目的 系统评价仙灵骨葆胶囊（XLGB）治疗股骨头坏死（ONFH）的临床疗效与安全性。方法 检索建库至2022年6月1日PubMed、Cochrane Library、Embase、中国学术期刊全文数据库（CNKI）、万方数据库（Wanfang Data）、中国生物医学文献数据库（SinoMed）、维普生物医学数据库（VIP）中有关XLGB治疗ONFH的随机对照试验（RCT）。两位研究者分别进行数据提取和偏倚风险评估。采用ReviewManager 5.4软件进行Meta分析，使用GRADE pro 3.6.1软件对汇总的证据进行分级。结果 共纳入13项RCTs，包括1126名患者。Meta分析显示，与常规西医治疗相比，联合XLGB治疗明显改善患者的Harris评分［MD=10.88，95%CI（6.66，15.10）］、髋关节功能优良率［RR=1.23，95%CI（1.15，1.30）］、视觉模拟评分［MD=-2.01，95%CI（-2.09，-1.93）］，提高患者Wards三角［MD=0.04，95%CI（0.03，0.04）］、股骨粗隆［MD=0.04，95%CI（0.03，0.04）］和股骨颈骨密度［MD=0.06，95%CI（0.05，0.08）］，改善部分凝血活酶时间［MD=8.47，95%CI（7.02，9.92）］和纤维蛋白原［MD=-0.42，95%CI（-0.50，-0.35）］，两组比较均有差异（P＜0.00001）。XLGB治疗不会提高不良反应的发生率；GRADE对现有证据质量评级为低或极低质量。结论 在临床中应用XLGB治疗ONFH患者疗效明确，安全可靠，但鉴于纳入文献研究质量不高，仍需更多高质量的临床试验验证本结论。

Objective To systematically assess the efficacy and security of the combination of Xianing Gubao Capsule (XLGB) with conventional western medicine (CWM) in the treatment of osteonecrosis of the femoral head (ONFH). Methods Data were electronically searched from PubMed, Cochrane Library, EMbase, CNKI, Wanfang Data, SinoMed, VIP from the date of establishment to June 1, 2022 for the randomized controlled trial (RCT) of the combination of XLGB and CWM in the treatment of ONFH. Two reviewers respectively regulated research selection, data extraction, and risk of bias assessment. ReviewManager 5.4 software was used for meta-analysis. Furthermore, GRADE pro 3.6.1 software was selected to grade the current evidence in our findings. Results A total of 13 RCTs involving 1 126 patients were included. The results of Meta-analysis suggested that, compared with CWM alone, the combination therapy significantly improve the Harris score [MD = 10.88, 95%CI (6.66, 15.10)], effective rate of hip function [RR = 1.23, 95%CI (1.15, 1.30)], Visual simulation scoring [MD = -2.01, 95%CI (-2.09, -1.93)], increase Wards triangle [MD = 0.04, 95%CI (0.03, 0.04)], femoral trochanter [MD = 0.04, 95%CI (0.03, 0.04)] and femoral neck bone density [MD = 0.06, 95%CI (0.05, 0.08)], improve partial thrombin time [MD = 8.47, 95%CI (7.02, 9.92)] and fibrinogen [MD = -0.42, 95%CI (-0.50, -0.35) ], differences were statistically significant between two groups (P<0.00001). In addition, XLGB treatment did not increase the incidence of adverse reactions. The GRADE evidence quality rating presented with low or extremely low quality of evidence for the available data. Conclusion The clinical application of XLGB in the treatment of patients with ONFH has clear efficacy, safety and reliability. However, in view of the low quality of the included literature, more high-quality RCTs are still needed to further verify this conclusion.

R286.7;R969.3

2019年国家中医临床研究基地科研专项课题（2019JDZX073）