Self-Heating Bitong Cataplasm Pharmacodynamics And Its Clinical Efficacy Of KOA

ObjectiveThis paper will study the safety and efficacy of the combined application of Bitong cataplasm and self-heat paste. It will be applicated in clinical on the basis of the safety and efficacy, and the clinical efficacy of curing the knee rheumatism will be observed by the methods of clinical epidemiology, clinical research methodology and mathematical statistical methods To provide a basis for researching new formulations, improve the clinical efficacy, it will improve the cataplasm currently in clinical use.MethodAn experimental study of clinical drug safety evaluation about using Bitong cataplasm in combination with spontaneous thermal paste:By means of animal experimental to evaluate the clinical drug safety of using Bitong cataplasm in combinaton with spontaneous thermal paste. Selected New Zealand rabbits used in acute toxicity test, medication skin irritant experiments; select albino guinea-pigs for skin allergy test.Selects the Bitong cataplasm and spontaneous thermal paste as an experimental drug, on the basis of difference experimental require to establish a control group for the following experiments.(A) Acute skin toxicity test of Bitong cataplasm and spontaneous thermal paste used in combination;(B) Experimental study of irritant skin medication for Bitong cataplasm and spontaneous thermal paste used in combination;(C) Experimental study on the skin irritation for Bitong cataplasm and spontaneous thermal paste used in combination.The pharmacodynamic studies of Bitong cataplasm and spontaneous thermal paste used in combination:Choose SPF experiment NIH mice for pharmacodynamic experimental study. To observe inflammatory response inhibition of pain, swelling and other symptoms by using Bitong cataplasm in combination with spontaneous thermal paste, provides a basis for external used Bitong cataplasm in combination with spontaneous thermal paste on clinical. Respectively, chose appropriate preparations from the Western medicine and the same type traditional Chinese medicine as the sample for comparative experiments. Select LaTeX voltaren (diclofenac diethylamine latex reagent), Tianhe gutong plaster, bitong cataplasm, Bitong cataplasm and spontaneous thermal paste used in combination as an experimental drug.Establishment of control group, voltaren LaTeX group, Tianhe gutong plaster, bitong cataplasm groups, Bitong cataplasm and spontaneous thermal paste used in combination set the following experiment.(A). Bitong cataplasm and spontaneous thermal paste used in combination on intraperitoneal injection of acetic acid stimulates twisting response of mice induced by pain;(B). Bitong cataplasm and spontaneous thermal paste used in combination effect on the hot-plate induced pain response in mice;(C). Bitong cataplasm and spontaneous thermal paste used in combination effect of mouse auricle swelling induced by p-xylene;(D). Bitong cataplasm and spontaneous thermal paste used in combination on rats effects of serotonin levels in the blood.All measurement data indicate by the mean plus or minus the standard deviation (x±s). Multiple mean comparison of single factor analysis of variance (One-Way ANOVA), the comparison groups mean22, using the LSD-t method for equal variance; Dunnett’s T3for unequal variances, and draw the histogram. Completed by SPSS15.0software, a=0.05. K-W rank test for count data,22LSD-t test for compared in two groups.Clinical research:Select patients with knee osteoarthritis from January to July2013in orthopaedic of our hospital, including outpatient and hospitalization for the study. Meet the doctors diagnosed with unilateral KOA and traditional Chinese medicine diagnosed as knee rheumatism is rheumatism by lacked of yang90cases. Using random numbers method90patients were randomly divided into3groups, each group of30patients. Bitong cataplasm and spontaneous thermal paste used in combination (test group):using Bitong cataplasm a combination of spontaneous heating application, external application on affected part, one group at a time, one day at a time. Bitong cataplasm Group (experiment Ⅱ)-Bitong cataplasm group, using Bitong cataplasm, groups of topical one pill, once a day. Control group:external application of Tianhe gutong plaster over one pill, once a day. WOMAC score evaluation before and after treatment in the treatment efficacy. Normal distribution of metering data indicate by mean±standard deviation (x±s), using paired t test to analysis the difference of patients with arthritis of the knee which using Bitong cataplasm and spontaneous thermal paste in combination and free bitong cataplasm and control group in symptoms after treatment improved, P<0.05believes that differences between two sets of data are statistically significant. Non-normal distribution of the measurement data indicate by the median and quartile, using the Wilcoxon statistics. K-W test for determine the differences between groups, P<0.05as a statistically significant. To compear with differences in treatment between groups.Rusults(A) During the clinical drug safety, there are no clear positive results in the experiment of skinny acute toxicity with the combined application of rheumatism cataplasm and Natural heat paste, no clear positive results in skin in the pathological section. In summary, it is said that the combined application of rheumatism cataplasm and Natural heat paste is safe and low rate of hypoallergenic.(B) In the study of drug efficacy experiment, under the combined application of rheumatism cataplasm and Natural heat paste there is obvious inhibition in the mice’response to the pain caused by acetic acid and caused by heating plate, it can reduce the weight of mice ears and its swollen rate, improve obviouly the quantity of serotonin in mice blood. General speeking, there are such three advantages in the combined application of rheumatism cataplasm and Natural heat paste(C)Before and after comparing the treatment of pain:after14days of treatment, the patients feel better about the knee pain in three groups, the combined application of rheumatism cataplasm and Natural heat paste group, the rheumatism cataplasm group, and the control group Compared with before treatment, a significant difference (KW test, P=0.001) between the combined application of rheumatism cataplasm and Natural heat paste group and the rheumatism cataplasm group, poultice from the heat associated with the group before and after treatment compared with arthralgia paste poultice group, the difference was statistically significance (using Dunnett T3multiple comparisons, self-heating group and poultice group, P=0.014); arthralgia poultice paste from the heat associated with the group before and after treatment compared with the control group score, the difference was significant (non-normal data state, using the Wilcoxon test, P=0.000).(D)Before and after stiff treatment comparison:14days of treatment, arthralgia associated with self-heating poultice paste, arthralgia poultice and control patients with knee stiffness score improved improved. Compared with before treatment, a significant difference (KW test, P=0.000) in the group differences; arthralgia poultice from the heat associated with the group before and after treatment compared with arthralgia paste poultice group, the difference was statistically significance (using Dunnett T3multiple comparisons, self-heating group and poultice group, P=0.018); arthralgia poultice paste from the heat associated with the group before and after treatment compared with the control group score, the difference was significant (P=0.003)(E)Daily activity before and after Treatment:Treatment for14days, arthralgia associated with self-heating poultice paste, arthralgia poultice and knee patients in the control group were improved daily activity score and the degree of improvement. Compared with before treatment, no statistically significant difference (KW test, P=0.874) associated with arthralgia poultice paste between the group and the self-heating Bitongkang poultice group differences; arthralgia poultice paste from the heat associated with the group scores before and after treatment with the control group, the difference was not statistically significant (data normality, paired T-test, P0.601).(F)Before and after treatment WOMAC total score comparison:14days of treatment, arthralgia associated with self-heating poultice paste, arthralgia poultice and control group patients’ daily activities of the knee score were improved and improved. Compared with before treatment, the difference was not statistically significant (one-way ANOVA, P=0.155); arthralgia associated paste poultice treatment group and the control group before and after scores with self-heating, the difference was significant (data is being normal distribution, paired T-test P=0.001).ConclusionArthralgia poultice paste from the heat associated with traditional Chinese medicines and similar comparison has the following advantages:ease around fine in pain, relieve central pain has a significant effect, with respect to relieve swelling symptoms Voltaren no obvious advantage. Self-regulating heating device may be directly or indirectly improve symptoms by5-HT, able to obtain some clinical results.Arthralgia poultice from the heat associated with arthralgia stickers and two Chinese herb poultice plaster osteoarthritis of the knee in improving clinical signs and symptoms of pain relief were significant effects. In relieve pain, stiffness symptoms, arthralgia associated poultice paste from the heat compared with the simple use Bitong cataplasm is better. It can be used in the clinical treatment.