尼尔雌醇联合醋酸甲羟孕酮治疗围绝经期妇女类风湿性关节炎的临床观察

Clinical Observation of Nilestriol Combined with Medroxyprogesterone Acetate for Rheumatoid Arthritis in Perimenopausal Women

目的：观察尼尔雌醇联合醋酸甲羟孕酮治疗围绝经期妇女类风湿性关节炎的临床疗效和安全性。方法：50例围绝经期类风湿性关节炎患者按随机数字表法均分为对照组和观察组。对照组患者给予甲氨蝶呤10mg，口服，每周1次。观察组患者中未绝经者给予尼尔雌醇1～2mg，2周1次＋每月月经第23天给予醋酸甲羟孕酮8mg，连用5d；绝经者给予尼尔雌醇1～2mg，2周1次＋每3～6个月给予醋酸甲羟孕酮10mg，连用5d；子宫已切除者给予尼尔雌醇2mg，2周1次，症状改善后减至1mg／2周，或2mg／月＋每3～6个月给予醋酸甲羟孕酮10mg／d，连用5d。两组患者均适当补充钙剂和维生素D。两组患者均治疗6个月后观察临床疗效，并观察治疗前后体征和实验室指标，雌二醇、胫骨骨密度水平及不良反应发生情况。结果：观察组患者总有效率显著低于对照组，差异有统计学意义（P〈0．05）；两组患者治疗前体征、实验室指标和雌二醇、胫骨骨密度水平比较，差异无统计学意义（P〉0．05）；两组患者治疗后体征、实验室指标均显著低于同组治疗前，但观察组显著高于对照组，差异均有统计学意义（P〈0．05）；对照组患者雌二醇、胫骨骨密度水平治疗后与治疗前比较，差异均无统计学意义（P〉0．05），而观察组治疗后与治疗前比较差异有统计学意义（P〈0．05）。观察组患者不良反应发生率显著低于对照组，差异有统计学意义（P〈0．05）。结论：尼尔雌醇联合醋酸甲羟孕酮尽管总有效率低于甲氨蝶呤，但仍能显著改善临床症状，且在增加雌激素和骨密度水平及安全性方面优于甲氨蝶呤。

OBJECTIVE： To observe the clinical efficacy and safety of nilestriol combined with medroxyprogesterone acetate for rheumatoid arthritis in perimenopausal women. METHODS： 50 perimenopausal women with rheumatoid arthritis were random- ized into control group and observation group. Control group was given methotrexate 10 mg orally once a day. Premenopausal pa- tients in observation group were given nilestriol 1-2 mg once every 2 weeks, and additionally given medroxyprogesterone acetate 8 mg since 23th day of the menstrual cycle for consecutive 5 days; postmenopausal patients were given nilestriol 1-2 mg once every 2 weeks, and additionally given medroxyprogesterone acetate 10 mg every 3-6 months for consecutive 5 days; the patients under- went hysterectomy were given nilestriol 2 mg every 2 weeks, and reducing to 1 mg every 2 weeks or 2 mg every month after symp- toms were improved, and additionally given medroxyprogesterone acetate 10 mg/d every 3-6 months for consecutive 5 days. Both groups were given certain calcium and vitamin D. Therapeutic efficacy, sign, laboratory items, estradiol, tibia bone density and ADR were observed in 2 groups after 6 months of treatment. RESULTS ： The total effective rate of observation group was signifi- cantly lower than control group; there was statistical significance （P〈0.05）. There was no statistical significance in sign, laboratory items, estradiol and tibia bone density between 2 groups before treatment （P〈0.05）. There was statistical significance in sign, laboratory items, estradiol and tibia bone density between 2 groups after treatment （P〈0.05）. There was no statistical significance in estradiol and tibia bone density of control group before and after treatment （P〉0.05）. Those of observation group after treatment were significantly higher than before; there was statistical significance （P〈0.05）. The incidence of ADR in observation group was significantly lower than in control group; there was statistical significance （P〈0.05）. CONCLUSIONS： Although total effective rate of nilestriol combined with medroxyprogesterone acetate is lower than that of methotrexate, it improves clinical symptoms and is better than methotrexate in improving estrogen, bone density and safety.