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    Home > Active Ingredient News > Infection > Rehabilitation of new fluids for the treatment of chronic skin ulcers in multi-center randomized controlled clinical studies.

    Rehabilitation of new fluids for the treatment of chronic skin ulcers in multi-center randomized controlled clinical studies.

    • Last Update: 2020-09-20
    • Source: Internet
    • Author: User
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    Chronic skin ulcers have complex and varied causes, such as varicose veins ulcers, arterial atherosclerotic ulcers, diabetic ulcers, radioactive ulcers, post-burn ulcers, pressure ulcers, poor healing ulcers after surgery, etc.
    chronic skin ulcers are common diseases, multiple morbidity, easy to delay, can affect the quality of life of patients, serious people even face amputation risk.
    traditional treatment for wound replacement or clean-up surgery, can only remove the local infection of the necrosis tissue, but can not solve other problems difficult to heal the wound.
    Rehabilitation new liquid in the clinical use of skin invasive surface including ulcer treatment has been more applications, in order to further clarify the clinical efficacy and safety of rehabilitation of new liquid, we took Chengdu University of Traditional Chinese Medicine Hospital, Peking University Third Hospital, Shanghai University of Traditional Chinese Medicine affiliated Longhua Hospital, Heilongjiang University of Traditional Chinese Medicine affiliated second hospital as a case collection center, rehabilitation of new liquid treatment of chronic skin ulcers was observed.
    1. Data and Methods 1.1 Clinical Data 1.1.1 General Data Selected from July 2011 to December 2014 at Chengdu University of Traditional Chinese Medicine Hospital, Peking University Third Hospital, Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital A total of 176 outpatients and inpatients at the Second Hospital affiliated with Heilongjiang University of Traditional Chinese Medicine, including 20 cases of atherosclerosis, 49 cases of diabetes, 28 cases of varicose veins, 12 cases of lower limb veins, 37 cases of trauma, and 30 other cases.
    1.1.2 diagnostic standards of Chinese medicine diagnostic standards refer to the "Chinese medicine certificate diagnostic efficacy standards."
    1) Have a history of trauma or infection, long-term bedridden, diabetes, varicose veins in the lower extremities, ionizing radiation, shingles, skin and mucosal laser therapy; The edges are sloped or thickened, the sores subside, pus is scarce or dirty and smelly, the sprouts are gray or dark red, the surrounding skin is dark, the board is hard, it is difficult to heal or heal and easily relapse; 3) The course of illness is more than 1 month.
    1.1.2.1 incorporated into Standard 1) to meet the above-mentioned diagnostic standards for chronic skin ulcers; 2) Age 18 to 80 years old; 3) Voluntary signing of informed consent.
    1.1.2.2 Exclusion Standard 1) TB ulcers, cancerous ulcers and other serious diseases affecting survival; 2) Mentally ill persons; 3) Pregnant or lactating women.
    1.2 Method 1.2.1 The treatment method randomly divided 176 patients with chronic skin ulcers into 59 cases in the rehabilitation new liquid extra-liquid group, 59 cases in the rehabilitation new liquid infusion and external use group, and 58 cases in the befuji external use group.
    all groups were routinely cleaned up, according to the patient's primary onset of disease treatment and related care.
    diabetics are given anti-diabetic drugs to control blood sugar, systemic anti-infection treatment based on bacterial, fungal culture and test results, and local routine clean-up of ulcers, if surgery is required.
    also pay attention to patient nutrition support, improve blood circulation and so on.
    new liquid exoded group to give rehabilitation new liquid (100 ml per bottle, good doctor Ponxi Pharmaceutical Co., Ltd., lot number 170318) for external use.
    new liquid infusion and external use group to give rehabilitation new liquid external use, while oral rehabilitation new liquid 10 ml at a time, 3 times a day.
    Bay Fuji external use group to Befuji (external recombination of cattle alkaline fibroblast growth son, 35000IU per bottle, Zhuhai Esheng Biopharmaceutical Co., Ltd., batch number 161220) for external use.
    All groups are routine clean-up, with dry cotton ball swab dry, rehabilitation of new liquid or befuji using wet or spray, and then no, bacteria gauze wrapped, all daily replacement dressing 1 time, a total of 4 weeks of treatment.
    1.2.2 observation indicators and methods before and after treatment to observe the area of skin loss and ulcer depth, ulcer color, secretions, newborn granulation tissue score.
    1) The area of skin loss and ulcer depth are measured 1 time before and after treatment with round gauge, the size of the ulcer area is calculated by the average length and average width, and the ulcer depth is measured.
    2) Ulcer color integral to the naked eye to observe the ulcer color, before and after treatment was recorded 1 time.
    0: Ruddy; 2: Dark Red; 4: Gray; 6: Purple Black.
    3) ulcer secretion integral, observe the number and odor of the secretion, before and after treatment was recorded 1 time.
    0 points: None; 2 points: a small amount, slightly smelly; 4 points: medium amount, obvious smell; 6 points: more amount, fishy odor.
    4) New granulated tissue integral, the naked eye to observe the growth of granulated tissue, before and after the treatment was recorded 1 time.
    0 points: no growth; 2 points: slow growth; 4 points: faster growth; 6 points: rapid growth.
    5) safety, observe the patient during treatment of pain, itching, allergies and other adverse events.
    1.2.3 efficacy assessment standards by reference to the "Chinese medicine medical certificate diagnostic efficacy standards" formulated, 1) healing: ulcer surface completely healed; 2) Effect: ulcer surface shrinks by 70%; 3) Improvement: ulcer surface shrinks by 30% but by 70%; 4) Invalid: The ulcer surface is reduced by 30%, or there is no shrinking at all, or there is a trend of expansion.
    total efficiency of the total number of cases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
    tracking the efficacy of traceable patients, as the disease is prone to repetition, and the prognosis of traceable patients is also examined.
    1.2.4 Statistical method using SPSS 21.0 software for statistics, the measurement data using the mean standard deviation (χ s) indicated that before and after treatment compared with pairing t test, multi-group comparison using Two-way variance analysis.
    grade data are expressed in cases and percentages and are χ2 tested.
    test level alpha is 0.05.
    2. Results The area of skin loss, ulcer depth, color integration and secretion integral decreased significantly compared to the pre-treatment of this group, and the points of neo-meat bud tissue increased significantly compared to the pre-treatment of this group (P. 0.05);
    the total clinical efficacy of the new liquid exoded group, the rehabilitation new liquid infusion service plus external use group, and the clinical efficacy of the befuji external use group were 94.83%, 96.61% and 92.98%, respectively.
    groups of patients in the course of treatment did not see pain, itching, allergies and other adverse reactions.
    conclusion that the clinical efficacy of the combined external treatment of chronic skin ulcers in the rehabilitation of new liquid infusions is positive, which is better than pure external use in reducing the area of skin loss and improving color, and there are no obvious adverse reactions. After treatment in
    treatment 3. Discussing chronic skin ulcers, also known as refractory ulcers, Chinese medicine believes that "toxic, rotting, shoaling, virtual" is the basic disease mechanism of its formation, the researchers believe that chronic skin ulcers "virtual" "shoal" are mutual cause and effect, gas increase blood clots;
    Chinese medicine has a long history of understanding and treatment of chronic skin ulcers, and puts forward the principles of treatment such as "replenishing the nihilism" and "corrupting myocardial life, long muscle flat skin".
    rehabilitation liquid as a clinical drug, its main components are the Great AmericanDry Bug Extract, the Large Americanis the largest insect in thedepartment.
    And drug use has a long history, "Shen Nong Herbs" records itsmain blood, cold heat, build-up, throat paralysis, internal cold no children", mainly contains peptides, amino acids, nucleosides, alkaloids, its function is to pass the blood veins, to nourish the pubic muscle.
    Modern pharmacological studies show that the rehabilitation of new fluid can significantly increase the number of neutral granulocytes, macrophages, lymphocytes, and improve its spontaneous and tendentious motor function, promote necrotic tissue shedding, create conditions for tissue repair;
    Previous studies have shown that rehabilitation of new fluids has the effects of promoting the growth of granulated tissue, improving the microcirculation of the wound surface, promoting angiogenesis, accelerating tissue repair regeneration, eliminating edema and enhancing the body's immune function, helping to repair and heal the ulcer wound as soon as possible, protecting the ulcer surface from infection and avoiding necrotasia.
    Befuji is an artificial recombinant bovine alkaline fibroblast growth factor, which has obvious tendency to active in traumatic cells, stimulates the movement of fibroblasts, vascular endostropheric cells, etc. to the wound site, and accelerates the healing speed of the wound surface, so this study is set as a control drug.
    results of this study show that the rehabilitation of new fluids alone with the external use of bee fuji can reduce the clinical symptoms of chronic skin ulcers, and clinical efficacy is comparable.
    compared with the treatment of chronic skin ulcers in the past, this study considers that the rehabilitation of new fluid has the effect of toned blood veins, the maintenance of negative muscle, pure external use at the same time also observed the efficacy of external joint oral.
    results showed that the simultaneous use of rehabilitation fluids inside and outside was superior to simple external rehabilitation fluids and berets in improving the area of chronic skin ulcer skin loss and skin loss color.
    source: MedSci Originals !-- content presentation ends -- !-- to determine whether the login ends.
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