目的探讨子午流注择时耳穴压豆治疗对2型糖尿病(T2DM)患者血糖控制、上消症状及失眠状况的影响。方法选取2020年1月至2022年12月河南省中西医结合医院内分泌科收治的138例T2DM患者作为研究对象,依据电脑数表随机抽取法分为西医组(常规...目的探讨子午流注择时耳穴压豆治疗对2型糖尿病(T2DM)患者血糖控制、上消症状及失眠状况的影响。方法选取2020年1月至2022年12月河南省中西医结合医院内分泌科收治的138例T2DM患者作为研究对象,依据电脑数表随机抽取法分为西医组(常规西医干预)46例、中医1组(耳穴压豆干预)46例和中医2组(子午流注择时耳穴压豆干预)46例,连续干预4周。比较三组患者的治疗总有效率、治疗前后的血糖水平[空腹血糖(FBG)、餐后2 h血糖(2 h PBG)、糖化血红蛋白(Hb1Ac)]、上消症状、睡眠质量[匹兹堡睡眠治疗指数(PSQI)]、Toll样受体4(TLR4)/细胞核因子κB(NF-κB)炎症信号通路因子[外周血TLR4、NF-κB、血清肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)]水平及不良反应发生情况。结果中医2组、中医1组患者的治疗总有效率分别为93.48%、84.78%,明显高于西医组的71.74%,差异均有统计学意义(P<0.05);干预4周后,中医2组患者的FBG、2 h PBG、Hb1Ac水平分别为(6.36±0.83)mmol/L、(8.18±1.05)mmol/L、(6.13±0.59)%,明显低于中医1组的(7.05±1.02)mmol/L、(9.37±1.16)mmol/L、(6.91±0.83)%及西医组的(7.81±1.10)mmol/L、(10.80±1.44)mmol/L、(7.88±0.75)%,差异均有统计学意义(P<0.05);干预4周后,中医2组患者的口干、多饮症状积分、PSQI各维度评分及总分明显低于中医1组、西医组,中医1组明显低于西医组,差异均有统计学意义(P<0.05);干预4周后,中医2组患者的外周血TLR4、NF-κB蛋白及血清TNF-α、IL-6水平分别为1.26±0.24、1.31±0.25、(26.76±4.38)pg/mL、(17.72±3.34)pg/mL,明显低于中医1组的1.59±0.31、1.53±0.29、(31.54±4.71)pg/mL、(20.53±4.11)pg/mL及西医组的2.02±0.35、2.06±0.37、(34.07±5.23)pg/mL、(23.18±3.62)pg/mL,差异均有统计学意义(P<0.05);三组患者治疗期间的总不良反应发生率比较差异无统计学意义(P>0.05)。结论子午流注择时耳穴压豆治疗T2DM具有一定的治疗效果,其可控制血糖水平,改善上消症状,提高睡眠质量,且具有一定安全性,其治疗机制可能与调节TLR4/NF-κB炎症信号通路有关。展开更多
Objective: To follow up the participants of the randomized clinical trial "Efficacy and Safety of Niaoduqing Particles(尿毒清颗粒) for Delaying Moderate-to-Severe Renal Dysfunction", and assess the long-term...Objective: To follow up the participants of the randomized clinical trial "Efficacy and Safety of Niaoduqing Particles(尿毒清颗粒) for Delaying Moderate-to-Severe Renal Dysfunction", and assess the long-term effects of Niaoduqing Particles on delaying the progression of renal dysfunction. Methods: Participants, who had previously been randomly assigned to receive Niaoduqing Particles or placebo for 24 weeks(146 cases in each group), were invited to follow-up and all were administered Niaoduqing Particles 5 g thrice daily and 10 g before bedtime for 24 weeks. The primary endpoints were changes in baseline serum creatinine(Scr) and estimated glomerular filtration rate(e GFR) after completion of the open-label treatment period. Results: After the double-blind period, the median(interquartile range) changes in Scr were 1.1(–13.0–24.1) and 11.7(–2.6–42.9) μmol/L for the Niaoduqing Particle and placebo groups, respectively(P=0.008), and the median changes in e GFRs were –0.2(–4.3–2.7) and –2.21(–5.7–0.8) mL·min^(-1)·1.73 m^(-2), respectively(P=0.016). There were significant differences in the double-blind period changes in renal function between groups. After the open-label period, the median changes in Scr were 9.0(–10.0–41.9) and 17.5(–6.0–50.0) μmol/L for the Niaoduqing Particle and placebo groups according to baseline grouping, respectively(P=0.214), and the median changes in eGFRs were –2.3(–6.4–1.9) and –3.7(–7.5–1.1) mL·min^(-1)·1.73 m^(-2), respectively(P=0.134). There were no statistical differences in the open-label period changes in renal function between groups. The eGFR reduction of participants who accepted Niaoduqing Particle treatment for 48 weeks was projected to 2.5 m L·min^(-1)·1.73 m(-2) per year. Conclusions: Niaoduqing Particles appear to have long-term efficacy for patients with moderate-to-severe renal dysfunction. Although there was no statistical difference, the early use of Niaoduqing Paticles seems to ameliorate the worsening of renal function.展开更多
文摘目的探讨子午流注择时耳穴压豆治疗对2型糖尿病(T2DM)患者血糖控制、上消症状及失眠状况的影响。方法选取2020年1月至2022年12月河南省中西医结合医院内分泌科收治的138例T2DM患者作为研究对象,依据电脑数表随机抽取法分为西医组(常规西医干预)46例、中医1组(耳穴压豆干预)46例和中医2组(子午流注择时耳穴压豆干预)46例,连续干预4周。比较三组患者的治疗总有效率、治疗前后的血糖水平[空腹血糖(FBG)、餐后2 h血糖(2 h PBG)、糖化血红蛋白(Hb1Ac)]、上消症状、睡眠质量[匹兹堡睡眠治疗指数(PSQI)]、Toll样受体4(TLR4)/细胞核因子κB(NF-κB)炎症信号通路因子[外周血TLR4、NF-κB、血清肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)]水平及不良反应发生情况。结果中医2组、中医1组患者的治疗总有效率分别为93.48%、84.78%,明显高于西医组的71.74%,差异均有统计学意义(P<0.05);干预4周后,中医2组患者的FBG、2 h PBG、Hb1Ac水平分别为(6.36±0.83)mmol/L、(8.18±1.05)mmol/L、(6.13±0.59)%,明显低于中医1组的(7.05±1.02)mmol/L、(9.37±1.16)mmol/L、(6.91±0.83)%及西医组的(7.81±1.10)mmol/L、(10.80±1.44)mmol/L、(7.88±0.75)%,差异均有统计学意义(P<0.05);干预4周后,中医2组患者的口干、多饮症状积分、PSQI各维度评分及总分明显低于中医1组、西医组,中医1组明显低于西医组,差异均有统计学意义(P<0.05);干预4周后,中医2组患者的外周血TLR4、NF-κB蛋白及血清TNF-α、IL-6水平分别为1.26±0.24、1.31±0.25、(26.76±4.38)pg/mL、(17.72±3.34)pg/mL,明显低于中医1组的1.59±0.31、1.53±0.29、(31.54±4.71)pg/mL、(20.53±4.11)pg/mL及西医组的2.02±0.35、2.06±0.37、(34.07±5.23)pg/mL、(23.18±3.62)pg/mL,差异均有统计学意义(P<0.05);三组患者治疗期间的总不良反应发生率比较差异无统计学意义(P>0.05)。结论子午流注择时耳穴压豆治疗T2DM具有一定的治疗效果,其可控制血糖水平,改善上消症状,提高睡眠质量,且具有一定安全性,其治疗机制可能与调节TLR4/NF-κB炎症信号通路有关。
基金Supported by the National Key Technology R&D Program(No.2015BAI12B06)Key Program of National Natural Science Foundation of China(No.81330019)+1 种基金General Program of National Natural Science Foundation of China(No.81670671)the Beijing Science and Technology Project(No.D171100002817002,D181100000118002,and D181100000118004)
文摘Objective: To follow up the participants of the randomized clinical trial "Efficacy and Safety of Niaoduqing Particles(尿毒清颗粒) for Delaying Moderate-to-Severe Renal Dysfunction", and assess the long-term effects of Niaoduqing Particles on delaying the progression of renal dysfunction. Methods: Participants, who had previously been randomly assigned to receive Niaoduqing Particles or placebo for 24 weeks(146 cases in each group), were invited to follow-up and all were administered Niaoduqing Particles 5 g thrice daily and 10 g before bedtime for 24 weeks. The primary endpoints were changes in baseline serum creatinine(Scr) and estimated glomerular filtration rate(e GFR) after completion of the open-label treatment period. Results: After the double-blind period, the median(interquartile range) changes in Scr were 1.1(–13.0–24.1) and 11.7(–2.6–42.9) μmol/L for the Niaoduqing Particle and placebo groups, respectively(P=0.008), and the median changes in e GFRs were –0.2(–4.3–2.7) and –2.21(–5.7–0.8) mL·min^(-1)·1.73 m^(-2), respectively(P=0.016). There were significant differences in the double-blind period changes in renal function between groups. After the open-label period, the median changes in Scr were 9.0(–10.0–41.9) and 17.5(–6.0–50.0) μmol/L for the Niaoduqing Particle and placebo groups according to baseline grouping, respectively(P=0.214), and the median changes in eGFRs were –2.3(–6.4–1.9) and –3.7(–7.5–1.1) mL·min^(-1)·1.73 m^(-2), respectively(P=0.134). There were no statistical differences in the open-label period changes in renal function between groups. The eGFR reduction of participants who accepted Niaoduqing Particle treatment for 48 weeks was projected to 2.5 m L·min^(-1)·1.73 m(-2) per year. Conclusions: Niaoduqing Particles appear to have long-term efficacy for patients with moderate-to-severe renal dysfunction. Although there was no statistical difference, the early use of Niaoduqing Paticles seems to ameliorate the worsening of renal function.
