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《The Journal of Traditional Chinese Orthopedics and Traumatology》 2018-08
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Oral application of Jianshen Fang(健肾方) and calcium carbonate and Vitamin D3 chewable tablets(Ⅱ) for treatment of postmenopausal osteoporosis with kidney-yang deficiency syndrome

LI Zhongwan;XU Shaojun;YANG Guanggang;YAO Liyun;FU Xiaoyong;PAN Yongxiong;Guangzhou Orthopedic Hospital;  
Objective: To observe the clinical curative effects and safety of oral application of Jianshen Fang( 健肾方,JSF) and calcium carbonate and Vitamin D3 chewable tablets( Ⅱ) for treatment of postmenopausal osteoporosis( PMOP) with kidney-yang deficiency syndrome. Methods: Eighty patients with kidney-yang deficiency type PMOP were enrolled in the study and randomly divided into 2 groups,40 cases in each group,and were treated with oral application of JSF and calcium carbonate and Vitamin D3 chewable tablets( Ⅱ)( JSF group) and oral application of alendronate sodium tablets and calcium carbonate and Vitamin D3 chewable tablets( Ⅱ)( alendronate sodium group) respectively for consecutive 6 months. Bone density,pain degree and serum contents of Estradiol( E2),osteoprotegerin( OPG) and insulin-like growth factor Ⅰ( IGF-Ⅰ) were measured and compared between the 2 groups before treatment and after the end of the treatment respectively,and the incidence rate of adverse reactions was observed. Results: Abnormal liver function indexes were found in 2 patients in JSF group and 1 patient in alendronate sodium group,and abnormal kidney function indexes were found in 2 patients in JSF group and 1 patient in alendronate sodium group. The drugs which caused adverse effects were withdrew immediately and liver and kidney protective agents were used,and the liver and kidney function recovered from injury 2 weeks later. There was no statistical difference in the incidence rate of adverse reactions between the 2 groups( χ2= 0. 180,P = 0. 671). There was no statistical difference in the bone density between the 2 groups before the treatment( t = 1. 014,P = 0. 314). The bone density increased after the end of the treatment compared to pretreatment in the 2 groups(-2. 69 +/-0. 12 vs-2. 09 +/-0. 22,t = 14. 343,P = 0. 000;-2. 72 +/-0. 13 vs-2. 37 +/-0. 09,t =14. 038,P = 0. 000),and was higher in JSF group compared to alendronate sodium group( t = 6. 931,P = 0. 000). There was no statistical difference in pain visual analogue scale( VAS) scores between the 2 groups before the treatment( t = 0. 465,P = 0. 644). The pain VAS scores decreased after the end of the treatment compared to pretreatment in the 2 groups( 4. 53 +/-0. 94 vs 2. 33 +/-0. 68 points,t =11. 366,P = 0. 000; 4. 42 +/-1. 03 vs 3. 21 +/-0. 87 points,t = 5. 522,P = 0. 000),and was lower in JSF group compared to alendronate sodium group( t = 4. 841,P = 0. 000). There was no statistical difference in serum contents of E2 between the 2 groups before the treatment( t = 0. 511,P = 0. 611). The serum contents of E2 increased after the end of the treatment compared to pretreatment in JSF group( 50. 91 +/-6. 24 vs 62. 88 +/-9. 02 pmol/L,t = 6. 546,P = 0. 000). There was no statistical difference in serum contents of E2 between pre-treatment and post-treatment in alendronate sodium group( 50. 17 +/-6. 31 vs 50. 88 +/-8. 16 pmol/L,t = 0. 425,P = 0. 672). The serum contents of E2 were higher in JSF group compared to alendronate sodium group after the end of the treatment( t = 6. 006,P =0. 000). There was no statistical difference in serum contents of OPG between the 2 groups before the treatment( t = 0. 348,P = 0. 729). The serum contents of OPG increased after the end of the treatment compared to pretreatment in the 2 groups( 140. 76 +/-14. 97 vs160. 18 +/-15. 70 pg/m L,t = 5. 371,P = 0. 000; 139. 55 +/-14. 99 vs 146. 68 +/-15. 68 pg/m L,t = 2. 027,P = 0. 046),and were higher in JSF group compared to alendronate sodium group( t = 3. 701,P = 0. 000). There was no statistical difference in serum contents of IGF-Ⅰbetween the 2 groups before the treatment( t = 0. 839,P = 0. 404). The serum contents of IGF-Ⅰincreased after the end of the treatment compared to pretreatment in the 2 groups( 25. 19 +/-8. 34 vs 35. 81 +/-9. 48 μg/L,t = 5. 042,P = 0. 000; 23. 53 +/-8. 74 vs 28. 87 +/-10. 29 μg/L,t = 2. 440,P = 0. 017),and were higher in JSF group compared to alendronate sodium group( t = 3. 012,P = 0. 004). Conclusion: Oral application of JSF and calcium carbonate and Vitamin D3 chewable tablets( Ⅱ) can increase the serum contents of E2,OPG and IGF-Ⅰand improve bone density and alleviate pain in patients with kidney-yang deficiency type PMOP,and its curative effect is better than that of oral application of alendronate sodium tablets and calcium carbonate and Vitamin D3 chewable tablets( Ⅱ),moreover,it has high safety.
【Fund】: 广东省中医药局科研课题(20172116)
【CateGory Index】: R580
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