SUMMARY: 60 patients diagnosed with early stage of threatened miscarriage due to kidney deficiency were randomly divided into control group (30 subjects) and treatment group (30 subjects) according to the random number table method. All subjects met the diagnostic criteria of early stage threatened miscarriage according to the “Obstetrics and Gynecology (9th Edition)”, as well as the diagnostic criteria of Kidney Deficiency according to “Guideline for Clinical Research of Traditional Chinese Medicine New Drugs (Trial)”. There was no significant difference in age, gestational age, and number of miscarriage between the two groups, and the two groups were therefore statistically comparable (P>0.05).
In the control group, subjects were prescribed 10mg of oral dydrogesterone three times a day for 2 weeks. In addition to dydrogesterone, subjects in the treatment group were also prescribed with 40 ml of Tonifying Kidney and Preventing Miscarriage Granule (补肾安胎冲剂) three times a day for 2 weeks. The granules contains herbs such as: Tu Si Zi (菟蕬子 Semen Cuscutae), Xu Duan 10g (續斷Dipsacus asperoides), Sang Ji Sheng (桑寄生 Ramulus Taxilli), Shu Di Huang (熟地黃 Radix Rehmanniae Praeparata), Zhi Huang Qi (炙黃耆 Radix Astragali Preparata), Bai Zhu (白朮 Rhizoma Atractylodis Macrocephalae, stir-fried), Dang Shen (黨參 Radix Condonopsis Pilosulae), Ning Ma Gen (苧麻根 Boehmeria nivea), etc.
In this study, clinical signs and symptoms (vaginal bleeding, back pain, lower abdomen pain or sensation of prolapse, dizziness, tinnitus, frequent nocturia, bilateral knee soreness or weakness, and tongue and pulse), serum SDF-1α, MMP-9 levels, color doppler ultrasound, and Traditional Chinese Medicine Syndrome Score Scale (TCMSSS) according to the “Guideline for Clinical Research of Traditional Chinese Medicine New Drugs (Trial)” were used to monitor the efficacy of the treatment. Efficacy index = (TCMSSS before treatment – TCMSSS after treatment) / TCMSSS before treatment × 100%. The result was considered as:
- Cured: vaginal bleeding stopped within 5 days of treatment, symptoms such as abdominal pain and back pain resolved; the size of the uterus and embryonic development were consistent with the gestational age according to the ultrasound; the efficacy index was ≥ 95%.
- Markedly Effective: vaginal bleeding stopped within 7 days after treatment, symptoms such as abdominal pain and back pain significantly improved; the size of the uterus and embryonic development were basically consistent with the gestational age according to the ultrasound; 70% ≤ efficacy index < 95%.
- Effective: aginal bleeding stopped within 10 days after treatment, symptoms such as abdominal pain and back pain improved; the size of the uterus and embryonic development were basically consistent with the gestational age according to the ultrasound; 30% ≤ efficacy index <70%.
- No response: no improvement or exacerbation in vaginal bleeding, abdominal pain, back pain and other symptoms after the treatment; the size of the uterus and embryonic development were basically consistent and less than the gestational age, or embryos stopped developing according to the ultrasound; efficacy index <30.
Table 1. Comparison of Treatment Efficacy between Treatment and Control Group
| Group | n | Cured | Markedly Effective | Effective | No Response | Average Rank | Z-value | P-value |
| Control | 30 | 5 | 13 | 9 | 3 | 35.40 | -2.367 | 0.018 |
| Treatment | 30 | 9 | 18 | 2 | 1 | 25.60 |
According to the result, the treatment group showed a more significant improvement in clinical signs and symptoms, TCMSSS, serum SDF-1α and MMP-9 levels (P<0.05). This suggested that adding Tonifying Kidney and Preventing Miscarriage Granule to routine treatment may effectively prevent threatened miscarriage due to kidney deficiency in early stage. The mechanism may be related to the up-regulation of SDF-1α and MMP-9 level, and therefore correcting the angiogenesis disorder at the maternal-fetal interface.
Xinhui Yu and Ping Jiang. J Anhui Univ Chinese Med. 2021. 40 (4): 19-23.
