密固達(dá)治療絕經(jīng)后骨質(zhì)疏松患者的3年臨床療效分析
發(fā)布時間:2018-04-11 14:15
本文選題:絕經(jīng)后骨質(zhì)疏松 + 唑來膦酸 ; 參考:《青島大學(xué)》2017年碩士論文
【摘要】:目的分析絕經(jīng)后骨質(zhì)疏松患者3年間每年輸注一次唑來膦酸(Zoledronic acid,商品名:密固達(dá))后的長期療效、抗骨折作用、緩解疼痛作用、安全性等。方法本實驗是一項臨床回顧性研究,查閱2011年2月至2016年12月間就診于青島大學(xué)附屬醫(yī)院的絕經(jīng)后骨質(zhì)疏松患者住院或門診診療記錄,選取絕經(jīng)后婦女、平均年齡63.4歲的骨質(zhì)疏松患者259人入組,根據(jù)其治療情況共分為4組,其中Z0組65人口服骨化醇及鈣劑,Z1、Z2、Z3組患者在服用骨化醇及鈣劑的基礎(chǔ)上:Z1組65人在第1天(初次接受注射時視為第1天)接受一次唑來膦酸(5mg)靜脈滴注,Z2組64人分別在第1天、第12個月時接受唑來膦酸共兩次注射,Z3組65人分別在第1天、12個月和24個月時接受唑來膦酸共三次注射。觀察所有患者至第36個月。通過分析各組各時期腰椎1-4(L1-4)、股骨頸、全髖骨密度(BMD)變化、新發(fā)骨折情況、疼痛評分、生化指標(biāo)、不良反應(yīng)和不良事件發(fā)生率,評價唑來膦酸的長期療效、抗骨折作用、緩解疼痛效果、生化指標(biāo)影響和藥物安全性。結(jié)果各組入組患者年齡、各部位骨密度、疼痛評分、生化指標(biāo)等相似。(1)骨密度變化:Z3組各部位的骨密度在各時期持續(xù)增加,第36個月時L1-4、股骨頸、全髖骨密度分別較第一次注射唑來膦酸前增加了(0.104g/cm2,15.55%)、(0.106g/cm2,15.78%)、(0.114g/cm2,16.94%);Z1、Z2組在注射唑來膦酸后骨密度均有增加,在終止治療后各部位骨密度進(jìn)行性下降。(2)新發(fā)骨折:Z0組(n=8,12.31%)、Z1組(n=5,7.69%)、Z2組(n=2,3.13%)、Z3組(n=1,1.5%),四組新發(fā)骨折比較有統(tǒng)計學(xué)意義(P=0.048),其中Z3組明顯低于Z0組(P=0.016)。(3)疼痛緩解情況:Z3組各時期疼痛評分持續(xù)下降;Z1、Z2組在注射唑來膦酸后疼痛評分均有下降,在終止治療后疼痛評分進(jìn)行性升高。(4)生化指標(biāo):各組各時期血鈣、血磷、甲狀旁腺素、尿素氮、肌酐水平與前一時期比較無明顯差異;Z3組堿性磷酸酶(ALP)持續(xù)下降;Z1、Z2組在注射唑來膦酸后堿性磷酸酶水平均有下降,在終止治療后堿性磷酸酶進(jìn)行性升高。(5)不良反應(yīng)及不良事件:接受唑來膦酸注射后有更多的不良反應(yīng),如發(fā)熱、流感樣癥狀、肌痛、關(guān)節(jié)痛等,多在每次治療后3天內(nèi)出現(xiàn),所有接受第一次注射后的患者不良反應(yīng)發(fā)生率為43.6%,第二、三次分別為13.2%、4.6%;歷次注射后均無嚴(yán)重不良事件發(fā)生。結(jié)論(1)唑來膦酸注射液能有效提升骨密度。(2)較于輸注一或兩次唑來膦酸后即終止的患者,連續(xù)輸注三次骨密度呈遞增趨勢。(3)連續(xù)輸注三次唑來膦酸降低了新發(fā)骨折發(fā)生率。(4)持續(xù)輸注唑來膦酸能有效改善疼痛。(5)多次輸注唑來膦酸能持續(xù)降低堿性磷酸酶水平。(6)輸注唑來膦酸有更多不良反應(yīng),但第二、三次治療后不良反應(yīng)明顯少于第一次。
[Abstract]:Objective to analyze the long-term effect of Zoledronic acidic acid once a year in postmenopausal osteoporosis patients, the effect of anti-fracture, analgesic effect, safety and so on.Methods from February 2011 to December 2016, the clinical data of postmenopausal osteoporosis patients who were admitted to Qingdao University Hospital from February 2011 to December 2016 were reviewed, and postmenopausal women were selected.259 patients with osteoporosis, with an average age of 63.4 years, were divided into 4 groups according to their treatment.At the 12th month, 65 patients in Z3 group received zoledronic acid for three injections at the first day, 12 months and 24 months, respectively.All patients were observed until 36 th month.The long-term efficacy and anti-fracture effect of zoledronic acid were evaluated by analyzing the changes of BMDs, new fractures, pain scores, biochemical indexes, adverse reactions and adverse events in the lumbar vertebrae 1-4, femoral neck and total hip bone density in each group.Pain relief effects, biochemical indicators and drug safety.Results the age, bone mineral density (BMD), pain score, biochemical index and so on were similar to those of the patients in each group.) the bone mineral density of each part of group Z3 continued to increase at every stage, and at 36-month, L1-4, neck of femur, and so on.The bone density of total hip was increased by 0.104 g / cm ~ (-2) and 0.106 g / cm ~ (2) ~ (15.78) g / cm ~ (2) and 0.114 g / cm ~ (2) 路cm ~ (2) ~ (16. 94) respectively compared with that before the first injection of zoledronic acid. The bone mineral density of group Z _ (1) and Z _ (2) increased after the injection of zoledronic acid.The pain score of Z1Z2 group decreased after zoledronic acid injection.Biochemical parameters: blood calcium, blood phosphorus, parathyroid hormone, urea nitrogen, serum calcium, phosphorus, parathyroid hormone, urea nitrogen in each group.There was no significant difference in creatinine level between Z3 group and the previous period. The ALP level of Z3 group continued to decrease. The ALP level of Z1Z2 group decreased after zoledronic acid injection.Adverse reactions and adverse events: more adverse reactions, such as fever, flu-like symptoms, myalgia, arthralgia, etc., occurred within 3 days of each treatment, after injection of zoledronic acid.The incidence of adverse reactions after the first injection was 43.6, and the second and third were 13.24.6. there were no serious adverse events after each injection.Conclusion 1) Zoledronic acid injection can effectively increase bone mineral density (BMD) in patients with one or two doses of zoledronic acid.Continuous infusion of trizoledronic acid decreased the incidence of new fracture. 4) continuous infusion of zoledronic acid can effectively improve pain. 5) multiple infusion of zoledronic acid can continuously reduce alkaline phosphatase.Level 6) Infusion of zoledronic acid had more adverse reactions,However, the second and third treatment of adverse reactions were significantly less than the first.
【學(xué)位授予單位】:青島大學(xué)
【學(xué)位級別】:碩士
【學(xué)位授予年份】:2017
【分類號】:R580
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