Observations on the efficacy of treating immunologic male infertility

To observe the clinical efficacy of Sequel Seed Formula in treating patients with immunologic male infertility. Sixty-five patients with immunologic male infertility, i.e., anti-sperm antibody positivity with acrosomal enzyme abnormality, were divided into Kirin Pill group (control group) and Renjie Seed Formula group (treatment group), with 30 cases in the control group and 35 cases in the treatment group. The control group was treated with Kirin Pill and the treatment group was treated with Seed Formula for 3 months. In the Qilin Pill group, there were significant improvements in sperm grade A, A+B and activity rate, anti-sperm antibody conversion rate with acrosomal enzyme activity before and after treatment (P<0.05), while there were significant improvements in sperm grade A, A+B and activity rate, anti-sperm antibody conversion rate with acrosomal enzyme activity before and after treatment with Seed Formula for Seed Renewal (P<0.05); in the Seed Formula for Renewal group, there were significant improvements in sperm grade A, A+B and activity rate, anti-sperm antibody conversion rate with acrosomal enzyme activity before and after treatment (P<0.05); in the Seed Formula for Seed Renewal group, there were significant improvements in sperm grade A, A+B and activity rate before and after treatment (P<0.05). grade, a+b grade and viability, and antisperm antibody conversion rate accompanied by improvement in acrosomal enzyme activity were significantly better than that of the Kirin pill group (P<0.05). The efficacy of the formula in improving sperm quality, especially in the conversion rate of anti-sperm antibodies and acrosomal enzyme activity, is worth further promotion and application in the clinic. The 65 patients were all male infertility patients with positive anti-sperm antibodies and abnormal acrosomal enzyme activity who attended the outpatient clinic of the Department of Men's Medicine of the First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine during the period of March 2011 - March 2012, 30 patients in the control group and 35 patients in the treatment group. The age of the Kirin Pill group (control group) was 26 to 51 years old, with an average of 31.55 years; the duration of the disease was 1 to 4 years, with an average of 1.55 years. The age of the Sequel Seed Formula group (treatment group) ranged from 26 to 50 years old, with an average of 30.69 years; the disease duration ranged from 1 to 4 years, with an average of 1.88 years. The cases in the two groups were statistically analyzed in terms of age and disease duration, and the differences were not statistically significant (P>0.05) and were comparable. 1.2 Diagnostic criteria 1.2.1 Western medical diagnostic criteria Male infertility according to WHO[1]:Cohabitation for more than 1 year after marriage, semen volume <2ml, sperm density less than 20×106/ml, class a+b <50%, class a sperm <25%, sperm viability <60%. Inclusion Criteria:Positive test by sperm membrane surface antibody IgG test kit (mixed agglutination reaction), i.e., 10% or more active spermatozoa wrapped around the sensitized microspheres (no clinical significance if binding is limited to the tail). Anyone who meets the diagnostic criteria for the disease and has a sperm acrosomal enzyme value <48.2 µUI/106 sperm. 1.2.2 Diagnostic criteria of traditional Chinese medicine: spleen and kidney deficiency, referring to the Guidelines for Clinical Research of New Chinese Medicines of the Ministry of Health of the People's Republic of China [2], the main symptoms are: dizziness, tinnitus, forgetfulness and hair loss; lumbar and knee soreness and weakness, orbital sallow color of the eyes, loose bowels, fatigue, frequent urination at night, and poor sexual function; pale and fat tongue, or teeth marks, and weak and sunken pulse. 1.3 Exclusion Criteria: Spouse with serious gynecological diseases or diagnosed infertility; regular sexual life without any contraception for less than one year or with erectile dysfunction or ejaculation abnormalities; taking drugs to inhibit testicular spermatogenesis and spermatozoa vitality, such as antiepileptic drugs, antitumor drugs, etc.; testicular atrophy, congenital anomalies, spermatic varicocele of more than Ⅱ degree; patients with cardio-cerebral and cerebrovascular, hepatic, renal, hematopoietic and other serious diseases; patients with severe mental illness; patients with severe mental illness. Serious diseases; patients with serious mental illness; those who do not meet the inclusion criteria, not taking medication, incomplete data, etc. to affect the efficacy of treatment; Chinese medicine identification and typing does not meet the type. 2 Treatment Methods Drug administration program: 2 weeks before treatment and during the treatment period of the two groups of cases to stop using other drugs for the treatment of this disease. The control group was treated with Kirin Pill (produced by Guangdong Taiantang Pharmaceutical Co., Ltd., State Drug License Z10930034) orally, 6g each time, 3 times a day, for 3 months. The treatment group orally took Sequence Seed Formula (empirical formula, the main drug composition: Sichuan Sequence 20g, Cuscuta sinensis 20g, Lycium barbarum 20g, Cortex Eucommiae 15g, Boneset 15g, Radix et Rhizoma Ginseng 30g, Atractylodes Macrocephala 15g, Poria 15g, Coix lacryma 15g, Huayishan 15g, Jujube 15g, etc., with the use of single-flavored Chinese herbal medicine formulated particles free of decoction of traditional Chinese medicines, manufactured by Jiangsu Jiangyin City Tianjiang Pharmaceutical Co. Ltd.), 1 dose per day, add boiled water about 200 ml mixed evenly twice in the morning and evening before meals. Observation indexes: the following items were examined before and after treatment: (1) Quantitative sperm acrosomal enzyme test: reagents were purchased from Shenzhen Huakang Biomedical Engineering Company Limited (batch no.: YZB/State 0840-2008), and the operation was completed in accordance with the instruction manual. (2) Anti-sperm antibody detection: before and after treatment, sperm membrane surface antibody IgG detection kit (mixed agglutination reaction) was used, the reagent was purchased from Shenzhen Huakang Biomedical Engineering Company Limited (Batch No.: YZB/State 0843-2008), the operation was completed in accordance with the instruction manual, and the results were judged by WLJY9000 Color Sperm Quality Detection System (Beijing Weili New Century Science and Technology Development Co. Ltd.). Statistical analysis: SPSS17.0 statistical software package was used. x2 test was used for counting data, t-test or paired t-test was used for measuring data, and data were analyzed by ( ±s). 3 Treatment results: There was a significant difference (P<0. 05) between the control group and the treatment group in terms of sperm a-grade, a+b-grade and viability before and after treatment. Table 1 Comparison of sperm a-grade, a+b-grade and viability before and after treatment between the two groups ( ±s) Group Number of cases (N) a a+b Activity rate Control group Pre-treatment 30 18.12±4.28 31.93±7.83 41.96±8.94 Post-treatment 30 24.46±7.02* 39.33±9.34* 50.75±11.29* Treatment group Pre-treatment 35 17.65±4.12 31.46±8.34 42.56±10.51 After treatment 35 27.83±6.03*△ 44.29±9.45*△ 57.38±10.82*△ Note: Compared with before and after treatment in this group, *P<0.05; compared with the control group after treatment, △P<0.05. Comparison of anti-sperm antibody turnover rate before and after treatment between the two groups, there is a significant difference (P<0.05), the specific data are shown in Table 2. Table 2 Comparison of antisperm antibody conversion rate before and after treatment ( ±s) Group Number of cases N Conversion N Ineffective Effective rate Control group 30 18 12 60.0% Treatment group 35 31 4 88.6% Note: F=7.11, P<0.05. Changes in acrosomal enzyme activity before and after treatment in the treatment group and the control group were statistically significant (P<0.05) , and the results are shown in Table 3: Table 3 Comparison of acrosomal enzyme activity changes before and after treatment ( ±s) Group Number of cases (N) Acrosomal enzyme activity Control group Pre-treatment 30 31.78±9.03 Post-treatment 30 42.79±7.85* Treatment group Pre-treatment 35 34.13±7.40 Post-treatment 35 48.31±10.21* △ Note: Compared with this group before and after treatment, *p<0.05; compared with the control group after treatment, △p<0.05. Adverse reactions: No adverse reactions were seen in the treatment group and the control group during the observation period. 4 DISCUSSION The presence of antisperm antibodies on the surface of the sperm membrane and low sperm acrosomal enzyme activity is one of the most important causes of male infertility, which belongs to the category of immunologic infertility, and most of the many unexplained infertility is also related to this. Due to infections, injuries, genetics, reproductive tract malformations, etc. can lead to sperm spillage, contact with the body's immune system, and its own production of anti. Sperm antibodies, anti-sperm antibodies (AsAb) are present in about 10% of infertile men, and their incidence accounts for about 3% of the etiology of all infertile couples. Sperm as a unique antigen and the body's immune system after contact, can cause self or homologous immune response and produce anti-sperm antibodies. However, under normal circumstances, the body's immune system will not produce an immune response to its own sperm due to the presence of the blood-testis barrier. It is only when the blood-testis barrier is damaged by inflammation of the reproductive system, trauma, or surgery that soluble antigens spill out and are phagocytosed, causing an immune response that leads to the production of antisperm antibodies. Positive anti-sperm antibodies can lead to sperm agglutination and braking, directly affecting the quality of sperm, which is a sperm autoimmunity that arises from within the body. Acrosomal enzymes are one of the most important indicators of sperm quality and fertility. Low acrosomal enzyme activity can lead to infertility and affect sperm viability, and acrosomal enzyme testing also provides a certain basis for assisted reproduction therapy. In clinical practice, there are some male patients who have normal semen routine tests but are unable to have children, it is even more necessary to do acrosomal enzyme testing. Sperm acrosomal enzyme exists in the sperm acrosome, is a kind of trypsin, which is synthesized in the form of zymogen and stored in the sperm acrosome, which is an important protein hydrolysis enzyme in the process of fertilization. It is an important protein hydrolyzing enzyme in the fertilization process. When sperm-egg binding occurs in the acrosome reaction, the release of acrosomal zymogen provides the conditions for sperm-egg binding. Low acrosomal enzyme activity affects the breakdown of the egg mound and the ability of the sperm to penetrate the zona pellucida. Therefore, anti-sperm antibody positivity and acrosomal enzyme abnormality are one of the major causes of male infertility. Male infertility is called "childlessness" in Chinese medicine. According to the motherland medicine, the kidneys store essence, the main reproductive, kidney essence hidden in the kidney, belongs to the invisible essence, is the essence of reproduction (i.e., tangible essence, hidden in the seminal chamber) of the material basis, the kidneys store essence, the main division of reproduction and growth and development, the kidneys are full of essence, then the reproduction and growth of the functions of the vigorous; the kidneys are insufficient, then the reproductive of the essence of the insufficient. The kidney is the foundation of the innate, and the spleen is the foundation of the innate, both of which are mutually supportive and interdependent. The essence of the kidneys depends on the cultivation and nourishment of the essence of the water and grains in order to become full and mature, while the spleen and stomach transform the essence of the water and grains with the help of the warmth and warmth of the kidney yang. In addition, the spleen is the source of the blood, and the essence and blood can be mutually transformed, and the spleen is healthy and active, so that the essence of the kidneys can only be supplemented by the essence of the spleen to maintain fullness and the essence of procreation. Therefore, the pathogenesis emphasizes the important influence of "deficiency of spleen and kidney" in male infertility. In addition, "when blood is abundant, sperm grows, and when qi gathers, sperm fills up". That is to say, if the spleen is weak and the source is weak, then the essence of the five organs is less and the kidney is lost, and it is difficult to produce the essence of reproduction; if the kidney is weak and the yang qi is weak, then the spleen loses warmth and the transportation and transformation is incompetent, which can also lead to the blood deficiency and less essence, and the lack of reproduction. For treatment, we choose to use the method of strengthening the spleen and the kidneys as a guide to form the Chinese medicine prescription of Sequence Seed Formula for the treatment of male infertility in patients with positive anti-sperm antibodies and abnormal parietal enzymes. The formula emphasizes the use of Radix et Rhizoma Dioscoreae, Radix et Rhizoma Ginseng to replenish the kidney and produce sperm, and strengthen the spleen; Semen Cuscutae, Fructus Lycii, Rhizoma Atractylodis Macrocephalae to replenish the spleen and kidney, produce sperm and fix the sperm; Cortex Eucommiae and Fructus Bone Marrow to replenish the kidney and fix the sperm, and Chinese Mountain, Poria, and Coix Seed to strengthen the spleen, promote the production of sperm and also promote the production of sperm. The combination of all the drugs, warm but not dry, tonic but not greasy, have tonifying the kidney, spleen and qi nourishing blood effect, play the essence of essence. Modern pharmacological research has confirmed that the Sequel, Radix et Rhizoma Ginseng, Semen Cuscutae has anti-hypoxia, anti-free radical damage, can make sperm vitality and motility enhancement. Lycium barbarum reduces spermatogenic cell damage caused by high temperature and promotes normal development of testicular germ cells. Atractylodes macrocephala and Cortex Eucommiae reduce the content of MDA and decrease DNA damage, thus achieving the effect of anti-free radical damage. In this study, the Sequence Seed Formula can significantly improve sperm quality, in terms of sperm antisperm antibody conversion rate, the total clinical effectiveness rate reached 88.6%, and at the same time promote the acrosomal enzyme value of sperm acrosomal enzyme in male infertility patients with acrosomal enzyme abnormality. During the period of taking the medicine, most of the patients complained of increased physical strength and energy, and there were no obvious adverse reactions, so it has definite effectiveness and good safety, and can be further promoted for use in the clinic.