目的 系統(tǒng)評價仙靈骨葆膠囊（XLGB）治療股骨頭壞死（ONFH）的臨床療效與安全性。方法 檢索建庫至2022年6月1日PubMed、Cochrane Library、Embase、中國學(xué)術(shù)期刊全文數(shù)據(jù)庫（CNKI）、萬方數(shù)據(jù)庫（Wanfang Data）、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫（SinoMed）、維普生物醫(yī)學(xué)數(shù)據(jù)庫（VIP）中有關(guān)XLGB治療ONFH的隨機(jī)對照試驗（RCT）。兩位研究者分別進(jìn)行數(shù)據(jù)提取和偏倚風(fēng)險評估。采用ReviewManager 5.4軟件進(jìn)行Meta分析，使用GRADE pro 3.6.1軟件對匯總的證據(jù)進(jìn)行分級。結(jié)果 共納入13項RCTs，包括1126名患者。Meta分析顯示，與常規(guī)西醫(yī)治療相比，聯(lián)合XLGB治療明顯改善患者的Harris評分［MD=10.88，95%CI（6.66，15.10）］、髖關(guān)節(jié)功能優(yōu)良率［RR=1.23，95%CI（1.15，1.30）］、視覺模擬評分［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?。跰D=0.04，95%CI（0.03，0.04）］和股骨頸骨密度［MD=0.06，95%CI（0.05，0.08）］，改善部分凝血活酶時間［MD=8.47，95%CI（7.02，9.92）］和纖維蛋白原［MD=-0.42，95%CI（-0.50，-0.35）］，兩組比較均有差異（P＜0.00001）。XLGB治療不會提高不良反應(yīng)的發(fā)生率；GRADE對現(xiàn)有證據(jù)質(zhì)量評級為低或極低質(zhì)量。結(jié)論 在臨床中應(yīng)用XLGB治療ONFH患者療效明確，安全可靠，但鑒于納入文獻(xiàn)研究質(zhì)量不高，仍需更多高質(zhì)量的臨床試驗驗證本結(jié)論。

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年國家中醫(yī)臨床研究基地科研專項課題（2019JDZX073）