Safety evaluation on the clinical application of Tenghuangjiangu tablet for osteoarthritis:a hospital registration study

摘要

To evaluate the treatment safety of Tenghuangjiangu tablet on osteoarthritis, 3365 osteoarthritis patients whose prescription included Tenghuangjiangu tablet from 15 hospitals were involved in the prospective and multi-center clinical trial. Tenghuangjiangu tablet dosage was decided by instruction or doctors’ experience. The course of treatment and observation was 4 weeks. The adverse drug reactions were observed in the treatment process. Results showed male and female patients were 1018(30.25%) and 2347(69.75%), respectively, and 528 patients had allergic history. The patients’ average age was 58.30 ± 8.99 years, and the average disease course was 33.29 ± 37.40 months. The average score of WOMAC scale was 95.07 ± 42.42, which indicated the light conditions. 2275 patients were treated with combined drug regimen. There were two adverse drug reactions in this research. One reaction was skin rashes with itching and the interventions were stopped original drugs and give antianaphylactic treatment. The other reaction was stomach discomfort with disgusting and the intervention was stopped the original drugs temporarily, then continued to take two drugs after 3 days and the reaction didn’t appear. The accident rate of adverse drug reaction was 0.059%. The safety of Tenghuangjiangu tablet clinical application was good, and the mechanism of adverse drug reaction should be researched in-depth.%为了评价藤黄健骨片治疗骨关节炎的安全性，本研究采用前瞻性、多中心、医院注册登记性临床研究方法，将15家医院处方应用藤黄健骨片的骨关节炎患者3365例纳入观察，根据藤黄健骨片说明书或医生临床经验用药。用药和观察周期为4周，观察治疗期间不良反应的发生情况。结果显示入组病例男性1018例（30.25%），女性2347例（69.75%），平均年龄58.30±8.99岁，平均病程33.29±37.40月，有过敏史者528例（15.69%）；病情以轻度为主，WOMAC量表评分平均分95.07±42.42，合并使用其他治疗药物2275例（67.61%）。本项研究共发生两例不良反应，均属于联合用药，一是皮疹伴瘙痒，停药并给予抗过敏治疗后痊愈；二是胃部不适伴恶心，短暂停药并减药后好转；不良反应发生率为0.059%，属于罕见范畴。藤黄健骨片临床应用安全性好，对其发生的罕见不良反应具体原因和机理尚需进一步研究。