^(99)锝亚甲基二膦酸盐注射液治疗老年骨质疏松性骨折和骨关节炎的临床研究

Clinical trial of technetium-99 methylenediphosphonate injection in the treatment of senile osteoporotic fracture and osteoarthriti

目的观察^(99)锝亚甲基二膦酸盐注射液(^(99)Tc-MDP)治疗老年骨质疏松性骨折及骨关节炎患者的临床疗效和安全性。方法将120例老年骨质疏松性骨折和骨关节炎患者随机分为对照组60例和试验组60例。对照组予以关节腔内注射玻璃酸钠注射液25 mg和倍他米松磷酸钠注射液7 mg,每周1次,连续治疗8周;与此同时接受口服碳酸钙D3片600 mg和阿法骨化醇胶囊0.25μg治疗,qd,连续治疗6个月;试验组在对照组治疗的基础上,予以静脉滴注^(99)Tc-MDP15 mg,qd,10 d为1个疗程,间隔30 d开始第2个疗程,连续治疗4个疗程。比较2组患者的临床疗效、治疗前后L1~L4的骨密度(BMD)值、血清骨特异性碱性磷酸酶(BALP)和25-羟化维生素D_3[25-(OH)D3]水平、血清Ⅰ型前胶原氨基端伸展肽(PINP)、骨钙素(BGP)和Ⅰ型胶原羧基末端肽(CTX)含量,以及药物不良反应发生情况。结果治疗后,试验组和对照组的总有效率分别为91.67%(55/60例)和78.33%(47/60例),差异有统计学意义(P<0.05)。治疗后,试验组L1~L4的BMD值分别为(0.94±0.15),(0.98±0.14),(1.14±0.17),(1.05±0.15),对照组L1~L4的BMD值分别为(0.84±0.14),(0.86±0.13),(0.92±0.16)和(0.90±0.13),2组比较差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组的股骨颈BMD分别为(0.94±0.11)和(0.83±0.08),血清BALP分别为(4.65±1.23),(4.18±1.03)μg·L^(-1),25-(OH)D3分别为(39.83±5.52),(33.65±5.16)ng·m L^(-1),PINP分别为(336.68±28.36),(286.92±23.65)ng·m L^(-1),BGP分别为(14.86±2.86),(11.53±1.88)ng·m L^(-1),CTX分别为(19.36±4.19),(14.65±3.67)μg·L^(-1),差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要为上腹部不适,对照组的药物不良反应主要为面色潮红,试验组和对照组的药物不良反应发生率分别为3.33%(2/60例)和1.67%(1/60例),差异无统计学意义(P>0.05)。结论99锝亚甲基二膦酸盐注射液治疗老年骨质疏松性骨折和骨关节炎的临床疗效显著,能够明显改善骨代谢相关指标,提高骨密度,且不增加药物不良反应的发生率。

Objective To investigate the clinical effect of technetium-99 methylenediphosphonate injection（^（99）Tc-MDP） in treatment of senile osteoporotic fracture and osteoarthriti. Methods A total of 120 cases of osteoporotic fracture or osteoarthritis were randomly divided into the control group（ n = 60） and the treatment group（ n = 60）. The patients in control group were given 8-week treatment of intra-articular injectionof sodium hyaluronate injection（ 25 mg,once a week） and betamethasone sodium phosphate injection（ 7 mg,once a week）; In the meantime,the patients also received oral calcium carbonate D3（ 600 mg,once daily） and alfacalcidol capsules（ 0. 25 g,once daily） for 6 months; the treatment group received 10-day course of intravenous infusion of^（99）Tc-MDP（ 15 mg,once daily） for 4 courses（ with 30 days of intervals between courses）. After a 6-month follow-up,the clinical efficacy of two groups was compared,and the effect of different treatment on L1 ~ L4 bone mineral density（ BMD） value,serum bone alkaline phosphatase（ BALP） and 25-hydroxy vitamin D3 25-（ OH） D3 level;procollagen I N-terminal propeptide（ PINP） and bone glaprotein（ BGP） and type I collagen carboxy terminal peptide（ CTX） content were compared between two groups and the occurrence of adverse drug reactions were recorded.Results After treatment,the total effective rate of the treatment group and the control group was 91. 67%（ 55/60cases） and 78. 33%（ 47/60 cases）,respectively,the difference was statistically significant（ P〈0. 05）. After treatment,the BMD of L1 ~ 4 in the treatment group were（ 0. 94 ± 0. 15）,（ 0. 98 ± 0. 14）,（ 1. 14 ± 0. 17） and（ 1. 05 ± 0. 15）,while the BMD of the control group were（ 0. 84 ± 0. 14）,（ 0. 86 ± 0. 13）,（ 0. 92 ± 0. 16） and（ 0. 90 ± 0. 13）,and significant differences were found between the two groups（ P〈0. 05）. In the treatment group and the control group, the serum BALP were（ 4. 65 ± 1. 23）,（ 4. 18 ± 1. 03） μg · L^-1,25-（ OH） D3 were（ 39. 83 ± 5. 52）,（ 33. 65 ± 5. 16） ng·m L^-1,PINP were（ 336. 68 ± 28. 36）,（ 286. 92 ± 23. 65） ng·m L^-1,BGP were（ 14. 86 ± 2. 86）,（ 11. 53 ± 1. 88） ng·m L^-1,CTX were（ 19. 36 ± 4. 19）,（ 14. 65 ± 3. 67） μg·L^-1,with statistically significant differences（ P〈0. 05）. The adverse drug reactions in treatment group was upper abdominal discomfort,the control group was facial flushing,the adverse drug reaction in control group and treatment group were3. 33%（ 2/60 cases） and 1. 67%（ 1/60 case）, the difference was not statistically significant（ P〈0. 05）.Conclusion The curative effect of^（99）Tc-MDP is significant in treatment of senile osteoporotic fracture and osteoarthriti,it can significantly improve the indexes of bone metabolism and increase bone density with high safety profile.