口服参蝎止痛胶囊治疗膝骨关节炎的临床研究

A clinical study on oral application of Shenxie Zhitong( 参蝎止痛) capsule for treatment of knee osteoarthritis

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)。3组患者不良反应发生率比较,差异无统计学意义(χ2=0.386,P=1.000)。结论:采用口服参蝎止痛胶囊和抗骨质增生胶囊治疗膝骨关节炎,均能改善膝关节功能,缓解膝关节疼痛和僵硬,不良反应小;但在改善膝关节疼痛及功能障碍方面,参蝎止痛胶囊优于抗骨质增生胶囊,值得临床推广应用。

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 and dysfunction scores were lower in Shenxie Zhitong capsules group compared with anti-hyperosteoge-ny capsules group（P=0.006,P=0.031 ）.The WOMAC aggregate scores,pain scores,stiffness scores and dysfunction scores were lower in Shenxie Zhitong capsules group and anti-hyperosteogeny capsules group compared with mimetic Shenxie Zhitong capsule group（P=0.000, P=0.000;P=0.000,P=0.000;P=0.000,P=0.000;P=0.000,P=0.000）.There was no statistical difference in the incidence rate of adverse reactions between the 3 groups（χ^2 =0.386,P=1 .000）.Conclusion：Oral application of either Shenxie Zhitong capsules or anti-hyperosteogeny capsules can improve the knee function and relieve knee pain and stiffness with less adverse reactions in the treatment of KOA.However,the former surpasses the latter in improving knee pain and dysfunction,so it is worthy of popularizing in clinic.