Product Overview
Generic name: Qiming granules
Chinese Pinyin: Qi Ming Keli
Product name: Wansheng
Ingredients: Astragalus, Pueraria lobata, Rehmannia glutinosa, Lycium barbarum, Cassia seed, Fuweizi, Puhuang, Leech.
Properties: This product is brown granules; slightly smelly, sweet and slightly bitter.
Functions and indications: Nourish the liver and kidney, clear the collaterals and improve eyesight. It is used for the simple type of type 2 diabetic retinopathy. The TCM dialectic is the syndrome of deficiency of qi and yin, insufficiency of liver and kidney, and stasis of the eyes and collaterals. Thirsty, constipation, soreness of waist and knees, dizziness, tinnitus.
Specification: 4.5g*15 bags/box
Usage and dosage: Take boiled water. 1 bag at a time, 3 times a day. The course of treatment is 3 to 6 months.
Adverse reactions: Individual patients have gastric discomfort after medication.
Taboo: Not yet clear
Note: 1. It is still necessary to take basic hypoglycemic drugs while taking this medicine in order to effectively control blood sugar.
2. Spicy and greasy food should not be eaten while taking this product.
3. People with spleen and stomach deficiency, chest tightness, gastrointestinal fullness, loose stools due to lack of food, or excessive phlegm should not be used.
4. Some patients have a slight increase in ALT after taking the medicine, and they cannot be completely queued up with this product.
5. Patients with gastric cavity discomfort and loose stools during the medication can be discontinued for observation.
6. When combined with a large-dose Chinese medicine for nourishing yin, promoting blood circulation and removing blood stasis, or combined with a large-dose vasodilator, you should consult the relevant physician.
Drug interactions: Unclear
Pharmacology and Toxicology: Pharmacological effects: Non-clinical pharmacodynamic test results show that this product can increase the body weight of streptozotocin-induced diabetes model rats, reduce HbA1c and blood sugar levels, and reduce whole blood viscosity, plasma viscosity, and Blood reduction viscosity, erythrocyte stiffness index, erythrocyte aggregation index and fibrinogen content; can reduce the thickness of retinal capillary basement membrane of streptozotocin-induced diabetic rats, reduce the degree of retinal vascular disease, and reduce retinal capillary endothelial cells and Pericyte ratio; Decrease the content of glucose, sorbitol, and fructose in the retina of diabetic rats induced by streptozotocin; increase the a wave and b wave of flash electroretinogram in diabetic rats induced by streptozotocin , Shorten the b-wave peak latent time, increase the amplitude of the retinal oscillatory potential and shorten the peak latent time
Clinical research: This product was approved for clinical research by the former State Drug Administration in 2000, and phase II and III clinical trials were carried out from October 2000 to May 2004. The phase II clinical trial adopts multi-center, randomized, double-blind, double-simulation, and controlled trial methods. The number of clinical trial cases is 214, with 107 cases in each of the Qiming granule group and the Daoshengming capsule control group; the phase III clinical trial uses multi-center , Randomized, parallel controlled trial method, the number of clinical trial cases is 529 cases, the treatment group is 353 cases, and the control group is 176 cases. Observed the treatment of Qiming Granules in the treatment of qi-yin deficiency, liver and kidney deficiency, blood congestion and collateral block syndrome caused by type 2 diabetes with simple retinopathy (clinical staging is Ⅰ～Ⅲ, phase Ⅲ clinical trials observed some patients with diabetic retinopathy of stage Ⅳ, But the number of cases is relatively small), the control drug is Daoshengming capsule. During the test, blood glucose was controlled at a relatively normal or almost normal level and was relatively stable. The course of treatment for phase Ⅱ clinical trials is 3 months; the course of treatment for phase Ⅲ clinical trials is 3 months, of which three clinical units observe the course of treatment for 6 months. Curative effect indicators are mainly based on vision, fundus examination (microangioma, bleeding, exudation, fundus fluorescein angiography, etc.), related symptoms and signs, and TCM syndromes. The main curative effect evaluation is based on the improvement of both vision and fundus examination. . In the phase II clinical trial, the overall efficacy of the Qiming Granules group was compared with that of the Daoshengming Capsule group, and the difference was statistically significant. The Qiming Granules group was better than the Daoshengming Capsule group. Compared with the curative effect of TCM syndromes, the difference was statistically significant in Phase II and III clinical trials. The Qiming granule group was better than the Daoshengming capsule group. However, after treatment, the number of retinal microangioma, fundus hemorrhage, hard exudation, and soft exudation were compared. There was no significant difference between the Qiming granule group and the Daoshengming capsule group. There is a statistically significant difference in individual visual acuity. The Qiming granule group is better than the Daoshengming capsule group. Comparison of the main symptoms of traditional Chinese medicine, dizziness of vision and improvement of binocular dryness, except that the improvement of binocular dryness in the phase III clinical trial for 3 months was better than that of Daoshengming Capsules, the difference was statistically significant, Ⅱ There was no significant difference between the Qiming Granule group and the Daoshengming Capsule group at 6 months of clinical phase and phase III clinical phase. There were no significant differences among the groups of fatigue, fatigue, spontaneous sweating, night sweats, thirsty and drinking, sore waist and knees, dizziness, and tinnitus. The blood, urine, stool routine, liver (ALT), kidney (BUN, Cr) function and electrocardiogram examination of Qiming granules before and after treatment, except for the slight increase in ALT after taking the drug in individual patients, it cannot be completely ruled out that it is related to this product In addition, no other obvious abnormalities and abnormal aggravation after taking Qiming granules were found. After treatment, some patients in the treatment group developed abnormalities or abnormalities such as blood routine, urine routine, ALT, BUN, Cr, and electrocardiogram, which were considered to be related to diabetic nephropathy, coronary heart disease, hypertension, fatty liver, urinary tract infection and other diseases; There were 9 adverse events in the Ming granule group. One case of gastric discomfort could not be ruled out. The clinician judged that it was definitely related. One case of half-body numbness was judged to be irrelevant by the clinician.
Storage: Sealed, kept in a cool and dry place (not exceeding 20°C).
Packing: Packed in aluminum-plastic composite film bags, 15 bags per box.
Validity period: 24 months
Approval number: National Medicine Standard Z20090036
Company Name: Zhejiang Wansheng Pharmaceutical Co., Ltd.
