滑膜炎颗粒治疗膝关节骨关节炎的临床试验

A clinical trial of Huamoyan granules for treating knee osteoarthritis

摘要:

[目的] 评价滑膜炎颗粒治疗膝关节骨关节炎的有效性和安全性。[方法] 467 例单膝骨性关节炎患者纳入本研究， 随机分为两组。其中，用药组 350 例，口服滑膜炎颗粒 1 袋/次，3 次/d；含夏枯草、女贞子、功劳叶、黄芪、防己、薏苡仁、 土茯苓、丝瓜络、泽兰、丹参、当归、川牛膝、豨莶草 13 味药中药；对照组 117 例，口服滑膜炎颗粒模拟剂，1 袋/次，3 次/ d，其外观、性状、气味与滑膜炎颗粒基本一致，不含任何有效成份。两组患者疗程均为 24 周。比较两组临床、超声检测与血液检测结果。[结果]试验过程中，不良反应率用药组为 2.0%，对照组为 2.6%；差异无统计学意义（P＞0.05）。随时间推移，两组患者膝关节周径、WOMAC 评分和 VAS 评分均显著减少（P＜0.05），综合有效率均显著增加（P＜0.05）。治疗前两组间上述指标差异均无统计学意义（P＞0.05），但是，治疗后 12 周，用药组膝关节周径 [(36.6±2.8) mm vs (37.4±2.9) mm, P＜0.001]、WOMAC 评分 [(27.0±21.5) vs (46.5±28.9), P＜0.001]、VAS 评分 [(3.0±2.4) vs (4.9±2.9), P＜0.001] 和综合有效率（92.2% vs 60.4%, P＜0.001）均显著优于对照组（P＜0.05）。随访期间患者症状加重率，用药组为 7.1%，对照组为 29.1%，差异有统计学意义（P＜0.05）。超声检测方面，治疗 12 周后，用药组髌上囊积液深度 [(4.0±2.5) mm vs (4.9±2.7) mm, P＜0.001] 和髌上滑膜厚度 [(1.6±1.7) mm vs (1.9±1.8) mm, P＜0.001] 均显著小于对照组。检测方面，治疗后 12 周，用药组的 CTX-Ⅱ [(6.9±2.2) μg/L vs (8.2±4.0) μg/L, P=0.001] 和 IL-6 [(32.8±2.7) pg/ml vs (50.0±5.6) pg/ml, P＜0.001] 均显著低于对照组。[结论] 此滑膜炎颗粒可以减轻膝关节骨关节炎的关节肿胀和疼痛，改善运动功能障碍，不良反应少，安全性好。

Abstract:

[Objective] To evaluate the clinical efficacy and safety of Huamoyan granules in the treatment of knee osteoarthritis. [Meth-ods] A total of 467 patients with unilateral osteoarthritis were included in this study and randomly divided into two groups. Among them, 350 patients in the trial group were given Huamoyan granules orally 1 bag/time and 3 times/day, which contained 13 medicinal herbs including Prunella, Ligustrum, Herba leaf, Astragalus, tetrandrhexis, Coix seed, Tuckahoe, loofah, Zeilan, Salvia miltiorrhiza, Angelica sinensis, Achy- ranthes Herba Siegesbeckiae, while the 117 patients in the control group received the granule simulation agent orally 1 bag/time and 3 times/ day, which was similar with the Huamoyan granules in appearance, character and odor without any active ingredients. The treatment course was lasted for 24 weeks in both groups, and the clinical, ultrasonic and blood test data were compared between the two groups. [Results] The adverse reaction rate during the treatment was 2.0% in the trial group, while 2.6% in the control group, which was not statistically significant (P＞0.05). The knee circumference, WOMAC score and VAS score for pain decreased significantly (P＜0.05), while the comprehensive effec- tive rates were significantly increased in both groups over time (P＜0.05). Although there were no significant differences in the abovesaid items between the two groups before treatment (P＞0.05), the trial group proved significantly superior to the control group in terms of knee cir- cumference [(36.6±2.8) mm vs (37.4±2.9) mm, P＜0.001], WOMAC score [(27.0±21.5) vs (46.5±28.9), P＜0.001] and VAS score [(3.0±2.4) vs (4.9±2.9), P＜0.001] and comprehensive efficiency (92.2% vs 60.4%, P＜0.001) 12 weeks after treatment. During the follow-up period, the rate of symptom aggravation was 7.1% in the trial group, whereas 29.1% in the control group, which was statistically significant (P＜0.05). Re- garding ultrasound, the trial group was significantly better than the control group in terms of depth of effusion in suprapatellar bursae [(4.0± 2.5) mm vs (4.9±2.7) mm, P＜0.001] and suprapatellar synovial thickness [(1.6±1.7) mm vs (1.9±1.8) mm, P＜0.001] 12 weeks after treatment. As results of blood test, the trial group also proved significantly superior to the control group in CTX-Ⅱ [(6.9±2.2) μg/L vs (8.2±4.0) μg/L, P=0.001] and IL-6 [(32.8±2.7) pg/ml vs (50.0±5.6) pg/ml, P＜0.001] 12 weeks after treatment. [Conclusion] This Huamoyan granule does relive the joint swelling and pain of knee osteoarthritis, improve the motor dysfunction with less adverse reactions, while good safety.