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BACKGROUND: Hanshibi granule indicates rheumatism due to blockage of cold and damp.OBJECTIVE: To observe the effects and safety of intervention of hanshibi granule on rheumatism due to blockage of cold and damp and the comparative observation was carried on by taking zhengqingfengtongning as the control drug.DESIGN: Case randomized-controlled observation was designed.SETTING: Luoyang Bone-setting Hospital of Henan Province.PARTICIPANTS: Totally 400 cases of rheumatism due to blockage of cold and damp visited in Luoyang Orthopedic Hospital of Henan Province were volunteered in the observation from May 2000 to February 2002.Hanshibi granule was composed of fuzhi (Radix Aconiti Praeparata),huangqi (Radix Astragali), weilingxian (Radix Clematidis), more than 10 herbs, 10 g each bag. Zhengqing fengtongning tablet is 20 mg each tablet.METHODS: Based on the randomization and sequence of visiting, the cases were divided into observing group and the control at the ratio of 3:1.In the observing group, hanshibi granule was administrated, 1 bag/time,3 times/day, infused with water. In the control, zhengqing fengtongning tablet was administered orally, 2 tablets/time, 3 times/day; 1 week later,if there was no harmful reaction, it was administered 3 tablets/time,3 times/day. For rheumatic arthritis (RA) and ankylosing spondylitis (AS),the drugs were taken for 2 months as 1 course, and for knee osteoarthritis,the drugs were taken for 1 month as 1 course. The changes of ESR, C-reactive protein (CRP) and rheumatic factor (RF) and uric acid (UA) were determined and recorded. Criteria on evaluation: ① Evaluation on therapeutic effects on syndromes: Remarkable effect: the symptoms were improved remarkably after treatment and symptom integral was 0-1 score or decreased by ≥ 2/3. Effect: the symptoms were improved after treatment and the symptom integral was decreased by≥1/3.② Evaluation on therapeutic effects on symptoms: Remarkable effect: The symptom integral was reduced to 0 score or reduced by 2 scores after treatment, such as joint pain, swelling, tender pain, morning stiffness and functional impairment. Effect: the integral was reduced by 1 score after treatment. ③ Evaluation on total therapeutic effects on diseases: Remarkable effect: the symptoms and physical signs disappeared basically, the main laboratory indexes were improved remarkably and reduced by ≥ 50%. Effect: The symptoms and physical signs were alleviated and the main laboratory indexes were improved.MAIN OUTCOME MEASURES:① Total clinical therapeutic effect,therapeutic effect on different symptoms and diseases between two groups.②Safety of hanshibi granule.RESULTS: Totally 400 cases were employed, of which, 300 cases were in observing group and 100 cases in the control. In observing group, 19 cases were dropped out and 281 cases were in the statistics. In the control,6 cases were dropped out and 94 cases were in the statistics.①Comparison of total clinical therapeutic effects between two groups: The total effective rate in the observing group was higher significantly than that in the control (94.31％, 84.04％, P ＜ 0.01). ② Comparison of therapeutic effects on different symptoms between two groups: There was no significant difference in the therapeutic effects on joint pain, swelling,tender pain, functional disturbance and morning stiffness between two groups (P ＞ 0.05). ③ Comparison of therapeutic effects on different diseases between two groups: There was no significant difference in the therapeutic effects on RA, AS and knee osteoarthritis (P ＞ 0.05). ④ Safetyof hanshibi granule: abnormal urine routine for a part of cases before treatment was improved after treatment. ST-T wave alternation in ECG for a part of cases before treatment was not aggravated obviously after medication.CONCLUSION: Both hanshibi granule and zhengqingfengtong tablet, the control drug improves significantly joint pain, swelling, tender pain, functional impairment and morning stiffness in rheumatism due to blockage of cold and damp, in which, the effect of intervention of hanshibi granule is superior to that of the control drug, without obvious harmful reactions;therefore, such drug can be taken as a safe and effective one for rheumatism due to blockage of cold and damp.
ABSTRACT
BACKGROUND: The biomechanical property(BP) of the bone is decided by its geometric structure and component material. Merely pursuing increase of the bone mineral density(BMD) might lead to deterioration of bone BP.However at present, some researohes on therapeutic action on osteoporosis emphasize excessively medical influence to BMD, and the change in the holistic BP of the bone in osteoporotic zone and its mechanism still need to investigate deeply.OBJECTIVE: To probe into the action and its mechanism of "the kidney tonifying compound of the Traditional Chinese Medical (TCM) "on BP of cortical bone in ovariectomized osteoporotic model rats.DESIGN: Completely randomized controlled experiment based on experimental animals.SETTING: Laboratory of Biomedical Engineering, Luoyang Hospital and Institute of Traditional Chinese Orthopedics and Traumatology in Henan Province.MATERIALS: The experiment was completed from November 2000 to July 2001 at Research Laboratory of Biomedical Engineering,Luoyang Institute of Traditional Chinese Orthopedics and Traumatology of Henan Province. The healthy Wistar female rats aged 10 months,weighing(350±20) g.METHODS: Fifty Whistar female rats aged 10 months were randomly divided into 5 groups: the normal, model, premarin-treated, xianling gubao-treated and migu capsule-treated with 10 in each group. The normal group was only given sham operation and the other four groups were ovariectomized. The rats after operation were fed normally for ninety days.Since the 91st day after operation,the rats had been given the medicines for 90 days and then killed. The thighbones were taken out,then BMD,femoral geometry sizes and BP were determined.MAIN OUTCOME MEASURES: ① The primary sequel was the comparison of the parameters of femoral BP. ② The secondary sequel was the changes in parameters of femoral geometric structure, area of cortical bone and BMD of every midsectional fomur.RESULTS: Femoral BP worsened significantly,its mechanical intensity reduced,its external diameter diminished,cortical bone area decreased and femoral BMD lowered in osteoporotic model rats. In comparison with the above,in "the kidney tonifying compound ofTCM " groups(migu capsule group and xianling gubao group) femoral BP raised significantly, its mechanical intensity advanced,its external diameter augmented,cortical bone area aggrandized and femoral BMD enhanced.CONCLUSION: "The kidney tonifying compound of TCM" can improve BP of the cortical bone(thighbone) in ovariectomized osteoporosis rats. Its primary mechanism of action is that the TCM compound prescription could enhance"the mechanism of biomechanical response and regulation"(MBRR) of macrostructure of cortical bone,consequently increase femoral external diameter,aggrandize cortical bone area and enhance BMD in ovariectomized rats.
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0.05). Conclusion Jingu Tongxiao Granules could effectively relieve the pain, morning stiffness and motor impairment of knee joint osteoarthritis safely. Compared with the original form, the efficacy and safety of Jingu Tongxiao Granules were the same.