叶酸联合维生素B6辅助治疗肥胖型多囊卵巢综合征的临床研究OA
Clinical trial of folic acid combined with vitamin B6 as an adjunctive therapy for obese polycystic ovary syndrome
目的 观察叶酸片联合维生素B6片辅助治疗肥胖型多囊卵巢综合征(PCOS)患者的临床疗效和安全性.方法 将本院收治的肥胖型PCOS患者依据用药方案分为试验组和对照组.对照组给予炔雌醇环丙孕酮片(每晚睡前口服1片)、盐酸二甲双胍片(0.25 g,早餐及晚餐前口服)和奥利司他胶囊(60 mg,每天2次)治疗,试验组在对照组基础上予以叶酸片(5 mg,每天1次)和维生素B6片(10mg,每天1次)治疗.对比2组的临床疗效、糖代谢指标、生殖内分泌激素、平均卵巢体积(MOV)、平均卵泡数目(MFN)、炎症因子、血清同型半胱氨酸(Hcy)、甘油三酯(TG)水平和身体测量参数,并进行安全性评价.结果 共纳入150例患者,试验组73例、对照组77例.治疗后,试验组和对照组的总有效率分别为90.41%(66例/73例)和77.92%(60例/77例),在统计学上差异有统计学意义(P<0.05).治疗后,试验组和对照组的空腹血糖(FPG)水平分别为(4.42±0.58)和(4.66±0.53)mmol·L-1,空腹胰岛素(FINS)水平分别为(9.16±1.77)和(10.03±2.06)mIU·L-1,胰岛素抵抗指数(HOMA-IR)水平分别为1.80±0.46和2.08±0.65,抗缪勒管激素(AMH)水平分别为(4.03±1.19)和(4.63±1.32)ng·mL-1,抑制素 B(INHB)水平分别为(102.33±14.54)和(108.81±17.63)pg.mL-1,MOV 分别为(7.36±1.88)和(6.77±1.24)cm3,平均卵泡数目(MFN)分别为(8.89±1.86)和(8.24±1.45)个,白细胞介素-6(IL-6)水平分别为(16.87±3.22)和(18.34±3.67)pg·mL-1,肿瘤坏死因子-α(TNF-α)水平分别为(10.19±3.06)和(11.83±3.22)pg·mL-1,高同型半胱氨酸(Hcy)水平分别为(14.78±3.52)和(16.16±3.64)μmol·L-1,TG 水平分别为(3.49±0.61)和(4.15±0.66)mmol·L-1,体质量指数(BMI)水平分别为(31.09±3.06)和(32.16±3.17)kg·m-2,体脂率分别为(31.42±3.24)%和(32.89±3.38)%,腰臀比(WHR)分别为 0.92±0.21 和1.01±0.26.试验组的上述指标与对照组相比,在统计学上差异均有统计学意义(P<0.05,P<0.01).试验组的药物不良反应为胃肠道不适;对照组为头痛.试验组和对照组的药物不良反应总发生率分别为1.37%(1例/73例)和2.60%(2例/77例),在统计学上差异无统计学意义(P>0.05).结论 叶酸片联合维生素B6片辅助治疗肥胖型PCOS的临床疗效和安全性较好,能够明显降低患者血清Hcy水平,改善患者的胰岛素抵抗状态和脂质代谢.
Objective To observe the clinical efficacy and safety of folic acid tablets combined with vitamin B6 tablets as an adjuvant therapy for obese patients with polycystic ovary syndrome(PCOS).Methods Obese PCOS patients admitted to our hospital were divided into treatment group and control group according to the medication plan.The control group was treated with ethinylestradiol and cyproterone acetate tablets(taken orally before bedtime every night),metformin hydrochloride tablets(0.25 g,taken orally before breakfast and dinner),and orlistat capsules(60 mg,twice a day).The treatment group was treated with folic acid tablets(5 mg,once a day)and vitamin B6 tablets(10 mg,once a day)in addition to control group.Compare clinical efficacy,glucose metabolism indicators,reproductive endocrine hormones,mean ovarian volume(MOV),mean number of follicles(MFN),inflammatory factors,serum homocysteine(Hcy),triglyceride(TG)levels and body measurement parameters between two groups,and evaluate their safety.Results A total of 150 patients were included,with 73 in treatment group and 77 in control group.The total effective rates of treatment and control group were 90.41%(66 cases/73 cases)and 77.92%(60 cases/77 cases),respectively,and the difference was statistically significant(P<0.05).After treatment,the fasting plasma glucose(FPG)levels of treatment group and control group were(4.42±0.58)and(4.66±0.53)mmol·L-1,respectively;the fasting insulin(FINS)levels were(9.16±1.77)and(10.03±2.06)mIU·L-1,respectively;the homeostatic model assessment of insulin resistance(HOMA-IR)levels were 1.80±0.46 and 2.08±0.65,respectively;the anti-Müllerian hormone(AMH)levels were(4.03±1.19)and(4.63±1.32)ng·mL-1,respectively;the inhibin B(INHB)levels were(102.33±14.54)and(108.81±17.63)pg·mL-1,respectively;the MOV levels were(7.36±1.88)and(6.77±1.24)cm3,respectively;the numbers of MFN were(8.89±1.86)and(8.24±1.45)cell,respectively;the interleukin-6(IL-6)levels were(16.87±3.22)and(18.34±3.67)pg·mL-1,respectively;the tumor necrosis factor-alpha(TNF-α)levels were(10.19±3.06)and(11.83±3.22)pg·mL-1,respectively;the Hcy levels were(14.78±3.52)and(16.16±3.64)μmol·L-1,respectively;the TG levels were(3.49±0.61)and(4.15±0.66)mmol·L-1,respectively;the body mass index(BMI)levels were(31.09±3.06)and(32.16±3.17)kg·m-2,respectively;the body fat percentages were(31.42±3.24)%and(32.89±3.38)%,respectively;and the waist-to-hip ratio(WHR)levels were 0.92±0.21 and 1.01±0.26,respectively.There were statistically significant differences in the above indicators between treatment group and control group(P<0.05,P<0.01).The adverse drug reactions in treatment group were gastrointestinal discomfort,while those in control group were headache.The overall incidence rates of adverse drug reactions in treatment and control groups were 1.37%(1 case/73 cases)and 2.60%(2 cases/77 cases),respectively,with no statistically significant difference(P>0.05).Conclusion The adjuvant treatment of PCOS with folic acid combined with vitamin B6 tablets has good clinical efficacy and safety.It can significantly reduce the levels of serum Hcy in patients and improve the insulin resistance status and lipid metabolism of patients.
吴琼;黄琦
厦门大学附属中山医院妇产科,福建厦门 361000厦门大学附属中山医院妇产科,福建厦门 361000
医药卫生
叶酸片维生素B6片肥胖型多囊卵巢综合征同型半胱氨酸生殖内分泌激素
folic acid tabletvitamin B6 tabletobese polycystic ovary syndromehomocysteinereproductive endocrine hormones
《中国临床药理学杂志》 2026 (9)
1238-1243,6
评论