CN111617090A - Clinical application of doxycycline hydrochloride dispersible tablet as medicine for treating demodex disease skin damage - Google Patents

Abstract

The invention relates to an application of doxycycline hydrochloride dispersible tablets in clinic as a medicine for treating demodex disease skin lesions. The medicine is orally taken by patients 1 time a day, 50mg is taken each time, and 4 weeks are 1 course of treatment. Clinical tests prove that the doxycycline hydrochloride dispersible tablet can obviously relieve symptoms of erythema, pimple, nodule, cyst and the like on the face of a patient with demodex disease, and can obviously inhibit leucocyte chemotaxis and granuloma formation in skin lesions of the demodex disease. The medicine has good curative effect, high safety, simple treatment method, wide applicable population, easier acceptance of patients and suitability for popularization.

Description

Clinical application of doxycycline hydrochloride dispersible tablet as medicine for treating demodex disease skin damage

Technical Field

The invention belongs to the field of medicines, relates to a new application of doxycycline hydrochloride dispersible tablets, and particularly relates to an application of doxycycline hydrochloride dispersible tablets in clinic as a medicine for treating demodex disease skin damage.

Technical Field

Doxycycline hydrochloride dispersible tablets (produced by Fuxiang (Dalian) pharmaceutical Co., Ltd.) belong to broad-spectrum bacteriostatic agents and have an antibacterial effect at high concentration. The doxycycline hydrochloride dispersible tablets are mainly applied to the following diseases: (1) rickettsial disease, such as epidemic typhus fever, endemic typhus fever, rocky mountain fever, tsutsugamushi disease and Q fever; (2) mycoplasma infection; (3) chlamydia infections, including psittacosis, venereal diseases, lymphogranuloma, nonspecific urethritis, salpingitis, cervicitis, and trachoma; (4) returning heat; (5) brucellosis; (6) cholera; (7) tularemia; (8) plague; (9) chancroid. The doxycycline hydrochloride dispersible tablet can also be used for treating tetanus, gas gangrene, jatas, syphilis, gonorrhea, leptospirosis, actinomyces and listeria infection of penicillin allergy patients, can be used for adjuvant therapy of moderate and severe acne patients, but the application of the doxycycline hydrochloride dispersible tablet to treatment of demodex disease skin damage is not reported yet.

Demodeiosis is caused by human Demodeiosis, a common parasitic infectious disease mainly composed of pilo-sebaceous gland units of the head, face and chest, and parasitizing only two species of human body, namely Demodeiosis pilaris and Demodernia sebacea. Demodex has been found to be common in the following skin disorders: cutaneous pruritus with or without erythema, telangiectasia or persistent telangiectasia, blepharitis, seborrheic dermatitis, papulopustular rash of the face, scalp or chest and back, perioral dermatitis, hormone-dependent dermatitis, and skin lesions in chemotherapy-induced immunosuppressed patients or AIDS patients.

Recent studies have shown that the pathogenic mechanism of demodex mainly includes: the mechanical stimulation, foreign body reaction, the chemical stimulation of the secretion and excretion of the demodex, which are caused by the demodex body, attract the immune cells of the organism, such as: the neutrophil, NK cell, lymphocyte and the like are involved, so that the organism generates chronic inflammatory reaction, skin inflammation symptoms such as erythema, pimple and the like are generated, in addition, the dead demodex releases inflammatory chemotactic factors in the skin, so that inflammatory cells are gathered and wrap broken demodex fragments to form inflammatory granuloma tissues, and subcutaneous nodules which are difficult to self-heal clinically are shown.

Along with the improvement of the requirements of people on beauty treatment, the psychological pressure of patients with demodex diseases is relieved, and the current treatment of the skin damage of the demodex diseases lacks special-effect medicines. The common medicament has oral ivermectin, can directly kill facial demodex by utilizing the antibacterial action of the ivermectin, cannot prevent the formation of inflammatory granuloma of demodex diseases, and can cause neurotoxicity in large dose; the external medicine comprises the Fumanling, the sulfur ointment and 5 percent of tea tree oil, but the external medicine has long medication period, complex usage, poor curative effect and poor patient compliance; in addition, there are systems using steroid drugs (betamethasone) and the like. Although there are many drugs for treating demodex, there is still a certain deficiency in application.

Disclosure of Invention

In view of the above, the incidence rate of demodex diseases is high, and the treatment lacks special drugs, the invention aims to provide the application of doxycycline hydrochloride dispersible tablets in clinic as the drugs for treating demodex disease skin lesions.

The doxycycline hydrochloride dispersible tablet is a tablet; the medicine is an oral preparation. And (3) packaging the finished product in a pressed film, and packaging in boxes, wherein each box comprises 1 plate and 12 plates (see figure 1, Chinese medicine standard H20060484).

The main component of the doxycycline hydrochloride dispersible tablet is doxycycline hydrochloride, and the chemical name of the doxycycline hydrochloride dispersible tablet is 6-methyl-4- (dimethylamino) -3,5,10,12,12a, -pentahydroxy-1, 11-dioxo-1, 4,4a, 5,5a,6,11,12 a-octahydro-2-tetracene formamide hydrochloride semi-ethanol hemihydrate. Molecular weight: C22H24N2O 8.

Calculated according to anhydrous ethanol-free substances, the doxycycline (C22H24N2O8) content is 88.0-94.0%.

The chemical structural formula is as follows:

the product is light yellow tablet; no smell, bitter taste. Storing at normal temperature.

The product is soluble in water or methanol, slightly soluble in ethanol or acetone, and hardly soluble in chloroform.

The product is precisely weighed, dissolved and diluted by adding methanol solution (1 → 100) of hydrochloric acid solution (9 → 100) to prepare solution containing 10mg per 1ml, and the specific rotation is-105 to-120 degrees calculated by anhydrous alcohol-free substances at 25 ℃.

The doxycycline hydrochloride dispersible tablet is a tetracycline drug, has an antibacterial effect at a high concentration, is orally taken for 2 times every day by adults at a dose of 100mg each time, can cause adverse reactions such as gastrointestinal discomfort, dizziness and the like on part of patients, can slowly disappear after stopping taking the doxycycline hydrochloride dispersible tablet, and has good safety. The low-dose doxycycline is a medicine suitable for treating the skin damage of the demodex disease, is orally taken by an adult for 1 time every day, 50mg every time, 4 weeks are 1 course of treatment, and is taken for 4-12 weeks according to the illness state of a patient.

The invention carries out histopathological examination on the skin lesion of a demodex patient, and the examination shows that the intradermal capillary vessel expands and the blood vessel grows, a granuloma structure is formed above the sebaceous gland, and the granuloma and the dermal superficial layer can show inflammatory cell infiltration (figure 2).

The mechanism of the doxycycline hydrochloride dispersible tablet as a medicament for treating demodex disease shows that:

demodex mite disease is a chronic inflammatory skin disease of the face, neck and chest and back with pilosebaceous unit caused by Demodex mite infection. Demodex mites (see figure 3) parasitize hair follicles and sebaceous glands of humans and mammals, enter the dermis of humans, stimulate proliferation of surrounding keratinocytes and infiltrate lymphocytes around the hair follicles of the Demodex mites. The proliferated demodex destroys hair follicle epithelial cells by chela; its salivary glands secrete catabolic enzymes, causing breakdown of the skin barrier; demodex mites and their tissue fragments were attacked by macrophages, causing granulomas centered on Demodex mites, resulting in erythema, papules, nodule formation, and cyst formation following secondary infection of some skin lesions (FIG. 4 a). Inflammation is a central link in pathogenesis of various skin lesions of demodex diseases, the occurrence and development of the inflammation are closely related to the accumulation of various inflammation factors such as Matrix Metalloproteinase (MMP), active oxygen (ROS), Nitric Oxide (NO) and the like, and doxycycline relieves the inflammatory skin lesions of the demodex diseases by directly inhibiting the activity and synthesis of MMP and eliminating excessive ROS and NO; the leucocyte in the dermis, especially the migration of the neutrophil granulocytes, is an important activity in the early stage of the demodex disease inflammation, after the doxycycline hydrochloride dispersible tablet is orally taken, the medicament is absorbed by gastrointestinal tracts and is widely distributed in tissues and body fluid, wherein the effective component doxycycline molecule reaches the focus of the dermis layer of the skin along with the blood transportation, so that the T lymphocyte proliferation reaction of a human body can be inhibited, and the superoxide anion synthesis and cell degranulation mediated by the neutrophil granulocytes can be inhibited, so that the early stage inflammation process is inhibited.

Meanwhile, the low-concentration doxycycline can inhibit inflammatory reaction by down-regulating tumor necrosis factors TNF-alpha, IL-l beta, IL-8, IL-10 and the like, and can up-regulate cell factors required for repair and regeneration, so that inflammation in the demodex disease skin lesion is gradually relieved, and further development of the demodex disease skin lesion inflammation is prevented. In addition, regarding the granuloma structure formed by the demodex, doxycycline can inhibit the formation of granuloma by antagonizing protein kinase C, so that inflammatory erythema, papules and cysts in the skin lesion of the demodex disease are gradually relieved and removed, and the formation of granuloma caused by the demodex, namely the formation of facial nodules can be effectively prevented. Doxycycline can scavenge ROS in demodex disease inflammation, and this ability also has neuroprotective effect. Doxycycline also inhibits Vascular Endothelial Growth Factor (VEGF) and smooth muscle cell proliferation-mediated angiogenesis, and prevents facial persistent erythema caused by excessive vasodilation and angiogenesis under chronic inflammatory stimuli of demodex disease.

The invention has the advantages that:

the doxycycline hydrochloride dispersible tablet is used for treating skin damage of patients with demodex diseases, and can obviously improve facial inflammatory erythema, pimples, nodules and cysts of the patients with demodex diseases. In clinical research, the total effective rate of treating facial inflammatory erythema, pimple, nodule and cyst with doxycycline hydrochloride dispersible tablet is 91.00%, 82.09%, 61.54% and 76.47%, respectively. The doxycycline hydrochloride dispersible tablet has good treatment effect on demodex diseases, less adverse reaction, simple treatment method and high patient compliance, can effectively eliminate facial skin lesions of patients, and relieves physical and psychological pain of the patients. Thus further proving that the doxycycline hydrochloride dispersible tablet has the function of treating the skin damage of the demodex patients by inhibiting leucocyte chemotaxis and inhibiting granuloma formation.

Description of the drawings:

figure 1 is the medicine appearance diagram of doxycycline hydrochloride dispersible tablet.

FIG. 2 is a pathological diagram of the skin lesion tissue of demodex disease observed under a microscope: granuloma structures in the dermis and inflammatory cell infiltration around the superficial and granuloma structures in the dermis.

FIG. 3 is a diagram of demodex observed under a microscope.

Figure 4a repeated erythema nodulocyst of the patient's face.

FIG. 4b patient treated at week 8 with substantial regression of facial erythema, flattening of some papules, slightly improved cysts than before, and no new nodules.

FIG. 4c shows that after the patient is treated for 12 weeks, the papule of the face erythema is flattened and disappeared, the cyst is obviously improved, and no obvious new hair and recurrent skin damage are seen.

FIG. 5a shows diffuse distribution of inflammatory erythema and pimples on a patient's face.

FIG. 5b patient treated at week 4, facial inflammatory erythema was reduced, local papules were spared, and inflammatory erythema was substantially resolved.

FIG. 5c patient had 8 weeks of treatment with disappearance of inflammatory erythema on the posterior aspect, recovery of the papules, visible post-inflammatory pigmentation spots scattered in the distribution, and no visible new hair and recurrent skin lesions.

FIG. 6a shows the patient's face is interspersed with erythema and papules.

Figure 6b patient treatment week 4, the papules on the face subsided and the inflammatory erythema partially subsided leaving local pigmentation.

FIG. 6c the patient had 8 weeks of treatment and the facial lesions had resolved without new hairs and recurrent lesions.

FIG. 7a shows a patient with erythema and pimple in the middle of the face.

FIG. 7b patient treated week 4 with significantly lighter facial erythema and more advanced localized papules.

FIG. 7c the erythema on the facial lesions had substantially resolved compared to the previous lesions, and the papules were completely healed without visible new and recurrent lesions, after 8 weeks of treatment.

FIG. 8a patient with erythema, papular nodule cyst.

FIG. 8b shows that at week 4 of treatment, bilateral cheek erythema is pale, localized papules are more profound, nodules formed by inflammatory granulomas are more moderate, and facial cysts are more profound.

FIG. 8c shows that after 8 weeks of treatment, the erythema of the facial skin lesion is obviously lightened, the papules are completely restored, the nodules are obviously restored, the inflammatory cysts are obviously improved, and no obvious new hair or recurrent skin lesion is seen.

FIG. 9a shows recurrent erythema on the patient's face.

FIG. 9b patient treated week 8 with a pale erythema on the facial lesions.

FIG. 9c the patient was treated for 12 weeks with substantial regression of erythema in the facial lesions and no visible new and recurrent lesions.

FIG. 10a shows repeated erythema and pimples on the patient's face.

FIG. 10b patient treated week 8 with pale erythema on the facial lesion, more advanced and more gradual local papules, and no new nodules.

FIG. 10c shows that after 12 weeks of treatment, the erythema on the facial lesions became markedly lighter than before, the papules were completely restored, and no new and recurrent lesions were evident.

Detailed Description

The invention will be described by taking a typical case as an example and combining the attached drawings, wherein the curative effect of doxycycline hydrochloride dispersible tablets as a medicine for treating skin lesions of patients suffering from demodex diseases is described as follows:

typical case 1: madam, male, 16 years old, visited a dermatology clinic of our hospital for 7 months in 2018 for "papulopapular nodule cyst on face 1 year" (fig. 4a), and the patient felt that the face was accompanied by mild itching. The skin lesion and hair follicle secretion of the patient are observed under a microscope to have the demodex existence, and the disease is diagnosed as demodex disease. When treating, patients should take doxycycline hydrochloride dispersible tablets orally 1 time a day, 50mg each time. At the 8 th week of treatment (fig. 4b), the patient had a pale erythema on the facial skin lesion, a more advanced and more moderate local papule, a slightly more advanced nodule formed by inflammatory granuloma, and a slightly better facial cyst; after the 12 th week of treatment (fig. 4c), the erythema of the facial skin lesion of the patient was significantly reduced earlier, the papules were completely restored, some nodules were significantly restored earlier, and inflammatory cysts were significantly improved earlier. The skin lesion does not relapse after 6 months of follow-up. As can be seen from fig. 4a to 4c, the patient's skin lesions improved significantly and the erythematous papulocyst regressed significantly.

Typical case 2: zhang, female, 42 years old, visit a clinic of dermatology department of our hospital for 8 months in 2019 due to the fact that the diffuse erythema papule nodule on the face is 6 months "(figure 5a), the existence of demodex is observed under an objective lens for skin damage and hair follicle secretion, the demodex disease is diagnosed, and a patient is ordered to take the doxycycline hydrochloride dispersible tablet orally 1 time per day, 50mg each time when in treatment. At week 4 of treatment (fig. 5b), the diffuse flush erythema area of the patient's face was reduced, the color was slightly lighter than before, and the local papules were more profound; after 8 weeks of treatment, the patient had a significant regression of the erythema, a reduction in the papules and a reduction in the subcutaneous nodules formed by granuloma than before (FIG. 5 c). The skin lesion does not relapse after 6 months of follow-up. As can be seen from FIGS. 5a to 5c, the patient's skin lesions improved significantly and the erythema papule nodules regressed significantly.

Typical case 3: a certain horse, a female, 34 years old, and 1 month in 2019, the patient is diagnosed with the demodex disease because of the 'erythema nodosum papule-1-month' (figure 6a) in an outpatient service of dermatology in our hospital, the existence of demodex is observed under objective lenses for skin damage and hair follicle secretion, the patient self-complains about pruritus symptoms, and the patient is ordered to take the doxycycline hydrochloride dispersible tablets orally 1 time per day and 50mg each time when the treatment is carried out. After 4 weeks of treatment (fig. 6b), the patient had a pale facial erythema, and a reduction in the area of the facial erythema, a reduction in inflammatory infiltration, a reduction in swelling, and a more gradual recovery of the local papules was observed; after 8 weeks of treatment, the lesions healed (fig. 6c), no erythema papules were evident on the face and the swelling subsided significantly. The skin lesion does not relapse after 6 months of follow-up. As can be seen from FIGS. 6a to 6c, the patient's skin lesions improved significantly and the erythema pimples regressed significantly.

Typical case 4: a certain Gong is diagnosed in an outpatient clinic of dermatology of our hospital in 2019 because of 'erythema and pimple in the middle of the face with pruritus for 6 months' (fig. 7a) in 40 years of age for a certain female, and the skin lesion and hair follicle secretion of a patient are observed to have the demodex under a microscope, so that the patient is diagnosed with the demodex disease. When treating, patients should take doxycycline hydrochloride dispersible tablets orally 1 time a day, 50mg each time. At week 4 of treatment (fig. 7b), the patient had significantly lighter erythema than before and more advanced localized papules; after week 8 of treatment (fig. 7c), the erythema in the patient's facial lesions had substantially subsided and the papules were completely restored. The skin lesion does not relapse after 6 months of follow-up. As can be seen from FIGS. 7a to 7c, the patient's skin lesions improved significantly and the erythema pimples regressed significantly.

Typical case 5: thanks to a certain woman, 20 years old, and 12 months in 2018, the patient visits the outpatient department of dermatology in our hospital for "erythema pimple nodule cyst 1 year" (fig. 8a), and the face of the patient is consciously accompanied by mild pruritus. The skin lesion and hair follicle secretion of the patient are observed under a microscope to have the demodex existence, and the disease is diagnosed as demodex disease. When treating, patients should take doxycycline hydrochloride dispersible tablets orally 1 time a day, 50mg each time. At week 4 of treatment (fig. 8b), the patient had pale cheek erythema on both sides, localized papules were more flattened than before, nodules formed by inflammatory granulomas were slightly flattened, and facial cysts were slightly better than before; after 8 weeks of treatment (fig. 8c), the erythema of the facial skin lesion of the patient was significantly reduced earlier, the papules were completely restored, some nodules were significantly restored earlier, and inflammatory cysts were significantly improved earlier. The skin lesion does not relapse after 6 months of follow-up. As can be seen from fig. 8a to 8c, the patient's skin lesions improved significantly and the erythematous papulocyst regressed significantly.

Typical case 6: a certain patient, male, aged 53 and diagnosed as Demodex mite disease, was visited in an outpatient clinic of dermatology of our hospital for 11 months in 2019 due to repeated erythema and pruritus on the face (fig. 9a), and the skin lesions and hair follicle secretions of the patient were observed under a microscope to have Demodex mite. When treating, patients should take doxycycline hydrochloride dispersible tablets orally 1 time a day, 50mg each time. At week 8 of treatment (fig. 9b), the patient's facial lesions turned pale in erythema; after week 12 of treatment (fig. 9c), the erythema had substantially subsided in the facial lesions of the patients. The skin lesion does not relapse after 6 months of follow-up. As can be seen from FIGS. 9a to 9c, the skin lesions of the patients were significantly improved and the erythema was significantly resolved.

Typical case 7: a certain Wang, a woman in 52 years, is diagnosed in an outpatient clinic of the dermatology department of the same hospital for 7 months in 2019 due to 'erythema on the face and pimple 6 months' (figure 10a), and the face is consciously accompanied by mild pruritus. The skin lesion and hair follicle secretion of the patient are observed under a microscope to have the demodex existence, and the disease is diagnosed as demodex disease. When treating, patients should take doxycycline hydrochloride dispersible tablets orally 1 time a day, 50mg each time. At week 8 of treatment (fig. 10b), the patient had a pale erythema on the facial lesion with a more prominent reduction in localized papules; after week 12 of treatment (fig. 10c), the patient had significantly lighter erythema on the facial lesions than before and the papules were completely restored. The skin lesion does not relapse after 6 months of follow-up. As can be seen from FIGS. 10a to 10c, the patient's skin lesions improved significantly and the erythema pimples regressed significantly.

The invention treats demodex patients, and carries out statistical analysis on the result:

(1) clinical data: 200 demodex patients treated in an outpatient clinic of dermatology in 2017 to 2019 within 12 are selected, wherein 166 female patients (83.00%), 34 male patients (17.00%), the age is 16-72 years, the average (32.17 +/-3.74) year, the course of disease is 0.10-14 years, and the average (3.94 +/-5.01) year. The test group is 100 cases of doxycycline hydrochloride dispersible tablet treatment group, and the control group is 100 cases of compound betamethasone treatment group. Clinical trial No.: ChiCTR-IPR-15006451.

(2) Reagents and materials: doxycycline hydrochloride dispersible tablets 0.1 g/tablet (manufacturing enterprise: Fuxiang (Dalian) pharmaceutical Co., Ltd.); compound betamethasone injection 1 ml/injection (manufacturing enterprise: Hangzhou Moshadong pharmaceutical Co., Ltd.)

(3) Grouping standard: inclusion criteria were: clinical presentation was consistent with demodex disease and facial demodex microscopic positive (figure 3). Exclusion criteria: pregnant women, lactating women and women with recent birth schedules; patients with serious primary diseases such as cardiovascular diseases, liver diseases, kidney diseases, gastrointestinal diseases and hematopoietic diseases; patients with psychosis and tumor; patients allergic to tetracycline and betamethasone in the past refuse hormone therapy.

All patients enrolled signed informed consent.

(4) Observation indexes and therapeutic effect evaluation standards: all patients are graded by fixed doctors before and after taking medicine, indexes comprise erythema, pimples, nodules and cysts, and each index is graded according to a four-level grading method: no point of 0, a lightness meter of 1, a moderate point of 2 and a severe point of 3.

Efficacy index is (pre-treatment-post-treatment) total score/pre-treatment total score x 100%.

And (3) curing: the curative effect index is more than or equal to 90 percent, and the skin damage is basically subsided in clinical manifestation;

the effect is shown: the curative effect index is more than or equal to 60 percent and less than 90 percent, and most of the skin damage is removed;

improvement: the curative effect index is more than or equal to 30 percent and less than 60 percent, and the skin damage is reduced to some extent;

and (4) invalidation: the curative effect index is less than 30%, and the skin damage is not obviously improved.

The total effective rate is (cure + significant effect)/the total number of people is multiplied by 100%.

(5) The treatment method comprises the following steps: experimental groups: the doxycycline hydrochloride dispersible tablets are taken with warm water, 50 mg/time is taken, 1 time is taken every day, 4 weeks are 1 course of treatment, the treatment is carried out for 4-12 weeks according to the skin lesion severity of a patient, and the follow-up visit is carried out for 6 months after the treatment is finished; control group: the injection is 1 ml/time, 3 weeks 1 time, 3 times, and the follow-up visit is 6 months after the treatment.

TABLE 1 comparison of erythema after treatment in two groups of patients

I

Group of	Number of examples	Cure of disease	Show effect	Improvement of life	Invalidation	Effective rate (%)
							Experimental group	100	72	19	7	2	91.00
Control group	100	74	20	5	1	94.00

TABLE 2 comparison of pimples after treatment in two groups of patients

Group of	Number of examples	Cure of disease	Show effect	Improvement of life	Invalidation	Effective rate (%)
							Experimental group	67	43	12	9	3	82.09
Control group	75	36	22	12	5	77.33

TABLE 3 comparison of nodules after treatment in two groups of patients

Group of	Number of examples	Cure of disease	Show effect	Improvement of life	Invalidation	Effective rate (%)
							Experimental group	13	5	3	3	2	61.54
Control group	11	6	1	2	2	63.63

TABLE 4 comparison of cysts after treatment in two groups of patients

Group of	Number of examples	Cure of disease	Show effect	Improvement of life	Invalidation	Effective rate (%)
							Experimental group	17	9	4	3	1	76.47
Control group	20	13	3	2	2	80.00

Observing each index, the total effective rate of doxycycline hydrochloride dispersible tablets for treating inflammatory erythema, pimples, nodules and cysts of patients is 91.00%, 82.09%, 61.54% and 76.47% respectively, and the total effective rate of compound betamethasone injection for treating inflammatory erythema, pimples, nodules and cysts is 94.00%, 77.33%, 63.63% and 80.00% respectively.

The response of both groups of drugs in the treatment of demodex lesions: in the doxycycline hydrochloride treatment group, 2 patients have gastrointestinal discomfort symptoms, but the symptoms show tolerance and relieve themselves after stopping taking the medicine; in the compound betamethasone treatment group, 4 patients have slight atrophy of local skin after the facial cyst is disappeared, 1 patient has the symptom of trunk hirsutism, 2 patients have acne on the face, 6 patients have telangiectasia, and 35 patients complain about the conditions of weight increase and facial swelling.

Glucocorticoids (such as betamethasone) have strong anti-inflammatory action, are widely applied to skin diseases, can inhibit a plurality of inflammatory reactions in the pathogenic links of the demodex diseases, have certain curative effects on the inflammatory skin lesions of the demodex diseases, but have great side effects (such as local skin atrophy, fat redistribution, hirsutism, acne, folliculitis and telangiectasia) caused by long-term use of the glucocorticoids, and have a plurality of contraindications (hypertension, diabetes, gastrointestinal ulcer, osteoporosis and the like) in use. The doxycycline hydrochloride dispersible tablet can obviously improve inflammatory erythema, pimple and cyst skin damage in demodex diseases, has a certain treatment effect on facial nodule symptoms, can avoid side effects caused by systemic hormone use, and can overcome contraindications of hormone use. The doxycycline hydrochloride dispersible tablet with low dose can inhibit inflammation by inhibiting chemotaxis of leucocytes, effectively avoid formation and further development of inflammatory granuloma by antagonizing protein kinase C, and has the advantages of simple treatment method, good patient compliance, wide applicable population and small side effect. Compared with demodex diseases of two groups of patients after treatment, doxycycline hydrochloride dispersible tablets are superior to glucocorticoid (compound betamethasone injection).

From clinical applications, we recognize that: demodex is a common chronic inflammatory disease. The research shows that: demodex mite disease is a genetically predisposed skin disease mediated by a specific immune function deficiency or reduction in the host. The skin barrier function is damaged through mechanical stimulation and inflammation mediation, and then skin lesions such as erythema, pimples, nodules and cysts are formed. In addition, the skin temperature is increased, the oily or mixed skin and the face are poor in cleaning condition, the face is thick in makeup, and other inducements cause the change of the skin microenvironment and the stimulation of the proliferation of the demodex, so that the occurrence of the demodex diseases is caused. The doxycycline hydrochloride dispersible tablet is absorbed into blood through intestinal tract after being orally taken, and relates to a plurality of links of the pathophysiology of demodex disease through a plurality of anti-inflammatory action mechanisms. Clinical tests show that the low-dose doxycycline can inhibit further development of the demodex disease inflammation, can effectively relieve facial inflammatory skin damage of the demodex, simultaneously prevent further formation of granuloma, cannot cause dysbacteriosis in an organism, and has few adverse reactions.

The doxycycline hydrochloride dispersible tablet oral tablet is used for treating skin lesions of patients with demodex diseases, can obviously improve symptoms of inflammatory erythema, pimple and cyst and prevent the formation and development of nodules after the doxycycline hydrochloride dispersible tablet oral tablet is taken, has obvious treatment effect on the inflammatory skin lesions of the patients no matter the patients with the demodex diseases are in early stage or late stage, and obtains exact clinical curative effect through clinical application. Clinical studies confirmed that: the doxycycline hydrochloride dispersible tablet has a good treatment effect on skin damage of demodex patients, is simple in use method, high in patient compliance, wide in application population, less in adverse reaction and capable of being gradually popularized.

Claims (1)

1. The doxycycline hydrochloride dispersible tablet is applied to the clinic as a medicine for treating demodex disease skin damage, and the clinical application method comprises the following steps: the preparation is administered orally 1 time daily, 50mg each time, and 4 weeks are 1 course of treatment.

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