Background Introduction
Myopia is one of the common ophthalmic diseases in China, especially in East Asia where the prevalence rate of children is as high as 90%. The length of the eye axis is closely related to the degree of myopia, and for every 1mm increase in the eye axis, it increases the diopter of 3D myopia. Myopia and its accompanying symptoms have become a serious public health problem.
Myopia prevention and control methods include defocus glasses, multifocal soft lenses, corneal shaping lenses, low concentration atropine, etc. Among the drugs used for myopia intervention, there is relatively little research on the impact of other drugs on the progression of myopia, except for atropine.
Difa Ming Pian is the only oral medication used in the European Union and Hong Kong to treat myopia, mainly composed of European blueberry fruit anthocyanin extract and β- Carotenoids. The pharmacological effects of Difaming tablets on myopia are as follows:
1. Suppress the expression of MMP2, increase the content of type I collagen, control the growth of the eye axis, and inhibit the increase of refractive index;
2. Improve the thickness of the choroid and sclera, increase choroidal blood flow, and improve fundus microcirculation;
3. Eliminate free radicals and combat peroxidation;
As early as 1977, Difrarel was used for the treatment of myopia. With more and more clinical research, we have the following clinical reports to verify the safety and effectiveness of Difrarel tablets.
1. Thirteen years of treatment for progressive myopia (treatment for progressive myopia)
-F. Ruel and D. Regal - Extra des archives ophtaimologie 1971, t, 31 (pp. 345-348)
2. A retrospective study on the effect of oral Difrarel tablets on controlling high myopia in children
-Deng Hongwei et al. - Chinese Journal of Practical Ophthalmology, Volume 31, Issue 8, August 2013, 1006-1007
3. The effect of European blueberry fruit extract on form deprivation myopia in guinea pigs
-Deng HW, Tian Y, Zhou XJ, Zhang XM, Meng J. -Journal of Ocular
Pharmacology and Therapeutics Volume 32, Issue 4. 2016. PP 196-202
4. Progress of Difrarel in alleviating high myopia in children: a 2-year follow-up study report
-Ismail Ahmed Nagib Oma Clin Ophthalmol.2018 Dec 12; 12: 2575-2579.
5. Effects of blueberry anthocyanins on the expression of MMP2 and collagen in human embryonic scleral fibroblasts
-Liu Limin et al. Chinese Journal of Pathophysiology 2018,34 (7): 1291-1296
In order to solve clinical difficulties and verify the effectiveness of Difa Mingpian in inhibiting axial growth and controlling refractive deepening in children with myopia, ophthalmologists are invited to collect relevant treatment cases. The specific collection method is as follows.
Case Collection Direction
Clinical observation on the use of Difrarel alone/in combination for myopia prevention and control
Case requirements
（1） Please complete the "Case Collection Form" (written or electronic)
1. Please fill in the basic information section completely (desensitize the patient's name)
2. The treatment process (dosage/frequency/duration of medication, etc.) and the observation of the progress of the condition need to be filled out in detail. The attached image for the examination should include the name of the case (desensitization treatment) and the examination time. The treatment observation period should be at least 3 months and at most 12 months.
During the overall treatment process of the patient, if they have previously used or combined with other drugs/special lenses for myopia prevention and control, they need to be described.
（2） Main indicators
1. Detect and count the refraction values of patients with ciliary muscle paralysis before and after treatment;
2. Detect and count the patient's eye axis before and after treatment;
（3） Evidence collection
The equipment and methods for examination before and after taking medication should be consistent. Evidence collection is guaranteed to be conducted using clinically recognized and effective methods, with clear images involved.
（4） Information desensitization
1. Desensitization involving patient identity information in the solicitation form and testimony (* can be used instead of the second character in the patient's name)
2. If patient privacy is involved in the image, mosaic processing can be performed
Submission Method
1. The case data (case collection form and its attachments) participating in this project can be found in the "Myopia Prevention and Control Clinical Clinic" provided by BGI Company
Upload under the exclusive account for case collection. www.szdll.com
2. Alternatively, submit the case collection form (written or electronic) to local case collection personnel for assistance in uploading.
3. Project contact person: Miss Jiang 18410176990 Miss Huang 17875500816
Difa Mingpian China Listed Holder
Huizhou Baijirui Pharmaceutical Co., Ltd
2023-5-22
