Longqi Granule Instructions
Comparison of the difference between stroke disease scores and TCM syndrome scores before and after treatment in the two groups:
Please read the instructions carefully and use it under the guidance of a physician is statistically significant, P <0.01; the comparison of the difference between groups after treatment is also statistically significant.
Generic name: Comparison of changes in the scores of major Chinese medicine symptoms and signs of Longqi Granules: language expression, upper limb shoulder joint,
Phonetic script: Longqi Keli
In terms of index of upper finger joint, lower limb hip joint, lower limb knee joint and comprehensive function, the components before and after treatment] Astragalus, Chuanxiong, Dilong.
Ratio, have statistical significance, P <0.01. But comparison between groups, only language expression, upper limb shoulder joints, upper limb finger guan traits] This product is brown particles; slightly fragrant, slightly acidic, sweet.
Knee joints and comprehensive functions of the lower limbs were statistically significant, and the treatment group was better than the control group. Treatment group and control group [function indication] Yiqi Huoxue, Xifeng Tongluo. It was used for comparison of Qi deficiency and blood in the recovery period of meridians during cerebral apoplexy. The upper limb failure, lower limb failure and fatigue were statistically significant, P <0.05. The treatment group was better than the control stasis syndrome. Seeing hemiplegia due to symptoms, slanted tongue, astringent or silent language, leaning towards numbness, embarrassing complexion, divine group.
Fatigue, low voice, salivation, dark tongue, thin white tongue coating, weak or astringent veins.
In terms of safety inspection: about 413 patients in the Longqi granule group had routine blood, urine, and stool before and after treatment, liver function specifications] 8g per bag
(ALT), renal function (BUN, Cr), and electrocardiogram, ‖ !, above-mentioned laboratory indicators in the phase III clinical trial, usage and dosage] boiled water. 1 bag at a time, 3 times a day. The course of treatment is 28 days.
Patients who turned into abnormal after normal treatment before treatment. In the phase ‖ clinical trial, 1 case of the Longqi granule group showed mild [adverse reaction]. Individual patients developed mild abdominal distension, tinnitus, and pruritus after administration.
The degree of bloating lasted for 2 days, and it was judged that it might be related to the drug. In the phase Ⅲ clinical trial, one case of drug contraindication in the Longqi granule group was unclear.
Later, there was mild tinnitus and itching, which was judged to be related to the drug. There are few precautions in the Longqi granule group in the phase III clinical trial.
The number of patients who had abnormalities before treatment was worsened after treatment, including 1 case of urinary WBCO-3 / HP before routine treatment, and clinical trials after treatment -4 / HP, 1 case had urinary RBCO-2 and WBCo-2 before routine urination and RBCO-1 after treatment
From September 2001 to August 2004, Longqi granules were used for the recovery of meridians during ischemic stroke (cerebral infarction).
WBC0-3; 1 case had urinary RBCO-2 before routine urine treatment and RBC + after consultation; 1 case had clinical efficacy and drug safety observation of Qi deficiency and blood stasis syndrome before routine urine treatment. test. ‖ Pro
RBC3-5, WBCO-3, WBc4-8 / HP after treatment; 1 case was treated with urobilinogen + before routine urine treatment, and the bed treatment trial was designed using a multi-center, randomized, blind method (phase Ⅱ double-blind, III! (Single-blind), positive control prescriptions followed by PRO +, LEU3 +, which were mainly manifested by urinary tract infections, and had nothing to do with medication; liver function test, the control drug was Xiaoshuan granules, and the number of clinical observation cases in the phase 203, of which Positive drug Xiaoshuan granules
There were 1 case of GPT before treatment, 60 cases after treatment, 1 case before treatment, 47 cases after treatment, and 48 cases after treatment; 1 case of renal function test BUN
103 cases, 101 cases in Longqi granule group. The number of clinical observation cases in phase III was 438, of which the positive drug Xiaoshuan Pill was 7.7 before treatment and 7.8 after treatment. All of the above are considered to have no clinical significance except for one exception.
There were 125 cases of granules and 313 cases of Longqi granule group.
[Pharmacology and toxicology] The results of non-clinical pharmacodynamic tests show that this product can increase the total neck movements in anesthetized dogs and anesthetized rats. The criteria for inclusion in clinical trials of the "phase" and "phase" clinical trials are that they meet the western medical diagnostic criteria for cerebral infarction and stroke pulse blood Flow, internal carotid arterial blood flow; can reduce the diagnostic criteria for the meridian recovery period of cerebral diseases including cerebral ischemia in rats with bilateral common carotid artery ligation, and TCM syndromes are the diagnostic criteria for qi deficiency and blood stasis. Drug usage test group: Dragon water volume and brain index, reduce cerebral vascular permeability; can extend the survival time of mice after ligation of bilateral common carotid arteries, Qi granules, 1 packet each time, 3 times a day. Control group; Xiaoshuan granules, 1 packet each time, 3 times a day.
Improve the ability of mice to withstand hypoxia at normal pressure; extend the clotting time of mice (slide method).
The course of treatment is 28 days. The efficacy indicators of this product are mainly to observe the language, motor function and syndrome indicators of patients,
Neurological symptoms and signs. The curative effect evaluation standards mainly include the curative effect of stroke, the curative effect of TCM syndromes,
[Packaging] Packaging for medicinal compound film, 8g / bag × 12 bags.
Changes and improvement of related symptoms and signs.
[Validity] 24 months.
Effectiveness: Phase Ⅰ clinical comparison of stroke and TCM syndromes. Comparison between treatment group and control group. [Executive Standard] State Food and Drug Administration Standard YBZ01132009
Compared with statistics, P <0.01, the differences between the two groups were significant, and the treatment group was better than the control group.
Approval number] National Medicine Standard Z20090083
Comparison of the difference between stroke disease scores and TCM syndrome scores before and after treatment in the two groups: comparison between the two groups before and after treatment [Manufacturer]
The difference was statistically significant, P <0.01; the difference between the groups after treatment was compared, and the differences between the two groups were company names: Hubei Wushi Pharmaceutical Co., Ltd. had significant significance, and the treatment group was better than the control group ; In the two groups before and after treatment, in terms of language expression, upper limb shoulder production address: Section 137, Bilu Road, Anlu City, Hubei Province, upper limb knuckles, lower limb hip joints, lower limb knee joints and comprehensive functions, etc. Code: 432600
After treatment, there were statistically significant differences, but between groups, only language expression, upper knuckle and comprehensive phone number: 0712-5222507
The function was statistically significant, and the treatment group was better than the control group.
Compared with the control group, the treatment group had upper limb dysfunction, lower limb dysfunction, numbness, embarrassing complexion, drooling.Registered address: No. 137 Bijing Road, Anlu City, Hubei Province, statistically significant, P <0.05, the treatment group was better than the control .