盐酸氨基葡萄糖片联合玻璃酸钠治疗颞下颌关节骨关节炎的临床随机对照试验  

Glucosamine hydrochloride combined with hyaluronate for temporomandibular joint osteoarthritis:A primary report of randomized controlled trial

作　　者：李春洁[1,2] 贾源源[2] 张绮[2] 史宗道[1] 陈海燕 

机构地区：[1]四川大学华西口腔医学院口腔颌面外科学教研室 [2]口腔疾病研究国家重点实验室,四川大学,成都610041 [3]四川新斯顿制药有限责任公司,成都610031

出　　处：《华西口腔医学杂志》2011年第6期632-635,639,共5页West China Journal of Stomatology

基　　金：2010年全国大学生创新性实验计划基金资助项目(101-061001)

摘　　要：目的初步探索通过双盲临床随机对照试验评估盐酸氨基葡萄糖治疗颞下颌关节骨关节炎的有效性和安全性。方法 28例被诊断为颞下颌关节骨关节炎的患者被随机分到试验组和对照组。试验组14例接受口服盐酸氨基葡萄糖片(每日服1.44 g)4周;对照组14例口服安慰剂。2组均同时接受颞下颌关节上下腔注射玻璃酸钠治疗(每周1次,共4次)。在试验基线和治疗后第2、3、4周分别测量2组的最大张口度、张口疼痛和张口偏斜;在试验基线和第4周使用OHIP-14量表测量患者的生存质量。统计分析采用意向性分析的方法。结果除对照组2例失访,其余患者均完成治疗及随访。2组基线各指标无明显差异。口服盐酸氨基葡萄糖能显著增加患者的最大张口度(P=0.03)、降低张口疼痛(P=0.02),但在改变张口偏斜和患者生存质量方面其短期效果不明显(P=0.67,P=0.77)。试验过程中未发现严重不良事件。结论盐酸氨基葡萄糖口服与玻璃酸钠关节内注射在颞下颌关节骨关节炎的治疗上有显著的效果和安全性。Objective To investigate effectiveness and safety of combined treatment with glucosamine hydrochloride orally and hyaluronate intraarticularly in patients with temporomandibular joint osteoarthritis. Methods Twenty eight participants who were diagnosed as temporomandibular joint osteoarthritis were randomly allocated to intervention and control groups （n=14）. The former received oral glucosamine hydrochloride （each day 1.44 g） and the latter placebo for four weeks. Both groups received intraarticular injection of hyaluronate for upper and inferior compartment, once a week for four weeks. Maximal mouth opening, pain on opening, deviation at the end of opening were measured at base- line and each week of follow up, quality of life was measured by using the instrument of oral health impact profile-14 （OHIP-14） at baseline and the fourth week. Intention-to-treat analysis was adopted for data anaysis. Results ,All participants except two in control group adhered to the follow-up. Parameters on baseline were balanced between the two groups. Maximal mouth opening was significantly increased in intervention group compared with control group （P= 0.03） and decrease was found for pain on opening （P=0.02）. No statistical difference was detected between the two groups on deviation （P---0.67）. The intervention group didn＇t show advantages compared with placebo on quality of life assessed by OHIP-14（P=-0.77）. No serious adverse drug events were detected in both groups. Conclusion The glucosamine hydrochloride plus double joint cavity injection of hyaluronate is safe and may reduce pain scores and improve opening in patients with temporomandibular joint osteoarthritis.

关 键 词：盐酸氨基葡萄糖 玻璃酸钠 颞下颌关节骨关节炎 随机对照试验 

分 类 号：R782.6[医药卫生—口腔医学]