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| 肾骨胶囊治疗绝经后骨质疏松症（肝肾不足证）的临床研究 |
| A clinical study on the treatment of postmenopausal osteoporosis (liver and kidney deficiency syndrome) with shengu capsules |
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| DOI：10.3969/j.issn.1006-7108.2025.06.005 |
| 中文关键词: 绝经后骨质疏松症 肾骨胶囊 肝肾不足证 醋酸钙 多中心随机对照 |
| 英文关键词:postmenopausal osteoporosis shengu capsules liver and kidney deficiency syndrome calcium acetate capsules multicenter randomized control |
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| 中文摘要: |
| 目的 采用多中心随机对照临床研究方法，评价肾骨胶囊治疗绝经后骨质疏松症（PMOP）肝肾不足证的疗效及安全性。方法 本研究在3个临床研究中心开展，按1∶1纳入试验组（肾骨胶囊）和对照组（醋酸钙胶囊），共240例，疗程为3个月。观察VAS评分、中医证候积分，检测碱性磷酸酶（ALP）、2,5羟基维生素D[2,5(OH)D]水平作为疗效指标；生命征、血钙（Ca）作为安全性指标；同时记录不良事件及合并用药情况。结果 本研究最终完成220例，试验组107例，对照组113例，脱落率5.83 %，剔除率2.5 %。两组受试者的基线差异无统计学意义，具有可比性。疗效评价：①治疗1、3个月后，两组受试者疼痛VAS评分、中医证候单项积分和总积分均降低，且试验组优于对照组（P＜0.05）；试验组和对照组总有效率分别为91.59 %和69.03 %。②治疗3个月后，两组ALP无明显变化；但试验组的2,5(OH)D较治疗前有所提高（P＜0.05）。安全性评价：两组受试者生命征、依从性、合并用药差异无统计学意义；部分受试者血Ca偏离，但差异无临床意义；部分受试者出现与药物相关的胃肠不适，停药后均可缓解。结论 肾骨胶囊治疗PMOP（肝肾不足证）能提高血清2,59OH)D水平，显著改善VAS评分、中医证候，并优于醋酸钙胶囊，临床用药安全、未见明显不良反应。 |
| 英文摘要: |
| Objective To evaluate the efficacy and safety of shengu capsules in the treatment of Postmenopausal osteoporosis (PMOP) liver and kidney deficiency syndrome using a multicenter randomized controlled clinical study method. Methods This study was conducted in three clinical research centers, with 240 participants (shengu capsules) and a control group (calcium acetate capsules) included in a 1:1 ratio. The treatment course was 3 months. Observe VAS scores, traditional Chinese medicine(TCM) syndrome, and detect alkaline phosphatase (ALP) and 2,5 hydroxy vitamin D (2,5 (OH) D) levels; vital signs, blood calcium (CA) as safety indicators; simultaneously record adverse events and concomitant medication use. Results 1. This study ultimately completed 220 cases, with 107 cases in the experimental group and 113 cases in the control group, resulting in a dropout rate of 5.83% and a rejection rate of 2.5%. There was no statistically significant difference in baseline between the two groups of subjects, indicating comparability. 2. Efficacy evaluation: After 1 and 3 months of treatment, both groups of subjects showed a decrease in VAS scores for pain, as well as a decrease in both individual and total scores for TCM syndrome. Moreover, the experimental group outperformed the control group（P＜0.05）; The total effective rates of the experimental group and the control group were 91.59% and 69.03%, respectively After 3 months of treatment, there was no significant change in ALP levels in both groups; But the 2,5 (OH) D of the experimental group increased compared to before treatment. 3. Safety evaluation: There was no statistically significant difference in vital signs, compliance, and concomitant medication between the two groups of subjects; Some subjects' blood CA deviated, but it had no clinical significance; Some subjects experienced drug-related gastrointestinal discomfort, which was relieved after discontinuing the medication. Conclusion The treatment of PMOP (liver and kidney deficiency syndrome) with shengu capsules can increase serum levels of 2,5 (OH) D, significantly improve VAS scores and TCM syndromes, and is superior to calcium acetate capsules. It is clinically safe to use and has no significant toxic side effects. |
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