| Objective Through clinical observation and case analysis to study the clinical efficacy of Conggui Yishen granules in the treatment of patients with type 2 diabetic osteoporosis. syndrome type is kidney deficiency with blood stasis. Objective to evaluate its clinical efficacy and drug safety, and provide objective basis for clinical application of Conggui Yishen granules to better serve the clinical service.Methods A randomized, controlled, parallel trial was conducted, according to diagnostic criteria of type 2 diabetic osteoporosis.A total of 62 cases of patients with diabetic osteoporosis were divided into two groups, including control group with 31 cases and treatment group with 31 cases, according to the proportion of 1:1. Based on the diet, exercise therapy and conventional diabetes hypoglycemic therapy, patients in the control group were treated with Alendronate Sodium Tablets 70 mg every Wednesday on an empty stomach in the morning. Treatment group on the basis of the control group with Conggui Yishen granules, morning and night two times, one dose every day. Two groups were treated 2 period of treatment with six months. Monitor the conventional indicators for patients with blood, urine, feces and liver and kidney function.Observed two groups of patients before and after treatment of TCM clinical symptoms score, fasting plasma glucose(FPG),2h postprandial blood glucose(2h PBG), glycated hemoglobin(Hb A1c), fasting insulin(FINS), 2- hour postprandial insulin(2h PINS), insulin resistance index(IRI), calcium(Ca), phosphorus(P), blood alkaline phosphatase(ALP), estradiol(E2), testosterone(P), each part of the bone mineral density(BMD), serum procollagen type I amino-terminal propeptide(PINP), I procollagen crosslinked carboxy-terminal peptide(CTX-I), tartrate-resistant acid phosphatase 5b(TRACP-5b), then adopt SPSS 23.0 to perform statistical analysis for objective evaluation of its clinical efficacy and drug safety.Results 1. Clinical observation shows that after 2 courses of treatment, the total effective rate of the treatment group was 86.2%, and the total effective rate was 64.3% in the control group, the treatment group was better than the control group with statistical significance(P<0.05). 2. The total score of TCM symptoms in the two groups were significantly decreased compared with before(P<0.05 or P<0.01), and the treatment group was significantly better than the control group(P<0.01). The symptoms and signs of the two groups were improved in different degree. The total effective rate of improvement of clinical symptomsthe in treatment group was 93.1%, and the total effective rate was72.4% in the control group. Thought statistical analysis processing to compare TCM clinical symptoms and signs of tow groups, the treatment group were significantly improved in fatigue, dizziness,tinnitus, spontaneous sweating, night sweating, frequent night urination compared with that in control group(P<0.01). The treatment group was also better than the control group to improve the symptoms with aching, or soreness and weakness of waist and knees, thirsty,drink more, upset insomnia(P<0.05). 3. After the treatment, the levels of FPG, 2h PBG, Hb Alc, FINS, 2h PINS, IRI of two groups were obviously improved than themselves before the treatment(P<0.05 or P<0.01); and the treatment group was obviously improved than the control group(P<0.05 or P<0.01). 4. Bone mineral density of two groups patients' s lumbar L1-4, femoral neck, femoral intertrochanteric and Ward triangle area were better than before, and the improvement rate of the treatment group was significantly better than that of the control group(P<0.05 or P<0.01). 5. After treatment, the serum calcium, phosphorus, serum alkaline phosphatase of two groups had been improved at certain degree, but no statistical significance.6. The levels of PINP, CTX-I and TRACP-5b in treatment group were significantly lower than those in control group with statistical significance(P<0.05 or P<0.01). 7. The serum estradiol levels of male patients in the treatment group was improved, but no statistical significance. The serum testosterone levels of male patients in the treatment group was higher than before treatment(P<0.05), and it was better than the control group(P<0.01). The serum estradiol level of male patients in the treatment group was significantly higher than that before treatment(P<0.01), and it was greater than the control group(P<0.01). The serum testosterone level of female patients in the treatment group was significantly lower than that before treatment(P<0.05), but there was no significant difference between the control group. 8. During treatment, two groups of patients of blood routine test, liver function and renal function had no obvious abnormalities. two groups were no serious adverse reaction.Conclusion Through the study found that the application of Conggui Yishen granules in the treatment of diabetic osteoporosis can not only improve patient symptoms of traditional Chinese medicine, but also can improve the bone mineral density, control of blood glucose level. It can significantly improve the total score of TCM syndromes in patients, syndrome type is kidney deficiency with blood stasis. At the same time, Conggui Yishen granules is made from traditional Chinese medicine concentrated granule, convenient taking, no obvious adverse reactions and side effects, and promote worth in diabetic osteoporosis. |
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