目的：探讨补肾健骨方配合西药治疗骨质疏松症患者临床疗效观察及其安全性评价。方法：根据随机数字表达将本组纳入的134例骨质疏松症患者随机分为治疗组（n ＝67）和对照组（n＝67）。治疗组采用补肾健骨方配合西药治疗，对照组仅采用西药治疗。两组均以3个月为1疗程，连续治疗2个疗程。评价两组疗程结束后疼痛缓解率，治疗前、后骨代谢生化治疗、腰椎、股骨颈骨密度、血中骨钙素及治疗期间不良反应发生情况。结果：治疗组治疗2个疗程后优良率（76．12％）显著高于对照组（50．75％），且具有统计学差异（ P ＜0．05）；两组ALP 治疗后较治疗前显著增加，U‐Ca 治疗后较治疗前显著降低，且均具有统计学差异（P＜0．05）；治疗组 ALP 治疗后显著高于对照组，U‐Ca 治疗后显著低于对照组，且均具有统计学差异（P＜0．05）；治疗组腰椎、股骨颈骨密度治疗后显著高于对照组，且具有统计学差异（P＜0．05）；两组血中骨钙素治疗后较治疗前显著增加，且具有统计学差异（P＜0．05）；治疗组血中骨钙素治疗后显著高于对照组，且具有统计学差异（P ＜0．05）；治疗期间两组均未见明显不良反应发生。结论：补肾健骨方配合西药治疗骨质疏松症患者临床疗效显著，且无明显不良反应，临床应用安全可靠。%Objective :To investigate the combination therapy in patients with osteoporosis clinical efficacy and safety evaluation .Methods :According to the expression of random numbers will be included in this group of 134 cases of osteoporosis were randomly divided into a treatment group (n= 67) and control group (n= 67) .The treatment group received the combination therapy ,the control group ,only the use of western medicine .The two groups are 3‐month course of treatment ,continuous treatment of two courses .After the evaluation of pain relief medication groups ,before and after treatment of bone metabolic biochemical treatment ,adverse events lumbar spine ,femoral neck bone mineral density ,serum osteocalcin and during treatment .Results :The treatment group after two courses of good rate (76 .12% ) was significantly higher (50 .75% ) ,and has a statistically significant difference (P< 0 .05) ;ALP groups after treatment than before treatment increased significantly ,U‐Ca after treatment than before treatment significantly reduced ,and both have significant differences (P< 0 .05 ) ;after treatment ,the treatment group was significantly higher ALP ,after U‐Ca treatment was significantly lower than that in the control group ,and were statistically different (P< 0 .05) ;treatment group ,lumbar spine ,femoral neck bone mineral density after treatment was significantly higher ,and has a statistically significant difference (P< 0 .05) ;significantly increased than before treatment serum osteocalcin groups after treatment ,and statistically difference (P< 0 .05) ;serum osteocalcin treatment group was significantly higher after treatment ,and has a statistically significant difference (P< 0 .05) ;the two groups during treatment showed no significant adverse reactions occur . Conclusion :The clinical efficacy of combination therapy in patients with osteoporosis significantly ,and no significant adverse reactions ,clinical application of safe ,reliable ,worthy of further study application .
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