Background:Diabetic kidney disease(DKD)is a chronic renal microvascular complication associated with abnormal glucose metabolism.According to traditional Chinese medicine(TCM)theory,Qi and Yin deficiency with blood st...Background:Diabetic kidney disease(DKD)is a chronic renal microvascular complication associated with abnormal glucose metabolism.According to traditional Chinese medicine(TCM)theory,Qi and Yin deficiency with blood stasis(the name of TCM symptoms,its main clinical features are fatigue,dry mouth,red or pale tongue,weak pulse,etc.)is the primary TCM syndrome of DKD,and Qiming granule(QMG)is suitable for the treatment of Qi and Yin deficiency with blood stasis syndrome.In view of this,we designed a randomized controlled trial to assess whether QMG is efficacious and safe in treating DKD patients.Methods:This protocol is for a randomized,double-blind,placebo-controlled,parallel group,six-centre clinical trial.A total of 180 participants will be randomized into the QMG group or placebo group,with a 1:1 ratio.The study will last for 50 weeks,including a 2-week run-in period,24 weeks of intervention,and 24 weeks of follow-up.The experimental intervention will be QMG,and the control intervention will be a placebo.The primary outcome will be the 24h urinary albumin excretion ratio and the change in the albumin-to-creatinine ratio.The secondary outcome will be evaluation of renal function,fundus changes,management of blood lipids,TCM symptom improvement and safety assessments.Adverse events will be recorded during the trial.Discussion:This study is a randomized controlled trial to test the effectiveness and safety of QMG for DKD patients.The findings of this study will help to provide evidence-based recommendations in treating DKD patients.Trial registration:Chinese Clinical Trial Registry,ChiCTR-TRC-12002953.Registered 23 December 2012.展开更多
Objective:To investigate the clinical study of Qiming granule combined with compound anisodine injection in the treatment of diabetic retinopathy.Methods:104 patients with nonproliferative diabetic retinopathy admitte...Objective:To investigate the clinical study of Qiming granule combined with compound anisodine injection in the treatment of diabetic retinopathy.Methods:104 patients with nonproliferative diabetic retinopathy admitted to department of ophthalmology in Xishui Hospital Affiliated to Hubei University of science and technology from September 2016 to May 2018 were selected as the study subjects.According to the principle of treatment,they were divided into 52 cases in the control group and 52 cases in the treatment group,the clinical efficacy,blood sugar and lipid levels,hemorheological changes and adverse reactions were compared between the two groups.Results:The total effective rate difference between the treatment group(92.31%)and the control group(71.15%)was statistically significant(χ^(2)=7.792,P=0.005).After treatment,the two groups of fasting plasma glucose(FPG),hemoglobin A1c(HbA1c),total cholesterol(TC),low density lipoprotein-cholesterol(LDL-C),whole blood high-viscosity,whole blood cut viscosity,whole blood low-cut viscosity,plasma viscosity,number of microangioma and area of the hemorrhage were significantly lower than before treatment(P<0.05),and the levels of FPG,HbA1c,TC,LDL-C,whole blood highviscosity,whole blood cut viscosity,whole blood low-cut viscosity,plasma viscosity,number of microangioma and area of the hemorrhage in the treatment group were significantly lower than those in the control group(χ^(2)=0.122,P=0.727).Conclusions:Qiming granule combined with compound anisodine injection can effectively improve the clinical efficacy of patients with non-proliferative DR,and its mechanism may be related to improve blood sugar and blood lipid levels and correct blood rheology disorder,reduce microangioma and hemorrhage.It has clinical promotion significance.展开更多
Objective:To systematically evaluate the clinical efficacy of Qiming Granule combined with conventional therapy in improving diabetic nephropathy.Methods:The Chinese and English databases such as Wanfang,VIP,CNKI,PubM...Objective:To systematically evaluate the clinical efficacy of Qiming Granule combined with conventional therapy in improving diabetic nephropathy.Methods:The Chinese and English databases such as Wanfang,VIP,CNKI,PubMed,Cochrane library and Web of Science database were searched.The searching time was from the database was established to March 1,2021.The papers were screened strictly according to the inclusion and exclusion criteria.The inclusion risk assessment tool provided by the Cochrane Collaboration was used to evaluate the included literature,the data was analyzed using STATA 12.0 software.Results:Twelve papers were included,involving 1369 patients.The results of meta-analysis showed that Qiming Granule combined with conventional treatment had statistical significance in improving the clinical total effective rate[RR=1.24,95%CI(1.12,1.36)],urinary albumin excretion rate[SMD=-2.68,95%CI(-3.86,-1.50)],creatinine[SMD=-1.46,95%CI(-1.84,-1.08)],urea nitrogen[SMD=-2.61,95%CI(-3.85,-1.36)],fasting blood glucose[SMD=-1.17,95%CI(-2.03,-0.31)]and cystatin C[SMD=-3.26,95%CI(-4.65,-1.87)]of patients with diabetic nephropathy.Conclusion:The combination of conventional therapy and Qiming Granule can improve the clinical effect for diabetic nephropathy.However,due to the low level of overall literature evidence,high risk and some kind of publication bias,it still needs more high-quality and large-scale clinical studies for further verification.展开更多
目的通过观察芪明颗粒对早期糖尿病肾病中医症候、生化指标、炎症因子及尿微量白蛋白的影响,明确与缬沙坦胶囊治疗效果的一致性及差异性。方法选入符合纳入标准的早期糖尿病肾病患者130例,采用简单数字表的随机方法分为治疗组65例和对照...目的通过观察芪明颗粒对早期糖尿病肾病中医症候、生化指标、炎症因子及尿微量白蛋白的影响,明确与缬沙坦胶囊治疗效果的一致性及差异性。方法选入符合纳入标准的早期糖尿病肾病患者130例,采用简单数字表的随机方法分为治疗组65例和对照组65例,2组均接受常规的治疗及护理,治疗组给芪明颗粒1袋/次,3次/d口服,对照组给予缬沙坦胶囊80 mg/次,1次/d口服,治疗16周后观察2组中医症候、生化指标、炎症因子及尿微量白蛋白的变化。结果治疗组与对照组临床疗效总有效率分别为92.31%、75.38%(P<0.05)。治疗前后2组在炎症因子方面均有所改善,但是对照组在hs-CRP、IL-6、IL-1β、TNF-α方面改善无统计学意义(P>0.05),治疗组在hs-CRP、IL-6、IL-1β、TNF-α、Cys-C方面与对照组比较有统计学意义(P<0.05),2组在血清β2-MG、24 h Um Alb方面比较,各组治疗前后有统计学意义(P<0.05),治疗后比较无统计学意义(P>0.05)。结论芪明颗粒在改善早期糖尿病肾病中医症候、炎症因子方面疗效显著,能明显改善血、尿微量白蛋白,延缓糖尿病肾病的发展。展开更多
基金This study is supported by the State Administration of Traditional Medicine of China.
文摘Background:Diabetic kidney disease(DKD)is a chronic renal microvascular complication associated with abnormal glucose metabolism.According to traditional Chinese medicine(TCM)theory,Qi and Yin deficiency with blood stasis(the name of TCM symptoms,its main clinical features are fatigue,dry mouth,red or pale tongue,weak pulse,etc.)is the primary TCM syndrome of DKD,and Qiming granule(QMG)is suitable for the treatment of Qi and Yin deficiency with blood stasis syndrome.In view of this,we designed a randomized controlled trial to assess whether QMG is efficacious and safe in treating DKD patients.Methods:This protocol is for a randomized,double-blind,placebo-controlled,parallel group,six-centre clinical trial.A total of 180 participants will be randomized into the QMG group or placebo group,with a 1:1 ratio.The study will last for 50 weeks,including a 2-week run-in period,24 weeks of intervention,and 24 weeks of follow-up.The experimental intervention will be QMG,and the control intervention will be a placebo.The primary outcome will be the 24h urinary albumin excretion ratio and the change in the albumin-to-creatinine ratio.The secondary outcome will be evaluation of renal function,fundus changes,management of blood lipids,TCM symptom improvement and safety assessments.Adverse events will be recorded during the trial.Discussion:This study is a randomized controlled trial to test the effectiveness and safety of QMG for DKD patients.The findings of this study will help to provide evidence-based recommendations in treating DKD patients.Trial registration:Chinese Clinical Trial Registry,ChiCTR-TRC-12002953.Registered 23 December 2012.
基金National Youth Science Fund Project(No.81900874)。
文摘Objective:To investigate the clinical study of Qiming granule combined with compound anisodine injection in the treatment of diabetic retinopathy.Methods:104 patients with nonproliferative diabetic retinopathy admitted to department of ophthalmology in Xishui Hospital Affiliated to Hubei University of science and technology from September 2016 to May 2018 were selected as the study subjects.According to the principle of treatment,they were divided into 52 cases in the control group and 52 cases in the treatment group,the clinical efficacy,blood sugar and lipid levels,hemorheological changes and adverse reactions were compared between the two groups.Results:The total effective rate difference between the treatment group(92.31%)and the control group(71.15%)was statistically significant(χ^(2)=7.792,P=0.005).After treatment,the two groups of fasting plasma glucose(FPG),hemoglobin A1c(HbA1c),total cholesterol(TC),low density lipoprotein-cholesterol(LDL-C),whole blood high-viscosity,whole blood cut viscosity,whole blood low-cut viscosity,plasma viscosity,number of microangioma and area of the hemorrhage were significantly lower than before treatment(P<0.05),and the levels of FPG,HbA1c,TC,LDL-C,whole blood highviscosity,whole blood cut viscosity,whole blood low-cut viscosity,plasma viscosity,number of microangioma and area of the hemorrhage in the treatment group were significantly lower than those in the control group(χ^(2)=0.122,P=0.727).Conclusions:Qiming granule combined with compound anisodine injection can effectively improve the clinical efficacy of patients with non-proliferative DR,and its mechanism may be related to improve blood sugar and blood lipid levels and correct blood rheology disorder,reduce microangioma and hemorrhage.It has clinical promotion significance.
基金This project was supported by the National Natural Science foundation of China(No.81774014).
文摘Objective:To systematically evaluate the clinical efficacy of Qiming Granule combined with conventional therapy in improving diabetic nephropathy.Methods:The Chinese and English databases such as Wanfang,VIP,CNKI,PubMed,Cochrane library and Web of Science database were searched.The searching time was from the database was established to March 1,2021.The papers were screened strictly according to the inclusion and exclusion criteria.The inclusion risk assessment tool provided by the Cochrane Collaboration was used to evaluate the included literature,the data was analyzed using STATA 12.0 software.Results:Twelve papers were included,involving 1369 patients.The results of meta-analysis showed that Qiming Granule combined with conventional treatment had statistical significance in improving the clinical total effective rate[RR=1.24,95%CI(1.12,1.36)],urinary albumin excretion rate[SMD=-2.68,95%CI(-3.86,-1.50)],creatinine[SMD=-1.46,95%CI(-1.84,-1.08)],urea nitrogen[SMD=-2.61,95%CI(-3.85,-1.36)],fasting blood glucose[SMD=-1.17,95%CI(-2.03,-0.31)]and cystatin C[SMD=-3.26,95%CI(-4.65,-1.87)]of patients with diabetic nephropathy.Conclusion:The combination of conventional therapy and Qiming Granule can improve the clinical effect for diabetic nephropathy.However,due to the low level of overall literature evidence,high risk and some kind of publication bias,it still needs more high-quality and large-scale clinical studies for further verification.
文摘目的通过观察芪明颗粒对早期糖尿病肾病中医症候、生化指标、炎症因子及尿微量白蛋白的影响,明确与缬沙坦胶囊治疗效果的一致性及差异性。方法选入符合纳入标准的早期糖尿病肾病患者130例,采用简单数字表的随机方法分为治疗组65例和对照组65例,2组均接受常规的治疗及护理,治疗组给芪明颗粒1袋/次,3次/d口服,对照组给予缬沙坦胶囊80 mg/次,1次/d口服,治疗16周后观察2组中医症候、生化指标、炎症因子及尿微量白蛋白的变化。结果治疗组与对照组临床疗效总有效率分别为92.31%、75.38%(P<0.05)。治疗前后2组在炎症因子方面均有所改善,但是对照组在hs-CRP、IL-6、IL-1β、TNF-α方面改善无统计学意义(P>0.05),治疗组在hs-CRP、IL-6、IL-1β、TNF-α、Cys-C方面与对照组比较有统计学意义(P<0.05),2组在血清β2-MG、24 h Um Alb方面比较,各组治疗前后有统计学意义(P<0.05),治疗后比较无统计学意义(P>0.05)。结论芪明颗粒在改善早期糖尿病肾病中医症候、炎症因子方面疗效显著,能明显改善血、尿微量白蛋白,延缓糖尿病肾病的发展。
