舒和胶囊治疗糖耐量低减的临床研究
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摘要
目的:本课题拟通过观察治疗前后体质改善情况及空腹血糖,餐后两小时血糖(口服75G无水葡萄糖后),空腹胰岛素,餐后两小时胰岛素(口服75G无水葡萄糖后),胰岛素敏感指数,血脂等指标,并从中医临床角度研究糖耐量低减(IGT)向糖尿病演变规律,初步探讨以清热化浊为治法的中药制剂舒和胶囊对改善IGT作用的可能机理,以及糖代谢调节与血脂、肥胖、血压等其他危险因素之间的变化规律的中医认识。
方法:以前瞻性的随机单盲对照法进行临床研究。观察门诊病例20例,住院病例20例,共40例,简单随机分配到试验组20例,对照组20例,并设立严格的诊断标准、纳入标准、排除标准。:治疗组:服用舒和胶囊4糊次,2次/日,连续服药3个疗程,30天为一个疗程。对照组:服用阿卡波糖(拜糖平),50mg,3次/日,餐中服用,连续服药3个疗程,30天为一个疗程。设计观察表记录试验前后患者体质改善情况、实验室检查指标,将临床所得资料结果输入电脑,建立数据库,进行数据管理,应用简明软件进行资料的统计分析,统计方法分类资料用X~2检验、多组均数比较用ANOVA(方差分析),并对不良事件,不良反应详细记录。
结果:治疗组患者经舒和胶囊治疗3月后,中医总体疗效较对照组明显改善,总有效率为90%。各个临床症状体症有显著改善,其中临床痊愈率为37.5%,有效率为46.4%总有效率83.9%;对照组患者经治疗3个月后,对症状体征的改善总有效率为55%:其中临床痊愈率30.4%,有效率为41.9%,总有效率为72.3%。组间对比表明,治疗组对糖耐量异常体质偏湿偏热患者的口中感觉、口气轻重、饮食偏嗜、大小便情况、精神状态、胃肠情况以及舌脉等的治疗作用明显优于对照组,经统计学处理,有显著性差异(P＜0.01)。治疗组与对照组经治疗后血糖均有改善,与治疗前比较,有显著性差异(P＜0.05-0.01),但是舒和胶囊治疗3月后P2HBG下降较对照组显著(P＜0.05,~(△△)P＜0.01);治疗组与对照组治疗后比较亦有显著性差异,与对照组比较,舒和胶囊对P2HBG的改善更为显著(P＜0.05);治疗组对血糖改善有效率明显高于对照组(P=0.0386＜0.05)。说明舒和胶囊单药治疗对糖耐量异常体质偏湿偏热患者血糖有良好的改善作用。在糖化血红蛋白、体重指数、腰臀比、CRP、ESR、UA方面,两组比较差异亦有显著性意义(P＜0.05),治疗组疗效优于对照组。
结论:证明舒和胶囊治疗糖耐量低减有较好的临床疗效,有力驳斥以往对于中药在改善患者实验室指标方面的缺陷,证明了中药辨证治疗有效性;本研究采用单一中药制剂治疗IGT,与西药治疗效果进行对比,不同于以往联合西药进行对照研究,避免了亦中亦西治疗可能引起的副作用;中医中药有降糖,调脂,减肥,降压及改善胰岛素抵抗等作用,西药的治疗虽能取得良好的效果,但其本身也可引起代谢紊乱,且副作用较大,针对性单一。中药作用靶点多,耐受性好,克服了西药的单一性引起的毒副作用。所以正确运用中医辩证治疗糖耐量异常是有很大的前景。
Objective:This subject to be observed before and after treatment through physical improvements and fasting blood glucose,two-hour postprandial bl ood glucose(oral glucose after anhydrous 75G),fasting insulin,two-hour postprandial insulin(after oral glucose anhydrous 75G),insulin sensiti vity index,blood lipids,such as indicators and clinical point of view from impaired glucose tolerance(IGT) to diabetes evolution,in order to Qingre Huazhuo preliminary study for the treatment of traditional Chinese medicine Shuhe capsule' s formulations to improve the role of the possibl e mechanism of IGT,as well as the regulation of glucose metabolism and b lood lipids,obesity,blood pressure and other risk factors for changes i n the law between the understanding of Chinese medicine.
Methods:A prospective randomized single-blind clinical study of the control method.Observation of 20 cases of out-patientcases,20 cases of hospitalized patients,a total of 40 cases,a simple test group were randomly assigned to 20 cases,20 cases of the control group and the establishment of strict diagnostic criteria,inclusion criteria,exclusion criteria.:Treatment group:taking capsule of Shuhe,4 capsules / time,2 times / day,for taking three courses,a course for 30 days.Control group:taking acarbose(acarbose), 50mg,3 times / day,taking meals in a row taking three courses,a course for 30 days.Designed to observe patients before and after the test form of physical records to improve the situation,laboratory indicators,the information the results of clinical input into the computer,the establishment of databases, data management,application software for simple statistical data analysis, statistical methods of information classification test using X~2,multi-group are few compared with ANOVA(analysis of variance),and adverse events,a detailed record of adverse reactions.
Results:The treatment group patients treated by capsule of Shuhe in March, the overall effect of Chinese medicine than in the control group improved significantly,with a total effective rate was 90%.Clinical symptoms in all patients with significant physical improvements,the clinical cure rate was 37.5%,46.4%effective rate was 83.9 percent overall efficiency;the control group patients were treated three months later,symptoms and signs of improvement in overall response rate was 55%:of which 30.4%clinical cure rate,effective rate was 41.9%,total effective rate was 72.3%,respectively. Inter-group comparison showed that the treatment group on the physical side impaired glucose tolerance in patients with the wet side of the mouth feel hot,the tone light and heavy,restaurants partial Anopheles,toilet cases, mental status,gastrointestinal,as well as the treatment of the tongue,such as the role of the pulse is better than the control group After statistical processing,were significantly different(P＜0.01).Treatment group and control group after treatment there was some improvement in blood glucose, compared with before treatment,the difference was significant(P＜0.05-0.01), but capsule of Shuhe' s P2HBG treatment in March after declining significantly over the control group(~ΔP＜0.05,~(ΔΔ)P＜0.01);0.01);the treatment group and control group after treatment compared also significant differences,compared with the control group,capsule of Shuhe of P2HBG more significant improvement(*P＜0.05);the treatment group to improve the efficiency of glucose significantly higher(P=0.0386＜0.05).capsule of Shuhe that single-drug therapy on the physical side impaired glucose tolerance in patients with wet heat partial improvement in blood sugar have a good role. In glycosylated hemoglobin,body mass index,waist-hip ratiO,CRP,ESR,UA, the difference between the two groups is also significant(P＜0.05),efficacy of the treatment group than the control group.
Oonclusion:Capsule of Shuhe in the treatment of impaired glucose tolerance have a better clinical efficacy,to refute the past,Chinese medicine in improving laboratory indicators in patients with deficiencies in the treatment of proven effectiveness of traditional Chinese medicine differentiation;In this study,a single treatment of Traditional Chinese Medicine IGT,and compared the effects of western medicine,western medicine is different from the previous joint-control study carried out to avoid the West also in therapy also may cause side-effects;Chinese medicine have hypoglycemic,lipid,weight, blood pressure and improve insulin resistance,such as the role of Western Although treatment can achieve good results,but also can cause metabolic disorders,and side effects,targeted single.Chinese targets,and tolerance, and unity to overcome the Western side effects caused.Therefore,the correct use of Chinese medicine treatment of impaired glucose tolerance dialectical there are a lot of prospects.
方法:以前瞻性的随机单盲对照法进行临床研究。观察门诊病例20例,住院病例20例,共40例,简单随机分配到试验组20例,对照组20例,并设立严格的诊断标准、纳入标准、排除标准。:治疗组:服用舒和胶囊4糊次,2次/日,连续服药3个疗程,30天为一个疗程。对照组:服用阿卡波糖(拜糖平),50mg,3次/日,餐中服用,连续服药3个疗程,30天为一个疗程。设计观察表记录试验前后患者体质改善情况、实验室检查指标,将临床所得资料结果输入电脑,建立数据库,进行数据管理,应用简明软件进行资料的统计分析,统计方法分类资料用X~2检验、多组均数比较用ANOVA(方差分析),并对不良事件,不良反应详细记录。
结果:治疗组患者经舒和胶囊治疗3月后,中医总体疗效较对照组明显改善,总有效率为90%。各个临床症状体症有显著改善,其中临床痊愈率为37.5%,有效率为46.4%总有效率83.9%;对照组患者经治疗3个月后,对症状体征的改善总有效率为55%:其中临床痊愈率30.4%,有效率为41.9%,总有效率为72.3%。组间对比表明,治疗组对糖耐量异常体质偏湿偏热患者的口中感觉、口气轻重、饮食偏嗜、大小便情况、精神状态、胃肠情况以及舌脉等的治疗作用明显优于对照组,经统计学处理,有显著性差异(P＜0.01)。治疗组与对照组经治疗后血糖均有改善,与治疗前比较,有显著性差异(P＜0.05-0.01),但是舒和胶囊治疗3月后P2HBG下降较对照组显著(P＜0.05,~(△△)P＜0.01);治疗组与对照组治疗后比较亦有显著性差异,与对照组比较,舒和胶囊对P2HBG的改善更为显著(P＜0.05);治疗组对血糖改善有效率明显高于对照组(P=0.0386＜0.05)。说明舒和胶囊单药治疗对糖耐量异常体质偏湿偏热患者血糖有良好的改善作用。在糖化血红蛋白、体重指数、腰臀比、CRP、ESR、UA方面,两组比较差异亦有显著性意义(P＜0.05),治疗组疗效优于对照组。
结论:证明舒和胶囊治疗糖耐量低减有较好的临床疗效,有力驳斥以往对于中药在改善患者实验室指标方面的缺陷,证明了中药辨证治疗有效性;本研究采用单一中药制剂治疗IGT,与西药治疗效果进行对比,不同于以往联合西药进行对照研究,避免了亦中亦西治疗可能引起的副作用;中医中药有降糖,调脂,减肥,降压及改善胰岛素抵抗等作用,西药的治疗虽能取得良好的效果,但其本身也可引起代谢紊乱,且副作用较大,针对性单一。中药作用靶点多,耐受性好,克服了西药的单一性引起的毒副作用。所以正确运用中医辩证治疗糖耐量异常是有很大的前景。
Objective:This subject to be observed before and after treatment through physical improvements and fasting blood glucose,two-hour postprandial bl ood glucose(oral glucose after anhydrous 75G),fasting insulin,two-hour postprandial insulin(after oral glucose anhydrous 75G),insulin sensiti vity index,blood lipids,such as indicators and clinical point of view from impaired glucose tolerance(IGT) to diabetes evolution,in order to Qingre Huazhuo preliminary study for the treatment of traditional Chinese medicine Shuhe capsule' s formulations to improve the role of the possibl e mechanism of IGT,as well as the regulation of glucose metabolism and b lood lipids,obesity,blood pressure and other risk factors for changes i n the law between the understanding of Chinese medicine.
Methods:A prospective randomized single-blind clinical study of the control method.Observation of 20 cases of out-patientcases,20 cases of hospitalized patients,a total of 40 cases,a simple test group were randomly assigned to 20 cases,20 cases of the control group and the establishment of strict diagnostic criteria,inclusion criteria,exclusion criteria.:Treatment group:taking capsule of Shuhe,4 capsules / time,2 times / day,for taking three courses,a course for 30 days.Control group:taking acarbose(acarbose), 50mg,3 times / day,taking meals in a row taking three courses,a course for 30 days.Designed to observe patients before and after the test form of physical records to improve the situation,laboratory indicators,the information the results of clinical input into the computer,the establishment of databases, data management,application software for simple statistical data analysis, statistical methods of information classification test using X~2,multi-group are few compared with ANOVA(analysis of variance),and adverse events,a detailed record of adverse reactions.
Results:The treatment group patients treated by capsule of Shuhe in March, the overall effect of Chinese medicine than in the control group improved significantly,with a total effective rate was 90%.Clinical symptoms in all patients with significant physical improvements,the clinical cure rate was 37.5%,46.4%effective rate was 83.9 percent overall efficiency;the control group patients were treated three months later,symptoms and signs of improvement in overall response rate was 55%:of which 30.4%clinical cure rate,effective rate was 41.9%,total effective rate was 72.3%,respectively. Inter-group comparison showed that the treatment group on the physical side impaired glucose tolerance in patients with the wet side of the mouth feel hot,the tone light and heavy,restaurants partial Anopheles,toilet cases, mental status,gastrointestinal,as well as the treatment of the tongue,such as the role of the pulse is better than the control group After statistical processing,were significantly different(P＜0.01).Treatment group and control group after treatment there was some improvement in blood glucose, compared with before treatment,the difference was significant(P＜0.05-0.01), but capsule of Shuhe' s P2HBG treatment in March after declining significantly over the control group(~ΔP＜0.05,~(ΔΔ)P＜0.01);0.01);the treatment group and control group after treatment compared also significant differences,compared with the control group,capsule of Shuhe of P2HBG more significant improvement(*P＜0.05);the treatment group to improve the efficiency of glucose significantly higher(P=0.0386＜0.05).capsule of Shuhe that single-drug therapy on the physical side impaired glucose tolerance in patients with wet heat partial improvement in blood sugar have a good role. In glycosylated hemoglobin,body mass index,waist-hip ratiO,CRP,ESR,UA, the difference between the two groups is also significant(P＜0.05),efficacy of the treatment group than the control group.
Oonclusion:Capsule of Shuhe in the treatment of impaired glucose tolerance have a better clinical efficacy,to refute the past,Chinese medicine in improving laboratory indicators in patients with deficiencies in the treatment of proven effectiveness of traditional Chinese medicine differentiation;In this study,a single treatment of Traditional Chinese Medicine IGT,and compared the effects of western medicine,western medicine is different from the previous joint-control study carried out to avoid the West also in therapy also may cause side-effects;Chinese medicine have hypoglycemic,lipid,weight, blood pressure and improve insulin resistance,such as the role of Western Although treatment can achieve good results,but also can cause metabolic disorders,and side effects,targeted single.Chinese targets,and tolerance, and unity to overcome the Western side effects caused.Therefore,the correct use of Chinese medicine treatment of impaired glucose tolerance dialectical there are a lot of prospects.
引文
[1]刘铜华.中医药防治糖耐量异常的思路与方法[J].国际中医中药杂志,2006;28(5):313-316.
[2]吕雄,张芸.中医药防治代谢综合征研究进展[J].中国中医急症,2007;16(10):1253-1254.
[3]吕雄,卢洪梅.糖耐量异常的中医药诊治概况[J].国医论坛,2007;650-52.
[4]姬厚民.七味白术散加芍药甘草汤治疗糖耐量减低患者31例疗效观察[J].中华实用医药杂志,2002;2(15):1395.
[5]陈刚.健脾逆瘅汤治疗糖耐量减低48例[J].四川中医,2001;19(11):43.
[6]陈霞波.糖耐量低减与脾不散精[J].浙江中医杂志,2005;3:118-119.
[7]樊敬波,王纯,张中申.中药治疗糖耐量异常的临床观察[J].衡阳医学学报,2000;28(5):493.
[8]刘得华.健脾散精汤治疗葡萄糖耐量减低31例[J].新中医,2001;33(2):59-60.
[9]吕雄,邱联群,张芸.舒正颗粒联合降糖西药治疗糖尿病并发冠心病30例临床观察[J].新中医,2006;38(8):44-45.
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[14]戴芳芳.克糖宁颗粒对糖耐量低减干预治疗的观察[J].中国基础与临床医学杂志,2002;1(1):56-58.
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[2]吕雄,张芸.中医药防治代谢综合征研究进展[J].中国中医急症,2007;16(10):1253-1254.
[3]吕雄,卢洪梅.糖耐量异常的中医药诊治概况[J].国医论坛,2007;650-52.
[4]姬厚民.七味白术散加芍药甘草汤治疗糖耐量减低患者31例疗效观察[J].中华实用医药杂志,2002;2(15):1395.
[5]陈刚.健脾逆瘅汤治疗糖耐量减低48例[J].四川中医,2001;19(11):43.
[6]陈霞波.糖耐量低减与脾不散精[J].浙江中医杂志,2005;3:118-119.
[7]樊敬波,王纯,张中申.中药治疗糖耐量异常的临床观察[J].衡阳医学学报,2000;28(5):493.
[8]刘得华.健脾散精汤治疗葡萄糖耐量减低31例[J].新中医,2001;33(2):59-60.
[9]吕雄,邱联群,张芸.舒正颗粒联合降糖西药治疗糖尿病并发冠心病30例临床观察[J].新中医,2006;38(8):44-45.
[10]周卓宁.自拟花芪降糖方干预糖耐量异常疗效观察[J].广西中医药,2001;24(6)13-15.
[11]曾永红,陈凡,王育珊等.中西医结合防治糖耐量异常及轻型糖尿病疗效观察[J].中国中西医结合脾胃杂志,2000;8(4):196-198.
[12]何颖.中药改善中老年IGT并脂代谢异常[J].长治医学院学报,2000;14,2:138-139.
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