| BackgroundRecurrent oral ulcer is high incidence of a disease of the oral mucosa, comparative stubborn a kind of disease, mainly for oral mucosa appeared again and again isolated, round or oval, shallow small ulcers single or multiple in any part of the oral mucosa with local severe burning-sensitive pain. Hot and cold are the stimulation such as sour and sweet and amplifying pain, pain, effect on language, diet, the course of lingering, seriously affect patients healthy and work study. For the treatment of recurrent oral ulcer, most commonly used method for received alimta, i. e., adopting anti-inflammatory pain, disease control much choose hormone (such as prednisone, dexamethasone) and methods of immunosuppression cellulose dissolved. Western medicine therapy effect is not ideal, side effects of larger, and the recurrence rate is high, often make patients lose treatment confidence. TCM therapy for recurrent oral ulcer has good effect, especially in improve patients'symptoms have relatively obvious advantages and fewer side effects.Pearl Dropping Pills is the traditional Chinese medicine developed by six new drugs of guizhou dropping PE hundred pharmaceutical Co. LTD. The prescription is made of herba Inulae cappae, licorice,borneol, pearl four kinds of medicinal composition. Priorities The drug, a detoxification medicine shall share the pain, muscle of reactive power, also a dressing charge acetanilide detumescence effect. Indications recurrent oral ulcer.ObjectiveThe purpose of this study is to evaluate the therapeutic effect and adverse reaction of Pearl Dropping Pills in treatment of Recurrent oral ulcer (Syndrome Of Intense Heat In Heart And Spleen). At the same time,to appraise the clinical curative effect and measure the security of this medicine by comparing with the nothing medicine. All the conclusion is to be offered scientific basis for clinical application.MethodsIt was a random,double blind, group controled study comparing with the placebo.60 patients with Recurrent oral ulcer were divided into 2 groups at random; the ratio of the test group and the control group is 1:1. The test group was treated with Pearl Dropping Pills 0.2g, per os,4 times a day for 5 days. The control group was treated with placebo 0.2g, per os,4 times a day for 5 days. All participants are check before and after drug. including renal function, electrocardiogram, liver function, blood and urine and shit routine. Drug use five days after the appointment, observation main clinical symptoms, signs, record adverse reactions, physical and chemicalexamination, compared to above index dropping, evaluation of the effectiveness and safety of Pearl Dropping Pills.The results 1. The main clinical symptoms, signs comparison:treatment before two group main symptom score was not statistically significant (P>0.05), material comparable. Five days later, between treatment group was statistically significant comparative, difference (P<0.01), illness, there were significant differences in the two groups. Before and after the treatment group housed within their comparison, are statistically significant difference (P<0.01), the control group have only improves pain difference (P<0.05).2. The total score comparison:TCM symptoms before and after the treatment group was statistically significant difference (P<0.01), the drug could evidently improve test condition. The control group compared before and after the treatment group, differences in was not statistically significant (P>0.05), contrast drugs cannot improve disease. Two groups of drug comparison (P<0.001), TCM group significantly improve sickness.3. The clinical curative effect of traditional Chinese medical syndrome 4.75%more comparison:clinical cure 4 cases, powerfully in 12 cases, effective in 12 cases, invalid in 2 cases; The control group got clinical cure 0 example,7 cases, effective in 15 cases, invalid 8 cases. The Ridit analysis, (P<0.01), two groups compare clinical curative effect of traditional Chinese medical syndrome there were significant differences in group a, better than control.4. The clinical curative effect of traditional Chinese medical syndrome and greater rate, total have rate quite:greater rate group decreasing, always have rate 93.3%; The control group, the total effective rate 23.3% explicitly 73.3%. The x2 inspection (P<0.05), two group of subjects and the total effective rate of greater than in statistically significant. Effective treatment group with notable effect.5. The fifth day subjects pain disappears, and ulcer healing situation comparison:4.75%more pain disappears rate by 40%, ulcer healing rate 13.3%; The control group pain disappears rate 6.7%, ulcer healing rate is zero. The x2 inspection (P<0.05), a statistically significant difference. Trial drug can promote ulcer surface healing, obviously alleviate pain.6. Security comparison:two groups before and after the subjects take blood routine, routine urine, and routine, liver, kidney and electrocardiogram safety check, not found out about the adverse reaction of. (P>0.05), the difference was not statistically significant.ConelusionThis clinical observation results show that pearl dropping pills have good fuctions of detoxified & analgesic therapy, and getting rid of saprophyte & bringing about vitality, and can be significant to make better of patient's main symptoms & signs who has a sickness of recurrent oral ulcer (Syndrome Of Intense Heat In Heart And Spleen). They can reduce ulcer pain & burning, promote ulcer healing, relieve dry mouth thirsty & dry constipation and related symptoms. The Total effective of clinical treatment is to 93.3%. Before and after treatment, with safety checks of geochemical indexes, the drug is found no adverse reactions related, therefore it is a safe and effective drug which can be used to popularize. |
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