第一部分、早泄的临床流行病学研究
目的：由于对早泄认识和定义的不断变化，既往各项研究中所发现的早泄危险因素也存在一定差异，目前国内外仍缺乏大样本量的广为接受的早泄临床流行病学数据。本次多中心的横断面研究以2013年ISSM对早泄定义的最新版本为基础，拟对国内早泄患者的临床流行病学特点及危险因素进行全面的收集与评估。
材料与方法：本研究对2017年3月1日至2017年7月1日就诊于国内五大区域共计16家医院的早泄患者进行了调查。建立信息收集表，收集参与研究人群的基本信息、性生活相关信息、精神心理状况相关信息、患者及其女性伴侣对早泄的态度，以及性交当日多次性生活排精对早泄认知影响的相关信息。采用Stata 12.0统计软件进行数据分析。
结果：本次研究共纳入1033名早泄患者以及3176名非早泄的体检者。早泄患者的平均年龄为34.68±7.92岁，平均病程为4.57±4.51年。患者的PEDT及IELT评分的平均值分别为11.29±2.59以及1.59±0.85 min，与非早泄体检者相比，PEDT评分显著升高（p<0.001）、IELT显著下降（p<0.001）。早泄患者的IIEF-EF评分的平均分值为21.53±5.62，与非早泄体检者相比，勃起功能显著下降（p<0.001）。多因素分析结果显示，早泄的发生与患者的文化程度、经济条件（月收入）、职业因素相关，并与吸烟、饮酒、糖尿病、慢性前列腺炎、焦虑以及抑郁状态等不良癖好及疾病呈正相关，与BMI以及性生活频率呈负相关。患者来就诊的始动因素分为患者对早泄不满意、女性伴侣对早泄不满意以及双方均不满意，所占比例分别为44.3%、21.39%以及33.98%。其中患者最不满的因素主要分为IELT短、射精控制能力差、夫妻关系紧张以及其他因素，所占比例分别为49.51%、17.86%、22.52%以及10.11%。女性伴侣最不满意的因素主要分为性唤起困难、性欲低下、无法达到性高潮、夫妻关系紧张或其他，所占比例分别为41.61%、19.93%、21.68%、14.51%以及2.27%。经过初步的咨询后，患者更加关注早泄治疗结果的比例占30.69%、女性伴侣更加关注早泄的治疗结果的占9.97%，双方均非常关注的占比为59.34%。曾尝试过性交日多次性生活的早泄患者占比43.51%，根据尝试频率分为<25%、25%~50%以及>50%三个层次，患者占比分别为63.83%、25.53%以及10.64%。未尝试过性交日多次性生活的早泄患者占比56.49%，未尝试的原因分为四种：不了解或从未想过可以同一天内多次性生活、多次性生活后勃起功能不佳、患者主观上不愿意以及女性伴侣不愿意配合，所占比分别为18.03%、41.80%、59.83%以及21.31%。对于能够性交日多次性生活的患者，其首次性生活的IELT及抽插次数的平均值分别为1.41±0.95 min以及65.68±56.38，患者第二次性生活的IELT和抽插次数分别为4.57±3.26 min以及235.19±207.33，均显著增加。
结论：本次研究对早泄的基本临床特点进行了系统性的研究和分析。早泄的发生与患者的文化程度、经济与条件（月收入）、及职业相关，与不良癖好及疾病，例如吸烟、饮酒、糖尿病、慢性前列腺炎、焦虑以及抑郁状态呈正相关，与BMI以及性生活频率呈负相关。早泄患者的女性伴侣对早泄的诊疗过程影响较大，临床医师在诊疗过程中应同时关注其女性伴侣的医学教育与指导；性交日内多次性生活这一现象在早泄患者中很常见，末次IELT、抽插频率会显著增加。

第二部分、早泄治疗效果评价体系的建立
目的：针对目前国际上缺乏对早泄治疗效果客观全面评估的现状，制定早泄治疗效果的评估体系，以利于客观全面评估早泄治疗的效果，为临床疾病诊疗提供实用工具。
材料与方法：分析目前国内外早泄治疗效果评估的现状，总结存在的问题。通过文献分析法及专家访谈形成评价体系的初步讨论稿；运用德尔菲专家咨询法以及层次分析法进一步建立了早泄患者疗效评估体系；通过实证研究评估该体系的信度及效度。
结果：文献分析法共纳入了临床指南3篇、系统综述与荟萃分析3篇以及临床研究10篇，并初步选取了5个一级指标和13个二级指标。研究者进一步进行了一次专家访谈以及两轮德尔菲专家咨询法，两轮均回收问卷47份，回收率100%。两轮的专家权威系数为0.80，第一轮的协调系数为0.335，第二轮的协调系数为0.355。最终确定了4个一级指标和5个二级指标。四个一级指标分别为：“阴道内射精潜伏期的改善”、“患者及其女性伴侣心理状况的改善”、“射精控制能力的改善”以及“性交满意度的改善”。四个一级指标的权重分别为0.108、0.301、0.244以及0.346。我们依据权重对所有指标进行了赋分，设计了早泄疗效评估问卷，该问卷总分为36分，当分数大于18分时计为有效，大于27分则计为显著有效。本次评估量表的克朗巴哈系数为0.86，Pearson相关分析的结果显示，所有条目的相关系数均大于0.6，提示本次评估体系的信度和效度较高。
结论：本次研究首次建立了早泄治疗效果评估体系，从“阴道内射精潜伏期的改善”、“患者及其伴侣心理状况的改善”、“射精控制能力的改善”以及“性交满意度的改善”这四个角度对干预的疗效进行系统、多维度地评价。规范、系统化地评估系统有利于早泄的临床研究。

 

Part 1: Analysis of the clinical features of the patients with premature ejaculation
Objective: Since the changes of the knowledge of the definitions of premature ejaculation, the risk factors of premature ejaculation varied from different studies. There is still a lack of knowledge of the clinical features of the patients with premature ejaculation with a well-established definition. In 2013, International society for sexual medicine provided an evidence-based definition of premature ejaculation, and the current multi-center cross-sectional study aimed to provide a comprehensive evaluation of the clinical features and risk factors of premature ejaculation using this definiton.
Materials and Methods: From March 1 2017 to July 1 2017, qualified participants were continuously enrolled from 15 medical centers in five different regions of China. A self-designed questionnaire was used to collect the information concerning basic characteristics, sexual function, psychological disorders, couples’ attitudes and the effects of multiple sexual intercourse in one day on premature ejaculation. Stata 12.0 was used for statistics.
Results: A total of 1033 patients and 3176 males without premature ejaculation were included in the current study. The mean age of the patients was 34.68±7.92 years and the mean duration was 4.57±4.51 years. The mean PEDT score and the mean IELT were 11.29±2.59 and 1.59±0.85min, respectively. Results indicated that the PEDT was significantly higher (p<0.001) and the IELT was significantly lower (p<0.001) than patients without premature ejaculation. The mean IIEF-EF value was 21.53±5.62, and significantly decreased in the patients. Multivariate analyses indicated that occurrence of premature ejaculation was positively associated with education levels, monthly income, office work status, smoking, drinking, hypertension, diabetes, chronic prostatitis, anxiety and depression. Additionally, occurrence of premature ejaculation is negatively associated with BMI and frequency of sexual intercourse. The reason why the patients seeking for the treatments including dissatisfaction of the males, dissatisfaction of the sexual partners and dissatisfaction of the both couples. The prevalence rates were 44.3%, 21.39% and 33.98%, respectively. In terms of the males who were dissatisfied with premature ejaculation, 49.51%, 17.86%, 22.52% and 10.11% of the males reported shortened IELT, inability to control ejaculation, affecting couple’s relationship and other factors. In terms of the sexual partners, 41.61%, 19.93%, 21.68%, 14.51% and 2.27% of them reported difficulties in arousal, lower sexual desire, orgasm dysfunction, affecting couple’s relationship and other factors, respectively. After counseling the doctors, 30.69% of the males were more concerned about the treatment effects while 9.97% of the females were more concerned about the treatment effects. Another 59.34% of the couples were both concerned about the treatment. There were 43.51% of the patients had tried multiple sexual intercourses in one day in the nearly three months. The frequencies of the attempts were divided into three groups: <25%, 25 ~ 50% and >50%. The proportion of the patients were 63.83%, 25.53% and 10.64%, respectively. 56.49% of the patients had not tried multiple sexual intercourses in one day. There were four causes: unaware or have not thought about this, fatigue after multiple sexual intercourses in one day, unwilling of the males and unwilling of the sexual partners. The proportion of the patients were 18.03%, 41.80%, 59.83% and 21.31%, respectively. For those patients who had tried multipe attempts in one day, their first IELT and times of vaginal insertion were 1.41±0.95 min and 65.68±56.38, respectively. Their second IELT and times of vaginal insertion were 4.57±3.26 min and 235.19±207.33, which were significantly improved.
Conclusions: The current study systematically demonstrated the basic characteristics of the patients with premature ejaculation. Occurrence of premature ejaculation was positively associated with education levels, monthly income, office work status, smoking, drinking, diabetes, chronic prostatitis, anxiety and depression. Additionally, occurrence of premature ejaculation is negatively associated with BMI and frequency of sexual intercourse. In addition, the attitudes of the sexual partner played an important role in the diagnosis and the treatment of premature ejaculation. Physicians should pay more attention on this issue. Multiple sexual intercourses in one day is common in patients with premature ejaculation. Last IELT and the number of vaginal insertions significantly improved compared with the first attempt.

Part 2: Establishment of the evaluation index system for the curative outcomes of premature ejaculation
Objective: Currently, there were no effective tools to evaluate the curative outcomes of premature ejaculation. The purpose of this study is to establish an index system for the evaluation of the curative outcomes of premature ejaculation, so as to set a standard for the future epidemiological studies.
Materials and Methods: The researchers have analyzed previous studies concerning the evaluation of premature ejaculation treatment. The existing problems were organized to formulate the preliminary discussion paper. In depth expert interview was performed to obtain the preliminary draft. Delphi methods and analytic hierarchy process was performed to establish the evaluation system. The evaluation system was further used in a preliminary research to assess the reliability and validity.
Results: A total of 3 guidelines, 3 systematic review and meta-analyses and 10 clinical researches were enrolled. The researches have selected 5 primary indicators and 13 secondary indicators at first. Further in-depth expert interview and two rounds of Delphi methods were performed. 47 expert consultation questionnaires were collected in both rounds and the response rate was 100%. The experts’ coefficient of authority was 0.80. The Kendall’s coefficients were 0.335 and 0.355 in the first and the second round of Delphi methods. Finally, a total of 4 primary indicators and 5 secondary indicators were confirmed. The 4 primary indicators were: “the improvements of IELT”, “the improvements of the couple’s psychological conditions”, “the improvement of the ability to control ejaculation” and “the improvement of the satisfaction of the sexual intercourse”. The weights of these indicators were 0.108, 0.301, 0.244 and 0.346, respectively. Based on the weights of these indicators, we have designed the scale for evaluating curative outcomes of premature ejacuation. The total score is 36 points. When the scores are more than 18, it suggests that the treatments have moderate effects. When the scores are more than 27, it suggests that the treatments have strong effects. The Cronbach’s alpha of the evaluation system was 0.86. Coefficients of the Pearson correlation analyses were more than 0.6 in all the items, indicating a good reliability and validity of this system.
Conclusions: The current study established an evaluation system for the treatment effects of premature ejaculation at the first time. The evaluation system has four aspects including “the improvements of IELT”, “the improvements of the couple’s psychological conditions”, “the improvement of the ability to control ejaculation” and “the improvement of the satisfaction of the sexual intercourse”. A standardized systematic evaluation system is helpful for the development of the epidemiological studies concerning treatment effects of premature ejaculation.