CN114146162A - Application of recombinant human platelet-derived growth factor PDGF in treatment of chronic neuropathic pain - Google Patents
Application of recombinant human platelet-derived growth factor PDGF in treatment of chronic neuropathic pain Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
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- A—HUMAN NECESSITIES
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Abstract
The invention discloses an application of a recombinant human platelet-derived growth factor PDGF in treating chronic neuropathic pain or preparing a medicament for treating the chronic neuropathic pain. After the injection is locally injected at a diseased point or a pain point or is locally injected around nerves controlling a pain part, the chronic neuropathic pain caused by diabetic foot, herpes zoster or vasculitis can be quickly reduced after 1 day; greatly expands the application of the recombinant human platelet derived growth factor PDGF and provides a new therapeutic drug for chronic neuropathic pain.
Description
Technical Field
The invention relates to the field of biomedicine, in particular to application of recombinant human platelet-derived growth factor PDGF in treating chronic neuropathic pain.
Background
Platelet Derived Growth Factor (PDGF) is a basic protein stored in Platelet alpha granules and is a low molecular weight mitogen. Can stimulate fibroblast, glial cell, smooth muscle cell, etc. arrested in G0/G1 stage to enter into division and proliferation cycle. Platelet-derived growth factor PDGF, a regulatory peptide for stimulating the growth of tissue cells such as connective tissue, which was discovered in 1974, is named because it is derived from platelets, exists in the α -granule of platelets under normal physiological conditions, is released from disintegrated platelets and activated when blood coagulates, and has biological activities of stimulating the chemotaxis of specific cells and promoting the growth of specific cells. In addition, macrophages, vascular smooth muscle cells, fibroblasts, endothelial cells, embryonic stem cells, etc. may also synthesize and release PDGF when tissues are damaged. When the liver is damaged, macrophages, platelets, infiltrating inflammatory cells, damaged endothelial cells and activated hepatic stellate cells can all secrete PDGF.
Recombinant human platelet-derived growth factor PDGF is currently the only bioengineered product of use of all of the numerous growth factors approved by the FDA in the united states as a clinical prescription drug. One application of the recombinant human platelet-derived growth factor PDGF Gel is to use the REGRANEX Gel in the PDGF Gel dosage form as debridement, healing and repair of diabetic end ulcer of limb. The recombinant human platelet derived growth factor PDGF is also a new wrinkle-removing and anti-aging material, and a fibroblast method acting on the dermis can be really absorbed by receptor cells through the dermal layer micromedia so as to achieve good anti-aging and wrinkle-removing effects.
Chronic neuropathic pain is caused by neuronal damage to the peripheral and central nervous systems, involving sensitization of these systems. In sensitization, stimulation of peripheral nociceptors is increased, thereby amplifying pain signals to the central nervous system. In central sensitization, neurons originating in the dorsal horn of the spinal cord are over-stimulated, increasing pain signals to the brain, and thus increasing pain sensation. It is usually associated with chronic allodynia and hyperalgesia. In other words, neuropathic pain is pain that is directly caused by injury or disease to the somatosensory nervous system. Neuropathic pain itself is a disease. For example, the 4 most common types of neuropathic pain in the clinic include diabetic peripheral neuropathy, trigeminal neuralgia, postherpetic neuralgia, and central pain (e.g., post-stroke pain). As another example, 40% of cancer pain has a component of chronic neuropathic pain.
At present, no report exists on the fact that the recombinant human platelet-derived growth factor PDGF can directly or indirectly treat chronic neuropathic pain alone.
Disclosure of Invention
The technical problem to be solved by the invention is to provide a new application of a recombinant human platelet-derived growth factor PDGF.
The invention unexpectedly discovers that the recombinant human platelet-derived growth factor PDGF can treat chronic neuropathic pain, and verifies the action effect of the PDGF on different chronic neuropathic pain through experiments. Based on this, the present invention was made.
In one aspect, the invention provides the use of recombinant human platelet-derived growth factor PDGF for the treatment of chronic neuropathic pain.
On the other hand, the invention also provides application of the recombinant human platelet-derived growth factor PDGF in preparing a medicament for treating chronic neuropathic pain.
The recombinant human platelet-derived growth factor PDGF is a disulfide-bond dimer PDGF-BB consisting of two amino acid B chain monomers.
The chronic neuropathic pain is chronic neuropathic pain caused by diabetic foot, herpes zoster or vasculitis.
The recombinant human platelet derived growth factor PDGF is used by local injection at diseased or painful sites or local injection around nerves controlling painful sites.
The local injection of the pain point is local multi-point injection.
The rapid treatment is a rapid decrease in pain assessment score of more than 30% after 1 day.
The rapid treatment is a rapid decrease in pain assessment score of more than 50% after 1 day.
The invention unexpectedly discovers and proves that the recombinant human platelet-derived growth factor PDGF can effectively treat chronic neuropathic pain; after the injection is used by local injection of pain or local injection around nerves controlling pain parts, the chronic neuropathic pain caused by diabetic foot, herpes zoster or vasculitis can be quickly reduced after 1 day; greatly expands the application of the recombinant human platelet derived growth factor PDGF and provides a new therapeutic drug for chronic neuropathic pain.
Drawings
The foregoing is only an overview of the technical solutions of the present invention, and in order to make the technical solutions of the present invention more clearly understood, the present invention is further described in detail below with reference to the accompanying drawings and the detailed description.
FIG. 1 is a diagram of a peri-sciatic nerve local injection (peripheral injection) method;
FIG. 2 is a graph showing the results of local injection of recombinant human PDGF growth factor around the nerve controlling pain site to significantly alleviate neuropathic pain in mice. The present method typically induces chronic neuropathic pain between 25-35 days. PWT (g) is the force used to trigger pain in the soles of the feet of the mice to lift the paw, expressed in g (grams);
FIG. 3 is a schematic representation of the 0-10 Numerical Pain Rating Scale (NPRS).
Detailed Description
Example 1
The purpose is as follows:
the recombinant human platelet derived growth factor PDGF (recombinant human PDGF growth factor) can quickly and effectively treat chronic neuropathic pain of mice.
The method comprises the following steps:
1. mouse sciatic neuropathy model and research method
Sciatic nerve injury has been used for over a century to study the course of nerve injury. Mosconi and Kruger, 1996, morphologically described a peripheral neuropathy model in which a polyethylene tube cuff (A2 mm long split section of poly-ethylene cuff, ID 0.38mm, ED 1.09mm, PE-20) was placed around the sciatic nerve of a rat or mouse, creating a neuropathic pain model, i.e., a short polyethylene tube cuff placed around the sciatic nerve trunk, causing homoipsilateral thermal hyperalgesia for about 3 weeks, and persistent homolateral mechanical pain for at least 2 months. The paw-touch induced pain (allodynea) of this sciatic neuropathic pain model was assessed using von Frey filiments.
This experiment is not intended to study acute analgesia, but rather to test for persistent allodynia and relief methods, and is generally done by testing the animals in the morning before the fifth dose on the day of consideration, to observe a sustained effect of the treatment on the previous days.
The negative control used in this model of neuropathic pain induced by placement of a short polyethylene cuff around the sciatic nerve trunk was saline, and 0.2ml of saline was locally injected (perineural injection) around the nerve controlling the pain site once a day for 10 days. The experimental administration was 0.1mg/ml X0.2ml local perinervous injection (perineuronal injection) of recombinant human PDGF growth factor, once a day for 10 consecutive days (as shown in FIG. 1).
The recombinant human PDGF growth factor used in this study was a disulfide-bonded dimer PDGF-BB consisting of two amino acid B chain monomers.
2. Mouse sole touch induced pain model and Manual Von Frey research method
The Von Frey test developed by the physiologist Maximilian Von Frey is a gold standard for the assessment of mechanical allodynia in mice. In this test, animals are individually placed in small cages with a mesh or other penetrable bottom. Monofilaments with tip diameters of 0.3 and 0.5mm were applied perpendicularly to the plantar surface of the hind paw until it flexed and provided a constant predetermined force, with mice typically delivering 0.1-7g of force and rats typically delivering 1-80g for 2-5 s. Note that: the force can be increased linearly by rotating the device handle. The response is considered positive if the animal exhibits any nociceptive behavior, including rapid paw withdrawal, paw licking, or paw shaking during application of the stimulus or immediately after removal of the filament. The sole surface is the most commonly used test area.
The specific scheme is as follows:
the purpose is as follows: mechanical sensitivity was assessed using a calibrated Von Frey test.
Experiment design: minimum number of variant animals: 7 males +7 females
Test time: for 10 weeks
The experimental sequence:
(1) habituation: the rats were placed in a laboratory on an elevated wire mesh and allowed to stand for one hour each for acclimation.
(2) The left hind paw was first tested using the following method.
(3) The 0.6g Von Frey test should be used as the starting filament, the filament applied to the plantar surface of the hind paw, and sufficient force applied to the filament to bend the filament and remain in contact for 1-2 seconds.
(4) The size of the next filament depends on the response to the previous filament; if no pullout reaction is observed, the next highest filament is tested; if there is a withdrawal response, the next lowest filament is tested.
(5) The use of the filaments was continued until the paw was tested 5 times with at least 2 minutes between each stimulation.
(6) The test procedure was repeated with the right hind paw.
Test 1: after 24 hours of habituation, mice were retested with the Von Frey test using the same procedure as during habituation.
And (3) testing 2: after 48 hours habituation, mice were retested with the Von Frey test using the same procedure as in the habituation phase.
As a result:
cuff molding (Cuff molding) + saline line control group was injected with 0.2ml of physiological saline once a day for 10 days around the nerve controlling the pain site. Cuff modeling + recombinant human PDGF growth factor group local injection (perineurial injection) of 0.2ml of recombinant human PDGF growth factor (0.1mg/ml) was administered once a day around the nerve controlling the pain site for 10 days. As shown in FIG. 2, the results show that local injection of recombinant human PDGF growth factor around the nerve controlling pain site can obviously relieve neuropathic pain of mice.
Discussion and conclusions:
the research shows that the recombinant human growth factor PDGF is locally injected around the nerve of the pain part to effectively treat the chronic neuropathic pain of the mouse.
Example 2
The purpose is as follows:
the recombinant human platelet derived growth factor PDGF (recombinant human PDGF growth factor) can quickly and effectively treat chronic neuropathic pain related to diabetic foot.
The method comprises the following steps:
the study used a single-blind (single-blind) clinical trial with treatment-following (non-random sampling) clinical trials of patients with chronic neuropathic pain associated with diabetic foot, with placebo saline pain in a local multi-point injection treatment negative control group and recombinant human PDGF growth factor pain in a local multi-point injection experimental group.
The recombinant human PDGF growth factor used in this study was a disulfide-bonded dimer PDGF-BB consisting of two amino acid B chain monomers.
The experimental treatment method is that 5ml of physiological saline or 5ml of recombinant human PDGF growth factor (0.1mg/ml) is injected into the pain part at multiple points every time.
The eligibility of the subject for participation includes age, sex, disease type and stage, and previous treatment or health issues, and then determines who may or may not be involved. The patients enrolled were all pain patients older than 18 years of age. In the study, 20 patients with chronic neuropathic pain related to diabetic foot, 10 recombinant human PDGF growth factor experimental groups and 10 normal saline control groups are studied.
The primary endpoint of this clinical study was a 30% or greater relief of pain symptoms after 1 day of treatment compared to before treatment.
Pain scales are tools used by physicians to help assess pain in patients. A person usually self-reports their pain using a specially designed scale, sometimes with the help of a doctor, parent or guardian. The pain scale may be used during hospitalization, during a visit, during physical activity, or post-surgery. Physicians use pain scales to better understand certain aspects of a patient's pain. These aspects include the duration, severity and type of pain. The pain scale may also help physicians make accurate diagnoses, develop treatment plans, and measure treatment efficacy.
Pain scales use text, images or descriptors to measure pain or pain relief, which is the most common simple method of assessing pain intensity. Each subject was rated on a scale of 0 to 10 or 0 to 5 for their pain. Zero means "no pain", 5 or 10 means "most pain". Pain intensity levels were assessed at the time of initial treatment and periodically after treatment. As shown in fig. 3, is a Numerical Pain Rating Scale (NPRS) rated on a scale of 0 to 10.
The clinical trial protocol was written according to the declaration of helsinki and the guidelines for good clinical practice and was approved by the ethical review committee of the ethical committee of the university of urambit hospital, mongolia. Written informed consent was obtained from each patient prior to starting the protocol normalization procedure. The study was supervised by an independent data and safety monitoring committee.
The statistical analysis needs the CRO company to assist in design. Statistical analysis data were counted using SPSS software 22 (SPSS inc., chicago, il, usa). An accurate test by the CMH- χ 2 (covariance analysis ANCOVA) method Fisher was used to perform the data set between qualitative comparisons, to find the Least Square (LS) mean, i.e., the Least squares mean, and also the 95% confidence interval CI. Student's t-test and analysis of variance were used to quantify the internal and comparative groups between data. Data comparison before and after treatment used paired t-test and repeated measurements.
As a result:
table 1, subjective pain assessment NPRS questionnaire score (n ═ 10) for patients with chronic neuropathic pain associated with diabetic foot 5ml of recombinant human PDGF growth factor (0.1mg/ml) after 1 day local multiple injection of pain.
TABLE 2 percentage of patients with diabetic foot-related chronic neuropathic pain (n 10) patients with recombinant human PDGF growth factor pain the reduction in NPRS (0-10) questionnaire score of > 30% was assessed by subjective pain assessment after 1 day local multipoint injection of the recombinant human PDGF growth factor
Discussion and conclusions:
the recombinant human PDGF growth factor can obviously relieve chronic neuropathic pain related to diabetic foot.
Example 3
The purpose is as follows:
the recombinant human platelet derived growth factor PDGF (recombinant human PDGF growth factor) can quickly and effectively treat chronic neuropathic pain related to herpes zoster.
The method comprises the following steps:
the study studied 20 patients with chronic neuropathic pain related to herpes zoster, 10 experimental groups of recombinant human PDGF growth factor and 10 control groups of normal saline, and the method was the same as that in example 2. As a result:
table 3 subjective pain assessment NPRS questionnaire score (n ═ 10) for patients with chronic neuropathic pain associated with herpes zoster 5ml recombinant human PDGF growth factor (0.1mg/ml) after 1 day local multiple injection of pain.
TABLE 4 percentage of patients with herpes zoster associated chronic neuropathic pain (n 10) patients with recombinant human PDGF growth factor pain after 1 day local multiple point injection subjective pain assessment NPRS (0-10) questionnaire score reduction ≥ 30% ()
Discussion and conclusions:
the recombinant human PDGF growth factor can obviously relieve chronic neuropathic pain related to herpes zoster.
Example 4
The purpose is as follows:
the recombinant human platelet derived growth factor PDGF (recombinant human PDGF growth factor) can quickly and effectively treat mixed chronic neuropathic pain caused by vasculitis.
The method comprises the following steps:
the study studied 20 patients with chronic neuropathic pain induced by vasculitis, 10 experimental groups of recombinant human PDGF growth factor, and 10 control groups of normal saline, the method was the same as that in example 2.
As a result:
table 5, subjective pain assessment NPRS questionnaire score (n ═ 10) for patients with chronic neuropathic pain induced by vasculitis 5ml of recombinant human PDGF growth factor (0.1mg/ml) after 1 day local multiple injection of pain.
TABLE 6 percentage of patients with chronic neuropathic pain induced by vasculitis (n 10) patients with recombinant human PDGF growth factor pain after 1 day local multiple point injection subjective pain assessment NPRS (0-10) questionnaire score reduction ≥ 30% of the test patients (%)
Discussion and conclusions:
the recombinant PDGF growth factor can obviously relieve chronic neuropathic pain caused by vasculitis.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the present invention in any way, and it will be apparent to those skilled in the art that the above description of the present invention can be applied to various modifications, equivalent variations or modifications without departing from the spirit and scope of the present invention.
Claims (8)
1. Use of recombinant human platelet-derived growth factor PDGF for the treatment of chronic neuropathic pain.
2. An application of PDGF in preparing the medicines for treating chronic neuropathic pain is disclosed.
3. The use of claim 1 or 2, wherein the recombinant human platelet-derived growth factor PDGF is a disulfide dimer PDGF-BB consisting of two amino acid B chain monomers.
4. Use according to claim 1 or 2, wherein the chronic neuropathic pain is chronic neuropathic pain caused by diabetic foot, herpes zoster or vasculitis.
5. Use according to claim 1 or 2, by local injection at the affected or painful site or peri-neuro local injection at the site of pain control.
6. The use of claim 5, wherein the local injection of a pain site is a local multi-site injection.
7. The use according to claim 1 or 2, wherein the rapid treatment is a rapid decrease in pain assessment score of more than 30% after 1 day.
8. The use of claim 1, wherein the rapid treatment is a rapid decrease in pain assessment score of more than 50% after 1 day.
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| US20210379152A1 (en) * | 2020-01-20 | 2021-12-09 | Creighton University | Methods and compositions for treating pain |
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| CN106267160A (en) * | 2016-11-02 | 2017-01-04 | 温州医科大学 | A kind of Nerve growth factors slow release aggregate for treating peripheral nerve injury and application thereof |
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