Objective

2

To observe the clinical efficacy Guilu Bugu prescription in treating postmenopausal osteoporosis （PMO） with deficiency of liver and kidney Yin based on syndrome differentiation and the effect on Th17/Treg cell factors.

Method

2

One hundred and forty patients were randomly divided into observation group （70 cases） and control group （70 cases） by random number table. Both groups' patients got basic treatment of western medicine. Patients in control group got Jintiange capsules， 3 grains/time， 3 times/day. Patients in observation group got Guilu Bugu prescription， 1 dose/day. The treatment lasted for 6 months. And the 6-month follow-up was recorded. Before treatment， at the 6

th

month after treatment and at the 6

th

month of follow-up， bone density of lumbar vertebra L

2-4

were detected by DXA， and Lumbar BMD were detected by QCT. Before treatment， at the 3

rd

and 6

th

month after treatment， deficiency of liver and kidney Yin and Chinese Osteoporosis-targeted quality of life questionnaire （COQOL） were scored. Before and after treatment， Estradiol （E

2

）， procollagen I amino terminal pro peptide （PINP）， osteoprotegerin （OPG）， collagen I cross linked C-terminal peptide （S-CTX）， tartrate resistant acid phosphatase （TRACP）， interleukin-17 （IL-17）， IL-22， IL-10， transforming growth factor-

β

1

（TGF-

β

1

） were detected， and CD4

+

cells， Th17 cells and Treg cells were calculated. And the safety was evaluated.

Result

2

At the 6

th

month after treatment and the 6

th

month of follow-up， DXA （bone mineral density and T-value of lumbar L

2-4

） and QCT bone mineral density increased （

P

<

0.01）， and the figures in observation group were all higher than those in control group （

P

<

0.01）. At the 3

rd

and 6

th

month after treatment， scores of deficiency of liver and kidney Yin and quality of life were all lower than those in control group （

P

<

0.01）. Levels of PINP， S-CTX， TRACP， Th17 cells， ratio of Th17 and Treg， IL-17 and IL-22 were all lower than those in control group （

P

<

0.01）， and levels of OPG， E

2

， Treg， IL-10 and TGF-

β

1

were all higher than those in control group （

P

<

0.01）.There was no adverse reaction related to Guilu Bugu prescription.

Conclusion

2

Based on the supplementation of calcium and vitamin D， Guilu Bugu prescription can further improve the bone mineral density， raise the estrogen level， regulate the expressions of bone metabolism markers， Th17， Treg and relevant factors， reverse the imbalance of Th17/Treg， relieve the clinical symptoms and improve the quality of life， with a better efficacy than that of Jintange capsule and a high safety.