Effect of Modified Yuquanwan Combined with Taohong Siwutang on Major Cardiovascular Risk Factors of Patients with Type 2 Diabetes

Yan-hong LI; Yan LI; Ya-lan WANG; Li ZHEN; Li LI

doi:10.13422/j.cnki.syfjx.20200233

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Effect of Modified Yuquanwan Combined with Taohong Siwutang on Major Cardiovascular Risk Factors of Patients with Type 2 Diabetes

Clinic | 更新时间：2020-09-16

- Effect of Modified Yuquanwan Combined with Taohong Siwutang on Major Cardiovascular Risk Factors of Patients with Type 2 Diabetes
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 26, Issue 19, Pages: 177-182(2020)
- 作者机构：
  
  武汉市武昌医院（武汉科技大学附属武昌医院），武汉 430063
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.20200233
  CLC： R287;R22;R24
- Received：29 October 2019，
  
  Published Online：26 November 2019，
  
  Published：05 October 2020
- 稿件说明：
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李艳红,黎艳,王亚兰等.玉泉丸合桃红四物汤加减对气阴两虚证2型糖尿病心血管主要危险因素的影响[J].中国实验方剂学杂志,2020,26(19):177-182.

LI Yan-hong,LI Yan,WANG Ya-lan,et al.Effect of Modified Yuquanwan Combined with Taohong Siwutang on Major Cardiovascular Risk Factors of Patients with Type 2 Diabetes[J].Chinese Journal of Experimental Traditional Medical Formulae,2020,26(19):177-182.
李艳红,黎艳,王亚兰等.玉泉丸合桃红四物汤加减对气阴两虚证2型糖尿病心血管主要危险因素的影响[J].中国实验方剂学杂志,2020,26(19):177-182. DOI： 10.13422/j.cnki.syfjx.20200233.

LI Yan-hong,LI Yan,WANG Ya-lan,et al.Effect of Modified Yuquanwan Combined with Taohong Siwutang on Major Cardiovascular Risk Factors of Patients with Type 2 Diabetes[J].Chinese Journal of Experimental Traditional Medical Formulae,2020,26(19):177-182. DOI： 10.13422/j.cnki.syfjx.20200233.

摘要

目的

观察玉泉丸合桃红四物汤加减对气阴两虚证2型糖尿病（T2DM）心血管主要危险因素的影响及对炎症因子和血管内皮功能的作用。

方法

将160例患者随机分为对照组和观察组各80例。两组均口服拜阿司匹林肠溶片，0.1 g/次，1次/d；注射用胰岛素或口服降糖药；口服辛伐他汀片，20 mg/次，1次/d；厄贝沙坦片，150 mg/次，1次/d。对照组加用天芪降糖胶囊，5粒/次，3次/d。观察组内服玉泉丸合桃红四物汤加减，1剂/d。两组患者均连续治疗24周，再进行48周随访。监测血糖、血脂和血压，空腹血糖（FPG），餐后2 h血糖（2 h PG），糖化血红蛋白（HbA1c），观察组收缩压（SBP），舒张压（DBP），每8周评价1次，记录治疗后8，16，24周的FPG，HbA1c，LDL-C，SBP和DBP的达标情况及三者联合达标情况，并比较不同时点血糖、血脂和血压水平；记录治疗期间和随访期间共72周内心血管事件、脑卒中事件、周围血管事件和微血管并发症的发生情况；检测治疗前后肿瘤坏死因子-

(TNF-

)，同型半胱氨酸(Hcy)，白细胞介素-6(IL-6)，超敏C反应蛋白(hs-CRP)，内皮素(ET-1)和一氧化氮(NO)；记录治疗后8，16，24周体质量指数（BMI）达标率。

结果

在治疗后24周，观察组HbA1c达标率为81.16%（56/69），高于对照组的64.71%（44/68）（

=4.701，

0.05），观察组SBP达标率为94.2%（65/69），高于对照组的82.36%（56/68）（

=4.662，

0.05）；在治疗后16，24周观察组LDL-C达标率分别为79.71%（55/69），88.41%（61/69），高于同期对照组的63.24%（43/68），70.59%（48/68）（

=4.5642，

=5.108，

0.05）；在16周时，观察组综合达标率（血糖、血压、血脂）为59.42%，高于对照组的41.18%（28/68）（

＝4.559，

0.05）；在24周时，观察组综合达标率69.57%（48/69），高于对照组的51.47%（35/68）（

=4.695，

0.05）；在16周时，观察组BMI达标率为60.87%（42/69），高于对照组的39.71%（27/68）（

=6.136，

0.05）；在24周时，观察组BMI达标率为72.46%（56/69），高于对照组的52.94%（36/68）（

=5.585，

0.05）；在治疗后16周，观察组2 h PG和HbA1c水平低于对照组（

0.05）；在治疗后24周，观察组FPG，2 h PG，HbA1c，SBP和DBP水平均低于对照组（

0.05）；观察组TNF-

，Hcy，IL-6和hs-CRP水平均低于对照组（

0.01）；观察组NO高于对照组（

0.01），ET-1均低于对照组（

0.01）；在72周的观察期间，观察组不良血管事件的发生为13.04%（9/69），低于对照组的30.88%（21/68）（

=5.957，

0.05）。

结论

在常规西医治疗的基础上，玉泉丸合桃红四物汤内服可进一步控制T2DM患者心血管主要危险因素，改善T2DM患者血管内皮功能，抑制促炎因子的表达，降低不良血管事件的发生。

Abstract

Objective

To observe the efficacy of modified Yuquanwan combined with Taohong Siwutang on major cardiovascular risk factors of type 2 diabetes and its effect on inflammatory factors and endothelial function.

Method

One hundred and sixty patients were randomly divided into control group (80 cases) and observation group (80 cases) by random number table. The control group was given Tianqi Jiangtang capsule 5 tablets/time

3 times/day. Bothgroups were taken orally. aspirin enteric-coated tablets

0.1 g/time

1 time/day

insulin for injection or oral antidiabetic

simvastatin tablets

20 mg/time

1 time/day

and irbesartan tablets

150 mg/time

1 time/day.patients in observation group were added with modified Yuquanwan combined with Taohong Siwutang for 24 weeks

1 dose/day

and a 48-week follow-up visit were paid. Blood glucose

lipid

blood pressure

fasting plasma glucose (FPG)

blood sugar 2 h after meal (2 h PG)

glycosylated hemoglobin (HbA1c)

systolic (SBP) and diastolic pressure (DBP) were detected for every 8 weeks

and at the 8

and 24

week after treatment

up-to-standard HbA1c

LDL-C

SBP

DBP and all of those indexes were recorded

and levels of blood glucose

lipids and blood pressure were compared at different time points. During the treatment and within the 72-week follow-up

cardiovascular events

stroke events

peripheral vascular events and microvascular complications were recorded. And levels of tumor necrosis factor-

(TNF-

)

homocysteine (Hcy)

interleukin-6 (IL-6)

hypersensitive C-reactive protein (hs-CRP)

endothelin (ET-1) and nitric oxide (NO) were detected

and at the 8

and 24

week after treatment

body mass index (BMI) was recorded.

Result

At the 24

week after treatment

the compliance rate of HbA1c in observation group was 81.16%（56/69）

which was higher than 64.71%（44/68） in control group (

=4.701

0.05)

and the compliance rate of SBP was 94.2%（65/69）

which was higher than 82.36%（56/68） in control group (

=4.662

0.05). At the 16

week and 24

week after treatment

the compliance rate of LDL-C were 79.71%（55/69） and 88.41%（61/69）

which were higher than 63.24%（43/68） and 70.59%（48/68） in control group (

=4.5642

=5.108

0.05). At the 16

week

the comprehensive compliance rate (blood glucose

blood pressure

blood lipid) in observation group was 59.42%（41/49）

which was higher than 41.18% （28/68） in control group (

=4.559

0.05). At the 24

week

the comprehensive compliance rate in observation group was 69.57% （48/69）

which was higher than 51.47% （36/68） in control group (

=4.695

0.05). At the 16

week

the compliance rate of BMI was 60.87% （42/69）

which was higher than 39.71% （27/68）in control group (

=6.136

0.05). At the 24

week

the compliance rate of BMI was 72.46% （50/69）

which was higher than 52.94% （36/68） in control group (

=5.585

0.05). At the 16

week after treatment

levels of 2 h PG and HbA1cin observation group were lower than those in control group (

0.05). At the 24

week after treatment

levels of FPG

2 hPG

HbA1c

SBP and DBP were lower than those in control group (

0.05). Levels of TNF-

Hcy

IL-6

hs-CRP and ET-1 were lower than those in control group (

0.01)

while level of NO was higher than that in control group (

0.01). During 72 weeks of observation period

the rate of adverse vascular events in observation group was 13.04%(9/69)

which was lower than 30.88%(21/68) in control group (

=5.957

0.05).

Conclusion

In addition to the conventional western medicine therapy

modified Yuquanwan combined with Taohong Siwutang can further control the main cardiovascular risk factors of patients with T2DM

improve the endothelial function of T2DM patients

inhibit the expression of pro-inflammatory factors

and reduce the incidence of adverse vascular events.

关键词

Keywords

references

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