Evaluation of clinical efficacy and safety of external application of Chinese herbal medicine fumigation with Eliminating Dampness and Dispelling Cold Decoction for knee osteoarthritis syndrome of cold-dampness due to kidney deficiency
ZHANG Yanzhen1 LU Cong2 ZHANG Chen1 SUN Songge1 QIU Xinping1▲
1.Department of Rheumatology, Shunyi Hospital, Beijing Hospital of Traditional Chinese Medicine, Beijing 101300, China;
2.Department of Endocrinology, Shunyi Hospital, Beijing Hospital of Traditional Chinese Medicine, Beijing 101300, China
Abstract:Objective To evaluate the clinical efficacy and safety of external application of Chinese herbal medicine fumigation with Eliminating Dampness and Dispelling Cold Decoction for knee osteoarthritis of syndrome of cold-dampness due to kidney deficiency. Methods Sixty-eight patients with knee osteoarthritis of syndrome of cold-dampness due to kidney deficiency admitted to Outpatient Department of Rheumatology, Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital from January to October 2017 were selected as research objects. They were divided into treatment group and control group by random number table method. The treatment group was treated with Chinese herbal medicine fumigation with Eliminating Dampness and Dispelling Cold Decoction, the control group was treated with external application of Diclofenac Diethylamine Emulsion, the course of the two groups was 2 weeks. The scores of joint pain (patient evaluation and doctor evaluation), Michel Lequesne index of severity for knee joint osteoarthritis (ISOA), WOMAC osteoarthritis index, and TCM syndrome integral, security indices were observed before and after treatment, so as to evaluate the effect and safety. Results After treatment, the scores of joint pain (patient evaluation) in the two groups were significantly lower than those before treatment (P < 0.01), and the scores of joint pain (patient evaluation) after treatment in the treatment group was lower than the control group (P < 0.05). After treatment, the scores of joint pain (physician evaluation) in the two groups were significantly lower than those before treatment (P < 0.01), and the scores of joint pain (physician evaluation) after treatment in the treatment group were lower than those in the control group (P < 0.05). After treatment, the scores of ISOA in the two groups were significantly lower than those before treatment (P < 0.01), and the scores of ISOA after treatment in the treatment group were lower than the control group (P < 0.05). After treatment, the scores of WOMAC osteoarthritis index in the two groups were significantly lower than those before treatment (P < 0.01), and the scores of WOMAC osteoarthritis index in the treatment group were lower than those in the control group (P < 0.05). After treatment, the total scores of TCM syndromes in the two groups were significantly lower than those before treatment (P < 0.01), and the total score of TCM syndromes in the treatment group after treatment was lower than the control group (P < 0.05). After treatment, the clinical efficacy of the treatment group was better than that of control group, the difference was significant (P < 0.05). The efficacy of TCM syndrome of the treatment group was better than that of control group, the difference was statistically different (P < 0.05). No adverse reactions occurred in either group. Conclusion The treatment of Chinese herbal medicine fumigation with Eliminating Dampness and Dispelling Cold Decoction has the effects of relieving symptoms and improving joint function and clinical signs in patients with knee osteoarthritis syndrome of cold-dampness due to kidney deficiency. Its curative effect is more significant than that of external application of Diclofenac Diethylamine Emulsion, and no adverse reactions are found. It is a safe and effective method.
张艳珍1 卢聪2 张辰1 孙颂歌1 邱新萍1▲. 祛湿散寒方中药熏蒸外治肾虚寒湿型膝骨关节炎的效果与安全性评价[J]. 中国医药导报, 2018, 15(16): 105-109.
ZHANG Yanzhen1 LU Cong2 ZHANG Chen1 SUN Songge1 QIU Xinping1▲. Evaluation of clinical efficacy and safety of external application of Chinese herbal medicine fumigation with Eliminating Dampness and Dispelling Cold Decoction for knee osteoarthritis syndrome of cold-dampness due to kidney deficiency. 中国医药导报, 2018, 15(16): 105-109.
[1] Mcalindon TE,Bannuru RR,Sullivan MC,et al. OARSI guidelines for the non-surgical management of knee osteoarthritis [J]. Osteoarthritis Cartilage,2014,22(3):363-388.
[2] 中华医学会风湿病学分会.骨关节炎诊断及治疗指南[J].中华风湿病学杂志,2010,14(6):416-419.
[3] Orozco L,Munar A,Soler R,et al. Treatment of knee osteoarthritis with autologous mesenchymal stem cells:two-year follow-up results [J]. Transplantation,2014,97(11):66-68.
[4] 关尚琪,滕菲,张志毅,等.骨关节炎流行病学研究进展[J].中华内科杂志,2017,56(6):450-452.
[5] 杨毅峰,黄健,YANG Yifeng,等.骨性关节炎的流行病学研究进展[J].医学综述,2017,23(3):497-501.
[6] 薛浩,刘岩,冉博,等.膝关节骨性关节炎治疗现状[J].医学综述,2018,24(2):321-325.
[7] 马嘉珩,曹海龙,陈雪,等.非甾体类抗炎药相关小肠黏膜损伤防治的研究进展[J].国际消化病杂志,2017,37(4):230-233.
[8] 余丹,刘世江,胡有力,等.非甾体类抗炎药在围术期使用的心血管事件风险的Meta分析[J].临床麻醉学杂志,2017,33(7):683-687.
[9] 康凯,高石军,郑晓佐,等.单髁置换术治疗中年膝关节内侧间室骨关节炎的中期疗效[J].中华骨科杂志,2014, 34(6):638-644.
[10] 李笑雨,赵崎慧,王磊,等.治疗膝关节退行性骨关节病的外科治疗进展[J].河北医学,2017,23(9):1577-1579.
[11] 孙振新,杨矛,朱玲玲,等.中医药治疗膝骨关节炎研究进展[J].辽宁中医药大学学报,2017,19(1):111-114.
[12] Altman R,Asch E,Bloch D,et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association [J]. Arthritis Rheum,1988,29(8):1039-1049.
[13] Kellgren JH,Lawdewe JS. Radiological assessment of rh-eumatoid arthritis [J]. Ann Rheum Dis,1957,16(4):485-493.
[14] 郑银驹,王立新,赖中华.隔姜灸配合推拿疗法治疗中老年人膝骨关节炎疗效观察[J].新中医,2017,49(5):118-120.
[15] 国家中医药管理局.中医病证诊断疗效标准[M].南京:南京大学出版社,1994:30-31.
[16] Dawson J,Linsell L,Doll H,et al. Assessment of the Lequesne indes of severity for osteoarthritis of the hip in an elderly population [J]. Osteoarthritis Cartilage,2005, 13(10):854-860.
[17] Lequesne M. Indice of severity and disease activity for osteoarthritis [J]. Semin Arthritis Rheum,1991,20(2):48-54.
[18] Bellamy N,Kirwan J,Boers M,et al. Reconnendations for a core set outcome measure for future phase Ⅲ clinical trials in knee,hip and hand OA [J]. J Rheumatol,1997, 24(4):799-802.
[19] 马骁,阎小萍,于辉,等.骨关节炎中医证候量化标准积分用于膝骨关节炎的研究[J].中日友好医院学报,2017, 31(3):145-148.
[20] 郑筱萸.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002:351-353.
[21] 肖壮,唐涛,孙先润,等.骨关节炎治疗药物的研究进展[J].中国药房,2016,27(35):5037-5040.
[22] 俞霞,冯莺,宋晴,等.清凉活化散载药护膝对膝骨关节炎急性发作的临床疗效与护理[J].中国现代医生,2017, 55(14):160-164.
[23] 余波,陈桥桥,陈日高,等.胡玲香主任医师针灸治疗膝痹经验初探[J].成都中医药大学学报,2017,40(4):69-71.
[24] 刘恩雄,王维敏,吴昌国,等.中药外敷联合盐酸氨基葡萄糖胶囊治疗老年膝骨关节炎68例[J].环球中医药,2016,9(11):1357-1359.
[25] 沈锦坤,林乔龄.膝骨关节炎的中医药诊疗研究进展[J].实用中西医结合临床,2016,16(1):90-92.
[26] 汪翼凡,石仕元,朱博,等.关节镜下关节清理扩创术结合运动疗法治疗膝骨关节炎患者的临床效果评价[J].中国现代医生,2017,55(8):70-72,76.
[27] 邓博,贾立群,邓超.不同寒热属性中药透皮及促透作用的研究进展[J].中华中医药学刊,2017,35(1):16-19.