OBJECTIVE: To probe into the efficacy of modified prescription of kidney-tonifying and bloodinvigorate in the treatment of knee osteoarthritis complicated with osteoporosis and its effect on serum toll-like receptor（ TLR）/nuclear factor-κb（ NF-κB） signaling pathway. METHODS: Prospective study was performed

totally 120 patients with knee osteoarthritis complicated with osteoporosis admitted into Sichuan Orthopaedic Hospital from Jan.2018 to Jan. 2020 were enrolled and randomly divided into control group and observation group via lottery method

with 60 cases in each group. Of which the control group was given conventional therapy

while the observation group was treated with modified prescription of kidney-tonifying and blood-invigorate based on the control group. Clinical efficacy at 1 month after treatment was observed in both groups

TCM symptom integral

bone mineral density（ BMD）

TLR and expression level of NF-κB mRNA

contents of inflammatory factors [interleukin 6（ IL-6）

interleukin 1β（ IL-1β） and tumor necrosis factor α（ TNF-α） ]

changes of coagulating function [activated partial thromboplastin time（ APTT）

prothrombin time（ PT）

D-dimer（ D-D） and fibrinogen（ FIB） ] before and after treatment were compared

and incidences of adverse drug reactions were recorded. RESULTS: The total effective rate of observation group was 98. 33%（ 59/60）

which was significantly better than that of the control group（ 86. 67%

52/60）

with statistically significant difference（ P < 0. 05）. Symptom integral of knee-joint pain

swelling

soreness and weakness

flexion and extension discomfort and anchylosis of both groups were significantly lower after treatment than before treatment

and the above symptom integral were significantly lower in the observation group than in the control group after treatment

with statistically significant differences（ P < 0. 05）. The BMD of both groups was significantly higher after treatment than before treatment

TLR and expression level of NF-κB mRNA were significantly lower after treatment than before treatment

the contents of IL-6

IL-1β and TNF-α were significantly lower after treatment than before treatment; compared with the control group

the BMD of observation group after treatment was significantly higher

TLR and the expression level of NF-κB mRNA of observation group were significantly lower

the contents of IL-6

IL-1β and TNF-α of observation group were significantly lower

with statistically significant differences（ P <0. 05）. The APTT and PT of both groups were significantly longer after treatment than before treatment

the FIB and D-D levels were significantly lower after treatment than before treatment

with statistically significant differences（ P <0. 05）; the PT of observation group after treatment was significantly longer than that of the control group

the FIB and D-D levels were significantly lower than those of the control group

with statistically significant differences（ P <0. 05）; there was no statistically significant difference in the APTT of patients in the observation group compared with the control group（ P > 0. 05）. The incidences of adverse drug reactions of observation group and control group were respectively 6. 67%（ 4/60） and 15. 00%（ 9/60） during treatment

the difference had no statistical significance（ P >0. 05）. CONCLUSIONS: Compared with conventional Western medicine treatment

the addition of modified prescription of kidney-tonifying and blood-invigorate can improve the efficacy in the treatment of knee osteoarthritis complicated with osteoporosis

which can reduce abnormal inflammatory immune response and improve clinical symptoms and blood hypercoagulability by inhibiting the activation of TLR/NF-κB signaling pathway

with high safety.