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基于中医优生思想的孕前风险评估模式研究
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摘要
研究背景:
     孕妇营养状态的改善以及产前保健水平的提高使新生儿死亡率和孕产妇死亡率大幅度降低,但出生缺陷、自然流产、早产、巨大儿、低体重新生儿等不良妊娠结局的发生率并没有随之降低。
     不良妊娠结局事件对女性及其后代均会带来不利的影响,因此降低不良妊娠结局的发生已成为妇幼保健和优生优育工程的首要目标。中医优生思想认为,对育龄女性进行保健及优生调理最关键的时期之一即为孕前期。《内经》中即已明确父母的身体秉性对后代的影响,认为父母元气充足有利于胎儿的健康发育。这一观点逐渐得到现代研究的证实:良好的妊娠结局确实在很大程度上取决于妇女在孕前的身体状况、生活方式以及生育史。
     纵览中医妇科胎产书籍,其中蕴藏着丰富的孕前保健思想。《女科经纶》提出女性在怀孕前“必阴阳完实,形气相资,兆始于先天有生之初,而再诊以脉之和平,始可有子也”。意思是,阴阳平衡是怀孕的最佳状态,如果女性在怀孕前并非阴阳平衡之态,则可认为其具有一定的妊娠风险,应进行调整,而后怀孕生子。阴阳失衡之态有很多种,可通过对女性经带、饮食、二便、胸腹不适等日常症状的综合辨识而推之。由此可知,中医孕前保健的思路是通过关注女性的主观感受,对其表现出来的日常症状进行整体辨识而后施行综合调养,使其达到最佳的妊娠状态。
     那么,女性孕前健康状态的主观感受(通过日常不适症状、各种阴阳失衡状态体现)与不良妊娠结局之间有着怎样的相关性?目前尚无足够文献报道及证据支持。而二者之间相关性的确定,是研制中医孕前风险辨识评估工具的必要前提,也是建立中医孕前风险评估模式的核心步骤。只有明确二者之间存在的相关性,才能真正实现通过孕前健康风险评估,有的放矢的进行孕前健康咨询及采取有针对性的中医调理干预,从而达到孕前保健的目的。
     研究目的:
     结合量表学、流行病学等方法,运用逻辑回归分析法探索女性孕前健康状态的主观感受与不良妊娠结局之间的相关性,从而实现通过对女性孕前健康状态的中医辨识,评估其发生不良妊娠结局的风险,在此基础上提出中医孕前风险评估模式的概念及内涵。
     研究方法:
     ①研制女性健康状态测评的量表工具:根据量表研制要求,在前期文献研究基础上,结合妇女生理特征及胎孕特点,在中医问诊原则指导下制定条目,形成《育龄女性健康状态调查问卷》初稿。通过专家咨询及人群测试调查的方式,对问卷进行调整、修订,定稿,并运用相关考评方法对该量表进行信效度检验。
     ②人群调研(孕前信息采集):在北京市丰台区对育龄女性进行流行病学调研,调查内容包括:基本信息、生活习惯、家族史、疾病史、生育史、避孕方式、孕检情况、及《育龄妇女健康状态调查问卷》信息。以分析女性孕前中医健康状态的分布规律及相关影响因素,同时为探索女性孕前健康状态与不良妊娠结局的相关性积累足够的样本队列。
     ③人群调研(妊娠结局随访):从上述女性队列中按照入组的时间顺序,采用电话或面对面方式进行妊娠结局随访。运用逻辑回归方法分析女性孕前主观感受(日常不适症状、各种阴阳失衡状态)与不良妊娠结局之间的相关性,以论证通过中医思维辨识女性孕前主观感受,评估其妊娠风险的可行性。
     ④中医孕前风险评估模式的提出及效果评价:在此基础上提出中医孕前风险评估的概念及内涵,并就中医孕前风险辨识工具与现行孕检工具的效果进行比较分析。
     研究结果:
     ①女性健康状态量表测评工具的研制:根据量表研制要求,在前期文献研究基础上,结合妇女生理特征及胎孕特点,在中医问诊原则指导下制定条目,形成《育龄女性健康状态调查问卷》初稿。在对338名育龄妇女进行预测试后,根据结果对问卷进行调整,最终形成包含7个维度31个条目的调查问卷测试版本。从2009年7月至2009年8月对770名育龄妇女再次进行问卷调查,运用SAS9.12分析数据进行问卷的信效度检验。统计分析结果显示,《育龄女性健康状态调查问卷》具有较好的信效度。问卷总体cronbach's α系数为0.86,说明信度较好:因子分析的结果符合理论构想,说明结构效度较好;运用本问卷辨识的女性健康状态结果与《中医体质分类与判定》的体质标准问卷的辨识结果显著相关,可知本问卷有较好的标准效度。
     ②育龄女性孕前健康状态调研结果:自2009年8月至2010年12月,运用《育龄女性健康状态调查问卷》共对6707名丰台区育龄女性进行流行病学调查。该队列的女性总体生活习惯良好,仅有0.4%的女性有吸烟习惯,鲜有饮酒、接触有害物质或噪音者,多数女性不挑食,但是大部分女性接触电脑(91.63%),及部分女性养宠物(15.85%)。该队列的女性大多无疾病问题。除家族糖尿病史(8.43%)外,大部分女性无其他不良家族遗传史、既往病史或现病史。有不良生育史者较多,且以人工流产(15.8%)、药物流产(7.6%)和自然流产(2.4%)史为主。尽管如此,统计结果仍显示,接近半数(47.30%)的育龄女性的健康状态存在阴阳偏颇(以阳虚、湿蕴、血瘀、气滞为主),亟待进行孕前调理。
     本部分研究还显示,中医辨识证型、及各状态的症状表现,均与年龄、饮食偏嗜、家族糖尿病史、各种生育史等风险因素密切相关。③不良妊娠结局与孕前健康状态的相关性分析:白2011年1月至2011年12月,共对上述队列中的1523例女性的生育结局进行了随访。其中已发生生育结局者762例,处于妊娠期167例,未怀孕541例,失访53例。在所有发生生育结局者中,巨大儿发生率为8.40%,流产(包括胎停育)发生率5.0%,早产发生率2.23%,低体重新生儿发生率1.05%,总体不良妊娠结局的发生率为16.67%。
     不良妊娠结局的孕前证型分布存在差异:流产者多见湿蕴、阳虚、气滞、血瘀型,胎停育者多见气滞、血瘀、湿蕴型,早产者以湿蕴、阳虚型为主,巨大儿者多见气滞、阳虚型,低体重儿者则以见阳虚、阴虚型为主。
     孕前日常不适症状对不良妊娠结局具有提示意义:本研究发现,31种日常症状中的“舌苔厚腻”是总体不良妊娠结局的孕前风险症状(OR:1.68,95%CI:1.03-2.76),'‘自汗”是流产的孕前风险症状(OR:2.88,95%CI:1.09-7.59),“月经色深”是胎停育的孕前风险症状(OR:12.2,95%CI:1.03-144.2),而“小便清长”、“大便秘结”及“善太息”是早产的孕前风险症状(小便清长OR:6.31,95%CI:1.1-36.13;大便秘结OR:14,95%CI:2.33-84.12;善太息OR:13.92,95%CI:13.92-123.44)。此外,初潮年龄大于15岁是早产的风险因素(OR:4.22,95%CI:1.01-17.64),家族糖尿病史是流产的风险因素(OR:2.75,95%CI:1.01-7.54)。
     ④构建以中医辨识评估为核心要素的孕前风险评估模式。即在中医理论指导下,对女性孕前健康状态进行辨识,结合已知孕前风险因素,综合评估其发生不良妊娠结局的风险,以指导中药、针灸、推拿、食疗等传统方法的综合使用,使其在孕前达到“阴阳完实”、“月事调和”的最佳孕育状态。
     最后,对中医孕前风险辨识评估工具与现行孕前检查工具进行效果比较。以“不良妊娠结局的检出率”(灵敏度,又称真阳性率,即筛查为不良妊娠风险者/实际发生不良妊娠结局者)作为结局指标,通过前期人群调研的结果,得出中医辨识工具的不良妊娠结局的检出率为35.71%,略高于孕检的检出率(31.52%),而两种工具的总体检出率为58.68%,由此推测,将孕检手段与中医辨识手段相结合,对女性孕前健康状态进行辨识评估,可能会是一种比现行孕前风险评估工具更灵敏、高效的新方法。研究结论:
     本研究通过大样本流行学调研,运用量表研制、统计分析等方法,对女性孕前健康状态的主观感受与不良妊娠结局之间的相关性进行探索分析,发现不良妊娠结局者的孕前证型分布有一定差异性;而某些日常不适症状对不良妊娠结局具有提示意义。
     此外,不良妊娠结局、女性孕前中医证型/孕前不适症状、孕前风险因素之间息息相关。孕前风险因素的综合作用体现是女性主诉的各种不适症状,不适症状的综合体现是中医证型状态,而不同的孕前中医证型又提示着不同的妊娠结局风险。由此可知,无论是对孕前风险因素、症状或证型的评估及干预均可在一定程度上降低不良妊娠结局的发生风险。
     因于此,本研究提出中医孕前风险评估模式,即在中医理论指导下,对女性孕前健康状态进行辨识,结合已知孕前风险因素,综合评估其发生不良妊娠结局的风险,以指导中药、针灸、推拿、食疗等传统方法的综合使用,使其在孕前达到“阴阳完实”、“月事调和”的最佳孕育状态。在此基础上进一步设想,将中医孕前风险评估模式与现行孕前检查模式有机结合,互相补充,可使孕前保健的内涵及方法更加丰富。
Background:
     Although there is a significant reduction of neonatal and maternal mortality rates, because of improvement of maternal nutritional status as well as prenatal care, the incidence of adverse pregnancy outcomes, such as birth defects, spontaneous abortion, premature delivery, low birth weight, still the same.
     Event of adverse pregnancy outcomes is adverse impact for both women and their offspring, thus reducing the occurrence of adverse pregnancy outcomes has become a primary goal of the project of promoting maternal and child health. Through the theory of Chinese medicine, preconception is one of the most important period of women during childbearing age. This view has been gradually confirmed by modern research:pregnancy outcome does largely depend on the physical condition, lifestyle and reproductive history of women before pregnancy.
     But how is the relationship between women's preconception health status (daily symptoms, or varieties of yin&yang imbalance status) and adverse pregnancy outcomes? It's still a question need to answer.
     Objective:
     By means of psychologcal, epidemiologcal and statistical methods, this paper explores the correlation between perconcetption health status and adverse pregnancy outcomes, in order to build a preconception risk assessment, which can assess women's pregnancy risk through the health status of women before pregnancy. Depend on it, this paper present the concept of Chinese medicine preconception care model.
     Methods:
     ①development of women's health status assessment tools:Based on early literature research and under the principle of Chinese medicine, this paper developed a questionnaire to assess women's health status, then adjust, amend and this questionnaire by means of expert advice and the crowd survey. Finally, the reliability and validity of questionnaire has been test.
     ②cohort study (preconceptional information collection):To explore the impact factors on women's health status before pregnancy, as well as accumulate sufficient sample queue to find the relationship between female pre-pregnancy health status and adverse pregnancy outcomes, we collect pre-pregnancy information on women during childbearing age in Fengtai District, Beijing. Information includes:basic information, habits, family history, disease history, reproductive history, contraceptive methods, pregnancy situation, and health status assessed by questionnaire developed above.
     ③cohort study (pregnancy outcome follow-up):From the above female queue, we follow-up pregnancy outcomes by telephone or face-to-face interview. We use logistic regression model to analysis the relationship between women's health status before pregnancy (daily symptoms, or varieties of yin&yang imbalance status) and adverse pregnancy outcomes.
     ④Proposed and evaluation on Chinese preconception care model:Based on result above, we present the concept and connotation of the Chinese medicine preconception care, and compared the effect between Chinese preconception risk assessement tool and current preconception testing tool.
     Results:
     ①development of women's health status assessment tools:Based on the results of pre-test on338women of childbearing age, the questionnaire has been adjusted in containing31items in seven dimensions ultimately. From July to August in2009, we survey this questionnaire among770women for testing it's reliability and validity. The statistical analysis showed that this questionnaire has good reliability and validity. The questionnaire's overall cronbach's alpha coefficient is0.86, indicating good reliability; factor analysis of the results is consistent with theoretical ideas, which indicats good construct validity; by compared to "Chinese constitution classification and judgment", we can see the questionnaire has good criterion validity.
     Epidemiological survey on women's preconception health status:Since August2009to December2010, an epidemiological study of6707women of childbearing age in Fengtai District has been conducted. Among these women, only0.4%of women have the habit of smoking, drinking, exposure to harmful substances or noise, most women aren't eat picky food, while most women have access to computers (91.63%), and some feed pets (15.85%). As to the family history,8.43%of diabetes, the majority have no other adverse family history, sickness history or present illness. Relatively, more female has adverse reproductive history, such as abortion (15.8%), medical abortion (7.6%) and spontaneous abortion (2.4%). Nevertheless, statistics still show that nearly half (47.30%) women of childbearing age exists yin or yang biased, in urgent need of pre-pregnancy conditioning.
     This part showed that women's preconception health status, is closely related with age, dietary habits, family diabetes history, reproductive history and other risk factors.
     ③Relationship between adverse pregnancy outcome and preconception health status:From January to December2011, a follow-up of1523cases of pregnancy outcome has been conducted. The result is,762cases in all has pregnanted,167in pregnancy,541non-pregnancy, and53missed. The total rate of adverse pregnancy outcomes is16.67%, includes8.40%macrosomia,5.0%abortion,2.23%preterm birth,1.05%low birth weight.
     Each adverse pregnancy outcome appears differences of preconception syndrome type:abortion appears Shi stagnation, Yang deficiency, Qi stagnation or blood stasis type, premature appears Shi stagnation or Yang deficiency, macrosomia appears Qi stagnation or Yang deficiency, while low birth weight infant appears Yang or Yin deficiency type-based.
     Some daily symptoms before pregnancy have significance of indicating adverse pregnancy outcomes:"thick greasy tongue further" indicates the overall adverse pregnancy outcome (OR:1.68,95%CI:1.03-2.76),"spontaneous" indicates the risk of miscarriage (OR:2.88,95%CI:1.09-7.59),"deep color of menstruation " is the risk symptom of intrauterus fetal growth retardation (OR:12.2,95%CI:1.03-144.2), and "increased urinary frequency","constipation" and "deep sigh" are all risk symptoms of preterm delivery (increased urinary frequency OR:6.31,95%CI1.1-36.13; constipation OR:14,95%CI:2.33-84.12; deep sigh OR,:13.92,95%CI:13.92-123.44).
     ④Based on results above, this paper present the preconception risk assessment and health promotion strategies, considered as two basic elements of Chinese medicine preconception care model.
     Finally, we compared the effect between Chinese preconception risk assessement tool and current preconception testing tool. We calculated the detection rate of adverse pregnancy outcomes (the number of adverse pregnancy outcomes among all pregnancy risk population/total number of adverse pregnancy outcome) to measure the effect. The result is, by using Chinese medicine tool, the detection rate is35.71%, which is slightly higher than pregnancy test (31.52%), while combined both, the overall rate rose up to58.68%.
     Conclusion:
     Based on a large scale cohort study, this paper indicated the interrelated between adverse pregnancy outcome, preconception health status (daily symptoms, or varieties of yin&yang imbalance status), and normal risk factors. The combined effects of normal risk factors reflected in the women complained of daily symptoms, special combination of daily symptoms indicates special TCM syndrome status, at last the preconception TCM status suggesting the risk of pregnancy outcome. Therefore, by assessing and intervening each of preconception normal risk factors, daily symptoms or TCM status, may reduce the risk of adverse pregnancy outcomes.
     Thus, this paper present the preconception risk assessment and health promotion strategies, considered as two basic elements of Chinese medicine preconception care model. This model is, by assessing and intervening women's pregnancy risk through the health status of women before pregnancy, under TCM theory, to improve pregnancy outcome.
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