俞氏中西医结合分型诊治方案对多囊卵巢综合征疗效影响的临床观察

Clinical observation on the efficacy of Dr. Yu’s integrated Chinese and western medicine classification and treatment for polycystic ovary syndrome

目的观察俞氏中西医结合分型诊治方案干预多囊卵巢综合征(PCOS)的临床疗效。方法将130例PCOS患者随机分成治疗组和对照组,每组65例。治疗组采用俞氏中西医结合分型诊治方案干预(即先将患者分为PCOSⅠa、PCOSⅠb、PCOSⅡa、PCOSⅡb四型,再予中药坤泰方并根据患者情况配合使用炔雌醇或地塞米松或二甲双胍治疗),对照组采用西药常规治疗推荐方案干预,两组疗程均为6个月。观察临床疗效、排卵率、妊娠率及用药安全性,比较生殖内分泌相关指标[促卵泡生成素(FSH)、促黄体生成素(LH)、雌二醇(E;)、睾酮(T)、硫酸脱氢表雄酮(DHEA-S)、性激素结合球蛋白(SHBG)、皮质醇(C)、17α-羟孕酮(17α-OHP)]、糖代谢指标[空腹葡萄糖耐量(FPG)、空腹胰岛素(FINS)、胰岛素抵抗指数(HOMA-IR)]、体质量指数(BMI)、腰臀围比值(WHR)。治疗后随访6个月,观察排卵率与妊娠率的情况。结果(1)最终完成试验者122例,治疗组60例,对照组62例。(2)其中,PCOSⅠa型有2例、占3.3%,PCOSⅠb型有19例、占31.7%,PCOSⅡa型有34例、占56.7%,PCOSⅡb型有5例、占8.3%。(3)治疗组、对照组总有效率分别为91.7%、82.3%;组间临床疗效比较,差异有统计学意义,治疗组优于对照组(P<0.05)。(4)治疗前后组内比较,两组BMI、WHR、FINS、HOMA-IR均较治疗前降低,差异有统计学意义(P<0.05)。组间治疗后比较,两组BMI、WHR、FINS、HOMA-IR差异无统计学意义(P>0.05)。(5)治疗前后组内比较,两组LH和T水平均明显降低(P<0.05),治疗组SHBG水平明显上升(P<0.05),而对照组SHBG水平差异无统计学意义(P>0.05)。组间治疗后比较,两组FSH、E;、DHEA-S、C和17α-OHP水平差异无统计学意义(P>0.05),SHBG和T水平差异有统计学意义,治疗组的改善优于对照组(P<0.05),而LH水平差异有统计学意义,对照组的改善优于治疗组(P<0.05)。(6)组间排卵率与妊娠率比较,治疗组均明显高于对照组(P<0.05)。(7)两组在治疗期间未发生与用药相关的严重需停药的不良反应事件。结论俞氏中西医结合分型治疗方案干预PCOS具有优于单纯西药常规治疗的临床疗效,可从整体上改善机体生殖内分泌及糖代谢紊乱状况,进而促进排卵率和妊娠率的提升。

Objective To evaluate the clinical efficacy of Dr.Yu’s integrated Chinese and Western medicine classification and treatment protocol for polycystic ovary syndrome(PCOS).Methods A total of 130 patients with PCOS were randomly divided into a treatment group(n=65)and a control group(n=65).The treatment group was treated with the integrated Chinese and Western medicine classification and treatment protocol first proposed by Dr.Yu Jin(i.e.,patients were first classified into 4 types:PCOS Ia,PCOS Ib,PCOSⅡa and PCOSⅡb,and then given Kuntai Prescription together with ethinyl estradiol(EE)or dexamethasone or metformin according to patients’condition),while the control group was treated with the recommended western medicine based on the conventional treatment scheme.The duration of treatment was 6 months in both groups.The clinical efficacy,ovulation rate,pregnancy rate and medication safety were observed,and the reproductive endocrine-related indexes[follicle-stimulating hormone(FSH),luteinizing hormone(LH),estradiol(E;),testosterone(T),dehydroepiandrosterone sulfate(DHEA-S),sex hormone-binding globulin(SHBG),cortisol(C),17α-hydroxyprogesterone(17α-OHP)],glucose metabolism indexes[fasting plasma glucose(FPG),fasting insulin(FINS),homeostatic model assessment for insulin resistance(HOMA-IR)],body mass index(BMI),waist-to-hip ratio(WHR)before and after treatment were compared.The ovulation rate and pregnancy rate were observed during 6 months follow-up after treatment.Results(1)There were 122 cases who finally completed the trial,60 cases in the treatment group and 62 cases in the control group.(2)Among them,2 cases(3.3%)had PCOS Ia,19 cases(31.7%)had PCOS Ib,34 cases(56.7%)had PCOSⅡa,and 5 cases(8.3%)had PCOSⅡb.(3)The total effective rate was 91.7%in the treatment group and 82.3%in the control group.The difference in the clinical efficacy between the two groups was statistically significant,and the treatment group showed better clinical efficacy than that of the control group(P<0.05).(4)The intra-group comparison showed that BMI,WHR,FINS and HOMA-IR were lowered after treatment in both groups,and the difference was statistically significant(P<0.05).The inter-group comparison showed that there was no significant difference in BMI,WHR,FINS,and HOMA-IR between the two groups after treatment(P>0.05).(5)The intra-group comparison showed that LH and T levels were significantly lowered in both groups after treatment(P<0.05),and SHBG levels significantly increased in the treatment group after treatment(P<0.05)while the difference in SHBG levels in the control group was not significant before and after treatment(P>0.05).According to the inter-group comparison after treatment,the differences in levels of FSH,E;,DHEA-S,C and 17α-OHP between the two groups were not statistically significant(P>0.05),but the differences in SHBG and T levels were statistically significant,with the improvement in the treatment group being better than that in the control group(P<0.05),while the difference in LH levels was statistically significant,with the improvement in the control group being better than that in the treatment group(P<0.05).(6)The intergroup comparison showed that the ovulation rate and pregnancy rate were significantly higher in the treatment group than those in the control group(P<0.05).(7)There were no serious adverse events related to medication administration that required discontinuation during the treatment course in the two groups.Conclusion Compared with the single use of conventional Western medicine,Dr.Yu’s integrated Chinese and Western medicine classification and treatment protocol for PCOS has shown better clinical efficacy,which can improve the overall reproductive endocrine and glucose metabolism disorders of the human body to promote the ovulation rate and pregnancy rate.