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利塞膦酸鈉膠囊治療絕經(jīng)后骨質疏松癥療效再評價
【摘要】 目的 運用LSC校正法評定利塞膦酸鈉膠囊治療絕經(jīng)后骨質疏松癥(PMOP)的療效。方法 采用隨機、雙盲、安慰劑平行對照方法，入選的42例PMOP患者隨機分為試驗組(n=21)和對照組(n=21)。試驗組晨起口服利塞膦酸鈉膠囊，對照組口服安慰劑，2組均在晚間口服碳酸鈣D咀嚼片，療程為12個月。治療前、治療6個月、12個月時，測量腰椎和髖部骨密度(BMD)，用LSC校正法計算BMD的療效，并與正態(tài)分析法比較。結果 LSC校正法分析表明，試驗組腰椎BMD在6個月、治療12個月時的變化與對照組比較差異均有顯著性(P<0.05)，但2組髖部BMD的變化之間的差異無顯著性(P>0.05)。上述結果與正態(tài)分析法對BMD的療效評價結果一致。結論 LSC校正法評價療效的結果與正態(tài)分析法具有高度一致性，兩種方法在評價療效時各有優(yōu)缺點，臨床評價BMD的療效時可視具體情況選用或同時應用。
【關鍵詞】 絕經(jīng)后骨質疏松癥;骨密度;最小有意義變化;雙能X線吸收法
Reassessment of the efficacy of risedronate sodium capsules
in the treatment of postmenopausal osteoporosis
GUO Junhao, YAO Rubing, ZHAO Zhiming, CAI Hui
(Department of Integrated Traditional Chinese and Western Medicine, Nanjing General Hospital of
Nanjing Military Command, PLA, Nanjing, Jiangsu 210002, China醫(yī).學全.在.線網(wǎng)站m.f1411.cn)
Abstract:Objective To evaluate efficacy of risedronate sodium capsules in the treatment of postmenopausal osteoporosis (PMOP) by the least significant change (LSC)-adjusted method (LAM).Methods This is a randomized double-blind, placebo-controlled clinical trial. 42 patients with PMOP were randomly divided into 2 groups: trial group (n=21) and control group (n=21). During 12 months, patients in the trail group received risedronate sodium capsules orally every morning, while patients of control group took placebo orally every morning, and meanwhile all patients took calcichew D orally every night. The double-energy bone density measurement was used to determine lumbar and hip bone mineral density (BMD) at 3 time points (before treatment, 6 months and 12 months after treatment). Meanwhile, the effect on BMD was evaluated by LAM to compare with the result evaluated by normal distribution analytical method (NAM).Results The sample change data for lumbar BMD by (LAM) showed that there was statistical significance in the changes 6 and 12 months after continuous treatment between the trial group and control group respectively (P<0.05), while no statistical significance in the change data for hip BMD was observed between the two groups (P>0.05). The results of efficacy about BMD by LAM were consistent with those by NAM.Conclusion The results by LAM and NAM have high concordance. There are both advantages and disadvantages respectively in the evaluation of the efficacy about BMD by LAM and NAM. The two methods should be used alone or meanwhile when necessary.
