Fu Min-Rui, He Li-Fang, Lyu Jian, Xi Jun-Yu, Liu Guang-Yu, Xie Yan-Ming
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China Wangjing Hospital, China Academy of Chinese Medical Sciences Beijing 100102, China.
Yunnan Yunhe Pharmaceutical Inc Honghe 650032, China.
Zhongguo Zhong Yao Za Zhi. 2022 Oct;47(19):5365-5374. doi: 10.19540/j.cnki.cjcmm.20220627.501.
This study aims to assess the efficacy and safety of Hulisan Capsules in the treatment of knee osteoarthritis, which is expected to serve as a reference for clinical practice. To be specific, randomized controlled trial(RCT) on the treatment of knee osteoarthritis with Hulisan Capsules was retrieved from EMbase, PubMed, Cochrane Library, Web of Science, CNKI, Wanfang, SinoMed, and VIP(from inception to November 15, 2021). Two researchers independently screened the articles, extracted the data, and evaluated the risk of bias with ROB. RevMan 5.4 was used for Meta-analysis. Finally, 12 RCTs were screened out, involving 1 703 cases(1 075 in the experimental group and 628 in the control group). Meta-analysis showed that conventional treatment + Hulisan Capsules was superior to conventional treatment alone in terms of symptom relief rate(RR=1.19, 95%CI[1.09, 1.30], P<0.000 1), Lysholm score(MD=11.17, 95%CI[7.35, 15.00], P<0.000 01), visual analogue scale(VAS) score(MD=-0.99, 95%CI[-1.30,-0.68], P<0.000 01), and knee function score(RR=8.94, 95%CI[6.51, 11.37], P<0.000 01). Hulisan Capsules alone was superior to the conventional treatment alone in terms of the symptom relief rate(RR=1.38, 95%CI[1.13, 1.69], P=0.002) and knee function score(MD=2.88, 95%CI[0.81, 4.94], P=0.006), but VAS score was insignificantly different between the patients treated with Hulisan Capsules alone and those with conventional treatment alone(MD=-0.57, 95%CI[-1.42, 0.29], P=0.19). Hulisan Capsules + conventional treatment showed insignificant difference in symptom relief rate from the Zhuifeng Tougu Capsules + conventional treatment(RR=1.07, 95%CI[0.91, 1.25], P=0.44). The Lequesne score was insignificantly different between Hulisan Capsules + conventional treatment and conventional treatment/Zhuifeng Tougu Capsules + conventional treatment(MD=-2.17, 95%CI[-6.29, 1.96], P=0.30). The incidence of adverse reactions in the experimental group was significantly lower than control group(RR=0.57, 95%CI[0.34, 0.96], P=0.03). According to the available data and methods, Hulisan Capsules/Hulisan Capsules + conventional treatment could improve the symptom relief rate, Lysholm score, knee function score, and VAS score of patients with knee osteoarthritis, and alleviate the symptoms of pain, stiffness, and swelling of them. No serious adverse reactions were found yet. In the future, more large-sample and standard clinical trials are needed to verify the effect and safety of Hulisan Capsules in the treatment of knee osteoarthritis.
本研究旨在评估虎力散胶囊治疗膝骨关节炎的有效性和安全性，以期为临床实践提供参考。具体而言，从EMbase、PubMed、Cochrane图书馆、科学网、中国知网、万方、中国生物医学文献数据库和维普数据库（建库至2021年11月15日）检索关于虎力散胶囊治疗膝骨关节炎的随机对照试验（RCT）。两名研究者独立筛选文献、提取数据，并采用ROB评估偏倚风险。使用RevMan 5.4进行Meta分析。最终，筛选出12项RCT，涉及1703例患者（试验组1075例，对照组628例）。Meta分析结果显示，与单纯常规治疗相比，常规治疗联合虎力散胶囊在症状缓解率（RR=1.19，95%CI[1.09，1.30]，P<0.0001）、Lysholm评分（MD=11.17，95%CI[7.35，15.00]，P<0.00001）、视觉模拟评分法（VAS）评分（MD=-0.99，95%CI[-1.30，-0.68]，P<0.00001）及膝关节功能评分（RR=8.94，95%CI[6.51，11.37]，P<0.00001）方面更具优势。与单纯常规治疗相比，单纯虎力散胶囊在症状缓解率（RR=1.38，95%CI[1.13，1.69]，P=0.002）及膝关节功能评分（MD=2.88，95%CI[0.81，4.94]，P=0.006）方面更具优势，但单纯虎力散胶囊治疗患者与单纯常规治疗患者的VAS评分差异无统计学意义（MD=-0.57，95%CI[-1.42，0.29]，P=0.19）。虎力散胶囊联合常规治疗与追风透骨胶囊联合常规治疗在症状缓解率方面差异无统计学意义（RR=1.07，95%CI[0.9l，1.25]，P=0.44）。虎力散胶囊联合常规治疗与常规治疗/追风透骨胶囊联合常规治疗的Lequesne评分差异无统计学意义（MD=-2.17，95%CI[-6.29，1.96]），P=0.30）。试验组不良反应发生率显著低于对照组（RR=0.57，95%CI[0.34，0.96]，P=0.03）。根据现有数据和方法，虎力散胶囊/虎力散胶囊联合常规治疗可提高膝骨关节炎患者的症状缓解率、Lysholm评分、膝关节功能评分及VAS评分，减轻疼痛、僵硬及肿胀症状。尚未发现严重不良反应。未来，需要更多大样本、规范的临床试验来验证虎力散胶囊治疗膝骨关节炎的疗效和安全性。
