| ObjectiveTo study the effect of Zhuang Gu Qiang Jin Tablet(ZGQJT)on the level of bone turnover markers(BTMs),symptom,and lunbar interbody fusion rate in Osteoporosis(OP)patients undergone Posterior Lumbar Interbody Fusion(PLIF),and to evaluat the clinical efficacy and safety of ZGQJT on patients afer lumbar fusion.MethodsThe total number of cases in this study was 80,these selected cases were patients from March 2015 to March 2016 the third bone's department in the third department of orthopedics in Dongguan Hospital of Traditional Chinese Medicine,intended to perform surgery of PLIF.Those patients were randomly assigned to the control group and the Chinese medicine group,the control group was treated with basic calcium,the Chinese medicine group was treated with basic calcium and ZGQJT.According to the inclusion criteria and the excluded criteria,the qualified cases were assigned to the control group and the Chinese medicine group according to the random number table.The control group:oral calcium,(Caltrate,Wyeth Pharmaceutical)calcium 600mg,vitamin D3 125 international unit after surgery,1.5g/time,2 times a day;the Chinese medicine group was treated with basic calcium in addition ZGQJT,a preparation of Dong Guan hospital of Chinese Medicine,3 times,each time 5 pieces(each weight of 0.25g).Results(1)There was no significant difference in age,gender,bone mineral density values,body mass index,total of operative segment,be comparable.The patients were followed up for six months.During the follow-up period,one patient in the control group had a suspicious end plate collapse,and the fusion device sank.Others were no screw loosening,nail breaking,end plate collapsing and fusion device sinking.(2)There were no significant differences in the bone turnover markers,PINP,between the two groups at the time of preoperative,postoperative 3 months and 6 months postoperatively(P>0.05).In terms of level of bone resorption markers,?-CTX.The overall average of the the Chinese medicine group was lower than the control group,the difference was statistically significant(P<0.05).There were no significant differences between the three time points of the control group(P>0.05).The level of ?-CTX in Chinese medicine groups at 6 months after operation was lower than those at the time of preoperative and postoperative 3 months(P<0.01,P<0.05),but there was no significant difference between the level of ?-CTX at the time of preoperative and postoperative 3 months.(3)The JOA score did not correlate with the three time points between two groups.Two groups' JOA scores of postoperative 1 week were both higher than preoperative(P<0.01);two groups' JOA scores of postoperative 3 months and 6 months were both higher than 1 week(P<0.05);but there was no difference between postoperative 3 months and 6 months(P>0.05).(4)The improved Brantigan score at 6 months after operation were both higher than 3 months,which has statistical differences(P<0.01).No statistical significance had been found in the improved Brantigan score,between the two groups,at the time of postoperative 3 months(P>0.05).The Brantigan score of the Chinese medicine group was higher than the control group at 6 months after operation,and the difference was statistically significant(P<0.05).(5)The interbody fusion rate of the Chinese medicine group,27.9%and 65.9%,at 3 months and 6 months after operation,was higher than that of the control group,9.3%and 44.2%(P<0.05);and the interbody fusion rate of both two groups at the time of postoperative 6 months were higher than that of 3 months(P<0.05).ConclusionZGQJT could maintain bone mass,reduce the level of ?-CTX,regulate bone metabolism,and improve the osteoporosis patients' interbody fusion rate.It can be considered that the effect was satisfactory,and QJZGT could provided OP patients who had suffer the lumbar interbody fusion a effective treatment program. |
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