目的：观察补肾益肝活血汤联合阿法骨化醇治疗老年原发性骨质疏松症（OP） 的疗效及其安全 性。方法：选取116 例老年原发性OP 患者，按随机数字表法分为对照组及治疗组各58 例。对照组给予阿法 骨化醇胶囊治疗，治疗组给予补肾益肝活血汤联合阿法骨化醇治疗。观察2 组临床疗效及不良反应发生率，比 较2 组治疗前后中医证候积分、骨代谢指标［骨特异性碱性磷酸酶（BALP）、骨钙素（BGP）、Ⅰ型前胶原氨基 端前肽（PⅠNP）］值、骨密度水平的变化。结果：治疗组临床疗效总有效率为98.28%，对照组为86.21%， 2 组比较，差异有统计学意义（P＜0.05）。治疗后，2 组中医证候腰膝酸痛、腰脊刺痛、手足心热、下肢痿弱 积分均较治疗前下降（P＜0.05），治疗组上述4 项中医证候积分均低于对照组（P＜0.05）。治疗后，2 组腰椎 L2～4、股骨颈骨密度均较治疗前升高（P＜0.05），治疗组腰椎L2～4、股骨颈骨密度均高于对照组（P＜0.05）。 治疗后，2 组BGP 水平均较治疗前升高（P＜0.05），BALP、PⅠNP 水平均较治疗前下降（P＜0.05）；治疗组 BGP 水平高于对照组（P＜0.05），BALP、PⅠNP 水平均低于对照组（P＜0.05）。对照组不良反应发生率为 17.24%，治疗组不良反应发生率为3.45%，2 组比较，差异有统计学意义（P＜0.05）。结论：补肾益肝活血汤 联合阿法骨化醇治疗老年原发性OP 患者疗效显著，能缓解临床症状，改善骨代谢水平，提高骨密度，减少不 良反应。
Abstract： Objective： To observe the clinical effect and safety of Bushen Yigan Huoxue Decoction combined with Alfacalcidol Capsules for senile patients with primary osteoporosis (OP). Methods：A total of 116 cases of senile patients with primary OP were selected and divided into the control group and the treatment group according to the random number table method，with 58 cases in each group. The control group was treated with Alfacalcidol Capsules， and the treatment group was treated with Bushen Yigan Huoxue Decoction combined with Alfacalcidol Capsules. The clinical effects and the incidence of adverse reactions in the two groups were observed；the changes of traditional Chinese medicine (TCM) syndrome scores，bone metabolism indexes [bone alkaline phosphatase (BALP)，bone gla protein (BGP)，procollagen ⅠN-terminal propeptide (PⅠNP)] and bone mineral density levels were compared before and after treatment between the two groups. Results：The total effective rate was 98.28% in the treatment group and 86.21% in the control group， the difference being significant (P＜0.05). After treatment， the scores of soreness and pain in waist and knee，stabbing pain in the lumbar spine，fever of palms and sole，and wilting and weakness of lower extremities in the two groups were decreased when compared with those before treatment (P＜0.05)， and the above four TCM syndrome scores in the treatment group were lower than those in the control group (P＜0.05). After treatment，the bone mineral density of lumbar L2- 4 and femoral neck in the two groups was increased when compared with that before treatment (P＜0.05)，and the bone mineral density of lumbar L2- 4 and femoral neck in the treatment group was higher than that in the control group (P＜0.05). After treatment，BGP levels in the two groups were increased when compared with those before treatment (P＜0.05)，and the levels of BALP and PⅠNP were decreased when compared with those before treatment (P＜0.05)；the BGP level in the treatment group was higher than that in the control group (P＜0.05)，and the levels of BALP and P ⅠNP were lower than those in the control group (P＜0.05). The incidence of adverse reactions was 17.24% in the control group and 3.45% in the treatment group， the difference being significant (P＜0.05). Conclusion： Bushen Yigan Huoxue Decoction combined with Alfacalcidol Capsules has a significant curative effect in treating senile patients with primary OP，which can alleviate clinical symptoms，improve bone metabolism，increase bone mineral density and reduce adverse reactions.