摘要
目的以塞来昔布、双氯芬酸钠为对照评价新癀片治疗热痹型膝关节骨性关节炎（KOA）的疗效和安全性。方法选择热痹型KOA患者90例，随机分为3组：塞来昔布组（A组）、双氯芬酸钠组（B组）和新癀片组（C组），每组30例。于服药前、服药3、7及14d时，分别进行膝骨关节症状、体征和关节指数评分评价不同药物临床疗效；于服药前和服药14d时进行血常规、尿常规和肝肾功能化验评估药物的安全性，并记录整个服药过程中不良反应。结果与治疗前比较，B组和C组治疗7d时和14d时症状总评分均降低（P〈0．05）；治疗14d时，B组和c组症状总评分显著低于A组（P〈0．05），两组的关节疼痛时间、疼痛程度、晨僵和肿胀、上楼梯和下蹲困难状况、最大步行距离和膝关节不稳定性8项症状改善均优于A组（P〈0．05），C组与B组比较差异无统计学意义（P〉0．05）。与治疗前比较，治疗3个时间点3组体征评分和关节指数评分均明显下降（P〈0．05）；治疗7d时，C组明显低于A组（P〈0．05）；治疗14d时，C和B组均显著低于A组（P〈0．05）。治疗后，3组患者血常规、尿常规和肝肾功能均未见明显异常。在整个治疗观察期间，仅B组出现5例胃肠道不适不良反应（16．7％）。结论新癀片在改善热痹型KOA患者临床症状、体征和关节功能方面有良好疗效，与双氯芬酸钠均优于塞来昔布，但双氯芬酸钠发生胃肠道不良反应者偏高。
Objective To evaluate the efficacy and safety of Xinhuang Tablet compared with celecoxib and diclofenac sodium in the treatment of knee osteoarthritis with pyretic arthromyodynia. Methods Ninety patients with knee osteoarthritis of pyretic arthromyodynia were randomly divided into three groups： eelecoxib group （group A） , dielofenac sodium group （group B） and Xinhuang tablet group （group C）. The clinical efficacy was evaluated before the treatment, and 3, 7 and 14 days after the treatment, including symptoms, signs and joint index scores which reflected function of joint. Blood and urine samples were taken for testing the liver and renal function before and 14 days after the administration to assess the safety of the drugs. Besides, the adverse reactions were recorded throughout the course of medication. Results The total scores of symptoms in group B and C were lower at 7 and 14 days after the treatment than those before the treatment （P〈 0.05）. The total scores in group B and C were significantly lower than those in group A （P 〈 0.05）. The eight symptoms, including duration and degree of joint pain, stiffness in the morning, swelling and squatting, the biggest walking distance and knee stability, were better than those in group A （P〈 0.05） , but without significant differences between group B and C （P〉 0.05）. The signs and joint index scores in the three groups were significantly lower at 3,7 and 14 days after the treatment than those bofore the treatment （P〈 0.05） ;the scores were lower at 7 days after the treatment in group C than those in group A, and lower at 14 days after the treatment in group B and C than those in group A （P 〈 0.05）. The blood and urine routine, liver and kidney function tests were not shown abnormality after the treatment in the three groups. During the entire course of treatment, only 5 patients revealed adverse gastrointestinal discomfort （16.7%） in group B. Conclusion Xinhuang tablet and diclofenae sodium can all improve clinical
出处
《实用疼痛学杂志》
2017年第1期4-9,共6页
Pain Clinic Journal
关键词
骨关节炎
膝
新癀片
塞来昔布
双氯芬酸钠
Osteoarthritis, knee
Xinhuang tablet
Celecoxib
Diclofenac sodium
