金天格胶囊治疗原发性骨质疏松症的临床疗效观察

目的 观察金天格胶囊治疗原发性骨质疏松症患者的临床疗效，并与钙尔奇D3片比较。方法 160例原发性骨质疏松症的患者，均为我院骨科门诊病人，全部经过临床及双光能Ｘ线检查测骨密度确诊，按随机数字法分成两组，观察组（金天格组，n=80）口服金天格胶囊（每次3粒，每日3次），对照组（钙尔奇组，n=80）口服钙尔奇D3片（每次1粒，每日2次），两组疗程均为9个月。对两组患者治疗前、治疗3个月、治疗6个月、治疗9个月时的症状进行评分，对治疗前及治疗9个月时骨密度进行测定，通过症状评分和骨密度改善情况进行疗效评估，总结其疗效。所有患者治疗前、治疗3个月、治疗6个月、治疗9个月时均常规行肝功、肾功、血钙等检查。结果 两组病人均全部得以随访，无失访。治疗3个月时，两组患者治疗后与治疗前腰背疼痛、腰膝酸软、下肢痿弱、步履艰难等症状评分相比差异均有统计学意义（P＜0.01），治疗3个月时组间差异有统计学意义（P＜0.01）；治疗6个月时及治疗9个月时两组患者腰背疼痛、腰膝酸软、下肢痿弱、步履艰难等症状评分与治疗3个月时相比有进一步改善，但差异均无统计学意义（P＞0.05）。观察组治疗9个月时较治疗前腰椎及股骨Ward三角区骨密度均明显升高，差异有统计学意义（P＜0.01）；对照组治疗后腰椎及股骨Ward三角区骨密度亦有升高，但差异无统计学意义（P＞0.05）；治疗后腰椎及股骨Ward三角区骨密度组间比较差异均有统计学意义（P＜0.01）。两组患者中均有少数病例出现口干、便秘不良反应，无高钙血症、肝功能异常、肾功能异常等不良反应。结论 金天格胶囊用于原发性骨质疏松症患者的治疗，可以缓解腰背疼痛、腰膝酸软、下肢痿弱、步履艰难等症状，并能显著增加骨密度，改善生活质量，无明显不良反应，为临床用药提供了一个很好的选择，具有良好的应用前景。

The clinical efficacy of Jintiange capsule on the treatment of primary osteoporosis

Objective To observe the clinical efficacy of Jintiange capsule in treatment of primary osteoporosis, and to compare the effect between Jintiange capsule and Caltrate with vitamin D3 tablet. Methods One hundred and sixty patients with primary osteoporosis from the outdoor department of our hospital were diagnosed using dual-energy X-ray absorptiometry. They were divided into the study group (Jintiange group, n=80) and the control group (Caltrate group, n=80) using random number table method. Patients in the study group were treated with Jintiange capsule, and patients in the control group were treated with Caltrate with vitamin D3 tablet. The treatment lasted for 9 months. The symptom score was observed before and 3, 6, and 9 months after the treatment. The bone mineral density (BMD) was observed before and 9 months after the treatment. The data of the symptom score and BMD were evaluated and summarized. The liver function, renal function, and blood calcium were examined before and 3, 6, and 9 months after the treatment. Results All patients were followed up without loss. After the treatment for 3 months, the lumbar and back pain, debilitation, and gait difficulty in both groups were all different comparing to those before the treatment (P<0.01). The difference between the groups was significant in 3 months. The lumbar and back pain, debilitation, and gait difficulty relieved further in 6 and 9 months after the treatment comparing to those in 3 months, but with no statistical significance. BMD of the lumbar vertebrae, the femur, and the Ward triangle area increased significantly in the study group after 9-month treatment comparing to that before the treatment (P<0.01). BMD of the lumbar vertebrae, the femur, and the Ward triangle area in the control group also increased, but with no statistical difference (P>0.05). After the treatment, BMD among the lumbar vertebrae, the femur, and the Ward triangle area was statistically different (P<0.01). A few patients had adverse reaction including dry mouth and constipation, without obvious hypercalcinemia, liver disfunction, and renal disfunction. Conclusion Jintiange capsule has definite effect without obvious adverse reaction in the treatment of primary osteoporosis. It can not only relieve the lumbar and back pain, the debilitation, and the gait difficulty, but also can increase the BMD and improve quality of life, which is a good choice for clinical medication and has a good prospect.