GBZ 107-2002 Diagnostic criteria for radiation-induced gonadal diseases
Some standard content:
ICS13.100
National Occupational Health Standard of the People's Republic of China GBZ107-2002
Diagnostic criteria for radiation induced gonad diseases
Diagnostic criteria for radiation induced gonad diseases Issued on April 8, 2002
Ministry of Health of the People's Republic of China
Implementation on June 1, 2002
4.2 of this standard is mandatory, and the rest are recommended. GBZ107-2002
This standard is specially formulated in accordance with the Law of the People's Republic of China on the Prevention and Control of Occupational Diseases. From the date of implementation of this standard, the original standard WS176-1999 will be abolished at the same time
Because gonads are one of the organs that are highly sensitive to ionizing radiation, infertility and menstrual disorders are often caused under radiation accidents and occupational exposure conditions, so this standard is proposed to be formulated.
The main contents of this standard include the definition, diagnostic criteria and treatment principles of radiation infertility and radiation amenorrhea. Appendix A of this standard is a normative appendix, and Appendix B and C are informative appendices. This standard is proposed and managed by the Ministry of Health of the People's Republic of China. The drafting unit of this standard is the Institute of Radiation Medicine of Bethune Medical University. The main drafters of this standard are Jin Yuke, Li Tieji and Chen Qiang. This standard is interpreted by the Ministry of Health of the People's Republic of China. 1 Scope
Diagnostic criteria for radiation-induced gonadal diseases
GBZ107-2002
This standard specifies the diagnostic criteria and treatment principles for gonadal diseases (radiation infertility and radiation amenorrhea) caused by ionizing radiation. This standard is applicable to radiation workers with gonadal damage caused by occupational radiation, and non-occupational exposed personnel can also refer to this standard for diagnosis and treatment. This standard does not apply to radiation infertility caused by intrauterine irradiation (including miscarriage, premature birth, and stillbirth). 2 Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. All subsequent amendments (excluding errata) or revisions to dated references are not applicable to this standard. However, parties that reach an agreement based on this standard are encouraged to study whether to use the latest versions of these documents. For undated references, the latest versions apply to this standard. GBZ106 Diagnostic Standard for Radiation Skin Diseases 3 Terms and Definitions
The following terms and definitions apply to this standard. Radiation Infertility 3.1
Infertility caused by a certain dose of irradiation of the gonads is called radiation infertility. According to the dose, it is divided into temporary and permanent infertility. 3.2 Radiation Induced Amenorrhea Ovarian function damage caused by ionizing radiation or combined with endometrial destruction, atrophy, and amenorrhea for more than three months is called radiation amenorrhea. 4 Diagnosis of Radiation Infertility
4.1 Diagnostic Principles wwW.bzxz.Net
Radiation infertility must be diagnosed based on a comprehensive analysis of irradiation history, irradiation dose (with personal dose files), clinical manifestations and laboratory tests to exclude other factors and diseases. 4.2 Diagnostic criteria
4.2.1 Dose threshold: The dose threshold for radiation infertility caused by different irradiation conditions is shown in Table 1. Table 1 Dose threshold for radiation infertility
Dose threshold, Gy
Irradiation conditions
Acute irradiation
Chronic irradiation
Irradiated organs
Temporary
Annual>0.2 irradiation years
Permanent
4.2.2 Clinical manifestations: A couple has lived together for 2 years without pregnancy. Males exposed to large doses of radiation in the late stage will have testicular atrophy and softening, and no changes in secondary sexual characteristics and sexual desire. Females exposed to radiation will have atrophy and shrinkage of the uterus, fallopian tubes, vagina, and breasts. Radiation-induced infertility will also cause amenorrhea, which may affect secondary sexual characteristics and cause clinical manifestations of menopausal syndrome. 4.2.3 Laboratory examination
GBZ107-2002
4.2.3.1 Semen examination: After acute irradiation, semen should be examined promptly as the background value of the patient's semen; semen should be examined 2-3 times 1 month and 1.5-2 months after irradiation. Chronic irradiation can be examined at any time according to diagnostic needs. The interval between each examination should not be less than 1 week, and at least 3 times. When collecting semen, it should be noted that: avoid sexual intercourse 3-5 days before collection, collect semen directly in a clean and dry glass bottle, keep it consistent with body temperature and send it for examination within 1 hour.
a) The sperm count is less than 20×10L (20 million/mL) in 2 of the 3 semen examinations or no one exceeds 40×10L (40 million/mL); b) The percentage of live sperm is less than 60% in 2 of the 3 semen examinations; c) The number of sperm with normal morphology is less than 60% in 2 of the 3 semen examinations. 4.2.3.2 Ovarian function test: After gonadal irradiation, the basal body temperature is measured as monophasic, the bottom cells in the vaginal exfoliated cells account for more than 20%, and the cervical mucus is less, viscous, and has no crystal formation.
4.2.3.3 Endocrine hormone measurement
a) Pituitary follicle stimulating hormone (FSH), after gonadal irradiation, the FSH level increases significantly with the decrease in sperm or decreased ovarian function. b) Pituitary luteinizing hormone (LH), the change pattern after irradiation is the same as FSH, but it is weaker than FSH in the feedback regulation of gonadal hormones and has poor sensitivity. c) The testosterone content may decrease in men after irradiation; women may experience a decrease in estrogen and progesterone levels after irradiation. 4.2.3.3 Testicular biopsy: When the sperm count is less than 25×10/L (25 million/mL), a testicular biopsy can be performed, which has a certain reference value for the differentiation from obstructive azoospermia and the judgment of the prognosis of infertility. 4.3 Treatment principles
4.3.1 Temporary radiation infertility: temporarily get rid of radiation, strengthen nutrition, and reexamine every year. After all examinations are normal, radiation work can be gradually resumed. 4.3.2 Permanent radiation infertility should be separated from radiation, treated with a combination of Chinese and Western medicine, strengthen nutrition, and follow up regularly, and reexamine every 1 to 2 years. 4.3.3 Male irradiated patients should take contraceptive measures before the sperm test results return to normal. 5 Diagnosis and treatment of radiation amenorrhea
Radiation amenorrhea is also divided into temporary and permanent amenorrhea (menopause). Long-term amenorrhea can be accompanied by reproductive organ atrophy and changes in secondary sexual characteristics. In order to further determine whether amenorrhea is accompanied by endometrial lesions, therapeutic tests can be performed. Use progesterone or estrogen treatment to observe whether there is withdrawal bleeding within 2 to 7 days after stopping the drug. If there is no bleeding in 3 tests, it means that the endometrium is damaged; if there is bleeding, it means that the endometrium is not obviously damaged. To further determine the functional status of the ovarian organ, relevant hormone tests should be performed. The radiation dose readings for amenorrhea, hormone examinations, diagnosis and treatment principles refer to the relevant provisions in Chapter 4 "Diagnosis of Radiation Infertility" of this standard. Appendix A
(Normative Appendix)
Normal reference values of several hormones
A1 Follicle-stimulating hormone (FSH) is a glycoprotein secreted by pituitary basophils. Its main function is to promote the development of ovarian follicles in women and sperm formation in men. The serum FSH concentration is determined by radioimmunoassay (RIA). The normal reference value is: 20-30 IU/L for women in the middle of menstruation and 10-20 IU/L at other times; 10-15 IU/L for men. A2 Luteinizing hormone (LH) is a glycoprotein secreted by pituitary basophils. Its main function is to promote ovulation in women and then maintain the secretory function of the corpus luteum. In men, it stimulates the interstitial Leydig cells of the testicles to secrete testosterone. The serum LH concentration is determined by radioimmunoassay (RIA). Normal reference values: 80 IU/L in women during the middle of the menstrual period, 10-30 IU/L in other periods, and 10-12 IU/L in men. A3 Testosterone is a male hormone produced by interstitial cells of the testicles. Women's ovaries also secrete a small amount of testosterone. Its main function is to stimulate the growth and development of reproductive organs, the appearance of male characteristics, and promote protein synthesis. Normal male testicles secrete about 4-9 mg of testosterone per day. The serum testosterone concentration is determined by radioimmunoassay (RIA). The normal reference value is: men: 14-28 nmol/L; women: 0.35-3.5nmol/L. A4 Estrogen
is a steroid hormone secreted by the ovarian endometrial cells before ovulation and the luteal cells after ovulation. It includes estradiol (estradiol, E:), estrone (estrone, E) and estriol (estriol, Es). Among them, the most active is E. Its main function is to stimulate the development and growth of reproductive organs and the appearance of female secondary sexual characteristics. In addition, it also affects metabolic function. The level of estrogen in serum is determined by radioimmunoassay (RIA). The normal reference value of estradiol is: 566.1pmol/L±40.7pmol/L in the follicular phase, with a peak value of: 1187.7pmol/L±159.1pmol/L; luteal phase: 484.7pmol/L±33.3pmol/L. A5 Progesterone, P
is a steroid hormone secreted by the ovarian luteal cells. The natural progesterone is called progesterone, which is an intermediate of many steroid hormones. Its main function is to enter the secretory phase of the endometrium on the basis of the action of estrogen, promote breast development, heat production and relaxation of blood vessels and digestive tract smooth muscles. The concentration of progesterone in serum is determined by radioimmunoassay (RIA). Normal reference value: 2.66nmol/L±0.32nmol/L in the follicular phase: 31.26nmol/L±2.30nmol/L in the luteal phase, with a peak value of 57.60nmol/L±13.34nmol/L. Appendix B
(Normative Appendix)
Diagnostic Criteria Reference Indicators and Differential Diagnosis
B1 The aberration rate of peripheral blood lymphocytes and sperm chromosomes increased significantly. GBZ107-2002
B2 Sperm electron microscopy showed a significant increase in the number of abnormal sperm. Normal reference values for routine sperm examination: sperm count 1.0-1.5×10'l/L (100 million-150 million/mL), percentage of active sperm (within 30-60 minutes) greater than 70%, and number of abnormal sperm less than 20%. B3 There may be radiation skin damage in the irradiated area. B4 Male infertility after irradiation should be differentiated from congenital testicular dysgenesis, varicocele, orchitis caused by mumps, systemic consumptive disease, vas deferens obstruction, impotence and premature ejaculation, and immune infertility. B5 Female infertility after irradiation should be differentiated from fallopian tube obstruction, endometrial inflammation or tumor, cervical inflammation, polyps, tumors, systemic diseases and ovarian diseases that affect the normal function of the ovary or immune factors. B6 In addition to detailed physical examination and relevant tests for male or female patients, it is also necessary to exclude the possibility of infertility in their spouses and conduct relevant examinations.
B7 Radiation amenorrhea should be differentiated from amenorrhea caused by psychoneurological factors, congenital uterine and ovarian dysplasia, pituitary and ovarian tumors, chronic inflammation and systemic wasting diseases. Appendix C
(Informative Appendix)
Instructions for the correct use of this standard
GBZ107-2002
C1 A clear history of overdose, certain clinical manifestations and abnormal semen or ovarian function are necessary conditions for diagnosis in this standard. The above three items can be diagnosed as radiation infertility. However, in order to further determine the changes in pituitary endocrine hormones caused by infertility, relevant endocrine hormone measurements should be performed.
C2 The dose threshold is the minimum dose value of ionizing radiation damage to the gonads. For example, temporary infertility may occur in men when they are exposed to 0.15Gy of radiation. This does not mean that most people will become infertile. Only a few of them may have the possibility of developing the disease. The reason why this standard adopts the dose reading is to prevent some people from being damaged by radiation and not being diagnosed and treated in time. The dose threshold provided in this standard is the reference dose that causes radiation infertility.
C3 This standard uses the term radiation infertility instead of infertility because the damage to the gonads caused by ionizing radiation mainly destroys the germ cells and cannot become pregnant; infertility refers to the inability to reproduce normally due to developmental disorders in the embryo or fetus after implantation. C4 This standard does not apply to infertility caused by intrauterine irradiation. Since intrauterine irradiation is the somatic effect of ionizing radiation directly acting on the embryo and fetus, and radiation infertility is the inability to become pregnant due to fertilization disorders, the two are obviously different in pathogenesis, diagnosis and treatment. Therefore, this standard cannot be used to diagnose infertility caused by intrauterine irradiation. C5 The treatment and handling of radiation infertility and radiation amenorrhea caused by occupational irradiation or work-related irradiation should be handled in accordance with relevant national regulations.
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