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1 research purposes through the randomized controlled trial observed ideas acupuncture clinical efficacy for the treatment of patients with skeletal fluorosis, kidney and spleen as the acupuncture intervention high fluoride water thyrotoxicosis explore ideas and treatment methods. 2 Methods 2.1 the case source premenstrual access high fluoride water intoxication epidemic investigation report and Hydrological Services the determine of Cangzhou City, Hebei Province, is a high fluoride water intoxication epidemic area, the study treated 72 patients are from September 2009 to June 2010 Task Force Qing Xian Cao temple town center, implementation issues to to Cao Sizhen Hospital, the local skeletal fluorosis patients recruited. 2.2 Diagnosis, clinical, inclusion and exclusion, off the standard reference the Health industry standard of the People's Republic of China WS192-2008, the development of diagnostic, clinical grading standard, and for strict inclusion and exclusion, shedding standards. 2.3 Sample size estimates the efficacy of the control group according to pre-test the efficacy and reported in the literature, the sample size estimation module the CHISS software calculations to determine the required minimum sample size of 30 cases, taking into account factors such cases depigmentation may ultimately determine each group included in 36 cases. 2.3 Experimental Design Methods This study research design methods and rules strictly follow the currently accepted scientific research strength RCT design. Stratified random severity in patients with stratification factors using the kidney Yunpi needling treatment, the treatment group and control group were oral medicine Caltrate D were treated for 2 months, VAS values ??were observed before and after treatment , urine fluoride, calcium, phosphorus, duration of morning stiffness, self-care ability, accompanied by symptoms, Chinese medicine symptom score indicators of true, accurate, timely and complete record of the CRF table. Application EpiData3.1 the establishment of a database, the collected before and after treatment the observed indicators entered in the database, the use of real-time verification of comparison and double entry verification comparison, verification database lock. SPSS statistical software to lock the database for statistical analysis. 2.4 treatment programs 2.4.1 acupuncture group interventions: mm needle with EA. Needle: the 30th 1.5-3 inch Huatuo brand sterile disposable acupuncture needles (Suzhou Medical Supplies Factory Co., Ltd.). Electro-acupuncture device: Hua card needle therapy device SDZ-II (Suzhou Medical Supplies Factory Co., Ltd.). Of acupoints: spleen, shenshu, Zusanli, too River, hand three years, Guan Yuan, air sea; joint pain, take a local Meridian: the shoulder Yu, Chize, Yang pool, Tianzhu, Yaoyangguan loop jump or home liao, Dubi, Xie River, and A is the point a. Acupuncture manipulation impose put plug Twist fill method, the local meridian points and A is the point with reducing method, after the gas needle 30Mn. Each 3 points on the electric needle, electric acupuncture points are used interchangeably, density waves, the intensity of patients able to tolerate the degree of treatment 30mmn. The remaining points during the needle retention the row pin 2 times, each time to get gas for the degree. Treatment: three times a week, every other day, each patient observed 2 months continuous treatment. 2.4.2 control group interventions: oral calcium carbonate D3 tablets (trade name Caltrate D, Tianjin Wyeth produced 600mg / tablets, 60 tablets / bottle). Dosage: 600mg, 2 times a day, morning and evening services. Treatment: continuous treatment per patient observed for two months. 2.5 Evaluation indicators 2.5.1 urine fluoride (take measurement of the fluoride ion electrode method) before treatment and treatment of February collected 24 hours after mixing urine urine fluorine content. 2.5.2 bone, the degree of joint pain visual analog scale pain visual analog scale (Visual Analogue Scale, VAS), painless 10 most painful. Each patient before and after acupuncture treatment using a visual analog scale to evaluate pain intensity. 2.5.3 of calcium and phosphorus were measured before and after treatment of the product of serum calcium, serum phosphorus is converted to calcium, phosphorus, calcium-phosphorus product changes observed before and after treatment, to evaluate the patient's bone metabolism. 2.5.4 joint activity with orthopedic protractor to measure patient activity is limited by the size of the joint range of motion before and after treatment, the qualitative and quantitative comparison of the range of motion before and after treatment. The the 2.5.5 daily activities of self-care ability of patients before and after the day-to-day activities of self-care ability score table based on the day-to-day activities of self-care ability. 2.5.6 morning stiffness morning stiffness according to the patient in remission within a few minutes after getting up to score. 2.5.7 convulsions, numbness and sense of local stiffness score accompanying symptom score. 2.5.8 symptom scores produced according to Chinese medicine clinical research guidelines spleen, kidney symptoms grading quantify Standings, re-grading score of each symptom in accordance with the light, the light, moderate, severe, adding the item symptom score for patients with traditional Chinese medicine clinical symptom scores, symptom scores compared with patients before and after treatment. 2.6 Data processing and statistical analysis methods 2.6.1 Data processing data acquisition: to ensure true, accurate, timely, complete a variety of data acquisition in the patient's course of treatment, and truthfully recorded in the CRF tables. Data management: the collection of data to sort out, eliminate invalid data, the formation of a pure data set. The establishment of a database: application EpiData3.1 establish the database. By the person responsible for the entry, real-time verification of alignment and the double-entry verification compared to ensure that the entry the lowest probability of error, check after database lock, as a statistical library. 2.6.2 statistical analysis using SPSS statistical software for statistical analysis of the data. Analysis of two sets of baseline comparability, Evaluation, and safety evaluation. The statistics of the data, count data using the x2 test; measurement data in accordance with the normal distribution and homogeneity of variance using the t test, t 'test of heterogeneity of variance, a group t test Statistics Section of the evaluation index, their treatment, paired t-test was used to compare the before and after. Measurement data were not normally distributed rank sum test. 3 Results 3.1 two sets of urine fluoride urinary fluoride difference between the treatment of the first two groups was not statistically significant (P gt; 0.05); After treatment, the urinary fluoride 11.06 ± 4.54mg / L higher than control group 8.30 ± 4.14mg / L (P lt; 0.05); treatment group before and after their treatment, urine fluoride compare treatment was significantly higher than before treatment (P lt; 0.01), the control group before and after treatment of urinary fluoride difference was not statistically significant. Fluoride intake of drinking water as usual in the case of the same case, urine fluoride in the treatment group was significantly higher that the treatment group effect is significant in promoting the excretion of urinary fluoride. 3.2 two sets of VAS treatment groups were compared after treatment VAS value of 1.93 ± 1.30 was significantly lower than the control group, 3.47 ± 2.29 (P lt; 0.01); self-comparison of the two groups of patients before and after treatment After treatment, VAS values ??were significantly lower than before treatment ( are P lt; 0.01), the index of the two groups to compare the efficacy index of the treatment group was significantly greater than that of the control group (P lt; 0.01) These results prove that the treatment group and the control group treatment to alleviate the high fluoride water intoxication in patients with bone, joint pain lower VAS scores are effective acupuncture effect is more pronounced. 33 two sets of calcium-phosphate product were compared between the two groups after treatment calcium-phosphate product were less than before treatment, after treatment, calcium-phosphate product 58.41 ± 31.54 was significantly lower than before treatment (P lt; 0.01), calcium-phosphate product less than the control group after treatment before treatment (P lt; 0.05), that have the effect of reducing the calcium-phosphate product, the treatment group was more significant treatment. 3.4 The two groups before and after treatment changes in range of motion 3.4.1 two groups waist activity (1) the two groups to improve the degree of lumbar efficiency comparison 20 of 64 patients, waist activity limitation, treatment group, 10 patients in the control group (n = 10) For example, the treatment group efficiency of 100%, higher than that of the control group, but the difference was not statistically significant by chi-square test. (2) the two groups to improve the lumbar ROM quantitative comparison of the treatment of the two groups before the waist activity difference was not statistically significant (P gt; 0.05), lumbar activity of the two groups after treatment were greater than before treatment, after treatment, activity 80.5 ± ± 23.62 was significantly greater than before treatment (P lt; 0.01), 63.00 ± 23.23, control group after treatment the waist activity greater than before treatment (P lt; 0.05) after treatment, but the difference was not statistically significant (P GT; 0.05 ) to prove that the treatment in both groups have the effect of improving the patient's waist joint activity, before and after treatment difference is more significant. 3.4.2 two sets of knee (1) the two groups to improve the activity of the knee efficient comparison of 64 patients with limited knee in 25 cases, the treatment group 10 cases, 15 cases of the control group, treatment group efficiency of 100% higher than that in the control group (P lt; 0.05), the difference was statistically significant, the to prove treatment group to improve the efficacy of knee activity higher than that in the control group. (2) two sets of knee quantitative comparison of before and after treatment knee activity before treatment difference was not statistically significant (P GT; 0.05), the treatment group, knee activity of 122 ± 7.88 greater than the control group 106.33 ± 16.41 (P lt; 0.05), the difference between the two groups was statistically significant; After treatment, the activity is greater than before treatment (P lt; 0.01), proven treatment to improve knee activity had a significant effect in the treatment group effective than the control group. 3.5 two sets of morning stiffness time treatment duration of morning stiffness of the first two groups was no significant difference (P gt; 0.05); After treatment, duration of morning stiffness were less than before treatment, after treatment, duration of morning stiffness of 0.93 ± 1.14 significantly below the treatment prior to 1.87 ± 1.93 (P lt; 0.01), duration of morning stiffness in the control group after treatment is also less than before treatment (P lt; 0.05) after treatment, the difference was not statistically significant (P gt; 0.05); prove two treatment group have the effect of reducing the duration of morning stiffness. 3.6 two sets of daily living before treatment, the two groups living skills difference was not statistically significant (P gt; 0.05); After treatment, no significant difference (P GT; 0.05); After treatment, self-care ability scores were less than before treatment (P lt; 0.01), proven treatment to reduce the self-care ability is limited score to improve daily living have a significant effect. 3.7 The two groups associated symptoms Compare Before treatment, numbness, local feeling stiff integral difference was not statistically significant (P gt; 0.05), two groups were comparable; convulsions points in the two groups before treatment difference was statistically significant (P lt ; 0.05) between the two groups not comparable the convulsions points of the control group was significantly higher than the treatment group, and therefore do not to compare two groups to improve the efficacy of convulsions integral. After treatment, numbness, local rigid sense of the difference was not statistically significant (P gt; 0.05); convulsions, numbness points in the two groups after treatment were less than before treatment (P lt; 0.01), to prove that treatment methods to improve skeletal fluorosis patients with convulsions, numbness have a significant effect, but can not prove that the treatment group than the control group. After treatment, the local rigid sense score lower than before treatment (P lt; 0.05). 3.8 two sets of symptom scores before treatment, two groups of symptom scores difference was not statistically significant (P gt; 0.05); After treatment, the difference was statistically significant (P lt; 0.05); After treatment, TCM symptoms Points are less than before treatment (P lt; 0.01), proven treatment to improve the TCM symptoms and the effect of the treatment group than the control group. 4 Conclusions 1. Spleen and kidney deficiency is the fundamental pathogenesis incidence of skeletal fluorosis, kidney Spleen guidance acupuncture treatment is an effective method of skeletal fluorosis intervention fluoride water poisoning; Kidney Spleen the idea of ??acupuncture therapy is to promote the effect of high fluoride water intoxication skeletal fluorosis patients with urinary fluoride excretion; 3 as a guide to kidney Spleen ideas acupuncture treatment to reduce high fluoride water intoxication skeletal fluorosis patients with bone, joint pain, lower VAS score results are obvious; kidney Spleen guiding ideas acupuncture treatment in patients with skeletal fluorosis joint activity to improve the high fluoride water intoxication significant; kidney Spleen guiding ideas acupuncture treatment can reduce high fluorine water intoxication in patients with skeletal fluorosis calcium-phosphate product, regulates calcium and phosphorus balance, improve the role of its abnormal bone metabolism; 6. kidney Spleen guiding idea of ??acupuncture treatment to reduce high fluoride water intoxication in patients with skeletal fluorosis duration of morning stiffness effect is remarkable; 7. ideas acupuncture treatment of kidney and spleen as a guide to improve the the fluoride water poisoning skeletal fluorosis patients with daily living, reduce the effect of convulsions, numbness, and local rigid sense significant.
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