Liang Hanting, Wang Ou, Cheng Zhifeng, Xia Peijin, Wang Liang, Shen Jie, Kong Xijian, Zeng Yuhong, Chao Aijun, Yan Limei, Lin Hua, Sun Haibiao, Cheng Qun, Zhu Mei, Hu Zhenming, Zhang Zhenlin, Tang Hai, Xia Weibo
Key Laboratory of Endocrinology of National Health Commission, Department of Endocrinology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, 100730, China.
Department of Endocrinology, The Fourth Affiliated Hospital of Harbin Medical University, China.
J Orthop Translat. 2022 Aug 24;35:53-61. doi: 10.1016/j.jot.2022.05.002. eCollection 2022 Jul.
To investigate the effectiveness of a Chinese patent medicine, Jintiange capsules with the main component of artificial tiger bone powder, combined with alfacalcidol on muscle strength and balance of the lower extremities in patients with primary osteoporosis.
A randomized, double-blind, double-dummy, positive-controlled, multicenter clinical trial.
A total of 400 patients diagnosed with primary osteoporosis or osteopenia were recruited and randomized into the Jintiange or control groups. During the 52-week treatment, the participants in the Jintiange group were treated with Jintiange capsules (1.2 g each time, 3 times per day) and calcium carbonate simulant, while those in the control group were treated with calcium carbonate (element calcium 0.3 g, twice a day) and a Jintiange capsule simulant. Alfacalcidol (0.25 μg/d) was applied in both groups. The timed up and go test (TUG), chair rising test (CRT), and tandem gait test (TGT) were performed to evaluate balance, muscle strength and fall risk of the participants.
There were 154 participants in the Jintiange group, and 157 participants in the control group were included in the per-protocol set. Comparing the data at week 52 from those at baseline, the TUG time decreased from 9.60 ± 2.25 s to 8.53 ± 2.06 s (p < 0.001) in the Jintiange group and decreased from 9.50 ± 1.91 s to 9.11 ± 1.95 s (p < 0.001) in the control group; the CRT time decreased from 11.49 ± 4.05 s to 8.57 ± 2.13 s (p < 0.001) and 11.17 ± 3.21 s to 9.74 ± 1.98 s (p < 0.001) in the Jintiange and control groups, respectively; the number of correct steps in the TGT increased significantly in both the control (7.40 ± 1.27 vs. 7.69 ± 0.87, p < 0.01) and Jintiange groups (7.21 ± 1.58 vs. 7.60 ± 1.12, p < 0.001). At the end of the study, the TUG and CRT results in the Jintiange group were superior to those in the control group (all p value < 0.05), while no obvious difference was found in the TGT between the two groups. At week 52, the high fall risk proportions in the Jintiange group were significantly lower than those in the control group according to TUG (3.25% vs. 9.55%, p = 0.023) and CRT (20.78% vs. 33.76%, p = 0.01).
Jintiange capsules combined with alfacalcidol can effectively improve muscle strength and the balance of the lower extremities and reduce fall risk in patients with primary osteoporosis/osteopenia.
Artificial tiger bone powder, a traditional Chinese patent medicine, can improve muscle strength and balance and reduce fall risks effectively among patients with primary osteoporosis. It might be a therapeutic option for osteoporosis individuals combined with sarcopenia to improve their muscle function.
探讨以人工虎骨粉为主要成分的中成药金天格胶囊联合阿法骨化醇对原发性骨质疏松症患者下肢肌肉力量和平衡能力的影响。
一项随机、双盲、双模拟、阳性对照、多中心临床试验。
共纳入400例诊断为原发性骨质疏松症或骨量减少的患者，随机分为金天格组和对照组。在52周的治疗期间，金天格组患者服用金天格胶囊（每次1.2 g，每日3次）和碳酸钙模拟剂，而对照组患者服用碳酸钙（元素钙0.3 g，每日2次）和金天格胶囊模拟剂。两组均应用阿法骨化醇（0.25 μg/d）。采用计时起立行走测试（TUG）、椅子起立测试（CRT）和串联步态测试（TGT）来评估参与者的平衡能力、肌肉力量和跌倒风险。
符合方案集分析中，金天格组纳入154例参与者，对照组纳入157例参与者。与基线时的数据相比，金天格组的TUG时间从9.60±2.25秒降至8.53±2.06秒（p<0.001），对照组从9.50±1.91秒降至9.11±1.95秒（p<0.001）；金天格组的CRT时间从11.49±4.05秒降至8.57±2.13秒（p<0.001），对照组从11.17±3.21秒降至9.74±1.98秒（p<0.001）；TGT中正确步数在对照组（7.40±1.27对7.69±0.87，p<0.01）和金天格组（7.21±1.58对7.60±1.12，p<0.001）均显著增加。研究结束时，金天格组的TUG和CRT结果优于对照组（所有p值<0.05），而两组TGT结果无明显差异。在第52周时，根据TUG（3.25%对9.55%，p=0.023）和CRT（20.78%对33.76%，p=0.01），金天格组高跌倒风险比例显著低于对照组。
金天格胶囊联合阿法骨化醇可有效提高原发性骨质疏松症/骨量减少患者的肌肉力量和下肢平衡能力，并降低跌倒风险。
人工虎骨粉这一传统中成药可有效提高原发性骨质疏松症患者的肌肉力量和平衡能力，并降低跌倒风险。它可能是骨质疏松合并肌肉减少症患者改善肌肉功能一个治疗选择。
