益气温经方在绝经后骨质疏松症肾虚血瘀证治疗中的应用

Application of Yiqi Wenjing Fang(益气温经方)in treatment of kidney-deficiency-blood-stasis-type postmenopausal osteoporosis:a clinical study

目的:观察益气温经方在绝经后骨质疏松症(postmenopausalosteoporosis,PMOP)肾虚血瘀证治疗中的应用价值。方法:将符合要求的240例PMOP肾虚血瘀证患者随机分为2组,每组120例,分别采用口服益气温经方联合碳酸钙D3片和阿法骨化醇胶囊(益气温经方组)与单纯口服碳酸钙D3片和阿法骨化醇胶囊(基础用药组)治疗。益气温经方,每日2次,每次1袋,每袋200mL;碳酸钙D3片,每日1次,每次1片;阿法骨化醇胶囊,每日1次,每次1粒;均3个月为1个疗程,疗程间隔1个月,共9个疗程。分别于治疗结束时、治疗结束后2年比较2组患者再骨折情况,分别于治疗前及治疗结束时、治疗结束后2年比较2组患者腰椎骨密度、腰背部疼痛视觉模拟量表(visualanaloguescale,VAS)评分,并观察并发症发生情况。结果:①受试者退出情况。共20例患者退出试验,益气温经方组13例因腹泻及不愿再服中药退出,基础用药组7例因服用其他药物退出。②再骨折发生情况。治疗结束时,益气温经方组4例出现再骨折、基础用药组6例出现再骨折;2组患者再骨折发生率比较,差异无统计学意义(χ^(2)=0.313,P=0.576)。治疗结束后2年,益气温经方组6例出现再骨折、基础用药组16例出现再骨折;益气温经方组再骨折发生率低于基础用药组(χ^(2)=4.466,P=0.035)。③腰椎骨密度。时间因素和分组因素存在交互效应(F=3.063,P=0.048);2组患者腰椎骨密度总体比较,组间差异有统计学意义,即存在分组效应(F=11.788,P=0.000);治疗前后不同时间点腰椎骨密度的差异有统计学意义,即存在时间效应(F=4.299,P=0.014);益气温经方组患者腰椎骨密度治疗前后比较,差异无统计学意义[(54.902±32.465)mg·cm^(-3),(58.174±14.320)mg·cm^(-3),(54.223±14.053)mg·cm^(-3),F=0.943,P=0.391];基础用药组患者腰椎骨密度随时间变化呈下降趋势[(55.449±32.111)mg·cm^(-3),(50.800±20.377)mg·cm^(-3),(44.283±10.340)mg·cm^(-3),F=6.242,P=0.002];治疗前,2组患者腰椎骨密度比较,差异无统计学意义(t=0.126,P=0.900);治疗结束时、治疗结束后2年,益气温经方组患者腰椎骨密度均高于基础用药组(t=3.708,P=0.002;t=5.998,P=0.000)。④腰背部疼痛VAS评分。时间因素和分组因素不存在交互效应(F=0.799,P=0.460);2组患者腰背部疼痛VAS评分总体比较,组间差异无统计学意义,即不存在分组效应(F=3.920,P=0.271);治疗前后不同时间点腰背部疼痛VAS评分的差异有统计学意义,即存在时间效应(F=402.283,P=0.000);2组患者腰背部疼痛VAS评分随时间变化均呈下降趋势,且2组的下降趋势完全一致[(6.76±1.99)分,(3.16±1.99)分,(2.21±1.52)分,F=181.117,P=0.000;(7.13±1.98)分,(3.10±1.79)分,(2.35±1.63)分,F=222.874,P=0.000]。⑤并发症。益气温经方组18例出现一过性胃部不适,基础用药组6例出现一过性胃部不适、4例出现一过性低热。2组并发症发生率比较,差异无统计学意义(χ^(2)=3.145,P=0.076)。结论:口服益气温经方可以降低PMOP肾虚血瘀证患者再骨折的发生率,提高患者骨密度,缓解患者疼痛症状,且安全性高。

Objective:To observe the applied values of Yiqi Wenjing Fang(益气温经方,YQWJF)in treatment of kidney-deficiency-blood-stasis-type postmenopausal osteoporosis(PMOP).Methods:Two hundred and forty patients with kidney-deficiency-blood-stasis-type PMOP were enrolled in the study and were randomly divided into YQWJF group and basic medication group, 120 cases in each group.The patients in YQWJF group were treated with oral application of YQWJF(twice a day, 200 mL at a time),calcium carbonate and Vitamin D3 tablets(one tablet a day)and alfacalcidol capsules(one capsule a day),while the others in basic medication group were merely with oral application of calcium carbonate and Vitamin D3 tablets and alfacalcidol capsules for consecutive 9 courses of treatment, 3 months for each course with a 1-month rest-insertion between courses.The incidence rate of refracture was compared between the 2 groups at the end of treatment and at 2 years after the end of treatment respectively.The bone mineral density(BMD)of lumbar vertebrae and low back pain visual analogue scale(VAS)scores were recorded and compared between the 2 groups before the treatment, at the end of treatment and at 2 years after the end of the treatment respectively, and the complications were observed.Results:Thirteen patients in YQWJF group and seven patients in basic medication group dropped out of the trial for unwillingness to take the requested medications due to diarrhea and taking other medications respectively.At the end of treatment, the refracture was found in 4 patients in YQWJF group and 6 patients in basic medication group.There was no statistical difference in the incidence rate of refracture between the 2 groups(χ2=0.313,P=0.576).At 2 years after the end of treatment, the refracture was found in 6 patients in YQWJF group and 16 patients in basic medication group.The incidence rate of refracture was lower in YQWJF group compared to basic medication group(χ2=4.466,P=0.035).There was interaction between time factor and group factor in BMD of lumbar vertebrae(F=3.063,P=0.048).There was statistical difference in BMD of lumbar vertebrae between the 2 groups in general, in other words, there was group effect(F=11.788,P=0.000).There was statistical difference in BMD of lumbar vertebrae between different timepoints before and after the treatment, in other words, there was time effect(F=4.299,P=0.014).There was no statistical difference in BMD of lumbar vertebrae between pre-treatment and post-treatment in YQWJF group(54.902±32.465,58.174±14.320,54.223±14.053 mg/cm(3),F=0.943,P=0.391);while the BMD of lumbar vertebrae presented a time-dependent decreasing trend in basic medication group(55.449±32.111,50.800±20.377,44.283±10.340 mg/cm(3),F=6.242,P=0.002).There was no statistical difference in BMD of lumbar vertebrae between the 2 groups before the treatment(t=0.126,P=0.900),whereas the BMD of lumbar vertebrae was higher in YQWJF group compared to basic medication group at the end of treatment and at 2 years after the end of treatment(t=3.708,P=0.002;t=5.998,P=0.000).There was no interaction between time factor and group factor in low back pain VAS scores(F=0.799,P=0.460).There was no statistical difference in the low back pain VAS scores between the 2 groups in general, in other words, there was no group effect(F=3.920,P=0.271).There was statistical difference in the low back pain VAS scores between different timepoints before and after the treatment, in other words, there was time effect(F=402.283,P=0.000).The low back pain VAS scores presented a time-dependent decreasing trend in the 2 groups, and the 2 groups were completely consistent with each other in the variation tendency(6.76±1.99,3.16±1.99,2.21±1.52 points, F=181.117,P=0.000;7.13±1.98,3.10±1.79,2.35±1.63 points, F=222.874,P=0.000).The transient stomach discomfort was found in 18 patients in YQWJF group and 6 patients in basic medication group, besides, the transient low-grade fever was found in 4 patients in basic medication group.There was no statistical difference in complication incidence rate between the 2 groups(χ2=3.145,P=0.076).Conclusion:Oral application of YQWJF can reduce the incidence rate of refracture, improve BMD and relieve pain in patients with kidney-deficiency-blood-stasis-type PMOP,and it exhibits high safety.