Khairi M R, Altman R D, DeRosa G P, Zimmermann J, Schenk R K, Johnston C C
Ann Intern Med. 1977 Dec;87(6):656-63. doi: 10.7326/0003-4819-87-6-656.
Subjects (109) with symptomatic Paget's disease of bone were treated with 5, 10, or 20 mg of sodium etidronate (EHDP)/kg body weight - day for 6 to 24 months. Significant decreases in serum alkaline phosphatase and urinary hydroxyproline were noted after 6 months of therapy; no significant further improvement resulted after prolonged therapy. Some patients maintained biochemical remission after withdrawal of EHDP but others showed a relapse, related primarily to the pretreatment severity. Clinical improvement was noted in 61% of the patients. Similar findings were seen after a second course of EHDP. No side-effects were noted in patients treated with 5 mg of EHDP/kg body weight - day. In patients treated with 10 or 20 mg of EHDP/kg body weight - day, severe diarrhea, bone pain, and nontraumatic fractures were noted in 3, 13, and 12 patients respectively. Quantitative histomorphometry showed mineralization delay in patients receiving 10 or 20 mg of EHDP/kg body weight - day but not in those receiving 5 mg/kg body weight - day. Five milligrams of EHDP/kg body weight - day was effective and appears to be safer than the higher doses.
109例有症状的骨Paget病患者接受了每日5、10或20毫克依替膦酸钠(EHDP)/千克体重的治疗,为期6至24个月。治疗6个月后,血清碱性磷酸酶和尿羟脯氨酸显著下降;长期治疗后未出现显著进一步改善。一些患者在停用EHDP后维持生化缓解,但其他患者出现复发,主要与治疗前的严重程度有关。61%的患者有临床改善。在第二疗程的EHDP治疗后观察到类似结果。每日5毫克EHDP/千克体重治疗的患者未观察到副作用。在每日10或20毫克EHDP/千克体重治疗的患者中,分别有3例、13例和12例出现严重腹泻、骨痛和非创伤性骨折。定量组织形态计量学显示,接受每日10或20毫克EHDP/千克体重治疗的患者有矿化延迟,而接受每日5毫克/千克体重治疗的患者未出现。每日5毫克EHDP/千克体重有效,且似乎比更高剂量更安全。