Aisien A O, Enosolease M E
Department of Obstetrics and Gynaecology, University of Benin Teaching Hospital, Benin-City, Edo State, Nigeria.
Niger J Clin Pract. 2010 Sep;13(3):331-5.
The study evaluated the safety, efficacy and acceptability of Implanon (etonogestrel) subdermal implant contraceptive amongst its acceptors.
This was part of an on going prospective longitudinal study that involved 32 women out of 46 sexually active healthy informed volunteers recruited from our family planning clinic between February and March 2007. All the subjects received the single rod subdermal implant Implanon which contains 68 mg etonogestrel. Data on socio-demographic characteristics, menstrual pattern, haematological indices, weight, blood pressure, side effects and user's satisfaction were collected and analysed. The subjects served as their own control.
The mean age and parity were 33.9 +/- 5.2 years and 3.1 +/- 1.7 respectively. The mean weight was 71.4 +/- 12.0 kg at pre-insertion. At 6 months the weight reduced to a non significant (p < 0.13) mean value of 70.0 +/- 10.5 kg and increased to a non significant (p < 0.88) mean value of 71.5 +/- 11.6 kg at 12 months. The mean systolic and diastolic blood pressures did not show statistical significant changes at 6 months follow up (p < 0.17/0.64). However at 12 months there were significant but within normal reductions (p < 0.003/0.05) in the systolic and diastolic blood pressures. The side effects were menstrual abnormalities. Eighteen (56.3%), 1 (3.1%) and 13 (40.6%) reported reduced, increased and combinations of bleeding patterns respectively. No participant had normal cycle. Other experiences were headache, 4 (12.5%) and reduced libido 3 (9.4%). The mean packed and white blood cell concentrations did not show statistical significant changes at 6 and 12 months follow up. At 12 months there was statistical significant increase (p < 0.04) in the mean +/- SD platelet count (205312.5 +/- 75694.8 per ul) when compared with the pre-insertion mean value (176343.8 +/- 52945.3 per ul). One acceptor had thrombocytopenia without any untoward effect. Two subjects discontinued method on account of menorrhagia and headache. The efficacy and continuation rate were 100% and 93.8% respectively. All the clients received adequate information about the method and most of them were satisfied with it at follow up.
Implanon was an effective, safe and acceptable method of contraception amongst its acceptors. Menstrual abnormalities were the major side effects which most of the subjects found tolerable with adequate counseling. The reduced platelet concentration of the one acceptor would require follow up to ascertain the trend.
本研究评估了依伴侬(依托孕烯)皮下埋植避孕法在使用者中的安全性、有效性和可接受性。
这是一项正在进行的前瞻性纵向研究的一部分,该研究纳入了2007年2月至3月从我们计划生育诊所招募的46名性活跃健康且知情的志愿者中的32名女性。所有受试者均接受了单根皮下埋植剂依伴侬,其含有68毫克依托孕烯。收集并分析了社会人口学特征、月经模式、血液学指标、体重、血压、副作用及使用者满意度等数据。受试者自身作为对照。
平均年龄和产次分别为33.9±5.2岁和3.1±1.7。植入前平均体重为71.4±12.0千克。6个月时体重降至70.0±10.5千克,差异无统计学意义(p<0.13),12个月时增至71.5±11.6千克,差异无统计学意义(p<0.88)。随访6个月时,平均收缩压和舒张压无统计学显著变化(p<0.17/0.64)。然而,随访12个月时,收缩压和舒张压虽有显著下降但仍在正常范围内(p<0.003/0.05)。副作用为月经异常。18名(56.3%)、1名(3.1%)和13名(40.6%)受试者分别报告月经量减少、增多及月经模式改变。无受试者月经周期正常。其他情况包括头痛,4名(12.5%);性欲减退,3名(9.4%)。随访6个月和12个月时,平均红细胞压积和白细胞浓度无统计学显著变化。与植入前平均值(每微升176343.8±52945.3)相比,随访12个月时平均血小板计数(每微升205312.5±75694.8)有统计学显著升高(p<0.04)。1名使用者出现血小板减少症,但未产生任何不良影响。2名受试者因月经过多和头痛停止使用该方法。避孕效果和持续使用率分别为100%和93.8%。所有服务对象均获得了关于该方法的充分信息,且大多数人在随访时对其感到满意。
依伴侬是一种在使用者中有效、安全且可接受的避孕方法。月经异常是主要副作用,大多数受试者在得到充分咨询后认为可以耐受。1名使用者血小板浓度降低的情况需要随访以确定其发展趋势。