不同方案联合用药治疗围绝经期及绝经后期骨质疏松症的疗效观察

目的 探讨不同方案联合用药治疗围绝经期及绝经后期骨质疏松症(OP)的疗效.方法 选择2008年7月至2009年12月在温州医学院附属第二医院妇科门诊就诊的伴有骨量减少或OP的围绝经期及绝经后期妇女109例,随机分为3组,A组36例,口服氨基酸螯合钙1000 mg/d+阿法骨化醇0.25μg/bid;B组40例,口服氨基酸螯合钙1000 mg/d+阿法骨化醇0.25 μg/bid+替勃龙1.25 mg/d;C组33例,口服氨基酸螯合钙1000 mg/d+阿法骨化醇0.25μg/bid+阿仑膦酸钠70 mg(每周1次).3组妇女均连续服药48周.治疗前、后采用双能X线吸收法测定腰锥第1～4节(L1-4)及左股骨骨密度(BMD);同时采用酶联免疫吸附试验检测血清骨碱性磷酸酶(BALP)、羟基末端肽(CTX)、25-羟维生素D325(OH)D3]水平.结果 109例中共有7例(6.4%,7/109)因自动停药、副反应较重不能忍受或失去联系而退出,其中A组2例(失去联系)、B组3例(自动停药)、C组2例(上腹部隐痛不适,烧灼感),退出病例未纳入统计.(1)疼痛症状改善:3组妇女治疗48周后,临床疼痛等症状均明显改善,改善率分别为85%(29/34)、92%(34/37)和94%(29/31);(2)BMD:3组妇女治疗后BMD均明显提高,治疗前A、B、C组L1-4BMD分别为(0.88±0.15)、(0.89±0.18)、(0.87±0.10)g/cm2;治疗后分别为(0.90±0.01)、(0.93±0.09)、(0.91±0.11)g/cm2;治疗前A、B、C组左股骨BMD分别为(0.87±0.07)、(0.87±0.07)、(0.85±0.12)g/cm2;治疗后分别为(0.90±0.03)、(0.91±0.08)、(0.89±0.12)g/cm2.B、C组与A组比较,差异均有统计学意义(P<0.01),而B、C两组间比较,差异无统计学意义(P>0.05);(3)骨代谢指标:治疗前A、B、C组BALP分别为(26±6)、(26±9)、(28±7)μg/L,治疗后分别为(22±5)、(20±9)、(22±8)μg/L,3组治疗后均较治疗前显著下降,差异有统计学意义(P<0.05);治疗前A、B、C组CTX分别为(0.85±0.20)、(0.84±0.47)和(0.88±0.11)ng/L,治疗后分别为(0.81 ±0.19)、(0.77±0.33)和(0.82±0.14)ng/L,3组治疗后均较治疗前显著下降,差异有统计学意义(P<0.05).结论 3种联合用药方案均可用于OP的治疗,可降低骨转换、增加BMD、减少骨吸收;A组方案可作为基础治疗,B、C组方案较基础治疗效果好.

Clinical study on combination of multiple regimens in treatment of osteoporosis in perimenopause and postmenopausal women

Objective To evaluate clinical efficacy of multiple regimen combination in treatment of osteoporosis of perimenopausal or postmenopausal women. Methods From Jul. 2008 to Dec. 2009, 109 women with low bone mineral density (BMD) or osteoporosis treated in Department of Obstetrics and Gynecology, Affiliated Second Hospital, Wenzhou Medical College were enrolled randomly into 3 group,including 36 women in Group A managed by osteoform 1000 mg/d + alfacalcidol 0. 25 μg/bid orally, 40 women in group B managed by osteoform 1000 mg/d + alfacalcidol 0. 25 μg/bid + tibolone 1.25 mg/d orally and 33 women in group C managed by ostcoform 1000 mg/d + alfacalcidol 0. 25 μg/bid +bisphosphonates 70 mg/w orally. After 48 weeks BMD on lumbar 1 -4 (L1-4) and left femur were detected by X-ray. Bone alkaline phosphatase(BALP) ,cross linked clelopeptide of type Ⅰ collagen(CTX) and 25-hydroxychole calciferol 25 (OH) D3] was measured by enzyme linked immunosorbent assay (ELISA).Result Seven women (6. 4%, 7/109) were withdrawed form this study, including 2 cases losing follow up in group A, 3 cases stopping treatment in group B, 2 cases giving up treatment due to severe adverse effect (burning in upper abdomen) in group C. (1) Pain relieve: after 48 weeks treatment, women in 3 groups improved symptom of pain significantly, the rates of pain relieve were 85% (29/34)in group A, 92% (34/37) in group B and 94% (29/31) in group C. (2) BMD: BMD was improved significantly in women in 3 groups after treatment. BMD of L1-4 were (0.88±0.15) g/cm2 in group A,(0.89±0.18) g/cm2 in group B and (0.87±0.10) g/cm2 in group C before treatment, and converted to (0.90±0.01) g/cm2 in group A, (0.93±0.09) g/cm2 in group B and (0.91±0.11) g/cm2 in group C after treatment. BMD of left femur were (0.87±0.07) g/cm2 in group A, (0.87±0.07) g/cm2 in group B and (0.85±0. 12) g/cm2 in group C before treatment and converted to (0.90± 0.03) g/cm2 in group A, (0.91±0.08) g/cm2 in group B and (0.89 ±0.12) g/cm2 in group C after treatment. It was shown significantly different BMD between group B or C and group A (P < 0. 01), however, there was no significant different BMD between group B and C (P >0. 05). (3) Index of bone metabolism: BALP were (26±6) μg/L in group A, (26±9) μg/L in group B and (28±7) μg/L in group C before treatment and converted to (22±5) μg/L in group A, (20±9)μg/L in group B and (22±8)μg/L in group C after treatment, which showed statistical difference (P < 0.05). CTX were (0.85±0.20) ng/L in group A, (0.84±0.47) ng/L in group B, and (0. 88 ±0. 11) ng/L in group C before treatment and converted to (0. 81 ±0. 19) ng/L in group A, (0. 77±0.33) ng/L in group B, and (0.82 ±0. 14) ng/L in group C after treatment, which showed statistical difference (P < 0. 05). Conclusions Those 3 regimens combination could be used in treatment of osteoporosis by decreasing bone conversion, increasing bone density, decreasing bone absorption. Regimen A was only suitable for basic therapy,the other two regimens could provide better treatment.