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散瘀化痰综合脏腑调理乳腺增生病辨证论治优化方案的研究
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摘要
目的:优化“散瘀化痰为核心、综合脏腑调理”乳腺增生病中医辨证论治方案,临床科学验证方案的有效、可靠、安全及可行性,形成规范、易行、便于推广、广泛共识的乳腺增生病辨证论治方案。
     方法:通过回顾乳腺增生病文献,归总临床经验,数据挖掘中医辨证及用药规律,经全国知名专家论证共识,创建乳腺增生病辨证论治优化方案,形成“散瘀化痰”基本方“开郁散结颗粒”及兼脏腑调理的Ⅰ-Ⅲ号方药。在评价中医临床试验质量基础上,通过全国七个研究中心,采用大样本、随机、双盲、分层法,以2:1试验药和安慰剂两组对照,对360例乳腺增生病患者进行临床研究。通过对疼痛、肿块、主要证候、生活质量以及安全性等指标观察,介入了彩色多普勒超声检测,且首次应用生活质量评价表等进行客观疗效指标评价。并进行后期疗效随访和3个基层医院临床推广应用。
     结果:1.形成乳腺增生病“气滞血瘀、痰浊结聚为共有病因病机,肝郁脾虚、肝肾不足、冲任失调为基础病变”的辨证思路,以及“以行气活血、化痰散结治其标,疏肝理气、健脾胜湿、调摄冲任治其本”的主要治则的乳腺增生病辨证论治优化方案。2.临床研究结果:(1)两组基线情况比较无统计学差异(P>0.05),具有可比性。(2)治疗一疗程后及随访时在疼痛评分、疼痛分级、触痛评分、疼痛总积分方面,试验组低于安慰剂组,较治疗前总积分减少试验组较安慰剂组明显,两组间比较,均有统计学差异(P<0.05)。治疗4周即起效。(3)治疗一疗程后,肿块分布、大小及总积分方面,试验组低于安慰剂组,组间比较,均有统计学差异(P<0.05),随访时在肿块质地、分布、大小及总积分方面,试验组低于安慰剂组,均有统计学差异(P<0.05)。治疗8周后起效。(4)治疗一疗程后及随访时在中医证侯总积分方面,试验组低于安慰剂照,有统计学差异(P<0.05)。治疗一疗程后疗效最明显,特别在缓解胸胁胀满、烦躁易怒及腹部胀满3个方面突出。但药效持续时间不久,随访时仅在缓解腹部胀满方面有效。(5)治疗一疗程后对乳腺增生病主证总有效率63.48%,中医证侯总有效率79.13%,疾病总有效率70%,停药后随访疾病总有效率72.17%,均高于安慰剂,有统计学差异(P<0.05)。(6)治疗一疗程后3种兼证型之间在疼痛积分、肿块积分、主证疗效、疾病总疗效方面均无统计学差异(P>0.05)。(7)治疗后试验组超声积分较对照组低,较治疗前积分减少更明显,与安慰剂比较有统计学差异(P<0.05)。(8)试验组中出现4例2例次不良事件,发生率为1.66%;安慰剂组中出现2例0例次不良事件,发生率为1.66%,组间比较无统计学差异。(9)基层推广临床结果:对乳房疼痛总有效率72.86%,肿块总有效率54.29%,主证总有效率74.29%,中医证候总有效率74.29%,疾病总疗效显愈率21.43%、总有效率75.71%。
     结论:本研究最终形成了规范、易行、便于推广的散瘀化痰为核心、综合脏腑调理乳腺增生病辨证论治临床优化方案;经临床验证能减轻乳房疼痛,缓解乳房肿块及改善全身症状及超声评价,疗效优于安慰剂,药效持久,对不同兼证作用均衡,且无明显毒副作用;经基层医院临床推广,进一步验证了其有效性、安全性、基层医院的适宜性与可操作性。
Objective: Optimized solution of treating the HMG by the method of reducingphlegm and Scattering stasis as the core and synthetically conditioning function of organs.Prove the effection,reliable,secure,and the feasibility of the solution scientifically,to form astandardized,easy,broad consensus diagnosis and treatment program due to HGM.Methods:First,researched literature and evaluate the quality of clinical trials of treating HMG byTCM.then mine the law of TCM and drug in treating HMG.and sumed up our own clinicalexperience,then proposed our treatment program of HMG.Second,after several rounds ofdiscussion by experts,the optimized program formatted gradually.third, demonstrate theeffectiveness and security of the solution and Kaiyu Sanjie Particles by the method ofmultiple centers,random,double-blind,parallel control.The syudy was carried out in7research center at the same time.Take8weeks as a treatment,then tell the patient to visit usat the time of8weeks after treating,the main outcome measure include the pain,thelumps,the systemic symptoms and the ultrasongraphic.And use the evaluation of qualitylife as the objective indicator at ehe first time.Result:1.Form the dialectical thinking ofHMG:take Qi stagnation,phlegm gather for a total of etiology and pathogenesis,take liverdepression and spleen,liver and kidney deficiency,disorder of Chong and Ren as the basedlesions.at the same time, the main treatment principles is formed: take stasising phlegm asthe main treatment rule of HMG.2.The result of clinical studies:(1)There were no statisticalsignificance difference between the two groups of Kaiyu Sanjie Particles and placebo inthe aspect of basic condition(P>0.05),so these two groups are comparable.(2)There aresignificant difference between the two groups on pain score,pain grade,tendernessscore,total pain score at the time of treatment and follow-up,and the cores of experimentalgroup are all lower than the placebo group (P<0.05).(3)The difference are also significant between the two groups on mass distribution,tumor size,total mass score at the time oftreatment. There are also significant difference between the two groups not only on theaspect of all of the above,but also on mass texture at the time of follow-up,andexperimental group is superior to placebo.(4) There are significant difference between thetwo groups on the score of the main symptoms at the time of treatment and follow-up,andthe cores of experimental group are all lower than the placebo group (P<0.05).particularlyon the aspects of easing xiong xie fullness,irritability and abdominal distension.Howeverthe efficacy duration soon,at the time of follow-up,it has effection in relieving abdominalfullness.(5)For the main symptoms:the total effective rate of treatment group is63.48%.For the systemic syptoms: it is79.13%.And for the disease: after8weeks,it is70%.At the time of8weeks after treatment, the total effective rate of treatment group is72.17%.The efficacy of all of the above, the difference between the two groups issignificant (P<0.05).(6)The difference are not significant between the three type ofsyndrome on mass score,pain score, the total effective rate at the time of treatment(P>0.05).(7) There are significant difference between the two groups on the score of ultrasound atthe time of treatment,and the cores of experimental group are lower than the placebogroup,and the reducment of score is more.(P<0.05).(8)There are four cases of adversevents in the experimental goup,and that in the placebo group is two cases,the incidence ofthat in both of the two groups are1.67%,and the difference of that is not significantbetween the two groups(P>0.05).(9)The result of grass-roots promotion:On the pain, thetotal effective rate is72.86%.On the mass,it is54.29%.On the main symptoms,it is74.29%.On the systemic symptoms,it is74.29%.And on the disease,it is75.71%.
     Conclusion:optimized solution of treating the HMG by the method of reducingphlegm and Scattering stasis as the core and synthetically conditioning function of organsform at last, and it is easy,broad consensus,and can be disseminated easily.The effectiverecipe of treating HMG is founded.and and Kaiyu Sanjie Particles have better efficacy thanplacebo on reducing breast pain,alleviating breast mass and improving syatemic symptoms,ultrasound evaluation, and it has balanced effect on the three type of syndrome,but has notoxicity.ao it is suitable for clinical use.Through the promotion of grass-roots,furtherverifying it’s effection,security,operability.
引文
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