Huang Guizhong,Li Weiju,Liu Yilan..Curative effect of Jiawei-Haiqi pill on senile osteoporosis[J].,2014,36(06):513-515.[doi:10.3760/cma.j.issn.1673-4246.2014.06.010]
加味海七丸治疗老年性骨质疏松症临床研究
- Title:
- Curative effect of Jiawei-Haiqi pill on senile osteoporosis
- Keywords:
- Jiawei-Haiqi pill; Senile; Osteoporosis; Curative effect observation
- 摘要:
- 目的 观察加味海七丸治疗老年性骨质疏松症的临床疗效。方法 收集2010年5月至2012年12月广东省汕头市中医医院骨科患者124例,均符合老年性骨质疏松症诊断标准。按病例尾号将患者随机分为两组,治疗组60例服用院内制剂加味海七丸,1次/d,6 g/次;对照组64例肌注鲑鱼降钙素,第1周每日肌注50 IU,第2周每2日肌注50 IU,第3周每3日肌注50 IU,两组均连续治疗3周随访问3个月。治疗结束后观察并记录两组患者症状积分,骨密度以及血清碱性磷酸酶(ALP )、空腹骨钙素(BGP)、尿钙素(UCa)方面的变化。结果 ①骨质疏松症疗效比较:治疗后3个月,治疗组总有效率为85.0%(51/60),对照组为79.7%(51/64),组间比较差异无统计学意义(P=0.776)。②骨密度疗效比较,治疗组总有效率为40.0%(24/60),对照组为39.1%(25/64),组间比较差异无统计学意义(P=0.991)。③骨密度及症状积分变化比较:两组治疗后3周,随访3个月时骨密度[治疗组分别为(0.69±0.08)g/cm2、(0.70±0.10)g/cm2,对照组分别为(0.69±0.0)g/cm2、(0.70±0.13)g/cm2]均较同组治疗前[治疗组为(0.69±0.05)g/cm2,对照组为(0.69±0.10)g/cm2]有所增加,但组内与组间比较差异均无统计学意义(P>0.05);两组治疗后3周,随访3个月时症状积分[治疗组分别为(9.90±2.00)分、(8.50±1.70)分,对照组分别为(10.40±2.40)分、(9.00±1.90)分]均较同组治疗前[治疗组为(16.10±2.00)分、对照组为(16.20±1.80)分]降低(P<0.05),但组间比较差异无统计学意义(P>0.05)。④骨代谢生化指标变化比较:治疗后3周治疗组BGP(9.08±5.05)ρ/(mg?L)较同组治疗前(5.10±3.50)ρ/(mg?L)升高(P<0.05)。结论 加味海七丸可有效改善老年性骨质疏松症患者临床症状,升高BGP水平。
- Abstract:
- Objective To observe the curative effect of Jiawei-Haiqi pill on senile osteoporosis. Methods 124 patients in Shantou hospital of Traditional Chinese orthopedics were gathered from May 2010 to December 2012 in accordance with the criterion of diagnosis of senile osteoporosis. The 124 patients were divided into 2 groups randomly according to their case number. Sixty cases in the study group were treated with Jiawei-Haiqi pill, 6 gram per time once a day. Sixty-four cases in the control group were given 50 IU salmon calcitionin see calcimar via intramuscular injection once a day in the fist week, once every two days in the second week, and once every three days in the third week. Both groups were treated for 3 weeks with 3 months visit. After the end of treatment, symptom score, record the bone mineral density and biochemical markers of bone metabolism(serum alkaline phosphatase(ALP), Fasting bone gla protein(BGP), Urinary calcium(UCa) were observed in both groups. Results ①Comparison of curative effect of osteoporosis: After 3 weeks treatment, the total effective rate was 85.0%(51/60) in the study group and 79.7%(51/64) in the control group. There was no significant difference(P=0.776) between the two groups. ②Comparison of bone mineral density effect: the total effective rate was 40% in the study group and 39.1% in the control group.The difference between the two groups was not statistically significant(P=0.991). ③Bone mineral density and symptom score changes bone mineral density in the two groups after 3 weeks and 3 months treatment [The study group respectively(0.69±0.08)g/cm2, (0.70±0.10)g/cm2, the control group respectively(0.69±0.0)g/cm2, (0.70±0.13)g/cm2] increased than those in the same group before treatment[The study group (0.69±0.05)g/cm2, the control group (0.69±0.10)g/cm2], but there were no significant difference within group and between group comparisons(P>0.05);symptom score in the two groups after 3 weeks and 3 months treatment [The study group respectively(9.90±2.00)min,(8.50±1.70)min, the control group respectively (10.40±2.40)min, (9.00±1.90)min] reduced than those in the same group before treatment[The study group(16.10±2.00)min, the control group (16.20±1.80)min] (P<0.05), but there were no significant difference within group and between group comparisons(P>0.05). ④Biochemical markers of bone metabolism changes, after 3 weeks treatment, BGP in the study group(9.08±5.05)ρ/(mg?L)increased than that before treatment (5.10±3.50)ρ/(mg?L)(P<0.05). Conclusion Jiawei-Haiqi pill could effectively improve the clinical symptoms of aged patients with osteoporosis and elevate the levels of their BGP.
参考文献/References:
[1] Genant HK,Cooper C,Poor G,et al. Interim report and recommendations of the World Health Organization Task-Force for Osteoporosis[J]. Osteoporos Int,1999,10(4):259-264. [2] 中华医学会. 临床诊疗指南-骨质疏松症和骨矿盐疾病分册[M]. 北京:人民卫生出版社,2006:2-3. [3] 郑筱萸. 中药新药临床研究指导原则(试行)[S]. 北京:中国医药科技出版社,2002:356-360. [4] 帅波,沈霖,杨艳萍,等. 健骨颗粒治疗原发性骨质疏松症(肝肾不足)Ⅲ期临床研究[J]. 中国中医骨伤科杂志,2008,16(3):27-30. [5] Reginster JY,Der0sst R,Leccart MP,et al. A double- blind, placebo-ontrolled,does-finding trail of intermitten,nasal solmon calcitionnin for prevertion of postmenopausal lumber spine bone loss[J]. Am J Med,1995,98:452-458.
更新日期/Last Update:
2014-06-04