Objective: To compare the effect of different endocrine therapy drugs on liver function in patients with early breast cancer. Methods: A retrospective cohort study was conducted to include 4 318 patients with early breast cancer who received adjuvant endocrine therapy in Department of Breast Surgery, Peking Union Medical College Hospital from January 1, 2013 to December 31, 2021. All the patients were female, aged (51.2±11.3) years (range: 20 to 87 years), including 1 182 patients in the anastrozole group, 592 patients in the letrozole group, 332 patients in the exemestane group, and 2 212 patients in the toremifene group. The mixed effect model was used to analyze and compare the liver function levels of patients at baseline, 6, 12, 18, 24, 36, 48, 60 months of medication, and 1 year after drug withdrawal among the three aromatase inhibitors (anastrozole, letrozole, exemestane) and toremifene. Results: ALT and AST of the 4 groups were significantly higher than the baseline level at 6 months (all P<0.01), and there were no significant differences in total bilirubin, direct bilirubin and AST levels among all groups one year after drug withdrawal (P: 0.538, 0.718, 0.061, respectively). There was no significant difference in the effect of all groups on AST levels (F=2.474, P=0.061), and in the effect of three aromatase inhibitors (anastrozole, letrozole, and exemestane) on ALT levels (anastrozole vs. letrozole, P=0.182; anastrozole vs. exemestane, P=0.535; letrozole vs. exemestane, P=0.862). Anastrozole and letrozole had significantly higher effects on ALT levels than toremifene (P<0.01, P=0.009). The proportion of abnormal liver function in each group increased significantly at 6 months compared with baseline, and then the proportion showed a decreasing trend over time. Conclusions: Three aromatase inhibitors (anastrozole, letrozole, and exemestane) and toremifene can significantly increase the level of ALT and AST in patients with breast cancer, and the levels can gradually recover to the baseline after 1 year of drug withdrawal. The effect of non-steroidal aromatase inhibitors (anastrozole, letrozole) on ALT levels is greater than toremifene.
Female ; Humans ; Anastrozole ; Aromatase Inhibitors/therapeutic use* ; Bilirubin ; Breast Neoplasms/drug therapy* ; Letrozole ; Liver ; Retrospective Studies ; Toremifene ; Young Adult ; Adult ; Middle Aged ; Aged ; Aged, 80 and over

Endocrine therapy is one of the primary treatment methods for hormone receptor-positive breast cancer patients. As of June 1 2023, the National Medical Product Administration has approved 56 drugs related to endocrine therapy in patients with HR+ /HER-2- breast cancer (including generic drugs that have passed the consistency evaluation), including 44 endocrine drugs which can be categorized according to their mechanisms of action into selective estrogen receptor modulators, selective estrogen receptor down-regulators, aromatase inhibitors, luteinizing hormone-releasing hormone analogs, and progestogens and 12 targeted drugs for combined with endocrine therapy, including CDK4/6 inhibitors, mTOR inhibitors, and HDAC inhibitors. The different pharmacological characteristics, mechanisms of action, and long-term medication factors of breast cancer endocrine therapy-related drugs can directly affect patients' medication adherence and medication safety. To standardize the pharmaceutical care of endocrine therapy drugs for breast cancer and promote rational use in clinical settings, the Oncology Specialty Pharmacist Subcommittee, in conjunction with multidisciplinary experts nationwide, has developed the "Guidelines for pharmaceutical care of endocrine therapy drugs for breast cancer (2023 edition)". The guidelines is based on clinical evidence-based evidence, relevant regulations of pharmaceutical management, and pharmaceutical care practices. The Delphi method and expert interviews were used to formulate the guidelines. The GRADE approach was used for assessing the certainty of evidence. This guideline mainly focuses on endocrine therapy for HR+ /HER-2- breast cancer patients. Due to space constraints, HER-2 positive targeted drugs were not included in the guideline. It covers 6 dimensions and 22 key problems of pharmaceutical care in the whole process of drug therapy, providing a scientific basis for pharmacists to carry out pharmaceutical care of such drugs.
Humans ; Female ; Breast Neoplasms/drug therapy* ; Aromatase Inhibitors/therapeutic use* ; Receptors, Estrogen

OBJECTIVE: To assess the efficacy and safety of aromatase inhibitors (AIs) combined growth hormone in treatment of adolescent boys with short stature. METHODS: One hundred and fifty-one short stature pubertal boys with age of 10-14 years and bone age of 13-15 years, who were admitted to the Department of Pediatrics, the First Affiliated Hospital, Zhejiang University School of Medicine, were included in this trial. According to their own or parents' intention, the children were divided into recombinant human growth hormone (rhGH)+AI group ( =108) and rhGH group ( =43). All children were injected subcutaneously with rhGH 0.15-0.2 IU·kg ·d , and those in rhGH+AI group were additionally given 2.5 mg/d letrozole or 1 mg/d anastrozole, orally for 12 months or longer. The children were followed-up every 3 months. During the follow-up visit, the predicted adult height (PAH), sex hormone level, glucose and lipid metabolism, and other indicators were measured, and adverse reactions were monitored. RESULTS: After intervention, there were significant differences in ΔBA(bone age)/ΔCA(chronological age), ΔHtSDS (height standard deviation score based on bone age)and ΔPAH between rhGH+AI group and the rhGH group( < 0.05 or < 0.01). During follow-up, 63.9%of the children in the rhGH+AI group had elevated uric acid and 51.9%had decreased high-density lipoprotein (HDL); 25.9%showed severe acne, excitement, hyperactivity and irritability, 11.1%had knee pain; 4.6%had fracture; 2.8%had mild renal dysfunction; 1.9%had inactivity, drowsiness, memory loss and performance decline; 1.9%showed mild abnormal liver function; 0.9%showed impaired fasting glucose; 0.9%showed granulocytopenia. In the rhGH group, 11.6%of the children presented with knee pain and 2.3%with impaired fasting glucose. CONCLUSIONS AI combined with rhGH can delay the growth of BA and effectively improve the PAH of adolescent boys with larger bone age. However, the occurrence of adverse reactions of AI should be closely monitored during treatment.
Adolescent ; Aromatase Inhibitors ; therapeutic use ; Body Height ; Child ; Growth Disorders ; Human Growth Hormone ; Humans ; Male ; Recombinant Proteins

Aromatase is the rate-limiting enzyme in estrogen biosynthesis. The third generation aromatase inhibitors (AIs), represented by letrozoleand and anastrozole, can combine with aromatase, effectively reducing the estrogen level in the body. Because of its high efficiency, selectivity and reversibility, it has been used in the treatment of McCune-Albright syndrome, familial male-limited precocious puberty, gynecomastia, and adolescent boy with short stature. The good efficacy and safety of AIs have been observed. However, so far the drug instructions of AIs usually do not show indications for children; there are risks of adverse reactions involving liver and kidney function, lipid metabolism, hyperandrogenemia and bone metabolism; especially the long-term effects on reproductive system and bone metabolism are still not clear. Therefore, it is necessary to prescribe it carefully and follow up closely. It was not recommended that AIs be routinely used to improve adult height of adolescent boy with short stature. And more clinical evidences are needed for the safety and effectiveness of AIs prescribed in pediatrics.
Adolescent ; Aromatase Inhibitors ; therapeutic use ; Child ; Estrogens ; Humans ; Male ; Puberty, Precocious

PURPOSE: To evaluate the efficacy of minimal stimulation using discretely administered gonadotropin combined with clomiphene citrate (CC) or letrozole (LTZ) for intrauterine insemination (IUI) cycles. MATERIALS AND METHODS: Total 257 IUI cycles from 158 infertile couples were assessed. A CC dose of 100 mg/day (n=126 cycles) or a LTZ dose of 5 mg/day (n=131 cycles) was administered on days 3-5 of the menstrual cycle for 5 days. Each group received human menopausal gonadotropin at a dose of 150 IU by two or three alternative day: CC combined with alternate-day regimen for 2 or 3 days (CC+300, n=37; CC+450, n=89) and LTZ combined with alternate-day regimen for 2 or 3 days (LTZ+300, n=36; LTZ+450, n=95). RESULTS: The clinical pregnancy rate was comparable between the CC and LTZ groups (18.3% vs. 13.0%, p=0.243). The clinical pregnancy rate also showed no significant difference among the 4 groups (21.6% vs. 16.9% vs. 11.1% vs. 12.6%, p=0.507). The multiple pregnancy rate was significantly higher in LTZ compared to CC group (37.5% vs. 8.7%, p=0.028) and in the LTZ+450 compared to CC+450 group (50% vs. 13.3%, p=0.038). Overall, there were 15 cases of ovarian hyperstimulation syndrome (OHSS), with the prevalence being significantly lower in the LTZ compared to CC group (1.5% vs. 10.3%, p=0.003). OHSS was more prevalent in the CC+450 compared to the LTZ+450 group (12.4% vs. 1.1%, p=0.002). CONCLUSION: Our findings suggest that minimal stimulation using two alternate-day gonadotropin with LTZ decreases the development of OHSS and multiple pregnancies, while maintaining comparable pregnancy rates in IUI cycles.
Adult ; Aromatase Inhibitors/administration & dosage ; Clomiphene/*administration & dosage/therapeutic use ; Drug Administration Schedule ; Drug Combinations ; Female ; Fertility Agents, Female/administration & dosage/therapeutic use ; Fertilization in Vitro ; Gonadotropins/*administration & dosage ; Humans ; Infertility, Female/*drug therapy ; Insemination, Artificial/*statistics & numerical data ; Nitriles/*administration & dosage ; Ovulation Induction/methods/*statistics & numerical data ; Pregnancy ; Pregnancy Rate ; Treatment Outcome ; Triazoles/*administration & dosage

PURPOSE: To evaluate the efficacy of minimal stimulation using discretely administered gonadotropin combined with clomiphene citrate (CC) or letrozole (LTZ) for intrauterine insemination (IUI) cycles. MATERIALS AND METHODS: Total 257 IUI cycles from 158 infertile couples were assessed. A CC dose of 100 mg/day (n=126 cycles) or a LTZ dose of 5 mg/day (n=131 cycles) was administered on days 3-5 of the menstrual cycle for 5 days. Each group received human menopausal gonadotropin at a dose of 150 IU by two or three alternative day: CC combined with alternate-day regimen for 2 or 3 days (CC+300, n=37; CC+450, n=89) and LTZ combined with alternate-day regimen for 2 or 3 days (LTZ+300, n=36; LTZ+450, n=95). RESULTS: The clinical pregnancy rate was comparable between the CC and LTZ groups (18.3% vs. 13.0%, p=0.243). The clinical pregnancy rate also showed no significant difference among the 4 groups (21.6% vs. 16.9% vs. 11.1% vs. 12.6%, p=0.507). The multiple pregnancy rate was significantly higher in LTZ compared to CC group (37.5% vs. 8.7%, p=0.028) and in the LTZ+450 compared to CC+450 group (50% vs. 13.3%, p=0.038). Overall, there were 15 cases of ovarian hyperstimulation syndrome (OHSS), with the prevalence being significantly lower in the LTZ compared to CC group (1.5% vs. 10.3%, p=0.003). OHSS was more prevalent in the CC+450 compared to the LTZ+450 group (12.4% vs. 1.1%, p=0.002). CONCLUSION: Our findings suggest that minimal stimulation using two alternate-day gonadotropin with LTZ decreases the development of OHSS and multiple pregnancies, while maintaining comparable pregnancy rates in IUI cycles.
Adult ; Aromatase Inhibitors/administration & dosage ; Clomiphene/*administration & dosage/therapeutic use ; Drug Administration Schedule ; Drug Combinations ; Female ; Fertility Agents, Female/administration & dosage/therapeutic use ; Fertilization in Vitro ; Gonadotropins/*administration & dosage ; Humans ; Infertility, Female/*drug therapy ; Insemination, Artificial/*statistics & numerical data ; Nitriles/*administration & dosage ; Ovulation Induction/methods/*statistics & numerical data ; Pregnancy ; Pregnancy Rate ; Treatment Outcome ; Triazoles/*administration & dosage

OBJECTIVETo study the effect of Shugan Jiangu Recipe (SJR) on bone mineral density (BMD) and serum bone metabolic biochemical markers in postmenopausal breast cancer patients with osteopenia.

METHODSTotally 38 patients of postmenopausal women with breast cancer, who received aromatase inhibitors (AIs), were assigned to the treatment group (21 cases) and the control group (17 cases) by using random digit table. All patients took Caltrate D Tablet (containing Ca 600 mg and Vit D3 125 IU), one tablet daily. Patients in the treatment group took SJR, 6 g each time, twice daily for 6 successive months. The bone mineral density (BMD) level was detected before treatment and at months 6 after treatment. Levels of bone alkaline phosphatase (BALP), bone gla protein (BGP), tartrate-resistant acid phosphatase (TRAP), and C-terminal telopeptide of type II collagen (CTX-II) were detected by enzyme linked immunosorbent assay (ELISA). The drug safety was also assessed.

RESULTSCompared with before treatment, BMD of L2-4 and femur neck obviously increased in the treatment group at month 6 after treatment (P < 0.01), serum BALP and TRAP decreased (P < 0.05). Compared with before treatment, BMD of L2-4 and femur neck obviously decreased in the control group at month 6 after treatment (P < 0.05), serum BALP and TRAP increased (P < 0.01). Compared with the control group, lumbar and femur neck BMD obviously increased, serum levels of BGP and BALP obviously decreased, and serum levels of CTX-II and TRAP obviously increased in the treatment group at month 6 after treatment (P < 0.01). No serious adverse event occurred during the treatment period. Bone fracture occurred in one case of the control group (5.8%).

CONCLUSIONSJR could attenuate bone loss of postmenopausal women with breast cancer who received AIs, increase BMD and improve abnormal bone metabolism.

Acid Phosphatase ; blood ; Aged ; Alkaline Phosphatase ; blood ; Aromatase Inhibitors ; adverse effects ; Bone Density ; drug effects ; Bone and Bones ; drug effects ; metabolism ; Breast Neoplasms ; drug therapy ; metabolism ; Collagen Type II ; blood ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Isoenzymes ; blood ; Middle Aged ; Osteocalcin ; blood ; Osteoporosis, Postmenopausal ; chemically induced ; prevention & control ; Peptide Fragments ; blood ; Tartrate-Resistant Acid Phosphatase

OBJECTIVETo investigate the efficacy of letrozole for delaying bone maturation and increasing predicted adult height in boys with idiopathic central precocious puberty (ICPP) who have a bone age above 13 years and a short stature, and its adverse effects.

METHODSTwenty ICPP boys with a bone age above 13 years and a short stature were randomly divided into letrozole treatment (n=10) and control groups (n=10). The letrozole treatment group received oral letrozole [2.5 mg/(m(2)·d), Qd] for 6 months, while the control group received no treatment and was observed periodically. Bone age, growth rate, height standard deviation (SD) score, predicted adult height SD score, sexual maturity, and levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), dehydroepiandrosterone, testosterone (T), estradiol (E2), progesterone (P), and androstenedione (ASD) were measured. The letrozole-related adverse reactions were evaluated.

RESULTSAfter 6 months of treatment, both groups had a significantly increased bone age, but the letrozole group had a significantly slowed increase in bone age compared with the control group (13.82 ± 0.23 years vs 14.47 ± 0.30 years; P<0.05); compared with the control group, the letrozole group had a significantly increased predicted adult height SD score (-1.69 ± 0.26 vs -1.91 ± 0.35; P<0.05) and a significantly increased T level (4.9 ± 0.9 nmol/L vs 4.4 ± 0.8 nmol/L; P<0.05). There was no significant difference in testicular volume between the two groups. The treatment led to no significant changes in growth rate, Tanner stage, and levels of FSH, LH, P, E2 and ASD in the two groups, and there was no significant difference in these indices between the two groups. No adverse reactions were observed during letrozole treatment.

CONCLUSIONSLetrozole delays bone maturation and increases predicted adult height in ICPP boys with a bone age above 13 years and a short stature, and it causes no obvious adverse reactions.

Adolescent ; Aromatase Inhibitors ; therapeutic use ; Body Height ; drug effects ; Bone Development ; drug effects ; Gonadal Steroid Hormones ; blood ; Humans ; Male ; Nitriles ; adverse effects ; therapeutic use ; Puberty, Precocious ; blood ; drug therapy ; Testis ; drug effects ; pathology ; Triazoles ; adverse effects ; therapeutic use

OBJECTIVETo evaluate the efficacy and prognostic factors of personalized treatment for breast cancer patients who failed chemotherapy.

METHODSSeventy-two patients with breast cancer who failed chemotherapy were treated at the Tumor Hospital of Harbin Medical University from January 2001 to January 2012. Among them, 42 cases received 5.6 cycles (range, 4-8 cycles) of postoperative adjuvant chemotherapy, and 30 cases received 12.2 cycles (range, 6-22 cycles), both postoperative adjuvant and salvage chemotherapy. All of the 72 patients of stage IV were given personalized treatment. Under guidance of the principle that multidisciplinary treatment improves control rate but does not or less damage the normal tissues and host immune function, precise radiotherapy combined with Chinese herbal medicine (CHM), biological agent and others were chosen for the patients.

RESULTSThe median survival time was 20 months. Univariate analysis showed that non-invasive ductal carcinoma, less metastasized organs, without brain, liver and lung metastasis, Karnofsky performance scores ≥ 80, not combined with chemotherapy, and multiple courses of Chinese herbal medicine and biolojical agent treatment had significant impact on survival (P < 0.05). Multivariate analysis showed that no brain metastasis, non-invasive ductal carcinoma, and Chinese herbal medicine and biological agent treatment ≥ 7 courses and not combined with chemotherapy had obvious significance (P < 0.05). The rate of grade 3 and 4 treatment-related hematological toxicity was 8.3% (6/72) and 5.6% (4/72), respectively. All the patients with grade 4 hematological toxicity were the cases of grade 3 at hospital admission. No grade 3 and 4 acute radiation damages of the lung and liver were noticed.

CONCLUSIONChinese herbal medicine combined with biological agents and others prolongs survival time in breast cancer patients who failed chemotherapy, and provides an alternative treatment modality for them.

Adult ; Aged ; Aromatase Inhibitors ; therapeutic use ; Bone Density Conservation Agents ; therapeutic use ; Bone Neoplasms ; drug therapy ; secondary ; Brain Neoplasms ; drug therapy ; secondary ; Breast Neoplasms ; drug therapy ; pathology ; radiotherapy ; surgery ; Carcinoma, Ductal, Breast ; drug therapy ; pathology ; radiotherapy ; secondary ; surgery ; Chemotherapy, Adjuvant ; Diphosphonates ; therapeutic use ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Follow-Up Studies ; Humans ; Imidazoles ; therapeutic use ; Lung Neoplasms ; drug therapy ; secondary ; Medicine, Chinese Traditional ; Middle Aged ; Neoplasm Staging ; Nitriles ; therapeutic use ; Radiotherapy, Adjuvant ; Radiotherapy, Conformal ; methods ; Remission Induction ; Retrospective Studies ; Survival Rate ; Treatment Failure ; Triazoles ; therapeutic use

Aromatase Inhibitors ; adverse effects ; therapeutic use ; Bone Density ; drug effects ; Bone Density Conservation Agents ; therapeutic use ; Breast Neoplasms ; drug therapy ; Calcium ; therapeutic use ; Diphosphonates ; therapeutic use ; Female ; Fractures, Bone ; chemically induced ; prevention & control ; Humans ; Imidazoles ; therapeutic use ; Osteoporosis, Postmenopausal ; chemically induced ; diagnosis ; prevention & control ; Postmenopause ; Vitamin D ; therapeutic use