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Abstract：
Previous studies found that Jinlida granules could significantly reduce blood glucose levels and enhance the low-glucose action of metformin. However, the role of Jinlida in the standard-reaching rate of blood glucose and improving clinical symptoms has yet to be studied. We aimed to elaborate on the efficacy of Jinlida in type 2 diabetes (T2D) patients who experience clinical symptoms based on secondary analysis of a randomized controlled trial.
Data were analyzed from a 12-week, randomized, placebo-controlled study of Jinlida. The standard-reaching rate of blood glucose, the symptom disappearance rate, the symptom improvement rate, the efficacy of single symptoms, and the total symptom score were evaluated. The correlation between HbA1c and the improvement of clinical symptoms was analyzed.
For 12 weeks straight, 192 T2D patients were randomly assigned to receive either Jinlida or a placebo. The treatment group showed statistically significant differences in the standard-reaching rate of HbA1c < 6.5% (p = 0.046) and 2hPG (< 10 mmol/L, 11.1 mmol/L) (p < 0.001), compared with the control group. The standard-reaching rate of HbA1c < 7% (p = 0.06) and FBG < 7.0 mmol/L (p = 0.079) were not significantly different between the treatment and control groups. Five symptoms exhibited a statistical difference in symptom disappearance rate (p < 0.05). All the symptoms exhibited a significant difference in symptom improvement rate (p < 0.05). The mean change in total symptom score from baseline to week 12 was -5.45 ± 3.98 in the treatment group and -2.38 ± 3.11 in the control group, with statistically significant differences (p < 0.001). No significant correlations were noted between symptom improvement and HbA1c after 12 weeks of continuous intervention with Jinlida granules or placebo.
Jinlida granules can effectively improve the standard-reaching rate of blood glucose and clinical symptoms of T2D patients, including thirst, fatigue, increased eating with rapid hungering, polyuria, dry mouth, spontaneous sweating, night sweat, vexing heat in the chest, palms, and soles, and constipation. Jinlida granules can be used as an effective adjuvant treatment for T2D patients who experience those symptoms.
Data were analyzed from a 12-week, randomized, placebo-controlled study of Jinlida. The standard-reaching rate of blood glucose, the symptom disappearance rate, the symptom improvement rate, the efficacy of single symptoms, and the total symptom score were evaluated. The correlation between HbA1c and the improvement of clinical symptoms was analyzed.
For 12 weeks straight, 192 T2D patients were randomly assigned to receive either Jinlida or a placebo. The treatment group showed statistically significant differences in the standard-reaching rate of HbA1c < 6.5% (p = 0.046) and 2hPG (< 10 mmol/L, 11.1 mmol/L) (p < 0.001), compared with the control group. The standard-reaching rate of HbA1c < 7% (p = 0.06) and FBG < 7.0 mmol/L (p = 0.079) were not significantly different between the treatment and control groups. Five symptoms exhibited a statistical difference in symptom disappearance rate (p < 0.05). All the symptoms exhibited a significant difference in symptom improvement rate (p < 0.05). The mean change in total symptom score from baseline to week 12 was -5.45 ± 3.98 in the treatment group and -2.38 ± 3.11 in the control group, with statistically significant differences (p < 0.001). No significant correlations were noted between symptom improvement and HbA1c after 12 weeks of continuous intervention with Jinlida granules or placebo.
Jinlida granules can effectively improve the standard-reaching rate of blood glucose and clinical symptoms of T2D patients, including thirst, fatigue, increased eating with rapid hungering, polyuria, dry mouth, spontaneous sweating, night sweat, vexing heat in the chest, palms, and soles, and constipation. Jinlida granules can be used as an effective adjuvant treatment for T2D patients who experience those symptoms.
摘要：
■先前的研究发现，津力达颗粒可以显着降低血糖水平并增强二甲双胍的低糖作用。然而,津力达在血糖达标率和改善临床症状方面的作用尚待研究。我们旨在根据一项随机对照试验的二次分析，详细说明Jinlida在出现临床症状的2型糖尿病（T2D）患者中的疗效。
■分析了12周的数据，随机化，Jinlida的安慰剂对照研究。血糖达标率,症状消失率，症状改善率，单一症状的功效，并对症状总评分进行评价。分析HbA1c与临床症状改善的相关性。
■连续12周，192名T2D患者被随机分配接受Jinlida或安慰剂。治疗组在HbA1c<6.5%(p=0.046)和2hPG(<10mmol/L,11.1mmol/L)(p<0.001)，与对照组相比。HbA1c<7%(p=0.06)和FBG<7.0mmol/L(p=0.079)的达标率在治疗组与对照组之间无明显差异。五种症状的症状消失率存在统计学差异(p<0.05)。所有症状均表现出症状改善率的显著差异(p<0.05)。治疗组自基线至第12周的总症状评分平均变化为-5.45±3.98,对照组为-2.38±3.11,差异有统计学意义(p<0.001)。经津力达颗粒或安慰剂连续干预12周后，症状改善与HbA1c无显著相关性。
■津力达颗粒可有效改善T2D患者的血糖达标率和临床症状，包括口渴,疲劳,随着快速饥饿而增加进食，多尿,口干,自发出汗,盗汗,胸部令人烦恼的热量，手掌,和鞋底，还有便秘.津力达颗粒可作为T2D患者出现这些症状的有效辅助治疗。
■分析了12周的数据，随机化，Jinlida的安慰剂对照研究。血糖达标率,症状消失率，症状改善率，单一症状的功效，并对症状总评分进行评价。分析HbA1c与临床症状改善的相关性。
■连续12周，192名T2D患者被随机分配接受Jinlida或安慰剂。治疗组在HbA1c<6.5%(p=0.046)和2hPG(<10mmol/L,11.1mmol/L)(p<0.001)，与对照组相比。HbA1c<7%(p=0.06)和FBG<7.0mmol/L(p=0.079)的达标率在治疗组与对照组之间无明显差异。五种症状的症状消失率存在统计学差异(p<0.05)。所有症状均表现出症状改善率的显著差异(p<0.05)。治疗组自基线至第12周的总症状评分平均变化为-5.45±3.98,对照组为-2.38±3.11,差异有统计学意义(p<0.001)。经津力达颗粒或安慰剂连续干预12周后，症状改善与HbA1c无显著相关性。
■津力达颗粒可有效改善T2D患者的血糖达标率和临床症状，包括口渴,疲劳,随着快速饥饿而增加进食，多尿,口干,自发出汗,盗汗,胸部令人烦恼的热量，手掌,和鞋底，还有便秘.津力达颗粒可作为T2D患者出现这些症状的有效辅助治疗。
