中文摘要：

目的：观察口服参蝎止痛胶囊治疗膝骨关节炎的临床疗效和安全性。方法：将120例膝骨关节炎患者按2∶1∶1的比例随机分为3组,分别采用口服参蝎止痛胶囊、抗骨质增生胶囊和参蝎止痛胶囊模拟剂治疗。分别于治疗前和治疗3周后,记录并比较3组患者膝关节西安大略和麦克马斯特大学（Western Ontario and Mc Master Universities,WOMAC）量表总积分及疼痛、僵硬、功能障碍积分,并比较3组患者不良反应发生情况。结果：治疗3周后,8例患者脱落。治疗前3组患者膝关节WOMAC量表总积分[（1044.43±76.04）分,（1014.93±83.13）分,（1034.03±74.10）分]、疼痛积分[（220.12±21.21）分,（213.87±22.59）分,（216.17±19.83）分]、僵硬积分[（66.77±10.31）分,（63.90±9.72）分,（63.67±9.46）分]及功能障碍积分[（757.55±52.43）分,（737.71±58.83）分,（754.20±52.74）分]比较,差异均无统计学意义（F=1.453,P=0.238;F=0.953,P=0.388;F=1.450,P=0.243;F=1.462,P=0.236）。治疗3周后3组患者膝关节WOMAC量表总积分[（763.02±85.42）分,（751.21±118.58）分,（964.08±70.15）分]、疼痛积分[（162.18±23.31）分,（176.54±23.62）分,（200.48±18.34）分]、僵硬积分[（43.49±8.72）分,（44.54±13.74）分,（60.93±9.66）分]及功能障碍积分[（524.00±87.48）分,（557.35±59.71）分,（699.85±51.39）分]比较,差异均有统计学意义（F=52.310,P=0.000;F=27.108,P=0.000;F=27.756,P=0.000;F=57.788,P=0.000）。进一步两两比较,参蝎止痛胶囊组WOMAC量表总积分和僵硬积分与抗骨质增生胶囊组比较,组间差异均无统计学意义（P=0.393,P=0.664）;参蝎止痛胶囊组疼痛积分及功能障碍积分均低于抗骨质增生胶囊组（P=0.006,P=0.031）;参蝎止痛胶囊组和抗骨质增生胶囊组的WOMAC量表总积分、疼痛积分、僵硬积分和功能障碍积分均低于参蝎止痛胶囊模拟剂组（P=0.000,P=0.000;P=0.000,P=0.000;P=0.000,P=0.000;P=0.000,P=0.000）?

英文摘要：

Objective：To observe the clinical curative effect and safety of oral application of Shenxie Zhitong（参蝎止痛）capsule in the treatment of knee osteoarthritis（KOA）.Methods：One hundred and twenty patients with KOA were randomly divided into 3 groups with a ratio of 2∶1∶1 ,and were treated with oral application of Shenxie Zhitong capsules,anti-hyperosteogeny capsules and mimetic Shenxie Zhi-tong capsules respectively.The total scores,pain scores,stiffness scores and dysfunction scores were assessed by using Western Ontario and McMaster Universities Osteoarthritis Index（WOMAC）scale and compared between the 3 groups before the treatment and after 3 -week treatment,and the incidence rate of adverse reactions was also recorded.Results：Eight patients fell off after 3-week treatment.There was no statistical difference in WOMAC aggregate scores（1 044.43 ＋/-76.04,1 01 4.93 ＋/-83.1 3,1 034.03 ＋/-74.1 0 points）,pain scores （220.1 2 ＋/-21 .21 ,21 3.87 ＋/-22.59,21 6.1 7 ＋/-1 9.83 points）,stiffness scores（66.77＋/-1 0.31 ,63.90＋/-9.72,63.67 ＋/-9.46 points）and dysfunction scores（757.55 ＋/-52.43,737.71 ＋/-58.83,754.20＋/-52.74 points）between the 3 groups before the treatment （F=1 .453,P=0.238;F=0.953,P=0.388;F=1 .450,P=0.243;F=1 .462,P=0.236）.There was statistical difference in WOMAC aggregate scores（763.02＋/-85.42,751 .21 ＋/-1 1 8.58,964.08＋/-70.1 5 points）,pain scores（1 62.1 8 ＋/-23.31 ,1 76.54＋/-23.62,200.48＋/-1 8.34 points）,stiffness scores（43.49 ＋/-8.72,44.54＋/-1 3.74,60.93 ＋/-9.66 points）and dysfunction scores（524.00＋/-87.48,557.35 ＋/-59.71 ,699.85 ＋/-51 .39 points）between the 3 groups after 3 -week treatment（F=52.31 0,P=0.000;F=27.1 08, P=0.000;F=27.756,P=0.000;F=57.788,P=0.000）.Further pairwise comparison showed that there was no statistical difference in WOMAC aggregate scores and dysfunction scores between Shenxie Zhitong capsules group and anti-hyperosteogeny capsules group （P=0.393,P=0.664）.The pain scores