Abstract:

Objective　To investigate the effect of Jintiange capsules combined with alfacalcitol for elderly patients with osteoporotic vertebral compression fracture (OVCF) after percutaneous kyphoplasty of vertebral body (PKP). Methods　Ninety-eight elderly patients with OVCF treated at Shandong Wendeng Osteopaths Yantai Hospital from February 2020 to May 2023 were selected for the randomized controlled trial, and were divided into a control group and an observation group by the coin toss method, with 49 cases in each group. The control group included 26 males and 23 females, with an age of (72.63±2.54) years; their disease course was (5.56±1.31) years. In the observation group, there were 29 males and 20 females; they were (72.89±2.60) years old; their disease course was (5.37±1.23) years. The patients in both groups took PKP; after PKP, the control group took alfacalcitol, and the observation group took alfacalcitol and Jintiange capsules, for 3 months. After the treatment, the treatment effects, symptom scores of traditional Chinese medicine, pain degrees, bone metabolism indicators, and adverse reactions were compared between the two groups. χ² and t tests were applied. Results　The effective rate of the observation group was higher than that of the control group [97.96% (48/49) vs. (81.63% (40/49); χ²=7.127; P=0.008]. After 3 months' treatment, the scores of main symptoms, secondary symptoms, and pain degree in the in the observation group were lower than those in the control group [(3.20±0.28) vs. (4.58±0.30), (1.20±0.16) vs. (1.96±0.21), and (1.58±0.27) vs. (3.29±0.41); t=23.540, 20.151, and 24.383; all P<0.001]. After 3 months' treatment, the levels of osteocalcin (BGP) and bone alkaline phosphatase (BALP) in the observation group were higher than those in the control group [(10.26±1.57) μg/L vs. (8.26±1.02) μg/L and (18.26±1.63) μg/L vs. (16.84±1.29) μg/L; t=7.478 and 4.782; both P<0.001]. The incidence of adverse reactions in the observation group was lower than that in the control group [6.12% (3/49) vs. (10.20% (5/49)], with no statistical difference (χ²=0.136; P=0.712). Conclusion　Jintiange capsules combined with alfacalcitol for elderly patients with OVCF after PKP can significantly improve their clinical symptoms and bone metabolism and reduce their pain degree and scores of traditional Chinese medicine symptoms, and is safe, so it is worth being generalized.

Key words:

Osteoporotic vertebral compression fracture, Jintiange capsules, Alfacalcitol, Percutaneous kyphoplasty of vertebral body

摘要：

目的　探讨金天格胶囊联合阿法骨化醇于老年骨质疏松性脊柱压缩性骨折（osteoporotic vertebral compression fracture，OVCF）患者经皮椎体后凸成形术（percutaneous kyphoplasty of vertebral body，PKP）术后应用的效果。方法　选取山东文登整骨烟台医院2020年2月至2023年5月收治的98例老年OVCF患者进行随机对照试验，采用掷硬币法将其分为对照组和观察组，各49例。对照组男26例，女23例，年龄（72.63±2.54）岁，病程（5.56±1.31）年。观察组男29例，女20例，年龄（72.89±2.60）岁，病程（5.37±1.23）年。两组患者给予PKP，对照组术后采用阿法骨化醇治疗，观察组术后另加用金天格胶囊治疗，两组均治疗3个月。治疗后，对比两组治疗效果、中医症候积分、疼痛程度、骨代谢指标、不良反应。采用χ²检验和t检验。结果　观察组治疗有效率高于对照组［97.96%（48/49）比81.63%（40/49）；χ²=7.127，P=0.008］。治疗3个月后，观察组主症积分、次症积分、疼痛程度评分均低于对照组［（3.20±0.28）分比（4.58±0.30）分、（1.20±0.16）分比（1.96±0.21）分、（1.58±0.27）分比（3.29±0.41）分；t=23.540、20.151、24.383，均P<0.001］。治疗3个月后，观察组骨钙素（osteocalcin，BGP）、骨碱性磷酸酶（bone alkaline phosphatase，BALP）水平均高于对照组［（10.26±1.57）μg/L比（8.26±1.02）μg/L、（18.26±1.63）μg/L比（16.84±1.29）μg/L；t=7.478、4.782，均P<0.001］。观察组不良反应发生率低于对照组［6.12%（3/49）比10.20%（5/49）］，但差异无统计学意义（χ²=0.136，P=0.712）。结论　老年OVCF患者PKP术后采用金天格胶囊联合阿法骨化醇治疗可明显改善临床症状，减轻疼痛程度，降低中医症候积分，改善骨代谢，安全性较好，值得推广。

关键词:

骨质疏松性脊柱压缩性骨折, 金天格胶囊, 阿法骨化醇, 经皮椎体后凸成形术