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目的 :观察艾塞那肽联合枸橼酸氯米芬治疗多囊卵巢综合征伴胰岛素抵抗的疗效和安全性。方法:98例多囊卵巢综合征伴胰岛素抵抗患者随机分为对照组(49例)和观察组(49例)。对照组患者给予枸橼酸氯米芬胶囊50 mg,口服,每日1次,连用5 d+二甲双胍肠溶片首次剂量0.25 g,口服,每日2次,后调整剂量至0.50~0.75 g,口服,每日2次,连用3个月经周期。观察组患者给予枸橼酸氯米芬胶囊(用法用量同对照组)+艾塞那肽注射液5 μg,每日2次,皮下注射1个月,后调整剂量至10 μg,每日2次,皮下注射2个月。观察两组患者的临床疗效,治疗前后促黄体生成素(LH)、促卵泡激素(FSH)、LH/FSH和胰岛素抵抗指数(IR),不孕患者治疗后排卵及妊娠情况,并记录不良反应发生情况。结果:观察组患者总有效率、排卵率、妊娠率均显著高于对照组,差异均有统计学意义(P<0.05)。治疗前,两组患者 LH、FSH、LH/FSH和IR比较,差异均无统计学意义(P>0.05)。治疗后,两组患者 LH、 LH/FSH、IR均显著低于同组治疗前,且观察组显著低于对照组;两组患者FSH均显著高于同组治疗前,且观察组显著高于对照组,差异均有统计学意义(P<0.05)。两组患者不良反应发生率比较,差异无统计学意义(P>0.05)。结论:艾塞那肽联合枸橼酸氯米芬治疗多囊卵巢综合征伴胰岛素抵抗的疗效显著,可通过改善胰岛素抵抗来提高排卵率及妊娠率,且未增加不良反应的发生。
OBJECTIVE: To observe clinical efficacy and safety of exenatide combined with clomiphene citrate in the treatment of polycystic ovary syndrome with insulin resistance. METHODS: 98 patients with polycystic ovary syndrome complicated with insulin resistance were randomly divided into control group (49 cases) and observation group (49 cases). Control group was given Clomiphene citrate capsule 50 mg orally, once a day, for 5 d+Metformin enteric-coated tablet with initial dose of 0.25 g orally, twice a day, adjusted to 0.50-0.75 g orally, twice a day, for 3 menstrual cycles. Observation group was given Clomiphene citrate capsule (usage and dosage same as control group)+Exenatide injection 5 μg subcutaneously, twice a day, adjusted to 10 μg subcutaneously, twice a day, for 2 months. Clinical efficacies of 2 groups were observed as well as the levels of LH, FSH, LH/FSH and IR before and after treatment, ovulation and pregnancy of infertility patients after treatment. The occurrence of ADR was recorded. RESULTS: Total response rate,ovulation rate and pregnancy rate of observation group were significantly higher than that of control group, with statistical significance (P<0.05). Before treatment, there was no statistical significance in the levels of LH, FSH, LH/FSH and IR between 2 groups (P>0.05). After treatment, the levels of LH, LH/FSH and IR in 2 groups were significantly lower than before, and the observation group was significantly lower than the control group, the levels of FSH in 2 groups was significantly higher than before,and the observation group was significantly higher than the control group, with statistical significance (P<0.05). There was no statistical significance in incidence of ADR between 2 groups (P>0.05). CONCUSIONS:Exenatide combined with clomiphene citrate shows significant therapeutic efficacy for polycystic ovary syndrome complicated with insulin resistance and can increase ovulation rate and pregnancy rate through improving insulin resistance, but doesn’t increase the occurrence of ADR.
艾塞那肽二甲双胍枸橼酸氯米芬胰岛素抵抗多囊卵巢综合征疗效安全性
ExenatideMetforminClomiphene citrateInsulin resistancePolycystic ovary syndromeEfficacySafety
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