Regulation Effect and Clinical Efficacy of Addition and Subtraction Therapy of Jinkui Shenqiwan Combined with Buzhong Yiqitang on Immune Inflammatory Factors of Patients with Postmenopausal Osteoporosis and Deficiency of Spleen and Kidney / 中国实验方剂学杂志

Objective:To observe the clinical efficacy of addition and subtraction therapy of Jinkui Shenqiwan combined with Buzhong Yiqitang to postmenopausal osteoporosis （PMO） with deficiency of spleen and kidney， and to investigate its regulation effect on immune inflammatory factors. Method:One hundred and sixty patients were randomly divided into observation group and control group， with 80 cases in each group. Both groups got comprehensive western medicine treatment measures. Patients in control group additionally got Zhuanggu Zhitong capsule， 4 capsules/time， 3 times/day. Patients in observation group additionally got addition and subtraction therapy of Jinkui Shenqiwan combined with Buzhong Yiqitang， 1 dose/day. The treatment was continued for 24 weeks. Before and after treatment， lumbar L2-4 bone mineral density （BMD） was detected by Dual energy X-ray absorptiometry （DXA） and lumbar BMD was detected by quantitative CT （QCT）. Scores of traditional Chinese medicine（TCM） syndromes and Chinese osteoporosis-targeted quality of life questionnaire （COQOL） were graded. Levels of Estradiol （E₂）， type Ⅰ procollagen amino terminal pro peptide （PINP）， serum osteocalcin （OC）， osteoprotegerin （OPG）， type Ⅰ collagen cross-linked C-terminal peptide （S-CTX）， tartrate resistant acid phosphatase （TRACP） and urinary pyridinoline （PYD） were detected. Levels of CD4⁺ T cells， CD8⁺ T cells， interleukin-17 （IL-17）， tumor necrosis factor-<italic>α</italic> （TNF-<italic>α</italic>）， <italic>γ-</italic>interferon（IFN-<italic>γ</italic>） and interleukin-4 （IL-4） were calculated. The proportion of T helper cell （Th）17 and regulatory T cell （Treg） in CD4⁺ T cells was calculated. Besides， the safety was evaluated. Result:Bone density was detected by DXA in observation group， and its T-value and bone density detected by QCT were all higher than those in control group （<italic>P</italic><0.01）. After treatment， scores of TCM syndrome and COQOL were lower than those in control group （<italic>P</italic><0.01）. Levels of PINP， OC， S-CTX， TRACP and PYD/Cr were all lower than those in control group （<italic>P</italic><0.01）. Levels of OPG， CD8⁺ and Treg were higher than those in control group （<italic>P</italic><0.05）， levels of Th17， Th17/Treg， CD4⁺/CD8⁺， IL-17， TNF-<italic>α</italic> and IFN-<italic>γ </italic>were lower （<italic>P</italic><0.01）， and levels of IL-4 and E₂ were higher than those in control group （<italic>P</italic><0.01）. The clinical efficacy in observation group was better than that in control group （<italic>Z</italic>=2.103， <italic>P</italic><0.05）. Conclusion:On the basis of calcium and vitamin D supplementation， Jinkui Shenqiwan combined with Buzhong Yiqitang can improve levels of E₂ and bone density， reduce clinical symptoms， improve quality of life， regulate bone metabolism index and immune inflammation reaction， with better clinical efficacy and safety.

Effect of Modified Anshentang on Serum Inflammatory Factors, Immune Function, Bone Metabolism on Treatment of Patients with Ankylosing Spondylitis in Early and Middle Stages / 中国实验方剂学杂志

Objective:This study aims to investigate the clinical efficacy of modified Anshentang on the treatment of ankylosing spondylitis in early and middle stages with kidney deficiency and cold-governing syndrome and its effect on serum inflammatory factors， immune function， and bone metabolism indexes of patients. Method:In this study， 120 patients were randomly divided into control group and observation group， 60 cases in each group. On the basis of ethotrexate treatment， patients in control group took Bushen Shuji granule orally， while patients in observation group took modified Anshentang orally for 8 weeks. Before and after treatment， patients in two groups were observed for clinical symptoms ［ bath ankylosing spondylitis patient global score （BAS-G）， bath ankylosing spondylitis disease activity index （BASDAI）， spondyloarthritis research consortium of Canada （SPARCC）， traditional Chinese medicine symptoms （TCM symptoms）<italic> </italic>］， serum inflammatory factors ［ tumor necrosis factor-<italic>α </italic>（TNF-<italic>α</italic>）， macrophage migration inhibitory factor （MIF）， interleukin-23 （IL-23）］， immune function ［ immunoglobulin A（IgA）， immunoglobulin G（IgG）， immunoglobulin M（IgM）］， bone metabolic indicators ［osteocalcin （BGP）， bone morphogenetic protein-2 （BMP-2）， bonespecific alkaline phosphatase （BALP）］. The clinical efficacy， adverse reactions and recurrence rates of 12 months in two groups were observed. Result:During the study， 4 cases dropped out from control group and 2 cases from observation group. The total effective rate of 96.55% （56/58） in observation group was higher than 80.36% （45/56） in control group （<italic>χ</italic>²=4.827，<italic>P</italic><0.05）. The recurrence rate of 5.17% （3/58） in observation group was lower than 19.64% （11/56） in control group （<italic>χ</italic>²=5.187， <italic>P</italic><0.05）. Compare with control group after treatment， BAS-G，BASDAI， SPARCC， TCM symptoms， TNF-<italic>α</italic>， MIF and IL-23 in observation group were significantly decreased （<italic>P</italic><0.05）， while BGP， BMP-2， BALP， IgA， IgG and IgM were significantly increased （<italic>P</italic><0.05）. The incidence of adverse reactions was 12.07%（7/58） in observation group， which was lower than 32.14%（18/56） in control group （<italic>χ</italic>²=4.826，<italic>P</italic><0.05）. Conclusion:Modified Anshentang is effective in the treatment of ankylosing spondylitis in early and middle stages with kidney deficiency and cold-governing syndrome， and the incidence of adverse reactions is low.

Regulatory Effect of Guilu Bugu Prescription in Treating Th17/ Treg Cell Factors of Patients with Postmenopausal Osteoporosis Based on Syndrome Differentiation / 中国实验方剂学杂志

Objective: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: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 6th month after treatment and at the 6th month of follow-up， bone density of lumbar vertebra L2-4 were detected by DXA， and Lumbar BMD were detected by QCT. Before treatment， at the 3rd and 6th 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 （E2）， 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-β1 （TGF-β1） were detected， and CD4+ cells， Th17 cells and Treg cells were calculated. And the safety was evaluated. Result:At the 6th month after treatment and the 6th month of follow-up， DXA （bone mineral density and T-value of lumbar L2-4） 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 3rd and 6th 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， E2， Treg， IL-10 and TGF-β1 were all higher than those in control group （P<0.01）.There was no adverse reaction related to Guilu Bugu prescription. Conclusion: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.