益肾清热化瘀法治疗2型糖尿病合并高脂血症肾虚瘀热证的临床研究
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摘要
目的:本文主要探讨中医学对2型糖尿病合并高脂血症的认识,采用益肾清热化瘀法治疗2型糖尿病合并高脂血症。通过对江苏省中医院内分泌科患者随机对照临床试验对比,观察益肾清热化瘀法对2型糖尿病合并高脂血症肾虚瘀热证患者血糖、血脂、血粘度、超氧化物歧化酶等指标的影响,探讨其防治本病的机理。
方法:采用随机平行对照的研究方法,将符合2型糖尿病合并高脂血症的患者,随机分为治疗组和对照组。在基础治疗和西药降糖治疗的基础上,治疗组给予中药水煎剂每日1剂,分早晚两次服用,疗程8周。治疗前后两组分别评价其临床症状、体征的变化,治疗前后观测血糖、血脂、血粘度等指标。全部数据以SPSS 13.0统计软件进行统计学分析。
结果:2型糖尿病合并高脂血症患者70例随机分为2组,治疗组35例,对照组35例(后脱落4例),治疗前两组的性别、年龄、病程等基线数据经统计学处理无显著性差异,有可比性。1、对症状体征的改善作用:治疗组患者治疗后症状有明显改善,治疗组中医症状改善情况优于对照组(P＜0.01)。2、降糖效果:治疗组与对照组患者空腹血糖、餐后血糖均明显降低,与治疗前比较均有显著性差异(P＜0.01);治疗组治疗后空腹血糖改善较对照组有显著差异(P＜0.01),治疗组餐后血糖改善较对照组有差异(P＜0.05),糖化血红蛋白的改善情况无统计学意义。3、降脂效果:治疗组患者甘油三酯、低密度脂蛋白与治疗前比较均明显下降(P＜0.01),对照组患者治疗后甘油三酯水平下降(P＜0.05),治疗组总胆固醇的改善情况优于对照组(P＜0.01)。4、改善血液流变学:治疗组患者纤维蛋白原与治疗前比较明显下降(P＜0.05)。治疗组血粘度、纤维蛋白原的改善情况优于对照组(P＜0.05)。5、清除氧自由基效果:治疗组患者SOD明显升高,与治疗前比较有差异(P＜0.05)。6、胰岛素指数:治疗组LN HOMA-IR与治疗前相比显著改善(P＜0.01),与对照组比较有统计学意义(P＜0.05)。治疗后两组LN HOMA-β与治疗前相比均有明显改善(P＜0.01),但组间比较无统计学差异。7、安全性指标:治疗组患者肝肾功能检查均在正常范围。对照组有4例患者出现轻度肝功能异常,退出试验。
结论:从初步临床研究来看,西药治疗合用益肾清热化瘀法效果优于单纯西药治疗,中药治疗既可改善2型糖尿病合并高脂血症患者的临床症状,降低血糖、血脂、改善血液流变学及清除氧自由基等,且安全、有效,具有广泛的应用前景,值得进一步深入研究。但因本研究周期较短,临床资料样本偏小,确切疗效仍需进一步大样本、长周期、多中心观察。
Purpose:To discuss the understanding of traditional Chinese medicine about type 2 diabetes with hypertension,using the therapy of tonifying kidney,clearing heat and removing stasis to treat type 2 diabetes with hyperlipidemia. To observe the therapeutic efficacy of this method in treating type 2 diabetes with hyperlipidemia by the indexes such as blood glucose,blood fat,haemorheology, superoxide dismutase.
Methods: A randomized, controlled trial was conducted. The patients of type 2 diabetes with hypertention were randomly classified into two groups. On the basic of normal treatment and western medicine,the patients of treated group were treated by Chinese medicine while the patients of controlled group were not. Eight weeks was a course of treatment. The observed indexes included curative effect indexes, such as clinic symptoms, blood glucose, blood fat, haemorheology, superoxide dismutase and so on.The complete data carries on statistics analysis by the SPSS13.0 statistics software.
Results: The diagnosis and included type 2 diabetic patients with 70 cases. 35 cases of treated group, while 35 cases of controlled group (lost 4 cases ) . Prior treatment ,the gender,age,course of disease of the two groups patients had no differeces. 1.Symptoms and signs improvement: the treated group after treatment had a significant improvement. The symptoms improvement of the treated group was better than the controlled group (P <0.01).2.Blood glucose: the FBG,PBG of treated group and controlled group were significantly lowered(P <0.01); After treatment, the FBG of the treated group had a significantly difference than controlled group(P <0.01).The PBG of treated group also had a difference than controlled group (P <0.05),while the improvement of HbA1c had no statistical significance.3. Blood fat: Compared with pre-treatment, in the treated group patients' TG,LDL-C was obviously lowered (P<0.01). The controlled group patients' TG was lowered(P<0.05).The improvement of treated group patients' TC was better than the controlled one (P<0.01).4.Haemorheology:The FIB of treated group was lowered than pretherapy(P<0.05). The improvement of treated group patients' blood viscosity and FIB was better than controlled group(P<0.05).5.SOD:The treated group patients' SOD advanced than pretherapy.6.Insulin index number:The LN HOMA-IR of treated group improved(P<0.01),which was better than the controlled group. After treatment,LN HOMA-8 of two groups improved,but which had no statistical significance between the two groups.7.Safety indicators: the liver and kidney function tests of treated group were within the normal range. 4 patients of controlled group had slightly dysfunction of liver and exited the test.
Conclusion: Through the preliminary clinical study, Chinese medicine of method in has sure curative effected in treating type 2 diabetes with hyperlipidemia. It is worth studying deeply and developing further.
方法:采用随机平行对照的研究方法,将符合2型糖尿病合并高脂血症的患者,随机分为治疗组和对照组。在基础治疗和西药降糖治疗的基础上,治疗组给予中药水煎剂每日1剂,分早晚两次服用,疗程8周。治疗前后两组分别评价其临床症状、体征的变化,治疗前后观测血糖、血脂、血粘度等指标。全部数据以SPSS 13.0统计软件进行统计学分析。
结果:2型糖尿病合并高脂血症患者70例随机分为2组,治疗组35例,对照组35例(后脱落4例),治疗前两组的性别、年龄、病程等基线数据经统计学处理无显著性差异,有可比性。1、对症状体征的改善作用:治疗组患者治疗后症状有明显改善,治疗组中医症状改善情况优于对照组(P＜0.01)。2、降糖效果:治疗组与对照组患者空腹血糖、餐后血糖均明显降低,与治疗前比较均有显著性差异(P＜0.01);治疗组治疗后空腹血糖改善较对照组有显著差异(P＜0.01),治疗组餐后血糖改善较对照组有差异(P＜0.05),糖化血红蛋白的改善情况无统计学意义。3、降脂效果:治疗组患者甘油三酯、低密度脂蛋白与治疗前比较均明显下降(P＜0.01),对照组患者治疗后甘油三酯水平下降(P＜0.05),治疗组总胆固醇的改善情况优于对照组(P＜0.01)。4、改善血液流变学:治疗组患者纤维蛋白原与治疗前比较明显下降(P＜0.05)。治疗组血粘度、纤维蛋白原的改善情况优于对照组(P＜0.05)。5、清除氧自由基效果:治疗组患者SOD明显升高,与治疗前比较有差异(P＜0.05)。6、胰岛素指数:治疗组LN HOMA-IR与治疗前相比显著改善(P＜0.01),与对照组比较有统计学意义(P＜0.05)。治疗后两组LN HOMA-β与治疗前相比均有明显改善(P＜0.01),但组间比较无统计学差异。7、安全性指标:治疗组患者肝肾功能检查均在正常范围。对照组有4例患者出现轻度肝功能异常,退出试验。
结论:从初步临床研究来看,西药治疗合用益肾清热化瘀法效果优于单纯西药治疗,中药治疗既可改善2型糖尿病合并高脂血症患者的临床症状,降低血糖、血脂、改善血液流变学及清除氧自由基等,且安全、有效,具有广泛的应用前景,值得进一步深入研究。但因本研究周期较短,临床资料样本偏小,确切疗效仍需进一步大样本、长周期、多中心观察。
Purpose:To discuss the understanding of traditional Chinese medicine about type 2 diabetes with hypertension,using the therapy of tonifying kidney,clearing heat and removing stasis to treat type 2 diabetes with hyperlipidemia. To observe the therapeutic efficacy of this method in treating type 2 diabetes with hyperlipidemia by the indexes such as blood glucose,blood fat,haemorheology, superoxide dismutase.
Methods: A randomized, controlled trial was conducted. The patients of type 2 diabetes with hypertention were randomly classified into two groups. On the basic of normal treatment and western medicine,the patients of treated group were treated by Chinese medicine while the patients of controlled group were not. Eight weeks was a course of treatment. The observed indexes included curative effect indexes, such as clinic symptoms, blood glucose, blood fat, haemorheology, superoxide dismutase and so on.The complete data carries on statistics analysis by the SPSS13.0 statistics software.
Results: The diagnosis and included type 2 diabetic patients with 70 cases. 35 cases of treated group, while 35 cases of controlled group (lost 4 cases ) . Prior treatment ,the gender,age,course of disease of the two groups patients had no differeces. 1.Symptoms and signs improvement: the treated group after treatment had a significant improvement. The symptoms improvement of the treated group was better than the controlled group (P <0.01).2.Blood glucose: the FBG,PBG of treated group and controlled group were significantly lowered(P <0.01); After treatment, the FBG of the treated group had a significantly difference than controlled group(P <0.01).The PBG of treated group also had a difference than controlled group (P <0.05),while the improvement of HbA1c had no statistical significance.3. Blood fat: Compared with pre-treatment, in the treated group patients' TG,LDL-C was obviously lowered (P<0.01). The controlled group patients' TG was lowered(P<0.05).The improvement of treated group patients' TC was better than the controlled one (P<0.01).4.Haemorheology:The FIB of treated group was lowered than pretherapy(P<0.05). The improvement of treated group patients' blood viscosity and FIB was better than controlled group(P<0.05).5.SOD:The treated group patients' SOD advanced than pretherapy.6.Insulin index number:The LN HOMA-IR of treated group improved(P<0.01),which was better than the controlled group. After treatment,LN HOMA-8 of two groups improved,but which had no statistical significance between the two groups.7.Safety indicators: the liver and kidney function tests of treated group were within the normal range. 4 patients of controlled group had slightly dysfunction of liver and exited the test.
Conclusion: Through the preliminary clinical study, Chinese medicine of method in has sure curative effected in treating type 2 diabetes with hyperlipidemia. It is worth studying deeply and developing further.
引文
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