| BackgroundRheumatoid arthritis is a chronic systemic autoimmune disease with multiple and symmetrical arthritis,which can cause serious malformation of the limbs.The patient and the community have incalculable economic losses.Now we use celastrus orbiculatus as the main drug,with polygonum cuspidatum and myrrh as the external coating liniment,named Nanhu Gel.Where celastrus orbiculatus is the monarch drug,polygonum cuspidatum as adjuvant drug,myrrh as adjuvant.With its effect of dispelling wind,removing obstruction in the meridians and relieving swelling with pain,the rheumatoid arthritis which TCM syndrome is heat syndrome could have good curative effect.ObjectivePatient who at the acute stage of rheumatoid arthritis and TCM Syndrome is heat syndrome would be the research object to discuss the effect of Nanhu Gels on alleviating the symptoms.MethodSelect the in-patient of rheumatoid arthritis collected from TCM-Integrated Cancer Center of Southern Medical University who has a complete history of rheumatoid arthritis.The diagnostic criteria is according to the 2009 American College of Rheumatology rheumatoid arthritis diagnostic criteria.Inclusion criteria:?meet the the 2009 American College of Rheumatology rheumatoid arthritis diagnostic criteria;?aged 12-89;?No other rheumatism;?signed the informed consent.Exclusion criteria:?the person who does not conform to the criteria;?patients aged<12 or>89 years old;?serious primary diseases and psychotic patients;?severe deformity of the advanced joints and the loss of work ability;?associate with other arthritis diseases or connective tissue disorders;?fail to the prescribed treatment and drug use,unable to determine the effect of the effect or incomplete data on the outcome of the decision;?pregnant women or the going to be ones,breast-feeding women.Drop off,remove,terminate the experimental standards:?Drop off:have been enrolled but fail to complete the clinical program of cases,such as the non-compliant patient who requiring withdrawal;?Remove:Excluding cases should not involve in the statistics and need to explain the reasons which include the following:Misdiagnosis;never use the drug;serious adverse events happen and the patient could not continue to receive treatment;take other congener drugs which would interfere in test results;stop medication;without safety and efficacy evaluation.?Termination of research:serious side effects were found during the course of the study;drugs has no efficacy.ProsessIn strict accordance with the diagnostic criteria,inclusion criteria and exclusion criteria to collect cases.According to random number table method,according to the ratio of 1:1:1 randomly divided into the experimental group,the control group and the blank group.Draw up 10 cases in each group,a total of 30 cases.Treatment:The experimental group to the basic drug with Nanhu Gel externally.In the control group,Votalin emulsion was applied externally to the patients.The blank group to the basic drug plus the same appearance with the Nanhu Gel.Respectively before the start of the experiment,the first week of each study index assessment.Data from clinical evaluation were processed by researchers and analyzed by using SPSS 19.0 statistical.Three groups of patients at different time points of the research indicators and the incidence of adverse reactions.ResultsIn this study,30 in-patients of rheumatoid arthritis were collected from TCM-Integrated Cancer Center of Southern Medical University from December during Dec.2017-May.2017.1)Comparison of the general conditions among the experimental group,the control group and the blank groupIn the experimental group,3 cases were males and 7 cases were females:no case of class ? pain,2 cases of class ? pain,6 cases of class ? pain and 1 case of class IV pain.In the control group,there were 2 males and 8 females.1 case of class I pain,3 cases of grade ? pain,5 cases of class ? pain,and 1 case of class IV pain.In the blank group,there were 10 males and 9 females,1 case of class I pain,3 cases of class? pain,6 cases of class ? pain,and 1 case of class IV pain.There were no statistically significant differences in gender,age distribution and severity of disease.2)Comparison of ESR and CRP before and after treatment in three groupsThe statistical analysis shows that difference among the three groups on ESR before and after treatment are not statistically significant(F=0.628,P=0.524,P>0.05).The statistical analysis also shows that difference are not statistically significant in CRP before and after treatment among the three groups(F=0.557,P=0.580,P>0.05).Hinting that in improving ESR or C-reactive protein index,the Nanhu Gel had no obvious advantage compared to Votalin emulsion,Blank Gel.3)Comparison of pain scores before and after treatment in three groupsThe scores of the three groups were significantly decreased,and the statistics had significant differences(H=8.659,P=0.013,P<0.05).The results also shows that the decrease value of the experimental group was greater than the control group.So the effect is better than that of Votalin emulsion,and Nanhu Gelata and Votalin emulsion have better curative effect than the Blank Gel.4)Changes of joint size before and after treatmentThe result of statistical analysis about joint size in three groups before and after treatment shows that there are significant differences among them(F= 15.810,P<0.05).Assuming that Nanhu Gel,Votalin emulsion and blank Gel effect on joint size have differences.According to the results of multiple comparison,the differences between each group were statistically significant,indicating that the Nanhu Gel has obvious advantages in improving the joint swelling.5)Comparison of onset time after treatmentStatistical analysis showes significant differences in the onset time among three groups(H=8.659,P<0.05).Therefor Nanhu Gel came into effect quicker than the other two groups.6)Comparison of clinical effects among three groupsThe total efficiency of the experimental group was 90%,higher than 80%in the control group,the difference was statistically significant(x2=11.804,P=0.029).Hinting that Nanhu Gel has a better effect on alleviating acute episodes of rheumatoid arthritis.7)Evaluation of treatment safety among three groupsThe incidence of adverse events caused by drugs during the entire treatment process was 0%.The liver and kidney function of the three groups of patients were not significantly changed after one weeks of medication.It shows that Nanhu Gel is safe and reliable in clinical use.ConclusionIn this small sample test,Nanhu Gelata has higher clinical efficiency than Votalin emulsion and Blank Gel,and its price is relatively low in votalin.Three groups of drugs had no significant effect on liver and kidney function.No serious side effects were observed in all cases,suggesting that it is safe and effective in 1 weeks'continuous use. |
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