ABSTRACT
Objective:
To verify the
clinical efficacy and
safety of Qufeng Tongxuan
method in treating low- and moderate-volume
intracerebral hemorrhage at acute stage.
Methods:
A prospective, multicenter, randomized, double-blind, placebo-controlled study was performed;
patients with low- and moderate-volume
intracerebral hemorrhage at the
basal ganglia and/or
thalamus accepted
treatment in 16
hospitals from September 2019 to April 2022 were enrolled. These
patients were divided into experimental and
control groups with a block randomized
method by SAS
software.
Patients in
control group were given conventional western
medicine treatment; those in experimental group accepted Qufeng Tongxuan
method (sequential
therapy of Shexiang Huayu Xingnao granules and Zhilong Huoxue Tongyu granules) besides conventional western
medicine treatment. NIHSS was used to assess neurological function before
treatment and on 7 th, 14 th, 30 th, and 90 th d of
treatment.
Prognoses of these
patients were assessed by modified Rankin scale (mRS) before
treatment and on 180 th d of
treatment.
Brain CT was performed before
treatment and on 7 th and 14 th d of
treatment to calculate the
hematoma volume. Before
treatment and on 14 th d of
treatment, changes of coagulation function,
liver and
kidney functions of the 2 groups were compared. Adverse reactions during
treatment in the 2 groups were recorded.
Results:
No significant differences in NIHSS scores were noted between the 2 groups before
treatment, on 7 th, 14 th, and 30 th d of
treatment ( P>0.05); NIHSS scores in experimental group on 90 th d of
treatment were signficantly lower than those in
control group ( P<0.05); NIHSS scores in experimental group decreased gradually before
treatment and on 7 th, 14 th, 30 th and 90 th d of
treatment, with statistical significances ( P<0.05). No significant differences in mRS scores were noted between the 2 groups before
treatment ( P>0.05); mRS scores in experimental group on 180 th d of
treatment were signfciantly lower than those in
control group ( P<0.05). No significant difference in
hematoma volume was noted between the 2 groups before
treatment and on 7 th and 14 th d of
treatment ( P>0.05); both groups had gradually decreased
hematoma volumes before
treatment and on 7 th and 14 th d of
treatment, respectively, with significant differences ( P<0.05); the volume difference of
hematoma between 14 th d of
treatment and before
treatment in experimental group (6.42[4.10, 11.73]) was significantly higher than that in
control group (4.00[1.25, 10.58], P<0.05). No significant differences in
liver and
kidney function indexes or coagulation function indexes were noted between the 2 groups before
treatment and on 14 th d of
treatment ( P>0.05). Adverse reaction
incidence was 9.52% ( n=12) in experimental group and 10.34% ( n=12) in
control group, without statistical difference ( P>0.05).
Conclusion:
Under premise of conventional western
medicine treatment, Qufeng Tongxuan
method can promote
hematoma absorption and improve neurological deficit symptoms in low- and moderate-volume
intracerebral hemorrhage at acute stage, without obvious adverse reactions.