【作者】 刘素贞；

【导师】 许丽绵；

【作者基本信息】 广州中医药大学 ， 中医妇科学， 2012， 硕士

【摘要】 目的：本研究主要探讨左归丸加减治疗肝肾阴虚型绝经前后诸证的临床疗效。绝经前后诸证临床以肝肾阴虚型为多见,本临床研究选用左归丸加减经行治疗,并与穴位注射当归注射液配五味子注射液行进行对照研究。进而观察左归丸加减在治疗肝肾阴虚型绝经前后诸证的临床疗效,并初步探讨其作用机理。方法：研究对象为肝肾阴虚型绝经前后诸证的患者。将符合纳入标准的60例肝肾阴虚型绝经前后诸证患者随机分为治疗组和对照组,其中治疗组30例,治疗上给予中药左归丸加减口服,对照组30例予当归注射液配五味子注射液行穴位注射。治疗组：方药以左归丸加减,药物组成(基本方)：熟地24g,山萸肉、山药、柴胡各12g,枸杞子15g,菟丝子、鹿角胶、龟板胶、牛膝、桂圆肉、当归各10g,柏子仁20g,砂仁6g。失眠多梦加炒酸枣仁30g；伴有心悸多汗者加煅龙骨30g,牡蛎30g；眼睑及下肢浮肿者加茯苓10g,泽泻10g；腰膝痛甚者加杜仲10g,牛膝15g。上药水煎服,每日1剂,分2次服,10天为1疗程,3个疗程后统计疗效。对照组：以当归注射液配五味子注射液行穴位注射。10天为一个疗程,连续观察三个疗程；治疗结束后,观察两组用药前后主要症状的改善情况,依据制定的症候观察评分表,统一评分,计算治疗前后的总分值变化,并从血、尿、大便常规、心电图、肝功能、肾功能方面评价其安全性。本临床研究结束之后,即将临床资料汇总,用Epi Data3.01软件建立数据库,用计算机进行数据管理,用SPSS软件进行统计分析。统计方法：分类资料用χ~2检验,等级资料用两样本比较Wilcoxon秩和检验(校正),两样本均数比较用t检验或Wilcoxon秩和检验,自身前后比较用配对t检验或Wilcoxon配对秩和检验。统计计算采用SPSS17.0统计软件完成。结果：本研究共有合格受试者60例,治疗组30例,对照组30例；其总有效率优于对照药。两组总疗效比较(P<0.05),差异有显著性意义,治疗组疗效优于对照组。治疗组痊愈率为16.67%,显效率为46.67%,有效率为30%,总有效率为93.3%；对照组痊愈率为13.33%,显效率为36.67%,有效率为36.67%,总有效率为86.67%。两组比较,差异有显著性意义。两组中医证候疗效比较,差异有显著性意义,治疗组疗效优于对照组。治疗组临床痊愈率为20%,显效率为43.33%,有效率为26.67%,总有效率为90%；对照组临床痊愈率为16.67%,显效率为43.33%,有效率为23.33%,总有效率为83.3%。两组比较,差异有显著性意义。症状积分对比：治疗组与对照组治疗后各自症状积分均有下降(P<0.01),而两组治疗前后差值对比有显著性意义(P<0.01),提示治疗组治疗后症状改善作用明显优于对照组。主要症状对比：两组治疗后潮热汗出、失眠、烦躁易怒、疲乏等主要症状均有疗效,且治疗组改善情况及疗效明显优于对照组(P<0.05)。结论：左归丸加减治疗肝肾阴虚型绝经前后诸证,可明显改善患者的主要症状,说明左归丸加减治疗绝经前后诸证具有良好的疗效,且临床应用安全。更多还原

【Abstract】 ObjectiveThe research mainly discusses the clinical curative effect of modified Kidney-yin Reinforcing Pills on various diseases around menopause due to liver and kidney yin deficiency. Clinically, syndromes around menopause are mainly due to liver and kidney yin deficiency. This research adopts Kidney-yin Reinforcing Pill for treatment. The control study takes acupoint injection of angelica injection in combination with Five Seeds Combo injection. Observe clinical curative effect of Kidney-yin Reinforcing Pills in the treatment of menopausal syndromes due to liver and kidney yin deficiency and make preliminary exploration of its mechanism.MethodsThe subjects are patients of menopausal syndromes due to liver and kidney yin deficiency. Classify the60qualified cases of patients randomly into the Treatment Group and Control Group.30cases are in the Treatment Group and take modified Kidney-yin Reinforcing pills orally.30cases are in the Control Group and take acupoint injection of angelica injection in combination with Five Seeds Combo injection. The Treatment Group:The prescription is modified Kidney-yin Reinforcing Pill. Ingredients (basic prescription):prepared rhizome of rehmannia24g, red osier12g, Chinese yam12g, radix bupleuri12g, medlar15g, dodder10g, deer-horn glue10g, tortoise plastron glue10g, radix achyranthis10g, cassia pulp10g, angelica10g, semen platycladi20g, fructus amomi6g. For insomnia, add Semen Ziziphi Spinosae30g; for palpitations and sweating, add calcined os draconis30g and oyster30g; for eyelid and lower limb swelling, add poria cocos10g and rhizome alismatis10g; for waist and knee pain, add eucommia ulmoides10g and radix achyranthis15g. Decoct in warm water and take1dose per day twice with half dose each time.10days make1treatment course. Use statistics to evaluate the curative effect. The Control Group:Conduct acupoint injection of angelica injection in combination with Five Seeds Combo injection.10days make1treatment course and observe for3consecutive courses.When the treatment finishes, observe the improvement of major symptoms before and after treatment of two groups. Evaluate with the score scale about syndrome. Calculate the total value before and after treatment and find the difference. Evaluate the safety from aspects of blood, urine and stool routines, cardiogram results, liver function and kidney function.After the clinical research, clinical material is timely summarized. Use computer for data management. Build a database with Epi Data3.01software. Use SPSS software for statistical analysis.Statistical methods:classification material is tested withx2inspection, ranked data samples are tested with Wilcoxon rank sum test (correction), and the self AP comparison is made with pairing t test or Wilcoxon pairing rank sum test. For statistics, use SPSS17.0software.ResultsThe study participants were60qualified subjects, with30cases in the Treatment Group and30in the Control Group. The total effective rate of the Treatment Group is superior to that of the control medicine.Two groups’total curative effect comparison shows significant difference, and the Treatment Group is superior to the Control Group.The Treatment Group:the full recovery rate is16.67%, the excellence rate is46.67%, the effective rate is30%, and the total effective rate is93.3%; The Control Group:the full recovery rate is13.33%, the excellence rate is36.67%, the effective rate is36.67%, and the total effective rate is86.67%. Two groups’comparison shows significant difference.Two groups’TCM syndrome curative effect comparison shows significant difference and the Treatment Group is superior to the Control Group.The Treatment Group:the clinical cure rate is20%, the excellence rate is43.33%, the effective rate is26.67%, and the total effective rate is90%; The Control Group:the clinical cure rate is16.67%, the excellence rate is43.33%, the effective rate is23.33%, and the total effective rate is83.3%. Two groups’comparison shows significant difference.Symptom score:After treatment, the Treatment Group’s and the Control Group’s respective symptom scores decreased (P<0.01). Two groups’ difference value comparison before and after treatment has significance (P <0.01), indicating that the Treatment Groups has better effect than the Control Group in improving symptoms.The main symptoms:Two groups are both effective for the treatment of major symptoms like flashing heat, insomnia, irritability and fatigue, etc. The Treatment Group has better curative effect and improvement than the Control Group (P<0.05).ConclusionUsing modified Kidney-yin Reinforcing Pills to treat menopausal syndromes of liver and kidney yin deficiency can significantly improve patients’main symptoms and clinical application safety.更多还原