The Clinical Research On The Therapeutic Effects Of GKKFY On Primary Osteoporosis (Syndrome Of Deficiency Of Kidney)

Objective:To investigate the clinical curative effect and safety of the Gukangkoufuye(GKKFY) in Patients with primary osteoporosis through clinical test study, get ready for the III part research of the GKKFY.Method:Adopting pairs of blind clinical test method that contrast at random, 240 cases primary OP patients(syndrome of deficiency of kidney), were divided into the GKKFY group(treated with GKKFY) and the control group(treated with XianLingGuBao) at random. Consulting"new traditional Chinese medicine clinical guideline"(try edition 2002) and this study progress of P, the period of treatment of both two groups was six months. Curative effect observation included: the change of patients clinical symptom, the change in bone mineral density (BMD) of lumbar vertebrae and hip by dual energy X-ray absorptiometry (DEXA) and the change of blood calcium, phosphorus and alkaline phosphorus before and after treatment. the security observation included: General physical examination, blood, urine and stool routine, electrocardiogram, liver function and renal function( BUN, Cr) before and after treatment.1. Select patients:The patient won't be brought into clinical examination unless he consistent with the following 3 conditions.(1) The symptoms Correspond with the diagnostic criteria which this project establishes and the symptoms of primary osteoporosis (syndrome of deficiency of kidney).(2) The age was among 50-70.(3) Accepting the informed consent.2. Delete patients:According with the following anyone conditions, the patient can't be brought into clinical examination.(1) The symptoms cannot correspond with the diagnostic criteria which this project establishes and the symptoms of primary osteoporosis (syndrome of deficiency of kidney).(2) The age was below 50 or above 70.(3) Female who was menopause within 2 years.(4) Someone who has suffered hyperparathyroidism, osteomalacia, arthritis deformans, general lymphadenomatosis and secondary osteoporosis or disabled.(5) Someone who has severity blood-heart diseases.(6) The AST or ALT upper to the limit of the normal and Cr>133umol/L.(7) Someone who was hypersensitiveness.(8) Someone who was a bedlam or senile dementia.(9) Someone has taken the HRT or CT during the past 3months, taken the BP for at lest for 15 days during the past 6months.(10) Someone from who cannot get the conclusion.3. Grouping principle:240 patients were come from the Union Hospital and so on 4 hospitals, all patients were accorded with diagnosis standards and were divided randomly into the treatment group and antitheses group, There were 120 patients in each group(1:1) without significant differences in sex, age, symptom pattern among tow groups(Pï¹¥0.05).4. Treatment project:(1) Treat group: GKKFY 1 bottle + false XLGB capsule 3 pills, two times per day.(2) Control group: False GKKFY 1 bottle + XLGB capsule 3 pills, two times per day. 24 weeks was a course of the treatment.5. Observation index:(1) Therapeutic efficiency observation: the curative effect of syndrome, the bone density, serum Ca, P, ALP.(2) Safety observation: the blood-routine, the urine-routine, the stool-routine, electr- ocardiogram, liver function (AST), kidney function (BUN, Cr).Results:1. The GKKFY has significant effects in symptom remission, the effective rate of treat group was 87.90%,while the control group's was 90.60%,there was no statistically significant difference between them(p>0.05). The accumulated points of symptom of traditional Chinese medicine were both statistically significant degraded (p<0.05), but there was no statistically significant difference between this two group (p>0.05). The increase of patient's bone density in two group was statistically significant (p<0.05). In group comparison, the difference has no statistically significance (p>0.05).The change of lever of Ca, P, ALP have no statistically significant difference in group comparison (p>0.05).2. Safety analysis: There were no untoward reactions in both treat group and control group in the clinical test.Conclusions:GKKFY has a constant effect on the patients of primary osteoporosis in this clinical practice: it can relieve the symptoms and improve physical signs and the related indexes of patients. It is a kind of safe medicine which can educe the preponderance of traditional Chinese medicine and be worth generalizing to clinical use.