俞氏化痰方联合盐酸二甲双胍治疗肾虚痰湿证多囊卵巢综合征疗效观察

Observation on the curative effect of Yu’s Huatan decoction combined with metformin hydrochloride on polycystic ovary syndrome with syndrome of kidney deficiency and phlegm-dampness

目的 观察俞氏化痰方联合盐酸二甲双胍治疗肾虚痰湿证多囊卵巢综合征(PCOS)的临床疗效。方法 将2018年1月—2020年12月就诊于海军军医大学第一附属医院的318例肾虚痰湿证PCOS患者随机分为2组,对照组给予盐酸二甲双胍治疗,治疗组给予俞氏化痰方联合盐酸二甲双胍治疗,2组患者均连续治疗3个月经周期并于治疗后随访3个月。观察2组患者治疗前后体质指数(BMI)、腰臀比、临床症状(多毛、痤疮、黑棘皮症)评分、中医症状分布情况(月经不调、神疲肢倦、胸闷痰多、大便溏泻、带下量多)、血清性激素[睾酮(T)、雌二醇(E_(2))、促黄体生成素(LH)、促卵泡生成素(FSH)、硫酸脱氢表雄酮(DHEAS)]及代谢指标[空腹血糖(FPG)、空腹胰岛素(FINS)及餐后30 min、60 min、120 min、180 min胰岛素]水平、胰岛素曲线下面积(IAUC)、胰岛素抵抗指数(HOMA-IR)、胰岛素敏感指数(ISI)的变化情况,统计2组患者的周期排卵率及有妊娠要求患者的妊娠率。结果 治疗后,2组患者BMI、腰臀比、黑棘皮症评分、月经不调占比和治疗组患者痤疮评分及神疲肢倦、胸闷痰多、大便溏泻、带下量多症状占比均明显降低(P均<0.05),且治疗组患者痤疮评分、黑棘皮症评分及月经不调、神疲肢倦、胸闷痰多、大便溏泻、带下量多症状占比均明显低于对照组(P均<0.05)。治疗后,治疗组患者E_(2)、LH、LH/FSH、FINS、餐后60 min胰岛素、餐后120 min胰岛素、餐后180 min胰岛素水平以及HOMA-IR、IAUC均明显降低(P均<0.05),ISI明显升高(P<0.05),且治疗组E_(2)、LH/FSH、FINS、餐后120 min胰岛素、餐后180 min胰岛素水平及HOMA-IR、IAUC均明显低于对照组(P均<0.05),ISI明显高于对照组(P<0.05)。治疗组和对照组患者的周期排卵率分别为72.45%(539/744)和32.23%(234/726),妊娠率分别为45.71%(11/38)和28.95%(16/35),临床总有效率分别为82.39%(131/159)和48.42%(77/159),治疗组均显著高于对照组(P均<0.05)。对照组不良反应总发生率为35.22%(56/159),治疗组为12.58%(20/159),治疗组明显低于对照组(P<0.05)。结论 俞氏化痰方联合盐酸二甲双胍可明显改善肾虚痰湿证PCOS患者的临床症状,纠正患者内分泌紊乱,促进患者排卵及妊娠,俞氏化痰方对盐酸二甲双胍具有一定程度的减毒增效作用。

Objective It is to observe the clinical efficacy of Yu’s Huatan decoction combined with metformin hydrochloride in the treatment of polycystic ovary syndrome(PCOS)with syndrome of kidney deficiency and phlegm-dampness.Methods Three hundred and eighteen PCOS patients with kidney deficiency and phlegm-dampness syndrome who were treated in the First Affiliated Hospital of Naval Military Medical University from January 2018 to December 2020 were randomly divided into 2 groups.The control group was treated with metformin hydrochloride,and the treatment group was treated with Yu’s Huatan decoction,both groups were treated for 3 consecutive menstrual cycles and were followed up for 3 months after treatment.The changes in body mass index(BMI),waist-to-hip ratio,scores of clinical symptoms(hirsutism,acne,acanthosis nigricans),distribution of traditional Chinese medical symptoms(irregular menstruation,tiredness,chest tightness and excessive phlegm,loose stool and diarrhea,leukorrhagia),the levels of serum sex hormones[testosterone(T),estradiol(E_(2)),luteinizing hormone(LH),follicle-stimulating hormone(FSH),dehydroepiandrosterone sulfate(DHEAS)]and metabolism indicators[fasting plasma glucose(FPG),fasting insulin(FINS)and 30 min,60 min,120 min,180 min postprandial insulin],insulin area under the curve(IAUC),insulin resistance index(HOMA-IR),insulin sensitivity index(ISI)before and after treatment were observed,the cycle ovulation rate of the patients in the two groups and the pregnancy rate of the patients with pregnancy requirements were calculated.Results After treatment,the BMI,waist-to-hip ratio,acanthosis nigricans score,proportion of irregular menstruation of the patients in the two groups,and the acne score,proportion of tiredness,chest tightness and excessive phlegm,loose stool and diarrhea,leukorrhagia in the treatment group were significantly decreased(P<0.05),and the acne score,acanthosis nigricans score,the proportion of irregular menstruation,tiredness,chest tightness and excessive phlegm,loose stool and diarrhea,leukorrhagia in the treatment group were significantly lower than those in the control group(all P<0.05).After treatment,the levels of E_(2),LH,LH/FSH,FINS,insulin at 60 min after meal,insulin at 120 min after meal,insulin at 180 min after meal,HOMA-IR and IAUC of the patients in the treatment group were significantly decreased(all P<0.05),ISI was significantly increased(P<0.05),and the levels of E_(2),LH/FSH,FINS,insulin at 120 min after meal,insulin at 180 min after meal,HOMA-IR and IAUC in the treatment group were significantly lower while the ISI was significantly higher than those in the control group(all P<0.05).The cycle ovulation rates of the treatment group and the control group respectively were 72.45%(539/744)and 32.23%(234/726),the pregnancy rates respectively were 45.71%(11/38)and 28.95%(16/35),the effective rates respectively were 82.39%(131/159)and 48.42%(77/159),and the rates of the treatment group were all significantly higher than those of the control group(all P<0.05).The total incidence of adverse reactions in the control group was 35.22%(56/159)and that in the treatment group was 12.58%(20/159),and the treatment group was significantly lower than the control group(P<0.05).Conclusion Yu’s Huatan decoction combined with metformin hydrochloride can significantly improve the clinical symptoms,correct endocrine disorders,promote ovulation and pregnancy of PCOS patients with syndrome of kidney deficiency and phlegm-dampness,this decoction also can attenuate toxicity of metformin and improve its efficiency.