增液润节汤和美洛昔康片治疗膝骨关节炎的对比研究

目的：对比增液润节汤和美洛昔康片治疗膝骨关节炎的临床疗效和安全性.方法：膝骨关节炎患者100例,随机分为2组,每组50例.治疗组口服增液润节汤,对照组口服美洛昔康片,共治疗2个月.观察2组患者症状缓解、关节功能改善及不良反应发生情况,并对2组患者的疗效和不良反应发生率进行比较.结果：治疗前2组患者Lequesne指数评分比较,差异无统计学意义[（12.40±1.51）分,（11.85±1.75）分;t=1.683,P=0.097）];治疗2个月后,2组患者症状缓解、患膝功能改善,Lequesne指数评分均下降,2组间比较差异有统计学意义[（6.82±1.64）分,（8.47±1.82）分;t=4.790,P=0.000];且治疗组下降程度更明显[（5.58±1.62）分,（3.38±1.36）分;t=7.355,P=0.000].参照中药新药治疗骨性关节炎的临床研究指导原则中的疗效判定标准评价疗效,治疗组临床控制11例、显效27例、有效11例、无效1例;对照组临床控制6例、显效23例、有效12例、无效9例;治疗组疗效优于对照组,差异有统计学意义（Z=-2.338,P=0.019）.治疗期间,治疗组出现胃肠道反应2例,肝功能异常1例;对照组出现胃肠道反应8例,心动过速2例,肝功能异常4例,白细胞下降2例,血肌酐增高3例.经对症处理后,2组患者不良反应均消失.2组患者不良反应发生率比较,差异有统计学意义（x2=14.918,P=0.000）.结论：采用增液润节汤和美洛昔康片治疗膝骨关节炎,均可有效缓解症状、改善患膝功能;但增液润节汤疗效优于美洛昔康片,且不良反应较少,更安全可靠.

A retrospective trial of ZENGYERUNJIE decoctions versus Meloxicam tablets in the treatment of knee osteoarthritis

Objective：To compare ZENGYERUNJIE decoctions and Meloxicam tablets in the clinical curative effects and safety for knee osteoarthritis（KOA）. Methods：One hundred patients with KOA enrolled in the trial were randomly divided into 2 groups ,50 cases in each group. Patients in treatment group were administrated with oral application of ZENGYERUNJIE decoctions, while the others in control group were administrated with oral application of Meloxicam tablets. The total disease course was 2 months. The symptoms relief,joint func- tion improvement and adverse reactions were observed, and the curative effects and incidence rate of adverse reactions were compared be- tween the 2 groups. Results：There was no statistical difference in the Lequesne indices scores between the 2 groups before the treatment （ 12.40 4/- 1.51 vs 11.85 4/- 1.75 points ; t = 1. 683, P = 0. 097）. After two-month treatment, the symptoms were relieved and the knee function were improved and the Lequesne indices scores decreased. There was statistical difference in Lequesne indices scores between the 2 groups（6.82 4/-1.64 vs 8.47 4/-1.82 points;t = 4. 790,P = 0. 000）, and the decreased degree was bigger in treatment group com- pared to control group（5.58 4/- 1.62 vs 3.38 4/- 1.36 points,t = 7. 355,P =0.000）. The curative effects were evaluated in accordance with the criterion in Guiding principles of clinical research on new Chinese medicine for osteoarthritis. Eleven patients got an excellent re- sult,27 good, 11 fair, and 1 poor in the treatment group ,while 6 patients got an excellent result ,23 good, 12 fair, and 9 poor in the control group. The treatment group surpassed the control group in the clinical effect and there was statistical difference between the 2 groups（Z = -2. 338 ,P =0.019）. During the treatment,gastrointestinal reactions（2 patients）and transient liver dysfunction（ 1 patients）were found in the treatment group ; while gastrointestinal reactions （ 8 patients ）, tachycardia （ 2 patients ）, transient liver dysfunction （ 4 patients ）, white blood cells （WBC）decrease （2 patients）and serum creatinine increase （3 patients）were found in the control group. Adverse reactions disap- peared after symptomatic treatment in both of the 2 groups. There was statistical difference in incidence rate of adverse reaction between the 2 groups （X2 = 14. 918, P = 0. 000 ）. Conclusion：In the treatment of KOA, oral application of both ZENGYERUNJIE decoctions and Meloxi- cam tablets can effectively relieve the symptoms and improve the knee function. However, the ZENGYERUNJIE decoctions surpassed the Meloxicam tablets in the clinical effect with less adverse reactions.