Evaluation of Efficacy and Safety of Tongluo Huatan Capsules(通络化痰胶囊) in the Treatment of Cerebral Infarction Recovery Phase with Phlegm-Stasis Obstructing Collaterals Syndrome: a Real World Study
ZHANG Dandan, FU Su, MA Xueyan, et al. Evaluation of Efficacy and Safety of Tongluo Huatan Capsules(通络化痰胶囊) in the Treatment of Cerebral Infarction Recovery Phase with Phlegm-Stasis Obstructing Collaterals Syndrome: a Real World Study[J]. Journal of Traditional Chinese Medicine2020, 61(1): 42-47.
ZHANG Dandan, FU Su, MA Xueyan, et al. Evaluation of Efficacy and Safety of Tongluo Huatan Capsules(通络化痰胶囊) in the Treatment of Cerebral Infarction Recovery Phase with Phlegm-Stasis Obstructing Collaterals Syndrome: a Real World Study[J]. Journal of Traditional Chinese Medicine2020, 61(1): 42-47.DOI: 10.13288/j.11-2166/r.2020.01.010.
to elevate the efficacy and safety of Tongluo Huatan Capsules(通络化痰胶囊) in the treatment of cerebral infarction patients of phlegm-stasis obstructing collaterals syndrome in the recovery phase. Methods This was a phase IV
multicenter
prospective
one-armed
real world study. Cases met the western medicine diagnostic criteria of atherosclerotic thrombotic cerebral infarction in the recovery phase and Chinese medicine diagnostic criteria of stroke in the meridians(phlegm-stasis obstructing collaterals syndromes) in 34 hospitals were included. All of the patients were given Tongluo Huatan Capsules for 4 weeks
3 times per day
30 mg each time for oral administration. Neurological function deficit was assessed with National Institute of Health Stroke Scale(NIHSS)
traditional Chinese medicine(TCM) syndrome scores and modified Rankin scores were used as efficacy evaluation indicators; blood routine
liver and kidney function were used as safety evaluation indicators. Results A total of 2169 cases were included. After treatment
the total effective rate of NIHSS and TCM syndrome scores was 84.09% and 81.01%
respectively. The modified Rankin score was 2.19±0.86 before treatment and 1.55±0.85 after treatment
and the difference was statistically significant(P<0.01). Thirteen cases showed mild adverse events. Conclusion Tongluo Huatan Capsules is effective and safe for improving the degree of neurological deficit
reducing disability and TCM symptoms in the treatment of cerebral infarction in the recovery phase
no matter using it alone or together with other basic treatment.