目的 探讨壮骨止痛胶囊联合伊班膦酸钠治疗原发性骨质疏松症的临床疗效。方法 选取2018年12月-2021年12月海口市第四人民医院收治的86例原发性骨质疏松症患者,随机分为对照组(43例)和治疗组(43例)。对照组患者静脉滴注伊班膦酸钠注射液,3 mg/次加入5%葡萄糖注射液250 mL中,滴注时间不少于2 h,每3个月注射1次。在对照组的基础上,治疗组口服壮骨止痛胶囊,4粒/次,3次/d。两组连续服药12个月。观察两组患者临床疗效,比较治疗前后两组患者症状好转时间,骨密度(BMD),生活质量评分量表(SF-36)评分,血清炎性因子白细胞介素-6(IL-6)、Ⅰ型前胶原氨基端前肽(PINP)、胰岛素样生长因子-1(IGF-1)、肿瘤坏死因子-α(TNF-α)水平。结果 治疗后,治疗组临床总有效率95.35%明显高于对照组患者(81.39%,P<0.05)。治疗后,治疗组症状好转时间均明显早于对照组(P<0.05)。治疗后,两组患者BMD、SF-36评分均明显升高(P<0.05),且治疗组BMD、SF-36评分均明显高于对照组(P<0.05)。治疗后,两组血清炎性因子IGF-1、PINP水平明显升高(P<0.05),而IL-6、TNF-α水平明显降低(P<0.05),且治疗组这些指标水平明显好于对照组(P<0.05)。结论 壮骨止痛胶囊联合伊班膦酸钠治疗原发性骨质疏松症效果确切,能有效提高机体骨密度含量,改善症状,减弱体内炎性反应,患者生活质量提高显著。

Objective To explore the clinical study of Zhuanggu Zhitong Capsules combined with ibandronate sodium in treatment of primary osteoporosis. Methods Patients (86 cases) with primary osteoporosis in the Fourth People's Hospital of Haikou from December 2018 to December 2021 were randomly divided into control (43 cases) and treatment (43 cases) group. Patients in the control group were iv administered with Sodium Ibandronate Injection, 3 mg/time added to 5% glucose injection 250 mL, drip time more than 2 hours, once every 3 months. Patients in the treatment group were po administered with Zhuanggu Zhitong Capsules on the basis of the control group, 4 grains/time, three times daily. Patients in two groups were treated for 12 months. After treatment, the clinical evaluation was evaluated, and the improvement time of symptom, bone mineral density, SF-36 scores, serum factor IGF-1, IL-6, TNF-α and PINP levels in two groups before and after treatment were compared. Results After treatment, the clinical effective rate of 95.35% in the treatment group was significantly higher than that in the control group (81.39%, P < 0.05). After treatment, the time of symptom improvement in the treatment group was significantly earlier than that in the control group (P < 0.05). After treatment, the scores of BMD and SF-36 in two groups were significantly increased (P < 0.05), and the scores of BMD and SF-36 in the treatment group were significantly higher than those in the control group (P < 0.05). After treatment, the levels of serum inflammatory factors IGF-1, and PINP was significantly increased, while the levels of IL-6, and TNF-α were significantly decreased in two groups (P < 0.05), and the level of these indexes in the treatment group was significantly better than that in the control group (P < 0.05). Conclusion Zhuanggu Zhitong Capsules combined with ibandronate sodium in treatment of primary osteoporosis is effective, which can effectively increase the bone mineral density, improve the symptoms, weaken the inflammatory reaction in vivo, and improve the quality of life of patients.

R977

海南省卫生计生科研计划项目(19A200104)