目的 探讨壮筋补骨丸治疗膝骨关节炎(Knee Osteoarthritis，KOA)患者发作及缓解期的临床疗效，并对其临床特征及用药规律进行系统分析。方法 选取2022年6月—2023年12月壮筋补骨丸治疗膝骨关节炎病例注册登记系统中共3家医院，一共505例患者。所提取数据包括性别、年龄、体质量指数(Body Mass Index，BMI)、分期、影像分级(Kell-gren-Lawrence，K-L分级)、用药时长、用药剂量、用药频率、联合用药情况、合并疾病以及不良反应。结果 对本研究患者的中医证候进行流行病学调查，并筛选出异常证候。结果显示，肿胀疼痛(94。85％)、关节僵硬(70。89％)、腰膝酸软(59。80％)、活动不利(58。02％)、腰身酸重(48。51％)等症候的出现频次相对较高。将所有患者按照不同疾病分期分为发作期、缓解期，根据2020年版《膝骨关节炎中医诊疗指南》中主要疗效指标视觉模拟评分(Visual Analogue Scale，VAS)和西安大略和麦克马斯特大学骨关节炎指数评分(The Western Ontario and McMaster Universities Osteoarthritis Index，WOMAC)对临床疗效进行评价，结果显示，患者发作期、缓解期治疗后的VAS评分和WOMAC总评分相较于治疗前均显著降低，差异具有统计学意义(P＜0。05)。发作期和缓解期患者相比较，在年龄和合并疾病方面差异具有统计学意义(P＜0。05)。505例患者中，单药治疗266例(52。67％)，联用1种药物147例(29。11％)，联用2种药物67例(13。26％)，联用3种25例(4。95％)。发作期患者单用和联合用药情况相较于缓解期患者，差异无统计学意义(P＞0。05)。临床使用壮筋补骨丸治疗KOA常联合西药口服、中成药口服、中药外用、西药外用以及关节腔药物注射等，口服西药主要为非甾体类抗炎镇痛药，关节腔药物注射以玻璃酸钠为主，中成药以补肾健骨、活血止痛类为主。本研究中，患者使用壮筋补骨丸治疗KOA的平均服药量为(6。12±0。53)g/次，用药频率为3次/d。壮筋补骨丸治疗KOA最常用的用药时长为4周。结论 真实世界中壮筋补骨丸治疗KOA人群女性较多，患者以缓解期为主，K-L分级主要分布于Ⅱ～Ⅲ级，发作期和缓解期患者均可收获良好临床效果;单独用药超过50％，联合用药主要包括西药口服、中成药口服、中药外用、西药外用以及关节腔药物注射等。
Clinical Characteristics and Medication Analysis of Zhuangjin Bugu Pill(壮筋补骨丸)in Treatment of Knee Osteoarthritis Based on The Real World
Objective To explore the clinical efficacy of Zhuangjin Bugu Pill(壮筋补骨丸)in the treatment of knee osteoar-thritis patients during the onset and remission period,and to systematically analyze its clinical characteristics and medication pat-terns.Method From June 2022 to December 2023,a total of 505 patients were selected from 3 hospitals in the registration system for the treatment of knee osteoarthritis with Zhuangjin Bugu Pill.The extracted data included gender,age,body mass index(BMI),staging,Kellgren Lawrence imaging grading(K-L grading),medication duration,medication dosage,medication frequen-cy,combination medication status,comorbidities and adverse reactions.Result Epidemiological investigation was conducted on the traditional Chinese medicine syndromes of the patients in this study,and abnormal syndromes were screened.The results showed that the frequency of symptoms such as swelling and pain(94.85％),joint stiffness(70.89％),lower back and knee soreness(59.80％),poor mobility(58.02％)and lower back soreness(48.51％)was relatively high.All patients were divided into at-tack and remission stages according to different disease stages.The clinical efficacy was evaluated based on Visual Analogue Scale(VAS)score and The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC).The results showed that the VAS score and WOMAC total score of patients after treatment in the attack and remission stages were significantly reduced compared to those before treatment,and the difference was statistically significant(P＜0.05).There was a statistically significant difference in age and comorbidities between patients in the onset and remission phases(P＜0.05).Among 505 patients,266 ca-ses(52.67％)received monotherapy,147 cases(29.11％)received combination therapy with one drug,67 cases(13.26％)re-ceived combination therapy with two drugs,and 25 cases(4.95％)received combination therapy with three drugs.There was no statistically significant difference in the use of monotherapy and combination therapy between patients in the attack phase and those in the remission phase(P＞0.05).The clinical use of Zhuangjin Bugu Pill in the treatment of KOA is often combined with oral western medicine or traditional Chinese patent medicines,external use of traditional Chinese medicine or western medicine and joint cavity drug injection,while western medicine oral drugs mainly include non steroidal anti-inflammatory drugs.The joint cavity drug injection is mainly sodium hyaluronate,and traditional Chinese patent medicines and simple preparations is main-ly kidney-tonifying,bone-activating,blood-activating and pain-relieving drugs.In this study,the average dosage of Zhuangjin Bugu Pill used by patients to treat KOA was(6.12±0.53)g/time,with a frequency of 3 times per day.The most commonly used medication for treating KOA with Zhuangjin Bugu Pill was 4 weeks.Conclusion In the real world,there are more women in the KOA population treated with Zhuangjin Bugu Pill,and the patients are mainly in the remission stage.The K-L grading is mainly distributed in grades Ⅱ-Ⅲ,and the patients in both the attack and remission stages can achieve good clinical effects.More than 50％of the drugs are used alone,and the combined drugs mainly include oral western medicine or traditional Chinese patent medicines,external use of traditional Chinese medicine or western medicine and joint cavity drug injection.
Zhuangjin Bugu Pill(壮筋补骨丸)knee osteoarthritisreal world researchclinical featuresmedication analy-sis
万方数据
维普
