| Objectives:To observe the effects to Bone Mineral Density(BMD) and the clinical symptom whichwere showed by the patients of primary osteoporosis by taking advantage of the Chinesemedicine called ZhuangGu Capsule. To study the treatment and safety which were delivered byclinical curative effect. To probe into the possible mechanisms that it treats an primaryosteoporosis and to provide scientific basis for the clinical application.Methods:To take the means of random, parallel comparison. First: To selected the the patients ofprimary osteoporosis as research objects. After subscribe the agreeing letter, the objects aredivided into the treated or comparison group by random. Before they accept the curingmedicine, the objects should have the investigate score of Chinese medicine symptom, themedical examine, the test of BMD, something else examine which related and various safetyindex check. Then record the examine results in Clinical Record Form(CRF). Second: To givethe medicine to the research objects according to the following means. The sufferers in treatedgroup: ZhuangGu Capsule 6#,Tid; The sufferers in comparison group: XianLing GuBaocapsule 3#,Tid. One treatment course is 3 months. All the cases of two sections were visited for3 months. Except the unusual instance taking place, the course is not ceased. During the periodof this research, every medicine which can cure primary osteoporosis is prohibited to use.Third: The clinical symptoms, curative effect guideline, security guideline should be recordedin CRF at the end of the test. Every bad affair should be recorded depending on the fact. Theresearch should be ceased, whenever the serious bad affair occurs. At last, To analyze the datain CRF according to SPSS13.0 statistic software in order to get the result of the clinicalobservation. The grade data uses a Ridit examination, the count data to use a X~2 examination,the calculate data to use at examination.Results:As assesses standard about curative effect, it adopt "the clinical research guideline of newtraditional Chinese drugs in treating osteoporosis", which come from "the clinical researchguideline of the new traditional Chinese drugs".The treated group has remarkable effect in treating the curative effect of osteoporosis, itsgeneral effective rate is 88.9%, show 35.6% of effect, valid 53.3%, invalid 11.1%; Comparedwith the comparison group which general effective rate is 89.6%, show 41.7% of effect, valid47.9%, invalid 10.4%. It dose not have significant excellence in general effective rate (P＞0.05).The general effective rate of treatment group is 95.6% on the aspects of curative effect in improving Chinese medical symptoms, in which the clinical recover from illness is 26.7%,show 40.0% of effect, valid 28.9%, invalid 4.4%;Matched control of general effective rate is93.7%, clinical recover from illness 31.3%, show of 35.4% effect, valid 27.1%, invalid 6.3%. Itdose not have significant excellence in general effective rate (P＞0.05).There are significant excellence inside section of curative effect (P＜0.05), and nostatistical difference between two section comparison on curative effect (P＞0.05) about variousindexes with bio-chemical, the BMD, the total integral calculus of Chinese medicine symptom.It has a significant excellence between curing before and after in either group (P＜0.01), inaddition to the Lassitude in lion and legs(P＜0.05), on improving Chinese medicine single-itemsymptom; however, doesn't have between two section comparison (P＞0.05).There isn't obvious difference between two sections. During the whole course of the test,the moderate bad affair never happened. The Zhuanggu Caposule has a good safety in termedof the statistics on safety index testing. But the treated group is great better than thecomparison group (P＜0.05) on the long-term curative effect through statistics.Conclusion:Zhuanggu Capsule has remarkable effects on the treat osteoporosis and has good security.Compared with Xianling Gubao capsule, it does not have remarkable merit. But it is greatbetter than the comparison group on the long-term curative effect. |
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