Original Article Effects of Gushen Antai decoction on serum homocysteine and anticardiolipin antibodies levels in patients with unexplained ...

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Int J Clin Exp Med 2021;14(1):340-346
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Original Article
Effects of Gushen Antai decoction on serum
homocysteine and anticardiolipin antibodies levels in
patients with unexplained recurrent spontaneous abortion
Minhuan Ye1, Runyi Fang1, Simin Lun1, Jianhua Fang2
1
 Department of Obstetrics and Gynecology, Houjie Hospital, Dongguan, Guangdong Province, China; 2Department
of Ultrasound, Houjie Hospital, Dongguan, Guangdong Province, China
Received September 7, 2020; Accepted November 6, 2020; Epub January 15, 2021; Published January 30, 2021

Abstract: Objective: To investigate the effects of heparin combined with Gushen Antai Decoction on the levels of ho-
mocysteine (Hcy) and anticardiolipin antibodies (ACA) in patients with unexplained recurrent spontaneous abortion
(URSA). Methods: A total of 100 patients with URSA who were admitted to our hospital were enrolled in this study.
According to the treatment options, they were divided into a control group (CG) (N=50) and an observation group
(OG) (N=50). The CG was given heparin combined with strategies that prevent miscarriage, and the OG was addi-
tionally treated with Gushen Antai decoction. The changes in serum ACA, Hcy and Th1/Th2 cytokines were observed
and compared between the two groups, and the clinical treatment efficacy of the two groups was recorded. Re-
sults: The OG showed an increased total response rate (86.00%), compared with the 58.00% of the CG (X2=6.146,
P
Effects of Gushen Antai decoction

dysfunction, and the application of Gushen          administrated until 12 weeks of pregnancy;
Antai Decoction significantly improved the im-      low molecular weight heparin was administer-
mune dysfunction in the rats [6]. It was found in   ed 4100 IU/time via Qd subcutaneous injec-
another study that the application of Gushen        tion until 16 weeks of gestation. The OG was
Antai pills combined with progesterone signifi-     treated with Gushen Antai decoction in addi-
cantly reduced the serum level of CA125 in          tion to the treatment option of the CG, includ-
patients with possible early abortion due to kid-   ing Angelica 10 g, Rehmannia glutinosa 15 g,
ney deficiency [7]. ACA and Hcy have been con-      Rehmannia glutinosa Libosch 15 g, Chinese
firmed to have a significant clinical correlation   yam 12 g, Codonopsis 15 g, Ejiao 10 g, wolf-
with a variety of pregnancy outcomes [8]. This      berry 10 g, licorice 6 g, Stir-fried atractylodes
study included 100 URSA patients and divided        rhizome 12 g, eucommia 15 g and Dipsacus
them into an observation group (OG) and a con-      15 g, which was prepared and consumed for
trol group (CG) according to the treatment regi-    16 weeks of pregnancy. During treatment, liver
men, and compared the effects of two regi-          function, coagulation function and platelet
mens on ACA, Hcy and Th1/Th2 cytokines in           count were reviewed every week in the two
patients with URSA.                                 groups. If abnormalities occurred, a dosage of
                                                    low-molecular-weight heparin was reduced or
Materials and methods                               withdrawn. Those with elevated transaminase
                                                    level were given liver-protecting drugs.
Baseline data
                                                    Evaluation criteria
A total of 100 patients with URSA who were
admitted to our hospital from October 2018          No response: heavy vaginal bleeding, fetal
to October 2019, were aged 25-38 years with         death or miscarriage. Improvement: improved
an average age (33.17±8.29) years, with 3-8         vaginal bleeding and other clinical symptoms,
miscarriages, with an average of (4.16±1.35)        with normal pregnancy. Cure: no vaginal bleed-
occurrences. According to treatment options,        ing, healthy fetus with success pregnancy. The
they were divided into the OG of 50 cases and       total response rate = cure rate + improvement
the CG of 50 cases. The OG had an average           rate.
age of (34.05±7.11) years and an average of
(3.88±8.42) miscarriages; the CG had an aver-       Outcome measurement
age age of (35.74±7.42) years and had an aver-
age of (4.27±1.34) miscarriages. This study         The clinical efficacy of two groups before and
has been approved by the Ethics Committee           after treatment was compared; 2 ml of cubital
of Houjie Hospital. All study participants pro-     venous blood was collected for serum separa-
vided written informed consent before partici-      tion and measured using enzyme-linked immu-
pating in the study.                                nosorbent assay. The changes of Th1 and Th2
                                                    cytokines before and after treatment in the
Inclusion and exclusion                             two groups were compared. The serum Hcy and
                                                    ACA levels were compared between the two
Inclusion criteria: patients with 3 times of        groups before and after treatment. ACA was
spontaneous miscarriage; with no abnormali-         detected by enzyme-linked immunosorbent
ties in chromosomes and reproductive organs;        assay, and Hcy was determined by high perfor-
with normal blood glucose, normal sex hor-          mance liquid chromatography; and the levels
mones and thyroid function; negative results        of PT, TT, DD, FIB and PAI-1 were recorded. The
for gonococcus and chlamydia. Exclusion crite-      ACA results are expressed in BI, BI = sample
ria: those with patients with miscarriages cau-     absorbance (A)/standard sample (A). If BI of
sed by immunity, infection, heredity, endocrine     sample > average BI of controls ±2 times of
and genital tract malformations.                    standard deviation, then ACA results are posi-
                                                    tive.
Treatment regimen
                                                    Statistical method
The CG was treated with western medicine and
heparin therapy, including aspirin enteric-coat-    The SPSS 22.0 was used for data analysis, the
ed tablets, progesterone injection, estradiol,      measurement data was measured by t-test,
dydrogesterone, and fenmetone, which were           and the count data was measured by chi-

341                                                         Int J Clin Exp Med 2021;14(1):340-346
Effects of Gushen Antai decoction

Table 1. Comparison of general clinical data in the two groups (x ± s)/[n (%)]
                                                              Observation           Control group
General data                                                                                        t/X2     P
                                                              group (n=50)             (n=50)
Gender                           M                                 27                    28         0.547   0.362
                                 F                                 23                    22
Average age (year)                                            45.98±4.33            46.01±4.29      0.036   0.987
Average weight (kg)                                           64.29±3.91            64.34±3.89      0.066   0.917
Average course of disease (year)                               2.89±0.28             2.93±0.18      0.871   0.317
Educational level                University and above              11                    16         0.781   0.334
                                 Senior high school                26                    24
                                 Junior high school and below      13                    10

Table 2. Comparison of response rate of the two groups after treat-                    squared test. P
Effects of Gushen Antai decoction

Table 3. Comparison of changes in Hcy levels before and after                      Discussion
treatment (x ± s)
                                                                                   URSA is a refractory infertility,
                               Before           After
Group                  n                                       t         P         and with the continuous im-
                             treatment       treatment
                                                                                   provement of living standards,
Observation group 50        19.34±4.29      10.63±3.39      11.427
Effects of Gushen Antai decoction

Figure 3. Comparison of the changes in ACA levels
before and after treatment in the two groups. The
                                                         Figure 4. Changes of coagulation function indexes
ACA levels in the observation group after treatment
                                                         before and after treatment in the two groups. The
was 10.00%, which was significantly lower than be-
                                                         levels of PT, TT, FIB, DD and PAI-1 in the observa-
fore treatment (32.00%) (P0.05). The levels of
which was significantly lower than before treatment
                                                         DD and PAI-1 were significantly improved compared
(P
Effects of Gushen Antai decoction

The present study found that the levels of ACA             Comparing serum levels of Th17 and Treg cyto-
and Hcy in the OG were significantly lower than            kines in women with unexplained recurrent
those in the CG after treatment (P
Effects of Gushen Antai decoction

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