多囊卵巢综合征临床试验受试者筛查分析

Analysis of screened subjects in polycystic ovary syndrome clinical trial

目的通过对多囊卵巢综合征(PCOS)临床试验受试者的筛查,了解患者对PCOS及其临床试验的认知程度,探究筛查环节在临床试验中的作用及PCOS发病的相关因素和临床特点。方法研究助手向PCOS患者宣讲PCOS及其临床试验的相关内容,同意接受筛查者,填写纸质版PCOS筛查-纳入情况记录表、门诊病历表及中医证候分级量化表,保留患者的必要检查结果,以作统计分析。结果 1)筛查患者对PCOS及其临床试验的认知程度较低;2)筛查后入组失败的原因主要是:距离远、不感兴趣等;3)受筛查的PCOS患者中医证型分布由高到低依次为:脾虚痰湿证、痰瘀互结证、肾虚肝郁证、肾虚血瘀证;4)基线资料:初潮后月经周期一直不规律者占72.04%;曾有规律的月经周期,后不规律者占27.96%;月经稀发或闭经者占95.70%,子宫异常出血者占4.30%;饮食方式不良者占52.78%,无运动习惯者占81.94%;有家族病史者占57.90%;多毛、痤疮、黑棘皮分别占32.47%、35.07%、41.56%;肥胖者占57.61%,其中向心性肥胖占68.00%;84例受筛查患者中,促黄体生成素(LH)/促卵泡生成素(FSH)比值异常33例,高雄激素血症58例,非酒精性脂肪肝48例,血脂异常24例,胰岛素抵抗(IR)51例,糖耐量异常16例。结论 PCOS患者多无良好的饮食、运动及生活习惯,有明显的家族疾病史,除典型的临床特征外,常表现为向心性肥胖,伴糖脂代谢异常。大多数PCOS患者对该疾病及其临床试验的认知程度低,试验前的筛查环节有助于PCOS知识的普及及早诊早治。

Objective Through the screen of subjects in polycystic ovary syndrome（ PCOS） clinical trial,to understand the subjects＇ awareness of PCOS and clinical trials,and to explore the role of screening in clinical trials and PCOS pathogenesis-related factors and clinical characteristics. Method Research Assistant explain the relevant content about PCOS and its clinical trails. The one who agreeds to accept screening will fill the screening-into,outpatient medical and TCM syndrome classification table in paper,and the necessary results of patient will be retained for statistical analysis. Result 1） Screened subjects＇ cognitive level of PCOS and its clinical is relatively low; 2） The causes of enrolling failure is mainly after screening are distance and no interest,etc; 3） The distribution of TCM syndrome type of the screened PCOS patients from high to low is spleen-deficiency and phlegm stagnation syndrome,phlegm and blood stasis syndrome,kidney insufficient and liver depression syndrome,kidney insufficient and blood stasis syndrome; 4）Baseline information： Irregular menstrual cycle after menarche and regular menstrual cycle accounts for 72. 04% and27. 96% respectively. The percentage of oligo/amenorrhoeaand,abnormal uterine bleeding,bad eating habits,no exercise habits,having family history,hairy,acne,acanthosis nigricans is 95. 70%,4. 30%,52. 78%,81. 94%,57. 90%,32. 47%,35. 07% and 32. 47%. Obese subjects account for 57. 61%,of which the centripetal obesity accounts for68%. Of 84 cases by screening,the anomalous ratio of luteinizing hormone（ LH）/follicle-stimulating hormone（ FSH）,hyperandrogenism,nonalcoholic fatty liver,dyslipidemia,insulin resistance（ IR） and abnormal glucose tolerance abnormal glucose tolerance account for 33,58,48,24,51 and 16 cases respectively. Conclusion Most PCOS patients have no good diet,exercise and lifestyle habits,and family history of disease. In addition to the typical clinical features,PCOS patients are often characterized by centripetal obesity and abnormity of blood lipid metabolic. A number of PCOS patients＇ cognition level of the disease and its clinical trials is low,and the screening before trails is helpful for the popularization of PCOS knowledge and the early diagnosis treatment.