Meta AnalysisID 6646

芪明颗粒同时治疗糖尿病眼肾微血管病变的疗效:系统评价和/或Meta分析方案

CRD42020193708

We will perform a systematic review to explore the efficacy of qiming granule in the simultaneous treatment of diabetic microangiopathy on eye and kidney.

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Record Fields

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Meta Analysis Id
6646
Evidence Id
15204
Core Evidence Id
15204
Source Meta Analysis Id
6629
Herb2 Meta Analysis Id
HBMA006629
Crd Id
CRD42020193708
Title
Efficacy of qiming granule in the simultaneous treatment of diabetic microangiopathy on eye and kidney: A protocol for systematic review and/or meta-analysis
Review Question
We will perform a systematic review to explore the efficacy of qiming granule in the simultaneous treatment of diabetic microangiopathy on eye and kidney.
Study Type Included
Inclusion: clinical randomized controlled trial, cohort studies, case series, case reports and clinical studies which are identified as eligible will be included. Exclusion: Excluded studies include conference abstract, expert opinion or suggestion, editorials or letters to the editor with critical appraisal of an article.
Condition Being Studied
Diabetic microangiopathy is a common chronic complication of diabetes mellitus, which causes serious damage to retina and kidney. According to the current research, early diabetic retinopathy, renal microvascular damage will occur in a certain period of time, and the key factor of both lesions is hyperglycemia environment. As a Chinese patent medicine approved by the State Food and Drug Administration in recent years, Qiming granule has been widely used in the treatment of diabetic retinopathy or diabetic kidney disease. However, there is still a lack of systematic review of its effectiveness in the simultaneous treatment of these two diseases . Therefore, we will collect the relevant literature in recent years, and make a systematic review and meta-analysis on its effectiveness and safety.
Participant
(1) DM patients diagnosed with DR and DKD (2) Informed consent and volunteers
Animal
Human Disease Modelled
Intervention
Qiming granule intervention. Other interventions or exposures: combination therapy 1. Combination of drugs and treatment (1) Drugs for routine control of blood pressure, blood sugar and blood lipids during testing. (2) Routine medications during ophthalmic examination: for example, pupil drugs. 2. Note: except for pupillary drugs, the researcher should record all the drugs taken by the subjects in the study history, including the general name of the drug, dosage, starting and stopping time, etc. (note should also be made) if the dosage of the basic drug is adjusted during the study.
Comparator Control
Placebo (on the basis of basic treatment, placebo without effective ingredients of Qiming granules but similar in package and dosage form was given. The usage and dosage of placebo were the same as those of the experimental group) is preferred, and positive control can also be included, or other interventions without Qiming granules.
Main Outcome
Change in main outcomes from baseline to the last available follow-up, measured using general indicators, ophthalmic related indicators, related indicators of renal function and TCM syndromes. 1. General indicators: blood glucose, body weight, glycosylated hemoglobin (HbA1b), systolic blood pressure (SBP), diastolic blood pressure (DBP), total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL-C), high density lipoprotein (HDL-C); 2. Ophthalmic related indicators: visual acuity, retinal microangioma, fundus hemorrhage, hard or soft exudation, retinal neovascularization, pathological section of retina, FFA, OCTA, electron microscopy examination, etc; 3. Related indicators of renal function: 24-hour urine protein, serum creatinine and glomerular filtration rate (GFR), glomerular pathological section, electron microscopy examination, etc; 4. TCM syndromes: symptoms, signs, tongue and pulse. Measures of effect Percentage and ratio were used to express the results of FFA and OCTA: microangioma, bleeding, exudation, neovascularization; at the same time, it can also be used for 24-hour urine protein quantification, glomerular filtration rate, serum creatinine clearance rate, etc. The effect of intervention will be expressed as incidence and odds ratio, outcome indicators and prognostic factors will be observed, and 95%CI will be used to measure credibility. The χ² test and the I² were applied to evaluate heterogeneity of studies.
Outcome Measure
Additional Outcome
Macular thickness, retinal neovascularization, kidney dialysis and kidney transplant Measures of effect Incidence rate and percentage
Study Method
Meta-analysis, Systematic review
Keyword
Diabetes Mellitus; Diabetic Angiopathies; Drugs, Chinese Herbal; Humans; Kidney; qiming
Contact
Doctor Luo [email protected]
Organisational Affiliation
Gansu University of Traditional Chinese Medicine
Funding Source
National Natural Science Foundation of China Lanzhou Talent Innovation and Entrepreneurship Project Grant number(s) <span style=font-size: 14px>State the funder, grant or award number and the date of award</span> 81960888 2019-Rc-62
Other Selection Criteria
Final Publication
Same Topic Review
Published Protocol
Review Type
Language
Country
China
Review Stage
Review Ongoing
First Submission Date
2020-06-30
Registration Date
2020-07-31
Anticipated Start Date
2020-07-15
Anticipated Completion Date
2022-12-31
Title Cn
芪明颗粒同时治疗糖尿病眼肾微血管病变的疗效:系统评价和/或Meta分析方案
Title En
Efficacy of qiming granule in the simultaneous treatment of diabetic microangiopathy on eye and kidney: A protocol for systematic review and/or meta-analysis
Bilingual Status
complete