骨龙胶囊治疗膝骨性关节炎的多中心随机对照临床研究  

Treatment of knee osteoarthritis patients with Gulong capsules:a multi-center randomized controlled study

作　　者：唐晓颇[1] 姜泉[1] 刘品莉[2] 刘英[3] 申洪波[4] 黄传兵[5] 阎小萍[6] 白云静 TANG Xiao-po;JIANG Quan;LIU Pin-li;LIU Ying;SHEN Hong-bo;HUANG Chuan-bing;YAN Xiao-ping;BAI Yun-jing(Guang＇anmen Hospital,China Academy of Chinese Medical Sciences,Beifing 100053,China;Shanxi Provincial Academy of Traditional Chinese Medicine,Taiyuan 030012;Shandong Provincial Hospital of Traditional Chinese Medicine,Jinan 250011,China;Peking University Third Hospital,Beijing 100083,China;Anhui Provincial Hospital of Traditional Chinese Medicine,Hefei 230031,China;China-Japan Friendship Hospital,Beijing 100029,China;PLA Army General Hospital,Beijing 100700,China)

机构地区：[1]中国中医科学院广安门医院,北京100053 [2]山西省中医药研究院,太原030012 [3]山东省中医院,济南250011 [4]北京大学第三医院,北京100083 [5]安徽省中医院,合肥230031 [6]北京中日友好医院,北京100029 [7]北京陆军总医院,北京100700

出　　处：《中国新药杂志》2018年第16期1865-1871,共7页Chinese Journal of New Drugs

摘　　要：目的:观察骨龙胶囊治疗膝骨性关节炎(肝肾不足、瘀血痹阻证)的临床疗效和安全性。方法:选取2012年3月至2013年7月7家医院收治的膝骨关节炎[中医(TCM)属肝肾不足、瘀血痹阻证]患者240例,随机分为对照组和试验组,每组120例。对照组给予维固力(硫酸氨基葡萄糖)胶囊和骨龙空白胶囊,试验组给予骨龙胶囊和维固力空白胶囊,疗程均为12周。比较两组骨关节炎疼痛视觉模拟量表(VAS)评分、骨关节炎评分指数评估量表(WOMAC)评分,以及中医证候评分、单项症状/体征改善情况及不良反应发生情况。同时观察两组给药期间不良反应。结果:治疗4,8,12周后,两组VAS评分与治疗前比较,差异有统计学意义,试验组的降幅高于对照组;两组WOMAC评分与治疗前比较,差异有统计学意义,试验组4周、8周的降幅高于对照组,且有统计学意义,12周降幅仍高于对照组,但差异无统计学意义;治疗4周后,试验组改善30%以上的比例(49.06%)高于对照组(29.63%),差异有统计学意义(P<0.05);两组WOMAC 5项疼痛计分变化值,试验组的降幅高于对照组,组间差异均有统计学意义;两组中医证候总积分与治疗前相比差异有统计学意义,试验组降幅高于对照组;试验组的痊愈、显效的比例高于对照组;试验组在改善中医症状上优于对照组,主要体现在腰膝酸软、关节活动不利、关节压痛;两组不良反应及不良事件的发生率差异无统计学差异。结论:骨龙胶囊具有补益肝肾、活血化瘀的功效特点,其治疗膝骨性关节炎的疗效优于维固力胶囊,是一种治疗膝骨关节炎有效、安全的治疗药物。Objective： To observe the clinical efficacy and safety of Gulong capsules in the treatment of knee osteoarthritis（ defined as deficiency of liver and kidney,blood stasis syndrome）. Methods： A total of 240 patients with knee osteoarthritis [defined as deficiency of liver and kidney,and blood stasis syndrome in traditional Chinese medicine（ TCM） ]who were admitted to 7 hospitals from March 2012 to July 2013 were randomly dividedinto the control group and test group,with 120 in each. The control group was given Weiguli（ glucosamine sulfate）capsules and Gulong blank capsules for 12 weeks,while the test group was given Gulong capsules and Weiguli blank capsules during the same period. The comparison included visual analog scale（ VAS） scores of osteoarthritis pain,the Western Ontario and Mc Master Universities（ WOMAC） scores,the TCM syndrome scores,improvement of individual symptoms/signs,and occurrence of adverse reactions. Results： After 4,8 and 12 weeks of treatment,the VAS scores of the two groups were significantly different from those before treatment. The decrease in the test group was higher than that in the control group. There was statistically significant difference between the two groups in terms of WOMAC scores before treatment. The decrease magnitudes of the test group at 4 weeks and 8 weeks were statistically larger than those of the control group. The 12-week decline was still higher than that of the control group,but the difference was not statistically significant. After 4 weeks of treatment,the proportion of patients with improvement of more than 30% in the test group（ 49. 06%） was higher than the control group（ 29. 63%,P 0. 05）; the decrease of WOMAC five pain score in the test group was statistically greater than the control group.The total scores of TCM syndromes in the two groups were statistically different from those before treatment. The test group had a higher decline than the control group; the recovery rate and significant effect of the test group were high

关 键 词：骨龙胶囊 维固力胶囊 膝骨性关节炎 

分 类 号：R969.4[医药卫生—药理学]