目的 探讨腰痛宁胶囊联合碳酸钙D₃片在缓解老年性骨质疏松性骨痛方面的临床疗效。方法 收集自2018年9月-2019年12月在陕西中医药大学附属医院骨伤科门诊就诊，符合老年性骨质疏松症诊断标准，疼痛视觉模拟评分法（visual analogue scale，VAS）评分在3~8分患者120例，随机分为对照组（60例）和治疗组（60例）。对照组口服碳酸钙D₃片作为基础治疗，每次0.6 g，1次/d；治疗组在对照组基础上内服腰痛宁胶囊治疗骨质疏松性骨痛，每次4粒，每晚睡前0.5 h黄酒10 mL兑少量温开水送服。降钙素类其他抗骨质疏松药物，医师知情可不改变剂量的情况下继续使用。连续用药2周，入组前及入组后3、7、14 d各随访1次，共4次，时间窗±1 d。治疗结束后根据各访视期VAS评分改变，以疼痛程度改善情况进行疗效评价。测定治疗前、后患者血清中疼痛相关因子。结果 治疗组60例患者总有效率91.7%。对照组60例患者总有效率23.3%，有效率明显低于治疗组，两组差异具有统计学意义（P<0.05）。治疗组治疗后与治疗前比较，从静息痛、触压痛、活动痛三方面观察，VAS评分均有所下降（P<0.05、0.01），疗效肯定；而对照组治疗后与治疗前比较，VAS评分的变化不明显，疗效不佳。经14 d治疗后，对照组患者血清前列腺素E2（PGE₂）、P物质（SP）和5-羟色胺（5-HT）的水平无显著变化，治疗组均显著下降（P<0.01）。结论 腰痛宁胶囊联合碳酸钙D₃片在缓解老年性骨质疏松症骨痛方面起效快，疗效显著。

Objective To investigate the clinical efficacy of Yaotongning Capsule in relieving osteoporotic bone pain in the elderly. Methods A total of 120 patients with pain VAS score between 3 and 8 in the department of orthopedics and traumatology, Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine from September 2018 to December 2019, in accordance with the diagnostic criteria of senile osteoporosis, were randomly divided into control group (60 cases) and treatment group (60 cases). The control the group was treated with oral Calcium Carbonate and Vitamin D₃, 0.6 g, once a day; The treatment group was treated with Yaotongning Capsule on the basis of control group, four capsules each time, 0.5 h before sleeping every night, with 10 mL yellow wine mixed with a small amount of warm boiled water. The dosage of other anti-osteoporosis drugs should not be changed. The drug was administered continuously for 2 weeks. The patients were followed up for 0, 3, 7 and 14 d, respectively, with a time window of±1 d. After treatment, according to the changes of visual analogue scale (VAS) score in each visit period, the curative effect was evaluated according to the improvement of pain degree. Serum pain media levels were tested between two groups before and after treatment. Results The total effective rate of 60 patients in the treatment group was 91.7%. The total effective rate of 60 patients in the control group was 23.3%, which was significantly lower than that in the treatment group, and the difference between the two groups was statistically significant. The scores of pain before and after treatment in the observation group were lower than those in the control group (P<0.01). After 14 d of treatment, the levels of PGE2, SP and 5-HT did not change significantly in the control group, but decreased significantly in the treatment group (P<0.01). Conclusion The results of this study show that Yaotongning Capsule has a rapid onset and significant effect in relieving bone pain of senile osteoporosis.

R28;R274

国家自然科学基金资助项目（81703777）