Observation on Efficacy of Modified Maxingyigan Decoction in Treating Patients with Damp-Heat Stagnation Type Anti-Synthetase Syndrome
Objective To observe the efficacy and safety of modified Maxingyigan decoction in treating patients with damp-heat stagnation type anti-synthetase syndrome(ASS).Methods A total of 120 patients with damp-heat stagnation type ASS were treated at the Respiratory Department at Beijing Hospital of Traditional Chinese Medicine be-tween July 2020 to May 2022 and were selected for the study.The random envelope method was employed,and block ran-domization was generated using SAS 9.3 programming to create a blinded random allocation.The patients were divided into a control group and a treatment group in a 1:1 ratio,with 60 patients in each group.The control group was treated with low-dose glucocorticoid plus placebo,while the treatment group was treated with low-dose glucocorticoid combined with modified Maxingyigan decoction granules.The total treatment course was 8 weeks.The clinical efficacy,adverse reactions,lung function[forced vital capacity(FVC),diffusing capacity of the lung for carbon monoxide(DLCO single-breath meth-od,DLCO-sb)],Leicester cough questionnaire(LCQ)scores,6-minute walking test(6MWT)distance,and changes in traditional Chinese medicine(TCM)syndrome scores before and after treatment were observed and compared between the two groups.Results After treatment,TCM syndrome scores for muscle weakness,chest tightness,wheezing,cough,sputum production,body heaviness,rash,and mechanic's hand were significantly lower in the treatment group compared to before treatment,with statistically significant differences(P＜0.05).These scores were also significantly lower in the treatment group compared to the control group,with statistically significant differences(P＜0.05).The 6MWT distance significantly increased in the treatment group after treatment,with statistically significant differences(P＜0.05);the 6MWT distance in the treatment group was also significantly higher than in the control group,with a statistically significant difference(P＜0.05).After treatment,FVC and DLCO-sb values decreased in both groups compared to before treatment,with statistical-ly significant differences(P＜0.05),but there was no statistically significant difference between the groups(P＞0.05).LCQ scores for coughing significantly improved in the treatment group after treatment,with statistically significant differ-ences(P＜0.05);LCQ scores in the treatment group were also significantly higher than in the control group,with statisti-cally significant differences(P＜0.05).The total clinical efficacy rate in the treatment group was 90.00％(54/60),signif-icantly higher than in the control group(70.20％,40/57),with a statistically significant difference(P＜0.05).During the treatment period,there were no significant abnormalities in liver or kidney function,and no serious adverse events oc-curred.The incidence of adverse reactions was not significantly different between the two groups(P＞0.05).Conclusion Modified Maxingyigan decoction can effectively improve activity tolerance and relieve cough symptoms in patients with damp-heat stagnation type ASS.It also demonstrated good safety,with no serious adverse reactions during treatment.
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