复方夏天无与双氯芬酸钠治疗膝骨关节炎的临床对照研究

为探讨复方夏天无治疗膝骨关节炎(OA)患者的疗效和安全性,本院门诊及住院部将符合纳入标准的79例膝OA患者,随机分为试验组和对照组。试验组(n=41例)服用复方夏天无1.8 g·d^-1,对照组(n=38例)服用双氯芬酸钠75 mg·d^-1。通过12周的治疗,患者、医生疗效评价总有效率在试验组是68.29%,63.41%,在对照组是71.05%,63.16%,2组比较无显著性差异。试验组和对照组在主要疗效指标(20 m步行痛)和次要疗效指标(关节触痛、WOMAC骨关节炎指数和健康状况调查问卷SF-36)均较治疗前明显改善(P<0.05),但2组疗效比较无显著性差异。与药物相关的不良事件发生率在试验组为24.39%,明显低于对照组47.37%,组间比较有显著性差异(P<0.05)。对照研究发现,应用复方夏天无治疗膝OA疗效与双氯芬酸钠基本相当,但耐受性更好,具有良好的临床应用前景。

Controlled clinical study on compound Decumbent Corydalis Rhizome and diclofenac in treatment of knee osteoarthritis

To evaluate the efficacy and safety of compound Decumbent Corydalis Rhizome (DCR) in treating patients with knee osteoarthritis (OA). Totally 79 patients with knee osteoarthritis were selected from out-patient and inpatient departments of West China Hospital and randomly divided into the test group and the control group. The test group(n=41) was given Compound DCR with the dosage of 1.8 g·d^-1, while the control group(n=38) was administered with diclofenac sodium with the dosage of 75 mg·d^-1. After 12 weeks of treatment, the total efficacy rates based on patients/physicians evaluation for experimental and control groups were 68.29%, 63.41% and 71.05%, 63.16%, respectively, without significant difference between the two groups. Both of the two groups showed significant improvements in the main efficacy indexes (pain on walking 20 m) and minor indexes(tenderness on palpation, Western Ontario and McMaster Universities OA index (WOMAC) and Short-Form Health Survey (SF-36)), but without significant difference in efficacy between them. The incidence of related adverse events was 24.39% in the test group and 47.37% in the control group, respectively, with significant differences between the two groups(P<0.05). In the controlled study, compound DCR is as efficient as diclofenac sodium but more tolerable, with a good clinical application prospect.