五子衍宗汤加减联合阿仑膦酸钠治疗更年期女性骨质疏松症临床疗效

Clinical Efficacy Study on Combination of Wuzi Yanzong Decoction and Alendronate in Treatment of Osteoporosis in Menopausal Women

目的探讨五子衍宗汤加减联合阿仑膦酸钠治疗更年期女性骨质疏松症的疗效、安全性及对患者生活质量的影响。方法选择更年期女性骨质疏松症患者100例,随机数字表法均分为观察组和对照组,每组50例,观察组给与阿仑膦酸钠+五子衍宗汤加减治疗,对照组采用阿仑膦酸钠治疗。治疗2个月后比较两组的临床疗效和治疗前后性激素指标、骨代谢指标及不良反应,采用生活质量问卷(SF-36)评价两组治疗后生活质量,观察两组治疗的安全性。结果观察组50例患者中显效22例,有效26例,缓解率96.00%(48/50),高于对照组。观察组患者治疗前后BMD明显上升。治疗前,两组FSH、LH水平均高于正常值,E2水平均低于正常值;治疗后,两组FSH、LH均出现降低,E2均出现上升。比较观察组和对照组指标改善程度发现,观察组优于对照组。观察组患者治疗后2个月生存质量总分(88.36±9.27)分,高于对照组总分(68.47±10.03)分。观察组不良反应发生率为20.00%(10/50),对照组不良反应发生率为24.00%(12/50)。两组患者治疗后PGE2和SP水平明显低于治疗前,此外,与治疗后的对照组相比,两组IPTH、CTX、N-MID、PINP水平均明显下调,Vd-T水平均明显上升,且比较观察组和对照组指标,且观察组指标改善程度明显优于对照组。结论五子衍宗汤加减联合阿仑膦酸钠不仅缓解骨质疏松,提高患者免疫力,还缓解患者骨质疏松性疼痛,提高患者生活质量,为更年期妇女骨质疏松的临床用药提供一定基础。

Objective To explore the efficacy,safety and effect of Modified Wuzi Yanzong Decoction combined with alendronate sodium in the treatment of osteoporosis in menopausal women. Methods A hundred menopausal female osteoporosis patients were selected,and according to the random number table method were divided into observation group and control group,50 cases in each group. The observation group was treated with alendronate sodium + Modified Wuzi Yanzong Decoction,and the control group was treated with alendronate sodium. After 2 months of treatment,we compared the clinical efficacy and sex hormone indexes,serum pain mediators,bone metabolism index and adverse reactions of the two groups before and after treatment. The quality of life questionnaire( SF-36) was used to evaluate the quality of life of the two groups after treatment and we observed the safety of treatment in the two groups. Results Of the 100 patients in the observation group,22 were markedly effective,26 were effective,and the remission rate was 96. 00%( 48/50),which was higher than that of the control group. The BMD of the observation group increased significantlyafter treatment. The levels of FSH and LH in the two groups were higher than normal,and the E2 level was lower than normal. FSH and LH decreased in both groups,and E2 increased. Comparing the improvement degree of the observation group and the control group,the observation group’s improvementwas superior to that of the control group. The total score of quality of life of the observation group 2 months after treatment [( 88. 36 ± 9. 27) points]was higher than that of the control group[( 68. 47 ± 10. 03) points]. The incidence of adverse reactions in the observation group was 20. 00%( 10/50),and the incidence of adverse reactions in the control group was 24. 00%( 12/50). After treatment,the levels of PGE2 and SP in the two groups were significantly lower than those before treatment. Compared with those of the control group after treatment,the levels of PGE2 and SP in the observation group were significantly lower. After treatment,the levels of IPTH,CTX,N-MID and PINP in the two groups were significantly lowered,and the Vd-T levels were significantly increased. The indicators of the observation group and the control group were compared,and the improvement of the indicators of the observation group was significantly better than the control group. Conclusion Wuzi Yanzong Decoction combined with alendronate not only relieves osteoporosis and improves the immunity of patients,but also relieves osteoporosis pain and improves the quality of life of patients. It provides a basis for the clinical use of osteoporosis in menopausal women.