| PurposeTo observe the efficacy and safety of yunpi jiedu tongluo qushi granule in the treatment of rheumatoid arthritis syndrome of spleen deficiency combined with dampness,toxin and stasis obstruction,to clarify its synergistic and detoxification effects,and to form a therapeutic advantage of traditional Chinese medicine synergistic and detoxification program.The research methodsA total of 68 patients with active rheumatoid arthritis syndrome of spleen deficiency combined with dampness,toxicity and stasis were enrolled in a prospective cohort study design.The exposure factors were taken as the syndrome differentiation and flavor treatment of TCM therapeutic program of synergism and detoxification.Among them,clearing damp granules of yunpi jiedu tongluo were derived from the empirical prescription of Professor Chengping Wen of Zhejiang Chinese Medicine University,which were divided into exposed group and non-exposed group.Among them,33 cases in the exposed group were treated with TCM basic prescription syndrome differentiation and flavoring combined with western medicine,and the western medicine treatment regimen was maintained before enrollment(methotrexate as the basic drug or other traditional treatment regimen with or without other anti-rheumatic drugs to improve the condition).35 cases in non-exposed group were treated with simple western medicine.Each group took 12 weeks as the treatment course,and 0weeks and 12 weeks as the visiting points.In order to control loss of follow-up,patients with good compliance were selected before inclusion,and patients were guided to participate in the interview by telephone,email and other methods.Record and analysis of Chinese and western medicine clinical signs and symptoms,integral changes of the patients.The results of the study1.Among the 68 patients observed in this study,females were about 4 times as many as males.Most of them were non-manual workers,and the ratio of physical and non-manual labor was 2:3.The incidence of disease without inducement was 8 times of that with inducement.Most of the patients were aged 50-59 years and the course of disease was less than 60 months.2.Both the exposed group and the non-exposed group had reduced effects on inflammatory indicators CRP and ESR.After treatment,the difference between the exposed group and the non-exposed group was statistically significant,indicating that the exposed group was better than the non-exposed group in improving inflammatory indicators.(P < 0.05)3.Both the exposed group and the non-exposed group could not reduce the diagnostic indexes RF and CCP,and the difference before and after treatment was not statistically significant.(P > 0.05)4.The number of joint swelling,number of joint pain and VAS were reduced in the exposed group and the non-exposed group,and the difference between the two groups after treatment was statistically significant,indicating that the exposed group was superior to the non-exposed group in terms of reducing joint swelling,pain and VAS.(P < 0.05)5.Both the exposed group and the non-exposed group had a reduced effect on the HAQDI table score,and there was no statistically significant difference between the exposed group and the non-exposed group after treatment.(P > 0.05)6.The scores of FACIT-Fatigue scale could be effectively improved in the exposure group before and after treatment(P < 0.05);The exposed group There was no significant difference before and after treatment(P Bb0 0.05).After treatment,the exposed group compared with the non-exposed group,The difference was statistically significant,indicating that the exposure group was better than the non-exposure group in improving the score of FACIT-Fatigue Scale Group.(P < 0.05)7.DAS28,CDAI and SDAI were decreased in both exposed and non-exposed groups;After treatment,the difference between the exposed group and the non-exposed group was statistically significant,indicating that the exposed group was better than the nonexposed group in reducing DAS28,CDAI and SDAI.(P < 0.05)8.Both the exposed group and the non-exposed group had a certain response rate to the baseline response of DAS28,among which the exposed group was 96.97% and the nonexposed group was 62.86%.The comparison of the total response rates between the two groups showed a statistically significant difference,indicating that the exposed group was better than the non-exposed group in improving the baseline change of DAS28.(P < 0.05)9.Both the exposed group and the non-exposed group improved the total score of TCM syndrome scores;After treatment,the difference between the exposed group and the nonexposed group was statistically significant.The exposed group was better than the nonexposed group in reducing the total score of TCM syndrome scores(P < 0.05).Both the exposed group and the non-exposed group had a certain effective rate on the evaluation criteria of TCM syndromes,among which the exposed group was 87.88% and the nonexposed group was 65.71%.Two sets of data between a statistically significant difference,indicating that the effective rate of the exposed group was better than that of the non-exposed group.(P < 0.05)10.In the exposed group,the difference of hemoglobin before and after treatment was significant(P < 0.05);There were no significant differences in ALT values of the exposed group,hemoglobin and ALT values of the non-exposed group and appeal values of the nonexposed group before and after treatment(P > 0.05).After treatment,the difference of creatinine value between the exposed group and the non-exposed group was statistically significant.(P < 0.05)Before and after treatment,the patients’ vital signs,systemic physical examination,blood lipid,blood glucose,urine protein,urine red blood cell,urine white blood cell,fecal occult blood and other indexes were recorded and analyzed,and no abnormalities were found.11.The combination of drug use between the exposed group and the non-exposed group was analyzed,and the difference was not statistically significant,indicating that the combination of drug use between the two groups did not affect the test results.(P > 0.05)12.Adverse reactions in the exposed group and the non-exposed group were analyzed,and the difference was not statistically significant.(P > 0.05)conclusionBy observing the clinical effect of Yunpi Jiedu Tongluo Qushi Granule on RA syndrome of spleen deficiency combined with dampness,toxicity and stasis,the following conclusions were drawn:(1)The efficacy of yunpi jiedu tongluo qushi granule combined with western medicine in the treatment of RA syndrome of spleen deficiency combined with dampness,toxin and stasis is more significant than that of western medicine alone,and it is more effective in improving the TCM syndrome score,joint swelling and pain and visual analog score of pain of patients;Reduce patients’ disease activity,inflammation index,improve patients’ quality of life.(2)Yunpi jiedu tongluo qushi granule has good safety,few side effects and no serious adverse reactions in the treatment of RA syndrome of spleen deficiency combined with dampness,toxin and stasis obstruction,which is worthy of clinical promotion. |
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