b>METHODS</b>Women with PCOSfrom West China Second Hospital of Sichuan University enrolled between September, 2011 and August, 2013 were randomlyallocated to receive either ethinyl oestradiol/cyproterone tablets (Group A, =355) or desogestrel/ethinyl oestradiol tablets(Group B, =357) for a prospective observation period of 6 months. Women with insulin resistance also received metformin. Atbaseline, 3 months, and 6 months, the patients were evaluated for menstruation, acne score, body mass index (BMI), waist-tohip ratio (WHR), plasma levels of sex hormones, fasting blood glucose (FPG), HOMA-insulin resistance index (HOMA-IR), serum lipid, ovarian volume, and the number of ovarian follicles.</p><p><b>RESULTS</b>All the patients had a regular menstrual cycle aftertreatments. Testosterone level, acne score, LH/FSH, ovarian volume, and the number of follicles decreased significantly afterthe treatments without significant differences between the two groups. Significant increases were noted in TG, TCh, LDL, HDL, and AIP, and HDL level in group A as compared with group B ( < 0.001). FPG decreased in both groups, and wassignificantly lower in group B at 6 months ( < 0.05). BMI and WHR decreased in all the patients with insulin resistance aftercombination treatment with metformin ( < 0.05), but increased significantly in patients without insulin resistance ( < 0.05). Ingroup A, HOMA- IR significantly increased in patientswithout insulin resistance at 3 months ( < 0.05), whereas asignificant increase was not observed until 6 months ingroup B ( < 0.05).</p><p><b>CONCLUSIONS</b>Both ethinyl oestradiol/cyproterone tablets and desogestrel/ethinyl oestradioltablets can relieve the symptoms of PCOS, but it isadvisable to assess the risk of cardiovascular diseasebefore the treatments.</p>
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Venous thromboembolism is well known as one of the rare but serious adverse effects of combined oral contraceptives (COCs). The COCs with third and fourth generation progestogens were found to have higher risk of venous thrombosis than those with second generation progestogens. We present a case of pulmonary embolism in a 23-year-old nulligravid woman who was using COCs containing the third generation progestogen (desogestrel). At the time of presentation of the adverse effect, she had been using the COCs for 4 months. She had no additional risk factors for thrombosis such as smoking, surgery, tumor as well as genetic factors. This case demonstrates even young women in otherwise good health may be at risk of venous thromboembolism from low-dose formulations of COCs as an over-the-counter drug. We describe this case with a brief review of literatures.
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Female , Humans , Young Adult , Contraceptives, Oral , Contraceptives, Oral, Combined , Desogestrel , Progestins , Pulmonary Embolism , Risk Factors , Smoke , Smoking , Thrombosis , Venous Thromboembolism , Venous ThrombosisABSTRACT
Objective To develop a HPLC method for determining the dissolution of desogestrel and ethinylestradiol tablets. Methods The dissolution was determined by the second method described in Chinese Pharmacopoeia(ChP)2015. In total 500 ml of 0.05%sodium lauryl sulfate solution was used as dissolution media,and the rotation speed was 50 r/min. The dissolution time was 30 min and the dissolution was determined by HPLC. The HPLC column was Agilent SB C18 column(150 mm×4.6 mm,5μm). The mobile phase:acetonitrile as mobile phase A,acetonitrile-water(50∶50,V/V)as mobile phase B with gradient elution. The flow rate was 1 ml/min. The detection wavelength of desogestrel and ethinylestradiol was 210 nm. The column temperature was 40℃and the injection volume was 100μl. Results The average recoveries were 99.68%for desogestrel and 99.40%for ethinylestrsdiol,and the stability of work?ing solutions was acceptable in 12 h. The calibration curves were linear within the range of(0.06-0.36)μg/ml(r=0.9999)for desoges?trel,(0.012-0.072)μg/ml(r=0.9999)for ethinylestradiol,respectively. Conclusion The method is convenient and precise in the dis?solution determination of desogestrel and ethinylestradiol tablets.
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Objective To develop a HPLC method for determining the dissolution of desogestrel and ethinylestradiol tablets. Methods The dissolution was determined by the second method described in Chinese Pharmacopoeia (ChP) 2015. In total 500 ml of 0.05% sodium lauryl sulfate solution was used as dissolution media, and the rotation speed was 50 r/min. The dissolution time was 30 min and the dissolution was determined by HPLC. The HPLC column was Agilent SB C18 column (150 mm×4.6 mm, 5 µm). The mobile phase: acetonitrile as mobile phase A, acetonitrile-water (50:50, V/V) as mobile phase B with gradient elution. The flow rate was 1 ml/min. The detection wavelength of desogestrel and ethinylestradiol was 210 nm. The column temperature was 40 and the injection volume was 100 µl. Results The average recoveries were 99.68% for desogestrel and 99.40% for ethinylestrsdiol, and the stability of working solutions was acceptable in 12 h. The calibration curves were linear within the range of(0.06-0.36)µg/ml (r=0.9999)for desogestrel, (0.012-0.072)µg/ml (r=0.9999)for ethinylestradiol, respectively. Conclusion The method is convenient and precise in the dissolution determination of desogestrel and ethinylestradiol tablets.
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Objective To observe the clinical efficacy and adverse reactions of desogestrel ethinylestradiol in the treatment of dysfunctional uterine bleeding ( adolescent Dub ) .Methods 86 cases with adolescent functional bleeding were divided into the treatment group and control group ,43 cases in each group .The control group received conjugated estrogen(Premarin) treatment,the treatment group was given desogestrel ethinylestradiol treatment .The hemostatic effect and drug adverse reaction of the two groups were observed .Results The cure rate of the treatment group was 65.1%,that in the control group was 23.3%,there was significant difference between the two groups (χ2 =15.28,P0.05).Conclusion Desogestrel ethinylestradiol in the treatment of ado-lescent functional bleeding has exact curative effect ,it has low incidence of adverse reactions and better acceptance .
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Objective To investigate the treatment of adolescent marvelon Metformin's clinical efficacy in patients with polycystic ovary syndrome.Methods 120 cases of adolescents with polycystic ovary syndrome were randomly divided into two groups,A group of 60 patients with single-agent oral therapy Marvelon, B group of 60 patients with Marvelon oral metformin therapy ,medication time was 3 courses; The levels of fasting insulin, fasting glucose, serum sex hormone levels were compared before and after treatment.Results The hormone levels in the two groups had significant difference before and after treatment (P <0.01) ;Two groups did not change in fasting blood glucose before and after treatment,no significant difference between the two groups(P >0.05) ;The insulin levels in two groups before and after treatment,was significantly different(P <0.05).Conclusion Metformin Marvelon adolescent polycystic ovary syndrome treatment can effectively reduce the T,LH,LH/FSH,insulin resistance,clinical results were satisfactory and better than single drug therapy Marvelon.
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Objective To evaluate the contraception efficacy, mode of bleeding, side effects and other positive effects of drospirenone-ethinylestradiol (Yasmin) in healthy Chinese women. Methods This was a multicenter, randomized, control study of 768 healthy Chinese women who consulted about contraception. The subjects were randomized into Yasmin group (30 μg ethinylestradiol plus 3 mg drospirenone, 573 cases) or desogestrel group (30 μg ethinylestradiol plus 150 μg desogestrel, 195 cases) with the ratio of 3: 1. Each individual was treated for 13 cycles. Further visits were required at cycle 4, cycle 7, cycle 10 and cycle 13 of treatment. Weight, height, body mass index were evaluated at each visit. The menstrual distress questionnaire (MDQ) was given to the women at baseline, visit 3 (cycle 7) and visit 5 (after cycle 13). Results The values of basal features were similar between two groups (P> 0.05). The Pearl index (method failure) of Yasmin was 0. 208/hundred women year which was lower than that of desogestrel (0. 601/hundred women year). The mode of bleeding was similar between two groups after trial without showing any significant difference. According to MDQ subscale, the improvement of water retention and increasing appetite during inter-menstrual period and water retention and general well-being during menstrual period in the Yasmin group ( -0. 297, -0. 057, 0. 033, 0. 150 respectively) was more obvious than that in the desogestrel group ( - 0. 108, 0. 023, 0. 231, - 0. 023 respectively) with a significant difference (P < 0. 05 ). Some other values which improved in beth two groups, especially the improvement of breast tenderness and pain and skin abnormality in Yasmin group (18.0%, 89/494; 12. 6%, 62/494) was more distinct than that in desogestrel group (11.3%, 19/168; 5.4%, 9/168). The mean weight increased in desogestrel group (0. 57 kg) while it decreased in Yasmin group ( -0. 28 kg) with a significant difference (P < 0. 01 ). Conclusions Both Yasmin and desogestrel have good efficacy on contraception and similar modes of menstrual bleeding. Yasmin is better than desogestrel in terms of weight control and premenstrual syndrome of oral contraceptive.
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Objective To explore the prevalence of nonalcoholic fatty liver disease(NAFLD)in patients with polycystic ovary syndrome(PCOS).MethodsA case-control study employing 60 non pregnant patients with PCOS and 60 non-pregnant patients without PCOS as control was conducted to compare the prevalence of NAFLD.Resuits The aminotransferase(ALT),fasting insulin and homeostasis model assessment of insulin resistance(HOMA-IR)levels were(29±15)U/L,(19±12)mU/L and 0.47±0.29 in PCOS group,which were significantly higher(P＜0.05)than corresponding parameters in control group[(15±13)U/L,(11±8)mU/L and 0.31±0.21)].The occurrence of insulin resistance and NAFLD was 63％(38/60)and 42％(25/60),higher than those in control group[35％(21/60)and 20％(12/60),P＜0.05].The increment of ALT was 40％(24/60)in PCOS group,higher than that of 3％(2/60)in control group(P＜0.01).Compared with patients witIlout NAFLD,patients with NAFLD had significantly increased body mass index(P＜0.01),waist-hip ratio,AIJT,C-reaction protein,fasting insulin,insulin and HOMA-IR levels 2 hours after oral glucose tolerance test(P＜0.05).Conchsion The increased prevalence of NAFLD in PCOS patients suggests an association between these two conditions and the necessity of hepatic screening among PCOS patients for potential NAFLD.
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Objective To evaluate the efficacy of Marvelon on treatment of adenomyosis.Methods A total of 42 women with adenomyosis were recruited in the study.They were given Marvelon on the first day of menstruation,1 piece,qd,continouly for 21 days.With an alternation of seven days a new cycle begins.There are 6 cycles in total.We observe their degree of dysmenorrheal,menstrual blood volume(MBV) ,hemoglobin and the volume of uterus before and after Marvelon used.Results After 6 months,the dysmenorrheal remitted obviously,the score decline from (8.51±1.73 ) to (0.62±0.70) ,P <0.01.The MBV reduced and hemoglobin rise distinctly ,before treatment Hb is (104.71±12.09) while (112.00±8.57)after therapy,P <0.01.After treatment the volume of uterus shrinks a little, but not significant(P > 0.05).Conclusion Marvelon is an effective drug in treatment of adenomyosis in the near future,and is cheap,convcnieat.
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0.05). However, incidence of amenorrhea and degree of endometrium atrophy were higher in patients treated with mifepristone than in those with esogestrel-ethinylestradiol(P