Study On The Post Market Safety Reevaluation Of Strong Bone Capsule

Strong Bone capsules are processed by a certain process after extracting active ingredients from Radix Polygoni Multiflori,Epimedium,Radix Rehmanniae,Tortoiseshell,Morinda,Eucommia,Dipsacus,Rhizoma Drynaria,Angelica sinensis and Chinese yam.This paper mainly combined with clinical trials to verify the safety of Strong Bone capsules in the treatment of primary osteoporosis.It lays a theoretical foundation for the safety of the drug in the treatment of primary osteoporosis(nephrine deficiency syndrome).Through this study,we can discover the risk signals that exist in the three main links of production,circulation,and use.Moreover,this study can also provide basis for relevant departments to formulate drug regulatory policies.Therefore,we can scientifically and rationally recognize the opportunities and challenges it faces in the prevention and treatment of osteoporosis.This study used a randomized,single-blind,parallel-controlled,positive-controlled,multi-center clinical study design approach.The participating centers conducted unified training and started and ended clinical research work at different locations according to the same plan.The experiment plan invites seven research centers to participate in the research and set up the experimental group:the control group=1:1.Let 136 pairs of postmenopausal osteoporosis group and 14 pairs of male osteoporosis group,a total of 150 pairs of 300 cases(including 20%of shedding and rejection cases);set interview point 1 for medication for 7 to 0 days,visit point 2 for medication for 12 weeks ± 7 days,and use the medication for 4 weekends and 8 weekends for telephone interviews.The trial focused on the treatment course of primary osteoporosis(nephrine deficiency syndrome)for 12 weeks.Subjects were treated with drugs for 12 weeks ± 7 days and observed for efficacy.For the evaluation of drug safety,six observation items including electrocardiogram,blood routine,urine routine,stool routine,blood biochemistry and adverse events were set up.The experimental program identified three analysis sets,namely the full analysis set(FAS),the compliance set(PPS),and the security analysis set(SS).FAS and PPS were used for efficacy analysis while SS was used for safety analysis.In addition,we analyzed the baseline characteristics of the test population from various aspects,the demographic characteristics of the subjects(including past history,family history,age,height,weight),etc.The data is roughly balanced between the two groups,showing that the two groups are comparable.The test results showed that the difference in vital signs between the subjects at the baseline and the 12th weekend and the baseline period-12 weekends,the difference between the experimental group and the control group,P>0.05,the difference was not statistically significant significance.That is,Strong Bone capsules have no effect on the subject's vital signs.Laboratory test results showed that the number of subjects with normal white blood cell and alkaline phosphatase test results was statistically significant between the experimental group and the control group at the end of the 12th week of treatment(P values were P=0.0037<0.05,P=0.0311<0.05).The number of subjects with normal laboratory results was not statistically different between the experimental group and the control group(P>0.05).Adverse events occurred in 39 of the 135 cases that entered the SS analysis of adverse events.The incidence of adverse events was 28.89%(39/135).The incidence of adverse events in the trial group was 27.94%(19/68)lower than the 29.85%(20/67)in the control group,ie,the incidence of adverse reactions in the trial group was lower than that in the control group.The adherence to medication in this test was 86.76%for good compliance.The test combination and drug use rate was 76.47%(52/68)higher than the control group 70.15%(47/67).There was no significant difference between the two groups in the non-concomitant drug use rates.That is,there are no problems with the medication compliance and combined medication of Strong Bone capsules.In summary,Strong Bone capsules have better safety than Xian Ling Gu Bao capsules.It can reduce the incidence of patient discomfort during treatment,thereby improving patient compliance.It can perform better in longer-term treatments.Combined with the efficacy indicators,Strong Bone capsules have a good therapeutic effect on primary osteoporosis(renal essence deficiency syndrome).Moreover,it has a better safety than the existing commonly used drugs,so it is worth further promotion and application in clinical aspects.