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Volume 41 Issue 12
Dec.  2023
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LI Hui, TANG Huaiyun, GUAN Huijuan, ZHANG Shuai. Effects of metformin hydrochloride tablets on clinical efficacy and number of dominant follicles in polycystic ovary syndrome[J]. Journal of Pharmaceutical Practice and Service, 2023, 41(12): 763-766. doi: 10.12206/j.issn.2097-2024.202208080
Citation: LI Hui, TANG Huaiyun, GUAN Huijuan, ZHANG Shuai. Effects of metformin hydrochloride tablets on clinical efficacy and number of dominant follicles in polycystic ovary syndrome[J]. Journal of Pharmaceutical Practice and Service, 2023, 41(12): 763-766. doi: 10.12206/j.issn.2097-2024.202208080

Effects of metformin hydrochloride tablets on clinical efficacy and number of dominant follicles in polycystic ovary syndrome

doi: 10.12206/j.issn.2097-2024.202208080
  • Received Date: 2022-08-19
  • Rev Recd Date: 2023-11-30
  • Available Online: 2023-12-22
  • Publish Date: 2023-12-25
  •   Objective  To explore the effect of metformin hydrochloride tablets on the clinical efficacy, number of dominant follicles and ovarian volume of polycystic ovary syndrome.   Methods  150 patients diagnosed with polycystic ovary syndrome who were diagnosed and treated in our hospital from January 2019 to March 2021 were selected .The patients were divided into observation group and control group by random number table. The control group was treated with letrozole + gonadotropin, and the observation group was treated with letrozole + gonadotropin + hydrochloric acid + Metformin tablets. The clinical efficacy, endometrial thickness, number of high-quality follicles, sex hormone levels, blood lipid levels, and adverse reactions were compared between the two groups.   Results  ① The effective rate of treatment in the observation group was 90.67%, which was significantly higher than that in the control group, 78.67% (P<0.05). ② After treatment, the endometrial thickness of the observation group was lower than that of the control group, and the number of high-quality follicles was more than that of the control group(P<0.05). ③ After treatment, the levels of Luteinizing Hormone-LH, Follicle Stimulating Hormone-FSH and Testosterone (T) in the observation group were lower than those in the control group (P<0.05). ④ After treatment, the total cholesterol (TC) and triglyceride (TG) in the observation group were lower than those in the control group (P<0.05). ⑤ The incidence of adverse reactions in the observation group was 8.00%, which was significantly lower than 20.00% in the control group (P<0.05).   Conclusion  Letrozole + gonadotropin + metformin hydrochloride tablets could significantly improve the sex hormone and blood lipid levels in patients with polycystic ovary syndrome, relieve the symptoms of the patients, and improve their uterine condition, which had a good clinical effect.
  • [1] 王孟玲. 屈螺酮炔雌醇与炔雌醇环丙孕酮治疗多囊卵巢综合征的疗效对比研究[J]. 中国民间疗法, 2021, 29(22):77-79.
    [2] SIMONE A, Laganà. Inositol in polycystic ovary syndrome: restoring fertility through a pathophysiology-based approach[J]. Trends Endocrinol Metab, 2018, 29(11):768-780. doi:  10.1016/j.tem.2018.09.001
    [3] BRUTOCAO C, ZAIEM F, ALSAWAS M, et al. Psychiatric disorders in women with polycystic ovary syndrome: a systematic review and meta-analysis[J]. Endocrine, 2018, 62(2):318-325. doi:  10.1007/s12020-018-1692-3
    [4] Rodriguez-Paris D, Remlinger-Molenda A, Kurzawa R, et al. Psychiat- ric disorders in women with polycystic ovary syndrome. Wystrome. s inwomenńpsychicznych u kobiet z zespospo zespospobiet z zespocy[J]. Psychiatr Pol, 2019, 53(4):955-966. doi:  10.12740/PP/OnlineFirst/93105
    [5] 吴盈, 朱冬琴, 王新. 枸橼酸氯米芬胶囊联合盐酸二甲双胍片治疗多囊卵巢综合征患者的临床研究[J]. 中国临床药理学杂志, 2020, 36(7):753-755.
    [6] VANDER HEIDEN M G, DEBERARDINIS R J. Understanding the intersections between metabolism and cancer biology[J]. Cell, 2017, 168(4):657-669. doi:  10.1016/j.cell.2016.12.039
    [7] 孙林, 王海燕, 王美仙, 等. 来曲唑联合二甲双胍对多囊卵巢综合征患者外周血T细胞亚群及氧化应激水平的影响[J]. 解放军预防医学杂志, 2019, 37(8):69-70.
    [8] 中华医学会妇产科学分会内分泌学组及指南专家组. 多囊卵巢综合征中国诊疗指南[J]. 中华妇产科杂志, 2018, 53(1):2-6.
    [9] 王燕, 王春莲, 员相冰, 等. 来曲唑与尿促性素在多囊卵巢综合征不孕患者促排卵中的应用[J]. 医学研究杂志, 2017, 46(8):160-163.
    [10] 宋燕. 来曲唑联合尿促性素对多囊卵巢综合征患者促排卵效果及临床妊娠的影响[J]. 中国医药科学, 2019, 9(16):75-78.
    [11] 谢莺, 张淳. 辅酶Q10联合维生素E治疗对多囊卵巢综合征患者糖代谢指标及性激素水平的影响[J]. 中国妇幼保健, 2019, 34(20):4747-4750.
    [12] 史樱. 来曲唑联合低剂量高纯度尿促性素治疗多囊卵巢综合征耐克罗米芬无排卵不孕患者的疗效观察[J]. 河北医学, 2017, 23(12):1974-1978.
    [13] 米娜瓦尔·艾则孜, 古再丽努尔·麦麦提图尔荪, 哈尼克孜·吐尔逊. 来曲唑联合高纯度尿促性素对多囊卵巢综合征患者助孕以及生殖激素变化的影响[J]. 实用临床医药杂志, 2017, 21(13):76-79.
    [14] Hou DF, Ding X, Zhao SX. Efficacy of clomiphene citrate combined with metfomin in the trearment of polycystic ovary syndrome and its influence on sex hormone and insulin resistance[J]. Hainan Med J, 2017, 28(17):2799-2801.
    [15] 余丽金, 肖淑, 许艳. 暖宫保孕丸联合二甲双胍对多囊卵巢综合征的临床效果研究[J].世界中医药,2020,15(22):3458-3461.
    [16] 郁从秀, 芮茂社, 赵馨. 来曲唑、炔雌醇环丙孕酮片联合二甲双胍治疗耐克罗米芬性多囊卵巢综合征60例[J]. 安徽医药, 2020, 24(5):999-1002.
    [17] KAHYAOGLU S, YUMUŞAK O H, OZYER S, et al. Clomiphene citrate treatment cycle outcomes of polycystic ovary syndrome patients based on basal high sensitive C-reactive protein levels: a cross-sectional study[J]. Int J Fertil Steril, 2017, 10(4):320-326.
    [18] 华彩红, 尹山兰, 郝尚辉, 等. 来曲唑联合二甲双胍治疗耐克罗米芬多囊卵巢综合征不孕患者的临床疗效及胰岛素抵抗、性激素水平的影响[J]. 中国医院药学杂志, 2018, 38(22):2343-2347.
    [19] 林霞, 孙启银, 徐菊玲. 枸橼酸氯米芬联合二甲双胍治疗肥胖型多囊卵巢综合征对患者性激素及糖脂代谢的改善效果[J]. 中国计划生育学杂志, 2022, 30(8):1726-1729.
    [20] 王金英, 罗涛, 王晓霞, 等. 来曲唑联合二甲双胍对多囊卵巢综合征患者血清胃生长素、性激素及血脂水平的影响及其临床疗效[J]. 现代生物医学进展, 2017, 17(16):3103-3106, 3151.
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Effects of metformin hydrochloride tablets on clinical efficacy and number of dominant follicles in polycystic ovary syndrome

doi: 10.12206/j.issn.2097-2024.202208080

Abstract:   Objective  To explore the effect of metformin hydrochloride tablets on the clinical efficacy, number of dominant follicles and ovarian volume of polycystic ovary syndrome.   Methods  150 patients diagnosed with polycystic ovary syndrome who were diagnosed and treated in our hospital from January 2019 to March 2021 were selected .The patients were divided into observation group and control group by random number table. The control group was treated with letrozole + gonadotropin, and the observation group was treated with letrozole + gonadotropin + hydrochloric acid + Metformin tablets. The clinical efficacy, endometrial thickness, number of high-quality follicles, sex hormone levels, blood lipid levels, and adverse reactions were compared between the two groups.   Results  ① The effective rate of treatment in the observation group was 90.67%, which was significantly higher than that in the control group, 78.67% (P<0.05). ② After treatment, the endometrial thickness of the observation group was lower than that of the control group, and the number of high-quality follicles was more than that of the control group(P<0.05). ③ After treatment, the levels of Luteinizing Hormone-LH, Follicle Stimulating Hormone-FSH and Testosterone (T) in the observation group were lower than those in the control group (P<0.05). ④ After treatment, the total cholesterol (TC) and triglyceride (TG) in the observation group were lower than those in the control group (P<0.05). ⑤ The incidence of adverse reactions in the observation group was 8.00%, which was significantly lower than 20.00% in the control group (P<0.05).   Conclusion  Letrozole + gonadotropin + metformin hydrochloride tablets could significantly improve the sex hormone and blood lipid levels in patients with polycystic ovary syndrome, relieve the symptoms of the patients, and improve their uterine condition, which had a good clinical effect.

LI Hui, TANG Huaiyun, GUAN Huijuan, ZHANG Shuai. Effects of metformin hydrochloride tablets on clinical efficacy and number of dominant follicles in polycystic ovary syndrome[J]. Journal of Pharmaceutical Practice and Service, 2023, 41(12): 763-766. doi: 10.12206/j.issn.2097-2024.202208080
Citation: LI Hui, TANG Huaiyun, GUAN Huijuan, ZHANG Shuai. Effects of metformin hydrochloride tablets on clinical efficacy and number of dominant follicles in polycystic ovary syndrome[J]. Journal of Pharmaceutical Practice and Service, 2023, 41(12): 763-766. doi: 10.12206/j.issn.2097-2024.202208080
  • 多囊卵巢综合征是一种常见的生殖功能障碍和糖代谢异常两者共存的内分泌疾病,临床上主要表现为稀发排卵、高雄激素血症、卵巢多囊样改变等[1],育龄期女性常常面临不孕,妊娠后的流产风险增加的困扰,严重威胁着女性朋友的生殖健康[2],因此,对于多囊卵巢综合征育龄期女性,目前临床上主要以纠正排卵治疗为主,能够有效抑制患者机体内雄性激素合成,阻碍外周循环的雄性激素生成[3-4]。盐酸二甲双胍片是临床上常用的胰岛素增敏剂,能够促进肠道吸收葡萄糖,减少肝糖原异生,同时增加外周组织对葡萄糖的利用,可以有效的改善患者机体对胰岛素的抵抗[5]。还有研究发现[6],肿瘤细胞在氧气充足时仍主要通过糖酵解而非氧化磷酸化的方式产生能量,该现象被称为“瓦伯格”效应。此后,越来越多的研究在包括卵巢癌在内多种恶性肿瘤中证实了该现象的存在,并发现有氧糖酵解在肿瘤发生发展的各个阶段均发挥重要的促进作用,与二甲双胍也有一定联系,本研究旨在研究盐酸二甲双胍片对多囊卵巢综合征治疗临床疗效、优势卵泡个数、卵巢体积的影响,具体报道如下。

    • 选取2019年1月至2021年3月在我院诊治且确诊为多囊卵巢综合征的150例患者作为研究主体,采用随机数字表法将其分为观察组和对照组,每组75例,对照组采用来曲唑+尿促性素治疗,观察组采用来曲唑+尿促性素+盐酸二甲双胍片治疗。其中对照组年龄25~36岁,平均年龄(30.40±3.31)岁,病程1~5年,平均病程(2.73±0.65)年。观察组年龄23~35岁,平均年龄(29.92±3.49)岁,病程1~6年,平均病程(2.81±0.56)年。两组患者的临床资料进行比较,无明显差异(P<0.05)。

    • ①符合我国《多囊卵巢综合征中国诊疗指南》[8]中的相关诊断标准;②3个月内未使用激素类药物;③男方精液检查基本正常者;④患者及家属知晓本次研究内容,自愿参加并签署知情同意书。

    • ①伴随着心肝肾肺功能不全者;②伴有卵巢及子宫解剖学异常或器质性病变者;③对本次研究的药物过敏者;④精神异常者;⑤其他内分泌紊乱疾病患者。

    • 对照组:采用来曲唑+尿促性素治疗,患者在月经周期第3天服用来曲唑(江苏恒瑞医药股份有限公司,批号:09112856),5 mg/d,连续服用5 d,同时添加尿促性素,根据患者情况调整剂量,隔日肌肉注射,在患者月经周期第11~12天采用超声检查卵泡的直径和子宫内膜的生长情况,当卵泡直径达到18~20 mm时可给予患者注射绒促性素10 000 IU(上海上药信谊药厂有限公司,批号:090102630),指导患者注射绒促性素10 000 IU当日和次日同房,48 h后阴超检查是否排卵。观察组:采用来曲唑+尿促性素+盐酸二甲双胍片,在对照组的基础上,患者在月经第1天加服盐酸二甲双胍片(上海上药信谊药厂有限公司,批号:090102630),500 mg/次,2次/d,餐前30 min服用。2组患者均进行促排卵治疗3周期,成功妊娠者停止治疗。

    • ①临床疗效[9]:对两组患者的治疗的效果进行评估,分为显著:卵巢功能基本恢复正常,停药后连续排卵>2个周期,月经正常,或者妊娠成功;有效:卵巢功能得到改善,偶尔有排卵,月经连续3个月正常,病情反复;无效:月经未得到改善,无排卵。治疗总有效率=(显著+有效)/总例数×100%。②子宫内膜厚度、优质卵泡数:用药前后,通过彩超检查两组患者的子宫内膜厚度和优质卵泡数,进行对比。③性激素水平:两组患者均清晨空腹抽取静脉血5 ml,待离心后取血清,采用放射性免疫法测定血清黄体生长激素(LH)、促卵泡激素(FSH)和睾酮(T)水平。采用过氧化物酶法检测总胆固醇(TC)水平;采用脂蛋白脂酶法检测甘油三酯(TG)水平。④不良反应发生情况:对两组患者治疗后出现的不良反应进行统计,包括恶心呕吐,头晕等。不良反应发生率(%)=(头痛+恶心呕吐+头晕)/总例数×100%。

    • 使用SPSS 26.0软件对数据进行统计学分析;满足正态分布的计量资料用($ \bar{x}\pm s $)表示并开展t检验,计数资料用(%)表示并开展x2检验,P<0.05表示差异有统计学意义。

    • 观察组的治疗有效率为90.67%,显著高于对照组的78.67%,差异具有统计学意义(P<0.05),见表1

      组别显著有效无效总有效率
      对照组(n=75)30(40.00)29(38.67)16(21.33)59(78.67)
      观察组(n=75)38(50.67)30(40.00)7(9.33)68(90.67)#
      x24.16
      P0.04
      #P<0.05,与对照组比较
    • 用药前,两组患者的子宫内膜厚度、优质卵泡数相比,差异无统计学意义(P>0.05);用药后两组患者的子宫内膜厚度明显降低,优质卵泡个数增加,观察组子宫内膜厚度、优质卵泡数均优于对照组,差异具有统计学意义(P<0.05),见表2

      组别 子宫内膜厚度(cm) 优质卵泡数(个)
      用药前 用药后 用药前 用药后
      对照组
      n=75)
      1.52±0.38 1.10±0.35* 1.05±0.38 1.70±0.65*
      观察组
      n=75)
      1.43±0.37 0.95±0.26*# 1.03±0.27 1.98±0.52*#
      t 1.47 2.98 0.37 2.91
      P 0.14 0.00 0.71 0.00
      *P<0.05,与用药前比较; #P<0.05,与对照组比较
    • 用药前,两组患者的LH、FSH和T水平相比,差异无统计学意义(P>0.05);用药后两组患者的LH、FSH和T水平明显降低,且观察组低于对照组,差异具有统计学意义(P<0.05),见表3

      组别 LH(U/L) FSH(U/L) T(nmol/L)
      用药前 用药后 用药前 用药后 用药前 用药后
      对照组
      n=75)
      16.20±
      3.44
      8.81±
      2.35*
      6.01±
      1.11
      4.98±
      0.94*
      2.90±
      0.73
      1.78±
      0.60*
      观察组
      n=75)
      16.04±
      4.42
      6.37±
      1.32*#
      5.89±
      1.23
      3.09±
      0.87*#
      2.87±
      0.80
      1.39±
      0.51*#
      t 0.25 7.84 0.63 12.78 0.24 4.29
      P 0.80 0.00 0.53 0.00 0.81 0.00
      *P<0.05,与用药前比较;#P<0.05,与对照组比较
    • 用药前,两组患者的TG和TC水平相比,差异无统计学意义(P>0.05);用药后两组患者的TG和TC水平明显降低,且观察组低于对照组,差异具有统计学意义(P<0.05),见表4

      组别 TG(mmol/L) TC(mmol/L)
      用药前 用药后 用药前 用药后
      对照组
      n=75)
      2.18±0.65 1.61±0.57* 6.26±1.00 5.20±1.08*
      观察组
      n=75)
      2.05±0.58 1.37±0.54*# 6.04±1.07 4.70±1.01*#
      t 1.29 2.65 1.30 2.93
      P 0.20 0.01 0.20 0.00
      *P<0.05,与用药前比较;#P<0.05,与对照组比较
    • 观察组患者中头痛2例,恶心呕吐合并头痛3例,头晕合并头痛1例,头痛合并头晕6例,其不良反应发生率为8.00%,对照组患者中头痛4例,头痛合并恶心呕吐5例,不良反应发生率为20.00%,差异具有统计学意义(P<0.05),见表5

      组别头痛恶心呕吐头晕总发生率
      对照组(n=75)4(5.33)5(6.67)6(8.00)15(20.00)
      观察组(n=75)2(2.67)3(4.00)1(1.33)6( 8.00)#
      x24.49
      P0.03
      #P<0.05,与对照组比较
    • 多囊卵巢综合征好发于育龄期女性,是妇科常见的内分泌疾病[10-11],该疾病是引起女性不孕的重要原因之一,临床上50%的女性无排卵性不孕归因于多囊卵巢综合征[12]。多囊卵巢综合征治疗,临床上主要采用促排卵手段。来曲唑能够选择性的抑制芳香化酶活性,从而降低雌激素的水平,同时又能够促进排卵;尿促性素能够直接用于卵巢,促进卵泡的发育,但过量使用会导致卵巢过度刺激,不利于患者的恢复[13]。盐酸二甲双胍片为临床上常用的一种降血糖药物,能够通过抑制肝糖原异生作用从而降低肝糖原的输出率,提高胰岛素的敏感性,抑制胰岛素的分泌,进而降低血液中的胰岛素水平,同时又能够提高对葡萄糖的利用率[14]

      研究结果显示,①观察组的治疗疗效优于对照组,而不良反应发生率低于对照组,说明来曲唑+尿促性素+盐酸二甲双胍片治疗多囊卵巢综合征具有较好的临床疗效,能够加快患者的康复,与余丽金等[15]研究结果相符。郁从秀等[16]研究表明,采用来曲唑,炔雌醇环丙孕酮片联合二甲双胍治疗多囊卵巢综合征,对患者的子宫内膜厚度以及优质卵泡数均有明显的改善作用。②治疗用药后两组患者的子宫内膜厚度明显降低,优质卵泡个数增加,且观察组改善效果均优于对照组,说明观察组的治疗方案能够更好地改善患者的性激素水平和子宫状况,与郁从秀等[16]研究结果相符。多囊卵巢综合征患者主要表现是患者的性激素水平分泌异常,LH水平较高,FSH水平无周期性变化[17]。③用药治疗后两组患者的LH、FSH和T水平明显降低,且观察组低于对照组,与华彩红等[18]研究结果相符,说明对多囊卵巢综合征患者实施来曲唑+尿促性素+盐酸二甲双胍片治疗,能够有效的改善患者的内分泌功能。该疾病的患者会有脂代谢紊乱,常常有肥胖、高脂血症等表现,有效的降低患者的血脂水平具有重要的意义。以往有研究[19]表明,对于肥胖型的多囊卵巢综合征患者需要兼顾糖脂代谢调节,而二甲双胍能够调节患者的糖代谢,直接作用于卵泡膜细胞,进一步抑制患者机体内的各种雄激素异常释放,进一步改善患者的临床效果。④用药后两组患者的TG和TC水平明显降低,且观察组低于对照组,说明来曲唑+尿促性素+盐酸二甲双胍片治疗能够有效的改善患者的血脂水平,促进患者的临床疗效,与王金英等[20]研究结果相一致。

      综上所述,来曲唑+尿促性素+盐酸二甲双胍片治疗能够明显地改善多囊卵巢综合征患者的性激素和血脂水平,缓解患者的症状,改善其子宫状况,具有较好的临床疗效。

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