SUMMARY: 60 patients with non-proliferative diabetic retinopathy (NPDR) were enrolled in this study. Subjects were divided into control group and treatment group, with 30 subjects in each group. All subjects met the diagnostic criteria of NPDR according to the “Guideline for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (2020) and the diagnostic criteria of NPDR due to Liver and Kidney Yin deficiency according to the “Internal Medicine of Traditional Chinese Medicine (2012) ”, “Guiding Principles for Clinical Study of New Chinese Medicines (2002)”, and “Diabetic Retinopathy Diagnosis and Treatment Standard of Traditional Chinese Medicine (2011)”. There was no significant difference in gender, age and course of disease between the treatment and control group, and the two groups were statistically comparable (P>0.05)
In the control group, subjects received routine blood glucose control treatment (hypoglycemic medication according to the individual needs) and calcium dobesilate (0.5g tid). In addition to the routine treatment, subjects in the treatment also received Qizhen Jiangtang granule (芪貞降糖顆粒10g tid). The ingredients of the Qizhen Jiangtang granule included: Nu Zhen Zi (女貞子 Fructus Ligustri Lucidi), Shan Zhu Yu (山茱萸 Fructus Corni), Huang Qi (黃耆 Radix Astragali seu Hedysari), Ren Shen (人參 Radix Ginseng), Huang Lian (黃連 Rhizoma Coptidis), Wu Bei Zi (五倍子 Galla Chinensis). Course of treatment was 24 weeks in both groups.
To assess the clinical efficacy, blood glucose control, and vascular inflammatory response, the followings were examined and monitored: TCM syndrome score, visual acuity, fundus, fasting blood sugar (FPG), 2h postprandial blood sugar (2hPG), glycosylated hemoglobin level (HgA1C), serum vascular endothelial growth factor (VEGF), intercellular adhesion molecule-1 (ICAM-1), and interleukin-1β (IL-1β).
According to the “Clinical Diagnosis and Efficacy Standard of Traditional Chinese Medicine”, total score = visual acuity improvement score + fundus improvement score (total score = 10); efficacy index = total score / 10 × 100%.The result was considered as:
- Markedly effective: efficacy index ≥ 70%;
- Effective: 30% ≤ efficacy index < 70%
- No response: efficacy index < 30%.
Table 1. Comparison of Clinical Efficacy between
the Treatment and Control Group
|Group||n||Markedly Effective/n||Effective/n||No Response/n||Average Rank||Z value||P value|
After the treatment, the TCM syndrome scores significantly decreased in both groups, and the visual acuity improvement score and fundus improvement score in both groups both increased (P<0.05); the treatment group showed a more significant improvement than the control group (P<0.05). The clinical efficacy of the treatment group was higher than the control group (P<0.05). After the treatment, the levels of FPG, 2hPG, VEGF, ICAM-1 and IL-1β in both groups significantly decreased (P<0.05), and the treatment group showed a more significant decrease (P<0.05). There was no significant difference in HbA1c levels between the two groups before and after treatment (P>0.05). The result suggested that adding Qizhen Jiangtang granules to the routine treatment can improve the levels of blood glucose and inflammatory response, relieve the clinical symptoms of patients, and improve the level of vision, eye health and clinical efficacy in patients with NPDR due to Liver and Kidney Yin deficiency.
Yanli Wang, et al. J Anhui Univ Chinese Med. 2022. 41 (5): 26-31