世界中医药

作者	单位
傅兰清1，胡亚俊1，王玲2	1 荆州市中心医院（华中科技大学同济医学院附属荆州医院）骨科，荆州，434020； 2 湖北省中药现代化工程技术研究中心，武汉，430052

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中文摘要:

目的：探索龙牡壮骨颗粒在绝经期骨质疏松性椎体压缩性骨折保守治疗中的临床疗效及安全性。方法：将72例绝经期骨质疏松性椎体压缩性骨折，接受保守治疗的患者随机分为2组。在经皮雌激素基础治疗之上，治疗组给予龙牡壮骨颗粒治疗，对照组给予钙尔奇D治疗。比较2组患者治疗1月、2月、3月的有效率、VAS评分、曲马多用量、骨密度变化及不良事件，并于半年、1年后随访VAS评分、OQOLS量表评分、骨密度与再骨折发生率及不良事件。结果：2组患者在基线时各项指标均无统计学意义，具有可比性（P>0.05）。治疗组与观察组各有2例在治疗2月时未随诊；治疗组有3例未接受治疗1年时的随访，对照组有4例未接受治疗1年时的随访，失访率无统计学意义（P>0.05）。治疗1月、2月时，2组有效率、VAS评分、曲马多用量、骨密度有统计学意义（P<0.05），治疗组优于对照组；但治疗3月时，2组有效率、VAS评分、曲马多用量、骨密度指标无统计学意义（P>0.05）。治疗半年、1年后随访时，VAS评分、骨密度与再骨折发生率无统计学意义（P>0.05）；但OQOLS量表评分有统计学意义，治疗组优于对照组（P<0.05）。2组患者在治疗期间均未发生与药物相关的不良反应，无再骨折，无新发高脂血症，无血栓事件，无新发胆囊疾病，无新发恶性肿瘤。结论：龙牡壮骨颗粒联合经皮雌激素治疗绝经期骨质疏松性椎体压缩性骨折能迅速提高骨密度，减轻疼痛症状，减少再骨折发生率，且安全性良好，值得临床推广使用。

English Summary:

To explore the clinical effect and safety of Longmu Zhuanggu Granule (Longmu Bone-strengthening Granule) in conservative treatment of postmenopausal osteoporotic vertebral compression fractures (POVCF). Methods: A total of 72 patients were randomized to Longmu Zhuanggu Granule (the treating group) or Caltrate D (the control group) to treat POVCF based on the transdermal estrogen therapy. The effective rates, VAS scores, dosages of Tramadol, bone mineral density changes and adverse events of treating group were compared with those of control group in1 month, 2 months and 3 months post-dose. And the VAS scores, OQOLS scale scores, bone mineral densities and refracture rates and adverse events were also evaluated through follow-up visits in 6 months and 1 year post-dose. Results: Every indicator of two groups had no significant differences at baseline (P>0.05) and could be comparable. There were 2 cases in either group failing to revisit at the 2nd month post-dose, and 3 cases in the treating group and 4 cases in the control group failing to take the follow-up visit in 1 year post-dose. Hence there was no significant difference of loss rates between two groups (P>0.05). At the 1 st month and the 2nd month, the effective rates, VAS scores, dosages of Tramadol and bone mineral densities of the treating group were better than those of the control group, and the differences were significant (P<0.05). However, there were no significant differences between two groups in 3 months, 6 months and 1 year post-dose(P>0.05). The OQOLS scale score of the treating group was better than that of the control group in 6 months and 1 year post-dose (P<0.05). Both groups had no adverse drug reactions, no refractures, no new hyperlipidemias, no thrombotic events, no new gallbladder diseases, no new malignant tumors during treatment. Conclusion: Longmu Zhuanggu Granule combined with transdermal estrogen in the treatment of POVCF could quickly improve bone mineral density, relieve pain symptoms and reduce the refracture rate, safe and worthy of clinical promotion.

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