中西医结合诊治多囊卵巢综合征(PCOS)不孕症临床研究
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摘要
[研究目的]
     本研究是在辨病、辨证的基础上,把PCOSⅠ型(非肥胖型)辩证为肾虚血瘀;PCOSⅡ型(肥胖型)辨证为脾虚血瘀,应用导师2个经验方即PCOSⅠ号方和PCOS2号方分别对PCOS2型即PCOSⅠ型(非肥胖型)合PCOSⅡ型(肥胖型)进行治疗,探讨2方对PCOS2型的临床症状、内分泌激素、排卵率、妊娠率、总疗效的作用,以指导临床治疗PCOS所致不孕症最佳治疗方案,并为临床中成药的开发提供临床基础。
     [研究方法]
     根据文献研究和导师经验把PCOS所致不孕症按非肥胖和肥胖分为2型,在CC促排卵的基础上分别配合PCOS1号方治疗PCOSⅠ型;以PCOS2号方治疗PCOSⅡ型。
     PCOSⅠ型(非肥胖型)临床研究:纳入病例标准符合PCOSⅠ型诊断标准及肾虚血瘀辨证标准,年龄在25岁至35岁已婚患者60例。按随机分配的原则分治疗组(中西结合组),对照组(西药组)各30例。
     中西结合组(治疗组):与月经或孕酮撤退性出血第1天测基础体温,第5天起应用克罗米芬胶囊(CC),每日一次,每次50mg口服,连用5天;同时加用PCOS1号方(即导师尤昭玲教授经验方)口服;对照组单用CC治疗。治疗组和对照组皆治疗3个月经周期为一疗程,用1个疗程,进行疗效统计。观察PCOS1号方对PCOSⅠ型的临床症状、内分泌激素、排卵率、妊娠率、总疗效的作用
     PCOSⅡ型(肥胖型)临床研究:纳入病例标准符合PCOSⅡ型诊断标准及脾虚血瘀辨证标准,年龄在25岁至35岁已婚患者60例。按随机分配的原则分治疗组(中西结合组),对照组(西药组)各30例。治疗组与月经或孕酮撤退性出血第1天测基础体温,第5天起应用克罗米芬胶囊(CC),每日一次,每次50mg口服,连用5天;同时加用PCOS2号方(即导师尤昭玲教授经验方)口服,余下治疗和观察同PCOSⅠ型(非肥胖型)临床研究。
     [结果]
     1 PCOSⅠ型所致不孕证临床研究结果:
     (1)治疗组妊娠率63.%,总有效率为90%;对照组妊娠率46.7%,总有效率为73.3%。两组比较,P<0.05,差异有显著性意义。
     (2)两组治疗后比较,治疗组在改善月经周期、腰骶酸痛、胸脘满闷、经行小腹胀痛、带下量多、嗜睡方面优于对照组,经统计学处理,差异有显著性(P<0.05),治疗组中医证候总有效率为63.3%,对照组为33.3%,两组差异有显著性(P<0.05),
     (3)血内分泌水平变化治疗组治疗前后比较内分泌激素有显著性变化(P<0.05),T、LH明显下降,E2升高。对照组治疗前后生殖内分泌激素虽稍有变化,但无统计学意义P>0.05
     (4)两组周期排卵率比较,治疗组周期排卵率63.5%,对照组周期排卵率28.4%,两组周期排卵率比较有统计学意义(P<0.01)
     2 PCOSⅡ型(肥胖型)临床研究结果
     (1)临床疗效观察:治疗组妊娠率46.7%,总有效率为76.7%;对照组妊娠率23.3%,总有效率为46.7%。两组进行统计学检验,P<0.05差异有显著性意义。
     (2)临床表现与中医证候治疗前后比较两组治疗后比较,治疗组在改善月经周期、腰骶酸痛、胸脘满闷、经行小腹胀痛、带下量多、嗜睡方面优于对照组,经统计学处理,差异有显著性(P<0.05)。治疗组中医证候总有效率为63.3%,对照组为33.3%,两组差异有显著性(P<0.05),
     (3)血内分泌水平变化治疗组治疗前后比较内分泌激素有显著性变化(P<0.05),T、INS明显下降。对照组治疗前后生殖内分泌激素虽稍有变化,但无统计学意义P>0.05,
     (4)两组周期排卵率比较治疗组周期排卵率39.5%,对照组周期排卵率19.0%,两组比较有统计学意义(P<0.01)。
     [结论]
     1. PCOSⅠ号方干预可提高PCOSⅠ型总疗效,并能有效提高妊娠率,达到调经助孕的目的。
     2. PCOSⅠ号方可明显改善PCOSⅠ型中月经周期异常、月经色、量异常、经行小腹胀痛、头晕、腰骶酸痛、粉刺、口干症状。对舌脉也有明显改善作用。对多毛症状无改善,可能与疗程短有关。
     3. PCOSⅠ号方能使非肥胖型PCOSⅠ型患者血清内分泌T、LH明显下降,E2升高,LH/FSH比值较治疗前降低,说明PCOSⅠ号方能改善卵巢功能,能调节下丘脑—垂体—卵巢轴的功能,纠正紊乱的内分泌环境。
     4. PCOSⅠ号方对非肥胖型PCOSⅠ型可提高排卵率,有促排卵作用。
     5. PCOSⅡ号方可提高肥胖型PCOSⅡ号总疗效,并能有效提高其妊娠率,但与PCOSⅠ型治疗妊娠率比较,PCOSⅡ型妊娠率明显低于PCOSⅠ型。
     6. PCOSⅡ号方干预PCOSⅡ型可明显改善月经周期异常、月经色、量异常、经行小腹胀痛、胸脘满闷、经行小腹胀痛、带下量多、嗜睡、腰骶酸痛等临床表现。但对肥胖稍有改善,这可能与疗程短有关。
     7. PCOSⅡ号方通过降低PCOSⅡ型胰岛素水平,改善外周胰岛素抵抗状态,调节糖、脂代谢以改善PCOS患者的卵巢局部异常的内分泌状态,降低雄激素水平,使排卵功能恢复,排卵率增加,改善生殖机能。
     8. PCOSⅡ型比较PCOSⅠ型妊娠率较低,单用CC治疗PCOSⅡ型妊娠率更低,可能与肥胖可加剧高胰岛素血症,导致过多的雄激素产生,使PCOS内分泌更为复杂
     综上所述,本研究在辨证施治的基础上辨病论治,以不同的方药对PCOS分型进行论治。中药可调节PCOS患者失调的内环境,促使其生殖功能的恢复。
Object:Polycystic ovary syndrome is a kind of endocrine disease that with different causes and polymorphism clinical manifestation. Moreover, PCOS is also a main reason that causes infertility because of not having ovary sends.
     The thesis intends to divide the PCOSⅠinto kidney efficiency and blood stasis and PCOSⅡinto spleen efficiency and blood stasis, on the basis of the researches of diseases and actual examples. Moreover, the author also intends to adopt her tutor's two excellent experiences-PCOSⅠmethod and PCOSⅡmethod to have a thorough study on PCOS 2, thus exploring the influence of the two methods on PCOS 2, including its clinical manifestations, inner incretion hormone, the ovary sends'rate, the pregnancy rate and the general effect, and instructing a clinical basis on the development of Chinese medicine.
     Methods:The author has not only divided the infertility caused by PCOS into obese and non-obese, on the basis of the established researches and the author's actual experience, but also has adopted the corresponding way of PCOS 1 to cure PCOSⅠand PCOS 2 for PCOSⅠon the basis of the research of CC, which helps to speed up the ovary sends.
     Clinical research of PCOSⅠ(Non-obese):A Case standards into line with PCOSⅠdiagnostic standard and kidney deficiency and blood stasis dialectical standard, the age of 25-year-old to 35-year-old married in 60 cases. According to the random distribution principle, it is divided into the treatment group (combination of Chinese and Western group) and the contrastive group (WM group) of the 30 cases.
     Treatment group and menstruation or progesterone withdrawal bleeding:have a temperature measurement basis at the first day, take the medicine clomiphene capsules (CC) after five days, once daily,50 mg orally each day for five days at the same time, plus the PCOS2 (i.e. the author's tutor Professor You Zhaoling's experience), oral. Treatment group and the control group were three of the menstrual cycle for treatment with a course of treatment and an efficient statistics. The observation side PCOS1 method plays a role in the clinical symptoms, endocrine hormone, ovulation rate, pregnancy rate and the total effect of PCOSⅠ
     PCOSⅡtype (obese) Clinical Research:A Case standards into line with PCOSⅡdiagnostic criteria and spleen deficiency and blood stasis standards, the age of 25-year-old to 35-year-old married in 60 cases. According to the random distribution principle, it is divided into the treatment group (combination of Chinese and Western), the control group (WM group) of the 30 cases. Treatment group and menstruation or progesterone withdrawal bleeding:have a temperature measurement basis at the first day, take the medicine clomiphene capsules (CC) after five days, once daily,50 mg orally each day for five days at the same time, plus the PCOS2 (i.e. the author's tutor Professor You Zhaoling's experience), oral, and the remaining treatment and observation has the same clinical study with PCOSⅠtype (non-obese).
     Result:
     1. PCOSⅠinduced infertility Clinical Study Results
     (1) The pregnancy rate of treatment group 63%,the total efficiency was 90%. The pregnancy rate of control group46.7%,the total efficiency was 73.3%. Using statistical test, the data showed statistical significance(P<0.05)
     (2) Comparison of the two groups after treatment, the treatment group in amending the menstrual cycle, releasing lumbosacral pain and chest distress, as well as lower abdomen pain, vaginal discharge volume, sleepiness was superior to the control group. Statistically, there were significant differences (P<0.05), Comparison of effects in TCM syndrome:the total efficiency in treatment group was 63.3%.33.3% of the control group. There were statistical differences (P<0.05),
     (3) Changes in level of endocrine:compared endocrinic hormones showed statistical differences in treatment group before and after treatment (P<0.05), the level of T and LH decreased significantly, E2 increased. Although in the control group some reproductive hormones changed after treatment, there were not statistical significance P>0.05
     (4) The rat of treatment group was 85.5%, The rat of control group was 28.4% There were statistical significance between tow grouos.(P<0.05)
     2 PCOSⅡtype (obese) Clinical Study Results
     (1) Clinical Observation on effect:The pregnancy rate of treatment group 46.7%,the total efficiency was 76.7%. The pregnancy rate of control group23.3%,the total efficiency was 46.7%. Using statistical test, the data showed statistical significance(P<0.05)
     (2) clinical performance and TCM syndrome:Compared between the two groups after treatment, the treatment group in amending the menstrual cycle, releasing lumbosacral pain and chest distress, as well as lower abdomen pain, vaginal discharge volume, sleepiness was superior to the control group. Statistically, there were significant differences (P<0.05). Comparison of effects in TCM syndrome:the total efficiency of 63.3%* in the treatment group, it was 33.3% in the control group. There were statistical differences (P <0.05)
     (3) Changes in level of endocrine:compared endocrinic hormones showed statistical differences in treatment group before and after treatment (P<0.05). The levels of T and INS were declined markedly. Although in the control group some reproductive hormones changed after treatment, there were not statistical significance P>0.05.
     (4) The rat of treatment group was,39.5% The rat of control group was 19.0% There were statistical significance between tow grouos.(P<0.05)
     Conclusion:The intervention of PCOSⅠcan not only improve the general effect of PCOSⅠ, but also can effectively increase the pregnancy rate, reaching the purposes of a freely balanced menstruation and an unexpected pregnant.
     PCOSⅠcan significantly decrease the following symptoms in PCOSⅠ:an abnormal menstrual cycle, the menstrual color of anomaly, the abnormal quantity of menstruation, abdomen pain, dizziness, lumbosacral pain, acne and dry mouth. Moreover, it has a noticeable improvements on the tongue. However, it has no improvements in furry because of a short duration.
     PCOSⅠmethod can rapidly decrease the serum endocrine-T and LH of the patients who have PCOSⅠ(non-obese). On the other hand, it increases its E2. moreover, the ratio of LH/FSH is lower down before taking treatment, which implies that PCOSⅠmethod can improve the ovarian function, regulate the hypothalamic-pituitary-an ovarian axis' functions and correct the disorder endocrine environment.
     PCOSⅠmethod:it can increase the ovulation rates and ovulation sends for PCOSⅠ(non-obese) type.
     PCOSⅡcan increase both the total effect of PCOSⅡand effectively improve the pregnancy rate. However, in comparison with PCOSⅠ, PCOSⅡhas an obviously lower pregnancy rate
     The intervention of PCOSⅡcan significantly improve the abnormal menstrual cycle, the menstrual color, the abnormal quantity, the abdomen pain, Chest Wan Man nausea, vaginal discharge volume, sleepiness, lumbosacral pain and other clinical manifestations. However, it only has a little improvement in the obesity, which may be related to the short duration.
     By lowering insulin levels of the PCOSⅡ, PCOSⅡcan improve peripheral insulin's resistance, and regulating glucose and lipid metabolism in patients with PCOS to improve local abnormal ovarian endocrine status and lower the levels of androgen, thus making the ovulation function recovered, ovulation rate increased and reproductive function improved.
     To PCOSⅠ, PCOSⅡhas a lower pregnancy rate, and while just adopting CC for treatment, PCOSⅡhas a even lower pregnancy rate. Moreover, it may be more complex than obesity exacerbating hyperinsulinemia, thus resulting in excessive androgen and producing a more complex PCOS endocrine.
     In conclusion, the study is based on differential treatment of the patients identified on the basis of governance, with different types of herbs on PCOS conduct of governance. Chinese medicine can balanced the PCOS patients'inner irregular environment to promote the recovery of their reproductive function.
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