全杜仲胶囊治疗骨质疏松性下肢骨折术后60例临床观察

Clinical Observation of Quanduzhong Capsule(全杜仲胶囊)for 60 Cases with Postoperative Osteoporotic Lower Limb Fracture

目的观察全杜仲胶囊治疗骨质疏松性下肢骨折术后患者的疗效及安全性。方法120例患者随机分为对照组和观察组各60例,对照组口服维D钙片,观察组加服全杜仲胶囊,3个月为1个疗程。比较两组临床疗效,检测患者骨密度(BMD),骨代谢指标[BGP、ALP、PINP、25-(OH)VD_(3)]和细胞免疫指标(CD^(+)_(3)、CD^(+)_(4)、CD^(+)_(8)、CD^(+)_(4)/CD^(+)_(8)),记录不良反应。结果治疗后,两组BMD、25-(OH)VD_(3)、CD^(+)_(3)、CD^(+)_(4)、CD^(+)_(4)/CD^(+)_(8)明显增加;BGP、ALP、T-PINP含量下降(P<0.05)。与对照组相比,观察组BMD、25-(OH)VD_(3)、CD^(+)_(3)、CD^(+)_(4)、CD^(+)_(4)/CD^(+)_(8)较高,血清BGP和T-PINP较低(P<0.05)。观察组有效率为83.3%(50/60),明显高于对照组的65.0%(39/60)(P<0.05)。其余指标相近。结论全杜仲胶囊治疗骨质疏松性下肢骨折术后患者安全且有效。

Objective To observe the efficacy and safety of Quanduzhong Capsule(全杜仲胶囊)for 60 cases with postoperative osteoporotic lower limb fracture.Methods A total of 120 patients were randomly divided into observation group and control group,with 54 cases in each group.The control group received calcium supplement with vitamin tablets and the observation group received conventional Quanduzhong Capsule additionally.The treatment course was 3 months.The clinical efficacy was compared.BMD,bone metabolism indexes[ALP,BGP,T-PINP and 25-(OH)-VD_(3)],cellular immune function(CD^(+)_(3),CD^(+)_(4),CD^(+)_(8)and CD^(+)_(4)/CD^(+)_(8))were detected,and the adverse reactions were recorded.Results After treatment,the BMD,serum level of 25-(OH)-VD_(3),CD^(+)_(3),CD^(+)_(4)and CD^(+)_(4)/CD^(+)_(8)were increased greatly.The serum levels of BGP,ALP and T-PINP were decreased greatly in both groups(P<0.05).Compared with those in control group,the BMD,serum level of 25-(OH)-VD_(3),CD^(+)_(3),CD^(+)_(4)and CD^(+)_(4)/CD^(+)_(8)were higher.The serum levels of BGP and T-PINP were lower in the observation group(P<0.05).The total effective rate was 83.3%(50/60),which was higher than that[65.0%(39/60)]of the control group(P<0.05).The other indexes were similar.Conclusion Quanduzhong Capsule is safe and effective for patients with postoperative osteoporotic lower limb fracture.