非手术牙周治疗下补充褪黑素对2型糖尿病合并慢性牙周炎患者的影响：一项双盲随机对照试验
Effects of melatonin supplementation in patients with type 2 diabetes mellitus and chronic periodontitis under nonsurgical periodontal therapy: A double-blind randomized controlled trial.
作者信息
Bazyar Hadi, Zare Javid Ahmad, Zakerkish Mehrnoosh, Yousefimanesh Hojat Allah, Haghighi-Zadeh Mohammad Hosein
机构信息
Health Research Institute, Diabetes Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Student Research Committee, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.
出版信息
J Res Med Sci. 2022 Jul 29;27:52. doi: 10.4103/jrms.JRMS_927_19. eCollection 2022.
BACKGROUND
The aim of the present study was to investigate the effects of melatonin supplementation along with nonsurgical periodontal therapy (NSPT) in patients with type 2 diabetes mellitus (T2DM) and chronic periodontitis (CP).
MATERIALS AND METHODS
The present study was a double-blind clinical trial. Fifty diabetic patients with periodontitis were randomly allocated to control ( = 25) and intervention groups ( = 25). Two tablets of 250 mg melatonin (6 mg net melatonin) or placebo were received by the intervention or control groups once a day for 8 weeks. Fasting blood glucose (FBG), glycosylated hemoglobin levels (HbA1c), lipid profile, systolic and diastolic blood pressure (SBP and DBP), anthropometric indices including weight, waist and hip circumference (WC and HC), and body mass index (BMI) were measured in patients at the beginning and end of the intervention.
RESULTS
Forty-four patients (22 patients in each group) completed the study. In the intervention group, a significant reduction was observed in HbA1c ( = 0.004), weight, BMI, WC, HC (all < 0.001), DBP ( = 0.017), and SBP ( = 0.006). The high-density lipoprotein-cholesterol was significantly increased in the intervention group after the intervention ( = 0.007). Moreover, after the adjustment of confounding factors, the mean changes of HbA1c (mean difference: -1.30, confidence interval [CI]: -2.41--0.19, = 0.02), weight (mean difference: -3.90, CI: -5.30-2.50, < 0.001), WC (mean difference: -1.37, CI: -2.19--0.55, = 0.002), BMI (mean difference: -1.41, CI: -1.92--0.89, < 0.001), HC (mean difference: -3.55, CI: -4.74--2.35, < 0.001), and SBP (mean difference: -1.24, CI: -2.41--0.06, = 0.03) improved significantly in the intervention group by comparison with the control group. No side effects were reported during the study.
CONCLUSION
The adjunct therapy of NSPT and melatonin may be useful in controlling the glycemic index, lipid profile, BP, and weight in T2DM with CP.
背景
本研究旨在探讨补充褪黑素联合非手术牙周治疗（NSPT）对2型糖尿病（T2DM）合并慢性牙周炎（CP）患者的影响。
材料与方法
本研究为双盲临床试验。50例糖尿病合并牙周炎患者被随机分为对照组（n = 25）和干预组（n = 25）。干预组或对照组每天服用两片250mg褪黑素（纯褪黑素6mg）或安慰剂，共8周。在干预开始和结束时测量患者的空腹血糖（FBG）、糖化血红蛋白水平（HbA1c）、血脂谱、收缩压和舒张压（SBP和DBP）、人体测量指标，包括体重、腰围和臀围（WC和HC）以及体重指数（BMI）。
结果
44例患者（每组22例）完成了研究。在干预组中，观察到HbA1c（P = 0.004）、体重、BMI、WC、HC（均P < 0.001）、DBP（P = 0.017）和SBP（P = 0.006）显著降低。干预后干预组高密度脂蛋白胆固醇显著升高（P = 0.007）。此外，在调整混杂因素后，与对照组相比，干预组HbA1c的平均变化（平均差值：-1.30，置信区间[CI]：-2.41--0.19，P = 0.02）、体重（平均差值：-3.90，CI：-5.30 - 2.50，P < 0.001）、WC（平均差值：-1.37，CI：-2.19--0.55，P = 0.002）、BMI（平均差值：-1.41，CI：-1.92--0.89，P < 0.001）、HC（平均差值：-3.55，CI：-4.74--2.35，P < 0.001）和SBP（平均差值：-1.24，CI：-2.41--0.06，P = 0.03）均有显著改善。研究期间未报告副作用。
结论
NSPT和褪黑素的辅助治疗可能有助于控制T2DM合并CP患者的血糖指数、血脂谱、血压和体重。
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