中药糖益康对葡萄糖耐量减低患者的临床干预研究
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摘要
目的:观察以益气化痰活血法为治则组成的中药糖益康结合治疗性生活方式改变对糖耐量减低患者(IGT)的临床干预疗效并探讨其作用机制。
方法:采用随机、安慰剂前瞻性平行对照的方法,将120例IGT患者随机分成治疗组(60例)和对照组(60例)。所有受试者在观察开始前均接受关于IGT方面的知识教育,并普及行为干预知识。治疗组接受行为干预加中药糖益康进行治疗,对照组接受行为干预加安慰剂进行治疗。观察时间为3个月,主要观察指标:临床症状、血糖、血脂、糖化血红蛋白、胰岛素水平、体重指数、腰臀比、炎症因子等。
结果:治疗组干预后空腹及餐后血糖、血脂、糖化血红蛋白、胰岛素水平、体重指数、腰臀比、临床症状积分等较前有明显改善,与对照组比较有显著性差异。试验期间未发现不良反应。一年后随访治疗组糖尿病转化率低于对照组。
结论:益气化痰活血法联合行为干预方式对IGT患者疗效显著,可以降糖、调脂;降低体重指数及腰臀比水平,改善胰岛素抵抗;能明显改善IGT患者的临床症状;较好地逆转IGT及延缓IGT向DM的转化进程,且用药安全,证明了中医药辨证论治的有效性,正确运用中医辩证治疗糖耐量减低具有很广阔的前景。
Objective: Study the clinical curative effect of Chinese patent drug“Tang Yi Kang”using the method of Yiqi expectorant huoxue method with combined therapy of sex way on patients with IGT and discuss the intervention mechanism.
Methods: Taking the method of randomized, placebo controlled prospective parallel, 120 patients with IGT were randomly divided into treatment group (n=60) and the control group (n=60).All the participants had received the knowledge about IGT and behavior intervention before the study.Treatment group received behavior intervention plus Tang Yi Kang treatment, and the control group received behavior intervention plus placebo treatment.Observation time last for 3 months, the main outcome measures are as follows: the clinical symptoms, the blood sugar, blood fat and glycated hemoglobin, insulin levels, body mass index, waist-hip ratios,inflammatory factor etc.
Results: The blood sugar, blood fat and glycated hemoglobin, insulin levels, body mass index, waist-hip ratios,clinical symptom of the treatment group were obviously improved, which showed significant difference from the control group.During the tests adverse reactions did not appear. And in a year later’s follow-up, diabetes conversion rate of the treatment group is lower than those of the control group.
Conclusion: The compound method of Yiqi expectorant huoxue method combined with behavior intervention has curative effect on IGT patients: decrease lipid sugar, reduce weight index and waist-hip ratios,improve the insulin resistance; the clinical symptoms of IGT can be obviously improved, the drug can be safely used and it may reverse IGT and delay the procedure of IGT-to-DM, which proved the validity of TCM treatment, and once correctly applied the TCM dialectical therapy to reduce glucose tolerance will have a broad prospect.
方法:采用随机、安慰剂前瞻性平行对照的方法,将120例IGT患者随机分成治疗组(60例)和对照组(60例)。所有受试者在观察开始前均接受关于IGT方面的知识教育,并普及行为干预知识。治疗组接受行为干预加中药糖益康进行治疗,对照组接受行为干预加安慰剂进行治疗。观察时间为3个月,主要观察指标:临床症状、血糖、血脂、糖化血红蛋白、胰岛素水平、体重指数、腰臀比、炎症因子等。
结果:治疗组干预后空腹及餐后血糖、血脂、糖化血红蛋白、胰岛素水平、体重指数、腰臀比、临床症状积分等较前有明显改善,与对照组比较有显著性差异。试验期间未发现不良反应。一年后随访治疗组糖尿病转化率低于对照组。
结论:益气化痰活血法联合行为干预方式对IGT患者疗效显著,可以降糖、调脂;降低体重指数及腰臀比水平,改善胰岛素抵抗;能明显改善IGT患者的临床症状;较好地逆转IGT及延缓IGT向DM的转化进程,且用药安全,证明了中医药辨证论治的有效性,正确运用中医辩证治疗糖耐量减低具有很广阔的前景。
Objective: Study the clinical curative effect of Chinese patent drug“Tang Yi Kang”using the method of Yiqi expectorant huoxue method with combined therapy of sex way on patients with IGT and discuss the intervention mechanism.
Methods: Taking the method of randomized, placebo controlled prospective parallel, 120 patients with IGT were randomly divided into treatment group (n=60) and the control group (n=60).All the participants had received the knowledge about IGT and behavior intervention before the study.Treatment group received behavior intervention plus Tang Yi Kang treatment, and the control group received behavior intervention plus placebo treatment.Observation time last for 3 months, the main outcome measures are as follows: the clinical symptoms, the blood sugar, blood fat and glycated hemoglobin, insulin levels, body mass index, waist-hip ratios,inflammatory factor etc.
Results: The blood sugar, blood fat and glycated hemoglobin, insulin levels, body mass index, waist-hip ratios,clinical symptom of the treatment group were obviously improved, which showed significant difference from the control group.During the tests adverse reactions did not appear. And in a year later’s follow-up, diabetes conversion rate of the treatment group is lower than those of the control group.
Conclusion: The compound method of Yiqi expectorant huoxue method combined with behavior intervention has curative effect on IGT patients: decrease lipid sugar, reduce weight index and waist-hip ratios,improve the insulin resistance; the clinical symptoms of IGT can be obviously improved, the drug can be safely used and it may reverse IGT and delay the procedure of IGT-to-DM, which proved the validity of TCM treatment, and once correctly applied the TCM dialectical therapy to reduce glucose tolerance will have a broad prospect.
引文
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