PEG-rhGH successfully improved the height of a patient with rare 45,X[40]/46,XY[31] disorder of sex development: the first reported case
Case Report

PEG-rhGH successfully improved the height of a patient with rare 45,X[40]/46,XY[31] disorder of sex development: the first reported case

Shitao Li1#, Rui Ge1#, Nana Liao1, Ying Su1, Can Lei1, Shuxin Hu1, Yanling Wang2, Ying Ren1

1Department of Child Growth and Development, Dezhou Maternal and Child Health Care Hospital, Dezhou, China; 2Department of Otorhinolaryngology, Dezhou Maternal and Child Health Care Hospital, Dezhou, China

Contributions: (I) Conception and design: S Li, R Ge, N Liao, S Hu; (II) Administrative support: Y Su, Y Wang, Y Ren; (III) Provision of study materials or patients: S Li, R Ge, N Liao, Y Su, C Lei; (IV) Collection and assembly of data: S Li, R Ge; (V) Data analysis and interpretation: S Li, R Ge; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

#These authors contributed equally to this work.

Correspondence to: Shuxin Hu, MM. Department of Child Growth and Development, Dezhou Maternal and Child Health Care Hospital, No. 835 Dongdi Middle Street, Decheng District, Dezhou 253000, China. Email: jiajiabao2314592@163.com; Yanling Wang, MM. Department of Otorhinolaryngology, Dezhou Maternal and Child Health Care Hospital, No. 835 Dongdi Middle Street, Decheng District, Dezhou 253000, China. Email: 976922937@qq.com; Ying Ren, MB. Department of Child Growth and Development, Dezhou Maternal and Child Health Care Hospital, No. 835 Dongdi Middle Street, Decheng District, Dezhou 253000, China. Email: renYing9865@126.com.

Background: 45,X/46,XY is a rare disorder of sex development (DSD). Pegylated recombinant human growth hormone (PEG-rhGH) is effective in treating growth hormone deficiency and idiopathic short stature. However, there is no research on the use of PEG-rhGH to improve height in children with DSD. Herein, we report for the first time the use of PEG-rhGH in short stature patient with 45,X/46,XY DSD.

Case Description: A girl diagnosed with 45,X [40]/46,XY [31] DSD, presenting with short stature, received PEG-rhGH treatment. Her height increased by 9.9 cm in the first year, 8.6 cm in the second year, and 2 cm in the first 3 months of the third year (equivalent to an annualized growth rate of 8.0 cm per year). Meanwhile, the patient’s IGF-1 level exhibited an elevation. During the 2.5-year treatment, thyroid function remained normal. Although one isolated blood glucose value of 2.97 mmol/L indicated mild hypoglycemia, overall glucose levels were stable with no clinically significant abnormalities. Additionally, no other obvious adverse effects were observed.

Conclusions: PEG-rhGH demonstrated a favorable efficacy and long-term safety profile in improving the height growth rate of patients with 45,X[40]/46,XY[31] DSD. This study is the first to successfully apply PEG-rhGH to the treatment of 45,X[40]/46,XY[31] DSD.

Keywords: Disorders or differences of sex development; pegylated recombinant human growth hormone (PEG-rhGH); chromosomal abnormality; short stature; case report

Submitted Feb 06, 2026. Accepted for publication Apr 08, 2026. Published online May 25, 2026.

doi: 10.21037/tp-2026-1-0147

Highlight box

Key findings

• This study first presents a case of a patient with rare 45,X[40]/46,XY[31] disorder of sex development (DSD) who achieved positive outcomes and a safe profile following treatment with pegylated recombinant human growth hormone (PEG-rhGH). PEG-rhGH may significantly enhance the rate of height growth in patients with 45,X[40]/46,XY[31] DSD and exhibits a favorable long-term therapeutic safety profile.

What is known and what is new?

• 45,X/46,XY is a rare disorder of sex development (DSD). However, the current studies of DSD are more focused on sexual development, etiology, and molecular aspects, with less evaluation of height. PEG-rhGH is a long-acting growth hormone formulation. A number of clinical studies have demonstrated its efficacy and safety, including the improvement of height growth in growth hormone deficiency (GHD) and idiopathic short stature (ISS). However, PEG-rhGH has not been reported in the treatment of DSD, and in particular, there are no studies of its use for height improvement in patients with the rare 45,X/46,XY DSD. This study is the first to use PEG-rhGH in a short stature patient with 45,X/46,XY DSD.

What is the implication, and what should change now?

• Our findings provide novel therapeutic evidence for growth disorders associated with this rare 45,X[40]/46,XY[31] DSD. The improvement in lifelong height requires further follow-up.

Introduction

Disorders (or differences) of sex development (DSD) are complex and relatively rare congenital conditions associated with chromosomal, gonadal and phenotypic sex abnormalities (1). DSD is divided into sex chromosome DSD, 46,XY DSD, and 46,XX DSD depending on the chromosome karyotype (2). Among the variety of DSD, 45,X/46,XY is a rarer sex chromosome DSD that belongs to mixed gonadal dysgenesis (MGD), with an estimated incidence of 1.5 per 10,000 newborns (3,4). It is regarded as a highly heterogeneous condition, rendering its management particularly challenging. It may present with short stature, ambiguous genitalia, delayed puberty, primary amenorrhea, or infertility. Meanwhile, for patients with short stature, females are more common than males (5). DSD causes anxiety and distress for patients and their families, increasing their psychological burden. However, the current studies of DSD are more focused on sexual development, etiology, and molecular aspects, with less evaluation of height (6,7).

At present, the management of DSD primarily involves hormone replacement therapy (androgen, estrogen, and glucocorticoid, etc.) and surgical intervention (8). For hormone therapy, androgen and estrogen are mainly focused on sexual development, and glucocorticoid is mainly used to treat adrenal insufficiency. However, DSD varies greatly among individuals, and individualized treatment plans need to be developed. Individuals with short stature may benefit from growth hormone (GH) therapy, which can promote bone cell growth (9). A study investigated the dynamics of GH in children with 45,X/46,XY karyotyping and MGD, and the results showed that growth deceleration in MGD subjects is attributed in part to impaired GH secretion and in part to GH insensitivity (10). Therefore, GH therapy may be necessary. However, conventional GH requires daily treatment with poor compliance. Until pegylated recombinant human growth hormone (PEG-rhGH, Changchun GeneScience Pharmaceutical Co., Ltd., China) was approved for marketing in China in 2014, which brought new treatment options for children with short stature worldwide.

PEG-rhGH is a long-acting GH formulation primarily used for children with GH deficiency (GHD). Compared with conventional GH, it improves protein stability through the covalent modification of proteins with polyethylene glycol, preventing non-specific adsorption and immunogenicity, and extending the half-life of drug metabolism to achieve a long-lasting effect (11). Moreover, a number of clinical studies have demonstrated its efficacy and safety, including the improvement of height growth in GHD and idiopathic short stature (ISS) (12-14). However, PEG-rhGH has not been reported in the treatment of DSD, and in particular, there are no studies of its use for height improvement in patients with the rare 45,X/46,XY DSD. This study is the first to use PEG-rhGH in a short stature patient with 45,X/46,XY DSD. We present this article in accordance with the CARE reporting checklist (available at https://tp.amegroups.com/article/view/10.21037/tp-2026-1-0147/rc).

Case presentation

A 3-year-6-month-old girl was admitted to the Dezhou Maternal and Child Health Care Hospital on 28 August 2021 due to short stature for over 6 months. The child was the second child in her family, delivered by caesarean section at full term. She weighed 3.25 kg at birth without a history of birth asphyxia. Her parents are healthy and not in a consanguineous marriage. Her mother conceived naturally without any history of infection or drug use during pregnancy. Her father is 170 cm tall, her mother is 151 cm tall, and her target height is 154±5 cm. However, the child’s actual height or current height was 88.5 cm (growth standard for children under 7 years of age, <P3), 2.79 standard deviations behind her peers, and her weight was 13 kg (P3–P10). The patient had a female sexual appearance with a high palatal arch, a low posterior hairline, a pterygium colli, wide breast spacing, cubitus valgus, and clinodactyly of the fifth fingers and brachydactyly (Figure 1A). Breast development was Tanner stage B1 bilaterally, and normal female external genitalia (Tanner stage PH1) with identifiable urethral and vaginal openings were noted. All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee(s) and with the Helsinki Declaration and its subsequent amendments. The study was approved by the Medical Ethics Committee of Dezhou Maternal and Child Health Hospital (YXLL-202418). Written informed consent was obtained from the patient’s guardian for publication of this case report and accompanying images. A copy of the written consent is available for review by the editorial office of this journal.

Figure 1 Disease diagnosis. (A) Appearance of the patient; (B) results of karyotype analysis.

Laboratory results revealed that the estradiol (E2) level of the child was <5.00 pg/mL (reference: 22.3–341 pg/mL), follicle-stimulating hormone (FSH) was 43.50 U/L (reference: 3.05–12.5 U/L), luteinizing hormone (LH) was 0.78 U/L (reference: 14–95.6 U/L), thyroid-stimulating hormone (TSH) was 2.10 µIU/mL (reference: 0.27–4.20 µIU/mL), anti-Müllerian hormone (AMH) was 0.597 ng/mL (reference for females aged 3–6 years: 0.21–4.9 ng/mL), inhibin B was 11.2 pg/mL (reference: 16.61–278.87 pg/mL). Karyotype analysis of peripheral blood lymphocytes showed 45,X[40]/46,XY[31] (Figure 1B). The SRY gene tested positive, and no other sex differentiation genes with clear significance were detected. The child’s bone age was determined to be 1 year and 8 months. The uterus showed no abnormalities, and the ovaries were not clearly visible. The pituitary gland height measured 0.43 cm, with normal morphology and no signs of occupying lesions or other abnormalities.

Based on the patient’s clinical features, laboratory tests, chromosomal and genetic test results, the patient was diagnosed with rare 45,X[40]/46,XY[31] DSD. The child’s social sex was female. At the same time, she was identified as female on the basis of her physical features and taking into account the inclinations of her family. The patient underwent bilateral streak gonads resection and bilateral inguinal hernia resection on December 1, 2021, as a preventive measure against cancer. To improve her height, PEG-rhGH (0.2 mg/kg/week) was administered subcutaneously at bedtime weekly for approximately 2.5 years after thorough communication with her family (Figure 2). During follow-up visits, the patient’s height and weight were monitored, and the blood glucose, thyroid hormone, and insulin-like growth factor 1 (IGF-1) levels were regularly checked. Additionally, left carpal bone radiographs were taken every 6 months to assess bone age (Figure 2). Following the treatment, the patient’s height increased by 9.9 cm in the first year, 8.6 cm in the second year, and 2 cm in the first 3 months of the third year (equivalent to an annualized growth rate of 8.0 cm per year) (Figure 3A). Moreover, the patient’s IGF-1 level was elevated, and there were no clinically significant abnormalities in thyroid function and blood glucose. All of them fluctuated within the normal range (Table 1, Figure 3B). No adverse effects were observed during the treatment.

Figure 2 Treatment timeline and bone age assessments at different stages. PEG-rhGH, pegylated recombinant human growth hormone.
Figure 3 Treatment outcomes. (A) The patient’s growth curve; (B) changes in patient’s IGF-1 level, thyroid function and blood glucose level. FT3, free triiodothyronine; FT4, free thyroxine; IGF-1, insulin-like growth factor 1; TSH, thyroid-stimulating hormone.

Table 1

Changes of various indicators at different stages of PEG-rhGH treatment

Indicators 2021-08-28 (3-year-6-month) 2022-04-20 (4-year-2-month) 2022-08-07 (4-year-5-month) 2023-02-12 (5-year) 2023-08-26 (5-year-6-month) 2023-12-09 (5-year-9-month) 2024-05-04 (6-year-2-month)
Height (cm) 88.5 96.0 98.4 103.0 107.0 109.0 112.4
Weight (kg) 13.0 16.0 16.7 19.0 21.5 22.5 23.5
BMI (kg/m2) 16.60 17.36 17.25 17.91 18.78 18.94 18.60
Blood glucose (mmol/L) 4.69 4.11 2.97 4.91 4.49 4.91 4.65
Thyroid function
   FT3 (pg/mL) 4.57 4.99 4.80 4.42 5.05 4.89 4.80
   FT4 (ng/dL) 1.38 1.46 1.84 1.48 1.65 1.53 1.40
   TSH (μIU/mL) 2.10 2.48 1.51 3.32 3.54 3.63 3.38
IGF-1 (ng/mL) 72.4 226 173 243.0 186.0 243.0 226.0
Bone age 1-year-8-month – – 4-year 4-year-9-month – 5-year
Bone age/chronological age 0.5 – – 0.8 0.9 – 0.8

BMI, body mass index; FT3, free triiodothyronine; FT4, free thyroxine; IGF-1, insulin-like growth factor 1; PEG-rhGH, pegylated recombinant human growth hormone; TSH, thyroid-stimulating hormone.

The patient and her family expressed satisfaction with the treatment process as well as the outcome.

Discussion

DSD stands out from other diseases due to a high level of individual variability, necessitating personalized treatment plans (15,16). GH plays a vital role in promoting somatic growth and height increase in children. Currently, GH is primarily used to treat GHD, ISS, Turner syndrome, children born small for gestational age (SGA), Prader-Willi syndrome, chronic renal insufficiency, and renal failure (17,18). However, there is limited research on the use of GH to improve height in children with DSD. Particularly, there are no studies of PEG-rhGH for height improvement in patients with the rare 45,X/46,XY DSD. This study first presents a case of a patient with rare 45,X[40]/46,XY[31] DSD who achieved positive outcomes and a safe profile following treatment with PEG-rhGH.

Li et al. reported a case of a 46,XX (SRY positive) testicular DSD with GHD in a boy. He was treated with conventional rhGH for 3 months, resulting in a 2.2 cm increase in height (19). RhGH stimulates the production of IGF-1 in the liver, which is involved in tissue growth and development. Specifically, IGF-1 acts as a growth factor that induces the proliferation of bone, muscle, and cartilage (20). However, patients require daily treatment, which poses challenges for compliance and long-term efficacy (21). Compared with rhGH, PEG-rhGH can prolong the elimination half-life, reduce protein binding, and decrease renal clearance, thus achieving better therapeutic effects (22). Moreover, PEG-rhGH can be administered only once a week, significantly reducing children’s fear and rejection of injections, thereby improving drug compliance and therapeutic efficacy. In addition to treating GHD, PEG-rhGH has also been shown to significantly improve the growth rate and increase the height of children with ISS and was well tolerated during treatment (13).

Based on the above, the trial of PEG-rhGH in this study for the treatment of a rare case of 45,X[40]/46,XY[31] DSD also yielded favourable results, with the most pronounced height increase of 9.9 cm in the first year. The average rate of height growth of the patients was about 9.56 cm/year. This rate exceeds the 6.8 cm growth rate observed in a 4-year-old girl with a karyotype of 45,X/46,X, del (X) (p21) (80%/20%) who was treated with conventional rhGH for 9 months (23). Furthermore, it is also better than the results reported by Yan et al. (24), who used rhGH to treat 78 children with Turner’s syndrome, resulting in an average height increase of 8.78±2.34 cm/year. This suggests that PEG-rhGH may have better efficacy than conventional rhGH. Of course, this may also be partly due to improved patient compliance.

A clinical study showed that children with ISS in the PEG-rhGH group with 0.2 mg/kg/week achieved a higher height velocity (HV) than those in the low-dose (0.1 mg/kg/week) and untreated control groups (10.04±1.76 vs. 8.02±1.21 vs. 6.13±1.21 cm/year) at week 52 (13). Jiang et al. found that in GHD treated with PEG-rhGH at doses of 0.14 mg/kg/week and 0.2 mg/kg/week, the HV at week 13 was 8.58±4.30 cm/year and 9.39±8.97 cm/year, respectively, and IGF-1 was also significantly elevated, which is similar to our results (25). Pharmacokinetic and pharmacodynamic analyses suggested that longer intervals or higher dosing strengths (e.g., 0.3 mg/kg/10 days) in children with GHD showed promise (22). The results of this study showed that the growth rate was highest in the first year of the patient, with an overall elevation in IGF-1 level. However, growth velocity decreased during the second and third years, and bone age showed a certain degree of catch-up growth but still lagged chronological age. This indicated that although bone age maturation was accelerated, there was no excessive or advanced progression, and no evidence suggested a risk of premature epiphyseal closure. Bone age progression is regulated by multiple factors, including sex hormones, thyroid function, nutritional status, and genetic background. Children with DSD have abnormal sexual development and a different pattern of sex hormone secretion compared with normal children, resulting in a more complex regulatory mechanism of skeletal maturation. A long-term study in children with non-syndromic short stature confirmed that GH therapy could induce physiological bone age catch-up without excessive advancement. During the first 6.5 years of GH treatment, bone age increased by approximately 1.5 months per year and then stabilized, with the BA-CA difference remaining negative throughout, which was consistent with our observations (26). Collectively, children with DSD may be more sensitive to the promoting effect of sex hormones on bone age due to abnormal gonadal development. Therefore, individualized evaluation and close monitoring are required during GH treatment.

The diagnosis and treatment of 45,X/46,XY DSD currently face significant challenges. Particularly, the benefits and risks of using GH for height improvement need careful consideration. Adequate communication with the patient’s family is essential to reach a consensus on treatment, along with regular monitoring and follow-up to ensure medication safety. Research indicated that the primary adverse events (AEs) associated with PEG-rhGH treatment include reduced thyroid function, elevated blood glucose levels, injection-site reactions, and lipoatrophy (11,13). However, in our 2.5-year study, there were no clinically significant abnormalities in thyroid function or blood glucose in patients. Additionally, no other AEs were observed. Certainly, further observation and follow-up are required to assess the growth rate in the later stages, as well as lifelong height improvement and potential side effects.

Conclusions

PEG-rhGH may significantly enhance the rate of height growth in patients with 45,X[40]/46,XY[31] DSD and exhibits a favorable long-term therapeutic safety profile. The improvement in lifelong height requires further follow-up.

Acknowledgments

We extend our gratitude to the patient and her parents for their enthusiasm to participate in this study.

Footnote

Reporting Checklist: The authors have completed the CARE reporting checklist. Available at https://tp.amegroups.com/article/view/10.21037/tp-2026-1-0147/rc

Peer Review File: Available at https://tp.amegroups.com/article/view/10.21037/tp-2026-1-0147/prf

Funding: This work was supported by the Shandong Province Medical System Staff Science and Technology Innovation Plan Project (to S.L.).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tp.amegroups.com/article/view/10.21037/tp-2026-1-0147/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee(s) and with the Helsinki Declaration and its subsequent amendments. The study was approved by the Medical Ethics Committee of Dezhou Maternal and Child Health Hospital (YXLL-202418). Written informed consent was obtained from the patient’s guardian for publication of this case report and accompanying images. A copy of the written consent is available for review by the editorial office of this journal.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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Cite this article as: Li S, Ge R, Liao N, Su Y, Lei C, Hu S, Wang Y, Ren Y. PEG-rhGH successfully improved the height of a patient with rare 45,X[40]/46,XY[31] disorder of sex development: the first reported case. Transl Pediatr 2026;15(5):199. doi: 10.21037/tp-2026-1-0147

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