【作者】 张文艳；

【导师】 李丽芸；

【作者基本信息】 广州中医药大学 ， 中医妇科学， 2007， 硕士

【摘要】 研究背景早期先兆流产是妇产科常见病，约占妊娠的15％。近年来，随着经济的发展、现代生活工作的紧张、环境的污染，先兆流产的发病率逐年升高。同时本病具有反复发生的倾向，是危害妇女健康、影响家庭稳定的重要原因，如何有效地防治早期先兆流产，一直是医学界关注的热点之一。西医治疗早期先兆流产途径单一，常规予补充孕酮、维生素E、HCG、叶酸，疗效欠佳，而补充孕酮只对黄体功能不全者有效，免疫因素所致者采用主动免疫法治疗。中医辨证论治则有明显优势，治法以安胎为主，结合临床经验及研究，认为本病肾虚、气血两虚型多见，重在补肾固冲。此外，中医药无副作用，口服制剂更符合现代人要求，应用前景广阔。目的本课题遵循循证医学、临床流行病学／DME的原则，评价孕宝口服液治疗早期先兆流产患者(肾虚、气血两虚型)的临床有效性及对患者性激素水平的影响，为孕宝口服液这一新药开发提供临床研究前的科学依据。方法本研究采用随机、对照方法，将60例早期先兆流产患者(肾虚、气血虚弱型)随机分成两组，治疗组45例，用孕宝口服液治疗，对照组15例，用孕康口服液治疗。比较观察两组病例治疗的临床疗效、前后症状、体征的改善及体内雌孕激素的变化。结果1．孕宝口服液治疗早期先兆流产患者(肾虚、气血虚弱型)45例，治愈40例，显效1例，有效0例，无效4例，总有效率为91.1％，其中痊愈率为88.9％，显效率为2.2％；孕康口服液治疗早期先兆流产患者(肾虚、气血虚弱型)15例，治愈5例，显效5例，有效3例，无效2例，总有效率为86.7％，其中痊愈率为33.3％，显效率为33.3％，有效率为20％；两组总有效率比较，差异无统计学意义(P＞0.05)；两组痊愈率相比较，差异有统计学意义(P＜0.05)；两组显愈率相比较，差异有统计学意义(P＜0.05)。两组治疗后腰酸胀痛、小腹痛坠相比较，差异均有统计学意义(P＜0.05)。可见孕宝口服液有良好的临床疗效，且在临床疗效、症候改善方面优于孕康口服液。2．两组患者血清β—HCG、E2与治疗前相比较，两组差异均有统计学意义(P＜0.05)。两组患者血清P与治疗前相比较，差异无统计学意义(P＞0.05)，考虑可能为样本不大所致。治疗后两组血清β—HCG、E2、P相比较，组间差异均无统计学意义(P＞0.05)。说明孕宝口服液能有效改善早期先兆流产患者(肾虚、气血两虚型)的内分泌，有利于继续妊娠。结论孕宝口服液的治疗效果优于孕康口服液，能有效改善患者的临床症状、体征及体内雌孕激素水平，不失为临床治疗早期先兆流产的有效途径。更多还原

【Abstract】 Backgroundthe early threatened abortion is the very popular gynecologicaldiseases, which composed the 15％of pregnant women. With the development of theeconomy, the pressure of modern life and the envirmental pollution, it has atendency to increase rencently. Besides, it has a tendency to occur again andagain, harm people’s health, and influence family stability. So how to effe—ctively prevent and control the early threatened abortion is arousing theattention of international medical circles. The common treatment of the earlythreatened abortion in modern medicine is only to supple progesterone, WeiSheng Su E, HCG, the effect of which is not well. Supplement of progesteroneis only to treat the patients whose corpus luteum function is defect. Activeimmunization is applied for the patients whose diseases are caused by immunity.However, determination of treatment based in pathogenesis obtained t hrou-ghdifferentiation of symptoms and signs is better than the treatment of modernmedicine. The main method of the disease is anti-abortion, which is focus oninvigorating the kidney and firming CHONG meridian. Based on the clinicalexperience and research, it is commonly thought that Asthenia ofkidney, asthenia of both QI and blood are the major types of syndrome.. Inaddition, traditional Chinese physician has no adverse re—action, oralapplication can be convenient to modern people and be used widely.ObjectiveAccording the evidence-based medicine and clinical epide—mioloy/DME, to observe the effect of Yubaokoufuye on the earlythreatened abortion(Asthenia of kidney, asthenia of both QI and blood) and the change of sexual hormone.MethodsUsing the randomized controllde trial, 60 patients were dividedinto two groups randomly:the treatment group(45 patients) and thecontrol group(15 patients). Yubaokoufuye were used in the treatedgroup, and yunkangkoufuye were used in the controlled group. Symp—toms and signs of each group were observed before and after t—reatment, Meanwhile the levels of E2、β-HCG were measured.Results1. 45 patients were treated by Yubaokoufuye. 40 patients were cured.1 patient was treated excellent. 4 patients were treated ineffectively. Thetotal effective rate of the treatment group and the control groupwere 91.11％and 86.67％, there was no significant difference betweenthe two groups(P＞0.05).The cure rate of the treatment group and thecontrol group were 88.89％and 33.33％,there was significantdifference between the two groups(P＜0.05). After trial, The vaginalbleeding score,waist soreness score, hypogastrium pain score and the totalsymptom score of two groups were decreased obviously, there were nosignificant deviation (P＞0.05);While, there were significantdeviation(P＜0.05) between two group in waist soreness score andhypogastrium pain score. Therefore the effect of Yunbaokoufuye is betterthan Yunkangkoufuye, and Yunbaokoufuye could ameliorate clinicalsymptom.2. After treating, The levels of E2、HCG of the two group wassignificantly improved, there were significant deviation(P＜0.05);The level of P of the two group was not significantly improved, therewas no significant deviation (P＞0.05). After treating, The levelof P of the treatment group compared with the controlled group wasnot significantly improved, there were no significant deviation(P＜0.05).So Yunbaokoufuye can be able to improve the level of E2、β-HCG of the treatment group significantly and make pregnancy keepon.ConclusionsYunbaokoufuye could ameliorate clinical symptom, improve thelevel of E2、β-HCG of the treatment groups significantly. It’s a good therapy for treating the early threatened abortion using yunba—okoufuye.更多还原