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目的基于疾病负担,循证评价与遴选我国乡镇卫生院合理治疗中老年妇女原发性骨质疏松症的基本药物。方法按本系列研究之二制定的方法、标准和流程,参考国内外循证或权威指南的推荐意见,并结合国内相关临床研究证据,循证评价并推荐相关药物。分别采用RevMan 5.1和GRADEpro 3.6等软件整理分析和评价证据质量。结果①共纳入18个治疗指南,其中14个是循证或结合专家意见制定,推荐药物包括双膦酸盐、降钙素、雌激素、甲状旁腺激素、选择性雌激素受体调节剂、锶盐类和中成药。②1个Quasi-RCT(极低质量)表明,碳酸钙–维生素D对老年妇女原发性骨质疏松症患者提高骨密度、改善骨痛及其他临床症状效果优于葡萄糖酸钙[MD=0.04,95%CI(0.02,0.06);RR=2.64,95%CI(1.40,4.96)]。虽少数病例出现胃肠不适、食欲不振、便秘、恶心等反应,但随后均消失。碳酸钙-维生素D费用1.00元/d,适用性好。③1个RCT(低质量)表明,服用12个月后,阿仑膦酸钠提高腰椎L2-4骨密度效果优于碳酸钙–维生素D[MD=0.06,95%CI(0.017,0.10)],改善骨痛症状效果也优于碳酸钙-维生素D[RR=1.8,95%CI(1.40,2.52)]。2个RCT(中等质量)表明,相比碳酸钙-维生素D,服用阿仑膦酸+碳酸钙-维生素D 6个月提高腰椎L2-4骨密度效果较优[MD=0.05,95%CI(0.02,0.08)],对降低血碱性磷酸酶的效果较优[MD=–31.9,95%CI(–54.99,–8.81)]。不良反应轻微,主要是消化系统反应。费用为2.67元/d,适用性较差。④1个RCT(中等质量)表明:治疗3个月后,仙灵骨葆胶囊(XLGB)联用钙剂的效果优于单独使用钙剂[MD=10,95%CI(0.05,0.15)]。1个RCT(中等质量)表明,治疗3、6个月后,XLGB+钙剂提高Ward’s三角骨密度和股骨大粗隆骨密度效果均优于钙剂。1个RCT(低质量)表明,XLGB+罗盖全对疼痛改善优于罗盖全[RR=1.26,95%C(I1.04,1.52)]。药物不良反应主要是消化系统、循环系统及皮肤,但均较轻微。费用为4.58元/d,适用性好。结论弱推荐阿仑膦酸钠片治疗中老年妇女骨质疏松及其所致疼痛、骨折。强推荐碳酸钙-维生素D片和仙灵骨葆胶囊防治中老年妇女骨质疏松及其所致疼痛、骨折。建议开展对农村地区老年人群骨质疏松普查,并在我国开展阿仑膦酸钠片及其联用钙剂治疗成人的大样本、高质量临床研究和经济学研究。
Objective Based on the burden of disease, evidence-based evaluation and selection of township hospitals in the reasonable treatment of primary osteoporosis in the elderly of essential drugs. Methods According to the methods, standards and procedures developed in this series of studies, refer to the recommendations of evidence-based or authoritative guidelines both at home and abroad, and in combination with evidence from clinical researches in China, evaluate and recommend relevant drugs based on evidence. RevMan 5.1 and GRADEpro 3.6 were used to analyze and evaluate the quality of evidence respectively. Results ① A total of 18 treatment guidelines were enrolled, of which 14 were evidence-based or combined with expert opinion. The recommended drugs include bisphosphonates, calcitonin, estrogen, parathyroid hormone, selective estrogen receptor modulators, Strontium salts and proprietary Chinese medicines. ② One Quasi-RCT (very low quality) showed that calcium carbonate-vitamin D was superior to calcium gluconate in improving bone mineral density, improving bone pain and other clinical symptoms in elderly women with primary osteoporosis [MD = 0.04, 95% CI (0.02, 0.06); RR = 2.64, 95% CI (1.40, 4.96)]. Although a small number of cases of gastrointestinal discomfort, loss of appetite, constipation, nausea and other reactions, but then disappear. Calcium carbonate - vitamin D costs 1.00 yuan / d, good applicability. ③ One RCT (low quality) showed that alendronate was superior to calcium carbonate - vitamin D [MD = 0.06, 95% CI (0.017, 0.10)] after 12 months of treatment. The effect of improving bone pain was also better than calcium carbonate-vitamin D [RR = 1.8, 95% CI (1.40, 2.52)]. Two RCTs (medium quality) showed that administration of alendronate + calcium carbonate-vitamin D for 6 months resulted in better lumbar L2-4 BMD compared with calcium carbonate-vitamin D [MD = 0.05, 95% CI ( 0.02, 0.08)], the effect of lowering blood alkaline phosphatase is better [MD = -31.9,95% CI (-54.99, -8.81)]. Minor adverse reactions, mainly the digestive system response. The cost is 2.67 yuan / d, the applicability is poor. ④ One RCT (medium quality) showed that XLGB combined with calcium was superior to calcium alone (MD = 10, 95% CI (0.05, 0.15)] after 3 months of treatment. One RCT (medium quality) showed that XLGB + calcium was superior to calcium in improving both Ward’s triangular bone mineral density and femoral greater trochanter bone mineral density after 3 and 6 months of treatment. One RCT (low quality) showed that XLGB + liduon was superior to lidavalin in pain improvement [RR = 1.26, 95% C (I1.04, 1.52)]. Adverse drug reactions are mainly digestive system, circulatory system and skin, but are minor. The cost is 4.58 yuan / d, good applicability. Conclusion Weak recommendation alendronate sodium tablets in the treatment of elderly women with osteoporosis and the resulting pain and fracture. Strongly recommended calcium carbonate - vitamin D tablets and Xianling Gubao capsule prevention and treatment of osteoporosis in older women and their pain, fractures. Proposed to carry out surveys of elderly population in rural areas of osteoporosis, and in our country alendronate tablets and its associated calcium treatment of adult large samples, high-quality clinical studies and economic studies.